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1 Orthopaedics Medical Device Industry Overview Market Analysis and Future Trends November 2016 Marco Berizzi Chief Financial Officer e-mail [email protected] mobile +39 342 9204033

Orthopaedics Medical Device Market Analysys and Future Trends

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Page 1: Orthopaedics Medical Device Market Analysys and Future Trends

1

Orthopaedics Medical Device Industry Overview

Market Analysis and Future Trends

November 2016

Marco BerizziChief Financial Officer

e-mail [email protected] mobile +39 342 9204033

Page 2: Orthopaedics Medical Device Market Analysys and Future Trends

Objective

• Historical perspective of Medical Device Macro

Sector and Orthopaedics Medical Device

Industry in terms of Market Size and

Competitive Landscape

• Focus on Factors driving Orthopaedics Medical

Device Industry Evolution

• Presentation of Orthopaedics Medical Device

Industry Market Size Trend

2

[email protected]

Page 3: Orthopaedics Medical Device Market Analysys and Future Trends

Agenda

• Historical perspective of Medical Device

Macro Sector and Orthopaedics Medical

Device Industry

• Business Drivers underlying Orthopaedics

Medical Device Industry Evolution

• Orthopaedics Medical Device Industry Market

Size Trend

3

[email protected]

Page 4: Orthopaedics Medical Device Market Analysys and Future Trends

In ’10 Implant Mkt accounts for ca. 25% of Medical Device Mkt with Orthopaedics having the Highest Share

4

[email protected] Note: Medical devices market data does not include Dental & Aesthetics. Cardiovascular does not include general cardiac surgerySource: Researches by health care information providers, investment banks and other analysts

Global Medical Device Market SizeGlobal Medical Device Market Size(2010;B$)

z

Orthopaedic

Cardiovascular

Opthalmic

Neurological

Pheripheral vascular

ElectrophysiologyElectrophysiology

Wound care

Surgical instruments

Infection control

Syringes

Vascular acc.Vascular acc.

Gravity adminGravity admin

Beds and transport

tools

Surgical fixt.Surgical fixt.

OtherOther

Urology and Urology and nephrology

Endoscopy

Patient monitoring

Patient monitoring

VentilationVentilation

Infusion

Hernia rep.Hernia rep.

AnestesiaAnestesia

Imaging

Energy and radiotherapy

Radio-pharma

Contrast agent

X-ray filmX-ray film

Tradiotional in vitro

diagnostics (IVD)

Point of care IVD

Molecular IVD

Non electrical diagnostic

Other

Hearing Hearing tools

Home respir.

Medical Medical non

wovens

Blood donat.

$71B

Procedural Instruments and

Devices

Imaging and Radiology

$57B

IVD and Non electrical

Diagnostics

$54B

Surgical Instrumentsand Medical

Supplies

$49B

Equipment

$44B

Other

$27B

0%

100%

50%

Tot. ca. $300B

Focus of next slides

Focus of next slides

Page 5: Orthopaedics Medical Device Market Analysys and Future Trends

In ’10 Orthopaedics Market is moderately Fragmented with a Few Number of Players covering All Segments

5

[email protected] Note: With exception of top player n° 4 focused only on “Spine and Biologics” therapeutic segmentSource: Researches by health care information providers, investment banks and other analysts

Mkt ShareMkt Share(2010;%)

Market Share by Therapeutic SegmentMarket Share by Therapeutic Segment(2010;B$;%)

• First 4 players represents ca. 50% of the market covering major* part of segments

• Small and medium size players are focused on specific segments

100%

Market Leader

Medium Player n°5

Top Player n°2

Top Player n°3

Top Player n°4

Medium Player n°6

Medium Player n°7

$11.9B

T3

ML

T2

M7

M6

OtherOther

$8.5B

T4

ML

M5

T2T2

S8S8

M6M6

S8S8

T3T3M7M7

Other

$4.0B

M5

ML

T2

M6

M7M7

T3T3

Other

$3.3B

M6

ML

S8

T2

M7M7

Other

S8

$1B

M5

M5

T2

T2

ML

ML

M7

M7

Oth

Oth

$1B

ML

ML

S8

S8

M5

M5

T3

T3

M7

M7

Oth

er

Oth

er

Hips and Knees Spine and Biologics Trauma Sport Medicine

Extrem-ities

Craniomaxilllo-

facial

0%

100%

50%

Tot. $29.6B

Other

Small Player[s] n°8Small Player[s] n°8

Page 6: Orthopaedics Medical Device Market Analysys and Future Trends

“Like-for-like” data treating M&A deals as if occurred 1st Jan 2010

Concentration of Orthopaedics Market through M&A deals occurs in ’10-’15 time interval

6

[email protected]: Researches by health care information providers, investment banks and other analysts

Mkt ShareMkt Share(2010;%)

Market Share by Therapeutic SegmentMarket Share by Therapeutic Segment(2010;B$;%)

• M&A deals concentrate almost 50% of the market in the hands of 2 players

• Concentration is particularly relevant in Hips/Knees and Spine/Biologics segments

100%

Top Player n°2

Top Player n°4

Medium Player n°6

$11.9B

ML α

T2

M6

OtherOther

$8.5B

T4

T2T2

S8S8M6M6

S8S8

Other

$4.0B

T2

M6

Other

$3.3B

M6

ML α

S8

T2

T βT β

Other

S8

$1B

T2

T2

Oth

Oth

$1B

S8

S8

Oth

er

Oth

er

Hips and Knees Spine and Biologics Trauma Sport Medicine

Extre-mities

Craniomaxilllo-

facial

0%

100%

50%

Tot. $29.6B

Other

Small Players n°8Small Players n°8

Market Leader α[Market leader +

Medium Player n°5]*

Medium

Top Player β[Top player 3 + Medium

Player n°7]*

T β

ML α

T βT β

ML α

T β

ML

αM

ML

αM

Note: * See categorization shown in previous slide

Concentration impact due to

M&A deals

Page 7: Orthopaedics Medical Device Market Analysys and Future Trends

Orthopaedics Demand is driven by Americas and Spine / Knees / Hips / Trauma Therapeutic Segments

7

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Orthopaedics Medical Device Market SizeOrthopaedics Medical Device Market Size(2010;B$;%)

Macro Business Driver

Macro Business Driver

Spine

Knees

Hips

Trauma

ExtremiteCMF

Sports med

Biologics

Americas

Europe

Asia-pacific

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Therapeutic Segments Geo Area

$29.6B $29.6B

• Americas and in particular US territory have driven and willlead evolution of orthopaedics medical device market …

• … Next chapter articulates business drivers defining orthopaedics market with special focus onUS territory

Main focus

of next

chapter

Main focus

of next

chapter

Source: Researches by health care information providers, life science information providers and other analysts

Page 8: Orthopaedics Medical Device Market Analysys and Future Trends

Agenda

• Historical perspective of Medical Device Macro

Sector and Orthopaedics Medical Device Industry

• Business Drivers underlying Orthopaedics

Medical Device Industry Evolution

• Orthopaedics Medical Device Industry Market

Size Trend

8

[email protected]

Page 9: Orthopaedics Medical Device Market Analysys and Future Trends

Specific Business Drivers determine Orthopaedics Medical Device Industry Evolution

9

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People Aging

Obesity

Activity and Inactivity

Product Innovation

Advertising

1

2

3

4

5

Public Health System Constraints

6

Hospital and Health Providers new Role

7

++++++++ --------= Positive Impact on Market Size

= Negative Impact on Market Size

++++++++

++++++++

++++++++

++++++++

++++++++

--------

--------

Orthopaedics Medical Device Industry Business Drivers

Page 10: Orthopaedics Medical Device Market Analysys and Future Trends

Almost 30% of US Population will be over 60 years old by ’45…

10

[email protected] Source: United Nations – Population Division – Department of Economic and Social Affairs – August 2016

1

US Demographic Trend by Age ClusterUS Demographic Trend by Age Cluster(2015-2045;%)

Over 60 years

20.7% 23.1% 25.2% 26.1% 26.8% 26.9% 27.4%

25% 25% 25% 24% 24% 24% 24%

60% 58% 57% 55% 54% 54% 55%

15% 17% 19% 21% 21% 22% 22%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2015 2020 2025 2030 2035 2040 2045

Over 65 years

20 - 64 years

0 - 19 years

100% 100% 100% 100% 100% 100% 100%

Page 11: Orthopaedics Medical Device Market Analysys and Future Trends

12%8%

38%

29%

29%

38%

22% 24%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1996-1998 2009-2011

Over 65 years

45 - 64 years

18 - 44 years

Under 18 years

…and People Aging will increment the Demand for Reconstructive Procedures

11

[email protected] Source: The Burden of Musculoskeletal Diseases in the United States – 2014 Report

1

Persons with Musculoskeletal Diseases by Age Cluster in USPersons with Musculoskeletal Diseases by Age Cluster in US(1996-1998 and 2009-2011;%)

100% 100%

Page 12: Orthopaedics Medical Device Market Analysys and Future Trends

Obesity is a rising Phenomenon which will affect more than 40% of US Population by ’30

12

[email protected]

Source: 2012 Elesevier – Am J Prev Med – “Obesity and Severe Obesity Forecasts Through 2030”

2

12.7%

22.1%

28.6%

30.9%

34.5%

37.4%

39.9%

42.2%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

1990 2000 2008 2010 2015 2020 2025 2030

0.9%2.6%

4.1%4.9%

6.4%7.9%

9.5%11.1%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

1990 2000 2008 2010 2015 2020 2025 2030

Obesity incidence on US Pop. ≥

Obesity incidence on US Pop. (1990-2030;%;BMI ≥30)

Severe Obesity incid. on US Pop. ≥ 4

Severe Obesity incid. on US Pop. (1990-2030;%;BMI ≥ 40)

Note: Study conducted in 2009 and 2010 with data from 1990 to 2008, sampling non pregnant adults aged ≥ 18 years and using non linear regression model

Page 13: Orthopaedics Medical Device Market Analysys and Future Trends

Major Part of Hip and Knee Surgeries is put in place for Obese and Overweight People

13

[email protected]

2

Joint Replacement Surgeries by Weight Cluster – US exampleJoint Replacement Surgeries by Weight Cluster – US example(2002-2004;%)

11%5%

30%

12%

59%

83%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Hip replacement Knee replacement

Obese

Overweight

Normal

Source: 2006 Springer Verlag – International Orthopaedics – “Obesity increases the likelihood of total joint replacement surgery among younger adults”

Note: Study conducted in 2006 on non elderly total joint replacement surgeries on 305 patients at MeritCareMedical Center in Fargo, ND or in the outreach facilities of Bemidji and Detroit Lakes, MN

100% 100%

Page 14: Orthopaedics Medical Device Market Analysys and Future Trends

Almost 50% of US Population get less Basic Exercises than Recommended…

14

[email protected]: Early Release of Selected Estimates Based on Data From the National Health Interview Survey, 2014

3

Persons respecting US Aerobic Activity (AA) Guidelines (GL)

Persons respecting US Aerobic Activity (AA) Guidelines (GL)

Persons respecting US AA GL and Muscle-strengthening GuidelinesPersons respecting US AA GL and Muscle-strengthening Guidelines

48% 50% 49% 49%

52% 51% 51% 51%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2011 2012 2013 2014

Not respect ofguide lines

Respect ofguide lines

21% 20% 20% 21%

80% 80% 80% 79%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2011 2012 2013 2014

Not respect ofguide lines

Respect ofguide lines

Note: Data are based on household interviews of a sample of the civilian noninstitutionalized population elder than 18. Estimates in this figure are limited to leisure-time physical activity only.

100% 100% 100% 100% 100% 100% 100% 100%

Page 15: Orthopaedics Medical Device Market Analysys and Future Trends

… while more Active Lifestyles are leading to an Increase in Injuries

15

3

[email protected]

“For America's baby boomers […] too much of a good thing has consequences. Encouraged by doctors to continue to exercise three to five times a week for their health, a legion of running, swimming and biking boomers are flouting the conventional limits of the middle-aged body's abilities and filling the nation's operating roomsand orthopedists' offices in the process. They need knee and hip replacements, surgery for cartilage and ligament damage, and treatment for tendinitis, arthritis, bursitis and stress fractures. The phenomenon even has a name in medical circles: boomeritis.”

The New York Times

“In the U.S. about 30 million children and teens participate in some form of organized sports and more than 3.5 million injuries each year which cause some loss of time of participation, are experienced by the participants. Almost one-third of all injuries incurred in childhood are sports-related injuries. By far the most common injuries are sprains and strains”

Standford Children’s Health

“Ever since the advent of the "X Games" in the mid-1990s, Americans have embraced so-called extreme sports such as mountain biking, skateboarding and snowboarding. But experts are warning that the fun can quickly turn to tragedy when amateurs try to mimic stunts they've seen on television. A new analysis finds that extreme sports have been linked to more than 4 million injuries since 2000, and now cause more than 40,000 head and neck injuries annually” Health Day News

Page 16: Orthopaedics Medical Device Market Analysys and Future Trends

Long-lasting Products and Less Invasive Surgery drive Use earlier in Life

16

[email protected] Source: *Arthritis Care Res (Hoboken) - 2014 June – “Time trends in the Characteristics of Patients Undergoing Primary Total Knee Arthroplasty”;^NCHS Data Brief n.° 186 – February 2015 - Hospitalization for Total Hip Replacement Among Inpatients Aged 45 and Over: United States, 2000–2010

4

Total Knee Replacement by Age Cluster in US*

Total Knee Replacement by Age Cluster in US*

Total Hip Replacement by Age Cluster in US^

Total Hip Replacement by Age Cluster in US^

2.9% 5.2%

19.5%

26.7%

67.2%

58.1%

10.4% 10.0%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

1993-1995 2002-2005

Over 80 years

65 - 79 years

50 - 64 years

Under 50 years

12.0%17.0%

24.0%

29.0%

34.0%

28.0%

30.0%26.0%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

2000 2010

Over 75 years

65 - 74 years

55 - 64 years

45 - 54 years

100% 100% 100% 100%

Page 17: Orthopaedics Medical Device Market Analysys and Future Trends

Consumer-Focused Advertising drives Patient-Led Demand

[email protected]

5

“Some manufacturers of orthopedic medical devices have launched new websites which first ask if you are a patient, surgeon or investor and then take the visitor to a separate site geared for the answer provided. A producer has launched several websites for patients describing specific products including mobile bearing kneesand the agility ankle”

Health care investor industry news

“An implant manufacturer has begun to air its television spot for its mobile bearing knee and another one has run TV advertisements in selected regions / cities on the US territory” Orthopaedic industry news

“Given changing patient demographics and the information revolution, the effects of Direct-to-consumer Advertising (DTCM) likely will continue to grow”

Orthopaedic scientific news

“Now medical device companies are directly contacting consumers but not necessarily through the traditional television airways. The above companies have patient education websites advertised on social media to deliver information about their products”

Spine and Orthopaedic industry news

“A medical device company websitefeatures patient stories about back pain and managing chronic pain issues. The websitehas a "doctor discussion guide" to optimize appointments and a tool to connect with back pain specialists”

Spine and Orthopaedic industry news

17

Page 18: Orthopaedics Medical Device Market Analysys and Future Trends

Public Health System Constraints affect Orthopaedics Expenditure

18

[email protected]

6

• Public health systems - in US and all around the world - are increasingly required to contain and rationalize expenditure

• Increased pricing pressure may be the norm in orthopaedics implant segment going forward

Public Health System Impact

• New reimbursement schemes are supposed to reward quality and efficiency

• Health care providers are strongly pushed to be accountable for resource use and for efficiency achievement

• Relevant impact on orthopaedics implant pricing and volumes is supposed to occur

Page 19: Orthopaedics Medical Device Market Analysys and Future Trends

Increased Grip on Sourcing by Hospitals and HC Providers affects Orthopaedics Expenditure

[email protected]

7

• Hospitals are progressively regulating interactions of physicians with med tech suppliers

• Physicians disintermediation allows sourcing centralization and standardization with relevant impact on orthopaedics implant pricing and volumes

• Improvement of sourcing practice in terms of new processes, resource quality and sound competences inside health care provider hospital procurement departments allows significant expenditure saving with relevant impact on orthopaedics implant pricing and volumes

Hospitals and Health Care Providers Role

Ph

ysic

ian

A

ffilia

tio

n

• Physician affiliation as hospital employees allows sourcing centralization and standardization with relevant impact on orthopaedics implant pricing and volumes

Page 20: Orthopaedics Medical Device Market Analysys and Future Trends

Agenda

• Historical perspective of Medical Device Macro

Sector and Orthopaedics Medical Device Industry

• Business Drivers underlying Orthopaedics

Medical Device Industry Evolution

• Orthopaedics Medical Device Industry

Market Size Trend

20

[email protected]

Page 21: Orthopaedics Medical Device Market Analysys and Future Trends

z

Orthopaedics Mkt in ’07-’20 is dominated by Americas with Asia Pacific registering Highest Growth Rate

21

[email protected]

Orthopaedics Medical Device Mkt Size Trend by Geo AreaOrthopaedics Medical Device Mkt Size Trend by Geo Area(2007-2020;B$;%)

18.021.3

22.8 23.7 24.5 25.429.0

4.2

5.35.8

6.16.4

6.8

8.5

2.1

3.1

3.84.1

4.54.9

6.5

24.3

29.6

32.433.8

35.437.0

44.0

0

5

10

15

20

25

30

35

40

45

2007 2010 2013 2014 2015 2016 2020

Asia-pacific

Europe

Americas

Total

Source: Researches by health care information providers, life science information providers and other analysts coupled with forecasting simulations

CAGR 07-13

CAGR 13-16

CAGR 16-20

10.1% 9.3% 7.2%

5.3% 5.4% 5.8%

4.1% 3.6% 3.4%

4.9% 4.6% 4.4%

Page 22: Orthopaedics Medical Device Market Analysys and Future Trends

z

Orthopaedics Mkt Trend in ’16-’20 period is driven by Knees, Hips and Trauma Therapeutic Segments

22

[email protected]

Orthopaedics Medical Device Mkt Size Trend by Therapeutic SegmentOrthopaedics Medical Device Mkt Size Trend by Therapeutic Segment(2007-2020;B$;%)

5.8 6.7 7.1 7.3 7.6 7.8 8.8

5.76.7 7.1 7.5 7.9 8.4

10.44.3

5.25.5

5.86.2

6.5

8.1

3.3

4.04.6

4.85.0

5.3

6.3

1.0

1.31.6

1.71.8

1.9

2.3

0.6

0.7

0.80.8

0.90.9

1.0

2.4

3.3

3.83.9

4.14.2

4.8

1.3

1.8

1.81.9

1.92.0

2.2

24.3

29.6

32.433.8

35.437.0

44.0

0

5

10

15

20

25

30

35

40

45

2007 2010 2013 2014 2015 2016 2020

Biologics

Sports med

CMF

Extremite

Trauma

Hips

Knees

Spine

Total ex dental

CAGR 07-13

CAGR 13-16

CAGR 16-20

5.5% 3.4% 3.0%

7.9% 3.6% 3.4%

6.3% 3.8% 3.6%

9.3% 4.7% 4.5%

5.7% 4.6% 4.4%

4.0% 5.9% 5.6%

3.9% 5.7% 5.5%

3.4% 3.3% 3.0%

4.9% 4.6% 4.4%

Source: Researches by health care information providers, life science information providers and other analysts coupled with forecasting simulations

Page 23: Orthopaedics Medical Device Market Analysys and Future Trends

DisclaimerDisclaimerDisclaimerDisclaimer

23

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• This document (“Document”) has been prepared by the author (“Author”) solely forinformational purposes

• The Author shall not have liability for the contents of, for any representation (expressed orimplied) contained in, or for omissions from, this Document or any other written or oralcommunication

• The information contained herein is being made as of the date of this Document, unlessanother time is specified, and the Author has no obligation to update such information

• Reference to other authors (“Other Authors”) publications, analysis, economic model orformula is made solely for communication or informational purposes and it does not implyany linkage between Other Authors and content presented within this Document in termsof accuracy and completeness of information conveyed

• This Document does not contain any data or confidential information concerning thebusiness, contractual arrangements, deals, transactions or particular affairs of theCompany or his affiliates for which the Author had or currently has an employmentagreement

Page 24: Orthopaedics Medical Device Market Analysys and Future Trends

AuthorAuthorAuthorAuthor

24

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Marco BerizziChief Financial Officer

e-mail [email protected] mobile +39 342 9204033linkedin https://ch.linkedin.com/in/marco-berizzi-6957bb12

MSc in Probability and Application (spec. Probability and Finance) UPMC - Pierre et Marie Curie University (Paris VI University), Paris

MSc and BSc in Economics L. Bocconi University, Milan