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WORLD PREVIEW 2014,

OUTLOOK TO 2020

October 2014
Welcome to the EvaluateMedTech
World Preview 2014, Outlook to 2020
EvaluateMedTech provides trusted insights on the global medtech sector in a single
solution that can easily integrate with your own analytical models. It allows medtech
companies, financial institutions, consultancies, service providers and others to easily and
rapidly track, benchmark and forecast the sector and focus on critical decisions to optimize
performance.
Our third annual EvaluateMedTech World Preview brings together many of our analyses to
provide a top level insight into the expected performance of the medtech industry between
now and 2020. Based on EvaluateMedTechs coverage of the worlds leading medical
device and diagnostic companies, the World Preview highlights trends in medtech including:
consensus sales forecasts of leading industry analysts by device area to 2020; the top 20
companies in 2020; R&D spend current and future; FDA approvals; M&A; venture financing;
IPOs; and enterprise value.

Copyright 2014 Evaluate Ltd. All rights reserved.

To find out more about this report and Evaluates range of services for the life science sector
please contact us:

North America:
Alan Raider
Tel: +1 617 573 9455
Email: alan.raider@evaluategroup.com

 est of the World:


R
Will Hau
Tel: +44 (0)20 7377 0800
Email: will.hau@evaluategroup.com

Japan:
Hiroshi Yamazaki
Tel: + 81 (0) 80 1164 4754
Email: hiroshi.yamazaki@evaluategroup.com

 or general questions:
F
Christine Lindgren
Tel: +1 617 866 3906
Email: christine.lindgren@evaluategroup.com

Disclaimer
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All rights reserved.

EvaluateMedTech
Foreword

he third edition of the EvaluateMedTech World Preview reveals that the medtech market
is expected to grow at 5% per year (CAGR) between 2013 and 2020, achieving global
sales of $514bn in 2020 (page 6). The analysis is based on in-depth forecast models for the
top 200 global medtech companies available within EvaluateMedTech. Our sales forecast
represents the only current consensus view from equity analysts of the medtech market.
J&J leads for now
October 2014 finds the medtech industry holding its breath. The year to date has been
a fascinating one, with a remarkable 363% increase in the value of completed mergers
in H1 2014 compared with the same time last year (page 18) but things are about to
get a lot more interesting.
The single biggest merger in the sectors history is set to close early next year, and when
Medtronic and Covidien join forces the changes will be seismic. The World Preview uses
consensus data based on analyst forecasts which do not as yet take this merger into
account as the $42.9bn deal has not yet closed. Consequently, current forecasts put
Johnson & Johnson as clear market leader in 2020 with medtech sales of $32.8bn.
But if it does engulf Covidien, Medtronic will seize the top spot.
The $13.4bn merger of Zimmer and Biomet will also contribute to a momentous year
for medtech, altering the orthopedics sector profoundly.
FDA premarket approvals pick up
The regulatory situation is changing significantly too. After a disappointing 2013 in terms
of first-time premarket approvals (PMAs) granted by the FDA, the agency has been more
liberal so far in 2014, with 20 new PMAs to end of August (page 12). This is a 43% increase
compared with the same point last year, and ties in with deliberate efforts the FDA is making
to speed devices to market, such as streamlining the de novo regulatory process and a
proposed expedited access PMA programme.
A billion dollars in IPOs

Copyright 2014 Evaluate Ltd. All rights reserved.

While the ultimate goal for many early-stage medtech companies is still a takeout by one
of the bigger groups, staying independent and going public has emerged as an increasingly
popular strategy. EvaluateMedTechs new IPO analysis, available this year for the first time,
shows that the first half of 2014 saw $1.3bn raised in completed IPOs (page 20). This is 44%
more than the $900m raised in the whole of 2013.
The global medical device market is growing fast and changing faster; the cardiology
and orthopedic spaces alone are set to alter almost beyond recognition thanks to the
megamergers. This time next year there could be a new market leader, and in an
industry forecast to be worth more than half a trillion dollars in 2020, that is no
insignificant achievement.

Ian Strickland
Product Manager, EvaluateMedTech
3

EvaluateMedTech World Preview 2014,


Outlook to 2020 Analysis Highlights

Worldwide

medtech sales forecast to grow by 5.0% (CAGR 2013 to 2020),


reaching $514bn more than half a trillion dollars by 2020

M
 edtech will grow more slowly compared with the prescription drug market,
with a CAGR of 5.0% compared with pharmas 5.3% between 2013 and 2020
J ohnson & Johnson is currently forecast to be the clear market leader in 2020 with
medtech sales of $32.8bn...

 but if the proposed merger between Medtronic and Covidien goes ahead as expected,
combined forecasts will put the new Medtronic at the top
M
 &A deal value jumps by an astonishing 363% to $30bn in H1 2014 vs. H1 2013,
though deal count drops 10%
T otal deal value of medtech venture financing falls 16% to $2.2bn in H1 2014 vs.
H1 2013; number of venture financing deals slumped 24% to 199
S ignificant increase in medtech IPO activity in 2014. H1 2014 saw $1.3bn raised
in completed IPOs, 44% more than the $900m raised in the whole of 2013
In vitro diagnostics expected to be the worlds largest medtech segment in 2020,
with sales of $71.6bn, with Roche to dominate with 17.0% market share in 2020
M
 edtronic remains top in cardiology to 2020 with sales of $11.1bn, a 19.4% market
share. Lead set to increase following addition of Covidien
J ohnson & Johnson continues to lead the orthopedics market with 2020 market share
of 24.7% and sales of $11.3bn

 but following completion of its acquisition of Biomet, Zimmer is set to catch up,
leapfrogging Stryker to take second place with a market share of 20.8% in 2020
Global medtech R&D spend set to grow by 4.2% (CAGR) to $30.5bn by 2020
J ohnson & Johnson and Siemens predicted to be neck and neck as the top medtech
R&D spenders in 2020, with both set to invest $2.1bn in new programmes

Copyright 2014 Evaluate Ltd. All rights reserved.

F DA grants 23 first-time PMAs in 2013, a massive decrease of 44% from the 2012
figure of 41; 510(k) clearances also down, by 3% to 3,085

 but the situation reverses in 2014, with 20 new PMAs to end of August,
representing a 43% increase compared with the same point last year

Copyright 2014 Evaluate Ltd. All rights reserved.

Table of Contents
6

Worldwide Medtech Sales by Device Area to 2020

Worldwide Medtech Sales in 2020: Top 20 Companies

Worldwide Medtech vs. Prescription Drug Sales (2007-20)

Worldwide Medtech R&D Spend (2007-20)

10

Medtech R&D Spend in 2020: Top 20 Companies

11

FDA Regulatory Analysis (2006-13)

12

2014 FDA First-Time PMAs and HDEs

13

In Vitro Diagnostics (IVD) Market to 2020

14

Cardiology Market to 2020

15

Diagnostic Imaging Market to 2020

16

Orthopedics Market to 2020

17

Ophthalmics Market to 2020

18

M&A Analysis: 2009 to H1 2014

19

Venture Financing Analysis: 2009 to H1 2014

20

IPO Analysis: 2013 and 2014

21

Enterprise Value & Focus Analysis: 2014 Latest vs. 2013

Worldwide Medtech Sales


by Device Area in 2020
Worldwide Medtech Sales Forecast to Exceed Half a Trillion Dollars by 2020; In Vitro Diagnostics Remains Number One in 2020
EvaluateMedTech
finds that
the worldwide
medtech
market isHalf
forecast
to grow
by by
5.0%
perInyear
between
2013 and 2020,
Worldwide
Medtech
Sales Forecast
to Exceed
a Trillion
Dollars
2020;
Vitro(CAGR)
Diagnostics
Remains
achieving sales ofNumber
$514bnOne
in 2020.
in 2020
EvaluateMedTech finds that the worldwide medtech market is forecast to grow by 5.0% per year (CAGR) between

As in previous Worldwide
years, EvaluateMedTech
that to
in Exceed
vitro diagnostics
(IVD)Dollars
is expected
to remain
largest segment
in 2020 with sales of
Medtech
Sales finds
Forecast
Half a Trillion
by 2020;
In Vitrothe
Diagnostics
Remains
2013 and 2020,
achieving
sales
of $514bn
in 2020.
$71.6bn, representing
14%
of years,
the worldwide
medtech market.
the IVD
market
is also to
setremain
to outpace
the medtech
Number
One in
2020
As in previous
EvaluateMedTech
finds thatImpressively,
in vitro diagnostics
(IVD)
is expected
the largest
segment market as a
EvaluateMedTech
finds
that
the
worldwide
medtech
market
is forecast
to grow
by 5.0%
per year the
(CAGR)
between
whole, growing
by
6.1%with
persales
year of
over
the same
timeframe.
in 2020
$71.6bn,
representing
14% of the
worldwide
medtech
market.
Impressively,
IVD market
is also
2013 and 2020, achieving sales of $514bn in 2020.
The fastest growing segment in the top 15 is neurology, with a 7.1% CAGR between 2013 and 2020 and expected 2020
in sales
2020 of
with
sales of $71.6bn, representing 14% of the worldwide medtech market. Impressively, the IVD market is also
$9.8bn.
set to outpace the medtech market as a whole, growing by 6.1% per year over the same timeframe.
The fastest growing segment in the top 15 is neurology, with a 7.1% CAGR between 2013 and 2020 and expected 2020
Analysis on Top 10 Device Areas in 2020, Market Share & Sales Growth (2013-20)
sales of $9.8bn.
Source: EvaluateMedTech (18 SEP 2014)

WW Market Share % in 2020


WW Market Share % in 2020

set to
outpacein
thethe
medtech
as a whole,
growing
by 6.1%between
per year over the
same
timeframe.
The fastest growing
segment
top 15market
is neurology,
with
7.1%
and
2020
and expected
2020
sales of $9.8bn.
As in previous
years,
EvaluateMedTech
finds
thata in
vitroCAGR
diagnostics (IVD)2013
is expected
to remain
the largest
segment

18%

Analysis on Top 10 Device Areas in 2020, Market Share & Sales Growth (2013-20)
Source: EvaluateMedTech (18 SEP 2014)

16%
18%

In Vitro
Diagnostics (IVD)

14%
16%
12%
14%
10%
12%
8%
10%
6%
8%
4%
6%
2%
4%
0%
2% +3.5%

Cardiology
Diagnostic
Imaging

Orthopedics

In Vitro
Diagnostics (IVD)

Cardiology
Ophthalmics

Diagnostic
Orthopedics
Imaging
General & Plastic
Endoscopy
Drug
Surgery
Delivery
Diabetic
General & PlasticDental
Endoscopy
Care Surgery
Drug
Delivery
Dental
Diabetic
Care
+4.0%

+4.5%

0% Note: Bubble = WW Sales in 2020


+3.5%
+4.0%
+4.5%
Note: Bubble = WW Sales in 2020

+5.0%

+5.5%

Ophthalmics

+6.0%

+6.5%

+7.0%

% Sales Growth: CAGR 2013-20

+5.0%

+5.5%

+6.0%

+6.5%

+7.0%

% Sales Growth: CAGR 2013-20

Copyright 2014 Evaluate Ltd. All rights reserved.

WW Medtech Sales by EvaluateMedTech Device Area: Top 15 Categories & Total Market (2013/20)

Source: EvaluateMedTech (18 SEP 2014)


6

Note: Analysis is based on the top 200 medtech companies. Sales in 2013 based on company reported data. Sales forecasts to 2020 based
6
on a consensus of leading equity analysts estimates for segmental sales.

Worldwide Medtech Sales in 2020:


Top 20 Companies
Johnson & Johnson Predicted to be Number One in 2020 - But This Could Change
EvaluateMedTech finds that Johnson & Johnson is currently forecast to be the largest medtech company in 2020, with sales of $32.8bn.
However, the Worldwide
companys market
share is expected
to fall
7.8%Top
to 6.4%
2013 and 2020 following the sale of its Ortho-Clinical
Medtech
Sales
infrom
2020:
20between
Companies
Diagnostics unit to private equity.
Johnson
& Johnson
Predicted
to account
be Number
in 2020megamerger
- But This Could
Change
Moreover, current
forecasts
do not
take into
theOne
proposed
of Medtronic
and Covidien. With estimated combined sales
Worldwide
Medtech
Sales
inwhen
2020:
Top
20
EvaluateMedTech
finds that Johnson
& Johnson
is currently
forecast
toCompanies
be the largest medtech company in 2020, with sales of
of $35.9bn in$32.8bn.
2020, representing
a
7.0%
market
share,
predictions
are
made
next
year
it
is likely
that2020
this following
new behemoth
of medtech
However, the company's market share is expected to fall from 7.8% to 6.4% between
2013 and
the sale of
will take the top
spot from
Johnson
& Johnson.
its
Ortho-Clinical
Diagnostics
unit to
to be
private
equity.
Johnson
& Johnson
Predicted
Number
One in 2020 - But This Could Change
Moreover,
current forecasts
doJohnson
not take &into
account
the proposed
megamerger
of Medtronic
and
Covidien.
estimated
EvaluateMedTech
finds
is
currently
forecast
to be the
largest
medtech
company
in With
2020,
with 16,
sales
of
The biggest fallers
in the
rankings
outthat
to
2020
are Johnson
Boston
Scientific
and
Novartis.
Novartis
falls
four
placesyear
to
number
largely
due to the
combined
of $35.9bn
in 2020,market
representing
a expected
7.0% market
share,
predictions
are made
is likely the
thatsale
this of
$32.8bn. sales
However,
the company's
share is
to fall
from when
7.8% to
6.4% between
2013 next
and 2020 itfollowing
disposal of itsnew
blood
diagnostic
business
in
2014
to
Grifols.
Boston
Scientific
falling
four
places
to
number
14
reflects
the
company
failing to
behemoth
of
medtech
will
take
the
top
spot
from
Johnson
&
Johnson.
its Ortho-Clinical Diagnostics unit to private equity.
The
biggest
fallerscardiology
in
the rankings
to into
2020
are Boston
Scientificmegamerger
and Novartis.
placesWith
to number
16, largely
replace sales from
its mature
Moreover,
current
forecasts
dobusiness.
notout
take
account
the proposed
of Novartis
Medtronicfalls
andfour
Covidien.
estimated
due
to the disposal
of its blood
diagnostic
business
in 2014
to Grifols.
Scientific falling
four next
places
to itnumber
reflects
combined
sales of $35.9bn
in 2020,
representing
a 7.0%
market
share,Boston
when predictions
are made
year
is likely14
that
this the
company
failing of
to medtech
replace sales
from
itstop
mature
cardiology
business.
new behemoth
will take
the
spot from
Johnson
& Johnson.
The biggest fallers in the rankings out to 2020 are Boston Scientific and Novartis. Novartis falls four places to number 16, largely
due to the disposal of its blood diagnostic business in 2014 to Grifols. Boston Scientific falling four places to number 14 reflects the
WW Medtech Sales: Top 10 Companies (2020)
company failing to replace sales from its mature cardiology business.
Source: EvaluateMedTech (18 SEP 2014)

WW Medtech Sales ($bn) in 2020


WW Medtech Sales ($bn) in 2020

40
35
40
30
35
25
30
20
25

WW Medtech Sales: Top 10 Companies (2020)


Source: EvaluateMedTech (18 SEP 2014)

Sales ($bn)
CAGR 2013-20 (%)
Ranking Change 2013-20

32.8
+2%
32.8
+2%

24.0
+4%
24.0

15
20

+4%

22.1
+4%
22.1
+4%

10
15
5
10
05
0

Sales ($bn)
CAGR 2013-20 (%)
Ranking Change 2013-20

15.3
+4%
15.3
+4%

13.8

13.7

13.1

+4%
13.8

+5%
13.7

+5%
13.1

+5%
(-)

(-)

(-)

(-)

(-)

+4%
(-)

Johnson &
Johnson
(-)

Siemens
(-)

Medtronic
(-)

Roche
(-)

Covidien
(-)

Johnson &

Siemens

Medtronic

Roche

Covidien

Abbott
Laboratories
(-)
Abbott

12.0

11.6

+3%
12.0

+3%
11.6

+5%
+2

-1
+3%

-1
+3%

Stryker
+2

General
Electric
-1

Stryker

WW MedtechJohnson
Sales: Top 20 Companies & Total Market (2013/20) Laboratories

WW Medtech Sales: Top 20 Companies &WW


Total
Market
Medtech
Sales(2013/20)
($bn)

Copyright 2014 Evaluate Ltd. All rights reserved.

WWCompany
Medtech Sales: Top 20 Companies
& Total
(2013/20)
Country
2013 Market
2020
% CAGR 13-20

General
Electric

10.4
+8%
10.4
+5
+8%
Essilor
International
+5

Philips
-1
Philips

Essilor
International

WW Market Share
Rank
2020
Chg. (+/-)
Chg. (+/-)
7.8% WW Market
6.4%Share
-1.4pp
Rank2013
2020
Chg.-0.2pp
(+/-)
Chg. (+/-)
4.9%
4.7%
2013

1 Johnson & Johnson USA


28.5 WW Medtech
32.8
+2.0%
Sales ($bn)
Country
2013
2020
% CAGR
13-20
2 Siemens
Germany
17.9
24.0
+4.3%
Company
Johnson & Johnson USA
31Medtronic
17.0
22.1
+3.8%
4.7%
4.3%
USA
28.5
32.8
+2.0%
7.8%
6.4%
Siemens
Germany
17.9
24.0
+4.3%
4.9%
4.7%
42Roche
Switzerland
11.3
15.3
+4.4%
3.1%
3.0%
Medtronic
USA
17.0
22.1
+3.8%
4.7%
4.3%
53Covidien
USA
10.2
13.8
+4.4%
2.8%
2.7%
Roche Laboratories
Switzerland
11.3
15.3
+4.4%
3.1%
3.0%
64Abbott
USA
9.9
13.7
+4.8%
2.7%
2.7%
Covidien
USA
10.2
13.8
+4.4%
2.8%
2.7%
75Stryker
USA
9.0
13.1
+5.4%
2.5%
2.5%
Abbott Laboratories
USA
9.9
13.7
+4.8%
2.7%
2.7%
Electric
86General
USA
9.8
12.0
+3.0%
2.7%
2.3%
Stryker
USANetherlands
9.0
13.1
+5.4%
2.5%
2.5%
97Philips
The
9.4
11.6
+3.0%
2.6%
2.3%
GeneralInternational
Electric
USA
9.8
12.0
+3.0%
2.7%
2.3%
108Essilor
France
6.0
10.4
+8.2%
1.6%
2.0%
Philips
The Netherlands
9.4
11.6
+3.0%
2.6%
2.3%
119Danaher
USA
7.0
9.6
+4.7%
1.9%
1.9%
EssilorDickinson
International USA
10Becton
France
6.0
10.4
+8.2%
1.6%
2.0%
12
7.0
9.4
+4.4%
1.9%
1.8%
Danaher
11Baxter
USA
7.0
9.6
+4.7%
1.9%
1.9%
International
13
USA
5.8
9.3
+7.0%
1.6%
1.8%
BectonScientific
Dickinson
12Boston
USA
7.0
9.4
+4.4%
1.9%
1.8%
14
USA
7.1
9.3
+3.8%
2.0%
1.8%
Baxter
International
13
USA
5.8
9.3
+7.0%
1.6%
1.8%
15 B. Braun Melsungen Germany
6.9
9.2
+4.3%
1.9%
1.8%
Boston
Scientific
14
USA
7.1
9.3
+3.8%
2.0%
1.8%
16 Novartis
Switzerland
7.0
9.0
+3.8%
1.9%
1.8%
B.
Braun
Melsungen
15
Germany
6.9
9.2
+4.3%
1.9%
1.8%
17 Olympus
Japan
4.9
8.0
+7.2%
1.4%
1.6%
Novartis
16St.
Switzerland
7.0
9.0
+3.8%
1.9%
1.8%
Jude Medical
18
USA
5.5
7.5
+4.6%
1.5%
1.5%
Olympus
17
Japan
4.9
8.0
+7.2%
1.4%
1.6%
19 3M
USA
5.1
7.1
+4.8%
1.4%
1.4%
18 St. Jude Medical
USA
5.5
7.5
+4.6%
1.5%
1.5%
20 Smith & Nephew
United Kingdom
4.4
6.4
+5.7%
1.2%
1.2%
19 3M
USA
5.1
7.1
+4.8%
1.4%
1.4%
Total Top 20
189.6
253.5
+4.2%
52.1%
49.4%
20 Smith & Nephew
United Kingdom
4.4
6.4
+5.7%
1.2%
1.2%
Other
174.2
260.0
+5.9%
47.9%
50.6%
Total Top 20
189.6
253.5
+4.2%
52.1%
49.4%
Total
363.8
513.5
+5.0%
100.0%
100.0%
Other
174.2
260.0
+5.9%
47.9%
50.6%
Source: EvaluateMedTech (18 SEP 2014)
Total
363.8
513.5
+5.0%
100.0%
100.0%
Source:
EvaluateMedTech
Note:
Analysis
is based on(18
theSEP
top2014)
200 medtech companies. Sales in 2013 based on company reported data.

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Sales forecasts to
Source: EvaluateMedTech (18 SEP 2014)
2020 based on a consensus of leading equity analysts' estimates for segmental sales.
Note: Analysis is based on the top 200 medtech companies. Sales in 2013 based on company reported data. Sales forecasts to
2020 based on a consensus of leading equity analysts' estimates for segmental sales.

Note: Analysis is based on the top 200 medtech companies. Sales in 2013 based on company reported data. Sales forecasts to 2020 based
on a consensus of leading equity analysts estimates for segmental sales.
7

7
7

Worldwide Medtech vs.


Prescription Drug Sales (2007-20)
Prescription Drug Market Forecast to Outstrip Medtech between 2013 and 2020
EvaluateMedTech finds that between 2013 and 2020 the prescription drug market is forecast to grow at 5.3% per year (CAGR), greater
Worldwide
Medtech
vs.is Prescription
Sales
than the medtech
industrys forecast
5.0%. This
in stark contrast toDrug
the period
2010 (2007-20)
to 2013 when the medtech sector grew much more
Worldwide Medtech vs. Prescription Drug Sales (2007-20)
rapidly than pharma.
Prescription Drug Market Forecast to Outstrip Medtech between 2013 and 2020

In the last twoWorldwide


EvaluateMedTech
World
Previews,
the
medtech
had
also
been
outstrip
the
market in the future.
EvaluateMedTech
finds
that
between
and
2020
the industry
prescription
drug
market
is forecast
forecast totogrow
at 5.3%
perpharma
year (CAGR),
Prescription
DrugMedtech
Market
Forecast
to2013
Outstrip
Medtech
between
2013
and
2020
vs.
Prescription
Drug
Sales
(2007-20)
greater
than
the medtech
industry's
forecast
5.0%.
Thisin
isconfidence
in
stark contrast
tomarket
the
period
2010 toto2013
the per
medtech
sector
grew the
EvaluateMedTech
finds
that
between
and 2020
the
prescription
drug
is forecast
growwhen
at 5.3%
year (CAGR),
With the passing
of the
pharma
patent
cliff
and
a2013
resurgence
in
the
pharmaceutical
and
biotech
industry,
however,
much more
than pharma.
greater
than rapidly
the medtech
industry's
forecast 5.0%. This is in stark contrast to the period 2010 to 2013 when the medtech sector grew
prescription drug
market
has
moved
ahead.
Prescription
Drug
Market
Forecast
to
Outstrip
Medtech
between
2013
and
2020
In the last two EvaluateMedTech World Previews, the medtech industry had also been forecast to outstrip the pharma market in the
much more rapidly than pharma.
EvaluateMedTech finds that between 2013 and 2020 the prescription drug market is forecast to grow at 5.3% per year (CAGR),

future.
With
the
passing
of the pharma
patent
cliff
and
resurgence
in confidence
inbeen
the pharmaceutical
andthe
biotech
industry,
In
the
last
two
EvaluateMedTech
World
Previews,
theaismedtech
industry
had
also
forecast
to
outstrip
pharma
market
in the
In 2014 and from
2016
onwards
prescription
drugs
are
forecast
tostark
grow
faster
medtech.
This
results
medtech
greater
thanthe
theprescription
medtech
industry's
forecast
5.0%.
This
in
contrast
tothan
the period
2010 to
2013
when in
thethe
medtech
sectormarket
grew falling to
however,
market
has
moved
ahead.
future.
With
the
passing
of drug
theinpharma
patent
cliff
and
ain
resurgence
in confidence in the pharmaceutical and biotech industry,
49.7% of the prescription
drug
market
2020,
versus
50.7%
2013.
much
more
rapidly
than
pharma.
In 2014 and from 2016 onwards prescription drugs are forecast to grow faster than medtech. This results in the medtech market falling

however,
the prescription
drug market
has
moved ahead.
In
last two
EvaluateMedTech
World
Previews,
the medtech
had also been forecast to outstrip the pharma market in the
tothe
49.7%
of from
the
prescription
drugprescription
market
in 2020,
versus
50.7% industry
in grow
2013.faster
In
2014
and
2016 onwards
drugs
are
forecast
to
than
medtech.
This results
the medtech
market falling
future.
With
the passing
of the pharma
patent cliff
and
a resurgence
in confidence
in the
pharmaceutical
andinbiotech
industry,
to 49.7% the
of the
prescription
drug
market
2020, ahead.
versus 50.7% in 2013.
however,
prescription
drug
market
hasinmoved

WW Medtech
& Rx Sales
($bn) ($bn)
WWWW
Medtech
& Rx
Medtech
& Sales
Rx Sales
($bn)

In 2014 and from 2016


drugs Drug
are forecast
to grow faster than medtech. This results in the medtech market falling
WW onwards
Medtechprescription
vs Prescription
Sales (2007-20)
to 49.7% of the prescription
drug vs
market
in 2020,and
versus
50.7%(2007-20)
in 2013.(18 SEP 2014)
Source:
EvaluateMedTech
EvaluatePharma
WW
Medtech
Prescription
Drug
Sales

Source: EvaluateMedTech and EvaluatePharma (18 SEP 2014)


WW Medtech vs Prescription
Drug
Sales
WW Prescription
Sales:
+5.3%(2007-20)
CAGR 2013-20
Source: EvaluateMedTech and EvaluatePharma (18 SEP 2014)

1,200

1,200

WW Prescription Sales: +5.3% CAGR 2013-20

1,000
1,200
1,000

WW Prescription Sales: +5.3% CAGR 2013-20

800
1,000
800
600
800
600
400
600
400
200
400
200

726

686

664

649

718
718

715
715

837

792

751

718

715

751
751

380

321

364

304

357

272

301

347

401

380

401

272

304

321

357

364

301

347

599

885
885
885

934

423

445

467

423

445

467

1,033
1,033

982
982
982

1,033

514
514

490
490

514
490
467
445
Medtech Sales: +5.0% CAGR 2013-20
401 WW 423

380

364

357

347

321

304

301

272

WW Medtech Sales: +5.0% CAGR 2013-20


WW Medtech Sales: +5.0% CAGR 2013-20

0
200
0

2007

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

2018

2019

2020

2007

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

2018

2019

2020

0
WW Sales
Growth
%
WWWW
Sales
Growth
% %
Sales
Growth

664
664

649
649

599
599

726
726

686
686

837
837

792
792

934
934

WW Growth Rate: Medtech vs. Prescription Drug Sales (2008-20)

2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
14% WW Growth Rate: Medtech vs. Prescription Drug Sales (2008-20)

14%
2009:
WorldMedtech
economy vs. Prescription
2012: Euro crisis
12% WW Growth
Rate:
Drug Sales (2008-20)
impacts euro sales
2012:
Eurotocrisis
converted
dollars.
impacts euro sales
converted
to dollars.
2012:
Euro crisis
impacts euro sales
converted to dollars.

contracted -2.2%
2009: World economy
contracted -2.2%
2009: World economy
contracted -2.2%

12%
14%
10%
10%
12%
8%
8%
10%
6%

2017

2018

2019

2020

Medtech Growth per Year


Prescription
(Rx) Growth
Medtech Growth
per Yearper Year

Prescription (Rx) Growth per Year


Medtech Growth per Year
Prescription (Rx) Growth per Year

6%
8%
4%
4%
6%
2%
2%
4%
0%
0%
2%
-2%
-2%
0%
-4%
-2%
-4%

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

2018

2019

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

2018

2019

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

2018

2019

2020

2020
2020

WW Medtech vs. Prescription Drug Sales (2007-20)


-4%

WW Medtech vs. Prescription


Drug Sales (2007-20)
WW Sales ($bn)

Copyright 2014 Evaluate Ltd. All rights reserved.

WW
Medtech
Prescription
Drug
Sales
2008 (2007-20)
2009 (2007-20)
2010 2011
Year 2007
WW Medtech
vs.vs.
Prescription
Drug Sales

2012 2013 2014 2015 2016 2017 2018 2019 2020


WW Sales ($bn)
WW Medtech Sales
272
301
304
321
347
357
364
380
401
423
445
467
490
514
Year 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020
WW
Sales
($bn)
Growth per Year
+10.5% +1.0% +5.7% +8.2% +2.6% +2.0% +4.4% +5.5% +5.4% +5.3% +5.1% +4.8% +4.8%
WW Medtech Sales
272
301
304
321
347
357
364
380
401
423
445
467
490
514
Year 2007
Medtech as % of Rx
45.5% 2008
46.3% 2009
45.7% 2010
46.8% 2011
47.8% 2012
49.9% 2013
50.7% 2014
50.6% 2015
50.6% 2016
50.5% 2017
50.3% 2018
50.0% 2019
49.9% 2020
49.7%
Growth per Year
+10.5% +1.0% +5.7% +8.2% +2.6% +2.0% +4.4% +5.5% +5.4% +5.3% +5.1% +4.8% +4.8%
WW
Sales(Rx)
272
301
304
321
347
357
364
380
401
423
WWMedtech
Prescription
599
649
664
686
726
715
718
751
792
837 445
885 467
934 490
982 514
1,033
Medtech as % of Rx
45.5% 46.3% 45.7% 46.8% 47.8% 49.9% 50.7% 50.6% 50.6% 50.5% 50.3% 50.0% 49.9% 49.7%
Growth
+10.5%
Growthper
perYear
Year
+8.5% +1.0%
+2.2% +5.7%
+3.3% +8.2%
+5.9% +2.6%
-1.6% +2.0%
+0.5% +4.4%
+4.6% +5.5%
+5.4% +5.4%
+5.7% +5.3%
+5.8% +5.1%
+5.6% +4.8%
+5.1% +4.8%
+5.2%
WW Prescription (Rx)
599
649
664
686
726
715
718
751
792
837
885
934
982
1,033
Medtech
% of Rx
45.5%
46.3% 45.7% (18
46.8%
Source:asEvaluateMedTech
& EvaluatePharma
SEP47.8%
2014) 49.9% 50.7% 50.6% 50.6% 50.5% 50.3% 50.0% 49.9% 49.7%
Growth
per
Year
+8.5% +2.2% +3.3% +5.9% -1.6% +0.5% +4.6% +5.4% +5.7% +5.8% +5.6% +5.1% +5.2%
WW Prescription (Rx)
599
649
664
686
726
715
718
751
792
837
885
934
982
1,033
Source:
EvaluateMedTech
& EvaluatePharma
(18
SEP+5.9%
2014) -1.6% +0.5% +4.6% +5.4% +5.7% +5.8% +5.6% +5.1% +5.2%
Growth per
Year
+8.5% +2.2% CAGR
+3.3% 2013-20

Source: EvaluateMedTech
EvaluateMedTech & (18
EvaluatePharma
(18Sales
SEP 2014)
Medtech
+5.0%
Source:
SEP WW
2014)
CAGR 2013-20

WW Prescription Drug Sales +5.3%


WW Medtech
Sales
+5.0%
CAGR
2013-20
WW
Prescription
DrugSales
Sales+5.0%
+5.3%

CAGR
2013-20
WW
Medtech
Note: Prescription drug sales based
on
top
500 pharmaceutical
and biotech
companies
from EvaluatePharma.
WWWW
Prescription
Drug
Sales
+5.3%
Sales to 2013 based on company
reported
sales
data.
Sales
forecasts to 2020 based
on a consensus of leading equity analysts'
Medtech
Sales
+5.0%
Note:
Prescription
drug
sales
based
on
top
500
pharmaceutical
and
biotech
companies
from EvaluatePharma.
estimates for segmental sales.
WW Prescription
DrugSales
Sales
+5.3%
Sales Prescription
to 2013 based
onsales
company
sales
data.
forecasts
to 2020
based
on
a consensus
of leading equity analysts'
Note:
drug
basedreported
on top 500
pharmaceutical
and biotech
companies
from
EvaluatePharma.
estimates
for segmental
sales. reported sales data. Sales forecasts to 2020 based on a consensus of leading equity analysts'
Sales
to 2013
based on company
estimates for segmental sales.

Note: Prescription drug sales based on top 500 pharmaceutical and biotech companies from EvaluatePharma. Sales to 2013 based8on
company reported sales data. Sales forecasts to 2020 based on a consensus of leading equity analysts estimates for segmental sales.8
8

Worldwide Medtech R&D Spend


(2007-20)
Global Medtech R&D Spend Set to Grow by 4.2% (CAGR) to $30.5bn by 2020
EvaluateMedTech
consensus Medtech
forecasts
find R&D
that worldwide
R&D spend is set to increase by 4.2% per year (CAGR) between 2013
Worldwide
R&D
Spendmedtech
(2007-20)
Worldwide
Medtech
Spend
(2007-20)
and 2020. This is lower than the forecast growth rate for medtech sales and, as such, R&D investment rate is forecast to fall to 5.9% in 2020
Set to
to Grow
Grow by
by4.2%
4.2%(CAGR)
(CAGR)toto$30.5bn
$30.5bnbyby2020
2020
GlobalMedtech
Medtech R&D
R&D Spend
Spend Set
from 6.3% in Global
2013.
EvaluateMedTech
forecasts find
findthat
thatworldwide
worldwidemedtech
medtechR&D
R&Dspend
spend
increase
4.2%
year
(CAGR)
EvaluateMedTech consensus
consensus forecasts
is is
setset
to to
increase
by by
4.2%
perper
year
(CAGR)

The top 20 medtech


companies,
however,
spending
slightly
more
than
the
medtech
industry
assuch,
a R&D
whole:
in 2020rate
they
between
2013
This isare
lower
than the
theforecast
forecastgrowth
growthrate
ratefor
for
medtech
sales
and,
R&D
investment
rate
is invest 7.7%
between
2013 and
and 2020.
2020.
lower
than
medtech
sales
and,
asas
such,
investment
is will
forecast
6.3% in
in 2013.
2013.
of their sales on
R&D.totofall
forecast
fall to
to 5.9%
5.9% in
in 2020 from 6.3%
The
however, are
arespending
spendingslightly
slightlymore
morethan
thanthe
themedtech
medtech
industry
a whole:
in 2020
invest
Thetop
top20
20medtech
medtech companies,
companies, however,
industry
as as
a whole:
in 2020
theythey
will will
invest
7.7%
7.7%ofoftheir
theirsales
sales on
on R&D.
R&D.

35
35

+9.4%
+9.4%

30
30

+9.6%
+9.6%

25
25

+5.8%
+5.8%

20
20
15
15

17.5
17.5

19.2
19.2

18.9
18.9

20.0
20.0

21.9
21.9

22.9
22.9

5
5

23.8
23.8

24.8
24.8

27.1
27.1

28.2
28.2

30.5
30.5

2008
2008

2009
2009

8% 8%
6%

6%

4%
+4.4% +4.5%
+4.3% +4.0% +3.9%
+3.9% +4.2%
+4.4% +4.5% +4.3%
+4.0% +3.9%
+3.9% +4.2%
2%
2%

0%

0%

-2%
-2%

-1.7%
-1.7%
2007
2007

10%10%

4%

+2.2% +2.5%
+2.2% +2.5%

10
10

0
0

22.4
22.4

25.9
25.9

29.4
29.4

R&D Spend Growth %

12%12%
+4.2%
CAGR
2013-20
+4.2%
CAGR
2013-20

R&D Spend Growth %

WW
WWMedtech
MedtechR&D
R&DSpend
Spend($bn)
($bn)

WW Medtech
Medtech R&D Spend
WW
Spend (2007-20)
(2007-20)
Source: EvaluateMedTech
EvaluateMedTech (18
Source:
(18SEP
SEP2014)
2014)

2010
2010

2011
2011

2012
2012

2013
2013

2014
2015
2016
2017
2018
2019
2020
2014
2015
2016
2017
2018
2019
2020

-4%
-4%

WW Medtech
R&D
Spend
(2007-20)
WW
Medtech
R&D
Spend
(2007-20)
WW Medtech R&D Spend (2007-20)
WW Medtech R&D & Medtech Sales ($bn)
2007
2008 R&D
2009
2010 2011
2012 2013 2014
2015
2016 2017 2018 2019 2020
Medtech
& Medtech
Sales ($bn)
Year WW
17.5
19.2
18.9
2008
2009 20.0
2010 21.9
2011 22.4
2012 22.9
2013 23.8
2014 24.8
2015 25.9
2016 27.1
2017 28.2
201829.4201930.52020
Year 2007

Medtech R&D Spend


Growth per
Year
Medtech
R&D
Spend
17.5 +9.6%
19.2 -1.7%
18.9 +5.8%
20.0 +9.4%
21.9 +2.2%
22.4 +2.5%
22.9 +3.9%
23.8 +4.2%
24.8 +4.4%
25.9 +4.5%
27.1+4.3%
28.2+4.0%
29.4+3.9%30.5
WW Medtech
Sales
272.1 +9.6%
300.7 303.7
513.5
Growth
per Year
-1.7% 321.1
+5.8% 347.4
+9.4% 356.5
+2.2% 363.8
+2.5% 379.9
+3.9% 400.8
+4.2% 422.6
+4.4%444.9
+4.5%467.5
+4.3%489.9
+4.0%
+3.9%
R&DMedtech
as % of Medtech
+6.4%
+5.9%
WW
Sales Sales
272.1 +6.4%
300.7 +6.2%
303.7 +6.2%
321.1 +6.3%
347.4 +6.3%
356.5 +6.3%
363.8 +6.3%
379.9 +6.2%
400.8 +6.1%
422.6+6.1%
444.9+6.0%
467.5+6.0%
489.9
513.5
R&Das
as%
%of
ofMedtech
Medtech Sales
Sales (Top+6.4%
20 in 2020)
R&D
+6.4% +6.2% +6.2% +6.3% +6.3% 8.1%
+6.3% +6.3%
+6.2%
+6.1% +6.1% +6.0% +6.0%7.7%
+5.9%
Source:
EvaluateMedTech
(18
SEP
2014)
R&D
as %EvaluateMedTech
of Medtech Sales (Top(18
20 in
2020)
8.1%
7.7%
Source:
SEP
2014)

Source: EvaluateMedTech (18 SEP 2014)

CAGR 2013-20 on Medtech R&D Spend +4.2%


CAGR 2013-20
on Medtech R&D Spend
+4.2%
Cumulative
5 yearon
R&D
Spend R&D
(2009-13)
$106bn
2013-20
Medtech
Spend
+4.2%
Cumulative CAGR
5CAGR
year 2007-13
R&D
Spend
(2009-13)
$106bn
+4.6%
on Medtech
R&D(2009-13)
Spend
Cumulative 5 year
R&D Spend
$106bn
CAGR 2007-13
on Medtech
R&D
Spend R&D Spend
+4.6% +4.6%
CAGR
2007-13 on
Medtech
Note: Analysis is based on the Top 200 medtech companies. R&D spend in 2013 based on company reported data.
Forecast medtech R&D spend based on a consensus of leading equity analysts' estimates for company level R&D spend,
extrapolated
toismedtech
R&D
a company
has
non-medtech
R&D
activity.
Note:
Analysis
based on
thewhen
Top 200
medtech
companies.
R&D
spend
in 2013 based on company reported data.
Medtechmedtech
R&D is not
disclosed
a number
of companies
and thisequity
analysis
is limited
to those for
companies
sufficient
disclosure.
Forecast
R&D
spend by
based
on a consensus
of leading
analysts'
estimates
companywith
level
R&D spend,
Notable
omissions:
Baxter
and
3M.
Note: Analysis
is based
the
Top
200
medtech
companies.
R&D spend
2013 based on company reported data.
extrapolated
toon
medtech
R&D
when
a company
has non-medtech
R&Dinactivity.
Medtech R&D is not disclosed by a number of companies and this analysis is limited to those companies with sufficient disclosure.
Forecast medtech
spendBaxter
basedand
on3M.
a consensus of leading equity analysts estimates for company level R&D spend, extrapolated
Notable R&D
omissions:

Copyright 2014 Evaluate Ltd. All rights reserved.

to medtech R&D when a company has non-medtech R&D activity.


Medtech R&D is not disclosed by a number of companies and this analysis is limited to those companies with sufficient disclosure.
Notable omissions: Baxter and 3M.

Medtech R&D Spend in 2020:


Top 20 Companies
Siemens andMedtech
Johnson &R&D
Johnson
Jointin
Top
Medtech
Spenders in 2020
Spend
2020:
TopR&D
20 Companies
EvaluateMedTech consensus forecasts find that Johnson & Johnson and Siemens will be neck and neck in terms of R&D spend in 2020, with
Medtech
R&Dset
Spend
in$2.1bn.
2020:
Top
Companies
Siemens
and Johnson
&
Joint Top
Medtech
R&D
Spendersare
in likely
2020 to be eclipsed, though, when forecasts are made next
expenditure at
both companies
toJohnson
reach
Both
of20
these
companies
EvaluateMedTech consensus forecasts find that Johnson & Johnson and Siemens will be neck and neck in terms of R&D spend
year for the combined
Medtronic and Covidien. This companys R&D spend could add up to $2.6bn in 2020, though it is likely to be a little
inSiemens
2020, with
expenditure
both companies
setMedtech
to reach R&D
$2.1bn.
Both of in
these
are likely to be eclipsed, though, when
and
Johnson
&atJohnson
Joint
Top
Spenders
2020companies
less than this forecasts
as cuts are
Nonetheless
combined
company
almost
certainly
be R&D
the top
spender.
aremade.
made next
year for thethe
combined
Medtronic
and will
Covidien.
This
company's
spend
could add up to $2.6bn in
EvaluateMedTech consensus forecasts find that Johnson & Johnson and Siemens will be neck and neck in terms of R&D spend

2020,
though
itexpenditure
is likely to be
a little
less
thisthe
cuts
are
made.
Nonetheless
the combined
company
will with
almost
be
Of the top 20,
Lifesciences
is
tothan
invest
most
into
R&D
as these
a percentage
ofare
medtech
sales,
ancertainly
R&D
investment
rate
inEdwards
2020,
with
at forecast
both
companies
set
toas
reach
$2.1bn.
Both
of
companies
likely
to be
eclipsed,
though,
when
the
topbut
spender.
forecasts
are
next year
for the
combined
Medtronic
and Covidien.
company's
R&Din
spend
could add up to $2.6bn in
of 13.7% in 2020,
thismade
represents
a fall
of 2.1
percentage
points
from theThis
15.8%
rate seen
2013.

Medtech R&D Spend ($bn) in 2020


Medtech R&D Spend ($bn) in 2020

Of
the top
20, Edwards
is forecast
invest
the most
R&D as athe
percentage
medtechwill
sales,
withcertainly
an R&Dbe
2020,
though
it is likely Lifesciences
to be a little less
than thistoas
cuts are
made.into
Nonetheless
combinedofcompany
almost
investment
rate of 13.7% in 2020, but this represents a fall of 2.1 percentage points from the 15.8% rate seen in 2013.
the top spender.
Of the top 20, Edwards Lifesciences is forecast to invest the most into R&D as a percentage of medtech sales, with an R&D
investment rate of 13.7% in 2020, but this represents a fall of 2.1 percentage points from the 15.8% rate seen in 2013.
WW Medtech R&D Spend: Top 10 Companies (2020)
Source: EvaluateMedTech (18 SEP 2014)
2,500
WW Medtech R&D Spend: Top 10 Companies (2020)
R&D Spend ($m)
Source: EvaluateMedTech (18 SEP 2014)

CAGR 2013-20 (%)

2,500

2,000
2,000

2,069
2,069

R&D Spend ($m)


CAGR 2013-20 (%)

2,068
2,068

1,500

1,844
1,844

1,500

1,285
1,000

1,285

1,267
1,267

1,255
1,141
1,255
1,141

1,000

1,005

915

1,005

801

915

500

801

500

+2%

+2% &
Johnson
0
Johnson
Johnson &
Johnson

+4%

+3%

+2%

+4%
Siemens

+3%
Medtronic

+2%
Roche

Siemens

Medtronic

Roche

+3%
+3%
Abbott
Laboratories
Abbott
Laboratories

+3%
+3%
Philips
Philips

+3%
+3%
General
Electric
General
Electric

+2%
+2%
Boston
Scientific
Boston
Scientific

+4%
+4%
St. Jude
Medical
St. Jude
Medical

+6%
+6%
Stryker
Stryker

Copyright 2014 Evaluate Ltd. All rights reserved.

WW Medtech R&D Spend: Top 20 Companies & Total Market (2013/20)


WW
Medtech
R&D
Spend:
Top
20 Companies
Total(2013/20)
Market (2013/20)
WW Medtech
R&D
Spend:
Top 20
Companies
& Total &
Market
Company
2013
1 Johnson
1,783
Company& Johnson
2013
21Siemens
1,614
Johnson & Johnson
1,783
32Medtronic
1,477
Siemens
1,614
Medtronic
43Roche
1,098
1,477
RocheLaboratories
1,098
54Abbott
1,007
Abbott Laboratories
1,007
65Philips
1,036
Philips Electric
1,036
76General
956
GeneralScientific
Electric
956
87Boston
859
Boston
859
Jude Scientific
Medical
98St.
691
St. Jude Medical
691
109Stryker
536
Stryker
10Danaher
536
11
551
Danaher
11Covidien
551
12
508
Covidien
12Becton
508
Dickinson
13
494
Becton Dickinson
13Terumo
494
14
303
Terumo Lifesciences
14Edwards
303
15
323
Lifesciences
15B.Edwards
323
Braun Melsungen
16
290
B. Braun Melsungen
16Essilor
290
International
17
218
17 Essilor International
218
18 Smith & Nephew
231
18 Smith & Nephew
231
19 Olympus
274
19 Olympus
274
20 bioMrieux
247
bioMrieux
20
247
Total Top 20
14,496
Total Top 20
14,496
Other
8,431
Other
8,431
Total
22,927
Total
22,927
Source: EvaluateMedTech (18 SEP 2014)
Source: EvaluateMedTech
(18 SEP
Source:
EvaluateMedTech
(18 2014)
SEP 2014)

Medtech R&D ($m)


2020
CAGR 13-20
Medtech
R&D ($m)
2,069
+2.1%
2020
CAGR
13-20

R&D As a % of Medtech
2020
R&D 2013
As a % of Medtech
6.3%
6.3%
2013
2020

Chg. (+/-)
Chg.+0.0pp
(+/-)

Rank
Chg. (+/-)
Rank
Chg. (+/-)

2,068
2,069
1,844
2,068

+3.6%
+2.1%
+3.2%
+3.6%

9.0%
6.3%
8.7%
9.0%

8.6%
6.3%
8.4%
8.6%

-0.4pp
+0.0pp
-0.3pp
-0.4pp

1,285
1,844

+2.3%
+3.2%

9.7%
8.7%

8.4%
8.4%

-1.3pp
-0.3pp

1,285
1,267

+2.3%
+3.3%

9.7%
10.1%

8.4%
9.2%

-1.3pp
-0.9pp

- +1

1,267
1,255
1,255
1,141

+3.3%
+2.8%
+2.8%
+2.6%

10.1%
11.0%
11.0%
9.8%

-0.9pp
-0.2pp
-0.2pp
-0.3pp

+1 -1
-1 -

1,141
1,005
1,005
915

+2.6%
+2.3%
+2.3%
+4.1%

915
801
801
761

+4.1%
+5.9%
+5.9%
+4.7%

9.8%
12.0%
12.0%
12.6%
12.6%
5.9%

9.2%
10.9%
10.9%
9.5%
9.5%
10.9%
10.9%
12.1%
12.1%
6.1%

761
714
714
661

+4.7%
+5.0%
+5.0%
+4.3%

5.9%
7.9%
7.9%
5.0%

6.1%
7.9%
7.9%
5.2%

661
456
456
423
423
389
389
381
381
364
364
341
341
331
331
18,470
18,470
12,024
12,024
30,494
30,494

+4.3%
+6.0%
+6.0%
+3.9%
+3.9%
+4.3%
+4.3%
+8.3%
+8.3%
+6.7%
+6.7%
+3.2%
+3.2%
+4.3%
+4.3%
+3.5%
+3.5%
+5.2%
+5.2%
+4.2%
+4.2%

5.0%
7.1%
7.1%
7.4%

5.2%
7.0%
7.0%
7.7%

7.4%
15.8%
15.8%
4.2%
4.2%
3.6%
3.6%
5.3%
5.3%
5.6%
5.6%
14.8%
14.8%
8.1%
8.1%

7.7%
13.7%
13.7%
4.2%
4.2%
3.7%
3.7%
5.7%
5.7%
4.3%
4.3%
13.1%
13.1%
7.7%
7.7%

6.3%
6.3%

5.9%
5.9%

-0.3pp
-1.2pp
-1.2pp
-0.4pp

-0.4pp
+0.2pp
+0.2pp
+0.0pp

- +1
+1 -1

+0.0pp
+0.2pp
+0.2pp
-0.1pp

-1 - -

-0.1pp
+0.3pp
+0.3pp
-2.1pp
-2.1pp
+0.0pp
+0.0pp
+0.0pp
+0.0pp
+0.4pp
+0.4pp
-1.3pp
-1.3pp
-1.6pp
-1.6pp
-0.4pp
-0.4pp

- +1
+1
-1
+5
+3
-1
-

-1
+5
+3
-1
-

Note:
companies.R&D
R&Dspend
spendinin2013
2013based
basedononcompany
company
reported
data.
Note:Analysis
Analysisisisbased
based on
on the
the top
top 200
200 medtech
medtech companies.
reported
data.
Forecast
a consensus
consensus of
of leading
leadingequity
equityanalysts'
analysts'estimates
estimatesforforcompany
company
level
R&D
spend,
Forecastmedtech
medtechR&D
R&D spend
spend based
based on
on a
level
R&D
spend,
extrapolated
has non-medtech
non-medtechR&D
R&Dactivity.
activity.
extrapolatedtotomedtech
medtechR&D
R&D when
when a
a company
company has
Medtech
R&D
not
disclosed
by
of companies
companies
and
thisanalysis
analysis
limitedon
thosecompanies
companies
with
sufficient
disclosure.
Medtech
R&D
nottop
disclosed
by aa number
number
of
and
this
limited
totothose
with
sufficient
disclosure.
Note: Analysis
is based
onisis
the
200 medtech
companies.
R&D
spend
in 2013isisbased
company
reported
data.

Forecast medtech R&D spend based on a consensus of leading equity analysts estimates for company level R&D spend, extrapolated
10 10
to medtech R&D when a company has non-medtech R&D activity.
Medtech R&D is not disclosed by a number of companies and this analysis is limited to those companies with sufficient disclosure.
Notable omissions: Baxter and 3M.
10

FDA Regulatory Analysis (2006-13)

FDA
Regulatory Analysis
(2006-13)
FDA
Regulatory
Analysis
Number of First-Time PMAs Almost Halves in 2013 to 23; 510(k) Clearances Down 3% to 3,085
(2006-13)
EvaluateMedTech
found
thatAlmost
the FDAHalves
grantedin23
newtoPMAs/HDEs/PDPs
(first-time
approvals)
in 2013, a massive decrease of
Number
of First-Time
PMAs
2013
23; 510(k) Clearances
Down
3% to 3,085
44% from the 2012 figure
41.the
510(k)
in 2013, but(first-time
much lessapprovals)
steeply, falling
3% atomassive
3,085. decrease of
EvaluateMedTech
foundofthat
FDAclearances
granted 23also
newdeclined
PMAs/HDEs/PDPs
in 2013,
In 2013
Medtronic
theof
most
overall clearances
approvals/clearances,
with
44%
from
the 2012had
figure
41. 510(k)
also declined
in 784.
2013, but much less steeply, falling 3% to 3,085.
In 2013
Medtronic hadAnalysis
the most overall
approvals/clearances, with 784.
FDA
Regulatory
(2006-13)
Number of First-Time PMAs Almost Halves in 2013 to 23; 510(k) Clearances Down 3% to 3,085
Numberfound
of First-Time
Almost
Halves
in PMAs/HDEs/PDPs
2013 to510(k)s
23; 510(k)&Clearances
Down
3% PMA/PDPs
to in
3,085
Count
of 1st
PMA/HDE/PDPs,
Supplementary
Per Year
(2006-13)
EvaluateMedTech
that
thePMAs
FDA
granted
23 new
(first-time
approvals)
2013, a massive
decrease
of 44%
found that
the FDA granted 23 new
PMAs/HDEs/PDPs
(first-time approvals) in 2013, a massive decrease of
Source:
SEP
2014)
from the 2012EvaluateMedTech
figure of 41. 510(k)
also declined in(18
2013,
but
much
less
steeply, falling
3% to 3,085.
Countclearances
ofEvaluateMedTech
1st PMA/HDE/PDPs,
510(k)s
& Supplementary
PMA/PDPs
Per Year (2006-13)
44% from the 2012 figure of 41. 510(k) clearances also declined in 2013, but much less steeply, falling 3% to 3,085.

60

3,500

50 40

40

3,258
3,103

3,037

30
30 20

20
10
10 10

0
0

1,1171,488

1,062

20

1,062

1,062

1,117

44
44
2006

44

2006

2006

1,488
1,488

32

2,382

2,326

32

2,000

1,498

3,085
3,085

30

18

18
30

2218

2008

2008

2009

2009

2010

22
43

500

43

22

2010

2011

41

41

43

2011

2012

23

41

0 2012

2013

2007
2008
2009
2010
2011
2012
PDP
510(k) PMA/ Supplementary
PMA/ PDP
1st Time 1st
PMA/Time
HDE/ PMA/
PDP HDE/
510(k)
Supplementary
PDP

1st Time PMA/ HDE/ PDP

510(k)

3,000
2,500

2,500

2,326
2,326

2,000

2,000
1,500

1,500
1,000

1,000

1,000

30

2007

2,382
2,382
2,500

1,500

1,117
32

2007

1,498
1,841
1,498

1,841
2,1951,841

3,085

2,195
2,195

2,850

30

3,500
3,000

3,185

3,150

3,044

3,185
3,185

3,000

of Sup
PMAs/
510(k)s
No.No.
of Sup
PMAs/
510(k)s

3,500

3,258
50 Count of 1st PMA/HDE/PDPs, 510(k)s & Supplementary PMA/PDPs Per Year (2006-13)
3,150
3,103
3,044
3,037
3,258
50 Source: EvaluateMedTech (18 SEP 2014)
3,150
3,103
60
2,850
3,044
3,037
2,850
40

No. of Sup PMAs/ 510(k)s

No. of 1st PMA/ HDE/ PDP

of 1st
PMA/
HDE/
PDP
No.No.
of 1st
PMA/
HDE/
PDP

Source:
EvaluateMedTech
(18
SEP
2014)
In 2013had
Medtronic
hadoverall
the most
overall approvals/clearances,
with
784.
In 2013 Medtronic
the most
approvals/clearances,
with
784.
60

500

23

23

2013

500
0

2013

Supplementary PMA/ PDP

Count
of 1st
PMA/HDE/PDPs,
510(k)s &510(k)s
Supplementary
PMA/PDPs (2006-13)
Count
of 1st
PMA/HDE/PDPs,
& Supplementary
PMA/PDPs

(2006-13)
Count of 1st PMA/HDE/PDPs, 510(k)s & Supplementary PMA/PDPs (2006-13)

2006
Year
Count of 1st PMA/HDE/PDPs,
Year
44
1st
Time PMA/ HDE/ PDP
1st
Time PMA/ HDE/ PDP
% Chg.
Year
Supplementary
PMA/ PDP
1,062
Chg. PMA/
1st%Time
HDE/ PDP
% Chg.
Supplementary
PMA/
PDP
% Chg.
510(k)
3,258
Chg.
%%
Chg.
Supplementary
PMA/ PDP
510(k)
Total
4,364
% Chg.
%%
Chg.
Chg.

2007
2008
2009 2010 2011 2012
2013
510(k)s
& Supplementary
PMA/PDPs
(2006-13) 2013
2006 30 2007
2008
2009 41 2010
32
18
22
43
23 2011 2012

44 -6%
-27%
2006

32
-40%
2007

30 +95%
18 -5% 2010
22
+22%
-44%
2008
2009

1,488-27%
1,498
44
32
+5%
+33% +1%
1,062
1,117
-27%

1,841
2,326
-6% 2,195
-40%2,382+22%

43
2011

41
2012

23
2013

-5%
41
2,382
-5%

-44%
23
2,326
-44%

+5%
-7%
-2%
1,062+2% 1,117

+95%
30
18
22
43
+23% +19% +9%
-2%
1,488
1,498
1,841
2,195
-6% 3,150
-40%
2,850
3,185+22%
3,085 +95%
+33%
+1%+1%+23%
-6%
-3% +19%
1,488+11%
1,498
1,841
2,195

3,2584,6213,037
4,186
4,560
+5%

3,103
3,044
4,713
5,434
+33% 5,388
+1%5,6082,850
+23%

+9%
2,382
3,185
+9%
+1%
3,185

-2%
2,326
3,085
-2%
-3%
3,085

5,608
+1%

5,434
-3%

1,117
3,037

3,103

3,044

Copyright 2014 Evaluate Ltd. All rights reserved.

3,150
+19%
-4%
+10% -7%
-1%
+3%
+14%
+4% -6%
-3% +11%
+2%
-2%
510(k)
3,258
3,037
3,103 3,044 2,850 3,150
Count
of PMA/HDE/PDPs, 510(k)s & Medtech
Spend (2013)
Total
4,364R&D 4,186
4,621
% Chg.
-7%
+2% 4,560
-2% 4,713
-6% 5,388
+11%

PMA/ HDEs - PMA/ -4%


R&D Spend
PDPs - +10%
510(k) -1% Total
% Chg.
+3% +14%
-3%
Total
4,364
4,186
4,621 4,560
4,713
5,388 +4%
5,608 5,434
First Approval
($m)
Company
Suppl.
Clearance
Approvals
Chg.
-4%
+10%
-1% (2013)
+3% +14%
-3%
Count
of PMA/HDE/PDPs, 510(k)s
& Medtech
R&D
Medtronic
2
722
60Spend
784
1,477 +4%
1%
Scientific
26
382
859
0 & Medtech
356
2 Boston
Count
ofof
PMA/HDE/PDPs,
510(k)s
Spend
(2013)
Count
PMA/HDE/PDPs,
510(k)s
& Medtech
Spend
PMA/
HDEsR&D
- R&D
R&D Spend
PMA/
PDPs
- (2013)
510(k)
Total
160
2
101
1,783
57
3 Johnson & Johnson
Approval
($m)
Company
Suppl.
Clearance
Approvals
Laboratories
2 First
133
146
1,007
11
4 Abbott
PMA/ HDEs - PMA/ PDPs R&D
Spend
510(k)
Total
Medtronic
2 98
60
784
1,477
Lifesciences
323 Approvals
105
7722
0 First Approval
5 1Edwards
($m)
Company
Suppl.
Clearance
1,098
105 26
19
1
6 2Roche
Scientific
382
859
02 85
356
Medtronic
722
60
784
1,477
1 Boston
691
99
14
0
85
7 St. Jude Medical
& Johnson
160
20
101
1,783
57
3 Johnson
Boston
Scientific
26
382
859
356
2
60
1,614
54
0
6
8 Siemens
Abbott
Laboratories
22 2
133
146
1,007
11
4Stryker
59
536
57
0
93
Johnson
& Johnson
160
101
1,783
57
Edwards
Lifesciences
323
105
7
02 54
5BIOTRONIK
0
3 98
57
123
10 4
Abbott Laboratories
133
146
1,007
11
23
3,085
5,434 19
Roche
1,098
105
102,326
85
6Total
Edwards Lifesciences
323
105
7
98
5
Source:
EvaluateMedTech
Jude Medical (18 SEP 2014)
691
99
14
01
85
7 St.
Roche
1,098
105
19
85
6
60
1,614
54
00
6
8 Siemens
Note:
Based
onMedical
Devices@FDA data.
St.
Jude
691
99
14
85
7
PMA
(Premarket Approval): a class III device which0is a life-sustaining
implantable device';
usually require
59
536
57
26 or life-supporting
9 Stryker
Siemens
60
1,614
54
0
8
trials.
00 Class I, II, III device
54
3 not required). 57
123
10
510(k):
"substantially equivalent to a legally marketed
(where PMA
Stryker
59
536
57
2
9 BIOTRONIK

23
2,326
3,085
5,434
Total
HDE
(Humanitarian Device Exemption): a device for
a disease/condition
that affects
0 treating or diagnosing
54
3
57 <4,000 individuals
123
10 BIOTRONIK
in the US per year.
11
Source:
EvaluateMedTech (18 SEP 2014) 23
2,326
3,085
5,434
Total

Source:
(18(18
SEPSEP
2014)2014)
Source:EvaluateMedTech
EvaluateMedTech

Note: Based on Devices@FDA data.


PMA (Premarket
Approval): a class
III device which is a life-sustaining or life-supporting implantable device'; usually require
Note:
Based on Devices@FDA
data.
trials. (Premarket Approval): a class III device which is a life-sustaining or life-supporting implantable device'; usually require
PMA
510(k):
"substantially
Note: Based ontrials.
Devices@FDA
data. equivalent to a legally marketed Class I, II, III device (where PMA not required).
HDE
(Humanitarian
Devicewhich
Exemption):
a device for
treating or diagnosing
disease/condition
thattrials.
affects <4,000 individuals
PMA (Premarket
Approval):
a class III device
istoa a
life-sustaining
or life-supporting
implantable
device;
usually
510(k):
"substantially
equivalent
legally
marketed
Class I, II, III
device a(where
PMA
notrequire
required).
in
the
US
per
year.
11
HDE (Humanitarian
Exemption):
for treating
or diagnosing
a disease/condition that affects <4,000 individuals
510(k): substantially
equivalent to aDevice
legally marketed
ClassaI,device
II, III device
(where PMA
not required).
in
the
US
per
year.
11
HDE (Humanitarian Device Exemption): a device for treating or diagnosing a disease/condition that affects <4,000 individuals in the
US per year.

11

2014 FDA First-Time


PMAs and HDEs
FDA Approves 20 New PMAs in 2014 to end of August, Representing a 43% Uptick Compared with the Same Point Last Year
EvaluateMedTech found that the FDA has so far approved 20 new PMAs and two HDEs in 2014 to 31st August. This represents a 43%
increase compared
the
14 new PMAs
thatand
had HDEs
been granted at this point last year.
2014with
FDA
First-Time
PMAs
As in 2013, one of the most predominant areas was that of molecular diagnostics. This fast-growing area saw four approvals, representing
FDA Approves 20 New PMAs in 2014 to end of August, Representing a 43% Uptick Compared with the Same Point Last Year
20% of the PMAs
to date this found
year.that
Also
were20heart
valves
threein PMAs
date
in 2014.
EvaluateMedTech
thewell
FDA represented
has so far approved
new PMAs
andwith
two HDEs
2014 to to
31st
August.
This represents a 43%

2014 FDA First-Time PMAs and HDEs

increase compared with the 14 new PMAs that had been granted at this point last year.
As in 2013, one of the most predominant areas was that of molecular diagnostics. This fast-growing area saw four approvals, representing 20%
FDA
20 New
PMAsAlso
in 2014
to end of August,
Representing
43% PMAs
UpticktoCompared
with the Same Point Last Year
of theApproves
PMAs to date
this year.
well represented
were heart
valves withathree
date in 2014.
EvaluateMedTech
found that
the FDA
has
so far
approved2014)
20 new PMAs and two HDEs in 2014 to 31st August. This represents a 43%
2014
FDAFirst-Time
First-Time
PMAs
(to
31st
August
2014 FDA
(tonew
31st
August
increase
compared withPMAs
the 14
PMAs
that2014)
had been granted at this point last year.
As
in 2013, one of the
mostClassification
predominant areas was thatDecision
of molecular diagnostics. This fast-growing area saw four approvals, representing 20%
EvaluateMedTech
Device
of
the 1PMAs to date
this2 year. AlsoLevel
well represented
wereDate
heart valves
with three
PMAsCode
to date
in 2014.Device Name (Approval Code)
Level
Level
3
Company
Product
Name
Anesthesia &
Anesthesia &
Other Anesthesia &
2014 FDA First-Time
PMAs (to 31st
August 2014)
Respiratory
Respiratory
Respiratory Therapeutic
EvaluateMedTech
Device Classification
Therapeutic
Devices
Devices
Level 1
Level 2
Level 3

Decision
Date
Company

Anesthesia &
Cardiology
Respiratory

30
Hypoglossal
24 Apr
Jun 14 Inspire
Sorin Medical Stimulator,
Heart-Valve,
Non-Allograft
Systems
Nerve,
Tissue Implanted, Apnea

INSPIRE
II UPPER
AIRWAY STIMULATOR
FREEDOM
SOLO STENTLESS
HEART VALVE
(P130008)
(P130011)

16 Jun 14 Edwards
Lifesciences
24 Jun 14 Sorin
17 Jan 14 Medtronic

Aortic Valve, Prosthesis,


Percutaneously Delivered
Heart-Valve, Non-Allograft
Aortic Valve, Prosthesis,
Tissue
Percutaneously Delivered
Aortic Valve, Prosthesis,
System, Endovascular Graft,
Percutaneously Delivered
Arteriovenous (Av) Dialysis
Aortic Valve,
Access
CircuitProsthesis,
Stenosis
Percutaneously
Delivered
Treatment

EDWARDS SAPIEN XT TRANSCATHETER


HEART VALVE AND ACCESSORIES (P130009)
FREEDOM SOLO STENTLESS HEART VALVE
MEDTRONIC COREVALVE SYSTEM (P130021)
(P130011)

Endovascular Graft,
System, Hemodynamic,
Arteriovenous
Implantable (Av) Dialysis
Access Circuit Stenosis
Treatment
Stent, Coronary
System, Hemodynamic,
Implantable

FLUENCY PLUSHF
ENDOVASCULAR
STENT
CARDIOMEMS
PRESSURE MEASUREMENT
GRAFT (P130029)
SYSTEM
(P100045)

Stent, Superficial Femoral


Artery Coronary
Stent,
Digital Breast Tomosynthesis

SUPERA PERIPHERAL STENT SYSTEM


(P120020)
REBEL
PLATINUM CHROMIUM CORONARY
STENT
SYSTEM
MONORAIL AND OVER THE
SENOCLAIRE
(P130020)
WIRE (P130030)

Stent,
Femoral
HybridSuperficial
Cochlear Implant
Artery
Digital
Breast Tomosynthesis
Test, Hepatitis
B (B Core, Be
Antigen, Be Antibody, B Core
Igm)
Hybrid Cochlear Implant
Test, Hepatitis B (B Core, Be
Antigen,
Be Antibody,
B Core
Test, Hepatitis
B (B Core,
Be
Igm)
Antigen, Be Antibody, B Core
Igm)
Molecular Erythrocyte Typing
Test
Test, Hepatitis B (B Core, Be
Antigen,
Be Antibody,
B Core
Cytomegalovirus
(Cmv)
Dna
Igm)
Quantitative
Assay
MolecularColorectal
Erythrocyte
Typing
System,
Neoplasia,
Test Methylation And
Dna
Hemoglobin
Detection
Cytomegalovirus
(Cmv) Dna
Quantitative
Assay
Somatic Gene
Mutation
DetectionColorectal
System Neoplasia,
System,
Dna Methylation
And
Ophthalmic
Sealant
Hemoglobin Detection

SUPERA
SYSTEM
NUCLEUSPERIPHERAL
HYBRID L24 STENT
IMPLANT
SYSTEM
(P120020)
(P130016)
SENOCLAIRE
(P130020)
ADVIA CENTAUR
HBSAGII (P110041)

Cardiology
Cardiology
Cardiology
Cardiology
Cardiology
Cardiology

Anesthesia
&
Cardiac Prosthetic
Respiratory
Devices
Therapeutic
Cardiac Prosthetic
Devices
Devices
Cardiac Prosthetic
Cardiac Prosthetic
Devices
Devices
Cardiac Prosthetic
Cardiac Prosthetic
Devices
Devices
Cardiac Prosthetic
Devices

Other Anesthesia
&
Tissue
Heart Valves
Respiratory Therapeutic
Devices
Transcatheter Heart
Valves
Tissue Heart Valves
Transcatheter Heart
Valves
Transcatheter Heart
Graft Prosthesis
Valves
Transcatheter Heart
Valves

30 Apr 14 Inspire Medical Stimulator, Hypoglossal


Systems
Nerve, Implanted, Apnea

16 Jun 14 Edwards
17 Jun 14 C. R. Bard
Lifesciences
17 Jan 14 Medtronic

Cardiology

Cardiac Prosthetic Graft


Prosthesis
Cardiovascular
ECG Monitoring
Devices &
Monitoring
Diagnostic Devices

17 May
Jun 14
C. R.
Bard
28
14 St.
Jude
Medical

Cardiology
Cardiology

Interventional
Cardiovascular
Cardiology
Monitoring &
Diagnostic
Devices
Interventional

Non-Drug-Eluting
ECG
Monitoring
Coronary
Stents

27 Jun 14 Boston
28 May 14 Scientific
St. Jude
Medical

Cardiology
Interventional
Cardiology
Computed
Tomography (CT)
Interventional
Ear
Devices
Cardiology
Computed
Immunoassays
Tomography (CT)
Ear Devices
Immunoassays
Immunoassays

Peripheral Vascular
Devices
Non-Drug-Eluting
Coronary
Stents
Other Computed
Tomography (CT)
Peripheral
Vascular
Hearing Implants
Devices
Other
Computed
Viral Immunoassays
Tomography (CT)
Hearing Implants
Viral Immunoassays
Viral Immunoassays

28 Mar 14 Abbott
Laboratories
27 Jun 14 Boston
26 Aug 14 Scientific
General
Electric
28
20 Mar 14 Abbott
Cochlear
Laboratories
26 May
Aug 14 General
16
Siemens
Electric
20 Mar 14 Cochlear
14 Mar 14 Roche
16 May 14 Siemens

Molecular
Diagnostics
Immunoassays
Molecular
Diagnostics
Molecular
Diagnostics
Molecular
Diagnostics
Molecular
Diagnostics
Molecular
Diagnostics Surgical
Ophthalmic
Devices
Molecular
Orthobiologics
Diagnostics
Ophthalmic
Surgical
Orthobiologics
Devices
Orthobiologics
Spinal
Devices

Hematology Molecular
Diagnostics
Viral
Immunoassays
Infectious Disease
Molecular Diagnostics
Hematology
Molecular
Oncology
Molecular
Diagnostics
Infectious Disease
Molecular Molecular
Diagnostics
Oncology
Diagnostics
Oncology Molecular
Diagnostics
Other
Ophthalmic
Surgical Devices
Oncology
Molecular
Viscosupplementation
Diagnostics
Other
Ophthalmic
Viscosupplementation
Surgical Devices
Viscosupplementation
Artificial Discs

21 May 14 Immucor
14 Mar 14 Roche
02 Jun 14 QIAGEN

Cardiology
Cardiology
Diagnostic Imaging
Cardiology
Ear,
Nose & Throat
(ENT)
Diagnostic
Imaging
In
Vitro Diagnostics
(IVD)
Ear, Nose & Throat
(ENT)
In Vitro Diagnostics
(IVD)
In
Vitro Diagnostics
(IVD)
In Vitro Diagnostics
(IVD)
In
Vitro Diagnostics
(IVD)
In Vitro Diagnostics
(IVD)
In Vitro Diagnostics
(IVD)
In Vitro Diagnostics
(IVD)
In
Vitro Diagnostics
(IVD)
In Vitro Diagnostics
(IVD)
Ophthalmics

Product Code Name

21
Immucor
11 May
Aug 14 EXACT
Sciences
02 Jun 14 QIAGEN
23 May 14 QIAGEN
11 Aug 14 EXACT
08 Jan 14 Sciences
Ocular
Therapeutix
In Vitro Diagnostics
23
Somatic
Gene Mutation
Orthopedics
09 May 14 QIAGEN
IBSA Institut
Acid,
Hyaluronic,
Intraarticular
(IVD)
Detection System
Biochimique
Ophthalmics
08 Feb
Jan 14 Ocular
Ophthalmic
Sealant
Orthopedics
25
Anika
Acid, Hyaluronic,
Intraarticular
Therapeutix
Therapeutics
09
14 Medtronic
IBSA Institut
Acid, Hyaluronic,
Intraarticular
Orthopedics
24May
Jul 14
Prosthesis,
Intervertebral
Disc
Biochimique
2014 FDA Humanitarian
Device Exemptions
(HDEs) 25
(toFeb
31st
2014)Acid, Hyaluronic, Intraarticular
Orthopedics
Orthobiologics
Viscosupplementation
14 August
Anika
EvaluateMedTech Device Classification
Decision Therapeutics
Orthopedics
Spinal
Artificial
24Date
Jul 14 Medtronic
Prosthesis,
Intervertebral
Level 1
Level Devices
2
Level 3Discs
Company
Product Code
Name Disc

2014
FDA
Humanitarian
Device
Exemptions
(to 31st
August
2014)
Anesthesia
&
Respiratory
Other Respiratory
12 Aug (HDEs)
14 Xvivo Perfusion
Normothermic
Preservation

Copyright 2014 Evaluate Ltd. All rights reserved.

2014 FDA Humanitarian


Device Exemptions
(HDEs) (to 31st August 2014)System For Transplantation
Respiratory
Therapeutic
Therapeutic Devices
EvaluateMedTech
Device Classification
Devices
Level 1
Level 2
Level 3

Decision
Date
Company

Anesthesia
Neurology &
Respiratory

12
14 Xvivo
Perfusion Normothermic
Preservation
25Aug
Jul 14
Terumo
Device, Neurovascular
System
For Transplantation
Embolization
Of Initially Unacceptable
Donor Lungs

Respiratory
Neurology
Therapeutic
Devices

Other
Respiratory
Neurovascular
Devices
Therapeutic Devices

Source: EvaluateMedTech (18 SEP 2014)

Of Initially Unacceptable
Donor
Lungs
Product
Code Name

INSPIRE II UPPER AIRWAY STIMULATOR


(P130008)

Device Name (Approval Code)

EDWARDS SAPIEN XT TRANSCATHETER


FLUENCY PLUS ENDOVASCULAR STENT
HEART VALVE AND ACCESSORIES (P130009)
GRAFT (P130029)
MEDTRONIC COREVALVE SYSTEM (P130021)

REBEL PLATINUM CHROMIUM CORONARY


CARDIOMEMS
HFMONORAIL
PRESSURE
MEASUREMENT
STENT SYSTEM
AND
OVER THE
SYSTEM
(P100045)
WIRE (P130030)

NUCLEUS HYBRID L24 IMPLANT SYSTEM


(P130016)
ELECSYS HBEAG IMMUNOASSAY AND
ELECSYS
PRECICONTROL
HBEAG (P130015)
ADVIA
CENTAUR
HBSAGII (P110041)
IMMUCOR PRECISETYPE (BP130026)
ELECSYS HBEAG IMMUNOASSAY AND
ELECSYS
HBEAG (P130015)
ARTUS
CMVPRECICONTROL
RGQ MDX KIT (P130027)
IMMUCOR PRECISETYPE
(BP130026)
COLOGUARD
(P130017)
ARTUS CMV RGQ MDX KIT (P130027)
THERASCREEN KRAS RGQ PCR KIT (P110027)
COLOGUARD (P130017)
RESURE SEALANT (P130004)
THERASCREEN
KRAS
RGQ PCR KIT0.8%)
(P110027)
SINOVIAL (SODIUM
HYALURONATE
(P110005)
RESURE
SEALANT
(P130004)
MONOVISC
(P090031)
SINOVIAL
HYALURONATE
0.8%)
PRESTIGE(SODIUM
LP CERVICAL
DISC (P090029)
(P110005)
MONOVISC (P090031)
PRESTIGE
LP CERVICAL
(P090029)
Device Name
(ApprovalDISC
Code)
XVIVO PERFUSION SYSTEM (XPS) WITH
STEEN SOLUTION PERFUSATE (H120003)

Device Name (Approval Code)


XVIVO
PERFUSION
SYSTEMINTRALUMINAL
(XPS) WITH
LOW-PROFILE
VISUALIZED
STEEN
SOLUTION
PERFUSATE
SUPPORT
DEVICE (LVIS
AND LVIS(H120003)
JR.)
(H130005)

Note:
Based on Devices@FDA
data
to 31st August
Neurology
Neurology
Neurovascular
Devices2014.
25 Jul 14 Terumo
Device, Neurovascular
LOW-PROFILE VISUALIZED INTRALUMINAL
PMA (Premarket Approval):
usually
require
Therapeutic a class III device which is a life-sustaining or life-supporting
Embolization implantable device';
SUPPORT
DEVICE
(LVIS AND LVIS JR.)
trials.
Devices
(H130005)
Source:
EvaluateMedTech
SEP 2014) a device for treating or diagnosing a disease/condition that affects <4,000 individuals
HDE
(Humanitarian
Device(18
Exemption):
in the US per year.
Source:
EvaluateMedTech
(18toSEP
Note: Based
on Devices@FDA data
31st2014)
August 2014.
PMA (Premarket Approval): a class III device which is a life-sustaining or life-supporting implantable device'; usually require
trials.
HDE (Humanitarian Device Exemption): a device for treating or diagnosing a disease/condition that affects <4,000 individuals
in the US per year.

Note: Based on Devices@FDA data to 31st August 2014.

12

PMA (Premarket Approval): a class III device which is a life-sustaining or life-supporting implantable device; usually require trials.
12

HDE (Humanitarian Device Exemption): a device for treating or diagnosing a disease/condition that affects <4,000 individuals in the US per year.
12

In Vitro Diagnostics (IVD)


Market to 2020
InVitro
VitroDiagnostics
Diagnostics(IVD)
(IVD)Market
Marketto
to2020
2020
In
Roche Maintains
Leading
Position
within
In Vitrowithin
Diagnostics
Roche
Maintains
Leading
Position
In VitroMarket
Diagnostics Market
Roche Maintains Leading Position within In Vitro Diagnostics Market
EvaluateMedTech
consensus
forecast
finds
that Roche
is expected
to remain
the
dominant
force
in thespace
in
EvaluateMedTech
consensus
forecast
finds
that
Roche
is
expected
to remain
the dominant
force
indominant
the
in vitro
diagnostic
to 2020.
EvaluateMedTech consensus forecast finds that Roche
is expected
to remain
the
force
in the in
vitro
diagnostic
space atomassive
2020. The
company
isshare
forecast
to command
a expected
massive 17.0%
market
share in 2020,
The company is
forecast
to
command
17.0%
market
in
2020,
with
sales
to
reach
$12.2bn.
vitro diagnostic space to 2020. The company is forecast to command a massive 17.0% market share in 2020,
with sales expected to reach $12.2bn.
with salesSysmex
expected
to reach to
$12.2bn.
The Japanese company
is predicted
be the
fastest growing
company
this field
with sales
expected
to grow
The Japanese company
Sysmex
is predicted
to be the
fastest in
growing
company
in this
field with
salesby 11% per year
The2013
Japanese
company
Sysmex
predicted
tojumping
be the fastest
growing
company
in this
fieldinwith
sales
(CAGR) between
and
This
results
in is
the
company
threeand
places
in the
rankings
2020.
expected
to 2020.
grow by
11%
per year
(CAGR)
between
2013
2020.
This
results to
in sixth
the company
jumping
expected to grow by 11% per year (CAGR) between 2013 and 2020. This results in the company jumping
three places in the rankings to sixth in 2020.
three places in the rankings to sixth in 2020.

WW Market
WW Share
Market%Share
in 2020
%
WW Market
WW Share
Market%Share
in 2020
%

WW In Vitro Diagnostics Sales, Market Share & Sales Growth (2013-20)


WW In Vitro Diagnostics Sales, Market Share & Sales Growth (2013-20)
Source: EvaluateMedTech (18 SEP 2014)
Source: EvaluateMedTech (18 SEP 2014)
140%
25%
140%
25%

Novo: Solid growth in its core insulin


Novo:
Solidincluding
growth inTresiba
its core(insulin
insulin
franchise,
franchise,
including
Tresiba
(insulin
degludec),
and GLP-1
Victoza
degludec), and GLP-1 Victoza

120%
120%
20%
20%
100%
100%

Roche
Roche

15%
15%
80%
80%

60%
60%
10%
10%

Takeda: Actos generic


Takeda:
Actos
generic 2012.
competition
expected
competition expected 2012.

Siemens
Siemens

40%
40%

Thermo Fisher
Thermo
Fisher
Scientific
Scientific

5%
5%
20%
20%

0%
0%
0%
0%+3%
0
0
+3%

Abbott
Abbott
Laboratories
Laboratories

Danaher
Danaher

Merck: Strong growth in


Merck:
growth
in
DPP-IVStrong
inhibitor
franchise
DPP-IV inhibitor franchise

0.2
0.2

+4% 0.4
+4% 0.4

0.6
0.6

+5%
+5%

0.8
0.8

Note: Bubble = WW Sales


Sales in
in2020
2018
Note: Bubble = WW Sales
Sales in
in2020
2018

1 +6%
1 +6%

1.2
1.2

1.4
+7%
1.4
+7%

% Sales
Growth:
2011-18
% Sales
Growth:
CAGRCAGR
2013-20
% Sales
Growth:
2011-18
% Sales
Growth:
CAGRCAGR
2013-20

Copyright 2014 Evaluate Ltd. All rights reserved.

WW In Vitro Diagnostics Sales: Top 10 Companies & Total Market (2013/20)


WW In
In Vitro
Vitro Diagnostics
DiagnosticsSales:
Sales:Top
Top10
10Companies
Companies&&Total
TotalMarket
Market(2013/20)
(2013/20)
WW
Rank Company
Rank Company
1 Roche
1 Roche
2 Siemens
2 Siemens
3 Danaher
3 Danaher
4 Abbott Laboratories
4 Abbott Laboratories
5 Thermo Fisher Scientific
5 Thermo Fisher Scientific
6 Sysmex
6 Sysmex
7 Becton Dickinson
7 Becton Dickinson
8 Alere
8 Alere
9 bioMrieux
9 bioMrieux
10 Werfen Group
10 Werfen Group
Top 10
Top 10
Other
Other
Total Industry
Total Industry

WW Sales ($m)
WW Sales ($m)
2013
2020
2013
2020

8,654
8,654
5,173
5,173
4,882
4,882
4,545
4,545
2,993
2,993
1,796
1,796
2,646
2,646
2,243
2,243
1,662
1,662
1,472
1,472
36,066
36,066
11,329
11,329
47,394
47,394

12,205
12,205
6,889
6,889
6,821
6,821
6,799
6,799
4,046
4,046
3,782
3,782
3,399
3,399
2,832
2,832
2,519
2,519
2,278
2,278
51,570
51,570
20,071
20,071
71,640
71,640

CAGR
CAGR
2013-20
2013-20
+5%
+5%
+4%
+4%
+5%
+5%
+6%
+6%
+4%
+4%
+11%
+11%
+4%
+4%
+3%
+3%
+6%
+6%
+6%
+6%
+5%
+5%
+9%
+9%
+6.1%
+6.1%

WW Market Share
WW Market Share
2013
2020
2013
2020

18.3%
18.3%
10.9%
10.9%
10.3%
10.3%
9.6%
9.6%
6.3%
6.3%
3.8%
3.8%
5.6%
5.6%
4.7%
4.7%
3.5%
3.5%
3.1%
3.1%
76.1%
76.1%
23.9%
23.9%
100.0%
100.0%

17.0%
17.0%
9.6%
9.6%
9.5%
9.5%
9.5%
9.5%
5.6%
5.6%
5.3%
5.3%
4.7%
4.7%
4.0%
4.0%
3.5%
3.5%
3.2%
3.2%
72.0%
72.0%
28.0%
28.0%
100.0%
100.0%

Rank Chg.
Rank Chg.
2013-20
2013-20
-

+3
+3
-1
-1
-1
-1
+1
+1
+1
+1

Source: EvaluateMedTech (18 SEP 2014); Consensus sales from equity analysts' reports

Source:EvaluateMedTech
EvaluateMedTech
(18 2014);
SEP 2014);
Consensus
sales
from
equity analysts'
Source:
(18 SEP
Consensus
sales from
equity
analysts
reports reports
Note: Excludes Glucose Test Systems which are included in Diabetic Care classification.
Note: Excludes Glucose Test Systems which are included in Diabetic Care classification.
Note: Excludes Glucose Test Systems which are included in Diabetic Care classification.

13

13
13

Cardiology Market
to 2020
Medtronic Set to Solidify Number One Position in Cardiology through Acquisition of Covidien
EvaluateMedTech consensus forecast finds that Medtronic will remain the worlds number one cardiology company with global sales of
$11.1bn in 2020.
This dominance is set to be further entrenched following completion of the proposed $42.9bn acquisition of Covidien. With sales of $1.5bn
forecast in 2020, Covidien sits just outside the top 10 cardiology companies at number 11. Together the companies are forecast to achieve
sales of $12.6bn in 2020, representing 22.0% market share.

Copyright 2014 Evaluate Ltd. All rights reserved.

WW Cardiology Sales: Top 10 Companies & Total Market (2013/20)

Source: EvaluateMedTech (18 SEP 2014); Consensus sales from equity analysts reports

Note: General Electric & Philips do not disclose cardiology sales. Medtronic does not include revenues from proposed acquisition of Covidien.

14

Diagnostic Imaging
Market to 2020
Siemens Extends
Leading Position
in Diagnostic
Imaging
in 2020
Diagnostic
Imaging
Market
to 2020

Diagnostic Imaging Market to 2020

EvaluateMedTech consensus forecast finds that Siemens is forecast to extend its position as the worlds leading diagnostic imaging
company in 2020.
TheExtends
companyLeading
is expected
to generate
$14.2bn
of salesinin2020
2020 representing a market share of 30.1%, an increase
Siemens
Position
in Diagnostic
Diagnostic
Imaging
Position
in
Imaging
in 2020
from 29.7% Siemens
in 2013. Extends Leading
EvaluateMedTech
consensus forecast finds that Siemens is forecast to extend its position as the world's leading
EvaluateMedTech consensus forecast finds that Siemens is forecast to extend its position as the world's leading

diagnostic imaging
imaging company
company
inset
2020.
The company
company
is expected
expected
to generate
generate
$14.2bn
of sales
sales in
in 2020
2020 representing
representing aa
Overall, the diagnostic
imaging
market isin
to grow
at 4.1% per
year (CAGR)
to $47.0bn
in 2020.
diagnostic
2020.
The
is
to
$14.2bn
of
market share
share of
of 30.1%,
30.1%, an
an increase
increase from
from 29.7%
29.7% in
in 2013.
2013.
market
Overall, the
the diagnostic
diagnostic imaging
imaging market
market is
is set
set to
to grow
grow at
at 4.1%
4.1% per
per year
year (CAGR)
(CAGR) to
to $47.0bn
$47.0bn in
in 2020.
2020.
Overall,

WW
WWMarket
MarketShare
Share%%inin2020
2020

WW Diagnostic
Diagnostic Imaging
Imaging Sales,
Sales, Market
Market Share
Share &
& Sales
Sales Growth
Growth (2013-20)
(2013-20)
WW
Source: EvaluateMedTech
EvaluateMedTech (18
(18 SEP
SEP 2014)
2014)
Source:
40%
40%
35%
35%
Siemens
Siemens

30%
30%
25%
25%
General
General
Electric
Electric

20%
20%
15%
15%

Philips
Philips

Toshiba
Toshiba

10%
10%
5%
5%

Carestream
Carestream
Health
Health

0%
0%
+2%
+2%

+3%
+3%

+4%
+4%

+5%
+5%

+6%
+6%

% Sales
Sales Growth:
Growth: CAGR
CAGR 2013-20
2013-20
%

Note: Bubble
Bubble == WW
WW Sales
Sales in
in 2020
2020
Note:

WW Diagnostic Imaging Sales: Top 10 Companies & Total Market (2013/20)

Copyright 2014 Evaluate Ltd. All rights reserved.

WW Diagnostic
Companies
& Total
Market
(2013/20)
WW
DiagnosticImaging
ImagingSales:
Sales:Top
Top1010
Companies
& Total
Market
(2013/20)
Rank Company
Company
Rank
1
Siemens
1 Siemens
General Electric
Electric
22 General
Philips
33 Philips
Toshiba
44 Toshiba
Carestream Health
Health
55 Carestream
Hitachi Medical
Medical
66 Hitachi
Konica Minolta
Minolta
77 Konica
Agfa-Gevaert
88 Agfa-Gevaert
Varian Medical
Medical Systems
Systems
99 Varian
10 Hologic
Hologic
10
Top 10
10
Top
Other
Other
Total Industry
Industry
Total

WW Sales
Sales ($m)
($m)
WW
2013
2020
2013
2020

10,539
10,539
8,372
8,372
4,706
4,706
4,102
4,102
1,539
1,539
1,179
1,179
823
823
909
909
546
546
421
421
33,137
33,137
2,335
2,335
35,472
35,472

14,164
14,164
10,294
10,294
5,779
5,779
5,717
5,717
2,054
2,054
1,359
1,359
1,043
1,043
1,033
1,033
984
984
783
783
43,210
43,210
3,770
3,770
46,980
46,980

CAGR
CAGR
2013-20
2013-20
+4%
+4%
+3%
+3%
+3%
+3%
+5%
+5%
+4%
+4%
+2%
+2%
+3%
+3%
+2%
+2%
+9%
+9%
+9%
+9%
+4%
+4%
+7%
+7%
+4.1%
+4.1%

WW Market
Market Share
Share
WW
2013
2020
2013
2020

29.7%
29.7%
23.6%
23.6%
13.3%
13.3%
11.6%
11.6%
4.3%
4.3%
3.3%
3.3%
2.3%
2.3%
2.6%
2.6%
1.5%
1.5%
1.2%
1.2%
93.4%
93.4%
6.6%
6.6%
100.0%
100.0%

Source: EvaluateMedTech
EvaluateMedTech (18
(18 SEP
SEP 2014);
2014); Consensus
Consensus sales
sales from
from equity
equity analysts'
analysts' reports
reports
Source:
Source:
EvaluateMedTech (18
SEP 2014);
Consensus sales
from equity
analysts reports

30.1%
30.1%
21.9%
21.9%
12.3%
12.3%
12.2%
12.2%
4.4%
4.4%
2.9%
2.9%
2.2%
2.2%
2.2%
2.2%
2.1%
2.1%
1.7%
1.7%
92.0%
92.0%
8.0%
8.0%
100.0%
100.0%

Rank Chg.
Chg.
Rank
2013-20
2013-20
+1
+1
-1
-1
+1
+1
+1
+1

Note: Segment
Segment sales
sales include
include servicing
servicing of
of equipment.
equipment. FUJIFILM's
FUJIFILM's Diagnostic
Diagnostic Imaging
Imaging sales
sales are
are not
not available.
available.
Note:

Note: Segment sales include servicing of equipment. FUJIFILMs Diagnostic Imaging sales are not available.

15
15

15

Orthopedics Market
to 2020
Johnson & Johnson
Continues to Market
Lead the Orthopedics
Orthopedics
to 2020 Market

Orthopedics Market to 2020

EvaluateMedTech consensus forecast finds that Johnson & Johnson continues to lead the pack in orthopedics, with sales expected to reach
$11.3bn - representing
market
share - in
Johnsona&24.7%
Johnson
Continues
to2020.
Lead the Orthopedics Market
Johnson & Johnson Continues to Lead the Orthopedics Market
However, following
the completionconsensus
of its pending
$13.4bn
of &Biomet,
Zimmer
will close
inthe
on pack
the leader
and is forecast to
EvaluateMedTech
forecast
finds acquisition
that Johnson
Johnson
continues
to lead
in orthopedics,
EvaluateMedTech consensus forecast finds that Johnson & Johnson continues to lead the pack in orthopedics,
with
sales
expected
to reach
$11.3bn
- representing
a 24.7%
market
share
in 2020.
leapfrog Stryker
to sales
take second
place
in the$11.3bn
rankings
with combined
revenue
forecast
to--reach
$9.5bn in 2020, giving it a 20.8% market
with
expected
to reach
- representing
a 24.7%
market
share
in 2020.
However, following the completion of its pending $13.4bn acquisition of Biomet, Zimmer will close in on the leader
share.
However, following the completion of its pending $13.4bn acquisition of Biomet, Zimmer will close in on the leader
and is forecast to leapfrog Stryker to take second place in the rankings with combined revenue forecast to reach
is forecast
to leapfrog
Stryker to
second
place
in the rankings
combined
revenue
reach
Of the top 20 and
companies,
Medtronic
to take
haveshare.
the lowest
growth
rate, withwith
sales
expected
to growforecast
by just to
1%
per year (CAGR)
$9.5bn in 2020,
giving itisaforecast
20.8% market
in 2020,
giving
a 20.8% market
share.
between 2013$9.5bn
and
owing
to itsit struggling
business.
Of
the2020
top 20
companies,
MedtronicBMP
is forecast
to have the lowest growth rate, with sales expected to grow by just
Of the top 20 companies, Medtronic is forecast to have the lowest growth rate, with sales expected to grow by just
1% per year (CAGR) between 2013 and 2020 owing to its struggling BMP business.
1% per year (CAGR) between 2013 and 2020 owing to its struggling BMP business.

WW
WWMarket
MarketShare
Share%%inin2020
2020

WW Orthopedics Sales, Market Share & Sales Growth (2013-20)


WW Orthopedics Sales, Market Share & Sales Growth (2013-20)
Source: EvaluateMedTech (18 SEP 2014)
Source: EvaluateMedTech (18 SEP 2014)
35%
35%
30%
30%
Johnson &
Johnson &
Johnson
Johnson

25%
25%
20%
20%
Medtronic: Slow growth due to
Medtronic:
Slow growth
decline in revenues
from due
BMPto
decline in revenues from BMP
business
business

15%
15%

Stryker
Stryker
Zimmer
Zimmer

10%
10%

Biomet
Biomet

Medtronic
Medtronic

5%
5%
0%
0%
+0%
+0%

+1%
+1%

+2%
+2%

+3%
+3%

+4%
+4%

+5%
+5%

+6%
+6%

+7%
+7%

% Sales Growth: CAGR 2013-20


% Sales Growth: CAGR 2013-20

Note:Bubble
Bubble =WW
WW
Sales
in 2018
Note:
Sales
in 2020
Note:
Bubble===WW
WW
Sales
in 2018
Note: Bubble
Sales
in 2020

Copyright 2014 Evaluate Ltd. All rights reserved.

WW Orthopedics Sales: Top 10 Companies & Total Market (2013/20)


WW Orthopedics
Orthopedics Sales:
(2013/20)
WW
Sales:Top
Top 10
10Companies
Companies&&Total
TotalMarket
Market
(2013/20)
Rank Company
Rank Company
1 Johnson & Johnson
1 Johnson & Johnson
2 Stryker
2 Stryker
3 Zimmer
3 Zimmer
4 Biomet
4 Biomet
5 Medtronic
5 Medtronic
6 Arthrex
6 Arthrex
7 Smith & Nephew
7 Smith & Nephew
8 NuVasive
8 NuVasive
9 Globus Medical
9 Globus Medical
10 Wright Medical Group
10 Wright Medical Group
Top 10
Top 10
Other
Other
Total Industry
Total Industry

WW Sales ($m)
WW Sales ($m)
2013
2020
2013
2020

8,948
8,948
5,228
5,228
4,384
4,384
2,964
2,964
3,041
3,041
1,550
1,550
2,004
2,004
646
646
434
434
474
474
29,674
29,674
4,146
4,146
33,820
33,820

11,345
11,345
7,436
7,436
5,599
5,599
3,941
3,941
3,224
3,224
2,912
2,912
2,582
2,582
1,019
1,019
778
778
600
600
39,434
39,434
6,487
6,487
45,920
45,920

CAGR
CAGR
2013-20
2013-20
+3%
+3%
+5%
+5%
+4%
+4%
+4%
+4%
+1%
+1%
+9%
+9%
+4%
+4%
+7%
+7%
+9%
+9%
+3%
+3%
+4%
+4%
+7%
+7%
+4.5%
+4.5%

WW Market Share
WW Market Share
2013
2020
2013
2020

26.5%
26.5%
15.5%
15.5%
13.0%
13.0%
8.8%
8.8%
9.0%
9.0%
4.6%
4.6%
5.9%
5.9%
1.9%
1.9%
1.3%
1.3%
1.4%
1.4%
87.7%
87.7%
12.3%
12.3%
100.0%
100.0%

24.7%
24.7%
16.2%
16.2%
12.2%
12.2%
8.6%
8.6%
7.0%
7.0%
6.3%
6.3%
5.6%
5.6%
2.2%
2.2%
1.7%
1.7%
1.3%
1.3%
85.9%
85.9%
14.1%
14.1%
100.0%
100.0%

Rank Chg.
Rank Chg.
2013-20
2013-20
+1
+1
-1
-1
+1
+1
-1
-1
+2
+2
-

Source: EvaluateMedTech (18 SEP 2014); Consensus sales from equity analysts' reports

Source:EvaluateMedTech
EvaluateMedTech
2014);
Consensus
analysts'
reports
Source:
(18(18
SEPSEP
2014);
Consensus
salessales
from from
equityequity
analysts
reports
Note: Zimmer does not include revenues from proposed acquisition of Biomet.
Note: Zimmer does not include revenues from proposed acquisition of Biomet.

Note: Zimmer does not include revenues from proposed acquisition of Biomet.

16

16
16

Ophthalmics Market
to 2020
Ophthalmics Market to 2020

Essilor to Replace
Novartis as Top Market
Ophthalmics
Ophthalmics
toCompany
2020 by 2020
EvaluateMedTech
consensus
forecast
finds as
that
Essilor,
the FrenchCompany
maker of by
optical
Essilor
to Replace
Novartis
Top
Ophthalmics
2020lenses, is expected to become the leading ophthalmics
Essilor
toare
Replace
Novartis
Top Ophthalmics
Company
by 2020
company in 2020.
Sales
forecast
to reachas$10.4bn
on
thethat
back
of strong
growth
ofoptical
8% (CAGR)
2013toand 2020.
EvaluateMedTech
consensus
forecast
finds
Essilor,
the annual
French
maker of
lenses,between
is expected
EvaluateMedTech
finds
that Essilor,
the French
of optical
lenses,
expected
to
become the leading consensus
ophthalmicsforecast
company
in 2020.
Sales are
forecastmaker
to reach
$10.4bn
on theisback
of strong
Valeant Pharmaceuticals
moves
into
the
top
5
following
its
acquisition
of
Bausch
+
Lomb
in
August
2013,
with
sales
forecast
to reach almost
become
the
leading
ophthalmics
company
in
2020.
Sales
are
forecast
to
reach
$10.4bn
on
the
back
of
strong
annual growth of 8% (CAGR) between 2013 and 2020.
$3bn in 2020.annual
growth
of
8%
(CAGR)
between
2013
and
2020.
Valeant Pharmaceuticals moves into the top 5 following its acquisition of Bausch + Lomb in August 2013, with
Valeant
Pharmaceuticals
moves$3bn
into in
the2020.
top 5 following its acquisition of Bausch + Lomb in August 2013, with
sales forecast
to reach almost
sales forecast to reach almost $3bn in 2020.

WW
Market
%%
WW
Market
Share
%Share
in
2020
WW
Market
Share
WW
Market
Share
%
in
2020

WW Ophthalmics Sales, Market Share & Sales Growth (2013-20)


WW
Ophthalmics
Sales, Market
Share
& Sales Growth (2013-20)
Source:
EvaluateMedTech
(18 SEP
2014)
Source: EvaluateMedTech (18 SEP 2014)
35%
140%
35%
140%

Novo: Solid growth in its core insulin


Novo:
Solidincluding
growth in
its core(insulin
insulin
franchise,
Tresiba
franchise,
Tresiba
(insulin
degludec),including
and GLP-1
Victoza
degludec), and GLP-1 Victoza

30%
120%
30%
120%
25%
100%
25%
100%

Essilor
Essilor
Novartis
Novartis
Valeant: Entered the
Valeant:
Entered
thein 2013
Ophthalmics
space
Ophthalmics
space inof2013
following acquisition
Bausch
following
acquisition
of Bausch
+ Lomb
+ Lomb

20%
80%
20%
80%
15%
60%
15%
60%
10%
40%
10%
40%

Takeda: Actos generic


Takeda:
Actos
generic2012.
competition
expected
competition expected 2012.

Johnson &
Johnson
&
Johnson
Johnson

HOYA
HOYA

Valeant
Valeant

5%
20%
5%
20%

Merck: Strong growth in


Merck:
growth
in
DPP-IVStrong
inhibitor
franchise
DPP-IV inhibitor franchise

0%
0%
0%
0%+0%
0
0.2 +5%
0.4
+0%
0
0.2 +5%
0.4
Note:
Sales
in 2020
Note:Bubble
Bubble= =WW
WW
Sales
in 2018
Note: Bubble
Sales
in 2020
Note:
Bubble= =WW
WW
Sales
in 2018

+10%0.6
+10%0.6

+15%
0.8
+15%
0.8

1
1

+20% 1.2
+20% 1.2

+25%
1.4
+25%
1.4

% Sales
CAGRCAGR
2013-20
% Growth:
Sales Growth:
2011-18
% Sales
CAGRCAGR
2013-20
% Growth:
Sales Growth:
2011-18

Copyright 2014 Evaluate Ltd. All rights reserved.

WW Ophthalmics Sales: Top 10 Companies & Total Market (2013/20)


WW Ophthalmics
Ophthalmics Sales: Top 10 Companies & Total
WW
Total Market
Market(2013/20)
(2013/20)
Rank Company
Rank Company
1 Essilor International
1 Essilor International
2 Novartis
2 Novartis
3 Johnson & Johnson
3 Johnson & Johnson
4 HOYA
4 HOYA
5 Valeant Pharmaceuticals
5 Valeant Pharmaceuticals
6 The Cooper Companies
6 The Cooper Companies
7 Carl Zeiss
7 Carl Zeiss
8 Abbott Laboratories
8 Abbott Laboratories
9 TOPCON
9 TOPCON
10 NIDEK
10 NIDEK
Top 10
Top 10
Other
Other
Total Industry
Total Industry

WW Sales ($m)
WW Sales ($m)
2013
2020
2013
2020

5,985
5,985
6,388
6,388
2,937
2,937
2,032
2,032
812
812
1,268
1,268
1,776
1,776
1,142
1,142
387
387
334
334
23,060
23,060
1,437
1,437
24,497
24,497

10,368
10,368
9,015
9,015
3,626
3,626
3,108
3,108
2,987
2,987
2,738
2,738
2,290
2,290
1,810
1,810
646
646
481
481
37,070
37,070
592
592
37,662
37,662

CAGR
CAGR
2013-20
2013-20
+8%
+8%
+5%
+5%
+3%
+3%
+6%
+6%
+20%
+20%
+12%
+12%
+4%
+4%
+7%
+7%
+8%
+8%
+5%
+5%
+7%
+7%

+6.3%
+6.3%

WW Market Share
WW Market Share
2013
2020
2013
2020

24.4%
24.4%
26.1%
26.1%
12.0%
12.0%
8.3%
8.3%
3.3%
3.3%
5.2%
5.2%
7.2%
7.2%
4.7%
4.7%
1.6%
1.6%
1.4%
1.4%
94.1%
94.1%
5.9%
5.9%
100.0%
100.0%

27.5%
27.5%
23.9%
23.9%
9.6%
9.6%
8.3%
8.3%
7.9%
7.9%
7.3%
7.3%
6.1%
6.1%
4.8%
4.8%
1.7%
1.7%
1.3%
1.3%
98.4%
98.4%
1.6%
1.6%
100.0%
100.0%

Rank Chg.
Rank Chg.
2013-20
2013-20
+1
+1
-1
-1
+4
+4
-2
-2
-1
-1
+1
+1
+1
+1

Source: EvaluateMedTech (18 SEP 2014); Consensus sales from equity analysts' reports

Source:EvaluateMedTech
EvaluateMedTech
2014);
Consensus
salesequity
from equity
analysts'
Source:
(18(18
SEPSEP
2014);
Consensus
sales from
analysts
reportsreports

Note: Valeant's 2013 ophthalmic revenues only include the Bausch + Lomb business from the date of the
Note:
Valeant's
2013 ophthalmic
only include
theforBausch
+ Lomb company
business is
from
the date
of 7%
the
closing
of the acquisition
(6 AUG revenues
2013). Proforma
CAGR
the combined
forecast
to be
closing
of 2013
the acquisition
between
and 2020.(6 AUG 2013). Proforma CAGR for the combined company is forecast to be 7%
between 2013 and 2020.
Note: Valeants 2013 ophthalmic revenues only include the Bausch + Lomb business from the date of the closing of the acquisition (6 AUG
2013). Proforma CAGR for the combined company is forecast to be 7% between 2013 and 2020.

17

17
17

M&A Analysis:
2009 to H1 2014
M&A Deal Value Jumps by a Massive 363% in H1 2014, though Deal Count Falls by 10%

M&A Analysis: 2009 to H1 2014

70
80
70
60
70
60
50
60
50
40
50
40
30
40
30
20
30
20
10
20
10
0
10
0
0

2009
270
AM Optics [ABT] $2.8bn
2009
AM Optics [ABT] $2.8bn
2009
178
AM Optics [ABT] $2.8bn

178
178

$13bn
$13bn
2009
$13bn
2009
2009

263

241

263

241
241

207
207
207

Target [Acquiror] Deal Value


H1 2014
Life Tech.
Target[Thermo-Fisher]
[Acquiror]
Deal $13.6bn
Value
H1[P.
2014
Ortho-Clinical
Equity] $4.2bn
Life
Tech.
[Thermo-Fisher]
Transitions Optical [Essilor]$13.6bn
$1.9bn
H1[P.
2014
Ortho-Clinical
Equity] $4.2bn
NVS
Blood Diag.
[Grifols]
$1.7bn
Life
Tech.
[Thermo-Fisher]
$13.6bn
Transitions
Optical
[Essilor]
$1.9bn
ArthroCare
[S&N]
$1.5bn
Ortho-Clinical
[P. [Grifols]
Equity] $4.2bn
NVS
Blood Diag.
$1.7bn
Transitions
Optical
[Essilor]
ArthroCare
[S&N]
$1.5bn
H1 2014 vs. $1.9bn
NVS Blood Diag.H1
[Grifols]
2013 $1.7bn
ArthroCareH1
[S&N]
2014$1.5bn
vs.
H1 2013
106 H1 2014 vs.
H1 2013 95

2010
Alcon* [NVS] $28bn
2012
2010$2.6bn
ev3 [COV]
Synthes [JNJ] $19.7bn
Alcon* [NVS] $28bn
Gen-Probe2012
[HOL] $3.7bn
2010$2.6bn
ev3 [COV]
Synthes [JNJ] $19.7bn
Alcon* [NVS] $28bn
Gen-Probe2012
[HOL] $3.7bn
106
ev3 [COV] $2.6bn
2011 Synthes [JNJ] $19.7bn
2013
Genzyme* [SAN]:Gen-Probe
$20.1bn [HOL] $3.7bn
B&L [Valeant] $8.7bn
106
2011 $9.6bn
2013 $3.9bn
Alcon* [NVS]
Gambro [Baxter]
Genzyme*
B&L [Valeant]
Beckman C[SAN]:
[DHR]$20.1bn
$6.8bn
MAKO
[Stryker]$8.7bn
$1.7bn
2011 $9.6bn
2013
Alcon*
[NVS]
Gambro [Baxter]
Conceptus
[Bayer]$3.9bn
$1.1bn
Kinetic
C [P.
Equity] $6.1bn
Genzyme*
B&L [Valeant]
Beckman C[SAN]:
[DHR]$20.1bn
$6.8bn
MAKO
[Stryker]$8.7bn
$1.7bn
Alcon*
[NVS]
$9.6bn
Gambro [Baxter]
Conceptus
[Bayer]$3.9bn
$1.1bn
Kinetic
C [P.
Equity]
$6.1bn
C [DHR] $6.8bn $46bn MAKO $28bn
[Stryker] $1.7bn $7bn
$51bn Beckman$78bn
Conceptus [Bayer] $1.1bn
Kinetic C [P. Equity] $6.1bn

95
95

300
250
250
250
200
200
200
150
150
150
100

DealDeal
Count
Deal
Count
Count

DealDeal
Value
Deal
Value
($bn)
Value
($bn)
($bn)

EvaluateMedTech found that total medtech M&A deal values came to $30bn in H1 2014, an increase of 363% on the $7bn in H1 2013.
M&A
Analysis:
2009
to H1
2014
M&A in
Deal
Value
by a Massive
H1 2014,
Despite the growth
deal
value,Jumps
the number
of overall363%
dealsinactually
fell though
by 10%Deal
to 95Count
in H1 Falls
2014.by 10%
EvaluateMedTech
found2009
that totalto
medtech
M&A deal values came to $30bn in H1 2014, an increase of 363% on
M&A
Analysis:
H1
2014
M&A
Deal
Value
Jumps
by
a
Massive
363%
in
H1
2014,
though
Deal
Count
Falls
by by
10%
This massive hike
in
H1
2014
vs
H1
2013
was
largely
due
to
the
major
acquisitions
of
Life
Technologies
Thermo-Fisher
and
the $7bn in H1 2013. Despite the growth in deal value, the number of overall deals actually
fell
by 10% to 95for
in $13.6bn,
H1
EvaluateMedTech
found
thatCarlyle
total medtech
M&A
deal values came to $30bn in H1 2014, an increase of 363% on
J&Js Ortho-Clinical
Diagnostics
unit
by The
Group
for
$4.2bn.
2014.
M&A
Deal
Value
Jumps
by
a
Massive
363%
in
H1
2014,
though
Deal
Count
Falls
by
10%
the
in H1hike
2013.
Despite
theH1
growth
inwas
deallargely
value, the to
number
of overall
deals actually
fell by 10% toby
95 in H1
This$7bn
massive
inand
H1
2014
2013
the
major
of2014,
Life
Technologies
EvaluateMedTech
found
thatvs
total medtech
M&A dealdue
values
came
to acquisitions
$30bn
in H1
an increase
of 363%
on and
The ongoing Medtronic/Covidien
Zimmer/Biomet
megamergers,
though,
will
dwarf
these
earlier
acquisitions.
Worth
$42.9bn
2014.
Thermo-Fisher
for $13.6bn,
and
J&J's
Ortho-Clinical
Diagnostics
unit
by
The deals
Carlyleactually
Group fell
for by
$4.2bn.
the
$7bn
in
H1
2013.
Despite
the
growth
in
deal
value,
the
number
of
overall
10%
to
95 in H1
This ongoing
massive
hike
H1 change
2014 vsthe
H1
2013
dueindustry.
to the major
acquisitions
of Life
Technologies
by
$13.4bn, respectively,
theseMedtronic/Covidien
dealsinwill
face
ofwas
the largely
medtech
The
and
Zimmer/Biomet
megamergers,
though,
will
dwarf
these
earlier
acquisitions.
2014.
Thermo-Fisher
for $13.6bn,
and J&J's Ortho-Clinical
Diagnostics
unit
The
Groupindustry.
for $4.2bn.
Worth
$42.9bnhike
and
these
deals
will change
theby
face
ofCarlyle
the medtech
This ongoing
massive
in$13.4bn,
H1 2014respectively,
vs H1
was
largely
due
to the major
acquisitions
of Life
Technologies
by
The
Medtronic/Covidien
and2013
Zimmer/Biomet
megamergers,
though,
will dwarf
these
earlier acquisitions.
Thermo-Fisher
for $13.6bn,
J&J's Ortho-Clinical
Diagnostics
The
Groupindustry.
for $4.2bn.
Worth $42.9bn and
$13.4bn,and
respectively,
these deals
will changeunit
theby
face
ofCarlyle
the medtech
The
ongoing
Medtronic/Covidien
andTotal
Zimmer/Biomet
megamergers,
though,
will dwarf these earlier acquisitions.
Count
of Medtech
M&A Deals vs.
Medtech M&A
Value (2009
- H1 2014)
Worth $42.9bn and $13.4bn, respectively, these deals will change the face of the medtech
industry.
Target [Acquiror]
(Deal Value)
Source:
EvaluateMedTech
(18
SEP
2014)
Count of Medtech M&A Deals vs. Total Medtech M&A Value (2009 - H1 2014)
80
Target
[Acquiror]
(Deal Value)300
Source: EvaluateMedTech
SEP 2014)
270(18vs.
Count
of Medtech M&A Deals
Total
Target [Acquiror] Deal Value
263Medtech M&A Value (2009 - H1 2014)
80
Target [Acquiror] (Deal Value)300
Source: EvaluateMedTech
270(18 SEP 2014)

100
100
50
50

$30bn

$51bn
2010
$51bn
2010

$78bn
$46bn
2011
2012
$78bn
$46bn
2011
Deal Value ($bn) 2012

$28bn
2013
$28bn
2013
Deal
Count

$7bn
H1 2013
$7bn
H1
2013

$30bn
H1 2014
$30bn
H1
2014

2010

2011
Deal
Value ($bn) 2012

2013
Deal
Count

H1 2013

H1 2014

50
0
0
0

Count of Medtech Closed M&A Deals vs. Total Medtech M&A Value (2009 - H1 2014)
Deal Value ($bn)
Deal Count
Count
Closed M&A
M&ADeals
Dealsvs.
vs.Total
TotalMedtech
MedtechM&A
M&A
Value
(2009
2014)
Count of
of Medtech
Medtech Closed
Value
(2009
- H1- H1
2014)
2010
2011
2012
2013 H1 2013
Period
Count of Medtech Closed2009
M&A Deals
vs. Total
Medtech
M&A
Value (2009 178
270
263
241
207
Deal
Count
2009
2010
2011
2012
2013
H1106
2013
Period
% Chg.
52%
-3%
-8%
-14%
178
270
263
241
207
106
Deal
Count
2009
2010
2011
2012
2013
H1
2013
Period
Deal
Value ($bn)
13
51
78
46
28
7
% Chg.
52%
-3%
-8%
-14%
178
270
263
241
207
106
Deal
Count
%
Chg.
285%
53%
-41%
-38%
Deal Value ($bn)
13
51
78
46
28
7
% Chg.
52%
-3%
-8%
-14%
% Chg.
285%
53%
-38%2014)
Top
10 Medtech
on Deal-41%
Value (H1
Deal
Value
($bn) M&A Deals13Closed:51Ranked78
46
28
7
Top
10 Medtech M&A Deals Closed:
Ranked
on Deal-41%
Value (H1
% Chg.
285%
53%
-38%2014)

H1 2014
H1
2014)
H1 95
2014
-10%
95

H1 30
2014
-10%
95
363%
30
-10%
363%
30
363%

Copyright 2014 Evaluate Ltd. All rights reserved.

Country
(Status)
Acquiror
Top
10
DealsClosed:
Closed:Ranked
Ranked
onDeal
DealValue
Value
(H12014)
2014)
TopTarget
10Medtech
Medtech M&A
M&A Deals
on
(H1
1 Life
Technologies
USA
(Listed)
Target
Country
(Status)
2
Ortho-Clinical
Diagnostics
USA
1 Life
Technologies
USA (Unit)
(Listed)
Target
Country
(Status)
3
Transitions Optical
USA (Unit)
(Private)
2 Ortho-Clinical
Diagnostics
USA
1
Life
Technologies
USA (Unit)
(Listed)
4
Novartis
Blood
Transfusion
Diagnostics
USA
3 Transitions Optical
USA (Private)
2
Diagnostics
USA
(Unit)
5 Ortho-Clinical
ArthroCare
USA (Unit)
(Listed)
4
Novartis
Blood Transfusion Diagnostics
USA
3
Transitions
Optical
USA
(Private)
6
Given
Imaging
Israel
(Listed)
5 ArthroCare
USA (Listed)
4
Blood
Transfusion
Diagnostics
USA
(Unit)
7 Novartis
BarrierSafe
Solutions
International
USA
6
Given
Imaging
Israel(Private)
(Listed)
5
USA
(Listed)
8 ArthroCare
BioFire Diagnostics
USA (Private)
(Private)
7
BarrierSafe
Solutions International
USA
6
Given
Imaging
Israel
(Listed)
9
IQuum Diagnostics
USA
8 BioFire
USA (Private)
(Private)
7 BarrierSafe
Solutions International
USA
(Private)
10
Coastal
Contacts
Canada
(Listed)
9 IQuum
USA (Private)
8 BioFire
USA (Private)
Other Diagnostics
10 Coastal
Contacts
Canada (Listed)
9 Total
IQuum
USA (Private)
Other
10
Coastal
Contacts
Canada (Listed)
Source:
TotalEvaluateMedTech (18 SEP 2014)
Other
Note:
Analysis
based on closing
deal.
Source:
EvaluateMedTech
(18 date
SEP of
2014)
Total

Thermo
AcquirorFisher Scientific
The Carlyle
Group
Thermo
Fisher
Scientific
Acquiror
Essilor
International
The Carlyle
Group
Thermo Fisher Scientific
Grifols
Essilor International
The
Carlyle
Group
Smith
& Nephew
Grifols
Essilor International
Covidien
Smith & Nephew
Grifols
Ansell
Covidien
Smith
& Nephew
bioMrieux
Ansell
Covidien
Roche
bioMrieux
Ansell
Essilor
Roche International
bioMrieux
Essilor International
Roche
Essilor International

Completion
Deal
Date
Value
($m)
Completion
Deal
03 Date
Feb 14 Value
13,600
($m)
Completion
Deal
30 Feb
Jun 14
4,150
03
14
13,600
Date
Value
($m)
01 Jun
Apr 14
1,855
30
14
4,150
03
Feb
14
13,600
09
Jan
14
1,675
01 Apr 14
1,855
30 May
Jun 14
4,150
29
14
1,500
09 Jan 14
1,675
01
Apr
14
1,855
27 May
Feb 14
860
29
14
1,500
09
Jan
1,675
03 Feb
Jan 14
14
615
27
14
860
29
14
1,500
16 May
Jan 14
14
450
03
Jan
615
27
Feb 14
14
860
10
450
16 Jun
Jan 14
450
03
14
615
28 Jan
Apr 14
393
10
Jun
14
450
16 Jan 14
450
4,720
28 Apr 14
393
10 Jun 14
450
30,268
4,720
28 Apr 14
393
30,268
4,720
30,268

*Alcon
& Genzyme
included
in analysis
>25% of company sales are derived from medtech.
Note: Analysis
based
on closing
date ofas
deal.
*Alcon & Genzyme included in analysis as >25% of company sales are derived from medtech.
Note: Analysis based on closing date of deal.
*Alcon & Genzyme included in analysis as >25% of company sales are derived from medtech.

Source:EvaluateMedTech
EvaluateMedTech
2014)
Source:
(18(18
SEPSEP
2014)

Note: Analysis based on closing date of deal.

18

*Alcon & Genzyme included in analysis as >25% of company sales are derived from medtech.

18
18

18

Venture Financing Analysis:


2009 to H1 2014
Venture Financing Analysis: 2009 to H1 2014

Value of Venture
Financing
Falls 16% in H1
2014; Deal Count
Decreases
Venture
Financing
Analysis:
2009
to H124%
2014

Valuefound
of Venture
Financing
Falls
inthe
H1 value
2014;
Dealnumber
Count
24%
Venture
Financing
Analysis:
2009
to
H1Decreases
EvaluateMedTech
significant
decreases
in16%
both
and
of2014
venture financing
deals in H1 2014 vs H1 2013. The total
EvaluateMedTech
found significant
decreases
in both
the
value
and
number
of venture
financing
deals in H1
2014
Value ofventure
Venturefinancing
Financing
16%
H1 2014;
Deal
Count
Decreases
24%
deal value of medtech
fellFalls
by 16%
toin$2.2bn,
whilst
the
number
of venture
financing
deals slumped
24%
to 199.
vs H1 2013. The total
dealsignificant
value of medtech
venture
financing
felland
by 16%
to $2.2bn,
whilst
the number
EvaluateMedTech
found
decreases
in both
the value
number
of venture
financing
dealsofinventure
H1 2014

ofsecured
Venture
Financing
Falls 16%
in H1in2014;
Dealraising
Count $120m
Decreases
24% G offering in June to help fund development
Proteus Digital Value
Health
the
largest
financing
round
H1 2014,
intoa $2.2bn,
Series
financing
deals
slumped
24%
to 199.
vs
H1 2013.
The
total
deal
value
of medtech
venture
financing
felland
by 16%
whilst
the number
EvaluateMedTech
found
significant
decreases
in both
the value
number
of venture
financing
dealsofinventure
H1 2014
of its digital health
feedback
system.
Proteus Digital
secured
largest financing round in H1 2014, raising $120m in a Series G offering in June
financing
deals Health
slumped
24% tothe
199.
vs H1 2013. The total deal value of medtech venture financing fell by 16% to $2.2bn, whilst the number of venture
to
help fund
development
of itstothe
digital
health
feedback
system.
Proteus
Digital
Health
secured
largest
financing
round
in H1 2014, raising $120m in a Series G offering in June
financing
deals
slumped
24%
199.
to
help fund
development
of its the
digital
health
feedback
system.
Proteus
Digital
Health secured
largest
financing
round
in H1 2014, raising $120m in a Series G offering in June
to help fund
development
of its Deals
digital health
feedback
system.
Count
of Financing
vs. Total
Financing
Value (2009 - H1 2014)
Source:ofEvaluateMedTech
(18Total
SEP Financing
2014)
Count
Financing Deals vs.
Value (2009 - H1 2014)
5000 Source: EvaluateMedTech (18 SEP 2014)
700
Count of Financing Deals vs. Total Financing Value (2009 - H1 2014)

DealDeal
Value
Deal
Value
($m)
Value
($m)
($m)

4000
4000
4000
3000
3000

700

Source: EvaluateMedTech (18


SEP 2014)
$4,805m
$4,670m
$4,670m

5000
$3,938m
$3,938m
$3,938m
407
407

3000

$4,670m
449
449

$4,805m
$4,805m
524
524

$4,162m
$4,162m
$4,162m
429
429

524

449

700
600
600

$4,586m
$4,586m
$4,586m
458
458

H1 2013
H1 2014 vs.
H1 2013

458

429

407

600
500
500

H1 2014 vs.
2013
H1H1
2014
vs.

$2,630m
$2,630m
262
$2,630m
262

2000
2000
2000

262

1000
1000

500
400
400

$2,206m
$2,206m
199
$2,206m
199
199

1000
0
0
0

2009
2009

2010
2010

2009

2010

2011
2011
Deal Value
2011
Deal Value

2012
2012

2013
2013
Deal Count
2012 Deal Count
2013

H1 2013
H1 2013

H1 2014
H1 2014

H1 2013

H1 2014

400
300
300

DealDeal
Count
Deal
Count
Count

5000

300
200
200
200
100
100
100
0
0
0

Count of Medtech Financing Deals vs. Total


Value
(2009
DealFinancing
Value
Deal
Count- H1 2014)

Count
MedtechFinancing
FinancingDeals
Deals
vs.
Total
Financing
Value
(2009
H1 2014)
Count of
of Medtech
vs.
Total
Financing
Value
(2009
- H1- 2014)
H1

Count of Medtech Financing Deals


- H1 2014)
2009vs. Total
2010 Financing
2011 Value
2012 (2009
2013
2013
H1

Copyright 2014 Evaluate Ltd. All rights reserved.

Period
Deal Count
Period
% Chg.
Deal
Count
Period
Deal
Value
% Chg.
Deal
Count ($m)
% Chg.
Chg.
Deal
Value ($m)
%
% Chg.
Deal
Value ($m)

2009
407

2010
449

2011
524

2012
429

2013
458

407
2009

10%
449
2010

17%
524
2011

-18%
429
2012

7%
458
2013

3,938
407
3,938

4,670
10%
449
19%
4,670
10%

4,805
17%
524
3%
4,805
17%

4,162
-18%
429
-13%
4,162
-18%

4,586
7%
458

2013
262
H1
262
2013

H1
2014
H1
2014
199
H1
-24%
199
2014

2,630
262
2,630

2,206
-24%
199
-16%
2,206
-24%

19%
3%
-13%
3,938
4,670
4,805
4,162
Top 10 Medtech Venture Financing
Deals:
Ranked
on Deal
Value (H1 2014) 2,630
% Chg.
19%
3%
-13%
10%
Top 10 Medtech Venture Financing Deals: Ranked on Deal
Value (H1
2014)

-16%
2,206

10%
4,586
7%
10%
4,586

Financing
Top10
10 Medtech
Medtech Venture
Ranked onon
Deal
Value
(H1 (H1
2014)
Top
VentureFinancing
FinancingDeals:
Deals:
Deal
Value
2014)
PrimaryRanked
Focus
Companty
Country
Round
Financing
1 Proteus
Digital Health
Patient Monitoring
USA
Series
G
Primary
Focus
Companty
Country
Round
Financing
2 Proteus
Adaptive
Biotechnologies
In Vitro Monitoring
Diagnostics
USA
1
Digital
Health
Patient
G
Primary
Focus
Companty
Country Series
RoundD
3 Proteus
Halt Medical
Obs.
& Gyne.
2
Adaptive
Biotechnologies
In
Vitro
Diagnostics
USA
Series
D
1
Digital
Health
Patient
Monitoring
USA
Series E
G
4
GC
Aesthetics
General
& Plastic Surgery
Ireland
Series
3
Medical
Obs.
& Gyne.
USA
E
2 Halt
Adaptive
Biotechnologies
In Vitro
Diagnostics
USA
Series A
D
5 Halt
Advanced
Accelerator Applications
Diagnostic
Imaging
France
Undisclosed
4
GC
Aesthetics
General
& Plastic
Surgery
Ireland
Series
3
Medical
Obs.
& Gyne.
USA
Series A
E
6
InSightec
Israel
Series A
D
5
Accelerator Applications
Diagnostic
Imaging
France
Undisclosed
4 Advanced
GC Aesthetics
General & Plastic
Surgery
Ireland
Series
7
AqueSys
Ophthalmology
USA
6
Diagnostic
Imaging
Israel
Series D
5 InSightec
Advanced Accelerator Applications
Diagnostic
Imaging
France
Undisclosed
8 InSightec
Holaira
Anesth. & Resp.
7
AqueSys
Ophthalmology
USA
Series D
D
6
Diagnostic
Imaging
Israel
Series
9
Inspire
Medical Systems
E
8
Anesth.
& Resp.
USA
Series
7 Holaira
AqueSys
Ophthalmology
USA
Series D
D
10
Medical
General
& Resp.
Plastic Surgery
USA
Series
9
Inspire
Systems
Anesth.
8 Benvenue
Holaira Medical
Anesth. &
&
Resp.
USA
Series E
D
Other Medical
10
Medical
General
& Resp.
Plastic Surgery
USA
Series
9 Benvenue
Inspire
Systems
Anesth. &
USA
Series E
E
Other
Total
10 Benvenue
Medical
General & Plastic Surgery
USA
Series E
TotalEvaluateMedTech (18 SEP 2014)
Source:
Other

-16%

Date
02 Date
Jun 14
07Date
Apr 14
02
Jun
01
Apr 14
07 Jun
02
14
21
01
Apr
07 Feb
Apr 14
14
17
14
21
01 Feb
Apr 14
30 Feb
Jun 14
17
21
Feb
14
16 Feb
Jan 14
30
Jun
17
14
03 Jun
Apr 14
16
Jan
30
14
15
14
03 May
Apr 14
16
Jan
14
18
Jun
14
15
14
03 May
Apr 14
18 May
Jun 14
15
14
18 Jun 14

Deal
Value
($m)
Deal
120($m)
Value
Deal
100($m)
120
Value
93
100
120
60
93
100
56
60
93
50
56
60
44
50
56
42
44
50
40
42
44
40
42
40
1,562
40
2,206
1,562
40
2,206
1,562

Source:
EvaluateMedTech
SEP 2014)
Total
2,206
Note:
Includes
investments in(18
medtech
companies only. Does not include pharmaceutical or biotech companies.
Includes
Privateinvestments
Investment in
in
Public
Source:
EvaluateMedTech
(18
SEP Equity
2014) (PIPE).
Note:
Includes
medtech
Source: EvaluateMedTech (18 SEP 2014)companies only. Does not include pharmaceutical or biotech companies.
Includes
Privateinvestments
Investment in
in medtech
Public Equity
(PIPE).only. Does not include pharmaceutical or biotech companies.
Note: Includes
companies
Includes Private Investment in Public Equity (PIPE).

Note: Includes investments in medtech companies only. Does not include pharmaceutical or biotech companies. Includes Private Investment
in Public Equity (PIPE).
19
19
19

19

IPO Analysis:
2013 and 2014
Medtech IPO Activity Picks Up from Q4 2013; $1.3bn Raised in H1 2014

IPOfound
Analysis:
2013
and
2014
EvaluateMedTech
a significant
increase
in IPO
activity in the medtech space in 2014, in terms of both value and number of closed
deals. By the end Medtech
of H1 2014
$1.3bn
had
been
raised
in
completed IPOs, which is 44% more than the $900m raised in the whole of 2013.
IPO Activity Picks Up from Q4 2013; $1.3bn Raised in H1 2014

foundHealth,
a significant
increase in
activity in
the medtech
space inin
2014,
in terms
both
value double that raised
The largest IPO in EvaluateMedTech
H1 2014 was Castlight
a healthcare
ITIPO
company,
which
raised $204m
March.
This ofwas
almost
IPO
2013
2014
andAnalysis:
number of closed
deals. and
By the end
of H1 2014 $1.3bn had been raised in completed IPOs, which is 44% more
by the second ranked
maker
K2M, which raised $120m in May.
thancompany,
the $900m spinal
raised device
in the whole
of 2013.
The largest
IPO
in H1 2014
a healthcare
ITin
company,
Medtech
IPO
Activity
Pickswas
UpCastlight
from
Q4 Health,
2013; $1.3bn
Raised
H1 2014which raised $204m in March. This was
IPO
Analysis:
2013
and
2014
almost
double that raised
the
second
ranked company,
spinal
makerspace
K2M, which
raised
$120m
in May.
EvaluateMedTech
foundby
a significant
increase
in IPO activity
in device
the medtech
in 2014,
in terms
of both
value

10

800
700
500
700
600

12

400
600
500
300
500
400

6
7

100
300
200

5
$200m

0
200
100

Q1 2013
$200m

8
12
10
6
10
8

10

4
8
6

4
6

7
2
6
4

$123m

4
$182m

$395m

$597m

$694m

Q2 2013

4
Q3 2013

Q4 2013

Q1 2014

Q2 2014

$123m

Deal
Value
$182m

$597m

$694m

Deal
Count
$395m

Count of Medtech
IPO Deals vs.
2013 - Q2 2014)
Q1 2013
Q2Total
2013 IPO Value
Q3(Q1
2013
Q4 2013

Copyright 2014 Evaluate Ltd. All rights reserved.

12

200
400
300

100
0

10

10
14
12

Q1 2014
$200m
$123m
$182m
$395m
$597m
0
Q1
Q2 Deal Value
Q3
Q4 Count Q1
Q2
Deal
Q1 2013
Q2 2013
Q3 2013
Q4 2013
Q1 2014
2013
2013
2013
2013
2014
2014
Quarter
Count
ofMedtech
Medtech
IPO
Deals
vs.
IPO
Value
(Q1
2013
2014)
Count
of
IPO
Deals
vs. Total
IPO Value
(Q1
2013
2014)
5 Total
7 Deal
4 - Q2
6- Q2
10
12
Deal
Count
Value
Deal
Count
% Chg. from previous quarter
40%
-43%
50%
67%
20%
Q1
Q2
Q3
Q4
Q1
Q2
Count
of Medtech
IPO Deals vs. Total
Deal
Value
($m)
200 IPO Value
123 (Q1 2013
182 - Q2 2014)
395
597
694
2013
2013
2013
2013
2014
2014
Quarter
% Chg. from previous quarter
-39%
48%
118%
51%
16%
5
7
4
6
10
12
Deal Count
Q1
Q2
Q3
Q4
Q1
Q2
% Chg.
from previous
40%
-43%
50%
67%
20%
2013on Deal2013
2013
2014
2014
Quarter
Top
10 Medtech
IPOquarter
Deals: Ranked
Value (H12013
2014)
Value ($m)
200
123
182
395
597
694
5
7
4
6
10
12
Deal Count
-39%
48%
118%
51%
16%
% Chg. from previous quarter
40%
-43%
50%
67%
20%
Country
Stock
Primary
DealCompany
Value ($m)
200
123 Focus 182
395
597Exchange694
Top
10 Medtech IPO Deals: Ranked on Deal
ValueIT(H1 2014) USA
1
Healthcare
NYSE
%Castlight
Chg. fromHealth
previous quarter
-39%
48%
118%
51%
16%
2 K2M
Orthopedics
USA
Nasdaq
Top
10
Medtech
IPO
Deals:
Ranked
on
Deal
Value
(H1
2014)
Top
10
Medtech
IPO
Deals:
Ranked
on
Deal
Value
(H1
2014)
3 Horizon Discovery
In Vitro Diagnostics
UK
LSE AIM
Company
Country
Stock Exchange
Primary Focus
4 Materialise Group
3D Printing
Belgium
Nasdaq
1 Castlight Health
Healthcare IT
USA
NYSE
5 TriVascular Technologies
Cardiology
USA
Nasdaq
2 Company
K2M
Orthopedics
USA
NasdaqExchange
Country
Stock
Primary Focus
6 CYBERDYNE
Rehabilitation
Japan
Tokyo Stock Exchange
3 Castlight
Horizon Discovery
In Vitro Diagnostics
UK
LSE
AIM
1
Health
Healthcare
IT
USA
NYSE
7 Inogen
Respiratory
USA
Nasdaq
4 K2M
Materialise Group
3D Printing
Belgium
2
Orthopedics
USA
Nasdaq
8 Supersonic Imagine
Diagnostic Imaging
France
NYSE Euronext
5 Horizon
TriVascular
Technologies
Cardiology
USA
Nasdaq
3
Discovery
In
Vitro Diagnostics
UK
LSE AIM
9 Lombard Medical Technologies
Cardiology
UK
Nasdaq
6
Rehabilitation
Japan
Tokyo Stock Exchange
4 CYBERDYNE
Materialise Group
3D Printing
Belgium
Nasdaq
10 Vital Therapies
Liver Disorders
USA
Nasdaq
7 TriVascular
Inogen
Respiratory
5
Technologies
Cardiology
USA
Nasdaq
Other
8
Imagine
Diagnostic
Imaging
France
NYSE
6 Supersonic
CYBERDYNE
Rehabilitation
Japan
Tokyo Euronext
Stock Exchange
Total
9
Cardiology
UK
Nasdaq
7 Lombard
Inogen Medical Technologies
Respiratory
USA
Source:
EvaluateMedTech
(18
SEP
2014)
10
Therapies
Liver
Disorders
USA
Nasdaq
8 Vital
Supersonic
Imagine
Diagnostic
Imaging
France
NYSE Euronext
Note:
Does Medical
not include
pharmaceutical or biotech
companies. UK
Other
9 Lombard
Technologies
Cardiology
Nasdaq
10 Total
Vital Therapies
Liver Disorders
USA
Nasdaq
OtherEvaluateMedTech (18 SEP 2014)
Source:
Total
Note:
Does not include pharmaceutical or biotech companies.

Source: EvaluateMedTech (18 SEP 2014)


Source: EvaluateMedTech (18 SEP 2014)
Note: Does not include pharmaceutical or biotech companies.

Deal Count
Deal Count
Deal Count

Deal Value
Deal Value
($m) Deal
($m)Value ($m)

and number of closed deals. By the end of H1 2014 $1.3bn had been raised in completed IPOs, which is 44% more
Medtech
IPO Activity
Picks
Up from
Q4 2013; $1.3bn Raised in H1 2014
than the $900m
raised in
the whole
of 2013.
Quarterly
Count
IPOCastlight
Dealsincrease
vs.
Total
Value
2013
- Q2which
2014)
EvaluateMedTech
found
significant
inaIPO
activity(Q1
in the
medtech
space
in 2014,
in terms
of both
The largest
IPO in H1
2014aof
was
Health,
healthcare
IT
company,
raised
$204m
in March.
Thisvalue
was
and
number
of
closed
deals.
By
the
end
ofSEP
H1 2014
$1.3bn
had been
raised
in K2M,
completed
is 44%
more
Source:
EvaluateMedTech
(18
2014)
almost double that raised by the second ranked
company,
spinal
device
maker
whichIPOs,
raisedwhich
$120m
in May.
than
800 the $900m raised in the whole of 2013.
14
The largest IPO in H1 2014 was Castlight Health, a healthcare IT company, which raised $204m in March. This was
almost double
that
raised
by
the
second
ranked
company,
spinal
device
maker
K2M,
which
raised
$120m
in
May.
Quarterly Count of IPO Deals vs. Total IPO Value (Q1 2013 - Q2 2014)
700
12
Source: EvaluateMedTech (18 SEP 2014)
12
800
14
Quarterly Count of IPO Deals vs. Total IPO Value (Q1 2013 - Q2 2014)
600
Source: EvaluateMedTech (18 SEP 2014)

0
4
2
2
0

Q2 2014
$694m
0
Q2 2014

Date
14 Mar 14
13 May 14
27 Mar 14
Date
25 Jun 14
14 Mar 14
16 Apr 14
13 Date
May 14
26 Mar 14
27 Mar 14
14
14 Feb 14
25 May
Jun 14
13
14
10 Jun 14
16 Mar
Apr 14
27
25 Apr 14
26
25 Mar
Jun 14
17 Apr 14
14
16 Feb
Apr 14
10 Mar
Jun 14
26
25 Feb
Apr 14
14
17 Jun
Apr 14
10
25 Apr 14
17 Apr 14

Deal
Value ($m)
204
120
Deal
114
Value ($m)
110
204
Deal
101
120($m)
Value
88
114
204
71
110
120
69
101
114
63
88
110
62
71
101
285
69
88
1,288
63
71
62
69
63
285
62
1,288
285
1,288

20

20

Note: Does not include pharmaceutical or biotech companies.

20

20

Enterprise Value & Focus Analysis:


2014 Latest vs. 2013
General Electric Number 1 in Latest Enterprise Value Rankings
EvaluateMedTech found US giant General Electric to be the largest company, judged by enterprise value, operating in the medtech space.
Focus
Analysis:
Latest
vs. 2013
With a figure ofEnterprise
$509bn as at 17 Value
SEP 2014,&
is a long way
ahead of the 2014
second ranked
company,
Johnson & Johnson, which has an
Enterprise
Value
&GEFocus
Analysis:
2014
Latest
vs. 2013
enterprise value of $285bn.
General Electric Number 1 in Latest Enterprise Value Rankings

The analysis includes


only
medtech
companies
that
are forecast
totohave
sales
in excess
of $1bn
in 2020.
EvaluateMedTech
found
US
General
Electric
beRankings
the
largest
company,
judged
by enterprise value, operating
General
Electric
Number
1
ingiant
Latest
Enterprise
Value
in the medtech space. With a figure of $509bn as at 17 SEP 2014, GE is a long way ahead of the second ranked

EvaluateMedTech
found US
giant General
Electric toand
be the
largestatcompany,
enterprise
value, operating
The highest ranking
pure-play
medtech
companies
are an
Medtronic
Covidien
positionsjudged
11 andby
12,
with enterprise
values of $63bn and
company,
Johnson
& Johnson,
which
enterprise
value
of $285bn.
in
the medtech
space.
With a figure
of has
$509bn
as at 17 SEP
2014,
GE is a long way ahead of the second ranked
$61bn, respectively.
Upon
completion
of
their
proposed
merger,
the
new
entitys
combined
enterprise
value
of
$124bn would move up to
The
analysis
includes
only
medtech
companies
that
are
forecast
to
have
sales
in
excess
of
$1bn
in
2020.
company, Johnson & Johnson, which has an enterprise value of $285bn.
The
highest ranking
medtech
companies
Covidien
positions
11 and
12, with enterprise
number 8 in the
rankings.
The
analysis
includespure-play
only medtech
companies
thatare
areMedtronic
forecast toand
have
sales inatexcess
of $1bn
in 2020.
values
of $63bn
andpure-play
$61bn, respectively.
Upon completion
of their
proposed
merger,
the new
medtech companies
are Medtronic
and
Covidien
at positions
11 entity's
and 12,combined
with enterprise
The
highest
ranking
enterprise
value and
of $124bn
move upUpon
to number
8 in the
values
of $63bn
$61bn,would
respectively.
completion
of rankings.
their proposed merger, the new entity's combined
enterprise value of $124bn would move up to number 8 in the rankings.
WW Ranking on Enterprise Value in 2014 (Latest)
Source:
EvaluateMedTech
SEP
WW
Ranking
on Enterprise (18
Value
in2014)
2014 (Latest)
Source: EvaluateMedTech (18 SEP 2014)
600
+20%

+16%
+16%

400
400

+18%
+18%
+12%
+12%

+15%
+15%

+9%
+9%

300
300

-5%
-5%

$64bn
$64bn

$66bn
$66bn

Abbott
Abbott
Laboratories
Laboratories

$98bn
$98bn

Thermo
Thermo
Fisher
Fisher
Scientific
Scientific

$132bn
$132bn

3M3M

$136bn
$136bn

Bayer
Bayer

$171bn
$171bn

Siemens
Siemens

$230bn
$230bn

Sanofi
Sanofi

$279bn
$279bn

Novartis
Novartis

$285bn
$285bn

Roche
Roche

-6%
-6%
$509bn
$509bn

+0%
+0%

-3%
-3%

-6%
-6%

+10%
+10%
+5%
+5%

+4%
+4%

Johnson
& &
Johnson
Johnson
Johnson

0
0

+13%
+13%

Return: +8%

200
200
100
100

+11%
+11%

S&P 2014 YTD


Return:
S&P
2014+8%
YTD

-10%
-10%

Share
Price
Performance
YTD
(%)(%)
Share
Price
Performance
YTD

+20%

500
500

General
General
Electric
Electric

Enterprise
Value
($bn)
Enterprise
Value
($bn)

600

-15%
-15%

Enterprise Value: Top 20 Medtech Companies in 2014 (2020 Sales: >$1bn)

Copyright 2014 Evaluate Ltd. All rights reserved.

Enterprise
Value: Top
Top20
20Medtech
MedtechCompanies
Companies
2014
(2020
Sales:
>$1bn)
Enterprise Value:
in in
2014
(2020
Sales:
>$1bn)
Company
Country
General Electric
Country
USA
1 Company
JohnsonElectric
& Johnson
USA
12 General
USA
Roche & Johnson
23 Johnson
USA
Switzerland
Novartis
34 Roche
Switzerland
Switzerland
Sanofi
45 Novartis
Switzerland
France
Siemens
56 Sanofi
France
Germany
Bayer
67 Siemens
Germany
Germany
3M
78 Bayer
Germany
USA
Thermo Fisher Scientific USA
89 3M
USA
Fisher Scientific USA
Abbott Laboratories
9 Thermo
10
USA
Laboratories
Medtronic
10
USA
11 Abbott
USA
Covidien
11
USA
12 Medtronic
USA
Valeant Pharmaceuticals USA
12
13 Covidien
Canada
DanaherPharmaceuticals Canada
13
14 Valeant
USA
Baxter International
14
USA
15 Danaher
USA
International
Kimberly-Clark
15
USA
16 Baxter
USA
Allergan
16
USA
17 Kimberly-Clark
USA
Toshiba
17
USA
18 Allergan
Japan
Philips
18
Japan
19 Toshiba
The Netherlands
Stryker
19
The
20 Philips
USANetherlands
Total Top 20
20 Stryker
USA
Total
Top 20
Source:
EvaluateMedTech
(18 SEP 2014)

% '14 Sales
%
'14 Sales
Medtech
Medtech
8%

Enterprise Value ($bn)


Enterprise
Value%($bn)
2013
Latest
Growth
2013
Latest
% Growth
533
509
-4%

Share Price ($ ADR)


Share Latest
Price ($ %
ADR)
2013
Growth
2013
Latest
28.03
26.27 % Growth
-6%

8%
40%

533
247

509
285

-4%
+15%

28.03
91.59

26.27
106.19

-6%
+16%

40%
22%

247
246

285
279

+15%
+13%

91.59
278.67

106.19
312.63

+16%
+12%

22%
12%

246
204

279
230

+13%
+13%

278.67
80.38

312.63
94.72

+12%
+18%

12%
2%

204
148

230
171

+13%
+15%

80.38
51.75

94.72
56.52

+18%
+9%
+9%
-6%

2%
18%

148
127

171
136

+15%
+7%

51.75
134.29

56.52
126.63

18%
4%

127
125

136
132

+7%
+6%

134.29
142.00

126.63
137.17

-6%
-3%

4%
17%

125
96

132
98

+6%
+3%

142.00
140.25

137.17
145.37

-3%
+4%

17%
24%

96
45

98
64

+3%
+43%

140.25
111.35

145.37
123.60

+4%
+11%

24%
46%

45
58

64
66

+43%
+13%

111.35
38.33

123.60
43.38

+11%
+13%

46%
100%

58
55

66
63

+13%
+16%

38.33
57.13

43.38
65.98

+13%
+15%

100%
100%

55
33

63
61

+16%
+84%

57.13
66.08

65.98
123.31

+15%
+87%

100%
19%

33
56

61
57

+84%
+2%

66.08
117.40

123.31
121.85

+87%
+4%

19%
47%

56
54

57
55

+2%
+2%

117.40
77.20

121.85
78.73

+4%
+2%

47%
38%

54
44

55
46

+2%
+5%

77.20
69.55

78.73
72.65

+2%
+4%

38%
8%

44
44

46
45

+5%
+1%

69.55
104.46

72.65
106.72

+4%
+2%

8%
14%

44
32

45
49

+1%
+55%

104.46
111.08

106.72
170.04

+2%
+53%
+53%
+8%

14%
6%

32
30

49
35

+55%
+17%

111.08
25.41

170.04
27.38

6%
30%

30
35

35
34

+17%
-5%

25.41
35.70

27.38
30.45

+8%
-15%

30%
100%

35
27

34
31

-5%
+14%

35.70
75.14

27
2,238

31
2,445

+14%
+9%

75.14

30.45
83.94
avg.
83.94

-15%
+12%
+12%
+12%

2,238

2,445

+9%

avg.

+12%

100%

Source:
EvaluateMedTech
(18
SEP
2014)
Source:
EvaluateMedTech
SEP
2014)
Note: Includes
companies (18
with
>$1bn
medtech sales in 2020.
Valuation
basedcompanies
on share price
close and
valuation
onin17
SEP 2014.
Note:
Includes
with >$1bn
medtech
sales
2020.
Valuation based on share price close and valuation on 17 SEP 2014.
21
21

Note: Includes companies with >$1bn medtech sales in 2020. Valuation based on share price close and valuation on 17 SEP 2014.

20
20

21

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