ortho and osteobiologics world industry 2014-2024

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Ortho and Osteobiologics: World Industry and Market Analysis

2014-2024

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Contents

1.1 Overview of Findings

1.2 Aims and Coverage of this Report

1.3 Structure of this Report

1.4 Research and Analysis Methods

1.5 Terms Related to This Report

2.1 What Are Orthobiologics?

2.2 How Do we Classify Orthobiologics?

2.3 Osteoblasts are Critical in Bone Healing

2.4 Autografts – The “Gold Standard” Bone Graft

2.5 Allografts- The Most Basic of Orthobiologics

2.6 Machined Bones- Creating Customised Implants

2.7 Demineralised Bone Matrix (DBM) – The Original Osteoinductive Orthobiologic

2.8 Growth Factors, the Signals That Encourage Tissue Formation

2.8.1 Bone Morphogenetic Proteins (BMPs) – Supercharging Osteoinduction

2.9 Stem Cells – The Future of Orthobiology

2.10 Regulation of Orthobiologics

2.10.1 The US Approval and Regulation System

2.10.2 The EU Approval and Regulation System

2.11 Osteoporosis – The Insidious Killer

2.12 From Bisphosphonates to Antibodies – Therapies to Improve Bone Density

2. Introduction to Orthobiologics

1. Executive Summary

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Contents 2.13 Biological Treatments for Osteoporosis – Monoclonal Antibodies Just Hitting the Market

3.1 Orthopaedic Devices: Worth More Than $29bn in 2012

3.2 Orthobiologics in 2012, a Diverse Multi-Billion Dollar Market

3.2.1 Trends in Orthobiologics, 2012

3.3 Which Segments Will Grow Fastest? Orthobiologics Market Forecast Breakdown, 2014-

2024

3.3.1 Steady Growth in Machined Bones, 2014-2024

3.3.2 Growth Spurt in Demineralised Bone Matrices, 2014-2024

3.3.3 Declining Growth Factor Sales, 2014-2024

3.3.4 Accelerated Growth for Bone Substitutes, 2013-2024

3.3.5 Sustained High Growth for Stem-Cells Therapies, 2014-2024

3.3.6 Allograft Market Remains Small, 2014-2024

3.4 Stem-Cell Therapies Will Lead the Orthobiologics Market

3.4.1 Stem-Cell Therapies: Drivers and Restraints

3.4.2 The Only Osteogenic Bone Graft Substitute

3.4.3 Better than Autograft

3.4.4 Treating at Risk Patients

3.4.5 What is the Alternative?

3.4.6 High Costs Limit Access

3.4.7 Where is the Clinical Evidence?

3.4.8 Human Tissue or Biological Product?

3.5 Growth Factors Fall From Grace

3. Orthobiologics: Global Market, 2014-2024

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Contents 3.5.1 Growth Factor Products: Drivers and Restraints

3.5.2 Autograft Equivalence

3.5.3 Surgeons Still like INFUSE

3.5.4 Off-label Adverse Events

3.5.5 High Unit Cost

3.5.6 Stem-Cell Competition

4.1 US and Japan are Crucial National Markets - Regional Breakdown of the Orthobiologics

Market, 2012

4.2 Japan and Germany Increase Market Share by 9%: National Markets, 2013-2018

4.3 BRIC Countries Increase Market Share by 38%: National Markets, 2018-2024

4.4 National Orthobiologic Market Analysis, 2014-2024

4.5 The US Remains Fundamental to Growth: Market Forecast, 2014-2024

4.5.1 Demographics, Drivers and Restraints

4.6 Steady Growth for Orthobiologics in the Five Leading European Nations, 2014-2024

4.6.1 Demographics, Drivers, and Restraints

4.7 Germany Leads Europe: Market Forecast, 2014-2024


4.8 Expanding Orthobiologics in the UK: Market Forecast, 2014-2024


4.9 Slow Growth in the French Orthobiologics: Market Forecast, 2014-2024


4.10 Stuttering Growth for Orthobiologics in Italy: Market Forecast, 2014-2024

4. Regional and National Markets, 2014-2024

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Contents 4.11 Dwindling Demand in Spain: Market Forecast, 2014-2024

4.12 The Rise of Orthobiologics in Japan: Market Forecast, 2014-2024


4.13 BRIC Nations to Increase Market Share by 42%: Regional Market Forecast, 2014-2024

4.14 China, the Principal Emerging Nation: Market Forecast, 2014-2024


4.15 Explosive Growth in Brazilian Orthobiologics: Market Forecast, 2014-2024


4.16 Too Soon for Orthobiologics in India: Market Forecast, 2014-2024?

4.17 Tepid Growth in Russian Orthobiologics: Market Forecast, 2014-2024


4.18 Orthobiologics in Minor Nations: Market Forecast, 2014-2024

5.1 Biologics Take 21.9% of the Osteoporosis Market in 2012

5.2 Leading Biologic Brands

5.2.1 Prolia (Denosumab; Amgen)

5.2.2 Forteo (Teriparatide; Eli Lilly)

5.2.3 Preotact (Recombinant Parathyroid Hormone; NPS Pharmaceuticals)

5.3 Forteo Spearheads the Market in 2012

5.4 Rapid Growth for Biologics: Global Market Forecast, 2014-2024

5.5 Forecasted Product Sales, 2014-2024

5.5.1 Prolia to Drive the Market

5.5.2 Forteo Loses Market Share

5. Biological Treatments for Osteoporosis: Market to 2024

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Contents 5.6 National Breakdown of the Osteobiologics Market, 2012

5.7 Declining Importance of Europe: Forecasted National Markets 2014-2024

5.8 US Dictates Growth: Market Forecast, 2014-2024


5.9 European Market Share to Decline by 27% Over Ten Years

5.10 German Market to Plateau: Market Forecast 2014-2024


5.11 Revenue Ceiling in the UK: Market Forecast 2014-2024


5.12 French Market to Double in Five Years: Market Forecast 2014-2024


5.13 Price Controls Restrict Italian Growth: Market Forecast 2014-2024


5.14 Limited Expansion in Spain: Market Forecast 2014-2024


5.15 Continual Growth in Japan: Market Forecast 2014-2024


5.16 BRIC Nations to Treble in Value in Less Than Ten Years

5.17 China Increases Market Share by 48%: Market Forecast 2014-2024


5.18 Brazil Set to Expand by 185%: Market Forecast, 2014-2024


5.19 Strong Growth but Poor Value in India: Market Forecast 2014-2024


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Contents 5.20 Limited Value in Russia: Market Forecast 2014-2024


5.21 Minor National Markets Forecast, 2014-2024

6.1 Orthobiologic Biomaterials Pipeline

6.1.1 i-FACTOR (Cerapedics) – Osteoinduction Without Hazardous Growth Factors

6.1.2 Bone Therapeutics, Focussed on Cell Therapies

6.1.2.1 PREOB – Leading Candidate For Non-Union and Osteoporosis

6.1.2.2 ALLOB – Early Stage Donor Cell Therapy

6.1.3 Map3 (RTI Biologics) – Competition for Osteocel and Trinity Evolution

6.1.4 NeoFuse (Mesoblast) – Comparable to the “Gold Standard”

6.1.5 Kuros Biosurgery – Partnered With Synthes to Develop Orthobiologics

6.1.5.1 KUR-111 – An Alternative to Autograft for Fusing the Tibia

6.1.5.2 KUR-113 – Another Parathyroid Hormone for Tibia Fractures

6.1.5.3 KUR-115 – About to Enter Phase II Trials for Spinal Fusion

6.1.6 Amplex (BioSET) – A Mimetic Peptide for BMP-2

6.1.7 UCB-1 (Nell-1; Bone Biologics) – Early Stage Protein with Sclerostin like Potential

6.2 Biological Osteoporosis Pipeline

6.2.1 Romosozumab (AMG 785) – Blockbuster in Waiting

6.2.2 Blosozumab (LY2541546) – Second in Class Sclerostin Antibody

6.2.3 ZP-PTH – Parathyroid by Way Micro Needle Patch

6.2.4 ZT-034 - Will Need More Than Biomarkers for Approval

6.2.5 BA058 – Looking to Compete With Forteo

6. R&D Pipeline for Orthobiologics

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Contents

7.1 Domination of Medtronic and Johnson & Johnson

7.2 Leading Companies in the Orthobiologics Market, 2013

7.3 Medtronic

7.3.1 INFUSE Sales Results

7.4 Johnson & Johnson (DePuy Synthes), Dominant in the Orthobiologics and Medical Device

Market

7.5 Vitoss Crucial to Stryker Sales

7.6 Integra LifeSciences, Looking to Innovation with Accell DBMs

7.7 NuVasive – The Leading Force in the Stem Cell Market

7.8 RTI Biologics, Producing the Full Spectrum of Orthobiologics

7.9 Baxter International, Acquiring Its Way into the Market

7.10 Biomet - Big in Orthopaedics, Building Up in Orthobiologics

7.11 Wright Medical, Shifting Focus into the Ankle Market

7.12 Globus Medical- The Fastest Growing Orthopaedics Company

7.13 Zimmer Spine, Weak Sales for a Multinational Powerhouse

7.14 Bacterin – Exclusively Biological Business Model

7.15 Olympus Biotech, Focussed on Minimally Invasive Surgery

7.16 Fragmented Market for Smaller Companies

7.17 Shift to High Margin Products and Specialisation

8.1 Strengths and Weaknesses of the Orthobiologics Market

8.2 Strengths

8. Qualitative Analysis of the Orthobiologics Market, 2014

7. Leading Companies in the Orthobiologics Market, 2013-2014

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Contents 8.2.1 Eli Lilly and Amgen Dominate the Biological Osteoporosis Market

8.2.2 Biologics Suit Minimally Invasive Surgery

8.2.3 Patients Stick to Biologics

8.3 Weaknesses

8.3.1 Intense Competition in the Biomaterials Market

8.3.2 Are Biologics Worth the Bill?

8.3.3 Soaring Clinical Development Costs

8.3.4 The Silent Disease

8.4 Opportunities and Threats in the Orthobiologics Market

8.5 Opportunities

8.5.1 Increase Diagnosis Rates to Increase Sales

8.5.2 Beat the Best in Class

8.5.3 Access to the Surgical Community

8.5.4 Replacing Autografts

8.6 Threats

8.6.1 Generic Bisphosphonate Competition

8.6.2 Getting Paid in the US and Europe

8.6.3 Accessing the Asian Markets

8.6.4 Treatment Only as a Last Resort

8.7 Social, Technological, Economic, and Political (STEP) Analysis

8.7.1 Social Factors

8.7.2 Ageing Populations in the Developed and BRIC Nations

8.7.3 Unhealthy Lifestyles and the Global rise in Prevalence of Diabetes

8.8 Technological Factors

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Contents 8.8.1 Harnessing Stem Cell and Gene Based Therapies

8.9 Economic Factors

8.9.1 Reimbursement and Cost Cutting in the Europe and the US

8.9.2 Free Trade within the European Union, Parallel Trade and Arbitrage

8.9.3 Record Low Cost of Borrowing – What Happens When the Music’s Over?

8.10 Political Factors

8.10.1 The Patient Protection and Affordable Care Act in the US

9.1 Interview with an Executive at an International Orthobiologics Company

9.1.1 Matching Products to Patients at Risk

9.1.2 Demanding Clinical and Economic Evidence

9.1.3 Stem Cells are Critical

9.1.4 Developed Markets and Latin America Drive Growth

9.1.5 Too Early for China?

9.1.6 Moving Away From Basic Bone Substitutes

9.1.7 Medical Education is Crucial

9.1.8 Safety and Efficacy of BMP Products

9.2 Interview with Dr Nancy Epstein M.D., Chief of Neurosurgical and Spine Education,

Winthrop University Hospital

9.2.1 INFUSE to be taken off the Market

9.2.2 An “Off-label” Product NOT Approved by the Food and Drug Administration

9.2.3 Surgeons Still Demand Innovation for Patients at Risk

9.2.4 Gene Therapy

9. Research Interviews

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Contents

10.1 Continued Growth in Orthobiologics

10.1.1 Stem-Cell Products Dominate the Market

10.1.2 Decline in Growth Factor Sales

10.1.3 US Continues to Dominate the Market

10.2 Biologics Break Osteoporosis

10.2.1 Patient Population Explosion

10.2.2 Prolia and Romosozumab Lead the Market

10.2.3 Early Access to Japan

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Appendix A

Appendix B

10. Conclusions

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Contents

Table 1.1 Currency Exchange Rates, 2013

Table 2.1 Mechanisms Involved in Bone Grafting

Table 3.1 Global Orthopaedic Device Market: Segment Revenue ($bn) and Market Share (%), 2012

Table 3.2 Global Orthobiologics Market: Segment Revenue ($m) and Market Share (%), 2012

Table 3.3 Global Orthobiologics Market Forecasts: Segment Revenue ($m), Annual Growth Rate (%), Segment Market Share (%), CAGR (%), 2013-2018

Table 3.4 Global Orthobiologics Market Forecasts: Segment Revenue ($m), Annual Growth Rate (%), Segment Market Share (%), CAGR (%), 2018-2024

Table 3.5 Global Machined Bone Market Forecast: Revenue ($m), Annual Growth Rate (%), CAGR (%), 2013-2024

Table 3.6 Global Demineralised Bone Matrix Market Forecast: Revenue ($m), Annual Growth Rate (%), CAGR (%), 2013-2024

Table 3.7 Global Growth Factor Market Forecast: Revenue ($m), Annual Growth Rate (%), CAGR (%), 2013-2024

Table 3.8 Global Bone Substitute Market Forecast: Revenue ($m), Annual Growth Rate (%), CAGR (%), 2013-2024

Table 3.9 Global Stem Cell Therapy Market Forecast: Revenue ($m), Annual Growth Rate (%), CAGR (%), 2013-2024

Table 3.10 Global Allograft Bone Market Forecast: Revenue ($m) Annual Growth Rate (%), CAGR (%), 2013-2024

Table 3.11 INFUSE Revenue Forecast: Revenue ($m), Annual Growth Rate (%), Peak of Sales (%), CAGR (%), 2011-2024

Table 4.1 Global Orthobiologics Market: National Market Revenue ($m), Market Share (%), 2012

Table 4.2 Global Orthobiologic Market: National Market Revenue ($m), Market Share (%), 2018

Table 4.3 Global Orthobiologic Market: National Market Revenue ($m), Market Share (%), 2024

List of Tables

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Contents Table 4.4 Global Orthobiologics Market: Regional Revenue Forecasts ($m), Annual Growth (%), Global Market Share (%), CAGR (%), 2013-2018

Table 4.5 Global Orthobiologics Market: Regional Revenue Forecasts($m), Annual Growth (%), Global Market Share (%), CAGR (%), 2018-2024

Table 4.6 US Orthobiologic Market: Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024

Table 4.7 Five Leading European Orthobiologic Markets: National Revenue Forecasts ($m), Annual Growth Rate (%), European Market Share (%), CAGR (%), 2013-2018

Table 4.8 Five Leading European Orthobiologic Markets: National Revenue Forecasts ($m), Annual Growth Rate (%), European Market Share (%), CAGR (%), 2018-2024

Table 4.9 German Orthobiologic Market: Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024

Table 4.10 UK Orthobiologic Market: Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024

Table 4.11 French Orthobiologic Market: Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024

Table 4.12 Italian Orthobiologic Market: Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024

Table 4.13 Spanish Orthobiologic Market: Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024

Table 4.14 Japanese Orthobiologic Market: Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024

Table 4.15 BRIC Orthobiologic Markets: Revenue Forecasts ($m), Annual Growth (%), BRIC Market Share (%), CAGR (%), 2013-2018

Table 4.16 BRIC Orthobiologic Markets: Revenue Forecasts ($m), Annual Growth (%), BRIC Market Share (%), CAGR (%), 2018-2024

Table 4.17 Chinese Orthobiologic Market: Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024

Table 4.18 Brazilian Orthobiologic Market: Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024

Table 4.19 Indian Orthobiologic Market: Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024

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Contents Table 4.20 Russian Orthobiologic Market: Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024

Table 4.21 Minor National Orthobiologic Markets: Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024

Table 5.1 Global Osteoporosis Market: Segment Revenue ($m), Market Share (%), 2012

Table 5.2 Biologics Osteoporosis Treatments, Product Revenue ($m) and Market Share (%), 2012 and 2013

Table 5.3 Global Osteoporosis Biologics Market Forecast: Total Revenue ($m), Annual Growth Rate (%), CAGR (%), 2013-2024

Table 5.4 Global Osteoporosis Biologics Market Forecasts: Product Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2018

Table 5.5 Global Osteoporosis Biologics Market Forecasts: Product Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2018-2024

Table 5.6 National Markets for Osteoporosis Biologics: Revenue ($m), Market Share (%), 2012

Table 5.7 Global Osteoporosis Biologics Market: Regional Revenue Forecasts ($m), Annual Growth (%), Global Market Share (%), CAGR (%), 2013-2018

Table 5.8 Global Osteoporosis Biologics Market: Regional Revenue Forecasts ($m), Annual Growth (%), Global Market Share (%), CAGR (%), 2018-2024

Table 5.9 US Market for Osteoporosis Biologics: Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024

Table 5.10 Reported Costs of Biological Osteoporosis Treatments in the US and UK Markets, 2013

Table 5.11 Five Leading European Nationals Markets for Osteoporosis Biologics: Revenue Forecasts ($m), Annual Growth Rate (%), European Market Share (%), Global Market Share (%), CAGR (%), 2013-2018

Table 5.12 Five Leading European Nationals Markets for Osteoporosis Biologics: Revenue Forecasts ($m), Annual Growth Rate (%), European Market Share (%), Global Market Share (%), CAGR (%), 2018-2024

Table 5.13 German Market for Osteoporosis Biologics: Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024

Table 5.14 UK Market for Osteoporosis Biologics: Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024

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Contents Table 5.15 French Market for Osteoporosis Biologics: Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024

Table 5.16 Italian Market for Osteoporosis Biologics: Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024

Table 5.17 Spanish Market for Osteoporosis Biologics: Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024

Table 5.18 Japanese Market for Osteoporosis Biologics: Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024

Table 5.19 BRIC Markets for Osteoporosis Biologics: National Revenue Forecasts ($m), Annual Growth Rate (%), BRIC Market Share (%), Global Market Share (%), CAGR (%), 2013-2018

Table 5.20 BRIC Markets for Osteoporosis Biologics: National Revenue Forecasts ($m), Annual Growth Rate (%), BRIC Market Share (%), Global Market Share (%), CAGR (%), 2018-2024

Table 5.21 Chinese Market for Osteoporosis Biologics: Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024

Table 5.22 Brazilian Market for Osteoporosis Biologics: Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024

Table 5.23 Indian Market for Osteoporosis Biologics: Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024

Table 5.24 Russian Market for Osteoporosis Biologics: Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024

Table 5.25 Minor National Markets for Osteoporosis Biologics: Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024

Table 6.1 Orthobiologic Biomaterials in Development, 2013

Table 6.2 Osteoporosis Biologics in Development, 2013

Table 7.1 Leading Orthobiologics Companies: Revenue ($m), Market Share (%), 2012

Table 7.2 INFUSE (rhBMP-2) Sales: Revenue ($m), Annual Growth Rate (%), Peak of Sales (%), CAGR, 2010-2014

Table 7.3 Smaller Orthobiologics Manufacturers: Listed A-E, 2013

Table 7.4 Smaller Orthobiologics Manufacturers: Listed G-T, 2013

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Contents

Figure 3.1 Orthopaedic Devices Market: Segment Market Shares (%), 2012

Figure 3.2 Global Orthopaedics Biomaterials Market: Segment Market Shares (%), 2012

Figure 3.3 Segmented Orthobiologics Market Forecast: Segment Revenues ($m), 2013-2024

Figure 3.4 Total Global Orthobiologics Forecast: Revenue ($m), 2013-2024

Figure 3.5 Machined Bone Market Forecast: Revenue ($m), 2013-2024

Figure 3.6 Global Demineralised Bone Matrix Market Forecast: Revenue ($m), 2013-2024

Figure 3.7 Global Growth Factor Market Forecast: Revenue ($m),2013-2024

Figure 3.8 Global Bone Substitute Market Forecast: Revenue ($m), 2013-2024

Figure 3.9 Global Stem Cell Therapy Market Forecast: Revenue ($m), 2013-2024

Figure 3.10 Global Allograft Bone Market Forecast: Revenue ($m), 2013-2024

Figure 3.11 Stem-Cell Therapy Market: Drivers and Restraints, 2014-2024

Figure 3.12 INFUSE Revenue Forecast: Revenue ($m), 2013-2024

Figure 3.13 Growth Factor Market: Drivers and Restraints, 2014-2024

Figure 4.1 Global Orthobiologics Market: National Market Shares (%), 2012

Figure 4.2 Global Orthobiologic Market: National Market Shares (%), 2018

Figure 4.3 Global Orthobiologic Market: National Market Shares (%), 2024

Figure 4.4 Global Orthobiologics Market: Regional Revenues ($m), 2013-2024

Figure 4.5 US Orthobiologic Market: Revenue ($m), 2013-2024

Figure 4.6 Five Leading European Orthobiologic Markets: National Market Revenues ($m), 2013-2024

Figure 4.7 German Orthobiologic Market: Revenue ($m), 2013-2024

Figure 4.8 UK Orthobiologic Market: Revenue ($m), 2013-2024

Figure 4.9 French Orthobiologic Market: Revenue ($m), 2013-2024

List of Figures

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Contents Figure 4.10 Italian Orthobiologic Market: Revenue ($m), 2013-2024

Figure 4.11 Spanish Orthobiologic Market: Revenue ($m), 2013-2024

Figure 4.12 Japanese Orthobiologic Market: Revenue ($m), 2013-2024

Figure 4.13 BRIC Orthobiologic Markets: National Revenues ($m), 2013-2024

Figure 4.14 Chinese Orthobiologic Market: Revenue ($m), 2013-2024

Figure 4.15 Brazilian Orthobiologic Market: Revenue ($m), 2013-2024

Figure 4.16 Indian Orthobiologic Market: Revenue ($m), 2013-2024

Figure 4.17 Russian Orthobiologic Market: Revenue ($m), 2013-2024

Figure 4.18 Minor National Orthobiologic Market: Revenue ($m), 2013-2024

Figure 5.1 Global Osteoporosis Market, Segment Market Shares (%), 2012

Figure 5.2 Biologics Osteoporosis Treatments: Product Revenue ($m), 2012 and 2013

Figure 5.3 Global Osteoporosis Biologics Market Forecast: Total Revenue ($m), 2013-2024

Figure 5.4 Global Osteoporosis Biologics Market Forecast: Product Revenues ($m), 2013-2024

Figure 5.5 Global Prolia Market Forecast: Revenue ($m), 2013-2024

Figure 5.6 Global Forteo Market Forecast: Revenue ($m), 2013-2024

Figure 5.7 Global Preotact Market Forecast: Revenue ($m), 2013-2024

Figure 5.8 Global Romosozumab Market Forecast: Revenue ($m), 2013-2024

Figure 5.9 Global Generics Market: Revenue ($m), 2013-2024

Figure 5.10 National Markets for Osteoporosis Biologics: Market Shares (%), 2012

Figure 5.11 Global Osteoporosis Biologics Market: Regional Revenues ($m), 2013-2024

Figure 5.12 US Market for Osteoporosis Biologics: Revenue ($m), 2013-2024

Figure 5.13 Five Leading European National Markets for Osteoporosis Biologics: Revenues ($m), 2013-2024

Figure 5.14 German Market for Osteoporosis Biologics: Revenue ($m), 2013-2024

Figure 5.15 UK Market for Osteoporosis Biologics: Revenue ($m), 2013-2024

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Contents Figure 5.16 French Market for Osteoporosis Biologics: Revenue ($m), 2013-2024

Figure 5.17 Italian Market for Osteoporosis Biologics: Revenue ($m), 2013-2024

Figure 5.18 Spanish Market for Osteoporosis Biologics: Revenue ($m), 2013-2024

Figure 5.19 Japanese Market for Osteoporosis Biologics: Revenue ($m), 2013-2024

Figure 5.20 BRIC Markets for Osteoporosis Biologics: Revenues ($m), 2013-2024

Figure 5.21 Chinese Market for Osteoporosis Biologics: Revenue ($m), 2013-2024

Figure 5.22 Brazilian Market for Osteoporosis Biologics: Revenue ($m), 2013-2024

Figure 5.23 Indian Market for Osteoporosis Biologics: Revenue ($m), 2013-2024

Figure 5.24 Russian Market for Osteoporosis Biologics: Revenue ($m), 2013-2024

Figure 5.25 Minor National Markets for Osteoporosis Biologics: Revenue ($m), 2013-2024

Figure 7.1 Leading Orthobiologics Companies: Revenues ($m), 2012

Figure 7.2 INFUSE (rhBMP-2) Sales: Revenue ($m), 2010-2014

Figure 8.1 Orthobiologics Market: Strengths and Weaknesses, 2014-2024

Figure 8.2 Orthobiologics Market: Opportunities and Threats, 2014-2024

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Contents

AAP Implante

Allosource

Alphatec

Amgen

Angel Biotechnology

ApaTech

Arthrocare

Atheriocyte Medical Systems Inc

Athersys

Azelon Pharmaceuticals

Bacterin

Baxter

Berkeley Advanced Biomaterials Inc

Biocomposites

Biocoral

Biological Therapies

Biomatlante

Biomet

BioMimetic Therapeutics

BioSET

BioTissue

BonAlive Biomaterials

Bone Biologics

Bone Solutions

Organisations Mentioned in this Report

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Contents Bone Therapeutics

BoneSupport

Brazilian Unified Health System (SUS)

Cardium Therapeutics

Celltech

Centre for Devices and Radiological Health (CDRH)

Ceramisys

Cerapedics

co.don

Collagen Matrix

Curasan

Cytomedix

Daiichi Sankyo

DePuy Synthes

Eli Lilly

ETEX Corporation

European Medicines Agency (EMA)

European Union (EU)

Exactech

Fitch Ratings

Food and Drug Administration (FDA)

Forest Laboratories

Geistlich Biomaterials

German Institute for Quality and Efficiency in Healthcare (IQWiG)

GlaxoSmithKline (GSK)

Globus Medical

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Contents Graftys

Histogenics Corporation

Integra LifeSciences

ISTO Technologies

Johnson & Johnson

Kasios

Kensey Nash

Kinetic Concepts

Kuros Biosurgery

Lindare Medical

Medtronic

Merck & Co

Mesoblast

MicroPort Medical

MiMedx Group

Monet Medical

Musculoskeletal Transplant Foundation

National Health Service (NHS)

National Institute for Clinical Excellence (NICE)

NovaBone Products LLC

Novartis

NPS Pharmaceuticals

NuVasive

Nycomed

Olympus Biotech

Orteq Bioengineering

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Contents Orthofix

Orthovita

Osiris Therapeutics

OsteoGeneX

Osteotech

Parcell Laboratories

Pharma and Medical Devices Agency (PMDA)

Pioneer Surgical Technologies

PolyNovo Biomaterials

Progenteq

Radius Health

Roche

Royal DSM

RTI Biologics

Scorpion Medical

Spinal Restoration

SpineSmith Partners LP

State Food and Drug Administration (SFDA, China)

Stryker

Takeda

Teknimed

Teva Pharmaceutical Industries

Tigenix

Tissue Banks International

Tissue Genesis

TissueGene

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Contents Tornier

UCB

Winthrop University Hospital

World Health Organization (WHO)

Wright Medical

Yale University

Zimmer

Zosano Pharma

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Ortho and Osteobiologics: World Industry and Market Analysis 2014-2024

accelerate over the next six years compared to that seen worldwide, generating a larger proportion

of the worldwide revenues.

Table 4.14 Japanese Orthobiologic Market: Revenue ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024

2012 2013 2014 2015 2016 2017 2018 Revenue ($m) 288 317 347 379 428 448 508 Annual growth rate (%) 10.0 9.6 9.3 12.8 4.7 13.4 Global market share (%) 10.0 10.5 10.9 11.1 11.3 10.8 11.1 CAGR (%)

9.9

2019 2020 2021 2022 2023 2024 Revenue ($m) 539 586 619 653 686 769 Annual growth rate (%) 6.0 8.7 5.8 5.4 5.0 12.2 Global market share (%) 10.7 10.6 10.4 10.1 10.0 10.6 CAGR (%) 7.2

Figure 4.12 Japanese Orthobiologic Market: Revenue ($m), 2013-2024


Favourable demographics trends will drive the market in Japan and increase demand for

orthobiologics over the forecast period. Japan already has one of the oldest populations worldwide,

owing to advances in healthcare and economic wealth over the last fifty years. Currently, 24% of

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2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024

Rev

enue

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Source: visiongain 2014

Source: visiongain 2014

www.visiongain.com Page 83

Ortho and Osteobiologics: World Industry and Market Analysis 2014-2024

the population is over 65 years old and 11.5% of the population is over 75 years old. These

proportions are predicted to rise over the forecast period to 31% over 65 and 18.25% over 75 in

2024. The progression towards an older society has been brought on by one of the world’s lowest

fertility rates, 1.39 births per woman, and ever increasing life expectancy. To sustain a working age

population in the developed world a fertility rate of 2.1 births per woman is required; in Japan the

last time this rate was recorded was in 1971. Visiongain predicts that of the national markets

covered by this report, Japan will be the first that demonstrates the effect of increasing age on

orthobiologic usage. Increased age will increase in the number of patients requiring surgery for

degenerative disk disorder (DDD), adding to the market for bone graft substitutes. Furthermore, the

rising prevalence of osteoporosis will cause increased demand for orthobiologics in fracture

surgery.

Although the market is predicted to grow, with strong demographic trends supporting substantial,

visiongain believes that regulatory and social pressures will limit expansion of the market. Both

pharmaceutical and medical devices have to go through a far more rigorous process of approval

for the Japanese market. The Pharmaceutical and Medical Devices Agency (PMDA) demand

clinical evidence in the Japanese population, and the entire registration process can often take up

to five years. Visiongain predicts uptake of innovative orthobiologics and novel stem-cell based

therapies will be hampered in the Japanese market during the forecast period due to regulation.

However the overriding demand within the market will lead companies to pursue costly registration

in Japan, with predicted product release of advanced orthobiologics toward the latter half of the

forecast period.

4.13 BRIC Nations to Increase Market Share by 42%: Regional Market

Forecast, 2014-2024

Tables 4.15, 4.16, and Figure 4.13 show the BRIC (Brazil, Russia, India, and China) markets for

orthobiologics forecasted to 2024. The market is predicted to grow at a compounded annual rate of

8.7% between 2012 and 2018, reaching a market value of $155m. Growth will accelerate to a

compounded annual rate of 14.0% between 2018 and 2024, reaching a market value of $341m.

The market is dominated by Chinese market, which accounts for 68.8% of the BRIC market in

2012.The Brazilian market increases its share between 2018 and 2024 to 27.7% of all BRIC

country revenue. On the global scale, the BRIC national markets are predicted to contribute to

4.7% of worldwide revenue in 2024, a 42% increase on the 2012 contribution. Individual national

markets are discussed in sections 4.14 to 4.18.