Regenerative Medicines: Bone and Joint Applications

Published by: BCC Research

Published: Oct. 1, 2009 - 290 Pages

Table of Contents

CHAPTER ONE: INTRODUCTION

OBJECTIVES AND GOALS OF STUDY

INTENDED AUDIENCE

SCOPE OF REPORT

METHODOLOGY

INFORMATION SOURCES

ANALYST CREDENTIALS

RELATED BCC REPORTS

BCC ONLINE SERVICES

DISCLAIMER

CHAPTER TWO: SUMMARY

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

SUMMARY FIGURE U.S. MARKET FOR REGENERATIVE MEDICINE PRODUCTS USED IN BONE AND JOINT APPLICATIONS, 2007-2014 ($ MILLIONS)

CHAPTER THREE: OVERVIEW AND OVERALL STATUS OF THE INDUSTRY

TOTAL SCOPE OF REGENERATIVE MEDICINE MARKET

TABLE 1 FUNCTIONAL ACTIVITIES WITH REGENERATIVE MEDICINE SECTOR

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

CURRENT R&D PRIORITIES

TABLE 2 PRINCIPAL REGENERATIVE MEDICINE BUSINESS R&D FOCUSES

TABLE 3 20-YEAR PLANNING HORIZON FOR REGENERATIVE MEDICINE BUSINESS: LIKELY DEVELOPMENTS, 2015-2030

TOTAL OUTPUT OF THE SECTOR

REGENERATIVE MEDICINE AND HEALTHCARE ECONOMICS

POPULATION TRENDS

MARKET TIMING

OVERSEAS INITIATIVES

CHAPTER FOUR: PRINCIPLE APPROACHES TO REGENERATIVE MEDICINE

PRINCIPLE APPROACHES TO REGENERATIVE MEDICINE

HUMAN SUBSTANCES

CELLS AND TISSUES

TISSUE ENGINEERING

Importance of Scaffolding in Tissue Engineering

Blood Vessel Scaffolding

Center for Integration of Medicine and Innovative Technology (CIMIT)

TABLE 4 PRINCIPLE RESEARCH PROJECTS OF CIMIT IN THE TISSUE-ENGINEERING AND BIOMATERIALS FIELDS, 2008-2010

Massachusetts General Hospital

Duke University Stem Cell and Regenerative Medicine Program

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

SETTING THE STAGE FOR REGENERATIVE MEDICINE TO TREAT BONE AND JOINT DISORDERS

NOVEL MATERIALS

GENE THERAPY

Gene Therapy Trials Targeting Bone and Joint Diseases and Disorders

BIOREACTOR USE IN REGENERATIVE MEDICINE

TABLE 5 COMMERCIAL SUPPLIERS OF BIOREACTORS FOR USE IN REGENERATIVE MEDICINE

THE IMPACT OF GENOMICS

CHAPTER FIVE: 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

GROWTH FACTORS

HOW BMPS FUNCTION

TABLE 6 BONE MORPHOGENETIC PROTEINS

Clinical Uses

Companies

CELLS AND TISSUES

TISSUE ENGINEERING

ARTIFICIAL SKIN

CARTILAGE

OTHER APPROACHES TO CARTILAGE

BIOSYNTHETIC COMPOSITES FOR CARTILAGE REPAIR

THE MARKET FOR TISSUE-ENGINEERED CARTILAGE PRODUCTS

TABLE 7 U.S. MARKET FOR TISSUE-ENGINEERED CARTILAGE PRODUCTS, THROUGH 2014 ($ MILLIONS)

OTHER PRODUCTS

CREATION OF ENTIRE ORGANS

EMBRYONIC STEM CELLS

NOVEL MATERIALS AND BIOMATERIALS

CHAPTER SIX: STEM CELL THERAPIES AND REGENERATIVE MEDICINE

STEM CELLS AS POTENTIAL REPLACEMENT CELLS

TECHNICAL IMPEDIMENTS

OVERVIEW OF FUNDING

TABLE 8 FEDERAL FUNDING FOR STEM CELL RESEARCH, THROUGH 2008 ($ MILLIONS)

STATE-LEVEL INITIATIVES FOR STEM CELL RESEARCH

TABLE 9 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

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

CHAPTER SEVEN: REGENERATIVE PRODUCTS TO TREAT BONE DISEASES

REGENERATIVE PRODUCTS TO TREAT BONE DISEASES

OSTEOBIOLOGICS

BONE GRAFTS

TABLE 10 CHARACTERISTICS OF IDEAL BONE GRAFT MATERIAL

TABLE 11 U.S. BONE GRAFT PROCEDURE VOLUMES BY APPLICATION, THROUGH 2014

TABLE 12 U.S. BONE GRAFT PROCEDURE VOLUMES BY TYPE OF GRAFT, THROUGH 2014

TABLE 13 BONE GRAFT MATERIALS

TABLE 14 SUBSTITUTE BONE GRAFTS

AUTOGRAFTS

BIOSEED GRAFTS

ALLOGRAFTS

DEMINERALIZED BONE MATRIX PRODUCTS

TABLE 15 SELECTED DBM PRODUCTS AND PERCENTAGE OF DEMINERALIZED BONE MATRIX

Accell

AlphaGRAFT

Allomatrix

Grafton DBM

DBX

DynaBlast and DynaGraft-D

Graftech

Grafton

Opteform

OrthoBlast II

Osteofil

Solo Cervical Allograft

XENOGRAFTS

THE MARKET FOR ALLOGRAFTS

TABLE 16 U.S. MARKET FOR PRECISION-MACHINED ALLOGRAFTS, THROUGH 2014 ($ MILLIONS)

FIGURE 1 U.S. MARKET FOR PRECISION-MACHINED ALLOGRAFTS, 2007-2014 ($ MILLIONS)

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

TYPES OF CERAMICS

Alpha-BSM

BioGran

Bio-Oss

BoneSource

Calcigen S

Collagraft Strip Bone Graft Matrix

Conduit TCP Granules

IsoTis Products

Mimix Bone Substitute Material

Norian SRS

OsteoGraf

Osteoset

OsteoStim Resorbable Bone Graft Substitute

PerioGlas

Pro Osteon Implant

Vitoss

POLYMER-BASED BONE GRAFT SUBSTITUTES

CORTOSS

HEALOS

IMMIX EXTENDERS AND IMMIX CB

THE MARKET FOR BONE GRAFT PRODUCTS

TABLE 17 WORLDWIDE MARKET FOR BONE REPLACEMENT PRODUCTS, THROUGH 2014 ($ MILLIONS)

FIGURE 2 WORLDWIDE MARKET FOR BONE REPLACEMENT PRODUCTS, 2007-2014 ($ MILLIONS)

TABLE 18 U.S. MARKET FOR BONE-REPLACEMENT PRODUCTS, THROUGH 2014 ($ MILLIONS)

FIGURE 3 U.S. MARKET FOR BONE-REPLACEMENT PRODUCTS, 2007-2014 ($ MILLIONS)

REGENERATIVE MEDICINE PRODUCTS IN DEVELOPMENT FOR BONE APPLICATIONS

BIOLOGIC/SYNTHETIC GRAFTS

CHRYSALIN

CHAPTER EIGHT: REGENERATIVE APPLICATIONS FOR BONES AND JOINTS

MATERIALS FOR BONE TISSUE REPAIR

INHERENT REGENERATION OF BONE

OVERALL SIZE OF BONE GRAFT BUSINESS

BONE GRAFT SUBSTITUTES

ALLOGRAFT TISSUE

OTHER OSTEOCONDUCTIVE BONE GRAFT SUBSTITUTES

HYDROGELS AND REGENERATION

COMPOSITION AND METHOD FOR SELF-ASSEMBLY AND MINERALIZATION OF PEPTIDE AMPHIPHILES

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

TABLE 19 DRUGS USED TO TREAT OSTEOPOROSIS

Hormones

Evista

Forteo

Miacalcin

STEROIDS AND OSTEOPOROSIS

Glucocorticoids

THE MARKET FOR PRODUCTS TO TREAT OSTEOPOROSIS.

TABLE 20 WORLDWIDE MARKET FOR DRUGS TO TREAT OSTEOPOROSIS, THROUGH 2014 ($ MILLIONS)

FIGURE 4 WORLDWIDE MARKET FOR DRUGS TO TREAT OSTEOPOROSIS, 2007-2014 ($ MILLIONS)

PAGET’S DISEASE

DRUGS CURRENTLY AVAILABLE TO TREAT PAGET’S DISEASE

Actonel

Aredia

Skelid

Zometa

THE MARKET FOR PRODUCTS TO TREAT PAGET’S DISEASE

TABLE 21 WORLDWIDE MARKET FOR DRUGS TO TREAT PAGET’S DISEASE, THROUGH 2014 ($ MILLIONS)

FIGURE 5 WORLDWIDE MARKET FOR DRUGS TO TREAT PAGET’S DISEASE, 2007-2014 ($ MILLIONS)

INJURIES AND DEGENERATIVE CONDITIONS

HIP FRACTURES

TABLE 22 WORLDWIDE HIP FRACTURE VOLUMES, THROUGH 2014

TABLE 23 U.S. HIP FRACTURE VOLUMES, THROUGH 2014

TRADITIONAL TREATMENTS FOR BONE AND JOINT DISORDERS

TABLE 24 U.S. MARKET SHARES FOR MUSCULOSKELETAL PRODUCTS, 2008 (%)

TABLE 25 U.S. RECONSTRUCTIVE DEVICE MARKET, 2008 (%)

MARKET LEADERS

JOINT-REPLACEMENT SURGERY

TABLE 26 HIP REPLACEMENT PROCEDURE VOLUMES, U.S., THROUGH 2014

TABLE 27 HISTORICAL RATES OF HIP REPLACEMEN IN SIX MAJOR STATES, 2001

TABLE 28 WORLDWIDE HIP REPLACEMENT MARKET, THROUGH 2014 ($ MILLIONS)

FIGURE 6 WORLDWIDE HIP REPLACEMENT MARKET, 2007-2014 ($ MILLIONS)

TABLE 29 U.S. HIP REPLACEMENT MARKET, THROUGH 2014 ($ MILLIONS)

FIGURE 7 U.S. HIP REPLACEMENT MARKET, 2007-2014 ($ MILLIONS)

KNEE REPLACEMENTS

TABLE 30 WORLDWIDE KNEE-REPLACEMENT PROCEDURE VOLUMES, THROUGH 2014

TABLE 31 U.S. KNEE REPLACEMENT PROCEDURE VOLUMES, THROUGH 2014

TABLE 32 WORLDWIDE KNEE REPLACEMENT MARKET, THROUGH 2014 ($ MILLIONS)

FIGURE 8 WORLDWIDE KNEE REPLACEMENT MARKET, 2007-2014 ($ MILLIONS)

TABLE 33 U.S. KNEE REPLACEMENT MARKET, THROUGH 2014 ($ MILLIONS)

FIGURE 9 U.S. KNEE REPLACEMENT MARKET, 2007-2014 ($ MILLIONS)

TABLE 34 U.S. MARKET FOR UNICONDYLAR KNEE REPLACEMENT, THROUGH 2014 ($ MILLIONS)

FIGURE 10 U.S. MARKET FOR UNICONDYLAR KNEE REPLACEMENT, 2007-2014 ($ MILLIONS)

NATURAL THERAPEUTIC TREATMENTS FOR ARTHRITIS

IMAGING AND REGENERATION

CHAPTER NINE: 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

MARKET SIZE

TABLE 35 WORLDWIDE MARKET FOR NONINVASIVE BONE GROWTH STIMULATORS, THROUGH 2014 ($ MILLIONS)

TABLE 36 U.S. MARKET FOR NONINVASIVE BONE GROWTH STIMULATORS, THROUGH 2007 ($ MILLIONS)

CHAPTER TEN: ORTHOPEDICS—FDA CLEARANCES AND NEW PRODUCT DEVELOPMENT

SUPPLIERS OF REGENERATIVE BONE AND JOINT PRODUCTS

TABLE 37 RECENTLY APPROVED ORTHOPEDIC BONE AND JOINT DEVICES BY PRODUCT, COMPANY, AND APPROVAL DATE, 2008-2009

CHAPTER ELEVEN: MARKET FOR TISSUE ENGINEERING PRODUCTS

TISSUE ENGINEERING AND CELL THERAPY

RESEARCH INITIATIVES

CHAPTER TWELVE: REGENERATIVE CONCEPTS AND PRODUCTS IN DENTISTRY

OVERVIEW

INDICATIONS AND HISTORY

CHARACTERTISTICS AND MATERIALS

BARRIER MEMBRANES

NON-RESORBABLE

RESORBABLE

COLLAGEN RESORBABLE MEMBRANES

SYNTHETIC RESORBABLE MEMBRANES

CHAPTER THIRTEEN: SKIN TECHNOLOGIES

SKIN-LIKE TISSUE DEVELOPED FROM HUMAN EMBRYONIC STEM CELLS

TABLE 38 SALES OF ENGINEERED SKIN GRAFTS AND REPLACEMENTS, THROUGH 2014 ($ MILLIONS)

CHAPTER FOURTEEN: NEUROLOGICAL APPLICATIONS IN REGENERATIVE MEDICINE

OVERVIEW

NEURODEGENERATIVE DISEASES

CURRENT CONVENTIONAL THERAPIES FOR THE TREATMENT OF NEURODEGENERATIVE DISEASE SYMPTOMS

SPINAL CORD INJURY, NEURODEGENERATIVE DISEASES, AND REGENERATIVE POTENTIAL

UNIVERSITY OF SOUTHERN CALIFORNIA (USC)

CHAPTER FIFTEEN: REGENERATIVE MEDICINE AND APPLICATIONS IN CARDIAC CARE

OVERVIEW

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 SIXTEEN: REGENERATIVE MEDICINE AND DIABETES

BACKGROUND

POSSIBLE APPLICATIONS FOR REGENERATIVE MEDICINE

CHAPTER SEVENTEEN: FDA APPROVED CLINICAL TRIALS INVOLVING REGENERATIVE MEDICINE

CURRENT STATUS OF THE REGENERATIVE MEDICINE BUSINESS

REGULATORY ENVIRONMENT

STATUS OF RESEARCH AND CLINICAL TRIALS

ANALYSIS OF CLINICAL TRIALS

TABLE 39 REGENERATIVE MEDICINE CLINICAL TRIALS BY MAJOR CATEGORY

TABLE 40 CURRENT CLINICAL TRIALS IN THE FIELD OF REGENERATIVE MEDICINE STATUS, CONDITIONS, INTERVENTION, AND SPONSOR

CHAPTER EIGHTEEN: OVERSEAS ACTIVITIES

DOMESTIC VERSUS OVERSEAS REGENERATIVE MEDICINE COMPANIES

JAPAN

EUROPE

AUSTRALIA AND CHINA

CHAPTER NINETEEN: PATENT ANALYSIS

ANALYSIS

TISSUE ENGINEERING PATENTS

TABLE 41 MOST FREQUENTLY CITED PATENT ASSIGNEES IN TISSUE ENGINEERING FIELD

GEOGRAPHIC DISTRIBUTION

TABLE 42 WORLD DISTRIBUTION OF REGENERATIVE MEDICINE PATENTS ISSUED, 1985-2009 (%)

RECENT PATENTS

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 TWENTY: COMPANY PROFILES

TABLE 43 PUBLICALLY TRADED COMPANIES IN THE REGENERATIVE MEDICINE INDUSTRY, AS OF JULY 1, 2009

AASTROM BIOSCIENCES, INC.

ADVANCED BIOHEALING, INC.

ADVANCED CELL TECHNOLOGY, INC

AESCULAP, INC.

ALDAGEN, INC.

ALPHATEC SPINE, INC.

ANGIOTECH PHARMACEUTICALS, INC.

ARTERIOCYTE MEDICAL SYSTEMS, INC.

ARTHREX, INC.

ARTHROCARE CORPORATION

BIOMET, INC.

BIOMIMETIC THERAPEUTICS, INC.

BIOTISSUE TECHNOLOGIES GMBH

CAPSTONE THERAPEUTICS

CENTERPULSE ORTHOPAEDICS, INC.

CERAPEDICS, INC.

CITAGENIX, INC.

CONMED CORPORATION

CROSSCART INC.

CRYOLIFE, INC.

CURIS

CYTORI THERAPEUTICS, INC.

DEPUY ORTHOPAEDICS, INC. (UNIT OF THE DEPUY COMPANIES)

DJO SURGICAL

ESBATECH AG

ETEX CORPORATION

EXACTECH, INC.

FATE THERAPEUTICS, INC.

GARNET BIOTHERAPEUTICS

GENZYME BIOSURGERY

GERON CORPORATION

INTEGRA LIFESCIENCES HOLDING CORP.

ISOTIS ORTHOBIOLOGICS, INC. (INTEGRA ORTHOBIOLOGICS)

INTERNATIONAL STEM CELL

INTERPORE CROSS INTERNATIONAL

ISTO TECHNOLOGIES, INC.

KENSEY NASH CORPORATION

LIFECELL (A SUBSIDIARY OF KINETIC CONCEPTS, INC.)

MCEWEN CENTRE FOR REGENERATIVE MEDICINE

MCGOWAN INSTITUTE FOR REGENERATIVE MEDICINE

MEDTRONIC, INC.

MESOBLAST, LIMITED

NATIONAL CENTER FOR REGENERATIVE MEDICINE

NATIONAL TISSUE ENGINEERING CENTER (NTEC)

NEURALSTEM

NOVABONE PRODUCTS, LLC

NOVARTIS CORPORATION

NOVOCELL, INC.

OPEXA THERAPEUTICS

ORGANOGENESIS INC.

ORTHOFIX INTERNATIONAL N.V.

ORTHOPEUTICS, L.P.

ORTHOVITA, INC.

OSIRIS THERAPEUTICS, INC.

OSTEOTECH, INC.

PFIZER, INC.

PLURISTEM THERAPEUTICS

REGEN BIOLOGICS, INC.

RENEURON

RTI BIOLOGICS, INC.

SCIL TECHNOLOGY GMBH

SMITH AND NEPHEW

STEMCELLS, INC.

STEMCOR SYSTEMS, INC.

STRAUMANN USA LLC

STRYKER CORP.

SYNTHES, INC.

TENGION

TEPHA

THERMOGENESIS CORP.

TIGENIX N.V.

UCB S.A. (HEADQUARTERS)

WAKE FOREST INSTITUTE FOR REGENERATIVE MEDICINE

WRIGHT MEDICAL GROUP, INC.

ZIMMER HOLDINGS, INC.

OTHER ORGANIZATIONS INVOLVED IN REGENRERATIVE MEDICINE R&D

ACADEMIC INSTITUTIONS

U.S. GOVERNMENT

OTHER SOCIETIES AND ORGANIZATIONS

CHAPTER TWENTY-ONE: GLOSSARY OF KEY TERMS IN REGENERATIVE MEDICINE BUSINESS

GLOSSARY OF KEY TERMS

LIST OF TABLES

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

TABLE 1 FUNCTIONAL ACTIVITIES WITH REGENERATIVE MEDICINE SECTOR

TABLE 2 PRINCIPAL REGENERATIVE MEDICINE BUSINESS R&D FOCUSES

TABLE 3 20-YEAR PLANNING HORIZON FOR REGENERATIVE MEDICINE BUSINESS: LIKELY DEVELOPMENTS, 2015-2030

TABLE 4 PRINCIPLE RESEARCH PROJECTS OF CIMIT IN THE TISSUE-ENGINEERING AND BIOMATERIALS FIELDS, 2008-2010

TABLE 5 COMMERCIAL SUPPLIERS OF BIOREACTORS FOR USE IN REGENERATIVE MEDICINE

TABLE 6 BONE MORPHOGENETIC PROTEINS

TABLE 7 U.S. MARKET FOR TISSUE-ENGINEERED CARTILAGE PRODUCTS, THROUGH 2014 ($ MILLIONS)

TABLE 8 FEDERAL FUNDING FOR STEM CELL RESEARCH, THROUGH 2008 ($ MILLIONS)

TABLE 9 STATE LEVEL PROGRAMS FOCUSED ON STEM CELL RESEARCH

TABLE 10 CHARACTERISTICS OF IDEAL BONE GRAFT MATERIAL

TABLE 11 U.S. BONE GRAFT PROCEDURE VOLUMES BY APPLICATION, THROUGH 2014

TABLE 12 U.S. BONE GRAFT PROCEDURE VOLUMES BY TYPE OF GRAFT, THROUGH 2014

TABLE 13 BONE GRAFT MATERIALS

TABLE 14 SUBSTITUTE BONE GRAFTS

TABLE 15 SELECTED DBM PRODUCTS AND PERCENTAGE OF DEMINERALIZED BONE MATRIX

TABLE 16 U.S. MARKET FOR PRECISION-MACHINED ALLOGRAFTS, THROUGH 2014 ($ MILLIONS)

TABLE 17 WORLDWIDE MARKET FOR BONE REPLACEMENT PRODUCTS, THROUGH 2014 ($ MILLIONS)

TABLE 18 U.S. MARKET FOR BONE-REPLACEMENT PRODUCTS, THROUGH 2014 ($ MILLIONS)

TABLE 19 DRUGS USED TO TREAT OSTEOPOROSIS

TABLE 20 WORLDWIDE MARKET FOR DRUGS TO TREAT OSTEOPOROSIS, THROUGH 2014 ($ MILLIONS)

TABLE 21 WORLDWIDE MARKET FOR DRUGS TO TREAT PAGET’S DISEASE, THROUGH 2014 ($ MILLIONS)

TABLE 22 WORLDWIDE HIP FRACTURE VOLUMES, THROUGH 2014

TABLE 23 U.S. HIP FRACTURE VOLUMES, THROUGH 2014

TABLE 24 U.S. MARKET SHARES FOR MUSCULOSKELETAL PRODUCTS, 2008 (%)

TABLE 25 U.S. RECONSTRUCTIVE DEVICE MARKET, 2008 (%)

TABLE 26 HIP REPLACEMENT PROCEDURE VOLUMES, U.S., THROUGH 2014

TABLE 27 HISTORICAL RATES OF HIP REPLACEMEN IN SIX MAJOR STATES, 2001

TABLE 28 WORLDWIDE HIP REPLACEMENT MARKET, THROUGH 2014 ($ MILLIONS)

TABLE 29 U.S. HIP REPLACEMENT MARKET, THROUGH 2014 ($ MILLIONS)

TABLE 30 WORLDWIDE KNEE-REPLACEMENT PROCEDURE VOLUMES, THROUGH 2014

TABLE 31 U.S. KNEE REPLACEMENT PROCEDURE VOLUMES, THROUGH 2014

TABLE 32 WORLDWIDE KNEE REPLACEMENT MARKET, THROUGH 2014 ($ MILLIONS)

TABLE 33 U.S. KNEE REPLACEMENT MARKET, THROUGH 2014 ($ MILLIONS)

TABLE 34 U.S. MARKET FOR UNICONDYLAR KNEE REPLACEMENT, THROUGH 2014 ($ MILLIONS)

TABLE 35 WORLDWIDE MARKET FOR NONINVASIVE BONE GROWTH STIMULATORS, THROUGH 2014 ($ MILLIONS)

TABLE 36 U.S. MARKET FOR NONINVASIVE BONE GROWTH STIMULATORS, THROUGH 2007 ($ MILLIONS)

TABLE 37 RECENTLY APPROVED ORTHOPEDIC BONE AND JOINT DEVICES BY PRODUCT, COMPANY, AND APPROVAL DATE, 2008-2009

TABLE 38 SALES OF ENGINEERED SKIN GRAFTS AND REPLACEMENTS, THROUGH 2014 ($ MILLIONS)

TABLE 39 REGENERATIVE MEDICINE CLINICAL TRIALS BY MAJOR CATEGORY

TABLE 40 CURRENT CLINICAL TRIALS IN THE FIELD OF REGENERATIVE MEDICINE STATUS, CONDITIONS, INTERVENTION, AND SPONSOR

TABLE 41 MOST FREQUENTLY CITED PATENT ASSIGNEES IN TISSUE ENGINEERING FIELD

TABLE 42 WORLD DISTRIBUTION OF REGENERATIVE MEDICINE PATENTS ISSUED, 1985-2009 (%)

TABLE 43 PUBLICALLY TRADED COMPANIES IN THE REGENERATIVE MEDICINE INDUSTRY, AS OF JULY 1, 2009

LIST OF FIGURES

SUMMARY FIGURE U.S. MARKET FOR REGENERATIVE MEDICINE PRODUCTS USED IN BONE AND JOINT APPLICATIONS, 2007-2014 ($ MILLIONS)

FIGURE 1 U.S. MARKET FOR PRECISION-MACHINED ALLOGRAFTS, 2007-2014 ($ MILLIONS)

FIGURE 2 WORLDWIDE MARKET FOR BONE REPLACEMENT PRODUCTS, 2007-2014 ($ MILLIONS)

FIGURE 3 U.S. MARKET FOR BONE-REPLACEMENT PRODUCTS, 2007-2014 ($ MILLIONS)

FIGURE 4 WORLDWIDE MARKET FOR DRUGS TO TREAT OSTEOPOROSIS, 2007-2014 ($ MILLIONS)

FIGURE 5 WORLDWIDE MARKET FOR DRUGS TO TREAT PAGET’S DISEASE, 2007-2014 ($ MILLIONS)

FIGURE 6 WORLDWIDE HIP REPLACEMENT MARKET, 2007-2014 ($ MILLIONS)

FIGURE 7 U.S. HIP REPLACEMENT MARKET, 2007-2014 ($ MILLIONS)

FIGURE 8 WORLDWIDE KNEE REPLACEMENT MARKET, 2007-2014 ($ MILLIONS)

FIGURE 9 U.S. KNEE REPLACEMENT MARKET, 2007-2014 ($ MILLIONS)

FIGURE 10 U.S. MARKET FOR UNICONDYLAR KNEE REPLACEMENT, 2007-2014 ($ MILLIONS)

Abstract

• Overall sales in the regenerative medicine productsmarket were worth $1.1 billion in 2007, and remained flat into 2009. By 2014, sales are projected to increase to nearly $1.8 billion, for a 5-year compound annual growth rate (CAGR) of 8.6%.
• The largest segment in the market, bone replacement/grafting, was valued at $714 million in 2007. This also has increased only slightly into 2009 but is projected to reach $979 million in 2014, for a 5-year CAGR of 6.3%.
• Sales in the bone growth stimulators product segment were worth $321 million in 2007, and were to increase slightly into 2009. By 2014, however, they are projected to increase to $578 million, for a 5-year CAGR of 11.9%.

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