Drug Device Combination Market to 2016 - Technological Convergence to be the New Business Model for Growth and Profitability

Summary

GBI Research’s medical devices report, “Drug Device Combination Market to 2016 - Technological Convergence to be the New Business Model for Growth and Profitability” provides key data, information and analysis on the global drgu-device combination market. The report provides market landscape, competitive landscape and market trends information on six dental devices market categories – Drug eluting stents, antimicrobial catheters, antibiotic-loaded bone cements, drug-eluting beads, photodynamic therapy. The report provides comprehensive information on the key trends affecting these categories, and key analytical content on the market dynamics. The report also reviews the competitive landscape, key pipeline products and technology offerings.

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

Scope

- Key geographies covered include the US, Canada, the UK, Germany, France, Italy, Spain, Japan, China, India, Australia, and Brazil.
- Market size and company share data for the drug-device combination market categories – Drug eluting stents, antimicrobial catheters, antibiotic-loaded bone cements, drug-eluting beads, photodynamic therapy
- Annualized market revenues data from 2002 to 2009, forecast forward for 7 years to 2016. Company shares data for 2009.
- Qualitative analysis of key market trends, market drivers, and restraints by each category within the drug-device combination market.
- The report also covers information on the leading market players, the competitive landscape, and the leading pipeline products and technologies.

Reasons to buy

- Develop business strategies by understanding the trends and developments that are driving the drug-device combination market globally.
- Design and develop your product development, marketing and sales strategies.
- Exploit M&A opportunities by identifying market players with the most innovative pipeline.
- Develop market-entry and market expansion strategies.
- Identify key players best positioned to take advantage of the emerging market opportunities.
- Exploit in-licensing and out-licensing opportunities by identifying products, most likely to ensure a robust return.
- What’s the next being thing in the drug-device combination market landscape? – Identify, understand and capitalize.
- Make more informed business decisions from the insightful and in-depth analysis of the global drug-device combination market and the factors shaping it.

Table Of Contents

1 Table of Contents 3
1.1 List of Tables 7
1.2 List of Figures 8
2 Introduction 9
2.1 GBI Research Guidance 9
3 Overview 10
3.1 Introduction to Drug/Device Combination Products 10
3.2 Commercialization Cycle of a Drug/Device CP 11
3.2.1 Categorization 11
3.3 Drug/Device CP: Applications 14
3.4 Drug/Device CP: Products 14
3.5 Research Scope 15
4 Drug/Device CP Market Characterization 16
4.1 Global Drug/Device CP Market 16
4.1.1 Historical Revenues 16
4.1.2 Market Forecasts 17
4.2 Key Market Trends 18
4.2.1 Large Volumes of Research and Development are Expected to Bring Forth Several New Product Launches 18
4.2.2 Cross-Disciplinary Alliances are Becoming Inevitable 19
4.2.3 Geographical Organic and Inorganic Expansion into APAC and Other Developing Nations is Bound to Spurt Growth 19
4.3 Technology Trends 20
4.3.1 Design and Development Technologies are Maturating 20
4.3.2 Large Numbers of New Product Developments are Undertaken to Stay in the Race 20
4.3.3 Shifting of Healthcare Provision Modes from Treatment in a Hospital Setting to Disease Prevention and Home Based Care 20
4.3.4 Changes in Design Concepts have Emerged from Alliances Between Drugs and Devices Industries 20
4.4 Market Drivers 21
4.4.1 Advances in Technology are Driving Growth of the Drug/Device CP Market 21
4.4.2 Rising Awareness among the Stakeholders Accelerates Market Growth 21
4.4.3 The Combination Products Promise to Avoid Systemic Effects and Toxicity and increases Efficacy of Therapy 22
4.4.4 Reviving of failed pharmaceutical products Lowers Development Time and Costs to Launch Newer CPs 22
4.4.5 Greater positive effects than the medical device operating alone 22
4.4.6 Regulatory processes are gaining clarity worldwide to invite bigger market participation 23
4.4.7 Rising Medical insurance coverage in increasing Clinical Adoption Rates 23
4.4.8 Broadening Range of Applications for Drug/Device CPs will increase Market Volumes Aggressively 23
4.4.9 A Competitive Pressure to Achieve Corporate Goals Lure Medical Device Companies into this Space 23
4.5 Market Restraints 24
4.5.1 Several Jurisdiction Issues Deter Market Growth Considerably 24
4.5.2 A Changing Regulatory Environment Creates Confusion and Lack of Clarity among Participants 24
4.5.3 Patient Compliance for these Products has Lowered Slightly, and is Affecting Adoption Rates 24
4.5.4 The relatively High Investment Costs in the Market Curtails Market Growth Considerably 24
4.6 Market Challenges 25
4.6.1 Cross-Industry Partnership Issues is a Major Challenge to Market Growth 25
4.6.2 Non-standard PMOA determination processes is a noteworthy lacunae in the regulatory processes 26
4.6.3 Several Major Business Risks Exist Within this Industry 26
4.6.4 Technology Issues Result in Large Development Timelines and Market Slow-down 26
4.7 Key Opportunity Areas 27
4.7.1 Addressing Legal and Regulatory Challenges Will Enlighten Dark Areas within The System And Enable Easy Transgression Through The Regulatory Cycles 27
4.7.2 Improving Finance Attracting Ability of Emerging Research-Oriented Bio-Tech Companies Will Aid in Promoting RandD 27
4.7.3 Expanding Product Portfolio Using Existing Knowledge Base Will Enable Easier Market Entry and Expansion 27
4.7.4 Increasing Product Accessibility to All Geographies With Unmet Demands Will Increase Sales Volumes For The Key Market Players 27
5 Drug/Device CP Market: Segment Analysis And Forecasts 28
5.1 Drug-Eluting Stents 28
5.1.1 Segment Overview 28
5.1.2 Market Forecasts 29
5.1.3 Market Drivers 30
5.1.4 Market Restraints 31
5.1.5 Market Opportunities 32
5.2 Antimicrobial Catheters 33
5.2.1 Segment Overview 33
5.2.2 Market Forecasts 34
5.2.3 Market Drivers 35
5.2.4 Market Restraints 35
5.2.5 Market Opportunities 36
5.3 Antibiotic-Loaded Bone Cements 37
5.3.1 Segment Overview 37
5.3.2 Market Forecasts 39
5.3.3 Market Drivers 40
5.3.4 Market Restraints 41
5.4 Drug Eluting Beads (DEB) 42
5.4.1 Segment Overview 42
5.4.2 Market Forecasts 43
5.4.3 Market Drivers 44
5.4.4 Market Restraints 44
5.5 Photodynamic Therapy 45
5.5.1 Segment Overview 45
5.5.2 Market Forecasts 49
5.5.3 Market Drivers 50
5.5.4 Market Restraints 51
5.5.5 Market Opportunities 51
6 Drug/Device CP Market: Geographical Analysis and Forecasts 52
6.1 The US Market 52
6.2 The European Union (EU) Market 54
6.3 The Rest-of-World (ROW) Market 54
7 Drug/Device CP Market: Regulatory Issues 56
7.1 Introduction 56
7.2 Common Regulatory Issues 57
7.2.1 Compliance Issues 57
7.2.2 Pre-Clinical Testing Issues 57
7.2.3 Sterilization Issues 58
7.2.4 Safety and Efficacy Issues 58
7.2.5 Good Manufacturing Practices (GMP) Issues 58
7.2.6 Packaging Issues 58
7.2.7 CMC Issues 59
7.2.8 Stability Issues 59
7.2.9 Patent Analysis and IPR Issues 60
7.2.10 Post_Market Surveillance 60
7.2.11 Incident Reporting 60
7.2.12 Adverse Event Reporting 61
7.2.13 Risk Management Issues 61
7.2.14 Reimbursement Issues 61
7.3 The FDA and the Office of the Combination Products (OCP) 62
7.4 The European Medical Device Directive (MDD) 64
7.4.1 Mode of Action (MOA) 64
7.5 Japanese Regulatory Approach: The MHLW 67
7.5.1 Drugs 67
7.5.2 Medical devices 67
7.5.3 CP Jurisdiction 67
7.6 The Australian Therapeutic Goods Administration (TGA) and the Office of Devices, Blood and Tissues (ODBT) 68
7.6.1 TGA Framework 68
7.6.2 Key Challenges faced under the TGA by CP Manufacturers 69
7.7 State Food and Drug Administration (SFDA) and the Regulatory Framework in China 69
7.8 International Standards for Drugs and Devices 70
8 Drug/Device CP Market: Competitive Landscape 71
8.1 DES Market 71
8.1.1 Key Industry Participants 71
8.1.2 Key Company Profiles 72
8.2 Antimicrobial Catheters 76
8.2.1 Key Industry Participants 76
8.2.2 Key Company Portfolios 76
8.2.3 Company Market Shares 77
8.2.4 Key Product Portfolios 77
8.3 Antibiotic Loaded Bone Cement 79
8.3.1 Key Industry Participants 79
8.3.2 Key Company Portfolios 79
8.3.3 Company Market Shares 80
8.3.4 Key Product Portfolios 81
8.4 Drug- Eluting Beads 82
8.4.1 Key Industry Participants 82
8.4.2 Key Company Portfolios 82
8.4.3 Company Market Shares 83
8.4.4 Key Product Portfolios 84
8.5 Photodynamic Therapy 85
8.5.1 Key Industry Participants 85
8.5.2 Key Company Portfolios 85
8.5.3 Company Market Shares 86
8.5.4 Key Product Portfolios 86
9 Drug/Device CP Market: Strategic Consolidation 88
9.1 Mergers and Acquisitions (MandA) 88
9.2 Licensing and Partnerships 88
9.2.1 Other notable alliances: 89
9.2.2 Existing Alliances: 89
9.3 Future Outlook 90
10 Appendix 91
10.1 Abbreviations 91
10.2 Definitions 93
10.3 Sources 93
10.4 Research Methodology 93
10.4.1 Secondary Research 93
10.4.2 Primary Research 94
10.4.3 Models 94
10.4.4 Forecasts 94
10.4.5 Expert Panels 95
10.5 Contact Us 95
10.6 Disclaimer 95

1.1 List of Tables
Table 1: Drug/Device CP Categorization 11
Table 2: Regulatory Processes for devices and drugs 13
Table 3: Drug/Device CP: Applications 14
Table 4: Total Drug/Devices CP Market, Global, Revenues ($m), 2007 - 2016 17
Table 5: Drug/Device CP Market split by Geography, 2007-2016 18
Table 6: DES Market, Global, Revenues Split by Region ($m), 2007-2016 30
Table 7: Anti-microbial Catheter Market, Global, Revenues ($m), 2007-2016 34
Table 8: Association between Fracture Grades, Fracture Healing Period and Infection Risk Percentage 37
Table 9: ALBC Market, Global, Revenues ($m), 2007-2016 39
Table 10: DEB Market, Global, Revenues($m), 2007-2016 43
Table 11: Clinically Approved Photosensitizers in a Region for a Particular Disease 48
Table 12: PDT Applications 48
Table 13: PDT Market, Global, Revenues ($m), 2007-2016 49
Table 14: Drug/Devices CP Market, the US, Revenues ($m) by Product Segment, 2007- 2016 53
Table 15: Drug/Devices CP Market, the EU, Revenues ($m) by Product Segment, 2007- 2016 54
Table 16: Drug/Devices CP Market, the RoW, Revenues ($m) by Product Segment, 2007- 2016 55
Table 17: Differences in Device and Drug Development and FDA Regulation 56
Table 18: Medical Device Vigilance (MDV) and Medical Device Reporting (MDR) requirements in different world regions 61
Table 19: International Standards for Drugs and Devices 70
Table 20: Key Industry Participants, DES Market, Global, 2009 71
Table 21: Key Industry Participants, AC Market, Global, 2009 76
Table 22: Antimicrobial Catheter Concepts 77
Table 23: Key Industry Participants, ALBC Market, Global, 2009 79
Table 24: Key Industry Participants, DEB Market, Global, 2009 82
Table 25: Key Industry Participants, PDT Market, Global, 2009 85

1.2 List of Figures
Figure 1: Drug/Device CP Development Stages and Timelines 12
Figure 2: Drug/Device CP market, Split by Product Segment, ($m) 2009 16
Figure 3: Total Drug/Devices CP Market, Global, Revenues ($m), 2007- 2016 17
Figure 4: Drug/Device CP Market split by Geography, 2007-2016 18
Figure 5: Market Drivers, Drug/Device CP Market, Global, 2007-2016 21
Figure 6: Key Market Challenges, Drug/Device CP Market, Global, 2007-2016 25
Figure 7: DES Market, Global, Revenues Split by Region ($m), 2007-2016 29
Figure 8: Anti-microbial Catheter Market, Global, Revenues ($m), 2007-2016 34
Figure 9: ALBC Market, Global, Revenues ($m), 2007-2016 39
Figure 10: DEB Market, Global, Revenues ($m), 2007-2016 43
Figure 11: A Schematic Representation of the PDT Principle 45
Figure 12: Type 1 and Type 2 Reaction Modes in a PDT Procedure 46
Figure 13: PDT Market, Global, Revenues ($m), 2007-2016 49
Figure 14: Population over 65 years, The US, 1980-2030 52
Figure 15: Drug/Devices CP Market, the US, Revenues ($m) by Product Segment, 2007- 2016 53
Figure 16: Drug/Devices CP Market, the EU, Revenues ($m) by Product Segment, 2007- 2016 54
Figure 17: Drug/Devices CP Market, the RoW, Revenues ($m) by Product Segment, 2007- 2016 55
Figure 18: Requirements of the Medical Devices Directive (MDD) 93/42/EEC 65
Figure 19: Role of Product Manufacturer, Notified Body and Competent Authority 66
Figure 20: Company Market Shares, DES Market, Global, 2009 73
Figure 21: Company Market Shares, Antimicrobial Catheters Market, Global, 2009 77
Figure 22: Company Market Shares, ALBC Market, Global, 2009 80
Figure 23: Company Market Shares, DEB Market, Global, 2009 83
Figure 24: Company Market Shares, PDT Market, Global, 2009 86

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