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Market Research Report

US Product Portfolio for Orthopedic Biomaterials 2017 - MedFolio

Published by iData Research Inc. Product code 454931
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US Product Portfolio for Orthopedic Biomaterials 2017 - MedFolio
Published: March 1, 2017 Content info: 502 Pages
Description

The full report suite on the U.S. market for orthopedic biomaterials includes bone graft substitutes, which is represented by allografts, demineralized bone matrix, and synthetic bone graft market. The report also includes orthopedic growth factors, cellular allografts, orthopedic cell therapy, hyaluronic acid viscosupplementation, orthopedic cartilage repair, and spinal machined bone allograft markets.

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

Orthopedic biomaterials are associated with high research and development (R&D) costs, which have subsequently led to premium pricing to recoup these initial costs. This is the case for competitors in the cellular allograft, cell therapy and growth factor segments of the U.S. orthopedic biomaterials market. In particular, orthopedic growth factors have had relatively high average selling prices (ASP) since their introduction to the market due to the high costs of recombinant growth factor technologies. The high R&D costs associated with the growth factor segment provide entry barriers against potential competitors. Currently there are only two growth factor BMP-2 products in the United States. Since they're both used in different indications, there is a lack of direct competition, allowing companies such as Medtronic to charge a premium for the Spine indication and recover the large initial costs associated with R&D. The commoditized nature in some parts of the market, such as the allograft and DBM segments, which is due to the lack of product differentiation, has limited growth. The market is being driven by more competitors venturing outside their traditional space to tap into the high growth segments where they can charge a premium. These segments may include the cell therapy and cellular allograft segments, both of which have relatively high ASP.

Table of Contents
Product Code: iDATA_USOB17_MF

TABLE OF CONTENTS

TABLE OF CONTENTS

LIST OF FIGURES

LIST OF CHARTS

EXECUTIVE SUMMARY

U.S. ORTHOPEDIC BIOMATERIALS MARKET OVERVIEW

COMPETITIVE ANALYSIS

MARKET TRENDS

MARKET DEVELOPMENTS

PROCEDURE NUMBERS

MARKETS INCLUDED

KEY REPORT UPDATES

VERSION HISTORY

RESEARCH METHODOLOGY

  • 1.1. RESEARCH SCOPE
  • 1.2. IDATA'S 9-STEP METHODOLOGY
    • Step 1: Project Initiation & Team Selection
    • Step 2: Prepare Data Systems and Perform Secondary Research
    • Step 3: Preparation for Interviews & Questionnaire Design
    • Step 4: Performing Primary Research
    • Step 5: Research Analysis: Establishing Baseline Estimates
    • Step 6: Market Forecast and Analysis
    • Step 7: Identify Strategic Opportunities
    • Step 8: Final Review and Market Release
    • Step 9: Customer Feedback and Market Monitoring

DISEASE OVERVIEW

  • 2.1. BASIC ANATOMY
    • 2.1.1. Osteology and Musculoskeletal System
  • 2.2. DISEASE PATHOLOGY AND DISORDERS
    • 2.2.1. General Diagnostic
    • 2.2.2. Osteoporosis
    • 2.2.3. Osteoarthritis
    • 2.2.4. Indication for Bone Graft Procedure
    • 2.2.5. Indication for Cartilage Repair
    • 2.2.6. Degenerative Disc Disease
  • 2.3. PATIENT DEMOGRAPHICS
    • 2.3.1. General Statistics

PRODUCT ASSESSMENT

  • 3.1. PRODUCT PORTFOLIOS
    • 3.1.1. Bone Graft Substitutes
    • 3.1.2. Growth Factors
      • 3.1.2.1. Other products
    • 3.1.3. Cellular Allografts
    • 3.1.4. Cell Therapy
    • 3.1.5. Hyaluronic Acid Viscosupplementation
    • 3.1.6. Cartilage Repair
    • 3.1.7. Spinal Machined Bone Allografts
  • 3.2. REGULATORY ISSUES AND RECALLS
    • 3.2.1. Bone Graft Substitutes
    • 3.2.2. Growth Factors
    • 3.2.3. Cell Therapy
    • 3.2.4. Hyaluronic Acid Viscosupplementation
    • 3.2.5. Cartilage Repair
    • 3.2.6. Spinal Machined Bone Allografts
  • 3.3. CLINICAL TRIALS
    • 3.3.1. Bone Graft Substitutes
    • 3.3.2. Growth Factors
    • 3.3.3. Cellular Allografts
    • 3.3.4. Cell Therapies
    • 3.3.5. Hyaluronic Acid Viscosupplementation
    • 3.3.6. Cartilage Repair
    • 3.3.7. Spinal Machined Bone Allografts

ABBREVIATIONS

APPENDIX II: COMPANY PRESS RELEASES

LIST OF CHARTS

  • Chart 1-1: Orthopedic Biomaterials Market by Segment, U.S., 2013 - 2023
  • Chart 1-2: Orthopedic Biomaterials Market Overview, U.S., 2016 & 2023

LIST OF FIGURES

  • Figure 1-1: Orthopedic Biomaterials Market Share Ranking by Segment, U.S., 2016 (1 of 2)
  • Figure 1-2: Orthopedic Biomaterials Market Share Ranking by Segment, U.S., 2016 (2 of 2)
  • Figure 1-3: Companies Researched in this Report, U.S., 2016
  • Figure 1-4: Factors Impacting the Orthopedic Biomaterials Market by Segment, U.S. (1 of 2)
  • Figure 1-5: Factors Impacting the Orthopedic Biomaterials Market by Segment, U.S. (2 of 2)
  • Figure 1-6: Recent Events in the Orthopedic Biomaterials Market, U.S., 2013 - 2016
  • Figure 1-7: Orthopedic Biomaterials Markets Covered, U.S., 2016 (1 of 2)
  • Figure 1-8: Orthopedic Biomaterials Markets Covered, U.S., 2016 (2 of 2)
  • Figure 1-9: Orthopedic Biomaterials Markets Covered, U.S., 2016(1 of 3)
  • Figure 3-1: Bone Graft Substitutes Products by Company (1 of 3)
  • Figure 3-2: Bone Graft Substitutes Products by Company (2 of 3)
  • Figure 3-3: Bone Graft Substitutes Products by Company (3 of 3)
  • Figure 3-4: Growth Factors Products by Company
  • Figure 3-5: Estimates of Funding for Stem Cell Research
  • Figure 3-6: Cellular Allograft Products by Company
  • Figure 3-7: Cell Therapy Products by Company
  • Figure 3-8: Hyaluronic Acid Viscosupplementationby Products by Company
  • Figure 3-9: Cartilage Repair Products by Company
  • Figure 3-10: Spinal Machined Bone Allograft Products by Company
  • Figure 3-11: Class 2 Device Recall Endobon Xenograft Granules
  • Figure 3-12: Class 2 Device Recall Accell Evo3c Demineralized Bone Matrix Putty
  • Figure 3-13: Class 2 Device Recall AlloFuse DBM Putty 5cc
  • Figure 3-14: Class 2 Device Recall MicroFuse Bone Void Filler
  • Figure 3-15: Class 2 Device Recall Grafton
  • Figure 3-16: Class 2 Device Recall Optimum Expanse
  • Figure 3-17: Class 2 Device Recall Integra Mozaik
  • Figure 3-18: Class 2 Device Recall INFUSER Bone Graft
  • Figure 3-19: Class 2 Device Recall Stryker Biotech
  • Figure 3-20: Class 2 Device Recall OnControl
  • Figure 3-21: Class 2 Device Recall Graft Delivery System
  • Figure 3-22: Class 3 Device Recall Euflexxa (1 sodium hyaluronate)
  • Figure 3-23: Class 2 Device Recall Smith & Nephew
  • Figure 3-24: Class 2 Device Recall Surgical Saw Blade Procedure Pack
  • Figure 3-25: Class 2 Device Recall Stryker Radius Spinal System
  • Figure 3-26: An ACDF Multi-Center Study Using ViviGen Cellular Bone Matrix
  • Figure 3-27: Cerament Treatment of Fracture Defects (CERTiFy)
  • Figure 3-28: Synthetic Bone Graft Substitute vs. Autologous Spongiosa in Revision Anterior Cruciate Ligament Reconstruction
  • Figure 3-29: Assessment of nanOss Bioactive 3D in the Posterolateral Spine
  • Figure 3-30: AttraX® Putty vs. Autograft in XLIF®
  • Figure 3-31: Evaluation of Fusion Rate Using K2M VESUVIUS® Demineralized Fibers With K2M EVEREST® Spinal System
  • Figure 3-32: Clinical Evaluation of GENEX® DS in Instrumented Posterolateral Fusion
  • Figure 3-33: Efficacy and Safety of SurgiFill™ on Spinal Fusion
  • Figure 3-34: Evaluation of DTRAX Graft in Patients With Cervical Degenerative Disc Disease
  • Figure 3-35: Comparison of nanOss Bioactive With Autograft and Bone Marrow Aspirate to Autograft in the Posterolateral Spine
  • Figure 3-36: Evaluation of Fusion Rate of Anterior Cervical Discectomy and Fusion (ACDF) Using Cervios ChronOs™ and Bonion™
  • Figure 3-37: A Study of INFUSE Bone Graft (BMP-2) in the Treatment of Tibial Pseudarthrosis in Neurofibromatosis Type 1
  • Figure 3-38: A Prospective Study of Instrumented, Posterolateral Lumbar Fusions (PLF) With OsteoAMP®
  • Figure 3-39: The Clinical Effect of i-FACTOR® Versus Allograft in Non-instrumented Posterolateral Spondylodesis Operation
  • Figure 3-40: Clinical Study of INFUSE® Bone Graft Compared to Autogenous Bone Graft for Vertical Ridge Augmentation
  • Figure 3-41: RCT of AttraX® Putty vs. Autograft in Instrumented Posterolateral Spinal Fusion (AxA)
  • Figure 3-42: Clinical Study of Injectable Ceramics Bone Graft Substitute Containing rhBMP-2
  • Figure 3-43: Prospective Study of Safety and Efficacy of InQu® Bone Graft Extender in Lumbar Interbody Fusion Surgery (Intebody)
  • Figure 3-44: Long-term Safety and Effectiveness of AUGMENT® Bone Graft Compared to Autologous Bone Graft
  • Figure 3-45: rhBMP-2 vs Autologous Bone Grafting for the Treatment of Non-union of the Docking Site in Tibial Bone Transport
  • Figure 3-46: Evaluation of Radiculitis Following Use of Bone Morphogenetic Protein-2 for Interbody Arthrodesis in Spinal Surgery
  • Figure 3-47: Transplantation of Autologous Bone Marrow or Leukapheresis-Derived Stem Cells for Treatment of Spinal Cord Injury
  • Figure 3-48: Safety and Efficacy of Autologous Mesenchymal Stem Cells in Chronic Spinal Cord Injury
  • Figure 3-49: rhBMP-2 in Cervical Arthrodesis
  • Figure 3-50: Interbody Spacers With map3® Cellular Allogeneic Bone Graft in Anterior or Lateral Lumbar Interbody Fusion
  • Figure 3-51: BMAC & Allograft vs BMP-2
  • Figure 3-52: Human Autograft Mesenchymal Stem Cell Mediated Stabilization of The Degenerative Lumbar Spine
  • Figure 3-53: Regenerative Medicine of Articular Cartilage: Characterization and Comparison of Chondrogenic Potential and Immunomodulatory Adult Mesenchymal Stem Cells (ARTHROSTEM)
  • Figure 3-54: Autologous Mesenchymal Stem Cells Transplantation for Spinal Cord Injury- A Phase I Clinical Study
  • Figure 3-55: Mesenchymal Stem Cells in Knee Cartilage Injuries
  • Figure 3-56: A Clinical Study of Outcomes in Foot and Ankle Bone Grafting Using map3® Cellular Allogeneic Bone Graft
  • Figure 3-57: Treatment of Knee Osteoarthritis With Allogenic Mesenchymal Stem Cells (MSV_allo)
  • Figure 3-58: Autologous Bone Marrow Derived Mesenchymal Stromal Cells Transplantation (BM-MSC) for Kienbock's Disease
  • Figure 3-59: The Effect of Platelet Rich Plasma (PRP) on Post Operative Pain in Anterior Cruciate Ligament Reconstruction
  • Figure 3-60: Comparative Assessment of Intra-articular Knee Injections of Platelet-rich Plasma (PRP) and Hyaluronic Acid
  • Figure 3-61: Evaluation of Safety and Exploratory Efficacy of CARTISTEM®, a Cell Therapy Product for Articular Cartilage Defects
  • Figure 3-62: Trial Comparing Botulin Toxin Versus Hyaluronic Acid by Intra-articular Injection (GOTOX)
  • Figure 3-63: Trial to Assess the Structural Effect and Long-term Symptomatic Relief of Intra-articular Injections of HA (ViscOA)
  • Figure 3-64: Platelet-rich Plasma vs. Hyaluronic Acid for Glenohumeral Osteoarthritis
  • Figure 3-65: Comparative Assessment of Viscosupplementation With Polynucleotides and Hyaluronic Acid (PNHA1401)
  • Figure 3-66: To Look at the Characteristics of Synovial Fluid and Cartilage Matrix in Osteoarthritic Knee After Hyaluronic Acid Injection
  • Figure 3-67: Platelet-rich Plasma vs Viscosupplementation in the Treatment of Knee Articular Degenerative Pathology (PRP)
  • Figure 3-68: Platelet-Rich Plasma Intra-Articular Injection in Treating Hemophilic Arthropathy
  • Figure 3-69: Effectiveness of Two Hyaluronic Acids in Osteoarthritis of the Knee
  • Figure 3-70: DeNovo NT Longitudinal Data Collection (LDC) Knee Study
  • Figure 3-71: NOVOCART®3D for Treatment of Articular Cartilage of the Knee (N3D)
  • Figure 3-72: Porous Tissue Regenerative Silk Scaffold for Human Meniscal Cartilage Repair (REKREATE)
  • Figure 3-73: Confirmatory Study of NeoCart in Knee Cartilage Repair
  • Figure 3-74: the Efficacy and Safety of a Modified Microfracture Using Collagen Compared to Those of a Simple Microfracture in Ankle
  • Figure 3-75: Efficacy of BST-CarGel in Treating Chondral Lesions of the Hip
  • Figure 3-76: BiPhasic Cartilage Repair Implant (BiCRI) IDE Clinical Trial - Taiwan
  • Figure 3-77: A Study to Compare Two Techniques for Articular Cartilage Repair:ACIC Vs. MCIC
  • Figure 3-78: Second Line Treatment of Knee Osteochondral Lesion With Treated Osteochondral Graft (ODPHOENIX2)
  • Figure 3-79: Neocartilage Implant to Treat Cartilage Lesions of the Knee
  • Figure 3-80: Study of Nucel for One and Two Level Lumbar Interbody Fusion
  • Figure 3-81: An ACDF Multi-Center Study Using ViviGen Cellular Bone Matrix
  • Figure 3-82: An Assessment of P-15 Bone Putty in Anterior Cervical Fusion With Instrumentation
  • Figure 3-83: Interbody Spacers With map3® Cellular Allogeneic Bone Graft in Anterior or Lateral Lumbar Interbody Fusion
  • Figure 3-84: Efficacy Study of NuCel® in Patients Undergoing Fusion of the Lumbar Spine
  • Figure 3-85: Prospective Study of Thoracolumbar Spinal Fusion Graft (BMAC)
  • Figure 3-86: Cellentra Viable Cell Bone Matrix (VCBM) Anterior Cervical Discectomy and Fusion Outcomes Study (VCBM/MaxAn) (VCBM/ACDF)
  • Figure 3-87: Prospective Study of Thoracolumbar Spinal Fusion Graft (BMAC)
  • Figure 3-88: PEEK and Allograft Spacers Evaluation in Spinal Fusion Surgeries (PEEK)
  • Figure 3-89: Restore CLINICAL TRIAL
  • Figure 3-90: A Prospective Study of NuCel® in Cervical Spine Fusion
  • Figure 3-91: Safety and Preliminary Efficacy Study of NeoFuse in Subjects Undergoing Multi-Level Anterior Cervical Discectomy
  • Figure 5-1: Press Release Summary
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