1. Executive Summary
1.1 Sector Highlights
1.2 Aim, Scope and Format of this Report
1.3 Chapter Outline
1.4 Research and Analysis Method
1.5 Glossary of Terms Relating to the Report
2. Introduction
2. Introduction to Medical Device Contract Manufacturing
2.1 Medical Devices
2.2 Classification of Medical Devices
2.2.1 The US Classification System
2.2.2 The European Classification System
2.3 Regulation of Medical Devices
2.3.1 The US Approval and Regulation System
2.3.2 The European Approval and Regulatory System
2.4 The Medical Device Industry
2.5 Medical Device Outsourcing
2.6 Benefits of Outsourcing
2.6.1 Reasons for Outsourcing Manufacturing
2.6.1.1 Focusing on Core Competencies
2.6.1.2 Shorter Time to Market
2.6.1.3 Tactical & Strategic
2.6.1.4 Lower Fixed Operating Costs
2.6.2 Reasons for Keeping Projects In-House
2.7 Service Agreement
2.7.1 Identifying CMOs
2.7.2 Contractual Agreement
2.7.3 Review of the Quality Manual
2.7.4 Audit and Site Visits
2.8 Final Discussions
2.8.1 Product Requirement Specifications
2.8.2 Term Sheets and Supply Agreements
2.8.3 Project Management
2.9 Medical Device Quality Management Systems
2.10 Medical Device Outsourcing Segments
2.10.1 Design Engineering
2.10.2 Device Manufacturing
2.10.2.1 Material Processing
2.10.2.2 Electronic Manufacturing Services
2.10.2.3 Finished Products
2.10.3 Final Goods Assembly
3. Medical Device Contract Manufacturing Market, 2011-2023
3.1 The Global Medical Device Market, 2011
3.2 Medical Device Outsourcing
3.2.1 Medical Device Outsourcing Segments
3.2.2 Trends in the Medical Device Outsourcing Market, 2011
3.3 Medical Device Contract Manufacturing Market, 2011
3.3.1 Medical Device Contract Manufacturing Market Segments, 2011
3.3.2 Medical Device Contract Manufacturing Market Forecast 2012-2023
3.3.3 Medical Device Contract Manufacturing Trends, 2012-2023
3.4 Growing Demand for Medical Devices will Drive the Contract Manufacturing Market
4. Medical Device Contract Manufacturing Segments, 2011-2023
4.1 Material Processing Market Overview
4.1.1 Materials Processing Market Forecast 2012-2023
4.1.1.1 Medical Molding
4.1.1.2 Medical Extrusion
4.2 Electronic Manufacturing Services (EMS) Overview
4.2.1 EMS Market, 2011
4.2.2 Medical EMS Market by Segments, 2011
4.2.3 Leading Companies in EMS Market, 2011
4.2.4 Electronics Outsourcing Market Forecast 2012-2023
4.3 Finished Products Overview
4.3.1 Finished Products Outsourcing Market Forecast 2012-2023
5. Leading Contract Manufacturing Organisations, 2011
5.1 A Highly Fragmented Market
5.2 Accellent Inc.
5.2.1 Revenues and Recent Performance Analysis, 2011
5.2.2 Business Capabilities
5.2.3 Asia Expansion
5.2.4 Regional Breakdown
5.3 Flextronics
5.3.1 Revenue and Recent Performance Analysis, 2011
5.3.2 Business Capabilities
5.3.3 Net Sales by Country, 2011
5.3.4 Medical Certification Award Enhances Company Portfolio
5.3.5 Acquisition of Stellar Microelectronics
5.4 Symmetry Medical
5.4.1 Revenue and Recent Performance Analysis, 2011
5.4.2 Total Solutions Approach
5.4.3 Acquisition of Olsen Medical
5.5 The Tech Group (Part of the West Pharmaceutical Services Company)
5.5.1 Revenues and Recent Performance Analysis, 2011
5.5.2 Focusing on Research & Development
5.5.3 Expansion into Asian Markets
5.6 Greatbatch Inc.
5.6.1 Revenue and Recent Performance Analysis, 2011
5.6.2 Capital Investment will Prompt Future Growth
5.6.3 Acquisitions, 2011
5.7 Nortech Systems Inc.
5.7.1 Revenue and Recent Performance Analysis, 2011
5.7.2 Nortech Life Sciences
5.7.3 Recent Acquisitions
5.8 Other Companies and Services
6. Leading Contract Manufacturing Markets, 2011-2023
6.1 Breakdown of the World Medical Device Contract Manufacturing Market, 2011
6.2 Global Medical Device Contract Manufacturing Market: Regional Forecast 2012-2023
6.3 The US Market
6.4 The European Market
6.4.1 Germany and France
6.4.2 Italy
6.4.3 Spain
6.4.4 The UK
6.5 The Japanese Market
6.6 Outsourcing to Emerging Markets
6.6.1 The Chinese Market
6.6.2 The Indian Market
6.7 Rest of the World
7. SWOT Analysis of the Medical Device Contract Manufacturing Market, 2012-2023
7.1 Contract Manufacturing Industry Trends
7.2 Strengths
7.2.1 Outsourcing on the Rise
7.2.2 Focus on Core Competencies
7.2.3 Access to Specialized Technologies
7.3 Weaknesses
7.3.1 Considerable Risk
7.3.2 Lack of Communication
7.3.3 Highly Fragmented Market
7.4 Opportunities
7.4.1 Globalization
7.4.1.1 Growth in Asia
7.4.2 Medical Device Excise Tax
7.5 Threats
7.5.1 Low Growth for Niche Players as OEMs Prefer One Stop Shop
8. Expert Opinion
8.1 Interview with Marketing Manager, Creganna-Tactx Medical
8.1.1 The Medical Device Contract Manufacturing Industry
8.1.2 Industry Mergers & Acquisitions
8.1.3 Industry Threats
8.1.4 The Future Medical Device Contract Manufacturing Industry
9. Conclusions
9.1 Overview
9.2 Electronic Manufacturing Services will Witness Strong Growth
9.3 Prominent Companies in the Market
9.4 Outsourcing and Offshoring will become a Strategic Necessity
9.5 Future Outlook and Concluding Remarks
List of Tables
Table 2.1 US and EU Classification of Medical Devices, 2011
Table 2.2 Tactical and Strategic Reasons for Outsourcing Manufacturing, 2011
Table 3.1 The Medical Device Market: Revenue ($bn) and Market Shares (%) by Sector, 2011
Table 3.2 Sectors of Medical Device Outsourcing Market: Revenue ($bn) and Market Shares (%), 2011
Table 3.3 Medical Device Market: Gross Margin and COGS, 2011
Table 3.4 Spending on In-house and Outsourced Device Manufacturing, 2011
Table 3.5 Sectors of Medical Device Contract Manufacturing Market: Revenue ($bn) and Market Shares (%)
Table 3.6 Medical Device Contract Manufacturing Market Forecast ($bn, %) 2011-2023
Table 3.7 Global Medical Devices Market Forecast ($bn, %), 2011-2023
Table 4.1 Material Processing Market Forecast ($bn, %), 2011-2023
Table 4.2 Some Companies Offering Moulding Services to Medical Devices OEMs, 2012
Table 4.3 Industries Served by EMS Providers: Revenue ($bn) and Market Shares (%), 2011
Table 4.4 Medical EMS Market: Revenue ($bn) and Market Shares (%) by Segments, 2011
Table 4.5 Leading Companies Offering EMS Services to Medical Device OEMs, 2012
Table 4.6 EMS Market Forecast ($bn, %), 2011-2023
Table 4.7 Finished Products Outsourcing Market Forecast ($bn, %), 2011-2023
Table 5.1 Accellent Financial Results: Revenue ($m), 2007- 2011
Table 5.2 Accellent Financial Results ($m), 2011
Table 5.3 Flextronics Market Segments: Revenue ($bn), FY 2012
Table 5.4 Flextronics Net Sales by Country: Revenue ($bn), FY 2012
Table 5.5 Symmetry Medical: Revenue ($m) and Market Shares (%) by Business Segments, 2011
Table 5.6 The Tech Group: Revenue ($m) by Fiscal Year, 2010& 2011
Table 5.7 Greatbatch: Revenue ($m) by Business Segments, 2011
Table 5.8 Greatbatch: Total Revenue ($m), 2007-2011
Table 5.9 Nortech Systems: Revenue ($m), 2010 & 2011
Table 5.10 Nortech Systems: Revenue ($m) and Market Share (%) by Business Sectors, 2011
Table 5.11 Other Companies in Medical Device Contract Manufacturing, 2012
Table 6.1 Medical Device Contract Manufacturing Market: Revenue ($bn) and Market Share (%) by Region, 2011
Table 6.2 Medical Device Contract Manufacturing Market Forecast (%, $bn) of leading Regions/Countries, 2011-2017
Table 6.3 Medical Device Contract Manufacturing Market Forecast (%, $bn) of leading Regions/Countries, 2017-2023
Table 6.4 The European Medical Device Contract Manufacturing Market: Revenue ($bn) and Market Shares (%), 2011
Table 6.5 The European Medical Device Contract Manufacturing Market Forecasts ($bn, %) by Leading Countries, 2011-2017
Table 6.6 The European Medical Device Contract Manufacturing Market Forecasts ($bn, %) by Leading Countries, 2017-2023
Table 7.1 SWOT Analysis of the Medical Device Contract Manufacturing Market, 2013-2023
Table 9.1 Medical Device Contract Manufacturing Market ($bn), 2011, 2017, 2019 and 2023
List of Figures
Figure 2.1 Services Offered by Medical Device Outsourcing Companies, 2011
Figure 3.1 Medical Device Market: Global Revenue ($bn) by Sector, 2011
Figure 3.2 Medical Device Market: Market Share (%) by Sector, 2011
Figure 3.3 Sectors of Medical Device Outsourcing Market: Market Shares (%), 2011
Figure 3.4 Market Share (%) of Spending on In-house and Outsourced Device Manufacturing, 2011
Figure 3.5 Sectors of Medical Device Contract Manufacturing Market: Revenue ($bn) by Segment, 2011
Figure 3.6 Sectors of Medical Device Contract Manufacturing Market: Market Shares (%) by Segments, 2011
Figure 3.7 Medical Device Contract Manufacturing Market Forecast: Revenue ($bn), 2011-2023
Figure 3.8 Global Medical Devices Market Forecast: Revenue ($bn), 2011-2023
Figure 4.1 Material Processing Market Forecast: Revenue ($bn), 2011-2023
Figure 4.2 Industries Served by EMS Providers: Market Share (%), 2011
Figure 4.3 Medical EMS Market: Revenue ($bn) by Segments, 2011
Figure 4.4 Medical EMS Market: Market Shares (%) by Segments, 2011
Figure 4.5 EMS Market Forecast: Revenue ($bn), 2011-2023
Figure 4.6 Finished Products Outsourcing Market Forecast: Revenue ($bn), 2011-2023
Figure 5.1 Accellent Financial Results: Revenue ($m), 2007- 2011
Figure 5.2 Flextronics Market Segments: Revenue ($bn), FY 2012
Figure 5.3 Flextronics Market Segments: Revenue ($bn), FY 2012
Figure 5.4 Symmetry Medical: Market Shares (%) by Business Segments, 2011
Figure 5.5 The Tech Group: Revenue ($m) by Fiscal Year, 2010 & 2011
Figure 5.6 Greatbatch: Market Shares (%) by Business Segments, 2011
Figure 5.7 Greatbatch: Total Revenue ($m), 2007-2011
Figure 5.8 Nortech Systems: Total Revenue ($m), 2010 & 2011
Figure 5.9 Nortech Systems: Market Shares (%) by Business Sectors, 2011
Figure 6.1 Medical Device Contract Manufacturing Market: Revenue ($bn) of Leading Regions/Countries, 2011
Figure 6.2 Medical Device Contract Manufacturing Market: Market Shares (%) of Leading Regions/Countries, 2011
Figure 6.3 The US Medical Device Contract Manufacturing Market Forecast: Revenue ($bn), 2011-2023
Figure 6.4 The European Medical Device Contract Manufacturing Market: Market Shares (%), 2011
Figure 6.5 The European Medical Device Contract Manufacturing Market Forecast: Revenue ($bn), 2011-2023
Figure 6.6 German and French Medical Device Contract Manufacturing Market Forecasts: Revenue ($bn), 2011-2023
Figure 6.7 Italian Medical Device Contract Manufacturing Market Forecast: Revenue ($bn), 2011-2023
Figure 6.8 Spanish Medical Device Contract Manufacturing Market Forecast: Revenue ($bn), 2011-2023
Figure 6.9 The UK Medical Device Contract Manufacturing Market Forecast: Revenue ($bn), 2011-2023
Figure 6.10 Japanese Medical Device Contract Manufacturing Market Forecast: Revenue ($bn), 2011-2023
Figure 6.11 Chinese Medical Device Contract Manufacturing Market Forecast: Revenue ($bn), 2011-2023
Figure 6.12 Indian Medical Device Contract Manufacturing Market Forecast: Revenue ($bn), 2011-2023
Figure 9.1 Medical Device Contract Manufacturing Market ($bn), 2011, 2017, 2019 and 2023