Ortho and Osteobiologics World Industry 2014-2024

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For an Executive Summary of this report please contact ediz.ibrahim@visiongain.com (+44 (0)20 7549 9976) or refer to our website http://www.visiongain.com/Report/1188/Ortho-and-Osteobiologics-World-Industry-and-Market-Analysis-2014-2024

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Ortho and Osteobiologics World Industry 2014-2024

  1. 1. Ortho and Osteobiologics: World Industry and Market Analysis 2014-2024 ©notice This material is copyright by visiongain. It is against the law to reproduce any of this material without the prior written agreement of visiongain. You cannot photocopy, fax, download to database or duplicate in any other way any of the material contained in this report. Each purchase and single copy is for personal use only.
  2. 2. Contents 1. Executive Summary 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. Introduction to Orthobiologics 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 www.visiongain.com
  3. 3. Contents 2.13 Biological Treatments for Osteoporosis – Monoclonal Antibodies Just Hitting the Market 3. Orthobiologics: Global Market, 2014-2024 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, 20142024 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 www.visiongain.com
  4. 4. 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. Regional and National Markets, 2014-2024 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 4.7.1 Demographics, Drivers, and Restraints 4.8 Expanding Orthobiologics in the UK: Market Forecast, 2014-2024 4.8.1 Demographics, Drivers, and Restraints 4.9 Slow Growth in the French Orthobiologics: Market Forecast, 2014-2024 4.9.1 Demographics, Drivers, and Restraints 4.10 Stuttering Growth for Orthobiologics in Italy: Market Forecast, 2014-2024 www.visiongain.com
  5. 5. Contents 4.11 Dwindling Demand in Spain: Market Forecast, 2014-2024 4.12 The Rise of Orthobiologics in Japan: Market Forecast, 2014-2024 4.12.1 Demographics, Drivers, and Restraints 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 4.14.1 Demographics, Drivers, and Restraints 4.15 Explosive Growth in Brazilian Orthobiologics: Market Forecast, 2014-2024 4.15.1 Demographics, Drivers, and Restraints 4.16 Too Soon for Orthobiologics in India: Market Forecast, 2014-2024? 4.17 Tepid Growth in Russian Orthobiologics: Market Forecast, 2014-2024 4.17.1 Demographics, Drivers, and Restraints 4.18 Orthobiologics in Minor Nations: Market Forecast, 2014-2024 5. Biological Treatments for Osteoporosis: Market to 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 www.visiongain.com
  6. 6. 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 5.8.1 Demographics, Drivers, and Restraints 5.9 European Market Share to Decline by 27% Over Ten Years 5.10 German Market to Plateau: Market Forecast 2014-2024 5.10.1 Demographics, Drivers, and Restraints 5.11 Revenue Ceiling in the UK: Market Forecast 2014-2024 5.11.1 Demographics, Drivers, and Restraints 5.12 French Market to Double in Five Years: Market Forecast 2014-2024 5.12.1 Demographics, Drivers, and Restraints 5.13 Price Controls Restrict Italian Growth: Market Forecast 2014-2024 5.13.1 Demographics, Drivers, and Restraints 5.14 Limited Expansion in Spain: Market Forecast 2014-2024 5.14.1 Demographics, Drivers, and Restraints 5.15 Continual Growth in Japan: Market Forecast 2014-2024 5.15.1 Demographics, Drivers, and Restraints 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 5.17.1 Demographics, Drivers, and Restraints 5.18 Brazil Set to Expand by 185%: Market Forecast, 2014-2024 5.18.1 Demographics, Drivers, and Restraints 5.19 Strong Growth but Poor Value in India: Market Forecast 2014-2024 5.19.1 Demographics, Drivers, and Restraints www.visiongain.com
  7. 7. Contents 5.20 Limited Value in Russia: Market Forecast 2014-2024 5.20.1 Demographics, Drivers, and Restraints 5.21 Minor National Markets Forecast, 2014-2024 6. R&D Pipeline for Orthobiologics 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 www.visiongain.com
  8. 8. Contents 7. Leading Companies in the Orthobiologics Market, 2013-2014 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. Qualitative Analysis of the Orthobiologics Market, 2014 8.1 Strengths and Weaknesses of the Orthobiologics Market 8.2 Strengths www.visiongain.com
  9. 9. 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 www.visiongain.com
  10. 10. 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. Research Interviews 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 www.visiongain.com
  11. 11. Contents 10. Conclusions 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 ENDPAGES About Visiongain’s Bespoke Research Service Appendix A Appendix B www.visiongain.com
  12. 12. Contents List of Tables 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 ($m), Market Share (%), 2024 www.visiongain.com
  13. 13. Contents Table 4.4 Global Orthobiologics Market: Regional Revenue Forecasts ($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 ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024 www.visiongain.com
  14. 14. Contents Table 4.20 Russian Orthobiologic Market: Revenue ($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 www.visiongain.com
  15. 15. 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 ($m), Annual Growth Rate (%), Peak of Sales (%), CAGR, 2010-2014 Table 7.3 Smaller Orthobiologics Manufacturers: Listed A-E, 2013 Table 7.4 Smaller Orthobiologics Manufacturers: Listed G-T, 2013 www.visiongain.com
  16. 16. Contents List of Figures Figure 3.1 Orthopaedic Devices Market: Segment Market Shares (%), 2012 Figure 3.2 Global Orthopaedics Biomaterials Market: Segment Market Shares (%), 2012 Figure 3.3 Segmented Orthobiologics Market Forecast: Segment Revenues ($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 www.visiongain.com
  17. 17. 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 www.visiongain.com
  18. 18. 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 www.visiongain.com
  19. 19. Contents Organisations Mentioned in this Report 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 www.visiongain.com
  20. 20. 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 www.visiongain.com
  21. 21. 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 www.visiongain.com
  22. 22. 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 www.visiongain.com
  23. 23. Contents Tornier UCB Winthrop University Hospital World Health Organization (WHO) Wright Medical Yale University Zimmer Zosano Pharma www.visiongain.com
  24. 24. 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 ($m), Annual Growth Rate (%), Global Market Share (%), CAGR (%), 2013-2024 Revenue ($m) Annual growth rate (%) Global market share (%) CAGR (%) Revenue ($m) Annual growth rate (%) Global market share (%) CAGR (%) 2012 288 10.0 2013 317 10.0 10.5 2014 347 9.6 10.9 2015 379 9.3 11.1 2016 428 12.8 11.3 2017 448 4.7 10.8 2019 539 6.0 10.7 2020 586 8.7 10.6 2021 619 5.8 10.4 2022 653 5.4 10.1 2023 686 5.0 10.0 2018 508 13.4 11.1 9.9 2024 769 12.2 10.6 7.2 Source: visiongain 2014 Figure 4.12 Japanese Orthobiologic Market: Revenue ($m), 2013-2024 900 800 Revenue ($m) 700 600 500 400 300 200 100 0 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024 Year Source: visiongain 2014 4.12.1 Demographics, Drivers, and Restraints 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 www.visiongain.com Page 82
  25. 25. 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. www.visiongain.com Page 83

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