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

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									    Drug Device Combination Market to 2016 - Technological
   Convergence to be the New Business Model for Growth and
                          Profitability
 Reference Code: GBIME0015MR                                                                                                  Publication Date: January 2011


                                    Drug/Device Combination Products (CP) represents a vast area of research and development
   The drug device                  within biomaterials and medicine; and the demand for sophisticated drug-delivery devices
   combination market is            continues to drive novel product development. This research explores this high-growth nascent
   valued at $8.4 billion in        market for these combination products and features the following areas:
   2009 and it is expected to
   grow at a CAGR of 12.6%          ·      Analysis of the technologies with background information and application areas for five
   during the period 2007-                 segments of Drug/Device combination products, namely the drug-eluting stents, antimicrobial
   2016.                                   catheters, antibiotic-loaded bone cements, drug-eluting beads and photodynamic therapy.
                                    ·      Analysis of global markets with data for 2006-2008, estimates for 2009, and projections of five
                                           year compound annual growth rates to 2016
                                    ·      Detailed discussion of the current regulatory environment for Drug/Device combination
                                           products and how this is affecting development and approval of such devices
                                    ·      Analysis of overall market trends and competitors, strategic consolidations and other relevant
                                           corporate activity.
                                    The report will help medical device companies and commercial biotechnology and pharmaceutical
                                    research labs get in-depth information about the recent developments and upcoming trends, as
                                    well as the key opportunity areas in the major segment/region of the global Drug/Device CP
                                    market.
                                    Drug Device Combination is Valued at $8.4 billion in 2009
                                    The Drug/Device CP market is valued at $8.4 billion in 2009 and it is expected to grow at a CAGR
                                    of 12.6% during the period 2007-2016. The US market for Drug/Device CP is the largest
                                    geographical market comprising nearly 47.6 % of the global markets. The drug-eluting stent market
                                    is the largest market within the Drug/Device CP market, making up nearly 57.1 % of the total
                                    market in 2009. However, the drug-eluting bead market is the fastest micro-market among the
                                    segments within the scope of this study with a CAGR of 59.1% during the period 2007-2016.

                                        Drug/Device CP, Global, Revenues by Geography ($m), 2007-2016

                                                                      25,000



                                                                      20,000
                                                      Revenues ($m)




                                                                      15,000



                                                                      10,000



                                                                       5,000



                                                                          0
                                                                                       2007                    2011                  2016
                                                                          Total US Market ($m)      Total EU Market ($m)     Total RoW Market ($m)

                                        Source: GBI Research




Drug Device Combination Market to 2016 - Technological                                                                       GBIME0015MR / Published JAN 2011
Convergence to be the New Business Model for Growth and
Profitability                                                                                                                                              Page 1
                                                                                            © GBI Research. This is a licensed product and is not to be photocopied
                                    Above figure represents a concatenated bar-chart representation of the total global Drug/Device
                                    CP market for the study period, 2007-2016, with 2009 as the base year.
                                    Superior Operational Efficiency of Drug/Device CP Compared to its Individual Components
                                    Drives Growth of this Market Exponentially
                                    Improved clinical outcomes of Drug/Device combination products as compared to its individual
                                    components, namely the medical device or the drug, has resulted in high growth of this market,
                                    with the CAGR estimated to be in double digit figures. Therapeutic efficiency of the drug in a CP is
                                    enhanced as a result of the controlled drug delivery locally, thus, also avoiding systemic toxicity.
                                    The anti-infective properties of the antimicrobial or antibiotic coatings on catheters and bone
                                    cements respectively permit the device to perform its functions for a longer period of time. This
                                    improved efficiency of the CP also, thus, improves the functional life of the implanted or inserted
                                    device. These benefits have resulted in greater user acceptance worldwide, and hence, the global
                                    revenues from this macro-market within the healthcare industry are poised for sharp growth in the
                                    next seven years corresponding to the period of this study.
                                    Cross-Industry Partnership Issues Heavily Restrain Growth of the Drug/Device Combination
                                    Products Market
                                    No single medical device manufacturer or drug company has the organizational backup or
                                    expertise required to model, develop and launch Drug/Device CPs to the market for clinical use.
                                    One of the biggest challenges is the difficulty between drug and device companies working
                                    together to offer the best product possible. This can be challenging because companies need to
                                    work not only through the potential cultural differences between their two countries, but also their
                                    industries, different practices and mind-sets, as well as different business strategies. Thus, non-
                                    availability of an integrated skill-set within any single organization restrains market growth
                                    tremendously during the study period (2007-2016).




Drug Device Combination Market to 2016 - Technological                                                  GBIME0015MR / Published JAN 2011
Convergence to be the New Business Model for Growth and
Profitability                                                                                                                         Page 2
                                                                       © GBI Research. This is a licensed product and is not to be photocopied
                                    1         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 & 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

Drug Device Combination Market to 2016 - Technological                                                                              GBIME0015MR / Published JAN 2011
Convergence to be the New Business Model for Growth and
Profitability                                                                                                                                                                Page 3
                                                                                       © GBI Research. This is a licensed product and is not to be photocopied
                                            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 R&D .................................................................... 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


Drug Device Combination Market to 2016 - Technological                                                                             GBIME0015MR / Published JAN 2011
Convergence to be the New Business Model for Growth and
Profitability                                                                                                                                                               Page 4
                                                                                       © GBI Research. This is a licensed product and is not to be photocopied
                                          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 & Acquisitions (M&A) ........................................................................................ 88
                                       9.2    Licensing & 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

Drug Device Combination Market to 2016 - Technological                                                                             GBIME0015MR / Published JAN 2011
Convergence to be the New Business Model for Growth and
Profitability                                                                                                                                                               Page 5
                                                                                       © GBI Research. This is a licensed product and is not to be photocopied
                                       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




Drug Device Combination Market to 2016 - Technological                                                                          GBIME0015MR / Published JAN 2011
Convergence to be the New Business Model for Growth and
Profitability                                                                                                                                                           Page 6
                                                                                    © GBI Research. This is a licensed product and is not to be photocopied
                                    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 M
								
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