World Medical Device Outsourcing Industry

  • January 2015
  • -
  • Global Industry Analysts
  • -
  • 259 pages

This report analyzes the worldwide markets for Medical Device Outsourcing in US$ Million by the following Device Categories: Class I, Class II, and Class III. The application areas also analyzed in the report Include - Radiology, Orthopedic, Neurology, Cardiology, and Others. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, and Rest of World. Annual estimates and forecasts are provided for the period 2013 through 2020. Also, a seven-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs. The report profiles 63 companies including many key and niche players such as -

Advanced Scientifics, Inc.
Aptiv Solutions
Benchmark Electronics, Inc.
Cadence, Inc.
Code Refinery LLC

Table Of Contents




I. INTRODUCTION, METHODOLOGY and PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation and Reporting Level I-2
Quantitative Techniques and Analytics I-3
Product Definitions and Scope of Study I-3
Device Category I-3
Application Area I-3
Device Category I-4
Class I Devices I-4
Class II Devices I-4
Class III Devices I-4
Application Area I-5
Radiology I-5
Orthopedic I-5
Neurology I-5
Cardiology I-5
Others I-5


II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW II-1
Prelude II-1
Outsourcing: A Delayed Yet Promising Strategy Chosen by
Medical Device OEMs II-2
Budgetary Constraints of the Healthcare System to Benefit
Outsourcing Services II-3
Impact of Economic Recession in Retrospect II-3
Strong Gains to Continue in the Years Ahead II-5
Improving Healthcare Expenditure to Bode Well for Market Growth II-6
Table 1: Per-Capita Healthcare Expenditure in Select Regions
(2013) (includes corresponding Graph/Chart) II-6

Table 2: Top 20 Countries with the Highest Healthcare
Spending as a Percentage of GDP (2012) (includes
corresponding Graph/Chart) II-7

2. NOTEWORTHY MARKET DRIVERS, TRENDS and ISSUES II-8
Rising Demand for Medical Devices Augurs Well for the Market II-8
Table 3: Global Medical Devices Market (2013): Percentage
Share Breakdown of Dollar Sales by Segment (includes
corresponding Graph/Chart) II-9

Table 4: Global Medical Devices Market (2013): Percentage
Share Breakdown of Dollar Sales by Country (includes
corresponding Graph/Chart) II-9
Ballooning Global Population Aids Market Growth II-9
Table 5: Top 25 Countries Worldwide in Terms of Population:
2007, 2010 and 2013 II-10
Aging Population’s Impact on Medical Devices: Favorable
Prospects for Outsourcing II-11
Table 6: Global Population Statistics for the 65+ Age Group
(2013) (includes corresponding Graph/Chart) II-12

Table 7: Life Expectancy at Age 60 and 80 Years -
(2010-2015), (2020-2025) and (2045-2050) (includes
corresponding Graph/Chart) II-13
Rapid Growth of Medical Device Markets in Emerging Nations II-13
Adoption of Stringent Regulations II-14
Steps towards Harmonized Regulatory System to Aid Market Growth II-15
Shift towards Offshoring II-15
Asia Emerging as a Favorable Outsourcing Destination II-16
Rise in Disease Incidences and Access to Modern Therapeutics
Foster Growth II-17
Focus on Core Competencies: A Major Objective of Contract
Manufacturing II-17
Contract Manufacturing: An Effective Tool for Small and Mid-Size
Companies II-17
Contract Manufacturing as a Brand Promotion Channel II-17
Expanding Role of Outsourcing Partners and Rising Demand for
Full-Service Providers II-18
Device Manufacturing Dominates, Design Engineering to Make Gains II-18
Table 8: Global Medical Device Outsourcing Market (2013):
Percentage Share Breakdown of Revenues by Segment - Device
Engineering, Device Manufacturing, Final Goods Assembly, and
Supply Chain Management (includes corresponding Graph/Chart) II-19
RandD and Post Market Engineering Support Services for Medical
Devices on the Rise II-19
Table 9: Global Medical Device Pre and Post Production
Outsourcing Market (2013): Percentage Share Breakdown of
Revenues by Type of Service (includes corresponding
Graph/Chart) II-20
CRO Outsourcing Picking Up Momentum II-20
Onshoring Trend Gains Ground II-20
Outsourcing of IVD Device Manufacturing Gains Momentum II-21
Orthopedic Contract Manufacturing Market: Favorable Growth
Potential II-21
Table 10: Global Orthopedic Market by Geographic Region
(2014E): Percentage Share Breakdown of Value Sales for
Asia-Pacific, Europe, Middle East and Africa, North America,
and Rest of World (includes corresponding Graph/Chart) II-22

Table 11: Global Orthopedic Market by Segment (2014E):
Percentage Share Breakdown of Value Sales for Extremities,
Hips, Knees, Orthobiologics, Spine, Trauma, and Others
(includes corresponding Graph/Chart) II-22
Medical Electronic Manufacturing Services Providers See
Increased Opportunities II-22
Top 10 Selection Criteria for EMS Partner Ranked by Order of
Importance II-24
Table 12: Global Medical EMS Market (2013): Percentage Share
Breakdown of Revenues by Application Segment (includes
corresponding Graph/Chart) II-24
Medical Device Miniaturization Drives Demand for Outsourcing
Services II-24
Shortening Product Lifecycles, Speed to Market Will Drive
Outsourcing Trend II-25
Protection of Intellectual Property and Licensing Rights Rises
in Importance II-25
A Brief Overview of Major Challenges II-25
Legal and Regulatory Issues II-25
Intellectual Property and Business Risks Deter OEMs to Seek
Alliances II-26
Delays in Contractual Obligations II-26
Consolidation Continues to Mark the Industry II-26
MandA Activity in Medical Device Outsourcing Market (2013-2014) II-28

3. AN INTRODUCTION TO MEDICAL DEVICE OUTSOURCING II-30
Introduction II-30
Industry Structure II-30
Advantages of Outsourcing II-30
Choosing the Right Manufacturing Partner II-31
Quality Management System II-31
Managing the Partnership II-31
Quality Remains Guiding Factor II-32
Medical Device Outsourcing Services: Definition II-32
Classification of Medical Devices II-32
Class I Devices II-33
Class II Devices II-33
Class III Devices II-33
Classification of Medical Devices by Therapeutic Area II-34
Cardiology II-34
Radiology II-34
Neurology II-34
Orthopedics II-34

4. RECENT INDUSTRY ACTIVITY II-35
Accellent Takes Over Lake Region Medical II-35
Accellent Rebrands itself as Lake Region Medical II-35
Laserage Technology Takes Over Venta Medical II-35
ICON Takes Over Aptiv Solutions II-35
Intrepid Orthopedics Expands its Capabilities II-35
CoorsTek Establishes CoorsTek Medical II-35
Creganna-Tactx Medical to Takeover Precision Wire Components II-36
Greatbatch Takes Over CCC Medical Devices II-36
Cadence Acquires Plainfield Precision Holdings’s Business Units II-36
Sparton Corporation Takes Over Aubrey Group II-36
Golden Equity Investments Takes Over Innovative Medical Device
Solutions (US) II-36
WuXi PharmaTech Inks Supply Agreement with Pharmacyclics II-36
BIT Analytical Instruments Takes Over Source Scientific II-37
Providien Takes Over Dynaroll II-37
inVentiv Health Takes Over Kforce Clinical Research II-37
Millstone Medical Outsourcing Establishes Sales Offices II-37
North American Science Associates Expands Laboratory II-37
Synteract to Acquire Harrison Clinical Research II-37
Medpace Takes Over MediTech Strategic Consultants II-38
MedImmune Enters into Joint Venture with WuXiAppTec II-38
Cadence to Setup Medical Device Facility II-38
ERT Improves Clinical Research Workflow Technology II-38

5. FOCUS ON SELECT PLAYERS II-39
Advanced Scientifics, Inc. (USA) II-39
Aptiv Solutions (USA) II-39
Benchmark Electronics, Inc. (USA) II-39
Cadence, Inc. (USA) II-40
Code Refinery LLC (USA) II-40
CregannaTactx Medical (Ireland) II-40
Celestica HealthTECH (Canada) II-41
CoorsTek Medical LLC (USA) II-41
Flextronics International (Singapore) II-41
Greatbatch, Inc. (USA) II-42
HCL Technologies Limited (India) II-42
Intertech Engineering Associates, Inc. (USA) II-42
Laserage Technology Corporation, Inc. (USA) II-43
Venta Medical Inc. (USA) II-43
Lake Region Medical (USA) II-43
Memry Corporation (USA) II-43
Millstone Medical Outsourcing, LLC (USA) II-44
Minnetronix, Inc. (USA) II-44
Nortech Systems, Inc. (USA) II-44
Plexus Corporation (USA) II-45
Providien, LLC (USA) II-45
RTEmd (USA) II-45
Symmetry Medical, Inc. (USA) II-46
The Tech Group, Inc. (USA) II-46
Vention Medical (USA) II-46
WuXiAppTec Co. Ltd (China) II-47

6. GLOBAL MARKET PERSPECTIVE II-48
Table 13: World Recent Past, Current and Future Analysis for
Medical Device Outsourcing Services by Geographic Region - US,
Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2013 through 2020 (includes corresponding
Graph/Chart) II-48

Table 14: World Historic Review for Medical Device Outsourcing
Services by Geographic Region - US, Canada, Japan, Europe,
Asia-Pacific, and Rest of World Markets Independently Analyzed
with Annual Revenue Figures in US$ Million for Years 2006
through 2012 (includes corresponding Graph/Chart) II-49

Table 15: World 15-Year Perspective for Medical Device
Outsourcing Services by Geographic Region - Percentage
Breakdown of Revenues for US, Canada, Japan, Europe,
Asia-Pacific, and Rest of World Markets for Years 2006, 2014 and
2020 (includes corresponding Graph/Chart) II-50
By Device Class II-51
Table 16: World Recent Past, Current and Future Analysis for
Medical Device Outsourcing Services for Class I Devices by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific,
and Rest of World Markets Independently Analyzed with Annual
Revenue Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) II-51

Table 17: World Historic Review for Medical Device Outsourcing
Services for Class I Devices by Geographic Region - US,
Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) II-52

Table 18: World 15-Year Perspective for Medical Device
Outsourcing Services for Class I Devices by Geographic Region -
Percentage Breakdown of Revenues for US, Canada, Japan,
Europe, Asia-Pacific, and Rest of World Markets for Years
2006, 2014 and 2020 (includes corresponding Graph/Chart) II-53

Table 19: World Recent Past, Current and Future Analysis for
Medical Device Outsourcing Services for Class II Devices by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific,
and Rest of World Markets Independently Analyzed with Annual
Revenue Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) II-54

Table 20: World Historic Review for Medical Device Outsourcing
Services for Class II Devices by Geographic Region - US,
Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) II-55

Table 21: World 15-Year Perspective for Medical Device
Outsourcing Services for Class II Devices by Geographic Region -
Percentage Breakdown of Revenues for US, Canada, Japan,
Europe, Asia-Pacific, and Rest of World Markets for Years
2006, 2014 and 2020 (includes corresponding Graph/Chart) II-56

Table 22: World Recent Past, Current and Future Analysis for
Medical Device Outsourcing Services for Class III Devices by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific,
and Rest of World Markets Independently Analyzed with Annual
Revenue Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) II-57

Table 23: World Historic Review for Medical Device Outsourcing
Services for Class III Devices by Geographic Region - US,
Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) II-58

Table 24: World 15-Year Perspective for Medical Device
Outsourcing Services for Class III Devices by Geographic
Region - Percentage Breakdown of Revenues for US, Canada,
Japan, Europe, Asia-Pacific, and Rest of World Markets for
Years 2006, 2014 and 2020 (includes corresponding Graph/Chart) II-59
By Application II-60
Table 25: World Recent Past, Current and Future Analysis for
Medical Device Outsourcing Services in Radiology by Geographic
Region - US, Canada, Japan, Europe, Asia-Pacific, and Rest of
World Markets Independently Analyzed with Annual Revenue
Figures in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) II-60

Table 26: World Historic Review for Medical Device Outsourcing
Services in Radiology by Geographic Region - US, Canada,
Japan, Europe, Asia-Pacific, and Rest of World Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) II-61

Table 27: World 15-Year Perspective for Medical Device
Outsourcing Services in Radiology by Geographic Region -
Percentage Breakdown of Revenues for US, Canada, Japan,
Europe, Asia-Pacific, and Rest of World Markets for Years
2006, 2014 and 2020 (includes corresponding Graph/Chart) II-62

Table 28: World Recent Past, Current and Future Analysis for
Medical Device Outsourcing Services in Orthopedics by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific,
and Rest of World Markets Independently Analyzed with Annual
Revenue Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) II-63

Table 29: World Historic Review for Medical Device Outsourcing
Services in Orthopedics by Geographic Region - US, Canada,
Japan, Europe, Asia-Pacific, and Rest of World Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) II-64

Table 30: World 15-Year Perspective for Medical Device
Outsourcing Services in Orthopedics by Geographic Region -
Percentage Breakdown of Revenues for US, Canada, Japan,
Europe, Asia-Pacific, and Rest of World Markets for Years
2006, 2014 and 2020 (includes corresponding Graph/Chart) II-65

Table 31: World Recent Past, Current and Future Analysis for
Medical Device Outsourcing Services in Neurology by Geographic
Region - US, Canada, Japan, Europe, Asia-Pacific, and Rest of
World Markets Independently Analyzed with Annual Revenue
Figures in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) II-66

Table 32: World Historic Review for Medical Device Outsourcing
Services in Neurology by Geographic Region - US, Canada,
Japan, Europe, Asia-Pacific, and Rest of World Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) II-67

Table 33: World 15-Year Perspective for Medical Device
Outsourcing Services in Neurology by Geographic Region -
Percentage Breakdown of Revenues for US, Canada, Japan,
Europe, Asia-Pacific, and Rest of World Markets for Years
2006, 2014 and 2020 (includes corresponding Graph/Chart) II-68

Table 34: World Recent Past, Current and Future Analysis for
Medical Device Outsourcing Services in Cardiology by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific,
and Rest of World Markets Independently Analyzed with Annual
Revenue Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) II-69

Table 35: World Historic Review for Medical Device Outsourcing
Services in Cardiology by Geographic Region - US, Canada,
Japan, Europe, Asia-Pacific, and Rest of World Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) II-70

Table 36: World 15-Year Perspective for Medical Device
Outsourcing Services in Cardiology by Geographic Region -
Percentage Breakdown of Revenues for US, Canada, Japan,
Europe, Asia-Pacific, and Rest of World Markets for Years
2006, 2014 and 2020 (includes corresponding Graph/Chart) II-71

Table 37: World Recent Past, Current and Future Analysis for
Medical Device Outsourcing Services in Other Applications by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific,
and Rest of World Markets Independently Analyzed with Annual
Revenue Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) II-72

Table 38: World Historic Review for Medical Device Outsourcing
Services in Other Applications by Geographic Region - US,
Canada, Japan, Europe, Asia-Pacific, and Rest of World Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) II-73

Table 39: World 15-Year Perspective for Medical Device
Outsourcing Services in Other Applications by Geographic
Region - Percentage Breakdown of Revenues for US, Canada,
Japan, Europe, Asia-Pacific, and Rest of World Markets for
Years 2006, 2014 and 2020 (includes corresponding Graph/Chart) II-74


III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
Market Overview III-1
Table 40: US Medical Device Pre and Post Production
Outsourcing Market (2013): Percentage Share Breakdown of
Revenues by Type of Service (includes corresponding
Graph/Chart) III-1
Medical Device Industry Dynamics Set the Tone of Market Growth III-2
Table 41: North American Elderly Population by Age Group
(1975-2050) (includes corresponding Graph/Chart) III-3
Rising Popularity of EMS Outsourcing III-3
US-based Medical Device OEMs Move towards Onshoring Services III-4
Healthcare Reforms and Other Legislations: An Overview III-4
MDSAP Pilot Program for Harmonized Regulatory System III-5
Competitive Structure III-5
Table 42: Leading Players in the US Medical Device
Outsourcing Market (2013): Percentage Share Breakdown of
Revenues for Greatbatch, Lake Region, Symmetry Medical, The
Tech Group, and Others (includes corresponding Graph/Chart) III-6
Strategic Corporate Developments III-6
Key Players III-9
B.Market Analytics III-16
By Device Category III-16
Table 43: US Recent Past, Current and Future Analysis for
Medical Device Outsourcing Services by Device Category -
Class I, Class II, and Class III Markets Independently
Analyzed with Annual Revenue Figures in US$ Million for
Years 2013 through 2020 (includes corresponding
Graph/Chart) III-16

Table 44: US Historic Review for Medical Device Outsourcing
Services by Device Category - Class I, Class II, and Class
III Markets Independently Analyzed with Annual Revenue
Figures in US$ Million for Years 2006 through 2012
(includes corresponding Graph/Chart) III-17

Table 45: US 15-Year Perspective for Medical Device
Outsourcing Services by Device Category - Percentage Share
Breakdown of Revenues for Class I, Class II, and Class III
Markets for Years 2006, 2014 and 2020 (includes corresponding
Graph/Chart) III-18
By Application III-19
Table 46: US Recent Past, Current and Future Analysis for
Medical Device Outsourcing Services by Application -
Radiology, Orthopedic, Neurology, Cardiology, and Other
Markets Independently Analyzed with Annual Revenue Figures
in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-19

Table 47: US Historic Review for Medical Device Outsourcing
Services by Application - Radiology, Orthopedic, Neurology,
Cardiology, and Other Markets Independently Analyzed with
Annual Revenue Figures in US$ Million for Years 2006
through 2012 (includes corresponding Graph/Chart) III-20

Table 48: US 15-Year Perspective for Medical Device
Outsourcing Services by Application - Percentage Share
Breakdown of Revenues for Radiology, Orthopedic, Neurology,
Cardiology, and Other Markets for Years 2006, 2014 and 2020
(includes corresponding Graph/Chart) III-21

2. CANADA III-22
A.Market Analysis III-22
Outlook III-22
Celestica Healthtech - A Major Player III-22
B.Market Analytics III-23
By Device Category III-23
Table 49: Canadian Recent Past, Current and Future Analysis
for Medical Device Outsourcing Services by Device Category -
Class I, Class II, and Class III Markets Independently
Analyzed with Annual Revenue Figures in US$ Million for
Years 2013 through 2020 (includes corresponding
Graph/Chart) III-23

Table 50: Canadian Historic Review for Medical Device
Outsourcing Services by Device Category - Class I, Class
II, and Class III Markets Independently Analyzed with
Annual Revenue Figures in US$ Million for Years 2006
through 2012 (includes corresponding Graph/Chart) III-24

Table 51: Canadian 15-Year Perspective for Medical Device
Outsourcing Services by Device Category - Percentage Share
Breakdown of Revenues for Class I, Class II, and Class III
Markets for Years 2006, 2014 and 2020 (includes corresponding
Graph/Chart) III-25
By Application III-26
Table 52: Canadian Recent Past, Current and Future Analysis
for Medical Device Outsourcing Services by Application -
Radiology, Orthopedic, Neurology, Cardiology, and Other
Markets Independently Analyzed with Annual Revenue Figures
in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-26

Table 53: Canadian Historic Review for Medical Device
Outsourcing Services by Application - Radiology,
Orthopedic, Neurology, Cardiology, and Other Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-27

Table 54: Canadian 15-Year Perspective for Medical Device
Outsourcing Services by Application - Percentage Share
Breakdown of Revenues for Radiology, Orthopedic, Neurology,
Cardiology, and Other Markets for Years 2006, 2014 and 2020
(includes corresponding Graph/Chart) III-28

3. JAPAN III-29
A.Market Analysis III-29
Outlook III-29
Growing Demand for Medical Devices to Spur Medical Device
Outsourcing III-29
B.Market Analytics III-30
By Device Category III-30
Table 55: Japanese Recent Past, Current and Future Analysis
for Medical Device Outsourcing Services by Device Category -
Class I, Class II, and Class III Markets Independently
Analyzed with Annual Revenue Figures in US$ Million for
Years 2013 through 2020 (includes corresponding
Graph/Chart) III-30

Table 56: Japanese Historic Review for Medical Device
Outsourcing Services by Device Category - Class I, Class
II, and Class III Markets Independently Analyzed with
Annual Revenue Figures in US$ Million for Years 2006
through 2012 (includes corresponding Graph/Chart) III-31

Table 57: Japanese 15-Year Perspective for Medical Device
Outsourcing Services by Device Category - Percentage Share
Breakdown of Revenues for Class I, Class II, and Class III
Markets for Years 2006, 2014 and 2020 (includes corresponding
Graph/Chart) III-32
By Application III-33
Table 58: Japanese Recent Past, Current and Future Analysis
for Medical Device Outsourcing Services by Application -
Radiology, Orthopedic, Neurology, Cardiology, and Other
Markets Independently Analyzed with Annual Revenue Figures
in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-33

Table 59: Japanese Historic Review for Medical Device
Outsourcing Services by Application - Radiology,
Orthopedic, Neurology, Cardiology, and Other Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-34

Table 60: Japanese 15-Year Perspective for Medical Device
Outsourcing Services by Application - Percentage Share
Breakdown of Revenues for Radiology, Orthopedic, Neurology,
Cardiology, and Other Markets for Years 2006, 2014 and 2020
(includes corresponding Graph/Chart) III-35

4. EUROPE III-36
A.Market Analysis III-36
Outlook III-36
Table 61: European Medical Device Pre and Post Production
Outsourcing Market (2013): Percentage Share Breakdown of
Revenues by Type of Service (includes corresponding
Graph/Chart) III-36
Medical Device Market in Europe: An Overview III-36
Table 62: Demographic Structure of Select European
Countries (2013) (includes corresponding Graph/Chart) III-38
Changes Proposed to Medical Device Directives III-39
B.Market Analytics III-39
Table 63: European Recent Past, Current and Future Analysis
for Medical Device Outsourcing Services by Geographic
Region - France, Germany, Italy, UK, Spain, and Rest of
Europe Markets Independently Analyzed with Annual Revenue
Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) III-39

Table 64: European Historic Review for Medical Device
Outsourcing Services by Geographic Region - France,
Germany, Italy, UK, Spain, and Rest of Europe Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-40

Table 65: European 15-Year Perspective for Medical Device
Outsourcing Services by Geographic Region - Percentage
Share Breakdown of Revenues for France, Germany, Italy, UK,
Spain, and Rest of Europe Markets for Years 2006, 2014 and
2020 (includes corresponding Graph/Chart) III-41
By Device Category III-42
Table 66: European Recent Past, Current and Future Analysis
for Medical Device Outsourcing Services by Device Category -
Class I, Class II, and Class III Markets Independently
Analyzed with Annual Revenue Figures in US$ Million for
Years 2013 through 2020 (includes corresponding
Graph/Chart) III-42

Table 67: European Historic Review for Medical Device
Outsourcing Services by Device Category - Class I, Class
II, and Class III Markets Independently Analyzed with
Annual Revenue Figures in US$ Million for Years 2006
through 2012 (includes corresponding Graph/Chart) III-43

Table 68: European 15-Year Perspective for Medical Device
Outsourcing Services by Device Category - Percentage Share
Breakdown of Revenues for Class I, Class II, and Class III
Markets for Years 2006, 2014 and 2020 (includes corresponding
Graph/Chart) III-44
By Application III-45
Table 69: European Recent Past, Current and Future Analysis
for Medical Device Outsourcing Services by Application -
Radiology, Orthopedic, Neurology, Cardiology, and Other
Markets Independently Analyzed with Annual Revenue Figures
in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-45

Table 70: European Historic Review for Medical Device
Outsourcing Services by Application - Radiology,
Orthopedic, Neurology, Cardiology, and Other Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-46

Table 71: European 15-Year Perspective for Medical Device
Outsourcing Services by Application - Percentage Share
Breakdown of Revenues for Radiology, Orthopedic, Neurology,
Cardiology, and Other Markets for Years 2006, 2014 and 2020
(includes corresponding Graph/Chart) III-47

4a. FRANCE III-48
Market Analysis III-48
By Device Category III-49
Table 72: French Recent Past, Current and Future Analysis for
Medical Device Outsourcing Services by Device Category -
Class I, Class II, and Class III Markets Independently
Analyzed with Annual Revenue Figures in US$ Million for
Years 2013 through 2020 (includes corresponding
Graph/Chart) III-49

Table 73: French Historic Review for Medical Device
Outsourcing Services by Device Category - Class I, Class
II, and Class III Markets Independently Analyzed with
Annual Revenue Figures in US$ Million for Years 2006
through 2012 (includes corresponding Graph/Chart) III-50

Table 74: French 15-Year Perspective for Medical Device
Outsourcing Services by Device Category - Percentage Share
Breakdown of Revenues for Class I, Class II, and Class III
Markets for Years 2006, 2014 and 2020 (includes corresponding
Graph/Chart) III-51
By Application III-52
Table 75: French Recent Past, Current and Future Analysis for
Medical Device Outsourcing Services by Application -
Radiology, Orthopedic, Neurology, Cardiology, and Other
Markets Independently Analyzed with Annual Revenue Figures
in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-52

Table 76: French Historic Review for Medical Device
Outsourcing Services by Application - Radiology,
Orthopedic, Neurology, Cardiology, and Other Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-53

Table 77: French 15-Year Perspective for Medical Device
Outsourcing Services by Application - Percentage Share
Breakdown of Revenues for Radiology, Orthopedic, Neurology,
Cardiology, and Other Markets for Years 2006, 2014 and 2020
(includes corresponding Graph/Chart) III-54

4b. GERMANY III-55
A.Market Analysis III-55
Outlook III-55
Strategic Corporate Development III-55
B.Market Analytics III-56
By Device Category III-56
Table 78: German Recent Past, Current and Future Analysis for
Medical Device Outsourcing Services by Device Category -
Class I, Class II, and Class III Markets Independently
Analyzed with Annual Revenue Figures in US$ Million for
Years 2013 through 2020 (includes corresponding
Graph/Chart) III-56

Table 79: German Historic Review for Medical Device
Outsourcing Services by Device Category - Class I, Class
II, and Class III Markets Independently Analyzed with
Annual Revenue Figures in US$ Million for Years 2006
through 2012 (includes corresponding Graph/Chart) III-57

Table 80: German 15-Year Perspective for Medical Device
Outsourcing Services by Device Category - Percentage Share
Breakdown of Revenues for Class I, Class II, and Class III
Markets for Years 2006, 2014 and 2020 (includes corresponding
Graph/Chart) III-58
By Application III-59
Table 81: German Recent Past, Current and Future Analysis for
Medical Device Outsourcing Services by Application -
Radiology, Orthopedic, Neurology, Cardiology, and Other
Markets Independently Analyzed with Annual Revenue Figures
in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-59

Table 82: German Historic Review for Medical Device
Outsourcing Services by Application - Radiology,
Orthopedic, Neurology, Cardiology, and Other Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-60

Table 83: German 15-Year Perspective for Medical Device
Outsourcing Services by Application - Percentage Share
Breakdown of Revenues for Radiology, Orthopedic, Neurology,
Cardiology, and Other Markets for Years 2006, 2014 and 2020
(includes corresponding Graph/Chart) III-61

4c. ITALY III-62
Market Analysis III-62
By Device Category III-62
Table 84: Italian Recent Past, Current and Future Analysis
for Medical Device Outsourcing Services by Device Category -
Class I, Class II, and Class III Markets Independently
Analyzed with Annual Revenue Figures in US$ Million for
Years 2013 through 2020 (includes corresponding
Graph/Chart) III-62

Table 85: Italian Historic Review for Medical Device
Outsourcing Services by Device Category - Class I, Class
II, and Class III Markets Independently Analyzed with
Annual Revenue Figures in US$ Million for Years 2006
through 2012 (includes corresponding Graph/Chart) III-63

Table 86: Italian 15-Year Perspective for Medical Device
Outsourcing Services by Device Category - Percentage Share
Breakdown of Revenues for Class I, Class II, and Class III
Markets for Years 2006, 2014 and 2020 (includes corresponding
Graph/Chart) III-64
By Application III-65
Table 87: Italian Recent Past, Current and Future Analysis
for Medical Device Outsourcing Services by Application -
Radiology, Orthopedic, Neurology, Cardiology, and Other
Markets Independently Analyzed with Annual Revenue Figures
in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-65

Table 88: Italian Historic Review for Medical Device
Outsourcing Services by Application - Radiology,
Orthopedic, Neurology, Cardiology, and Other Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-66

Table 89: Italian 15-Year Perspective for Medical Device
Outsourcing Services by Application - Percentage Share
Breakdown of Revenues for Radiology, Orthopedic, Neurology,
Cardiology, and Other Markets for Years 2006, 2014 and 2020
(includes corresponding Graph/Chart) III-67

4d. THE UNITED KINGDOM III-68
Market Analysis III-68
By Device Category III-69
Table 90: UK Recent Past, Current and Future Analysis for
Medical Device Outsourcing Services by Device Category -
Class I, Class II, and Class III Markets Independently
Analyzed with Annual Revenue Figures in US$ Million for
Years 2013 through 2020 (includes corresponding
Graph/Chart) III-69

Table 91: UK Historic Review for Medical Device Outsourcing
Services by Device Category - Class I, Class II, and Class
III Markets Independently Analyzed with Annual Revenue
Figures in US$ Million for Years 2006 through 2012
(includes corresponding Graph/Chart) III-70

Table 92: UK 15-Year Perspective for Medical Device
Outsourcing Services by Device Category - Percentage Share
Breakdown of Revenues for Class I, Class II, and Class III
Markets for Years 2006, 2014 and 2020 (includes corresponding
Graph/Chart) III-71
By Application III-72
Table 93: UK Recent Past, Current and Future Analysis for
Medical Device Outsourcing Services by Application -
Radiology, Orthopedic, Neurology, Cardiology, and Other
Markets Independently Analyzed with Annual Revenue Figures
in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-72

Table 94: UK Historic Review for Medical Device Outsourcing
Services by Application - Radiology, Orthopedic, Neurology,
Cardiology, and Other Markets Independently Analyzed with
Annual Revenue Figures in US$ Million for Years 2006
through 2012 (includes corresponding Graph/Chart) III-73

Table 95: UK 15-Year Perspective for Medical Device
Outsourcing Services by Application - Percentage Share
Breakdown of Revenues for Radiology, Orthopedic, Neurology,
Cardiology, and Other Markets for Years 2006, 2014 and 2020
(includes corresponding Graph/Chart) III-74

4e. SPAIN III-75
Market Analysis III-75
By Device Category III-75
Table 96: Spanish Recent Past, Current and Future Analysis
for Medical Device Outsourcing Services by Device Category -
Class I, Class II, and Class III Markets Independently
Analyzed with Annual Revenue Figures in US$ Million for
Years 2013 through 2020 (includes corresponding
Graph/Chart) III-75

Table 97: Spanish Historic Review for Medical Device
Outsourcing Services by Device Category - Class I, Class
II, and Class III Markets Independently Analyzed with
Annual Revenue Figures in US$ Million for Years 2006
through 2012 (includes corresponding Graph/Chart) III-76

Table 98: Spanish 15-Year Perspective for Medical Device
Outsourcing Services by Device Category - Percentage Share
Breakdown of Revenues for Class I, Class II, and Class III
Markets for Years 2006, 2014 and 2020 (includes corresponding
Graph/Chart) III-77
By Application III-78
Table 99: Spanish Recent Past, Current and Future Analysis
for Medical Device Outsourcing Services by Application -
Radiology, Orthopedic, Neurology, Cardiology, and Other
Markets Independently Analyzed with Annual Revenue Figures
in US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) III-78

Table 100: Spanish Historic Review for Medical Device
Outsourcing Services by Application - Radiology,
Orthopedic, Neurology, Cardiology, and Other Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-79

Table 101: Spanish 15-Year Perspective for Medical Device
Outsourcing Services by Application - Percentage Share
Breakdown of Revenues for Radiology, Orthopedic, Neurology,
Cardiology, and Other Markets for Years 2006, 2014 and 2020
(includes corresponding Graph/Chart) III-80

4f. REST OF EUROPE III-81
A.Market Analysis III-81
Outlook III-81
Strategic Corporate Development III-81
Select Player III-81
B.Market Analytics III-82
By Device Category III-82
Table 102: Rest of Europe Recent Past, Current and Future
Analysis for Medical Device Outsourcing Services by Device
Category - Class I, Class II, and Class III Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2013 through 2020 (includes corresponding
Graph/Chart) III-82

Table 103: Rest of Europe Historic Review for Medical
Device Outsourcing Services by Device Category - Class I,
Class II, and Class III Markets Independently Analyzed with
Annual Revenue Figures in US$ Million for Years 2006
through 2012 (includes corresponding Graph/Chart) III-83

Table 104: Rest of Europe 15-Year Perspective for Medical
Device Outsourcing Services by Device Category - Percentage
Share Breakdown of Revenues for Class I, Class II, and
Class III Markets for Years 2006, 2014 and 2020 (includes
corresponding Graph/Chart) III-84
By Application III-85
Table 105: Rest of Europe Recent Past, Current and Future
Analysis for Medical Device Outsourcing Services by
Application - Radiology, Orthopedic, Neurology, Cardiology,
and Other Markets Independently Analyzed with Annual
Revenue Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) III-85

Table 106: Rest of Europe Historic Review for Medical
Device Outsourcing Services by Application - Radiology,
Orthopedic, Neurology, Cardiology, and Other Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-86

Table 107: Rest of Europe 15-Year Perspective for Medical
Device Outsourcing Services by Application - Percentage
Share Breakdown of Revenues for Radiology, Orthopedic,
Neurology, Cardiology, and Other Markets for Years 2006,
2014 and 2020 (includes corresponding Graph/Chart) III-87

5. ASIA-PACIFIC III-88
A.Market Analysis III-88
Outlook III-88
Table 108: Asia-Pacific Medical Device Pre and Post
Production Outsourcing Market (2013): Percentage Share
Breakdown of Revenues by Type of Service (includes
corresponding Graph/Chart) III-88
South Asia: Transforming into a Preferred Destination for
Medical Device Outsourcing III-88
Preferred Outsourcing Destinations Worldwide III-89
Stringent Quality Standards Establish Asia-Pacific as a
Manufacturing Hub III-90
Establishment of IPOs and Outsourcing of Box-Build Assembly III-90
China and India to Dominate Outsourcing Destination III-90
India: A Promising Outsourcing Destination III-90
India Lags Behind in Outsourced Medical Devices
Manufacturing Sector III-91
Regulations Present Challenges to Medical Device Market’s
Progress III-92
Vietnam - The Next Big Thing III-92
Harmonized Regulatory System to Aid Market Growth III-92
Regulatory Changes in China and South Korea III-92
Strategic Corporate Development III-93
Select Players III-93
B.Market Analytics III-95
By Device Category III-95
Table 109: Asia-Pacific Recent Past, Current and Future
Analysis for Medical Device Outsourcing Services by Device
Category - Class I, Class II, and Class III Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2013 through 2020 (includes corresponding
Graph/Chart) III-95

Table 110: Asia-Pacific Historic Review for Medical Device
Outsourcing Services by Device Category - Class I, Class
II, and Class III Markets Independently Analyzed with
Annual Revenue Figures in US$ Million for Years 2006
through 2012 (includes corresponding Graph/Chart) III-96

Table 111: Asia-Pacific 15-Year Perspective for Medical
Device Outsourcing Services by Device Category - Percentage
Share Breakdown of Revenues for Class I, Class II, and
Class III Markets for Years 2006, 2014 and 2020 (includes
corresponding Graph/Chart) III-97
By Application III-98
Table 112: Asia-Pacific Recent Past, Current and Future
Analysis for Medical Device Outsourcing Services by
Application - Radiology, Orthopedic, Neurology, Cardiology,
and Other Markets Independently Analyzed with Annual
Revenue Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) III-98

Table 113: Asia-Pacific Historic Review for Medical Device
Outsourcing Services by Application - Radiology,
Orthopedic, Neurology, Cardiology, and Other Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-99

Table 114: Asia-Pacific 15-Year Perspective for Medical
Device Outsourcing Services by Application - Percentage
Share Breakdown of Revenues for Radiology, Orthopedic,
Neurology, Cardiology, and Other Markets for Years 2006,
2014 and 2020 (includes corresponding Graph/Chart) III-100

6. REST OF WORLD III-101
A.Market Analysis III-101
Outlook III-101
Brazil: ANVISA Changes BGMP Certification Requirements III-101
Strategic Corporate Development III-101
B.Market Analytics III-102
By Device Category III-102
Table 115: Rest of World Recent Past, Current and Future
Analysis for Medical Device Outsourcing Services by Device
Category - Class I, Class II, and Class III Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2013 through 2020 (includes corresponding
Graph/Chart) III-102

Table 116: Rest of World Historic Review for Medical Device
Outsourcing Services by Device Category - Class I, Class
II, and Class III Markets Independently Analyzed with
Annual Revenue Figures in US$ Million for Years 2006
through 2012 (includes corresponding Graph/Chart) III-103

Table 117: Rest of World 15-Year Perspective for Medical
Device Outsourcing Services by Device Category - Percentage
Share Breakdown of Revenues for Class I, Class II, and
Class III Markets for Years 2006, 2014 and 2020 (includes
corresponding Graph/Chart) III-104
By Application III-105
Table 118: Rest of World Recent Past, Current and Future
Analysis for Medical Device Outsourcing Services by
Application - Radiology, Orthopedic, Neurology, Cardiology,
and Other Markets Independently Analyzed with Annual
Revenue Figures in US$ Million for Years 2013 through 2020
(includes corresponding Graph/Chart) III-105

Table 119: Rest of World Historic Review for Medical Device
Outsourcing Services by Application - Radiology,
Orthopedic, Neurology, Cardiology, and Other Markets
Independently Analyzed with Annual Revenue Figures in US$
Million for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-106

Table 120: Rest of World 15-Year Perspective for Medical
Device Outsourcing Services by Application - Percentage
Share Breakdown of Revenues for Radiology, Orthopedic,
Neurology, Cardiology, and Other Markets for Years 2006,
2014 and 2020 (includes corresponding Graph/Chart) III-107


IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 63 (including Divisions/Subsidiaries - 66)

The United States (53)
Canada (1)
Europe (7)
- Germany (2)
- The United Kingdom (1)
- Rest of Europe (4)
Asia-Pacific (Excluding Japan) (5)

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