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再生医療の世界市場:骨および関節への応用

Regenerative Medicines: Bone and Joint Applications

発行 BCC Research 商品コード 102126
出版日 ページ情報 英文 309 Pages
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再生医療の世界市場:骨および関節への応用 Regenerative Medicines: Bone and Joint Applications
出版日: 2015年05月30日 ページ情報: 英文 309 Pages
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概要

米国における骨・関節用途の再生医療製品市場は、2015年の29億米ドルから2020年に約41億米ドルへと6.8%のCAGRで拡大すると予測されています。

当レポートでは、世界の骨、関節に応用される再生医療市場を包括的に分析し、市場成長予測、現在の治療法を含めた主な再生医療技術動向、規制問題、主要企業のプロファイルを織り交ぜ、お届けいたします。

第1章 イントロダクション

第2章 サマリー

第3章 概要および業界動向

  • 再生医療市場の範囲
  • 再生医療分野における企業数の推計
  • 整形外科分野の規模・主要サプライヤー
  • 再生医療の活用法
  • 要望に応じた組織・臓器
  • 再生医療の障壁
  • 現在の研究開発における優先順位
  • 米国立科学財団 (National Science Foundation, NSF) の優先順位
  • 総生産高
  • 再生医療と医療経済学
  • 人口動向
  • 海外への取組み

第4章 再生医療の基本的アプローチ

  • 人間の物質
  • 細胞と組織
    • 組織エンジニアリング
    • ES細胞
    • 成人幹細胞
    • 幹細胞研究特許と幹細胞マーケターへの影響
    • 骨・関節幹細胞治療の参入企業
  • 骨・関節疾患治療のための再生医療の適応
    • 新しい材料
    • 遺伝子治療
  • 再生医療におけるバイオリアクターの使用
  • ゲノミクスの影響

第5章 製品および技術:再生医療の分類

  • 遺伝子・プロテインに基づいたアプローチ
    • 抗体
  • 成長因子
    • BMPS機能
  • 細胞と組織
    • 組織エンジニアリング
    • 人工皮膚
    • 軟骨
  • その他の製品
  • 組織全体の作成
  • ES細胞
  • 新しい材料・バイオマテリアル

第6章 幹細胞治療と再生医療

  • 将来的な置換細胞としての幹細胞
  • 全体市場・参入企業
  • 幹細胞市場のリスク
  • 技術的課題
  • 幹細胞研究のための州レベルの取組み
  • 将来のアプリケーション:現況
    • インビボリプログラミング
    • 臍帯血幹細胞
    • iPS細胞
  • Geron社と最初の臨床試験
  • その他の幹細胞研究
  • その他の治験の状況

第7章 骨疾患治療に用いられる再生製品

  • 骨疾患治療に用いられる再生製品
  • オーソバイオロジクス
  • 骨移植片
  • 骨移植片の主な用途
  • 骨置換・修復製品
  • その他の骨用再生医療製品の研究開発

第8章 骨・関節のための再生技術応用

  • 骨組織修復材
  • 骨の再生能力
  • 骨移植片ビジネスの規模
  • 代用骨移植片
  • 組織同種移植片
  • その他の骨誘導代用骨移植片
  • ハイドロゲル・再生
  • 骨に影響を及ぼす主な疾患・適応症
  • パジェット病
  • 外傷・変性状態
  • 従来の骨・関節疾患向け治療
  • 関節置換手術
  • 膝関節置換
  • 自家組織 他

第9章 電気的骨成長刺激材市場

  • 概要
  • 科学的根拠
  • 骨治療向け超音波骨形成刺激剤
  • 侵襲・低侵襲電気的骨成長刺激材市場
  • 市場規模
  • R&D:将来の可能性

第10章 整形外科:FDAの認可と新製品開発

第11章 組織エンジニアリング製品市場

第12章 歯科における再生コンセプトと製品

第13章 皮膚技術

第14章 再生医療の神経科への応用

第15章 心臓病への応用

第16章 再生医療と糖尿病

第17章 再生医療に関わるFDA認可の臨床検査

第18章 海外の取組み

第19章 特許分析

第20章 企業プロファイル

第21章 再生医療ビジネスにおける用語解説

図表リスト

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目次
Product Code: PHM032D

The U.S. market for regenerative medicine products used in bone and joint applications is expected to grow at a compound annual growth rate (CAGR) of 6.8% from $2.9 billion in 2015 to nearly $4.1 billion in 2020.

This report provides: An overview of the market for regenerative medicines in bone and joint applications, whose key objectives are the utilization of living cells to repair or replace body tissue damaged by injury, disease, or the aging process. Analyses of market trends, with data from 2014, estimates for 2015, and projections of CAGRs through 2020. Coverage of other regenerative applications, such as dental, neurologic, organ regeneration, cardiovascular, urologic, diabetes, and wound care, as well as stem cell research. Identification of market drivers, including an increase in diseases and disorders that will benefit from these products, primarily arthritis, osteoporosis, and various types of bone and joint trauma (e.g., hip fractures, knee injuries); increasing use of nonautograft products by physicians; and innovative devices that incorporate bone- and cartilage-growth-stimulating agents in a regenerative appliance. Descriptions of products, such as bone and cartilage grafting and regenerative products derived from autologous, allogeneic, and synthetic sources, as well as electrical stimulators for bone growth and regenerative cartilage products.

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REPORT SCOPE

STUDY SCOPE AND FORMAT

The U.S. has been the main regenerative medicine market in terms of R&D innovation, patents and product sales often accounting for as much as half of the market depending on the product niche; hence, the scope of the study is mainly the U.S., although worldwide developments are discussed and measurements provided where relevant. The Overview section provides a background of the demographics underlying the market for bone and joint products, a definition of regenerative medicine and the technologies involved, and a discussion of regenerative products in development for applications other than bones and joints. Various application sections describe the leading bone and joint diseases and disorders applicable to regenerative technologies, including incidence and current methods of treatment.

The section on Products provides extensive descriptions and analyses (e.g., comparative analysis) of regenerative products used to treat bone and joint disorders, as well as a discussion of products in development.

The section on FDA clinical trials and newly approved products provides a discussion of regulatory issues affecting regenerative medicine products.

An extensive Company Profiles section provides estimates for the revenues of the leading companies and a concise description of leading and emerging companies in the area of regenerative products for bones and joints, including product introductions, patents and overall business strategies.

ANALYST'S CREDENTIALS

Research analyst Kevin Gainer holds both B.A. and M.A. degrees in quantitative economic analysis, and has 25 years of economic and market research experience. He is the author of five published books; dozens of technical papers, analyses, and studies published in conference proceedings; and many unpublished reports within corporations. He has worked as a Research Editor and Project Analyst at BCC Research, and, over the last 25 years, has authored many BCC technology market research reports.

Table of Contents

CHAPTER 1 INTRODUCTION

  • OBJECTIVES AND GOALS OF STUDY
  • INTENDED AUDIENCE
  • STUDY SCOPE AND FORMAT
  • METHODOLOGY
  • INFORMATION SOURCES
  • ANALYST'S CREDENTIALS
  • RELATED BCC REPORTS
  • BCC RESEARCH WEBSITE
  • DISCLAIMER

CHAPTER 2 SUMMARY

  • SUMMARY TABLE U.S. MARKET FOR REGENERATIVE MEDICINE PRODUCTS USED IN BONE AND JOINT APPLICATIONS, THROUGH 2020 ($ MILLIONS)
  • SUMMARY FIGURE U.S. MARKET FOR REGENERATIVE MEDICINE PRODUCTS USED IN BONE AND JOINT APPLICATIONS, 2014-2020 ($ MILLIONS)

CHAPTER 3 OVERVIEW AND OVERALL STATUS OF THE INDUSTRY

  • SCOPE OF REGENERATIVE MEDICINE MARKET
  • ESTIMATED NUMBER OF COMPANIES IN REGENERATIVE SECTOR
  • TABLE 1 FUNCTIONAL ACTIVITIES WITH REGENERATIVE MEDICINE SECTOR
  • TABLE 2 MOST PROMINENT COMPANIES IN THE REGENERATIVE MEDICINE BUSINESS
  • SIZE OF ORTHOPEDIC SECTOR AND LEADING SUPPLIERS
  • TABLE 3 REVENUES FOR TOP SUPPLIERS OF ORTHOPEDIC PRODUCTS AND MATERIALS, 2014 ($ BILLIONS)
  • HOW REGENERATIVE MEDICINE WORKS
  • TISSUES AND ORGANS ON DEMAND
    • ORGAN REPLACEMENT IS A $100 BILLION PER YEAR BUSINESS
    • EXAMPLES OF IMPACT ON EXISTING CONDITIONS AND DISEASES
  • BARRIERS TO REGENERATIVE MEDICINE
  • TABLE 4 NINE PRINCIPAL MARKET DRIVERS
  • CURRENT R&D PRIORITIES 1
  • TABLE 5 R &D FOCUSES FOR PRINCIPAL REGENERATIVE MEDICINE
  • TABLE 6 TWENTY-YEAR PLANNING HORIZON FOR REGENERATIVE MEDICINE BUSINESS: LIKELY DEVELOPMENTS
  • NATIONAL SCIENCE FOUNDATION PRIORITIES
  • TABLE 7 NATIONAL SCIENCE FOUNDATION REGENERATIVE MEDICINE FUNDING PRIORITIES, APRIL 1, 2015 ($)
  • TOTAL OUTPUT OF THE SECTOR
  • REGENERATIVE MEDICINE AND HEALTHCARE ECONOMICS
    • POPULATION TRENDS
    • MARKET TIMING
  • OVERSEAS INITIATIVES

CHAPTER 4 PRINCIPLE APPROACHES TO REGENERATIVE MEDICINE

  • HUMAN SUBSTANCES
  • CELLS AND TISSUES
    • TISSUE ENGINEERING
      • Importance of Scaffolding in Tissue Engineering
        • Plastic Scaffolding
        • Blood Vessel Scaffolding
      • Center for Integration of Medicine and Innovative Technology (CIMIT)
      • TABLE 8 PRINCIPLE RESEARCH PROJECTS OF CIMIT IN THE TISSUE-ENGINEERING AND BIOMATERIALS FIELDS, 2008-2012
        • Massachusetts General Hospital
        • Duke University Stem Cell and Regenerative Medicine Program
        • University of Iowa
    • EMBRYONIC STEM CELLS
      • Therapeutic Cloning
    • ADULT STEM CELLS: JUST AS GOOD AS EMBRYONIC STEM CELLS
      • Genzyme
      • University of Minnesota Stem Cell Institute
    • STEM CELL RESEARCH PATENTS AND EFFECT ON STEM CELL MARKETERS
      • Stem Cells via Indirect Lineage Conversion (ILC)
    • COMPANIES INVOLVED IN BONE AND JOINT STEM CELL-BASED THERAPEUTICS
    • TABLE 9 COMPANIES INVOLVED IN BONE AND JOINT STEM CELL-BASED THERAPEUTICS
  • SETTING THE STAGE FOR REGENERATIVE MEDICINE TO TREAT BONE AND JOINT DISORDERS
    • NOVEL MATERIALS
      • Nanoneedles
    • GENE THERAPY
      • Gene Therapy Trials Targeting Bone and Joint Diseases and Disorders
  • BIOREACTOR USE IN REGENERATIVE MEDICINE
  • TABLE 10 COMMERCIAL SUPPLIERS OF BIOREACTORS FOR USE IN REGENERATIVE MEDICINE
  • THE IMPACT OF GENOMICS

CHAPTER 5 PRODUCTS AND TECHNOLOGIES: CATEGORIES OF REGENERATIVE MEDICINE

  • GENE- AND PROTEIN-BASED APPROACHES
    • ANTIBODIES
      • The Importance of Antibody Drugs
      • Advantages of Monoclonal Antibody Drugs
      • Antibodies and Osteoarthritis
      • Denosumab
  • GROWTH FACTORS
    • HOW BMPS FUNCTION
    • TABLE 11 BONE MORPHOGENETIC PROTEINS
      • Clinical Uses
      • Companies
  • CELLS AND TISSUES
    • TISSUE ENGINEERING
    • ARTIFICIAL SKIN
    • CARTILAGE
      • Other Approaches to Cartilage
      • haMPC Therapy for Knee Osteoarthritis
      • Biosynthetic Composites for Cartilage Repair
      • 3D Tissue Printing of Cartilage
      • 3D Tissue Printing of Bone
      • Histogenics
      • Columbia University Work
      • The Market for Tissue-Engineered Cartilage Products
      • TABLE 12 U.S. MARKET FOR TISSUE-ENGINEERED AND CELL THERAPY-BASED CARTILAGE PRODUCTS, THROUGH 2020 ($ MILLIONS)
  • OTHER PRODUCTS
  • CREATION OF ENTIRE ORGANS
  • EMBRYONIC STEM CELLS
  • NOVEL MATERIALS AND BIOMATERIALS
  • TABLE 13 WORLD'S LARGEST IMPLANTABLE BIOMATERIALS COMPANIES

CHAPTER 6 STEM CELL THERAPIES AND REGENERATIVE MEDICINE

  • STEM CELLS AS POTENTIAL REPLACEMENT CELLS
  • OVERALL MARKET AND PARTICIPANTS
  • STEM CELL MARKET RISKS
  • TECHNICAL IMPEDIMENTS
    • OVERVIEW OF FUNDING
    • TABLE 14 FEDERAL FUNDING FOR STEM CELL RESEARCH, THROUGH 2013 ($ MILLIONS)
  • STATE-LEVEL INITIATIVES FOR STEM CELL RESEARCH
  • TABLE 15 STATE LEVEL PROGRAMS FOCUSED ON STEM CELL RESEARCH
  • POTENTIAL APPLICATIONS: CURRENT STATUS
    • IN VIVO REPROGRAMMING
    • UMBILICAL CORD BLOOD STEM CELLS
      • Recent Research Developments
    • INDUCED PLURIPOTENT STEM CELLS
      • Recent Research Developments
      • Adult Multipotent Stem Cells
      • Embryonic Stem Cells
      • Adipose Stem Cells for Bone and Joint Applications
  • GERON AND THE FIRST HUMAN TRIALS
  • OTHER STEM CELL RESEARCH
  • STATUS OF OTHER CLINICAL TRIALS
    • STEM CELL THERAPY FOR ALS
    • STEM CELL THERAPY FOR DUCHENNE MUSCULAR DYSTROPHY
    • STEM CELL THERAPY AND BONE MARROW TRANSPLANTS 7

CHAPTER 7 REGENERATIVE PRODUCTS TO TREAT BONE DISEASES

  • REGENERATIVE PRODUCTS TO TREAT BONE DISEASES
  • OSTEOBIOLOGICS
  • BONE GRAFTS
  • PRINCIPAL USES OF BONE GRAFTS
  • TABLE 16 CHARACTERISTICS OF IDEAL BONE GRAFT MATERIAL
  • TABLE 17 U.S. BONE GRAFT PROCEDURE VOLUMES BY APPLICATION, THROUGH 2020 (NUMBER)
  • TABLE 18 U.S. BONE GRAFT PROCEDURE VOLUMES BY TYPE OF GRAFT, THROUGH 2020 (NUMBER)
  • TABLE 19 BONE GRAFT MATERIALS
  • TABLE 20 SUBSTITUTE BONE GRAFTS
    • AUTOGRAFTS
    • BIOSEED GRAFTS
    • ALLOGRAFTS
      • Demineralized Bone Matrix Products
      • TABLE 21 SELECTED DBM PRODUCTS AND PERCENTAGE OF DEMINERALIZED BONE MATRIX
      • Allograft Suppliers
        • Accell
        • AlphaGRAFT
        • Allomatrix
        • Bioset, BioReady
        • Mozaik
        • Grafton DBM
        • DBX
        • DynaBlast and DynaGraft-D
        • Graftech
        • Grafton
        • Opteform
        • OrthoBlast II
        • AlphaGRAFT
      • Xenografts
      • Market for Allografts
      • TABLE 22 U.S. MARKET FOR PRECISION-MACHINED ALLOGRAFTS, THROUGH 2020 ($ MILLIONS)
  • BONE REPLACEMENT AND REPAIR PRODUCTS
    • CELL-BASED BONE GRAFT SUBSTITUTES
      • Factor-based Bone Graft Substitutes
    • BONE MORPHOGENIC PROTEINS
      • InductOs
      • InFUSE Bone Graft
      • OP-1 Implant
    • CERAMIC-BASED BONE GRAFT SUBSTITUTES
      • Bioactive Glasses
      • Types of Ceramics
        • Alpha-BSM
        • BioActys
        • BioGran
        • Bio-Oss
        • BoneSource
        • Calcigen S
        • Collagraft Strip Bone Graft Matrix
        • Conduit TCP Granules
        • Exabone
        • Gamma-bsm
        • IsoTis Products
        • Mimix Bone Substitute Material
        • Norian SRS
        • OsteoGraf
        • OsteoMatrix
        • Osteoset
        • Osteostim Resorbable Bone Graft Substitute
        • PerioGlas
        • Pro Osteon Implant
        • Vitoss
    • POLYMER-BASED BONE GRAFT SUBSTITUTES
      • Cortoss
      • Healos
      • Immix Extenders and Immix CB
    • MARKET FOR BONE GRAFT PRODUCTS
    • TABLE 23 GLOBAL MARKET FOR BONE REPLACEMENT PRODUCTS, THROUGH 2020 ($ MILLIONS)
    • TABLE 24 U.S. MARKET FOR BONE-REPLACEMENT AND GRAFTING PRODUCTS, THROUGH 2020 ($ MILLIONS)
  • RESEARCH AND DEVELOPMENT OF OTHER REGENERATIVE MEDICINE PRODUCTS FOR BONE APPLICATIONS
    • BIOLOGIC/SYNTHETIC GRAFTS
    • CHRYSALIN
    • NEW SCAFFOLDING TECHNIQUES
      • Honeycomb Implants
      • Electrospun Fiber Multiwell Plates
    • BIOCELLULAR GRAFTS

CHAPTER 8 REGENERATIVE APPLICATIONS FOR BONES AND JOINTS

  • MATERIALS FOR BONE TISSUE REPAIR
  • TABLE 25 EXAMPLES OF NANOSTRUCTURED BIOMATERIALS USEFUL IN BONE AND JOINT REGENERATION
    • VANADIUM COMPOUNDS TO ACCELERATE BONE HEALING
    • BIONANOPARTICLES IN BONE HEALING
    • BIODEGRADABLE NANOSCALE FILAMENTS
    • SILK PROTEIN MICROFIBERS
  • INHERENT REGENERATION OF BONE
  • OVERALL SIZE OF BONE GRAFT BUSINESS
  • BONE GRAFT SUBSTITUTES
  • ALLOGRAFT TISSUE
  • OTHER OSTEOCONDUCTIVE BONE GRAFT SUBSTITUTES
  • HYDROGELS AND REGENERATION
    • UNIVERSITY OF ROCHESTER RESEARCH ON HYDROGELS
    • HYDROGEL SCAFFOLDING
    • HYDROGEL PATENTS
      • Bone Implant Materials Comprising Cross-Linked Bioactive Hydrogel Matrices
        • Abstract
      • Hydrogel Bone Void Filler
        • Abstract
      • Amphiphilic Peptides and Hydrogel Matrices Thereof for Bone Repair
        • Abstract
      • Hydrogel Bioscaffold and Coating for Bone and Tooth Repair
        • Abstract
      • Antimicrobial Nanostructured Hydrogel Web Containing Silver
        • Abstract
      • Injectable Peptide Hydrogel That Kills Methicillin-Resistant Staphylococcus Aureus
        • Abstract
      • Method to Repair a Damaged Intervertebral Disc Through the Use of a Bioadhesive, Thermogelling Hydrogel
        • Abstract
      • Hydrogel Compositions
        • Abstract
      • Self-Assembling Protein Hydrogel With Bio-Active Protein
        • Abstract
      • Superporous Hydrogel with Cells Encapsulated Therein and Method for Producing the Same
        • Abstract
      • Hydrogel Particles
        • Abstract
      • Composition and Method for Self-Assembly and Mineralization of Peptide Amphiphiles
        • Abstract
      • Chondroitinase ABC I Polynucleotides
        • Abstract
      • Transdiscal Administration of Cycline Compounds
        • Abstract
      • Composition and Method for Preparing Biocompatible Surfaces
        • Abstract
      • Spinal Mobility Preservation Apparatus Having an Expandable Membrane
        • Abstract
  • MAJOR DISEASES AND CONDITIONS AFFECTING BONES
    • OSTEOPOROSIS
      • Currently Available Products to Treat Osteoporosis
        • Bisphosphonates
          • Fosamax
          • Boniva
      • New Approaches
        • Sclerostin Antibody
        • Romosozumab
        • Probiotics
        • Stem Cell Treatments
        • TABLE 26 DRUGS USED TO TREAT OSTEOPOROSIS
      • Hormones
        • Evista
        • Forteo
        • Miacalcin
    • STEROIDS AND OSTEOPOROSIS
      • Glucocorticoids
    • MARKET FOR PRODUCTS TO TREAT OSTEOPOROSIS
    • TABLE 27 GLOBAL MARKET FOR DRUGS TO TREAT OSTEOPOROSIS BY CATEGORY, THROUGH 2020 ($ MILLIONS)
  • PAGET'S DISEASE
    • DRUGS CURRENTLY AVAILABLE TO TREAT PAGET'S DISEASE
      • Actonel
      • Aredia
      • Skelid
      • Zometa
    • MARKET FOR PRODUCTS TO TREAT PAGET'S DISEASE
    • TABLE 28 GLOBAL MARKET FOR DRUGS TO TREAT PAGET'S DISEASE, THROUGH 2020 ($ MILLIONS)
  • INJURIES AND DEGENERATIVE CONDITIONS
    • HIP FRACTURES
    • TABLE 29 GLOBAL HIP FRACTURE VOLUMES, THROUGH 2020 (NUMBER)
    • TABLE 30 U.S. HIP FRACTURE VOLUMES, THROUGH 2020 (NUMBER/%)
  • TRADITIONAL TREATMENTS FOR BONE AND JOINT DISORDERS
  • TABLE 31 U.S. MARKET SHARES FOR MUSCULOSKELETAL PRODUCTS BY CATEGORY, 2014 (%)
  • TABLE 32 U.S. MARKET SHARES FOR RECONSTRUCTIVE DEVICES BY CATEGORY, 2014 (%)
    • MARKET LEADERS
  • JOINT-REPLACEMENT SURGERY
  • TABLE 33 NUMBER OF U.S. HIP REPLACEMENT PROCEDURE VOLUMES, THROUGH 2020
  • TABLE 34 NUMBER OF HIP REPLACEMENT PROCEDURES IN SIX MAJOR STATES, 2001
  • TABLE 35 GLOBAL MARKET FOR HIP REPLACEMENTS, THROUGH 2020 ($ MILLIONS)
  • TABLE 36 U.S. MARKET FOR HIP REPLACEMENTS, THROUGH 2020 ($ MILLIONS)
  • KNEE REPLACEMENTS
    • VENDORS
    • TABLE 37 GLOBAL KNEE-REPLACEMENT PROCEDURE VOLUMES, THROUGH 2020 (NUMBER)
    • TABLE 38 U.S. KNEE REPLACEMENT PROCEDURES, THROUGH 2020 (NUMBER)
    • TABLE 39 GLOBAL MARKET FOR KNEE REPLACEMENTS, THROUGH 2020 ($ MILLIONS)
    • TABLE 40 U.S. MARKET FOR KNEE REPLACEMENTS, THROUGH 2020 ($ MILLIONS)
    • TABLE 41 U.S. MARKET FOR UNICONDYLAR KNEE REPLACEMENTS, THROUGH 2020 ($ MILLIONS)
    • NATURAL THERAPEUTIC TREATMENTS FOR ARTHRITIS
    • IMAGING MARKETS AND REGENERATIVE THERAPIES

CHAPTER 9 ELECTRICAL BONE GROWTH STIMULATOR MARKET

  • OVERVIEW
  • SCIENTIFIC BASIS
  • ULTRASONIC OSTEOGENESIS STIMULATORS FOR BONE HEALING
  • MARKETERS OF INVASIVE AND NONINVASIVE ELECTRICAL BONE GROWTH STIMULATORS
    • BIOMET
    • ORTHOFIX
    • DJO INC.
    • SMITH & NEPHEW (BIOVENTUS)
  • MARKET SIZE
  • TABLE 42 GLOBAL MARKET FOR NONINVASIVE BONE GROWTH STIMULATORS BY APPLICATION, THROUGH 2020 ($ MILLIONS)
  • TABLE 43 U.S. MARKET FOR NONINVASIVE BONE GROWTH STIMULATORS BY APPLICATION, THROUGH 2020 ($ MILLIONS)
  • R&D - FUTURE PRODUCT POSSIBILITIES

CHAPTER 10 ORTHOPEDICS - FDA CLEARANCES AND NEW PRODUCT DEVELOPMENT

  • SUPPLIERS OF REGENERATIVE BONE AND JOINT PRODUCTS
  • TABLE 44 RECENTLY APPROVED ORTHOPEDIC BONE AND JOINT DEVICES BY PRODUCT, 2008-2015

CHAPTER 11 MARKET FOR TISSUE ENGINEERING PRODUCTS

  • COMPANY INVOLVEMENT
  • TISSUE ENGINEERING AND CELL THERAPY
  • RESEARCH INITIATIVES
    • NATIONAL INSTITUTES OF HEALTH (NIH)
    • DREXEL UNIVERSITY
    • BIO2 TECHNOLOGIES INC.
    • YESHIVA UNIVERSITY

CHAPTER 12 REGENERATIVE CONCEPTS AND PRODUCTS IN DENTISTRY

  • OVERVIEW
  • INDICATIONS AND HISTORY
  • CHARACTERISTICS AND MATERIALS
    • BARRIER MEMBRANES
      • Nonresorbable
      • Resorbable
    • COLLAGEN RESORBABLE MEMBRANES
    • SYNTHETIC RESORBABLE MEMBRANES
    • BIOENGINEERED HYBRID TEETH FROM AUTOLOGOUS GUM CELLS
    • STEM CELL STUDY RAISES HOPE FOR BONE REPAIR PASTES
  • DENTAL REGENERATIVE PRODUCT VENDORS
    • GEISTLICH PHARMA NORTH AMERICA INC.
    • ZIMMER
    • ORGANOGENESIS INC.
    • MATRICEL GMBH
    • COLLAGEN MATRIX INC.
    • CURASAN AG

CHAPTER 13 SKIN TECHNOLOGIES

  • TABLE 45 EXAMPLES OF FDA APPROVED HUMAN SKIN SUBSTITUTES
  • TABLE 46 GLOBAL MARKET FOR ENGINEERED SKIN GRAFTS AND REPLACEMENTS, THROUGH 2020 ($ MILLIONS)
  • SKIN-LIKE TISSUE DEVELOPED FROM HUMAN EMBRYONIC STEM CELLS
  • SOLUBLE SYSTEMS
    • INVESTIGATIONAL SKIN AND SOFT TISSUE SUBSTITUTES
    • TABLE 47 INVESTIGATIONAL SKIN AND SOFT TISSUE SUBSTITUTES, MARCH 2015

CHAPTER 14 NEUROLOGICAL APPLICATIONS IN REGENERATIVE MEDICINE

  • OVERVIEW
  • NEURODEGENERATIVE DISEASES
  • BEST PROSPECTS FOR STEM CELLS IN THIS MARKET
    • STROKE 201
    • MULTIPLE SCLEROSIS
    • ALZHEIMER'S
  • CURRENT CONVENTIONAL THERAPIES FOR THE TREATMENT OF NEURODEGENERATIVE DISEASE SYMPTOMS
  • SPINAL CORD INJURY, NEURODEGENERATIVE DISEASES AND REGENERATIVE POTENTIAL
    • UNIVERSITY OF SOUTHERN CALIFORNIA (USC)

CHAPTER 15 REGENERATIVE MEDICINE AND APPLICATIONS IN CARDIAC CARE

  • OVERVIEW
    • ACTIVE COMPANIES
      • Aastrom
      • Amorcyte
      • Athersys Inc.
      • Capricor
      • Cytomedix
      • Cytori Therapeutics
      • Juventas Therapeutics
      • Mesoblast
      • VentriNova
  • GENETIC BASIS FOR REGENERATING CELLS AFTER HEART ATTACK
  • STEM CELLS FOR THE FUTURE TREATMENT OF HEART DISEASE
  • PARTICULAR R&D PRIORITIES
  • STEM CELLS AND BIOLOGICAL PACEMAKERS
  • HEART PROGENITOR CELLS DEVELOPED FROM EMBRYONIC STEM CELLS
  • OTHER CURRENT REGENERATIVE MEDICINE AS IT RELATES TO THE HEART

CHAPTER 16 REGENERATIVE MEDICINE AND DIABETES

  • BACKGROUND
  • POSSIBLE APPLICATIONS FOR REGENERATIVE MEDICINE
  • CLINICAL TRIALS
    • SERNOVA CORP
    • ATHERSYS INC.
    • MESOBLAST
    • VIACYTE

CHAPTER 17 FDA-APPROVED CLINICAL TRIALS INVOLVING REGENERATIVE MEDICINE

  • CURRENT STATUS OF THE REGENERATIVE MEDICINE BUSINESS
  • REGULATORY AND LEGAL ENVIRONMENT
  • STATUS OF RESEARCH AND CLINICAL TRIALS
  • ANALYSIS OF CLINICAL TRIALS
  • TABLE 48 REGENERATIVE MEDICINE CLINICAL TRIALS BY CATEGORY (NUMBER/%)
  • TABLE 49 CURRENT CLINICAL TRIALS IN THE FIELD OF REGENERATIVE MEDICINE, STATUS, CONDITIONS AND SPONSOR, MARCH 30, 2015

CHAPTER 18 OVERSEAS ACTIVITIES

  • DOMESTIC VERSUS OVERSEAS REGENERATIVE MEDICINE COMPANIES
    • JAPAN
    • Japan's Regenerative Therapies Market Prospects
    • TABLE 50 JAPAN'S MARKET FOR REGENERATIVE AND TISSUE ENGINEERING, 2009 AND 2020
    • EUROPE
      • REMEDIC
      • Nanobiocom
      • Regenerating Bone Defects using New Biomedical Engineering Approaches - (REBORNE)
      • Gene Activated Matrices for Bone and Cartilage Regeneration in Arthritis - (GAMBA)
      • BIRAX
    • AUSTRALIA AND CHINA

CHAPTER 19 PATENT ANALYSIS

  • ANALYSIS
  • TISSUE ENGINEERING PATENTS
  • TABLE 51 TOP PATENT ASSIGNEES IN THE TISSUE ENGINEERING FIELD
  • GEOGRAPHIC DISTRIBUTION
  • TABLE 52 GLOBAL DISTRIBUTION OF REGENERATIVE MEDICINE PATENTS ISSUED BY COUNTRY, 1985-2012 (%)
  • RECENT PATENTS
    • METHOD FOR OBTAINING PANCREATIC PROGENITOR CELL USING NEPH3
      • Abstract
    • SPONTANEOUSLY IMMORTALIZED MULTIPONENT MESENCHYMAL CELL-LINE DERIVED FROM MOUSE SUBCUTANEOUS ADIPOSE TISSUE: TOOL FOR REGENERATIVE MEDICINE AND BIOACTIVE MOLECULES AND/OR DRUGS SCREENING
      • Abstract
    • METHODS OF MANUFACTURING BIOACTIVE GELS FROM EXTRACELLULAR MATRIX MATERIAL
      • Abstract
    • ALIMENTARY PROTEIN-BASED SCAFFOLDS (APS) FOR WOUND HEALING, REGENERATIVE MEDICINE AND DRUG DISCOVERY
      • Abstract
    • POLYMER CARRIER 244
      • Abstract
    • HERBAL COMPOSITION FOR THE TREATMENT OF WOUND HEALING, A REGENERATIVE MEDICINE
      • Abstract
    • MAGNETIC CELL AND METHOD OF USING THE SAME 245
      • Abstract
    • THREE-DIMENSIONAL BIOPRINTING OF BIOSYNTHETIC CELLULOSE (BC) IMPLANTS AND SCAFFOLDS FOR TISSUE ENGINEERING
      • Abstract
    • BIOMATERIAL BASED ON WHARTON'S JELLY FROM THE HUMAN UMBILICAL CORD
      • Abstract
    • NONWOVEN FABRIC AND PROCESS FOR PRODUCING THE SAME
      • Abstract
    • THERAPEUTIC APPLICATIONS OF P53 ISOFORMS IN REGENERATIVE MEDICINE, AGING AND CANCER
      • Abstract
    • DIAGNOSTIC, PROGNOSTIC AND THERAPEUTIC USES OF LONG NON-CODING RNAS FOR CANCER AND REGENERATIVE MEDICINE
      • Abstract
    • NANO/MACROPOROUS BONE TISSUE SCAFFOLDS FOR REGENERATIVE MEDICINE
      • Abstract
    • GUIDED DELIVERY OF CELL-, PARTICLE- AND DRUG-BASED THERAPIES
      • Abstract
    • TRANSGENIC NONHUMAN ANIMAL AND METHODS FOR STEM CELL ENGRAFTMENT
      • Abstract
    • METHODS FOR MODULATING THE PROLIFERATION AND DIFFERENTIATION POTENTIAL OF STEM CELLS AND PROGENITOR CELLS
      • Abstract
    • BIOPOLYMER PRODUCED BY FERMENTING THE EXTRACT OF SOYBEAN WITH FOLIC ACID AND A COMPOSITION CONTAINING THEREOF
      • Abstract
    • SUBPOPULATIONS OF BONE MARROW-DERIVED ADHERENT STEM CELLS AND METHODS OF USE THEREFOR
      • Abstract
    • METHOD FOR PREPARING BIOLOGICAL SCAFFOLD MATERIAL
      • Abstract
    • COMPOSITION FOR REGENERATIVE TREATMENT OF CARTILAGE DISEASE
      • Abstract
    • REGULATION OF STEM CELL GENE PRODUCTION WITH SPECIFIC AND SELECTIVE ELECTRIC AND ELECTROMAGNETIC FIELDS
      • Abstract
    • COMPOSITIONS AND METHODS FOR BONE FORMATION AND REMODELING
      • Abstract
    • NEURAL CELL POPULATIONS FROM PRIMATE PLURIPOTENT STEM CELLS
      • Abstract
    • OSTEOINDUCTIVE BONE MATERIAL
      • Abstract
    • GENES WITH ES CELL-SPECIFIC EXPRESSION
      • Abstract
    • USE OF TGF BETA SUPERFAMILY ANTAGONISTS AND NEUROTROPHINS TO MAKE NEURONS FROM EMBRYONIC STEM CELLS
      • Abstract
    • HYDROXYPHENYL CROSS-LINKED MACROMOLECULAR NETWORK AND APPLICATIONS THEREOF
      • Abstract
    • MAGNETIC CELL AND METHOD OF USING THE SAME
      • Abstract
    • DIRECT DIFFERENTIATION METHOD FOR MAKING CARDIOMYOCYTES FROM HUMAN EMBRYONIC STEM CELLS
      • Abstract
    • ISOLATION AND PRESERVATION OF FETAL HEMATOPOIETIC AND MESENCYMAL SYSTEM CELLS FROM NONCONTROVERSIAL MATERIALS AND/OR TISSUES RESULTING FROM MISCARRIAGES AND METHODS OF THERAPEUTIC USE
      • Abstract
    • USE OF TGF BETA SUPERFAMILY ANTAGONISTS TO MAKE DOPAMINERGIC NEURONS FROM EMBRYONIC STEM CELLS
      • Abstract
    • DIRECT DIFFERENTIATION METHOD FOR MAKING CARDIOMYOCYTES FROM HUMAN EMBRYONIC STEM CELLS
      • Abstract
    • METHOD FOR PREPARING NOVEL TRANSCRIPTION FACTORS AND USE
      • Abstract
    • ENDODERM CELLS FROM HUMAN EMBRYONIC STEM CELLS
      • Abstract
    • GENES WITH ES CELL-SPECIFIC EXPRESSION
      • Abstract
    • MARKER SYSTEM FOR PREPARING AND CHARACTERIZING HIGH-QUALITY HUMAN EMBRYONIC STEM CELLS
      • Abstract

CHAPTER 20 COMPANY PROFILES

  • TABLE 53 PUBLICLY TRADED COMPANIES IN THE REGENERATIVE MEDICINE INDUSTRY, MARCH 6, 2015 ($/$ MILLIONS)
  • TABLE 54 COMPANIES ESTIMATED SALES ATTRIBUTABLE TO REGENERATIVE THERAPIES (BONE AND JOINT), 2012 ($ MILLIONS)
  • ACELITY
  • AESCULAP INC.
  • ALPHATEC SPINE INC.
  • ANIKA THERAPEUTICS INC.
  • APERION BIOLOGICS INC.
  • ARTERIOCYTE MEDICAL SYSTEMS INC.
  • ARTHREX INC.
  • ARTHROCARE CORP.
  • AUDAX MEDICAL INC.
  • BAXTER
  • BERKELEY ADVANCED BIOMATERIALS INC.
  • BIOMATLANTE
  • BIOMET INC.
  • BIOMIMETIC THERAPEUTICS INC.
  • BIOSURFACE ENGINEERING TECHNOLOGIES (BIOSET)
  • BIOTIME INC.
  • BIOTISSUE TECHNOLOGIES GMBH
  • BONALIVE BIOMATERIALS LTD
  • BONE SOLUTIONS INC.
  • CAM BIOCERAMICS B.V.
  • CAPSTONE THERAPEUTICS
  • CELLING BIOSCIENCES LLC
  • CERAPEDICS INC.
  • CESCA THERAPEUTICS
  • CITAGENIX INC.
  • CO.DON AG
  • COLLPLANT LTD.
  • CONMED CORP.
  • CRYOLIFE INC.
  • CURASAN AG
  • CURIS
  • CYTORI THERAPEUTICS INC.
  • DELENEX THERAPEUTICS AG
  • DEPUY ORTHOPAEDICS INC. (UNIT OF THE DEPUY COMPANIES)
  • DISCGENICS
  • DJO SURGICAL
  • ETEX CORP.
  • EXABONE GMBH
  • EXACTECH INC.
  • FATE THERAPEUTICS INC.
  • GARNET BIOTHERAPEUTICS
  • GEISTLICH PHARMA AG
  • GERON CORP.
  • GRAFTYS
  • HARVARD BIOSCIENCE
  • HISTOGEN
  • INTEGRA LIFESCIENCES HOLDING CORP.
  • INTELLICELL BIOSCIENCES INC.
  • INTERNATIONAL STEM CELL CORP.
  • INTERPORE CROSS INTERNATIONAL
  • ISTO TECHNOLOGIES INC.
  • K2M INC.
  • KENSEY NASH CORP.
  • KUROS BIOSURGERY AG
  • MCEWEN CENTRE FOR REGENERATIVE MEDICINE
  • MCGOWAN INSTITUTE FOR REGENERATIVE MEDICINE
  • MEDTRONIC INC.
  • MESOBLAST LTD
  • MIMEDX GROUP INC.
  • NATIONAL CENTER FOR REGENERATIVE MEDICINE
  • NATIONAL TISSUE ENGINEERING CENTER (NTEC)
  • NEURALSTEM INC.
  • NOVABONE PRODUCTS LLC
  • NOVARTIS CORP.
  • NUO THERAPEUTICS
  • NUVASIVE
  • OCATA THERAPEUTICS INC.
  • OLYMPUS BIOTECH CORP.
  • OPEXA THERAPEUTICS INC.
  • ORGANOGENESIS INC.
  • ORTHOFIX INTERNATIONAL N.V.
  • ORTHOPEUTICS L.P.
  • OSIRIS THERAPEUTICS INC.
  • OSTEOGENICS BIOMEDICAL INC.
  • PARCELL LABORATORIES
  • PFIZER INC.
  • PLURISTEM THERAPEUTICS
  • PROMOCELL GMBH
  • REGENECURE LTD.
  • REGENTIS BIOMATERIALS LTD.
  • RENEURON
  • REPLACEMENT THERAPY MATERIALS (R.T. MAT)
  • REPLIGEN CORP.
  • ROSLIN CELLAB
  • RTI SURGICAL INC.
  • SANOFI BIOSURGERY
  • SCIL TECHNOLOGY GMBH
  • SHIRE REGENERATIVE MEDICINE
  • SIGMA-ALDRICH CORP.
  • SMITH & NEPHEW
  • STEMCELLS INC.
  • STRAUMANN USA LLC
  • STRYKER CORP.
  • SURGICAL SPECIALTIES, INC.
  • SYNTHES INC.
  • TEKNIMED
  • TEPHA INC.
  • TETEC TISSUE ENGINEERING TECHNOLOGIES AG
  • TIGENIX N.V.
  • UCB S.A. (HEADQUARTERS)
  • VERICEL CORP.
  • VIACYTE INC.
  • WAKE FOREST INSTITUTE FOR REGENERATIVE MEDICINE
  • WRIGHT MEDICAL GROUP INC.
  • ZIMMER HOLDINGS INC.
  • OTHER ORGANIZATIONS INVOLVED IN REGENERATIVE MEDICINE R&D
    • ACADEMIC INSTITUTIONS
    • U.S. GOVERNMENT
    • OTHER SOCIETIES AND ORGANIZATIONS

CHAPTER 21 GLOSSARY OF KEY TERMS IN REGENERATIVE MEDICINE BUSINESS

LIST OF TABLES

  • SUMMARY TABLE U.S. MARKET FOR REGENERATIVE MEDICINE PRODUCTS USED IN BONE AND JOINT APPLICATIONS, THROUGH 2020 ($ MILLIONS)
  • TABLE 1 FUNCTIONAL ACTIVITIES WITH REGENERATIVE MEDICINE SECTOR
  • TABLE 2 MOST PROMINENT COMPANIES IN THE REGENERATIVE MEDICINE BUSINESS 12
  • TABLE 3 REVENUES FOR TOP SUPPLIERS OF ORTHOPEDIC PRODUCTS AND MATERIALS, 2014 ($ BILLIONS)
  • TABLE 4 NINE PRINCIPAL MARKET DRIVERS
  • TABLE 5 R &D FOCUSES FOR PRINCIPAL REGENERATIVE MEDICINE
  • TABLE 6 TWENTY-YEAR PLANNING HORIZON FOR REGENERATIVE MEDICINE BUSINESS: LIKELY DEVELOPMENTS
  • TABLE 7 NATIONAL SCIENCE FOUNDATION REGENERATIVE MEDICINE FUNDING PRIORITIES, APRIL 1, 2015 ($)
  • TABLE 8 PRINCIPLE RESEARCH PROJECTS OF CIMIT IN THE TISSUE-ENGINEERING AND BIOMATERIALS FIELDS, 2008-2012
  • TABLE 9 COMPANIES INVOLVED IN BONE AND JOINT STEM CELL-BASED THERAPEUTICS
  • TABLE 10 COMMERCIAL SUPPLIERS OF BIOREACTORS FOR USE IN REGENERATIVE MEDICINE
  • TABLE 11 BONE MORPHOGENETIC PROTEINS
  • TABLE 12 U.S. MARKET FOR TISSUE-ENGINEERED AND CELL THERAPY-BASED CARTILAGE PRODUCTS, THROUGH 2020 ($ MILLIONS)
  • TABLE 13 WORLD'S LARGEST IMPLANTABLE BIOMATERIALS COMPANIES
  • TABLE 14 FEDERAL FUNDING FOR STEM CELL RESEARCH, THROUGH 2013 ($ MILLIONS)
  • TABLE 15 STATE LEVEL PROGRAMS FOCUSED ON STEM CELL RESEARCH
  • TABLE 16 CHARACTERISTICS OF IDEAL BONE GRAFT MATERIAL
  • TABLE 17 U.S. BONE GRAFT PROCEDURE VOLUMES BY APPLICATION, THROUGH 2020 (NUMBER)
  • TABLE 18 U.S. BONE GRAFT PROCEDURE VOLUMES BY TYPE OF GRAFT, THROUGH 2020 (NUMBER)
  • TABLE 19 BONE GRAFT MATERIALS
  • TABLE 20 SUBSTITUTE BONE GRAFTS
  • TABLE 21 SELECTED DBM PRODUCTS AND PERCENTAGE OF DEMINERALIZED BONE MATRIX
  • TABLE 22 U.S. MARKET FOR PRECISION-MACHINED ALLOGRAFTS, THROUGH 2020 ($ MILLIONS)
  • TABLE 23 GLOBAL MARKET FOR BONE REPLACEMENT PRODUCTS, THROUGH 2020 ($ MILLIONS)
  • TABLE 24 U.S. MARKET FOR BONE-REPLACEMENT AND GRAFTING PRODUCTS, THROUGH 2020 ($ MILLIONS)
  • TABLE 25 EXAMPLES OF NANOSTRUCTURED BIOMATERIALS USEFUL IN BONE AND JOINT REGENERATION
  • TABLE 26 DRUGS USED TO TREAT OSTEOPOROSIS
  • TABLE 27 GLOBAL MARKET FOR DRUGS TO TREAT OSTEOPOROSIS BY CATEGORY, THROUGH 2020 ($ MILLIONS)
  • TABLE 28 GLOBAL MARKET FOR DRUGS TO TREAT PAGET'S DISEASE, THROUGH 2020 ($ MILLIONS)
  • TABLE 29 GLOBAL HIP FRACTURE VOLUMES, THROUGH 2020 (NUMBER)
  • TABLE 30 U.S. HIP FRACTURE VOLUMES, THROUGH 2020 (NUMBER/%)
  • TABLE 31 U.S. MARKET SHARES FOR MUSCULOSKELETAL PRODUCTS BY CATEGORY, 2014 (%)
  • TABLE 32 U.S. MARKET SHARES FOR RECONSTRUCTIVE DEVICES BY CATEGORY, 2014 (%)
  • TABLE 33 NUMBER OF U.S. HIP REPLACEMENT PROCEDURE VOLUMES, THROUGH 2020
  • TABLE 34 NUMBER OF HIP REPLACEMENT PROCEDURES IN SIX MAJOR STATES, 2001
  • TABLE 35 GLOBAL MARKET FOR HIP REPLACEMENTS, THROUGH 2020 ($ MILLIONS)
  • TABLE 36 U.S. MARKET FOR HIP REPLACEMENTS, THROUGH 2020 ($ MILLIONS)
  • TABLE 37 GLOBAL KNEE-REPLACEMENT PROCEDURE VOLUMES, THROUGH 2020 (NUMBER)
  • TABLE 38 U.S. KNEE REPLACEMENT PROCEDURES, THROUGH 2020 (NUMBER)
  • TABLE 39 GLOBAL MARKET FOR KNEE REPLACEMENTS, THROUGH 2020 ($ MILLIONS)
  • TABLE 40 U.S. MARKET FOR KNEE REPLACEMENTS, THROUGH 2020 ($ MILLIONS)
  • TABLE 41 U.S. MARKET FOR UNICONDYLAR KNEE REPLACEMENTS, THROUGH 2020 ($ MILLIONS)
  • TABLE 42 GLOBAL MARKET FOR NONINVASIVE BONE GROWTH STIMULATORS BY APPLICATION, THROUGH 2020 ($ MILLIONS)
  • TABLE 43 U.S. MARKET FOR NONINVASIVE BONE GROWTH STIMULATORS BY APPLICATION, THROUGH 2020 ($ MILLIONS)
  • TABLE 44 RECENTLY APPROVED ORTHOPEDIC BONE AND JOINT DEVICES BY PRODUCT, 2008-2015
  • TABLE 45 EXAMPLES OF FDA APPROVED HUMAN SKIN SUBSTITUTES
  • TABLE 46 GLOBAL MARKET FOR ENGINEERED SKIN GRAFTS AND REPLACEMENTS, THROUGH 2020 ($ MILLIONS)
  • TABLE 47 INVESTIGATIONAL SKIN AND SOFT TISSUE SUBSTITUTES, MARCH 2015
  • TABLE 48 REGENERATIVE MEDICINE CLINICAL TRIALS BY CATEGORY (NUMBER/%)
  • TABLE 49 CURRENT CLINICAL TRIALS IN THE FIELD OF REGENERATIVE MEDICINE, STATUS, CONDITIONS AND SPONSOR, MARCH 30, 2015
  • TABLE 50 JAPAN'S MARKET FOR REGENERATIVE AND TISSUE ENGINEERING, 2009 AND 2020
  • TABLE 51 TOP PATENT ASSIGNEES IN THE TISSUE ENGINEERING FIELD
  • TABLE 52 GLOBAL DISTRIBUTION OF REGENERATIVE MEDICINE PATENTS ISSUED BY COUNTRY, 1985-2012 (%)
  • TABLE 53 PUBLICLY TRADED COMPANIES IN THE REGENERATIVE MEDICINE INDUSTRY, MARCH 6, 2015 ($/$ MILLIONS)
  • TABLE 54 COMPANIES ESTIMATED SALES ATTRIBUTABLE TO REGENERATIVE THERAPIES (BONE AND JOINT), 2012 ($ MILLIONS)

LIST OF FIGURES

  • SUMMARY FIGURE U.S. MARKET FOR REGENERATIVE MEDICINE PRODUCTS USED IN BONE AND JOINT APPLICATIONS, 2014-2020 ($ MILLIONS)
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