1 Table Of Contents
1 Table Of Contents 2
1.1 List of Tables 7
1.2 List of Figures 9
2 Introduction 11
2.1 What Is This Report About? 11
3 Definitions of the Markets Covered in the Report 12
3.1 Orthopedic Braces and Supports 12
3.1.1 Ankle Braces and Supports 12
3.1.2 Knee Braces and Supports 12
3.1.3 Wrist and other Braces and Supports 12
3.2 Splints and Casts 12
4 Healthcare Sector Review 13
4.1 Healthcare Expenditure 13
4.2 Healthcare Infrastructure 18
4.2.1 Healthcare Personnel Data 20
4.2.2 Healthcare Facilities Data 23
4.3 United States Healthcare Trade Statistics 25
5 Regulation System 26
5.1 Regulation System 26
5.2 Medical Equipment Approval Process 26
5.2.1 Pre-market Approval Process 27
5.2.2 Intended use and Indications for use 27
5.2.3 Predicate Device 28
5.2.4 Safe and Effective 28
5.2.5 Other Category Devices 30
5.2.6 Post-Market Approval Process 31
5.2.7 Compliance and Enforcement 31
5.2.8 Registration Fee 32
5.2.9 Approval Time 32
6 Pricing and Reimbursement 33
6.1 Government Policies 33
6.2 Private Insurance 34
6.3 Diagnosis Related Groups (DRG) 35
7 Distribution Structure 36
7.1 Distribution Structure 36
8 Orthopedic Braces and Supports Cross Country Comparison 37
9 Orthopedic Braces and Supports in United States 38
9.1 Orthopedic Braces and Supports Overall Revenues (2000-2012) 38
9.2 Orthopedic Braces and Supports Overall Volume (2000-2012) 42
9.3 Orthopedic Braces and Supports Category Revenues (2000-2012) 45
9.3.1 Soft Braces and Supports Revenues (2000-2012) 45
9.3.2 Rigid Braces and Supports Revenues (2000-2012) 47
9.3.3 Casts Revenues (2000-2012) 49
9.3.4 Splints Revenues (2000-2012) 51
9.4 Orthopedic Braces and Supports Category Volume (2000 - 2012) 53
9.4.1 Soft Braces and Supports Volume (2000-2012) 53
9.4.2 Rigid Braces and Supports Volume (2000-2012) 55
9.4.3 Casts Volume (2000-2012) 57
9.4.4 Splints Volume (2000-2012) 59
9.5 Orthopedic Braces and Supports Average Price (2000-2012) 61
9.6 Orthopedic Braces and Supports Distribution Share (2006-2007) 62
9.7 Orthopedic Braces and Supports Overall Company Share (2006-2007) 63
10 DeRoyal Industries, Inc. Company Profile 64
10.1 Company Overview 64
11 DJO Incorporated Company Profile 65
11.1 Company Overview 65
11.2 Value Chain Analysis 65
11.2.1 Manufacturing 66
11.2.1.1 In House Manufacturing 66
11.2.1.2 Outsourcing 66
11.2.2 Product Development 66
11.2.2.1 Regulatory Approvals 66
11.2.2.2 Clinical Trials 66
11.2.2.3 Research and Development 67
11.2.3 Sales and Marketing 67
11.2.3.1 Partnerships and Alliances 67
11.2.3.2 Licensing Agreements 67
11.2.3.3 E-distribution 67
12 Orthofix International N.V. Company Profile 68
12.1 Company Overview 68
12.2 Value Chain Analysis 68
12.2.1 Manufacturing 69
12.2.1.1 In House Manufacturing 69
12.2.1.2 Outsourcing 69
12.2.2 Product Development 69
12.2.2.1 Regulatory Approvals 69
12.2.2.2 Clinical Trials 69
12.2.2.3 Research and Development 69
12.2.3 Sales and Marketing 70
12.2.3.1 Partnerships and Alliances 70
12.2.3.2 Licensing Agreements 70
12.3 Orthofix International N.V. Pipeline Products 70
12.3.1 Orthofix International N.V. Pipeline Products by Equipment Type 70
12.3.2 Orthofix International N.V. Pipeline Products by Development Stage 70
12.3.3 Orthofix International N.V. Pipeline Products by Therapy Area 71
12.3.4 Orthofix International N.V. Pipeline Products by Clinical Trials 71
12.3.5 Orthofix International N.V. Pipeline Products by News Summary 71
13 Hanger Orthopedic Group, Inc. Company Profile 72
13.1 Company Overview 72
13.2 Value Chain Analysis 72
13.2.1 Manufacturing 73
13.2.1.1 In House Manufacturing 73
13.2.1.2 Outsourcing 73
13.2.2 Product Development 73
13.2.2.1 Regulatory Approvals 73
13.2.2.2 Clinical Trials 73
13.2.2.3 Research and Development 73
13.2.3 Sales and Marketing 73
13.2.3.1 Partnerships and Alliances 73
13.2.3.2 Licensing Agreements 74
13.3 Hanger Orthopedic Group, Inc. Pipeline Products 74
13.3.1 Hanger Orthopedic Group, Inc. Pipeline Products by Equipment Type 74
13.3.2 Hanger Orthopedic Group, Inc. Pipeline Products by Development Stage 74
13.3.3 Hanger Orthopedic Group, Inc. Pipeline Products by Therapy Area 75
13.3.4 Hanger Orthopedic Group, Inc. Pipeline Products by Clinical Trials 75
13.3.5 Hanger Orthopedic Group, Inc. Pipeline Products by News Summary 75
14 Ossur hf. Company Profile 76
14.1 Company Overview 76
14.2 Value Chain Analysis 76
14.2.1 Manufacturing 76
14.2.1.1 In House Manufacturing 76
14.2.1.2 Outsourcing 77
14.2.2 Product Development 77
14.2.2.1 Regulatory Approvals 77
14.2.2.2 Clinical Trials 77
14.2.2.3 Research and Development 77
14.2.3 Sales and Marketing 77
14.2.3.1 Partnerships and Alliances 77
14.2.3.2 Licensing Agreements 77
14.2.3.3 E-distribution 77
15 A-T Surgical Mfg. Co., Inc. Company Profile 78
15.1 Company Overview 78
16 Aircast Company Profile 79
16.1 Company Overview 79
17 Baiwa, Inc. Company Profile 80
17.1 Company Overview 80
18 FLA Orthopedics, Inc. Company Profile 81
18.1 Company Overview 81
19 Financial Deals Landscape 82
19.1 Acquisition 82
19.1.1 DJO Acquires Aircast From Tailwind Capital And Other Shareholders 82
19.1.2 Ossur Acquires Innovation Sports 84
19.1.3 Trulife Group Acquires Seattle Systems 85
19.1.4 Langer To Sell Regal Medical Supply 86
19.2 Private Equity 88
19.2.1 Tailwind Capital Exits From Aircast 88
19.2.2 Cortec Group Sells Royce Medical Holdings To Ossur 90
20 APPENDIX 92
20.1 Global Markets Direct Research Methodology 92
20.2 Coverage 93
20.3 Secondary Research 93
20.4 Primary Research 94
20.5 Models 94
20.6 Forecasts 95
20.7 Expert Panels 95
20.8 Currency Conversion 96
20.9 Contact Us 97
20.10 Disclaimer 97
1.1
List of Tables
Table 1: United States Healthcare Expenditure, 2003-2010 14
Table 2: United States Healthcare Expenditure by Age (per person), 2000-2003 15
Table 3: United States Healthcare Expenditure by Sex (per person), 2000-2003 15
Table 4: United States Healthcare Expenditure by Race (per person), 2000-2003 15
Table 5: United States Personal Healthcare Expenditure by Type, 2000-2004 16
Table 6: United States Personal Healthcare Expenditure by Source, 2000-2004 17
Table 7: Total Number of Doctors in the United States, 2003-2010 20
Table 8: Number of Doctors by Specialty in the United States, 2003-2010 21
Table 9: Doctors by Region (Number per 10,000 Civilian Population), 2002-2004 22
Table 10: Doctors by Region (Number per 10,000 Civilian Population), 2002-2004 (Cont.) 23
Table 11: Total Hospitals in the United States, 2000-2004 23
Table 12: Community Hospitals by Number of Beds in the United States, 2000-2004 24
Table 13: Number of Hospital Beds in the United States, 2000-2004 24
Table 14: Number of Hospital Beds by Range in the United States, 2000-2004 24
Table 15: United States Healthcare Trade Statistics, 2001-2006 25
Table 16: Medical Equipment Registration Fee in United States, 2007 32
Table 17: Medical Device Approval Time in United States, 2004 32
Table 18: Orthopedic Braces and Supports Cross Country Comparison 37
Table 19: Orthopedic Braces and Supports, United States, Overall Revenues ($ mn), 2000-2012 38
Table 20: Orthopedic Braces and Supports, United States, Portfolio Analysis 39
Table 21: Orthopedic Braces and Supports, United States, Overall Revenues ($ mn), Historic, 2000-2007 40
Table 22: Orthopedic Braces and Supports, United States, Overall Revenues ($ mn), Forecast, 2007-2012 41
Table 23: Orthopedic Braces and Supports, United States, Overall Volume (Units), 2000-2012 42
Table 24: Orthopedic Braces and Supports, United States, Overall Volume (Units), Historic, 2000-2007 43
Table 25: Orthopedic Braces and Supports, United States, Overall Volume (Units), Forecast, 2007-2012 44
Table 26: Soft Braces and Supports, United States, Revenues by Segment ($ mn), Historic, 2000-2007 45
Table 27: Soft Braces and Supports, United States, Revenues by Segment ($ mn), Forecast, 2007-2012 46
Table 28: Rigid Braces and Supports, United States, Revenues by Segment ($ mn), Historic, 2000-2007 47
Table 29: Rigid Braces and Supports, United States, Revenues by Segment ($ mn), Forecast, 2007-2012 48
Table 30: Casts, United States, Revenues by Segment ($ mn), Historic, 2000-2007 49
Table 31: Casts, United States, Revenues by Segment ($ mn), Forecast, 2007-2012 50
Table 32: Splints, United States, Revenues ($ mn) by Segment, Historic, 2000-2007 51
Table 33: Splints, United States, Revenues ($ mn) by Segment, Forecast, 2007-2012 52
Table 34: Soft Braces and Supports, United States, Volume (Units), Historic, 2000-2007 53
Table 35: Soft Braces and Supports, United States, Volume (Units), Forecast, 2007-2012 54
Table 36: Rigid Braces and Supports, United States, Volume (Units), Historic, 2000-2007 55
Table 37: Rigid Braces and Supports, United States, Volume (Units), Forecast, 2007-2012 56
Table 38: Casts, United States, Volume (Units), Historic, 2000-2007 57
Table 39: Casts, United States, Volume (Units), Forecast, 2007-2012 58
Table 40: Splints, United States, Volume (Units), Historic, 2000-2007 59
Table 41: Splints, United States, Volume (Units), Forecast, 2007-2012 60
Table 42: Orthopedic Braces and Supports, United States, Average Price ($), Historic, 2000-2007 61
Table 43: Orthopedic Braces and Supports, United States, Average Price ($), Forecast, 2007-2012 62
Table 44: Orthopedic Braces and Supports, United States, Distribution Share (2006-2007) 62
Table 45: Orthopedic Braces and Supports, United States, Company Share by Revenue ($ mn), 2006-2007 63
Table 46: Orthofix International N.V. Pipeline Products by Equipment Type 70
Table 47: Orthofix International N.V. Pipeline Products By Development Stage 70
Table 48: Orthofix International N.V. Pipeline Products By Therapy Area 71
Table 49: Orthofix International N.V. Pipeline Products By Clinical Trials 71
Table 50: Orthofix International N.V. Pipeline Products By News Summaries 71
Table 51: Hanger Orthopedic Group, Inc. Pipeline Products by Equipment Type 74
Table 52: Hanger Orthopedic Group, Inc. Pipeline Products By Development Stage 74
Table 53: Hanger Orthopedic Group, Inc. Pipeline Products By Therapy Area 75
Table 54: Hanger Orthopedic Group, Inc. Pipeline Products By Clinical Trials 75
Table 55: Hanger Orthopedic Group, Inc. Pipeline Products By News Summaries 75
Table 56: Currency Conversion from USD to Local Currency at 2007 Constant Rate 96
1.2
List of Figures
Figure 1: United States, Healthcare Expenditure by Source, 2003 14
Figure 2: United States, Healthcare Infrastructure, Top Level View, 2007 19
Figure 3: Healthcare Expenses Segmentation by End User, 2003 20
Figure 4: Medical Equipment Approval Process in the United States, 2007 27
Figure 5: PMA Approval Process in the United States, 2007 29
Figure 6: The 510(k) Approval Process for Medical Devices in the United States, 2007 30
Figure 7: Reimbursement Structure in the United States, 2007 35
Figure 8: Distribution Structure of Medical Equipment in the United States, 2006 36
Figure 9: Orthopedic Braces and Supports Cross Country Comparison 37
Figure 10: Orthopedic Braces and Supports, United States, Overall Revenues ($ mn), 2000-2012 38
Figure 11: Orthopedic Braces and Supports, United States, Portfolio Analysis 39
Figure 12: Orthopedic Braces and Supports, United States, Overall Revenues ($ mn), Historic, 2000-2007 40
Figure 13: Orthopedic Braces and Supports, United States, Overall Revenues ($ mn), Forecast, 2007-2012 41
Figure 14: Orthopedic Braces and Supports, United States, Overall Volume (Units), 2000-2012 42
Figure 15: Orthopedic Braces and Supports, United States, Overall Volume (Units), Historic, 2000-2007 43
Figure 16: Orthopedic Braces and Supports, United States, Overall Volume (Units), Forecast, 2007-2012 44
Figure 17: Soft Braces and Supports, United States, Revenues by Segment ($ mn), Historic, 2000-2007 45
Figure 18: Soft Braces and Supports, United States, Revenues by Segment ($ mn), Forecast, 2007-2012 46
Figure 19: Rigid Braces and Supports, United States, Revenues by Segment ($ mn), Historic, 2000-2007 47
Figure 20: Rigid Braces and Supports, United States, Revenues by Segment ($ mn), Forecast, 2007-2012 48
Figure 21: Casts, United States, Revenues by Segment ($ mn), Historic, 2000-2007 49
Figure 22: Casts, United States, Revenues by Segment ($ mn), Forecast, 2007-2012 50
Figure 23: Splints, United States, Revenues ($ mn) by Segment, Historic, 2000-2007 51
Figure 24: Splints, United States, Revenues ($ mn) by Segment, Forecast, 2007-2012 52
Figure 25: Soft Braces and Supports, United States, Volume (Units), Historic, 2000-2007 53
Figure 26: Soft Braces and Supports, United States, Volume (Units), Forecast, 2007-2012 54
Figure 27: Rigid Braces and Supports, United States, Volume (Units), Historic, 2000-2007 55
Figure 28: Rigid Braces and Supports, United States, Volume (Units), Forecast, 2007-2012 56
Figure 29: Casts, United States, Volume (Units), Historic, 2000-2007 57
Figure 30: Casts, United States, Volume (Units), Forecast, 2007-2012 58
Figure 31: Splints, United States, Volume (Units), Historic, 2000-2007 59
Figure 32: Splints, United States, Volume (Units), Forecast, 2007-2012 60
Figure 33: Orthopedic Braces and Supports, United States, Company Share (%), 2007 63
Figure 34: DJO Incorporated, Value Chain Analysis 65
Figure 35: Orthofix International N.V., Value Chain Analysis 68
Figure 36: Hanger Orthopedic Group, Inc., Value Chain Analysis 72
Figure 37: Ossur hf., Value Chain Analysis 76
Figure 38: Global Markets Direct Methodology 92