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Published by: BCC Research
Published: Dec. 1, 2005 - 213 Pages
Table of Contents
- INTRODUCTION
- REASON FOR DOING THE STUDY
- STUDY GOAL AND OBJECTIVES
- CONTRIBUTIONS OF THE STUDY AND FOR WHOM
- SCOPE AND FORMAT
- METHODOLOGY AND INFORMATION SOURCES
- ANALYST'S CREDENTIALS
- OTHER RELEVANT BCC REPORTS AND PUBLICATIONS
- BCC ONLINE SERVICES
- DISCLAIMER
- SUMMARY
- Summary Table: GLOBAL FORECAST OF REVENUES FOR STEM CELL AND CYTOKINE THERAPIES IN REGENERATIVE MEDICINE, THROUGH 2010 ($ BILLIONS)
- Summary Figure: GLOBAL FORECAST OF REVENUES FOR STEM CELL AND CYTOKINE THERAPIES IN REGENERATIVE MEDICINE, 2003-2010 ($ BILLIONS)
- OVERVIEW
- Table 1 PERCENT OF PERSONS USING PRESCRIPTION DRUGS IN THE PAST MONTH IN THE U.S., 1999-2000
- GROWTH FACTORS AND CYTOKINES
- Table 2 SELECTED CYTOKINES OR GROWTH FACTORS RELEVANT TO REGENERATIVE MEDICINE
- STEM AND PROGENITOR CELLS
- WORLDWIDE MARKETS FOR REGENERATIVE MEDICINE
- Table 3 LEADING CAUSES OF DEATH IN THE U.S., 2001
- Table 4 PREVALENCE OF MEDICAL CONDITIONS IN THE U.S. WITH POTENTIAL CELL THERAPIES
- Table 5 AGING OF THE U.S. POPULATION
- CELL THERAPIES AS A SUBSTITUTE FOR TRANSPLANTS
- THE U.S. MARKET VERSUS THE REST OF THE WORLD
- Table 6 POPULATION OF COUNTRIES OF THE EUROPEAN UNION, 2003
- DISTRIBUTION OF REVENUES AND EFFORT
- TYPES OF STEM OR PROGENITOR CELLS
- Table 7 DESCENDANTS OF THE HUMAN MESENCHYMAL STEM CELL
- Autologous Cells
- Allogeneic Cells
- UMBILICAL CORD BLOOD
- Table 8 A PARTIAL LIST OF DISEASES TREATED USING CORD BLOOD STEM CELLS
- EMBRYONIC STEM CELLS
- Table 9 DERIVATION OF BODY TISSUE TYPES FROM GERM LAYERS
- Table 10 CELL TYPES DERIVED FROM EMBRYONIC STEM CELLS IN VITRO
- Identification of Stem Cells
- Table 11 MARKERS OF PLURIPOTENT CELLS IN MOUSE, MAN, AND MONKEY
- Therapeutic Cloning
- Utility of ES Cells
- Ethical Considerations
- Position of the Catholic Church
- Position of the National Academy of Sciences
- Politics and Funding for Embryonic Stem Cell Research
- NIH Guidelines
- Table 12 EMBRYONIC STEM CELL LINES THAT MEET NIH FUNDING REQUIREMENTS, WHICH ARE AVAILABLE FOR SHIPPING
- Patents
- GERM CELLS
- WHAT MAKES A STEM CELL A STEM CELL?
- CELL-BASED GENE THERAPY
- U.S. REGULATION
- DEVICES
- Table 13 FOOD AND DRUG ADMINISTRATION BODIES INVOLVED IN IMPLANT REGULATION
- BIOLOGICALS
- ORPHAN PRODUCT STATUS
- INTERNATIONAL ISSUES
- OFFSHORE CELL-THERAPY TREATMENTS
- APPLICATIONS FOR PROGENITOR CELL THERAPIES
- APPLICATIONS OF REGENERATIVE MEDICINE FOR BLOOD AND THE IMMUNE SYSTEM
- Figure 1 HEMATOPOIESIS
- Table 14 A PARTIAL LIST OF DISEASES TREATED WITH HEMATOPOIETIC STEM CELLS
- HARVESTING HEMATOPOIETIC STEM CELLS
- Bone Marrow
- Peripheral Blood Progenitor Cell Collection
- Umbilical Cord Blood
- Drug-Resistant Hematopoietic Stem Cells
- PRODUCTS AND SERVICES IN SUPPORT OF HEMATOPOIETIC STEM CELL TRANSFERS
- Table 15 COMMERCIAL OPPORTUNITIES FOR HEMATOPOIETIC STEM CELL TRANSPLANTATION
- CYTOKINES FOR STEM CELL THERAPY
- Table 16 APPROVED BIOPHARMACEUTICALS FOR THE REGENERATION OF BLOOD AND IMMUNE CELLS AFTER CHEMOTHERAPY
- G-CSF and GM-CSF
- AMD3100
- Erythropoietins
- MARKET OPPORTUNITIES FOR REGENERATIVE CYTOKINES
- Table 17 SALES OF THERAPEUTIC REGENERATIVE CYTOKINES FOR BLOOD AND IMMUNE DISEASES, THROUGH 2010 ($ MILLIONS)
- Figure 2 SALES OF THERAPEUTIC REGENERATIVE CYTOKINES FOR BLOOD AND IMMUNE DISEASES, 2003-2010 ($ MILLIONS)
- HARVESTING AND STORAGE OF UMBILICAL CORD BLOOD
- Table 18 COMMERCIAL UMBILICAL CORD BLOOD STORAGE COMPANIES
- Market Opportunities for Umbilical Cord Blood Storage
- Table 19 FEES CHARGED BY MAJOR UMBILICAL CORD BLOOD BANKS, 2005 ($)
- Table 20 WORLDWIDE REVENUES FROM CORD BLOOD HARVEST AND STORAGE, THROUGH 2010 ($ MILLIONS)
- Figure 3 WORLDWIDE REVENUES FROM CORD BLOOD HARVEST AND STORAGE, 2003-2010 ($ MILLIONS)
- EXPANSION OF STEM CELLS
- Market Opportunities for Stem Cell Expansion.
- Table 21 WORLDWIDE REVENUES FROM EXPANSION AND CULTURE OF THERAPEUTIC STEM CELLS, THROUGH 2010 ($ MILLIONS)
- Figure 4 WORLDWIDE REVENUES FROM EXPANSION AND CULTURE OF THERAPEUTIC STEM CELLS, 2003-2010 ($ MILLIONS)
- GRAFT-VERSUS-HOST DISEASE
- IMMUNE DEFICIENCIES
- Acquired Immunodeficiency Syndrome
- Table 22 AQUIRED IMMONDEFICIENCY CASES REPORTED BY YEAR IN THE U.S., 1985-2003
- Natural Resistance
- Current Therapies for AIDS
- Progenitor Cell Therapies for AIDS
- Market Opportunities for AIDS Therapies
- Table 23 SIZE OF THE AIDS/HIV EPIDEMIC
- SUMMARY: BLOOD AND IMMUNE DISEASES
- Table 24 GLOBAL FORECAST OF REVENUES FOR BLOOD AND IMMUNE DISEASES ($ MILLIONS)
- Table 5 GLOBAL FORECAST OF REVENUES FOR BLOOD AND IMMUNE DISEASES ($ MILLIONS)
- SKIN
- SKIN CELL PROGENITORS
- BURNS
- ULCERS
- MARKET OPPORTUNITIES FOR SKIN CELL THERAPIES
- Table 25 GLOBAL FORECAST OF REVENUES FOR REGENERATIVE WOUND THERAPY PRODUCTS, THROUGH 2010 ($ MILLIONS)
- Figure 6 GLOBAL FORECAST OF REVENUES FOR REGENERATIVE WOUND THERAPY PRODUCTS, 2003-2010 ($ MILLIONS)
- BONE
- BONE FRACTURES
- Bone Metabolism
- Current Therapies
- Cell Therapies for Bone Fractures
- Growth Factors and Morphogenic Proteins
- Table 26 GROWTH FACTOR PRODUCTS FOR BONE HEALING
- Table 27 GROWTH FACTORS DEVELOPED BUT NOT YET APPROVED FOR BONE INDICATIONS
- Market Opportunities for Regenerative Therapies for Fractures and Spinal Fusions
- Table 28 SPINAL FUSION DATA, U.S. 1998-2002 ($)
- Table 29 NUMBER OF LOWER LEG FRACTURE, 1998-2002
- Table 30 GLOBAL FORECAST OF REVENUES FOR REGENERATIVE THERAPIES FOR SPINAL FUSIONS AND BONE FRACTURES ($ MILLIONS)
- Figure 7 GLOBAL FORECAST OF REVENUES FOR REGENERATIVE THERAPIES FOR SPINAL FUSIONS AND BONE FRACTURES ($ MILLIONS)
- CARTILAGE
- Table 31 PRODUCTS FOR REGENERATIVE CARTILAGE REPAIR
- MENISCUS REPAIR
- INJURIES OF THE KNEE
- INTERVERTEBRAL DISC REGENERATION
- MARKETS FOR CARTILAGE REPAIR
- Table 32 GLOBAL FORECAST OF SALES OF CELL THERAPY PRODUCTS TO REPAIR CARTILAGE, THROUGH 2010 ($ MILLIONS)
- Figure 8 GLOBAL FORECAST OF SALES OF CELL THERAPY PRODUCTS TO REPAIR CARTILAGE, 2003-2010 ($ MILLIONS)
- CARDIOVASCULAR SYSTEM
- CONGESTIVE HEART FAILURE
- Current Therapies
- CORONARY HEART DISEASE
- Current Therapies
- CELL THERAPIES FOR CHF OR CORONARY DISEASE
- CARDIAC ARRYTHMIA
- Current Therapy
- Cell Therapies
- MARKET OPPORTUNITIES FOR CARDIOVASCULAR CELL THERAPIES
- Table 33 PREVALENCE OF HEART DISEASE IN U.S. ADULTS (18 YEARS AND OVER), 2002 (THOUSAND)
- TEETH
- HAIR
- BRAIN AND NERVOUS SYSTEM
- NEURAL STEM CELLS
- LYSOSOMAL STORAGE DISEASES
- DISORDERS OF THE MYELIN SHEATH
- SPINAL CORD INJURY
- STROKE
- Table 34 DEATH RATES PER 100,000 FROM CEREBROVASCULAR DISEASE (STROKE) IN THE U.S., 1960 AND 2002
- PARKINSON'S DISEASE
- Cell Therapies
- The Market Opportunities for Regenerative Treatments to Treat Neural Disease
- EYES
- Market Opportunities
- LIVER
- HUMAN CELL THERAPIES
- Markets for Regenerative Therapies for the Liver
- KIDNEY
- Potential Cell Therapies for Kidney Disease
- Market Opportunities for Regenerative Kidney Therapies
- DIABETES
- Table 35 GLOBAL PREVALENCE OF DIABETES IN EUROPE, AGES 20 TO 79 2003 AND 2025 (THOUSANDS)
- COMPLICATIONS OF DIABETES
- Current Treatments
- Edmonton Protocol
- STEM CELL THERAPIES
- Market Opportunities for Regenerative Diabetes Therapies
- REPRODUCTIVE MEDICINE
- MARKET OPPORTUNITIES FOR OOCYTE CRYOPRESERVATION
- Table 36 GLOBAL FORECAST OF REVENUES DERIVED FROM OOCYTE STORAGE, THROUGH 2010 ($ MILLION)
- Figure 9 GLOBAL FORECAST OF REVENUES DERIVED FROM OOCYTE STORAGE, 2003-2010 ($ MILLION)
- PRODUCTS USED IN CELL THERAPY AND REGENERATIVE MEDICINE
- PRODUCTS USED FOR AMPLIFYING, CULTURING, OR TRANSFERRING STEM CELLS
- AASTROMREPLICELL SYSTEM
- MYOCATH PERCUTANEOUS DELIVERY SYSTEM
- PLURIX BIOREACTOR SYSTEM
- CYTOMATRIX
- CYTOKINES AND GROWTH FACTORS
- Table 37 CYTOKINES AND GROWTH FACTORS IN REGENERATIVE MEDICINE
- AMD3100
- ARANESP
- BMP-7
- CHRYSALIN
- CTCE-0214
- CYT 99 007
- EPOGEN/PROCRIT
- INFUSE/INDUCTOS
- NEULASTA
- NEUMEGA
- NEUPOGEN
- OP-1
- REGRANEX GEL
- THYMOSIN BETA FOUR
- TUMOR GROWTH FACTOR ALPHA
- LIVING CELL THERAPIES
- HEMATOPOIETIC AND IMMUNE CELL THERAPIES
- Table 38 LIVING BLOOD AND IMMUNE CELL THERAPEUTIC PRODUCTS IN DEVELOPMENT
- Highly Purified Hematopoietic Stem Cells
- HGTV-43
- MP Cells
- Procord
- SKIN
- Table 39 LIVING SKIN EQUIVALENTS USED THERAPEUTICALLY
- Apligraf
- Dermagraft
- EpiCel
- Hyalograft 3D
- Laserskin Autograft
- OrCel
- CARTILAGE
- Table 40 LIVING-CELL PRODUCTS USED THERAPEUTICALLY TO REPAIR CARTILAGE
- Carticel
- Cartilink
- Chondrogen
- Co.Don Chondrotransplant
- Co.Don Chondrotransplant DISC
- Hyalograft C
- ICX-PRO
- ICX-SKN
- NEURAL STEM CELLS
- HuCNS-SC
- MUSCLE
- Table 41 MUSCLE CELLS USED AS THERAPEUTIC PRODUCTS
- Biopace
- MyoCell
- Myocell VT
- Provacel
- OTHER MESENCHYMAL CELLS
- Prochymal
- Tissue Repair Cells - Aastrom Bioscience
- PANCREAS
- IxSC-1
- KIDNEY
- Renal Assist Device
- STEM CELL STORAGE
- BIOARCHIVE STEM CELL SYSTEM
- CCEL CELLULAR STORAGE FREEZER
- STRUCTURE OF THE INDUSTRY
- CYTOKINE AND GROWTH FACTOR COMPANIES
- Table 42 COMPANIES SUPPLYING APPROVED CYTOKINE OR GROWTH FACTOR THERAPIES
- MARKET SHARES OF CYTOKINE AND GROWTH FACTOR COMPANIES
- Table 43 RANKINGS AND MARKET SHARES OF COMPANIES FOR CYTOKINES AND GROWTH FACTORS IN 2004 (REVENUES)
- PRODUCTS UNDER DEVELOPMENT
- Table 44 COMPANIES DEVELOPING GROWTH FACTOR OR CYTOKINE PRODUCTS
- UMBILICAL CORD STEM CELL COMPANIES
- Table 45 2004 WORLDWIDE MARKET RANKINGS FOR UMBILICAL CORD STEM CELL STORAGE COMPANIES
- CELL THERAPY COMPANIES
- Table 46 FOCUS OF STEM AND PROGENITOR CELL THERAPY COMPANIES
- PATENTS
- Table 47 U.S. PATENT APPLICATIONS FROM JANUARY 1, 2001 THROUGH SEPTEMBER 8, 2005, WITH SELECTED STEM CELL SEARCH TERMS
- Table 48 SELECTED U.S. STEM CELL PATENTS ISSUED BETWEEN JANUARY 2002 AND SEPTEMBER 2005
- ATTRITION
- Table 49 DISAPPEARING NAMES IN REGENERATIVE MEDICINE
- COMPANY PROFILES
- AASTROM BIOSCIENCES
- ADERANS RESEARCH INSTITUTE
- ADVANCED CELL TECHNOLOGY
- ADVANCED CELL THERAPEUTICS
- AMGEN
- ANORMED
- ATHERSYS
- BAXTER INTL.
- BEFUTUR BIOTECHNOLOGIES
- BIOHEART
- BIOMATRIX SCIENTIFIC GROUP
- BIOTISSUE, INC.
- BIOTISSUE TECHNOLOGIES AG
- BRAINSTORM CELL THERAPEUTICS
- CELLARTIS
- CELL BASED DELIVERY
- CELLERANT THERAPEUTICS
- CELLRESEARCH CORP.
- CELLULAR DYNAMICS
- CHEMOKINE THERAPEUTICS
- CO.DON AG
- CORCELL
- CORD BLOOD AMERICA
- CORD BLOOD REGISTRY
- CYGENICS
- CORDLIFE PTE, LTD./ CELL SCIENCES PTE, LTD.
- CYTOMATRIX
- CRYO-CELL INTL.
- CYTHERA
- CYTORI THERAPEUTICS
- DENTIGENIX, INC.
- ENCELLE
- ENZO BIOCHEM
- EXTENDFERTILITY
- FIDIA FARMACEUTICI SPA
- FREZER, INC.
- GENZYME BIOSURGERY
- GENVEC
- GERON
- HISTOSTEM
- INTERCYTEX
- INTERFACE BIOTECH A/S
- ISLET TECHNOLOGY
- ISTO TECHNOLOGIES
- IXION BIOTECHNOLOGY
- KALEIDOS PHARMACEUTICAL
- JOHNSON & JOHNSON
- LIFEBANK CRYOGENICS
- MEDRA
- MESOBLAST, LTD.
- MILTENYI BIOTEC GMBH
- MORPHOGENESIS
- NEOSTEM
- NEPHROS THERAPEUTICS
- NEURALSTEM BIOPHARMACEUTICALS
- NEURONYX
- NOVARTIS INTERNATIONAL AG
- NS GENE A/S
- ODONTIS
- ORGANOGENESIS
- ORTEC INTL.
- ORTHOLOGIC
- OSIRIS THERAPEUTICS
- PHARMA FRONTIERS
- PHARMASTEM THERAPEUTICS
- PLURISTEM LIFE SYSTEMS
- PRIMEGEN BIOTECH, LLC
- PROGENITOR CELL THERAPY
- PRONEURON BIOTECHNOLOGIES
- REGENERX BIOPHARMACEUTICALS
- RENEURON
- SANERON CCEL THERAPEUTICS, INC.
- STEMCELLS, INC.
- STEMCELL PHARMA, INC.
- STEM CELL SCIENCES
- STEM CELL THERAPEUTICS CORP.
- STEM CELL THERAPY INTL.
- THERMOGENESIS
- TISSERA
- U.S. BIODEFENSE, INC.
- VESTA THERAPEUTICS
- VIACELL
- WICELL RESEARCH INSTITUTE
- APPENDIX
- GLOSSARY OF TERMS AND ABBREVIATIONS
AbstractINTRODUCTION
In March 2002, BCC published its first study focused on stem cells and progenitor cell therapy. Since that time, stem cell and regenerative companies have had a difficult time because of a shortage of funding. However, new companies have sprung up, as new research prompts new avenues of exploration.
The political climate for embryonic stem cells has changed. The Bush Administration maintains a ban in the U.S. on federal funding for research using newly established lines. However, California and Illinois have begun funding this research and others seem likely to follow. The House of Representatives has passed a bill reversing Bush's ban, and the Senate is likely to pass it. Meanwhile, other countries are making embryonic stem cell research a priority. For most of 2005, for instance, it seemed as if South Korean scientists had surpassed the rest of the world in the ability to generate patient-specific embryonic stem cells through nuclear transfer. It now appears that these results were fabricated; respectable peer-reviewed journals were taken in by the hoax because the achievements described were quite feasible, given similar results acheived in animal studies.
Given these many changes taking place in regenerative medicine, it seems a good time to renew our study of this field. This comprehensive and cohesive technical market research report from BCC is set within the existing regulatory framework and takes into account not only technical accomplishments but also political and financial realities. The study, therefore, establishes the necessary context from which to make rational decisions regarding business decisions in this expanding field.
SCOPE OF STUDY
The report contains:
- An overview that introduces the various kinds of stem cells, gives definitions, and discusses political, regulatory aspects, and the major developments of 2005 including the retraction of previously published South Korean stem cell research results
- Analysis of applications including current and potential cytokine and cell therapies with forecasts through 2010
- A discussion of current products as well as many that are still in clinical trials
- An industry structure analysis including companies in the field and their focus
- Profiles of individual companies, and includes the names of key officers.
METHODOLOGY AND INFORMATION SOURCES
The information reported herein has been gathered from a variety of industry and other sources. The 10K forms and other SEC filings from public companies have been examined along with annual reports, catalogues, and press releases. The World Wide Web is a rich source of information, as almost every commercial concern now has its own Web page. Where appropriate, medical literature and scientific literature have served as a research source.
We have also gathered statistical information from the U.S. government, the World Health Organization, and private foundations. Armed with the industry and statistical information garnered all of these sources, market participants were interviewed to fill in the gaps.
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