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Orthotic and Prosthetic (O&P) Devices - US Analysis and Market Forecasts

Summary

The global orthotics and prosthetics (O&P) market, which includes braces and supports and prosthetic devices, is an expansive market covering a broad range of indications. Braces and supports, external devices that provide support to joints and weakened musculoskeletal groups to facilitate function and healing, are utilized prominently in osteoarthritis management; fracture, sprain, strain, and tear treatment; and prophylactic sports use. For this report, prosthesis use is focused on a single indication: extremity amputation.

The growing global aging population and subsequent rise in the prevalence of diseases that primarily affect the elderly, including diabetes, vascular disease, and osteoarthritis, as well as the increase in adoption of braces and supports for non-invasive treatment, particularly in fracture management and post-operative rehabilitation, are expected to drive growth in the O&P market. Emerging O&P technologies focus on improving patient comfort and functionality to facilitate increased product adoption.

This report examines O&P device adoption and challenges faced by current competitors in the US. The analysis also identifies unmet needs in the market, specifies the major drivers and barriers to device adoption, and provides an understanding of physician perception and outlook with an overall emphasis on current and future industry trends in the US.

Highlights

Key Questions Answered

- What is the current and future O&P market outlook in the US market? What trends are affecting this O&P market?
- Which are the key, high growth markets that O&P manufacturers should expand into? Which markets are growing the fastest, and what are the top-selling products in each segment?
- What are the unmet needs with O&P products currently on the market? How will emerging technologies fulfill these unmet needs?
- What clinical factors and technical specifications influence a physician to use one type of brace or prosthetic device over another? What is physician perception and market outlook of O&P?
- What are the challenges and complications of O&P that have hindered widespread adoption?
- With developing the next-generation of O&P products, what aspects of the technology are device manufacturers focused on optimizing? How will new entrants impact the global O&P market?

Scope

- Annualized total O&P market revenue by type of device, direct and indirect costs of disease, procedure trends, and market outlooks for the US through 2021.
- Key topics covered include strategic competitor assessment, market characterization, identification of unmet needs, reimbursement and regulatory considerations, evaluating market access in the US, and implications of the emerging technologies on the market.
- Pipeline analysis: Comprehensive data split across different stages of development, including a discussion of emerging trends and O&P products in development.
- Analysis of the current and future market competition in the US O&P market. Insightful review of the key industry drivers, opportunities, barriers and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to buy

- “What Physicians Think” quotes provide a unique insight into how healthcare professionals are reacting to events within the industry, and what their responses could mean for industry strategists. In this report you will understand the perceptions of leading orthopedic surgeons and O&P practitioners from around the world. This information is essential for all strategic decision makers in every organization allowing them to act on high quality information.

Table Of Contents

Orthotic and Prosthetic (OandP) Devices - US Analysis and Market Forecasts
1 Table of Contents
1 Table of Contents 5
1.1 List of Tables 11
1.2 List of Figures 14
2 Introduction 15
2.1 Catalyst 15
2.2 Related Reports 16
3 Industry Overview 17
3.1 Overview 17
3.2 Procedure Trends 17
3.2.1 By Country 17
3.3 Market Access 18
3.3.1 Purchasing Decisions 18
3.4 Brand Loyalty 19
3.5 Adoption 20
3.6 Regulation 21
3.6.1 US 21
3.7 Reimbursement 22
3.7.1 US 22
3.8 Product Recalls 24
3.8.1 Ability Dynamics Recalls Rush81 Prosthetic Foot (June 2014) 24
3.8.2 Zimmer Recalls Drop-Lok Knee Brace, Cartilage Knee Brace, Hinged Knee Support, and Tennis Elbow Support (April 2014) 25
3.8.3 Ossur Recalls Symbionic Leg (February 2014) 25
3.9 Mergers and Acquisitions 26
3.9.1 Ottobock Entered Licensing Agreement with Ekso Bionics (November 2014) 27
3.9.2 Breg to Merge with United Orthopedic Group (October 2014) 27
3.9.3 Ottobock to Distribute Artec's 3D Scanners (July 2014) 27
3.9.4 Hanger Acquired Prosthetic Laboratories of Rochester (June 2014) 27
3.9.5 Hanger Acquired Four Patient Care Companies (August 2013) 28
3.9.6 Ossur Acquired TeamOlmed for $47m (May 2013) 28
3.9.7 DJO Global Acquired Exos (December 2012) 28
3.9.8 Hanger Acquired Two Patient Care Companies (December 2012) 28
3.9.9 Hanger Acquired Five Companies (August 2011) 29
3.9.10 Thuasne Acquired Townsend Design (January 2011) 29
3.10 Economic Impact 29
3.10.1 Indirect Costs 29
3.10.2 Direct Costs 30
4 Unmet Needs 32
4.1 Need for More Upper Limb Prostheses 32
4.2 Reducing Custom Orthosis and Prosthesis Production Timeline 34
4.3 Lower Limb Prosthetic Socket Fit 36
4.4 Changes in Patient Need 38
4.5 Replacement and Reimbursement Limitations 39
4.6 Shortage of Orthotic and Prosthetic Professionals 43
5 Market Drivers, Barriers, and Opportunities 46
5.1 Driver: Combat Injuries 46
5.2 Driver: Aging Global Population 46
5.3 Driver: Orthoses Used as Non-invasive and Mobile Treatments 48
5.4 Driver: Diabetes and Vascular Disease 49
5.5 Barrier: Medical Device Excise Tax 50
5.6 Barrier: Established Orthotics and Prosthetics Market 50
5.7 Barrier: Restricted Reimbursement 51
5.8 Opportunity: Active Lower Extremity Prostheses 52
5.9 Opportunity: Computer Aided Design and Computer Aided Manufacture 53
5.10 Opportunity: 3D Printing 54
5.11 Opportunity: Osseointegration 55
6 Competitive Assessment 58
6.1 Overview 58
6.2 Technology and Product Offerings 58
6.3 Product Portfolios 59
6.3.1 Bauerfeind 59
6.3.2 Breg 60
6.3.3 BSN 62
6.3.4 DeRoyal 63
6.3.5 DJO 64
6.3.6 Endolite (Blatchford) 66
6.3.7 Hanger 67
6.3.8 Medi 68
6.3.9 Ossur 69
6.3.10 Ottobock 71
6.3.11 Spinal Tech 73
6.3.12 Touch Bionics 74
6.3.13 WillowWood 76
6.4 Product Category SWOT Profiles 78
6.4.1 Orthotics 78
6.4.2 Prosthetics 79
7 Pipeline Assessment 81
7.1 Orthotic Products 81
7.2 Prosthetic Products 82
8 Clinical Trials to Watch 86
8.1 Overview 86
8.2 Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA) 86
8.3 Use of Subtle Vibration to Improve Walking Ability by Lower Limb Amputees 87
8.4 Home Study of an Advanced Upper Limb Prosthesis 88
8.5 Feasibility of Implantable Myoelectric Sensors to Control Upper Limb Prostheses (IMES) 88
8.6 The General Use of Robots in Stroke Recovery: The Anklebot 89
8.7 Validation of a New Generation of Optimized Orthoses for Personalized Treatment of Adolescent Idiopathic Scoliosis 89
8.8 Comparing Functional Outcomes in Individuals Using Micro-processor Controlled Orthosis Versus Stance Control Orthosis 90
8.9 Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees (MPK-AOPA) 91
9 Current and Future Players 93
9.1 Overview 93
9.2 Trends in Corporate Strategy 93
9.3 Bauerfeind AG 94
9.3.1 Overview 94
9.3.2 Portfolio Assessment 95
9.3.3 SWOT Analysis 95
9.4 Breg, Inc. 95
9.4.1 Overview 95
9.4.2 Portfolio Assessment 97
9.4.3 SWOT Analysis 97
9.5 BSN Medical GmbH 97
9.5.1 Overview 97
9.5.2 Portfolio Assessment 98
9.5.3 SWOT Analysis 98
9.6 DeRoyal Industries, Inc. 99
9.6.1 Overview 99
9.6.2 Portfolio Assessment 99
9.6.3 SWOT Analysis 100
9.7 DJO Global, Inc. 100
9.7.1 Overview 100
9.7.2 Portfolio Assessment 101
9.7.3 SWOT Analysis 101
9.8 Endolite (Blatchford) 102
9.8.1 Overview 102
9.8.2 Portfolio Assessment 102
9.8.3 SWOT Analysis 103
9.9 Hanger, Inc. 103
9.9.1 Overview 103
9.9.2 Portfolio Assessment 104
9.9.3 SWOT Analysis 104
9.10 Medi GmbH and Co. KG 105
9.10.1 Overview 105
9.10.2 Portfolio Assessment 105
9.10.3 SWOT Analysis 106
9.11 Ossur hf. 106
9.11.1 Overview 106
9.11.2 Portfolio Assessment 107
9.11.3 SWOT Analysis 107
9.12 Ottobock HealthCare GmbH 108
9.12.1 Overview 108
9.12.2 Portfolio Assessment 109
9.12.3 SWOT Analysis 109
9.13 Spinal Technology, Inc. 110
9.13.1 Overview 110
9.13.2 Portfolio Analysis 110
9.13.3 SWOT Analysis 111
9.14 Touch Bionics Limited 111
9.14.1 Overview 111
9.14.2 Portfolio Assessment 112
9.14.3 SWOT Analysis 112
9.15 WillowWood 112
9.15.1 Overview 112
9.15.2 Portfolio Assessment 113
9.15.3 SWOT Analysis 113
10 Strategic Competitive Assessment 114
10.1 Orthotics: Company Market Share 114
10.1.1 By Country 114
10.2 Prosthetics: Company Market Share 115
10.2.1 By Country 115
11 Market Outlooks by Geography 116
11.1 Orthotics 116
11.1.1 US 116
11.2 Prosthetics 118
11.2.1 US 118
12 Appendix 121
12.1 Bibliography 121
12.2 Abbreviations 126
12.3 Report Methodology 129
12.3.1 Overview 129
12.3.2 Coverage 129
12.3.3 Secondary Research 129
12.4 Forecasting Methodology 131
12.5 Physicians and Specialists Included in This Study 132
12.5.1 Key Opinion Leaders 132
12.6 Primary Research - Prescriber Survey 133
12.7 About the Authors 133
12.7.1 Analysts 133
12.7.2 Global Head of Healthcare 134
12.8 About GlobalData 135
12.9 Disclaimer 135

1.1 List of Tables
Table 1: Medicare ICD-9 Codes and DRG codes for Common Orthotic and Prosthetic Needs 22
Table 2: HCPCS Codes for Common Orthotic and Prosthetic Devices, 2015 24
Table 3: Mergers and Acquisitions (2011-2014) 26
Table 4: Bauerfeind's Orthotics Portfolio 60
Table 5: Breg's Orthotics Portfolio 61
Table 6: Bledsoe Brace Systems' Orthotics Portfolio 62
Table 7: BSN Medical's Orthotics Portfolio 63
Table 8: DeRoyal's Orthotics Portfolio 64
Table 9: DJO's Orthotics Portfolio 65
Table 10: Endolite's Prosthetics Portfolio 66
Table 11: Hanger's Orthotics Portfolio 68
Table 12: Medi's Orthotics and Prosthetics Portfolio 69
Table 13: Ossur's Orthotics and Prosthetics Portfolio 70
Table 14: Ottobock's Orthotics and Prosthetics Portfolio 72
Table 15: Spinal Tech's Orthotics Portfolio 74
Table 16: Touch Bionics' Prosthetics Portfolio 76
Table 17: WillowWood's Prosthetics Portfolio 77
Table 18: SWOT Analysis — Custom-Fabricated Orthoses 78
Table 19: SWOT Analysis — Off-the-Shelf Orthoses 78
Table 20: SWOT Analysis — Active Upper Extremity Prostheses 79
Table 21: SWOT Analysis — Passive Upper Extremity Prostheses 79
Table 22: SWOT Analysis — Mechanical Lower Limb Prostheses 79
Table 23: SWOT Analysis — Microprocessor Lower Limb Prostheses 80
Table 24: SWOT Analysis — Non-functional Lower Limb Prostheses 80
Table 25: Pipeline Products in the Global Orthotics Market, 2015 81
Table 26: Pipeline Products in the Global Prosthetics Market, 2015 83
Table 27: Osseointegrated Prostheses for the Rehabilitation of Amputees (OPRA) 87
Table 28: Use of Subtle Vibration to Improve Walking Ability by Lower Limb Amputees 87
Table 29: Home Study of an Advanced Upper Limb Prosthesis 88
Table 30: Feasibility of Implantable Myoelectric Sensors to Control Upper Limb Prostheses (IMES) 89
Table 31: The General Use of Robots in Stroke Recovery: The Anklebot 89
Table 32: Validation of a New Generation of Optimized Orthoses for Personalized Treatment of Adolescent Idiopathic Scoliosis 90
Table 33: Comparing Functional Outcomes in Individuals Using Micro-processor Controlled Orthosis Versus Stance Control Orthosis 91
Table 34: Comparative Effectiveness Between Microprocessor Knees and Non-Microprocessor Knees (MPK-AOPA) 92
Table 35: Company Profile — Bauerfeind AG 95
Table 36: SWOT Analysis — Bauerfeind 95
Table 37: Company Profile — Breg, Inc. 96
Table 38: SWOT Analysis — Breg 97
Table 39: Company Profile — BSN Medical GmbH 98
Table 40: SWOT Analysis — BSN 98
Table 41: Company Profile — DeRoyal Industries, Inc. 99
Table 42: SWOT Analysis — DeRoyal 100
Table 43: Company Profile — DJO Global, Inc. 101
Table 44: SWOT Analysis — DJO 101
Table 45: Company Profile — Endolite 102
Table 46: SWOT Analysis — Endolite 103
Table 47: Company Profile — Hanger 104
Table 48: SWOT Analysis — Hanger 104
Table 49: Company Profile — Medi GmbH and Co. KG 105
Table 50: SWOT Analysis - Medi 106
Table 51: Company Profile — Ossur hf. 107
Table 52: SWOT Analysis - Ossur 107
Table 53: Company Profile — Ottobock HealthCare GmbH 109
Table 54: SWOT Analysis — Ottobock 109
Table 55: Company Profile — Spinal Technology, Inc. 110
Table 56: SWOT Analysis — Spinal Tech 111
Table 57: Company Profile — Touch Bionics Limited 111
Table 58: SWOT Analysis — Touch Bionics 112
Table 59: Company Profile — WillowWood 113
Table 60: SWOT Analysis — WillowWood 113
Table 61: US Market Value Forecast by Market Segment for Orthotics, $m, 2012-2021 117
Table 62: US Market Value Forecast by Market Segment for Prosthetics, $m, 2012-2021 119

1.2 List of Figures
Figure 1: US Procedure Volume Forecast by Market Segment, 2012-2021 18
Figure 2: US Company Market Shares for Orthotics, 2014 114
Figure 3: US Company Market Shares for Prosthetics, 2014 115
Figure 4: US Market Value Forecast by Market Segment for Orthotics, $m, 2012-2021 116
Figure 5: US Market Value Comparison by Market Segment for Orthotics, 2014 and 2021 118
Figure 6: US Market Value Forecast by Market Segment for Prosthetics, $m, 2012-2021 119
Figure 7: US Market Value Comparison by Market Segment for Prosthetics, 2014 and 2021 120

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