General Report Contents
• Market Analyses include: Unit Sales, ASPs, Market Value & Growth Trends
• Market Drivers & Limiters for each chapter segment
• Competitive Analysis for each chapter segment
• Section on recent mergers & acquisitions
The U.S. market reacted strongly to public opinion on the backlash of product INFUSE® for its performance. Initially approved for spinal fusion in 2001, INFUSE® was subsequently approved for tibial fractures in 2004, then for dental operations in 2007. Lawsuits have accused Medtronic of hiding side effects and promoting unapproved use. The decline seen in unit sales in 2013 can be attributed to the controversy and lawsuits surrounding the misuse of INFUSE® for unapproved indications in the spine.
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TABLE OF CONTENTS I
LIST OF FIGURES XVII
LIST OF CHARTS XIX
EXECUTIVE SUMMARY 1
U.S. ORTHOPEDIC BIOMATERIALS MARKET OVERVIEW 1
COMPETITIVE ANALYSIS 4
MARKET TRENDS 6
MARKET DEVELOPMENTS 8
PROCEDURE NUMBERS 9
MARKETS INCLUDED 11
KEY REPORT UPDATES 13
VERSION HISTORY 13
RESEARCH METHODOLOGY 14
1.1 RESEARCH SCOPE 14
1.2 IDATA’S 9-STEP METHODOLOGY 14
Step 1: Project Initiation & Team Selection 14
Step 2: Prepare Data Systems and Perform Secondary Research 16
Step 3: Preparation for Interviews & Questionnaire Design 17
Step 4: Performing Primary Research 18
Step 5: Research Analysis: Establishing Baseline Estimates 20
Step 6: Market Forecast and Analysis 21
Step 7: Identify Strategic Opportunities 23
Step 8: Final Review and Market Release 24
Step 9: Customer Feedback and Market Monitoring 25
DISEASE OVERVIEW 26
2.1 BASIC ANATOMY 26
2.1.1 Osteology and Musculoskeletal System 26
2.2 DISEASE PATHOLOGY AND DISORDERS 28
2.2.1 General Diagnostic 28
2.2.2 Osteoporosis 29
2.2.3 Osteoarthritis 29
2.2.4 Indication for Bone Graft Procedure 30
2.2.5 Indication for Cartilage Repair 31
2.2.6 Degenerative Disc Disease 32
2.3 PATIENT DEMOGRAPHICS 34
2.3.1 General Statistics 34
PRODUCT ASSESSMENT 36
3.1 PRODUCT PORTFOLIOS 36
3.1.1 Growth Factors 37
3.1.1.1 Other products 40
3.2 REGULATORY ISSUES AND RECALLS 42
3.2.1 Growth Factors 42
3.3 CLINICAL TRIALS 43
3.3.1 Growth Factors 43
ORTHOPEDIC GROWTH FACTOR MARKET 48
4.1 INTRODUCTION 48
4.1.1 BMP-2 (Medtronic) 49
4.1.2 PDGF-BB (Wright Medical) 49
4.1.3 BMP-7 (Olympus Biomaterials) 50
4.3 MARKET ANALYSIS AND FORECAST 51
4.4 DRIVERS AND LIMITERS 53
4.4.1 Market Drivers 53
4.4.2 Market Limiters 53
4.5 COMPETITIVE MARKET SHARE ANALYSIS 56
ABBREVIATIONS 59
APPENDIX II: COMPANY PRESS RELEASES 61
Chart 1 1: Orthopedic Biomaterials Market by Segment, U.S., 2013 – 2023 3
Chart 1 2: Orthopedic Biomaterials Market Overview, U.S., 2016 & 2023 3
Chart 4 1: Orthopedic Growth Factor Market, U.S., 2013 – 2023 52
Chart 4 2: Leading Competitors, Orthopedic Growth Factor Market, U.S., 2016 58
MedtronicGenzymeDePuy SynthesAnika TherapeuticsFerring PharmaceuticalsStrykerNuVasiveBioventusZimmer BiometIntegra LifeSciencesRTI SurgicalFidia PharmaceuticalsMTFOrthofixArthrexAlloSourceAastromBaxterHarvest TechnologiesWright MedicalBacterin InternationalArteriocyteExactechLifeNet HealthBiocompositesAlphatec SpineCelling BiosciencesGlobus MedicalNuo TherapeuticsK2M*Not all companies are currently active in every segment or sub-report from this suite. For more details contact an iData Research Product Advisor.