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Regenerative Medicines: Bone and Joint Applications

September 19, 2013

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London (PRWEB) September 19, 2013

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

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 R&D PRIORITIES 16

TABLE 4 R&D 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 & 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

R&D – 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 R&D 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 & 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 R&D 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 R&D 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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Regenerative Medicines: Bone and Joint Applications

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