Regenerative Medicines: Bone and Joint Applications

  • June 2013
  • -
  • BCC Research
  • -
  • 290 pages

INTRODUCTION

Regenerative medicine in orthopedic applications is a $2.7 billion per year niche sector in America’s $2.6 trillion per year healthcare system. However, it is a sector of immense interest in terms of technical and medical possibilities. The best analogy to the current state of regenerative therapies in the bone and joint healing sector is the nascency of the microprocessors business back in 1971. At that time, microprocessors (namely Intel’s 4004), and related innovations, were just an infinitesimal segment of electronic component sales, but this innovation came to dominate the economy. The regenerative therapies sector, particularly areas such as cell therapy and stem cell derived products is in a comparable position today.

The regenerative medicine industry has been in existence for nearly 25 years. Actual product sales, along with research and development (R&D) expenditures, are projected to amount to approximately $2.7 billion in economic activity in 2013, of which venture capital and R&D funding accounts for about $145 million. The rapid evolution of this business is evidenced by the industry consolidation that has occurred since the first edition of this BCC Research report was published in 2003 and even since the most recent edition in 2009. Innumerable buyouts, consolidations, product abandonments, new firms and a few bankruptcies, too, have occurred in just the last several years. These changes are reflected in the Company Profiles section of this report. In addition, intensive R&D efforts at universities, the National Institutes of Health, the National Science Foundation and at FDA centers that focus on cutting–edge technology underscore the importance of this industry.

Regenerative therapies have the potential to improve medical outcomes, enhance quality of life, and reduce overall healthcare costs. A key objective is the utilization of living cells to repair or replace body tissue damaged by injury, disease, or the aging process. The most successful products have drawn upon multidisciplinary fields such as biology, medicine, engineering, and, particularly, biomedical engineering.

The principal focus in this report is on bone and joint applications; however, other regenerative applications such as dental, neurologic, organ regeneration, cardiovascular, urologic, diabetes, and wound care are important and are briefly covered to underscore the larger importance of regenerative therapies. Stem–cell research is an important component of the sector as well. For example, the successful differentiation of embryonic stem cells into specific cell types is widely sought as a means to treat traumatic spinal–cord injury, as well as diseases such as diabetes, Duchenne muscular dystrophy, heart disease, and vision and hearing loss.

OBJECTIVES AND GOALS OF STUDY

This report focuses on the bone– and joint–related applications of and markets for the various categories of regenerative medicine products currently available and projected to be introduced during the five–year forecast period from 2013 through 2018. Market drivers discussed include the status of R&D and what is likely to issue from R&D in the way of actual products and therapies. Other market drivers include the incidence, and rate of growth, of 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 non–autograft products by physicians; and innovative devices that incorporate bone– and cartilage–growth–stimulating agents in a regenerative appliance. Products discussed include 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.

Profiles are provided of leading and emerging companies in the bone and joint regenerative medicine markets, along with analyses of the current and future positioning of their products and businesses in this active and rapidly changing market. Developmental and clinical stage companies are well covered.

CONTRIBUTION OF THE STUDY AND INTENDED AUDIENCE

The aim of this report is to provide an overview of regenerative medicine products, both available and emerging, for the treatment of diseases and disorders of the bones and joints. The information and analysis presented are important assets in decision making for managers involved in business development, marketing, market research, product development, mergers and acquisitions, licensing, business management, investment banking, and deal creation, as well as for consultants to the pharmaceutical and biotechnology industries. The study provides a comprehensive analysis of the current markets for regenerative medicine products for bones and joints, relevant applications, and the potential of products in development.

STUDY SCOPE AND FORMAT

The U.S. has been the main regenerative medicine market both 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 global 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.

METHODOLOGY

Both primary and secondary research methodologies were used to prepare this market research report. The base year for this study is 2012. Data for 2013 are estimated and 2018 is the forecast terminal year. Sales data are estimated in nominal dollars (unadjusted for inflation). Information to prepare this study was derived from market intelligence provided by leading companies involved in the regenerative medicine market. Data was accessed from government agencies and regulatory bodies that monitor and/or regulate medical devices. Searches of secondary material such as company annual reports and 10Ks, medical journal articles, prospectus assessments, government resources, and data from healthcare institutions were conducted.

INFORMATION SOURCES

The information and analyses presented in this report are based on an extensive survey of the biotechnology and pharmaceutical industries, as well as a detailed examination of published literature and reports obtained from regulatory authorities, medical research institutions, pharmaceutical trade associations, and national and world health organizations.

ANALYST 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.

REPORT HIGHLIGHTS

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 2012, estimates for 2013, and projections of compound annual growth rates (CAGRs) through 2018.
• 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.


Table Of Contents

TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 2

OBJECTIVES AND GOALS OF STUDY 2
CONTRIBUTION OF THE STUDY AND INTENDED AUDIENCE 3
STUDY SCOPE AND FORMAT 3
METHODOLOGY 4
INFORMATION SOURCES 4
ANALYST CREDENTIALS 4
RELATED BCC REPORTS 4
BCC ONLINE SERVICES 5
DISCLAIMER 5

CHAPTER 2 SUMMARY 7

SUMMARY TABLE U.S. MARKET FOR REGENERATIVE MEDICINE PRODUCTS USED IN
BONE AND JOINT APPLICATIONS, THROUGH 2018 ($ MILLIONS) 8
SUMMARY FIGURE U.S. MARKET FOR REGENERATIVE MEDICINE PRODUCTS USED
IN BONE AND JOINT APPLICATIONS, 2012-2018 ($ MILLIONS) 8

CHAPTER 3 OVERVIEW AND OVERALL STATUS OF THE INDUSTRY 10

TOTAL SCOPE OF REGENERATIVE MEDICINE MARKET 10
ESTIMATED NUMBER OF COMPANIES IN REGENERATIVE SECTOR 10
TABLE 1 FUNCTIONAL ACTIVITIES WITH REGENERATIVE MEDICINE SECTOR 11
SIZE OF ORTHOPEDIC SECTOR AND LEADING SUPPLIERS 12
TABLE 2 2012 REVENUES FOR TOP SUPPLIERS OF ORTHOPEDIC PRODUCTS AND
MATERIALS ($ BILLIONS) 12
HOW REGENERATIVE MEDICINE WORKS 12
TISSUES AND ORGANS ON DEMAND 13
ORGAN REPLACEMENT IS A $100 BILLION PER YEAR BUSINESS 14
EXAMPLE IMPACT ON EXISTING CONDITIONS AND DISEASES 14
BARRIERS TO REGENERATIVE MEDICINE 14
TABLE 3 TEN PRINCIPAL MARKET DRIVERS (RANKED, MOST SIGNIFICANT TO LEAST
SIGNIFICANT) 16
CURRENT RandD PRIORITIES 16
TABLE 4 RandD FOCUSES FOR PRINCIPAL REGENERATIVE MEDICINE 17
TABLE 5 20-YEAR PLANNING HORIZON FOR REGENERATIVE MEDICINE BUSINESS:
LIKELY DEVELOPMENTS 18
NATIONAL SCIENCE FOUNDATION PRIORITIES 18
TABLE 6 NATIONAL SCIENCE FOUNDATION REGENERATIVE MEDICINE FUNDING
PRIORITIES AS OF MAY 1, 2013 ($) 19
TOTAL OUTPUT OF THE SECTOR 19
REGENERATIVE MEDICINE AND HEALTHCARE ECONOMICS 20
POPULATION TRENDS 21
MARKET TIMING 21
OVERSEAS INITIATIVES 21

CHAPTER 4 PRINCIPLE APPROACHES TO REGENERATIVE MEDICINE 24

HUMAN SUBSTANCES 25
CELLS AND TISSUES 25
TISSUE ENGINEERING 25
Importance of Scaffolding in Tissue Engineering 25
Plastic Scaffolding 26
Blood Vessel Scaffolding 27
Center for Integration of Medicine and Innovative Technology (CIMIT) 27
TABLE 7 PRINCIPLE RESEARCH PROJECTS OF CIMIT IN THE TISSUE-ENGINEERING
AND BIOMATERIALS FIELDS, 2008-2011 27
Massachusetts General Hospital 28
Duke University Stem Cell and Regenerative Medicine Program 29
EMBRYONIC STEM CELLS 29
Therapeutic Cloning 29
ADULT STEM CELLS: JUST AS GOOD AS EMBRYONIC STEM CELLS 30
Genzyme 30
University of Minnesota Stem Cell Institute 30
STEM CELL RESEARCH PATENTS AND EFFECT ON STEM CELL MARKETERS 31
Stem Cells via Indirect Lineage Conversion (ILC) 32
COMPANIES INVOLVED IN BONE AND JOINT STEM CELL-BASED
THERAPEUTICS 33
TABLE 8 COMPANIES INVOLVED IN BONE AND JOINT STEM CELL-BASED
THERAPEUTICS 33
SETTING THE STAGE FOR REGENERATIVE MEDICINE TO TREAT BONE AND JOINT
DISORDERS 33
NOVEL MATERIALS 34
GENE THERAPY 34
Gene Therapy Trials Targeting Bone and Joint Diseases and Disorders 35
BIOREACTOR USE IN REGENERATIVE MEDICINE 35
TABLE 9 COMMERCIAL SUPPLIERS OF BIOREACTORS FOR USE IN REGENERATIVE
MEDICINE 36
THE IMPACT OF GENOMICS 36

CHAPTER 5 PRODUCTS AND TECHNOLOGIES: CATEGORIES OF REGENERATIVE
MEDICINE 38

GENE- AND PROTEIN - BASED APPROACHES 38
ANTIBODIES 38
The Importance of Antibody Drugs 39
Advantages of Monoclonal Antibody Drugs 40
Antibodies and Osteoarthritis 40
Denosumab 42
GROWTH FACTORS 42
HOW BMPS FUNCTION 43
TABLE 10 BONE MORPHOGENETIC PROTEINS 44
Clinical Uses 44
Companies 45
CELLS AND TISSUES 46
TISSUE ENGINEERING 46
ARTIFICIAL SKIN 46
CARTILAGE 47
Other Approaches to Cartilage 48
Biosynthetic Composites for Cartilage Repair 49
3D Tissue Printing of Cartilage 50
The Market for Tissue-Engineered Cartilage Products 50
TABLE 11 TOTAL U.S. MARKET FOR TISSUE-ENGINEERED CARTILAGE PRODUCTS,
THROUGH 2018 ($ MILLIONS) 50
OTHER PRODUCTS 50
CREATION OF ENTIRE ORGANS 51
EMBRYONIC STEM CELLS 52
NOVEL MATERIALS AND BIOMATERIALS 53

CHAPTER 6 STEM CELL THERAPIES AND REGENERATIVE MEDICINE 56

STEM CELLS AS POTENTIAL REPLACEMENT CELLS 56
OVERALL MARKET AND PARTICIPANTS 57
STEM CELL MARKET RISKS 57
TECHNICAL IMPEDIMENTS 58
OVERVIEW OF FUNDING 58
TABLE 12 FEDERAL FUNDING FOR STEM CELL RESEARCH THROUGH 2012 ($
MILLIONS) 59
STATE-LEVEL INITIATIVES FOR STEM CELL RESEARCH 59
TABLE 13 STATE LEVEL PROGRAMS FOCUSED ON STEM CELL RESEARCH 60
POTENTIAL APPLICATIONS: CURRENT STATUS 60
IN VIVO REPROGRAMMING 61
UMBILICAL CORD BLOOD STEM CELLS 61
Recent Research Developments 62
INDUCED PLURIPOTENT STEM CELLS 62
Recent Research Developments 62
Adult Multipotent Stem Cells 63
Embryonic Stem Cells 63
Adipose Stem Cells for Bone and Joint Applications 65
GERON AND THE FIRST HUMAN TRIALS 66
OTHER STEM CELL RESEARCH 68
STATUS OF OTHER CLINICAL TRIALS 68
STEM CELL THERAPY FOR ALS 69
STEM CELL THERAPY FOR DUCHENNE MUSCULAR DYSTROPHY 70
STEM CELL THERAPY AND BONE MARROW TRANSPLANTS 71

CHAPTER 7 REGENERATIVE PRODUCTS TO TREAT BONE DISEASES 74

REGENERATIVE PRODUCTS TO TREAT BONE DISEASES 74
OSTEOBIOLOGICS 74
BONE GRAFTS 75
PRINCIPAL USES OF BONE GRAFTS 75
TABLE 14 CHARACTERISTICS OF IDEAL BONE GRAFT MATERIAL 76
TABLE 15 U.S. BONE GRAFT PROCEDURE VOLUMES BY APPLICATION, THROUGH
2018 77
TABLE 16 U.S. BONE GRAFT PROCEDURE VOLUMES BY TYPE OF GRAFT, THROUGH
2018 77
TABLE 17 BONE GRAFT MATERIALS 78
TABLE 18 SUBSTITUTE BONE GRAFTS 80
AUTOGRAFTS 80
BIOSEED GRAFTS 81
ALLOGRAFTS 82
DEMINERALIZED BONE MATRIX PRODUCTS 83
TABLE 19 SELECTED DBM PRODUCTS AND PERCENTAGE OF DEMINERALIZED BONE
MATRIX 84
ALLOGRAFT SUPPLIERS 84
Accell 84
AlphaGRAFT 85
Allomatrix 85
Bioset, BioReady 85
Mozaik 85
Grafton DBM 85
DBX 85
DynaBlast and DynaGraft-D 86
Graftech 86
Grafton 86
Opteform 86
OrthoBlast II 87
Osteofil 87
Solo Cervical Allograft 87
XENOGRAFTS 87
THE MARKET FOR ALLOGRAFTS 87
TABLE 20 TOTAL U.S. MARKET FOR PRECISION-MACHINED ALLOGRAFTS, THROUGH
2018 ($ MILLIONS) 88
CELL-BASED BONE GRAFT SUBSTITUTES 88
FACTOR-BASED BONE GRAFT SUBSTITUTES 89
BONE MORPHOGENIC PROTEINS 90
INDUCTOS 91
INFUSE BONE GRAFT 91
OP-1 IMPLANT 92
CERAMIC-BASED BONE GRAFT SUBSTITUTES 92
TYPES OF CERAMICS 93
Alpha-BSM 94
BioActys 94
BioGran 94
Bio-Oss 94
BoneSource 94
Calcigen S 95
Collagraft Strip Bone Graft Matrix 95
Conduit TCP Granules 95
Exabone 95
IsoTis Products 96
Mimix Bone Substitute Material 96
Norian SRS 96
OsteoGraf 97
OsteoMatrix 97
Osteoset 97
OsteoStim Resorbable Bone Graft Substitute 97
PerioGlas 97
Pro Osteon Implant 97
Vitoss 98
POLYMER-BASED BONE GRAFT SUBSTITUTES 98
CORTOSS 98
HEALOS 99
IMMIX EXTENDERS AND IMMIX CB 100
THE MARKET FOR BONE GRAFT PRODUCTS 100
TABLE 21 TOTAL GLOBAL MARKET FOR BONE REPLACEMENT PRODUCTS,
THROUGH 2018 ($ MILLIONS) 100
TABLE 22 U.S. MARKET FOR BONE-REPLACEMENT PRODUCTS, THROUGH 2018 ($
MILLIONS) 101
OTHER REGENERATIVE MEDICINE PRODUCTS IN DEVELOPMENT FOR BONE
APPLICATIONS 101
BIOLOGIC/SYNTHETIC GRAFTS 101
CHRYSALIN 102
NEW SCAFFOLDING TECHNIQUES 103
Honeycomb Implants 103
Electrospun Fiber Multiwell Plates 103
BIOCELLULAR GRAFTS 104

CHAPTER 8 REGENERATIVE APPLICATIONS FOR BONES AND JOINTS 106

MATERIALS FOR BONE TISSUE REPAIR 106
TABLE 23 EXAMPLES OF NANOSTRUCTURED BIOMATERIALS USEFUL IN BONE AND
JOINT REGENERATION 107
BIONANOPARTICLES IN BONE HEALING 107
BIODEGRADABLE NANOSCALE FILAMENTS 108
SILK PROTEIN MICROFIBERS 109
INHERENT REGENERATION OF BONE 110
OVERALL SIZE OF BONE GRAFT BUSINESS 110
BONE GRAFT SUBSTITUTES 111
ALLOGRAFT TISSUE 112
OTHER OSTEOCONDUCTIVE BONE GRAFT SUBSTITUTES 113
HYDROGELS AND REGENERATION 114
HYDROGEL SCAFFOLDING 114
HYDROGEL PATENTS 115
Antimicrobial Nanostructured Hydrogel Web Containing Silver 115
Injectable Peptide Hydrogel That Kills Methicillin-Resistant
Staphylococcus Aureus 116
Method to Repair a Damaged Intervertebral Disc Through the Use of
a Bioadhesive, Thermogelling Hydrogel 116
Hydrogel Compositions 117
Self-Assembling Protein Hydrogel with Bio-Active Protein 117
Superporous Hydrogel with Cells Encapsulated Therein and Method
for Producing the Same 117
Hydrogel Particles 118
Composition and Method for Self-Assembly and Mineralization of
Peptide Amphiphiles 118
Chondroitinase Abc I Polynucleotides 119
Transdiscal Administration of Cycline Compounds 119
Composition and Method for Preparing Biocompatible Surfaces 119
Spinal Mobility Preservation Apparatus Having an Expandable
Membrane 120
MAJOR DISEASES AND CONDITIONS AFFECTING BONES 120
OSTEOPOROSIS 121
Currently Available Products to Treat Osteoporosis 122
Bisphosphonates 122
Fosamax 123
Boniva 124
New Approaches 124
Sclerostin Antibody 124
Romosozumab 124
Probiotics 124
Stem Cell Treatments 125
TABLE 24 DRUGS USED TO TREAT OSTEOPOROSIS 125
Hormones 126
Evista 126
Forteo 126
Miacalcin 128
STEROIDS AND OSTEOPOROSIS 129
Glucocorticoids 129
THE MARKET FOR PRODUCTS TO TREAT OSTEOPOROSIS 130
TABLE 25 GLOBAL MARKET FOR DRUGS TO TREAT OSTEOPOROSIS, THROUGH
2018 ($ MILLIONS) 130
PAGET'S DISEASE 130
DRUGS CURRENTLY AVAILABLE TO TREAT PAGET’S DISEASE 131
Actonel 131
Aredia 131
Skelid 131
Zometa 132
THE MARKET FOR PRODUCTS TO TREAT PAGET'S DISEASE 132
TABLE 26 TOTAL GLOBAL MARKET FOR DRUGS TO TREAT PAGET’S DISEASE,
THROUGH 2018 ($ MILLIONS) 132
INJURIES AND DEGENERATIVE CONDITIONS 132
HIP FRACTURES 133
TABLE 27 TOTAL GLOBAL HIP FRACTURE VOLUMES THROUGH 2018 134
TABLE 28 TOTAL U.S. HIP FRACTURE VOLUMES THROUGH 2018 134
TRADITIONAL TREATMENTS FOR BONE AND JOINT DISORDERS 134
TABLE 29 U.S. MARKET SHARES FOR MUSCULOSKELETAL PRODUCTS, 2012 (%) 134
TABLE 30 U.S. RECONSTRUCTIVE DEVICE MARKET, 2012 (%) 135
MARKET LEADERS 135
JOINT-REPLACEMENT SURGERY 135
TABLE 31 U.S. HIP REPLACEMENT PROCEDURE VOLUMES, THROUGH 2018 136
TABLE 32 HISTORICAL RATES OF HIP REPLACEMENT IN SIX MAJOR STATES, 2001 136
TABLE 33 GLOBAL HIP REPLACEMENT MARKET, THROUGH 2018 ($ MILLIONS) 136
TABLE 34 TOTAL U.S. HIP REPLACEMENT MARKET, THROUGH 2018 ($ MILLIONS) 137
KNEE REPLACEMENTS 137
VENDORS 137
TABLE 35 TOTAL GLOBAL KNEE-REPLACEMENT PROCEDURE VOLUMES, THROUGH
2018 138
TABLE 36 TOTAL U.S. KNEE REPLACEMENT PROCEDURE VOLUMES, THROUGH 2018 138
TABLE 37 TOTAL GLOBAL KNEE REPLACEMENT MARKET THROUGH 20181 ($
MILLIONS) 138
TABLE 38 TOTAL U.S. KNEE REPLACEMENT MARKET THROUGH 2018 ($ MILLIONS) 139
TABLE 39 TOTAL U.S. MARKET FOR UNICONDYLAR KNEE REPLACEMENT THROUGH
2018 ($ MILLIONS) 139
NATURAL THERAPEUTIC TREATMENTS FOR ARTHRITIS 139
IMAGING MARKETS AND REGENERATIVE THERAPIES 140

CHAPTER 9 ELECTRICAL BONE GROWTH STIMULATOR MARKET 143

OVERVIEW 143
SCIENTIFIC BASIS 144
ULTRASONIC OSTEOGENESIS STIMULATORS FOR BONE HEALING 144
MARKETERS OF INVASIVE AND NONINVASIVE ELECTRICAL BONE GROWTH
STIMULATORS 145
BIOMET 145
ORTHOFIX 146
DJO INC. 147
SMITH and NEPHEW (BIOVENTUS) 148
MARKET SIZE 148
TABLE 40 GLOBAL MARKET FOR NONINVASIVE BONE GROWTH STIMULATORS,
THROUGH 2018 ($ MILLIONS) 148
TABLE 41 U.S. MARKET FOR NONINVASIVE BONE GROWTH STIMULATORS,
THROUGH 2018 ($ MILLIONS) 149
RandD - FUTURE PRODUCT POSSIBILITIES 149

CHAPTER 10 ORTHOPEDICS - FDA CLEARANCES AND NEW PRODUCT DEVELOPMENT 152

SUPPLIERS OF REGENERATIVE BONE AND JOINT PRODUCTS 152
TABLE 42 RECENTLY APPROVED ORTHOPEDIC BONE AND JOINT DEVICES BY
PRODUCT, COMPANY, AND APPROVAL DATE, 2008-2012 153

CHAPTER 11 MARKET FOR TISSUE ENGINEERING PRODUCTS 168

TISSUE ENGINEERING AND CELL THERAPY 168
RESEARCH INITIATIVES 169
NATIONAL INSTITUTES OF HEALTH (NIH) 170

CHAPTER 12 REGENERATIVE CONCEPTS AND PRODUCTS IN DENTISTRY 173

OVERVIEW 173
INDICATIONS AND HISTORY 173
CHARACTERISTICS AND MATERIALS 174
BARRIER MEMBRANES 174
NON-RESORBABLE 174
RESORBABLE 174
COLLAGEN RESORBABLE MEMBRANES 174
SYNTHETIC RESORBABLE MEMBRANES 175
BIOENGINEERED HYBRID TEETH FROM AUTOLOGOUS GUM CELLS 175
STEM CELL STUDY RAISES HOPE FOR BONE REPAIR PASTES 176
DENTAL REGENERATIVE PRODUCT VENDORS 177
GEISTLICH PHARMA NORTH AMERICA, INC. 177
ZIMMER 177
ORGANOGENESIS, INC. 177

CHAPTER 13 SKIN TECHNOLOGIES 180

TABLE 43 EXAMPLES OF FDA APPROVED HUMAN SKIN SUBSTITUTES 180
SKIN-LIKE TISSUE DEVELOPED FROM HUMAN EMBRYONIC STEM CELLS 181
TABLE 44 TOTAL SALES OF ENGINEERED SKIN GRAFTS AND REPLACEMENTS,
THROUGH 2018 ($ MILLIONS) 182

CHAPTER 14 NEUROLOGICAL APPLICATIONS IN REGENERATIVE MEDICINE 184

OVERVIEW 184
NEURODEGENERATIVE DISEASES 184
BEST PROSPECTS FOR STEM CELLS IN THIS MARKET 184
STROKE 184
MULTIPLE SCLEROSIS 185
ALZHEIMER'S 185
CURRENT CONVENTIONAL THERAPIES FOR THE TREATMENT OF
NEURODEGENERATIVE DISEASE SYMPTOMS 186
SPINAL-CORD INJURY, NEURODEGENERATIVE DISEASES, AND REGENERATIVE
POTENTIAL 187
UNIVERSITY OF SOUTHERN CALIFORNIA (USC) 188

CHAPTER 15 REGENERATIVE MEDICINE AND APPLICATIONS IN CARDIAC CARE 190

OVERVIEW 190
GENETIC BASIS FOR REGENERATING CELLS AFTER HEART ATTACK 190
STEM CELLS FOR THE FUTURE TREATMENT OF HEART DISEASE 191
PARTICULAR RandD PRIORITIES 191
STEM CELLS AND BIOLOGICAL PACEMAKERS 193
HEART PROGENITOR CELLS DEVELOPED FROM EMBRYONIC STEM CELLS 193
OTHER CURRENT REGENERATIVE MEDICINE AS IT RELATES TO THE HEART 194

CHAPTER 16 REGENERATIVE MEDICINE AND DIABETES 197

BACKGROUND 197
POSSIBLE APPLICATIONS FOR REGENERATIVE MEDICINE 197
CLINICAL TRIALS 198

CHAPTER 17 FDA APPROVED CLINICAL TRIALS INVOLVING REGENERATIVE MEDICINE 200

CURRENT STATUS OF THE REGENERATIVE MEDICINE BUSINESS 200
REGULATORY AND LEGAL ENVIRONMENT 200
STATUS OF RESEARCH AND CLINICAL TRIALS 202
ANALYSIS OF CLINICAL TRIALS 203
TABLE 45 REGENERATIVE MEDICINE CLINICAL TRIALS BY MAJOR CATEGORY
(NUMBER/%) 203
TABLE 46 CURRENT CLINICAL TRIALS IN THE FIELD OF REGENERATIVE MEDICINE
STATUS, CONDITIONS AND SPONSOR (AS OF MAY 1, 2013) 204

CHAPTER 18 OVERSEAS ACTIVITIES 222

DOMESTIC VERSUS OVERSEAS REGENERATIVE MEDICINE COMPANIES 222
JAPAN 222
Japan Regenerative Therapies Market Prospects 223
TABLE 47 PROJECTED REVENUES OF REGENERATIVE AND TISSUE ENGINEERING
MARKETS IN JAPAN, 2009 AND 2020 ($ MILLIONS) 223
EUROPE 224
REMEDIC 224
Nanobiocom 224
Regenerating Bone Defects Using New Biomedical Engineering
Approaches - (REBORNE) 225
Gene Activated Matrices for Bone and Cartilage Regeneration in
Arthritis - (GAMBA) 225
AUSTRALIA AND CHINA 226

CHAPTER 19 PATENT ANALYSIS 228

ANALYSIS 228
TISSUE ENGINEERING PATENTS 228
TABLE 48 TOP PATENT ASSIGNEES IN TISSUE ENGINEERING FIELD 229
GEOGRAPHIC DISTRIBUTION 229
TABLE 49 WORLD DISTRIBUTION OF REGENERATIVE MEDICINE PATENTS ISSUED
1985-2012 (%) 230
RECENT PATENTS 230
TRANSGENIC NON-HUMAN ANIMAL AND METHODS FOR STEM CELL
ENGRAFTMENT 230
METHODS FOR MODULATING THE PROLIFERATION AND DIFFERENTIATION
POTENTIAL OF STEM CELLS AND PROGENITOR CELLS 230
BIOPOLYMER PRODUCED BY FERMENTING THE EXTRACT OF SOYBEAN
WITH FOLIC ACID AND A COMPOSITION CONTAINING THEREOF 231
SUBPOPULATIONS OF BONE MARROW-DERIVED ADHERENT STEM CELLS
AND METHODS OF USE THEREFOR 231
COMPOSITION FOR REGENERATIVE TREATMENT OF CARTILAGE DISEASE 232
REGULATION OF STEM CELL GENE PRODUCTION WITH SPECIFIC AND
SELECTIVE ELECTRIC AND ELECTROMAGNETIC FIELDS 232
COMPOSITIONS AND METHODS FOR BONE FORMATION AND REMODELING 233
NEURAL CELL POPULATIONS FROM PRIMATE PLURIPOTENT STEM CELLS 233
OSTEOINDUCTIVE BONE MATERIAL 234
GENES WITH ES CELL-SPECIFIC EXPRESSION 234
USE OF TGF BETA SUPERFAMILY ANTAGONISTS AND NEUROTROPHINS TO
MAKE NEURONS FROM EMBRYONIC STEM CELLS 235
HYDROXYPHENYL CROSS-LINKED MACROMOLECULAR NETWORK AND
APPLICATIONS THEREOF 235
MAGNETIC CELL AND METHOD OF USING THE SAME 235
DIRECT DIFFERENTIATION METHOD FOR MAKING CARDIOMYOCYTES FROM
HUMAN EMBRYONIC STEM CELLS 236
ISOLATION AND PRESERVATION OF FETAL HEMATOPOIETIC AND
MESENCYMAL SYSTEM CELLS FROM NON-CONTROVERSIAL MATERIALS
AND/OR TISSUES RESULTING FROM MISCARRIAGES AND METHODS OF
THERAPEUTIC USE
236
USE OF TGF BETA SUPERFAMILY ANTAGONISTS TO MAKE DOPAMINERGIC
NEURONS FROM EMBRYONIC STEM CELLS 237
DIRECT DIFFERENTIATION METHOD FOR MAKING CARDIOMYOCYTES FROM
HUMAN EMBRYONIC STEM CELLS 237
METHOD FOR PREPARING NOVEL TRANSCRIPTION FACTORS AND USE 238
ENDODERM CELLS FROM HUMAN EMBRYONIC STEM CELLS 238
GENES WITH ES CELL-SPECIFIC EXPRESSION 238
MARKER SYSTEM FOR PREPARING AND CHARACTERIZING HIGH-QUALITY
HUMAN EMBRYONIC STEM CELLS 239

CHAPTER 20 COMPANY PROFILES 241

TABLE 50 PUBLICLY TRADED COMPANIES IN THE REGENERATIVE MEDICINE
INDUSTRY, AS OF MAY 1, 2013 241
TABLE 51 COMPANIES ESTIMATED SALES ATTRIBUTABLE TO REGENERATIVE
THERAPIES (BONE AND JOINT), 2012 242
AASTROM BIOSCIENCES INC. 242
ADVANCED CELL TECHNOLOGY INC. 243
AESCULAP INC. 243
ALDAGEN INC. 243
ALPHATEC SPINE INC. 244
ANGIOTECH PHARMACEUTICALS INC. 244
ANIKA THERAPEUTICS INC. 245
APERION BIOLOGICS INC. 245
ARTERIOCYTE MEDICAL SYSTEMS INC. 246
ARTHREX INC. 246
ARTHROCARE CORPORATION 246
AUDAX MEDICAL INC. 247
BAXTER 247
BERKELEY ADVANCED BIOMATERIALS, INC. 248
BIOMATLANTE 248
BIOMET, INC. 249
BIOMIMETIC THERAPEUTICS INC. 249
BIOSURFACE ENGINEERING TECHNOLOGIES (BIOSET) 250
BIOTIME INC. 251
BIOTISSUE TECHNOLOGIES GMBH 252
CAM BIOCERAMICS B.V. 252
CAPSTONE THERAPEUTICS 253
CELLING BIOSCIENCES LLC 253
CENTERPULSE ORTHOPAEDICS INC. 254
CERAPEDICS INC. 254
CITAGENIX INC. 254
CO.DON AG 255
COLLPLANT LTD. 256
CONMED CORPORATION 256
CRYOLIFE, INC. 257
CURASAN AG 258
CURIS 258
CYTOMEDIX INC. 259
CYTORI THERAPEUTICS INC. 259
DELENEX THERAPEUTICS AG 260
DEPUY ORTHOPAEDICS INC. (UNIT OF THE DEPUY COMPANIES) 260
DISCGENICS 261
DJO SURGICAL 261
ETEX CORPORATION 262
EXABONE GMBH 262
EXACTECH, INC. 263
FATE THERAPEUTICS INC. 263
GARNET BIOTHERAPEUTICS 264
GEISTLICH PHARMA AG 264
GENZYME BIOSURGERY 265
GERON CORPORATION 265
GRAFTYS 266
HARVARD BIOSCIENCE 266
HISTOGEN 267
INTEGRA LIFESCIENCES HOLDING CORP. 268
INTELLICELL BIOSCIENCES INC. 269
INTERNATIONAL STEM CELL CORPORATION 269
INTERPORE CROSS INTERNATIONAL 270
ISTO TECHNOLOGIES INC. 271
K2M INC. 271
KENSEY NASH CORPORATION 272
KUROS BIOSURGERY AG 273
LIFECELL 274
MCEWEN CENTRE FOR REGENERATIVE MEDICINE 274
MCGOWAN INSTITUTE FOR REGENERATIVE MEDICINE 275
MEDTRONIC INC. 275
MESOBLAST, LIMITED 276
NATIONAL CENTER FOR REGENERATIVE MEDICINE 277
NATIONAL TISSUE ENGINEERING CENTER (NTEC) 278
NEURALSTEM INC. 279
NOVABONE PRODUCTS LLC 280
NOVARTIS CORPORATION 280
NUVASIVE 280
OLYMPUS BIOTECH CORPORATION 281
OPEXA THERAPEUTICS INC. 282
ORGANOGENESIS INC. 282
ORTHOFIX INTERNATIONAL N.V. 283
ORTHOPEUTICS, L.P. 284
ORTHOVITA INC. 284
OSIRIS THERAPEUTICS INC. 285
OSTEOGENICS BIOMEDICAL INC. 285
OSTEOTECH INC. 286
PARCELL LABORATORIES 286
PFIZER INC. 286
PLURISTEM THERAPEUTICS 287
PROMOCELL GMBH 287
REGENECURE LTD. 288
REGENTIS BIOMATERIALS LTD. 288
RENEURON 289
REPLACEMENT THERAPY MATERIALS (R.T. MAT.) 289
REPLIGEN CORPORATION 289
ROSLIN CELLAB 290
RTI BIOLOGICS INC. 290
SCIL TECHNOLOGY GMBH 291
SHIRE REGENERATIVE MEDICINE 291
SIGMA-ALDRICH CORPORATION 292
SMITH and NEPHEW 292
STEMCELLS INC. 293
STEMCOR SYSTEMS INC. 293
STRAUMANN USA LLC 294
STRYKER CORP. 294
SYNTHES INC. 294
TEKNIMED 295
TENGION 295
TEPHA INC. 296
TETEC TISSUE ENGINEERING TECHNOLOGIES AG 297
THERMOGENESIS CORP. 297
TIGENIX N.V. 298
UCB S.A. (HEADQUARTERS) 299
VIACYTE INC. 299
WAKE FOREST INSTITUTE FOR REGENERATIVE MEDICINE 300
WRIGHT MEDICAL GROUP INC. 301
ZIMMER HOLDINGS INC. 301
OTHER ORGANIZATIONS INVOLVED IN REGENERATIVE MEDICINE RandD 302
ACADEMIC INSTITUTIONS 302
U.S. GOVERNMENT 303
OTHER SOCIETIES AND ORGANIZATIONS 303

CHAPTER 21 GLOSSARY OF KEY TERMS IN REGENERATIVE MEDICINE BUSINESS 306



LIST OF TABLES

SUMMARY TABLE U.S. MARKET FOR REGENERATIVE MEDICINE PRODUCTS USED IN
BONE AND JOINT APPLICATIONS, THROUGH 2018 ($ MILLIONS) 8
TABLE 1 FUNCTIONAL ACTIVITIES WITH REGENERATIVE MEDICINE SECTOR 11
TABLE 2 2012 REVENUES FOR TOP SUPPLIERS OF ORTHOPEDIC PRODUCTS AND
MATERIALS ($ BILLIONS) 12
TABLE 3 TEN PRINCIPAL MARKET DRIVERS (RANKED, MOST SIGNIFICANT TO LEAST
SIGNIFICANT) 16
TABLE 4 RandD FOCUSES FOR PRINCIPAL REGENERATIVE MEDICINE 17
TABLE 5 20-YEAR PLANNING HORIZON FOR REGENERATIVE MEDICINE BUSINESS:
LIKELY DEVELOPMENTS 18
TABLE 6 NATIONAL SCIENCE FOUNDATION REGENERATIVE MEDICINE FUNDING
PRIORITIES AS OF MAY 1, 2013 ($) 19
TABLE 7 PRINCIPLE RESEARCH PROJECTS OF CIMIT IN THE TISSUE-ENGINEERING
AND BIOMATERIALS FIELDS, 2008-2011 27
TABLE 8 COMPANIES INVOLVED IN BONE AND JOINT STEM CELL-BASED
THERAPEUTICS 33
TABLE 9 COMMERCIAL SUPPLIERS OF BIOREACTORS FOR USE IN REGENERATIVE
MEDICINE 36
TABLE 10 BONE MORPHOGENETIC PROTEINS 44
TABLE 11 TOTAL U.S. MARKET FOR TISSUE-ENGINEERED CARTILAGE PRODUCTS,
THROUGH 2018 ($ MILLIONS) 50
TABLE 12 FEDERAL FUNDING FOR STEM CELL RESEARCH THROUGH 2012 ($
MILLIONS) 59
TABLE 13 STATE LEVEL PROGRAMS FOCUSED ON STEM CELL RESEARCH 60
TABLE 14 CHARACTERISTICS OF IDEAL BONE GRAFT MATERIAL 76
TABLE 15 U.S. BONE GRAFT PROCEDURE VOLUMES BY APPLICATION, THROUGH
2018 77
TABLE 16 U.S. BONE GRAFT PROCEDURE VOLUMES BY TYPE OF GRAFT, THROUGH
2018 77
TABLE 17 BONE GRAFT MATERIALS 78
TABLE 18 SUBSTITUTE BONE GRAFTS 80
TABLE 19 SELECTED DBM PRODUCTS AND PERCENTAGE OF DEMINERALIZED BONE
MATRIX 84
TABLE 20 TOTAL U.S. MARKET FOR PRECISION-MACHINED ALLOGRAFTS, THROUGH
2018 ($ MILLIONS) 88
TABLE 21 TOTAL GLOBAL MARKET FOR BONE REPLACEMENT PRODUCTS, THROUGH
2018 ($ MILLIONS) 100
TABLE 22 U.S. MARKET FOR BONE-REPLACEMENT PRODUCTS, THROUGH 2018 ($
MILLIONS) 101
TABLE 23 EXAMPLES OF NANOSTRUCTURED BIOMATERIALS USEFUL IN BONE AND
JOINT REGENERATION 107
TABLE 24 DRUGS USED TO TREAT OSTEOPOROSIS 125
TABLE 25 GLOBAL MARKET FOR DRUGS TO TREAT OSTEOPOROSIS, THROUGH 2018
($ MILLIONS) 130
TABLE 26 TOTAL GLOBAL MARKET FOR DRUGS TO TREAT PAGET’S DISEASE,
THROUGH 2018 ($ MILLIONS) 132
TABLE 27 TOTAL GLOBAL HIP FRACTURE VOLUMES THROUGH 2018 134
TABLE 28 TOTAL U.S. HIP FRACTURE VOLUMES THROUGH 2018 134
TABLE 29 U.S. MARKET SHARES FOR MUSCULOSKELETAL PRODUCTS, 2012 (%) 134
TABLE 30 U.S. RECONSTRUCTIVE DEVICE MARKET, 2012 (%) 135
TABLE 31 U.S. HIP REPLACEMENT PROCEDURE VOLUMES, THROUGH 2018 136
TABLE 32 HISTORICAL RATES OF HIP REPLACEMENT IN SIX MAJOR STATES, 2001 136
TABLE 33 GLOBAL HIP REPLACEMENT MARKET, THROUGH 2018 ($ MILLIONS) 136
TABLE 34 TOTAL U.S. HIP REPLACEMENT MARKET, THROUGH 2018 ($ MILLIONS) 137
TABLE 35 TOTAL GLOBAL KNEE-REPLACEMENT PROCEDURE VOLUMES, THROUGH
2018 138
TABLE 36 TOTAL U.S. KNEE REPLACEMENT PROCEDURE VOLUMES, THROUGH 2018 138
TABLE 37 TOTAL GLOBAL KNEE REPLACEMENT MARKET THROUGH 20181 ($
MILLIONS) 138
TABLE 38 TOTAL U.S. KNEE REPLACEMENT MARKET THROUGH 2018 ($ MILLIONS) 139
TABLE 39 TOTAL U.S. MARKET FOR UNICONDYLAR KNEE REPLACEMENT THROUGH
2018 ($ MILLIONS) 139
TABLE 40 GLOBAL MARKET FOR NONINVASIVE BONE GROWTH STIMULATORS,
THROUGH 2018 ($ MILLIONS) 148
TABLE 41 U.S. MARKET FOR NONINVASIVE BONE GROWTH STIMULATORS, THROUGH
2018 ($ MILLIONS) 149
TABLE 42 RECENTLY APPROVED ORTHOPEDIC BONE AND JOINT DEVICES BY
PRODUCT, COMPANY, AND APPROVAL DATE, 2008-2012 153
TABLE 43 EXAMPLES OF FDA APPROVED HUMAN SKIN SUBSTITUTES 180
TABLE 44 TOTAL SALES OF ENGINEERED SKIN GRAFTS AND REPLACEMENTS,
THROUGH 2018 ($ MILLIONS) 182
TABLE 45 REGENERATIVE MEDICINE CLINICAL TRIALS BY MAJOR CATEGORY
(NUMBER/%) 203
TABLE 46 CURRENT CLINICAL TRIALS IN THE FIELD OF REGENERATIVE MEDICINE
STATUS, CONDITIONS AND SPONSOR (AS OF MAY 1, 2013) 204
TABLE 47 PROJECTED REVENUES OF REGENERATIVE AND TISSUE ENGINEERING
MARKETS IN JAPAN, 2009 AND 2020 ($ MILLIONS) 223
TABLE 48 TOP PATENT ASSIGNEES IN TISSUE ENGINEERING FIELD 229
TABLE 49 WORLD DISTRIBUTION OF REGENERATIVE MEDICINE PATENTS ISSUED
1985-2012 (%) 230
TABLE 50 PUBLICLY TRADED COMPANIES IN THE REGENERATIVE MEDICINE
INDUSTRY, AS OF MAY 1, 2013 241
TABLE 51 COMPANIES ESTIMATED SALES ATTRIBUTABLE TO REGENERATIVE
THERAPIES (BONE AND JOINT), 2012 242



LIST OF FIGURES

SUMMARY FIGURE U.S. MARKET FOR REGENERATIVE MEDICINE PRODUCTS USED IN
BONE AND JOINT APPLICATIONS, 2012-2018 ($ MILLIONS) 8

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