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Chapter- 1: INTRODUCTION

OBJECTIVES AND GOALS OF STUDY
INTENDED AUDIENCE
SCOPE OF REPORT
METHODOLOGY
INFORMATION SOURCES
ANALYST CREDENTIALS
RELATED BCC REPORTS
BCC ONLINE SERVICES
DISCLAIMER

Chapter-2: 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-3: 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-4: 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-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
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-6: 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-7: 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-8: 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-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
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-10: 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-11: MARKET FOR TISSUE ENGINEERING PRODUCTS

TISSUE ENGINEERING AND CELL THERAPY
RESEARCH INITIATIVES

Chapter-12: 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-13: SKIN TECHNOLOGIES

SKIN-LIKE TISSUE DEVELOPED FROM HUMAN EMBRYONIC STEM CELLS
TABLE 38 SALES OF ENGINEERED SKIN GRAFTS AND REPLACEMENTS, THROUGH 2014 ($ MILLIONS)

Chapter-14: 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-15: 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-16: REGENERATIVE MEDICINE AND DIABETES

BACKGROUND
POSSIBLE APPLICATIONS FOR REGENERATIVE MEDICINE

Chapter-17: 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-18: OVERSEAS ACTIVITIES

DOMESTIC VERSUS OVERSEAS REGENERATIVE MEDICINE COMPANIES
JAPAN
EUROPE
AUSTRALIA AND CHINA

Chapter-19: 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-20: 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-21: GLOSSARY OF KEY TERMS IN REGENERATIVE MEDICINE BUSINESS

GLOSSARY OF KEY TERMS