Studie - Outsourcing in the Global Medical Equipment Industry - The Market Expected to Register High Growth in the Future

GlobalData
01.2010
79 Seiten

 
Typ:
Studie
Verfüg­barkeit:
verfügbar
Regionen/­Länder:
  • Europa
  • Asien / Pazifik
  • Mittlerer Osten / Afrika
  • Nordamerika / USA
  • Australien
  • Mittel- / Südamerika
Sprache:
Deutsch

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Outsourcing in the Global Medical Equipment Industry - The Market Expected to Register High Growth in the Future

Summary

GlobalData's new report, 'Outsourcing in the Global Medical Equipment Industry - The Market Expected to Register High Growth in Future provides key data, information and analysis on the global medical device outsourcing industry. The report analyses the drivers behind outsourcing of manufacturing, clinical research and other support services to low-cost service providers based in Asian countries and elsewhere. The report also provides information on the key economies attracting majority of medical equipment outsourced work. The report is also supplemented with information on the preferred vendors executing most of the medical equipment outsourcing work.

This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GlobalData's team of industry experts.

Scope

- Data and information by types of outsourcing — Contract Research and Contract Manufacturing.
- Qualitative analysis of market drivers, and restraints by each category within the medical equipment outsourcing industry.
- Information and analysis on specific countries expected to drive outsourcing of manufacturing, clinical research and other support services.
- Information and analysis on the key trends leading to outsourcing initiatives by the leading medical equipment manufacturers.
- The report also covers information on the leading market players. Key players covered include Accellent, Symmetry Medical, Greatbatch Medical, W. C. Heraeus and Flextronics.

Reasons to buy

- Develop cost-reduction strategies by exploring outsourcing opportunities for manufacturing and clinical research functions
- Explore partnership opportunities by identifying the leading outsourcing service providers and their services.
- Capitalize by identifying the leading destinations for medical equipment manufacturing and other outsourcing initiatives.
- What is being outsourced by the leading medical equipment manufacturers? — Identify, understand and capitalize.

Press Release:
Outsourcing in the Global Medical Equipment Industry - The Market Expected to Register High Growth in the Future

GlobalData's new report, 'Outsourcing in the Global Medical Equipment Industry - The Market Expected to Register High Growth in Future provides key data, information and analysis on the global medical equipment outsourcing industry. The report analyses the drivers behind outsourcing of manufacturing, clinical research and other support services to low-cost service providers based in Asian countries and elsewhere. The report also provides information on the key economies attracting majority of medical equipment outsourced work. The report is also supplemented with information on the preferred vendors executing most of the medical equipment outsourcing work.

Outsourcing Market will Continue to Grow Driven by the Demand from Medical Equipment Industry

The global medical equipment outsourcing market is forecast to reach $40.1 billion by 2016 with a CAGR of 16.3%. The ageing population, advancements in technology, desires to lead active lifestyles, the rise in chronic conditions and increased public & private spending are expected to drive the medical equipment market. These drivers are providing a promising opportunity for the medical equipment companies and service providers. Also, the increasing desire by the medical equipment companies to improve cost savings and to bring products to the market quickly is expected to drive the medical equipment outsourcing market in the future.

Medical Equipment Outsourcing, Global, Revenues ($bn), 2009 — 2016

Source: GlobalData

Contract Manufacturing is Expected to Remain the Major Contributor of Medical Outsourcing Market

Contract manufacturing accounted for 90% of the global medical equipment outsourcing market in 2009 and is expected to contribute 91.7% by 2016. This market is forecast to reach $36.8 billion by 2016 with a CAGR of 16.5%. Contract manufacturing remains the key market segment driving growth within the outsourcing market. The contract manufacturing market is expected to be driven by the increasing desire of the medical equipment manufacturers to reduce direct expenses and streamline supply chains. Outsourcing of manufacturing activities has helped medical equipment companies to reduce costs by between 10% and 25%.

Medical Equipment Outsourcing, Global, Segment Analysis (%), 2008

Source: GlobalData

Contract Organizations are Emerging as Strategic Partners to Reduce Time to Market and Cost

The medical equipment industry is forming strategic partnerships with contract organizations to leverage their global presence and research expertise. The agreements with contract organizations are aimed at lowering the time to market as well as reducing costs. The service models of the contract organizations are evolving to become more functional, where services are outsourced based on the analysis of their core competencies. The increasing focus on strategic partnerships will drive the growth in emerging outsourcing destinations which have many small niche contract organizations specializing in different functions. Medical equipment companies are expected to increasingly rely on contract organizations to enhance their product pipeline strength by bringing the products to approval at a faster rate.

Regions such as Latin America, India and China Attract Increased Contract Research Outsourcing due to Competitive Benefits and Increased Regulatory Compliance

The US and Europe dominate the contract research outsourcing market and account for the majority of clinical research activities. However, this trend is changing with the emergence of regions such as Latin America, India and China as preferred locations for outsourcing. These regions provide a cost advantage, better patient enrollment and expert personnel. These emerging regions are more cost effective with quality standards on par with the developed regions. All these countries have aligned their clinical research regulations with the international standards and requirements which allows them to conduct clinical trials and research on behalf of medical device companies in developed countries.
1 Table of contents

1 Table of contents 2

1.1 List of Tables 5

1.2 List of Figures 5

2 Introduction 6

2.1 GlobalData Research Guidance 6

3 Global Medical Equipment Outsourcing 7

3.1 Overview 7

3.2 Global Medical Equipment Outsourcing Market Service Models 8

3.2.1 Fully Integrated Service Model 8

3.2.2 Functional Service Model 9

3.3 Global Medical Equipment Outsourcing Market Characterization 9

3.4 Global Medical Equipment Outsourcing Market Dynamics 11

3.4.1 Global Medical Equipment Outsourcing Market Drivers 11

3.4.2 Global Medical Equipment Outsourcing: Market Restraints 14

4 Global Medical Equipment Market 15

4.1 Global Medical Equipment Market Characterization 15

4.1.1 Growth in the Global Medical Equipment Market to Drive the Growth of Outsourcing Industry 15

4.1.2 Global Medical Equipment Market Dynamics 16

4.1.3 North America and European Medical Equipment Manufacturers are Expected to be Major Contributors for the Outsourcing Market 19

4.1.4 Top 10 Medical Companies Contributed 25% towards Global Medical Equipment Market 20

5 Contract Research Outsourcing (CROs) 21

5.1 Overview 21

5.2 Contract Research Organization (CRO) Market Characterization 21

5.2.1 Contract Research Organization (CRO), Revenue, 2009-2016 21

5.3 CRO Market Dynamics 22

5.3.1 CRO Market Drivers 22

5.3.2 CRO Market Restraints 22

5.4 Contract Research Outsourcing Services Process 22

5.4.1 Design and Prototype 23

5.4.2 Device Validation and Verification 23

5.4.3 Pre-Clinical Development 23

5.4.4 Clinical trials 24

5.4.5 Review and Approval from the Regulatory Agencies 24

5.4.6 Post-marketing Studies 24

5.5 Criteria for Selecting a Contract Research Organization (CRO) 25

6 Contract Manufacturing Outsourcing (CMOs) 26

6.1 Overview 26

6.2 Contract Manufacturing Outsourcing (CMO) Market Characterization 26

6.2.1 Contract Manufacturing Outsourcing (CMO), Revenue, 2009-2016 26

6.2.2 Strategic Advantages of CMO for Medical Equipment Companies 26

6.3 CMO Market Dynamics 27

6.3.1 CMO Market Trends 27

6.3.2 CMO Market Drivers 27

6.3.3 Global CMO Restrains 27

6.4 Capabilities of Contract Manufacturing Organizations (CMO) 28

6.4.1 Device Design and Engineering 28

6.4.2 Precision Component Manufacturing 29

6.4.3 Device Assembly & Testing 29

6.4.4 Electronic Manufacturing Services (EMS) 30

6.4.5 Supply Chain Management 30

6.5 CMO Manufacturing 30

6.5.1 Criteria for Selecting a Contract Manufacturing Organization (CMO) 31

6.5.2 Key Steps Involved in Executing Projects 31

7 Medical Equipment Outsourcing: Key Companies 34

7.1 Accellent 34

7.1.1 Company Overview 34

7.1.2 Customer Base 34

7.1.3 Financial 34

7.1.4 Partnership 35

7.1.5 Deals 35

7.2 Alquest, Inc. 36

7.2.1 Company Overview 36

7.3 Avail Medical Products, Inc. 36

7.3.1 Company Overview 36

7.4 Creganna Medical Devices Limited 36

7.4.1 Company Overview 36

7.4.2 Manufacturing Facilities 37

7.4.3 Deals 37

7.5 Doncasters Medical Technologies 38

7.5.1 Company Overview 38

7.6 Flextronics International 38

7.6.1 Company Overview 38

7.6.2 Deals 38

7.7 Fort Wayne Metals 39

7.7.1 Company Overview 39

7.8 Greatbatch, Inc., 39

7.8.1 Company Overview 39

7.8.2 Geographic Locations 39

7.8.3 Financials 39

7.8.4 Product Offerings 39

7.8.5 Deals 40

7.9 Memry Corporation Company 40

7.9.1 Company Overview 40

7.10 NAMSA 41

7.10.1 Company Overview 41

7.11 Parexel International Corporation (Parexel) 41

7.12 Quintiles 41

7.12.1 Company Overview 41

7.12.2 Deals 42

7.13 Symmetry Medical Inc 42

7.13.1 Company Overview 42

7.13.2 Geographic Locations 42

7.13.3 Customer Base 42

7.13.4 Financials 42

7.13.5 Deals 43

7.14 TriVirix International Inc. 43

7.14.1 Company Overview 43

7.14.2 Deals 44

7.15 The Tech Group 44

7.15.1 Company Overview 44

7.16 Lake Region Manufacturing, Inc. 45

7.16.1 Company Overview 45

7.16.2 Deals 45

8 Medical Equipment Outsourcing Market: Regulatory Framework 46

8.1 Role of Asian Markets in the Global Medical Equipment Outsourcing Market 46

8.1.1 Manufacturing 46

8.1.2 Research and Development (R&D) 46

8.1.3 Clinical Trials 46

8.2 India 46

8.2.1 Overview 46

8.2.2 Factors Driving the Indian Outsourcing Market 48

8.2.3 Regulations 48

8.3 China 52

8.3.1 Overview 52

8.3.2 Factors Driving the China Outsourcing Market 52

8.3.3 Regulations 52

8.4 Malaysia 56

8.4.1 Overview 56

8.4.2 Factors Driving the Malaysian Outsourcing Market 57

8.4.3 Regulations 57

8.4.4 Initiatives 57

8.5 Singapore 57

8.5.1 Overview 57

8.5.2 Factors Driving the Singapore Outsourcing Market 58

8.5.3 Regulations 58

8.6 Latin America 59

8.6.1 Overview 59

8.6.2 Factors Driving the Outsourcing Market in Latin America 59

8.7 Costa Rica 60

8.8 US 61

8.8.1 Factors Driving the Outsourcing Market in the US Market 62

8.9 Central and Eastern Europe 62

8.9.1 Factors Driving the Outsourcing Market in the Central and East European Outsourcing Market 62

8.10 Medical Equipment Regulations in the Developed Nations 62

8.10.1 US 63

8.10.2 Japan 65

8.10.3 European Union 66

8.11 Essential Certifications for Outsourcing 68

8.11.1 ISO 13485 69

8.11.2 ISO 9001:2000 69

8.11.3 ISO 14971 69

8.11.4 FDA Title 21 CFR Parts 800-1200 69

8.11.5 510(k) vs. PMA 69

9 Global Medical Equipment Outsourcing: Mergers and Acquisitions 71

9.1.1 Vesta Acquires ExtruMed From Inverness Graham And Wedbush Capital in March 2009 71

9.1.2 Saw Mill Capital Acquires Filtrona Extrusion From Filtrona in March 2009 72

9.1.3 PolyMedex Discovery Group Acquires Putnam Plastics in February 2009 72

9.1.4 Arkema Acquires Oxford Performance Materials in February 2009 72

9.1.5 Innovative Medical Device Solutions (IMDS) Acquires Cencast in January 2009 72

9.1.6 Moog Acquires Ethox International in January 2009 72

9.1.7 The Riverside Company Acquires Coeur From Hammond, Kennedy, Whitney in October 2008 73

9.1.8 ExtruMed Acquires Innovative Extrusions in September 2008 73

9.1.9 Charlesbank Capital Partners Acquires Tecomet From Cardinal Health in September 2008 73

9.1.10 Nypro Acquires Additional 30% Stake In Nypro Precision Assemblies in August 2008 73

9.1.11 Theragenics Acquires NeedleTech Products in July 2008 73

9.1.12 SAES Getters Acquires Memry, An Orthopedic Vendor 74

9.1.13 Sandvik Materials Technology Acquires Eurocut in May 2008 74

9.1.14 Royal DSM Acquires The Polymer Technology Group in May 2008 74

9.1.15 Parker Hannifin Acquires Hi-Tech Group in April 2008 74

10 Appendix 75

10.1 Definitions 75

10.1.1 Outsourcing 75

10.1.2 Contract Research Organizations (CRO) 75

10.1.3 Contract Manufacturing Organizations (CMO) 75

10.2 Acronyms 75

10.3 Research Methodology 77

10.3.1 Secondary Research 78

10.3.2 Primary Research 78

10.3.3 Models 78

10.3.4 Forecasts 79

10.3.5 Expert Panels 79

10.4 GlobalData Consulting 79

10.5 Contact Us 79

10.6 Disclaimer 79



1.1 List of Tables

Table 1: Medical Equipment Outsourcing, Global, Revenues ($ billion), 2009 — 2016 9

Table 2: Medical Equipment Outsourcing, as % of Total Medical Equipment Market, 2009 — 2016 10

Table 3: Medical Equipment Companies, R&D Expenditure, ($m), 2006-2008 12

Table 4: Medical Equipment, Global, Revenues ($ Billions), 2009 — 2016 15

Table 5: Healthcare Expenditure as Percentage of GDP, Top 12 Countries, 2008 17

Table 6: Medical Equipment, Global, Revenues by Geographic (%), 2008 19

Table 7: Medical Equipment, Global, Company Share, %, 2008 20

Table 8: Contract Research Organization (CRO), Global, Revenues ($ Billions), 2009 — 2016 22

Table 9: Contract Manufacturing Outsourcing (CMO), Global, Revenues ($ Billions), 2009 — 2016 26

Table 10: Materials Mix, Medical Equipment 28

Table 11: CMO, Global, Design and Engineering, Capability 29

Table 12: CMO, Global, Device Assembly, Capability 29

Table 13: CMO, Global, Supply Chain Management, Capability 30

Table 14: Accellent, Inc., Deals Summary 35

Table 15: Creganna Medical Devices Limited, Inc., Deals Summary 37

Table 16: Greatbatch, Inc, Deal Summary 40

Table 17: Symmetry Medical Inc., Deals Summary 43

Table 18: TriVirix International, Inc., Deals Summary 44

Table 19: Approval Times for Clinical Trials, India 47

Table 20: Cost Comparison, Clinical Trials , India 47

Table 21: Proposed Medical Equipment Classification in India, 2005 50

Table 22: Malaysian, Medical Equipment, Companies 56

Table 23: Medical Equipment, Supplier Base, Costa Rica 61

Table 24: Medical Device Classification, United States, 2008 63

Table 25: FDA PMA User Fees, 2007 65

Table 26: Device Classification in Japan 65

Table 27: Estimated Approval Costs, PMDA 66

Table 28: Device Classification in the European Union, 2008 67

Table 29: Comparative Overview of the Three Systems 68

Table 30: Global Medical Equipment Outsourcing, Key M&A Deals, 2008 — 2009 71



1.2 List of Figures

Figure 1: Global, Medical Device Outsourcing, Industry Structure 7

Figure 2: Contract Organizations, Fully Integrated Service Model 8

Figure 3: Medical Equipment Outsourcing, Global, Revenues ($ billion), 2009 — 2016 9

Figure 4: Medical Equipment Outsourcing, as percentage of Total Medical Equipment Market,

2009 — 2016 10

Figure 5: Medical Equipment Outsourcing, Global, Market Drivers & Restraints Analysis 11

Figure 6: Strategic Advantages of Outsourcing 11

Figure 7: Medical Equipment, Global, Revenues ($ Billions), 2009 — 2016 15

Figure 8: Medical Equipment, Global, Market Drivers & Restraints Analysis 16

Figure 9: Healthcare Expenditure as Percentage of Gross Domestic Product (GDP), Top 12 Countries, 2008 17

Figure 10: Medical Equipment, Global, Revenues by Geographic, %, 2008 19

Figure 11: Medical Equipment , Global, Company Share, %, 2008 20

Figure 12: Contract Research Outsourcing Market, Global, Basic Services Provided 21

Figure 13: Contract Research Organization (CRO), Global, Revenues ($ Billions), 2009 — 2016 21

Figure 14: Clinical Research Process 23

Figure 15: Contract Manufacturing Outsourcing (CMO), Global, Revenues ($ Billions), 2009 — 2016 26

Figure 16: Singapore, Medical Equipment License Application Process 59

Figure 17: Medical Equipment Approval Process in the US, 2008 64

Figure 18: Medical Equipment Approval Timeline, US, EU and Japan 67

Figure 19: Average Time for Total Review of a 510k and PMA Application, 2001 — 2006 70

Figure 20: GlobalData Methodology 77



Companies mentioned:

Accellent

Alquest, Inc

Avail Medical Products, Inc.

Creganna Medical Devices Limited

Doncasters Medical Technologies

Flextronics International

Fort Wayne Metals

Greatbatch, Inc.,

Memry Corporation Company

NAMSA

Parexel International Corporation (Parexel)

Quintiles

Symmetry Medical Inc

TriVirix International Inc

The Tech Group

Lake Region Manufacturing, Inc

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