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Emerging Technologies and Opportunities in Structural Tissue Engineering

Few areas of study and development receive as much attention in both the scientific and lay press as Tissue Engineering. This comprehensive report from Kalorama Information examines current products (including features and benefits) and products under development including:

  • Isolated cells used for implantation
  • Cells combined with biomaterials and active substances
  • Biomaterial based scaffolds
  • Administration of active substances to affect endogenous tissue

In addition, key technologies used in research as well as scientific and social issues will be presented and discussed. Market forecasts and shares will be presented for existing products and estimates for new product entries will be presented and will include any type or level of product displacement.

Over 70 companies will be presented who are either existing suppliers and/or have active R&D programs.


Scope and Content of Report

Tissue engineering and its enabling technologies have developed over the past decade. As a result, the definition of tissue engineering has broadened. Many of the enabling and complementary technologies impacting tissue engineering, such as stem cell technologies, xenotransplantation, and acellular biomatrix technologies have been considered by some to be part of tissue engineering. This report contains information primarily on companies involved in core tissue engineering areas. We have chosen to exclude pure stem cell research, gene and cell therapies from this report because they are the subjects of an upcoming separate report.

The report includes profiles and information on over 45 companies involved in tissue engineering. Companies in this report include: Aastrom Biosciences, Advanced Tissue Sciences, BioHybrid Technologies, Biotransplant, Circe Biomedical, Collagen, Circe, Diacrin, Encelle, Genzyme BioSurgery, Integra Life Sciences, Islet Technology, LifeCell, Organogenesis, Orquest, Osiris Therapeutics, Osteotech, ReGen Biologics, and VivoRx.

Because of the early stages of product development, near-term estimates on products currently in development would be speculation. As such, we have attempted to identify the size of the market for current therapies for which the respective tissue engineering technology may enter or replace. The vast majority of products to be discussed have yet to be licensed, and we expect that by 2005, projections made here will be seen as quite inaccurate. Because this is a very rapidly developing field, readers are advised to use these estimates and the reasoning behind them as a starting point for developing market assessments, and to supplement them with developments that take place subsequent to the publishing of this project.

Methodology

The information in this report was taken from primary industry sources: interviews with company, government, and academic organization officials; company submissions such as 10K reports to the SEC; annual reports; biotechnology analyst reports; trade journals; and medical literature. The author contacted over 80 companies and individuals involved in the development of tissue engineering products.

The Brave New World of Tissue Engineering

New! the Tissue Engineering report, published by Kalorma Information is now available through MarketResearch.com. This study examines the most current products available and under development in the ‘brave new world” of tissue engineering. Some of the topics included in this report are:

  • Isolated Cells used for implantation
  • Cells combined with biomaterials and active substances
  • Biomaterial based scaffolds

There are few areas of study and development that receive as much attention in both scientific and lay press as tissue engineering. In this report some of the leading tissue engineering product features as well as benefits are examined. Current market forecasts and market shares in this industry are presented in addition to the market forecast for new product entries. This report is key for anyone interested in understanding the market of this new and exciting industry.

Some of the issues addressed in this report are:

  • The Impact of New Products and Emerging Technologies
  • Acquisitions or divestitures
  • Reasons for Growth or Decline in the Market

Key technologies used in research as well as scientific and social issues are covered. Over 70 companies have been profiled in this report that are either existing suppliers and/or have active research and development programs.

The Tissue Engineering report is available through MarketResearch.com, the leading provider of global market intelligence products and services. With MarketResearch.com, you can purchase The Tissue Engineering report as a complete study, or buy discrete segments using the options below:

  • MarketLooks – concise, graphic-rich summaries of full-length market research reports available for online delivery. These PowerPoint slides provide industry high points in a presentation-ready format.
  • Buy By the Slice – a cost-effective option that enables you to select and purchase exactly what you value most.

Issues Addressed:

  • Key Market issues
  • Demographics
  • Reasons for Growth or Decline in the Market
  • Advent of New Technologies
  • Scientific and Social Issues
  • The Impact of New Products and Emerging Technologies
  • Acquisitions or divestures

Categories Covered:

  • Demographics & Description of Industry and Potential Disease Modalities
  • The Products
  • Market Forecasts & Market Shares
  • Company Profiles
  • Strategic Issues and Conclusions
  • Summary Conclusion

Companies/Sites Discussed:

  • Astrom Biosciences
  • Acorda Therapeutics
  • Advanced Skin Cell Therapeutics
  • Diacrin, Inc.
  • FibroGen
  • INAMED Corp.
  • MorphoGen Pharmaceuticals
  • Osteotech
  • Spinal Concepts Inc.
  • Titan Pharmaceuticals
  • VivoRx Inc.

Press Release

“Market Potential for Tissue Engineering Estimated at $80 Billion”

New York, August 8, 2001/PR Newswire—Engineered and regenerated tissues have a market potential of $80 Billion dollars, according to a new study released today from Kalorama Information, a division of MarketResearch.com, and the race is on to begin capitalizing on this huge unmet need.

According to the report, entitled Emerging Technologies and Opportunities in Structural Tissue Engineering, a growing number of companies spent nearly $600 million last year pursuing tissue engineering solutions to a vast array of diseases and degenerative conditions, including dermatologic, orthopedic, cardiovascular, and liver and pancreatic conditions. Almost 70 companies are actively developing products and enabling technologies.

The study found that despite the enormous potential for this industry, there are several major hurdles to overcome, both technical and financial. In particular, funding was identified as one of the industry’s greatest concerns.

“FDA approval requires long financial staying power,” noted Steven Heffner, Kalorama’s Acquisitions Editor. “Many smaller companies will have to seek out partnering opportunities to see their technologies through to the market place.”

The three currently approved tissue-engineered products had combined sales of only $49 million in 2000, according to the report, and the industry in general is predicted to run at a significant net loss for a few more years. However, the clinical and monetary potential combined with many promising technical developments should sustain the current 24% growth in research spending.

Produced by Kalorama Information, a division of MarketResearch.com, Emerging Technologies and Opportunities in Structural Tissue Engineering is a comprehensive, in-depth analysis of technologies, players, trends, and opportunities in the tissue engineering sector worldwide.

The report forecasts sales data and market shares through 2005. Future products and technologies, including production issues, are also examined with estimates of time to entry and projections for the first 5 years.

Foreward

  • Objectives
  • Target Audience
  • Scope and Content of Report
  • Methodology

1. Executive Summary and Introduction

  • Executive Summary
    • Tissue Engineering Industry Overview
    • Products on the Market
    • Market Forecasts and Market Share
    • Tissue Engineering Demographics
    • Tissue Engineering Industry
    • Size of the Potential Engineered Tissue Market
    • Sales of FDA-Approved Tissue Engineering Products
    • Challenges Facing the Tissue Engineering Industry
    • Market Estimates
    • Market Trends
    • Market Forecast
    • International Tissue Engineering Activity
    • Novel Bioreactor Design—Europe Following U.S. Lead
    • Tissue Engineering Companies and Organizations
    • Trends in Company Activities
    • Investment Trends
    • Strategic Issues in Tissue Engineering
    • Key Factors in Future Development
    • Standards Development in the U.S.
  • Introduction
    • Tissue Engineering Essentials
    • A Natural Form of Medicine
    • A Fast-Growing Industry
    • Tissue Engineering Techniques
    • Regenerative Biology
    • The Potential for Tissue Engineering
    • Developmental Biology and Functional Genomics
    • Contributions by MIT and Harvard
    • Challenges in Tissue Engineering
    • Tissue Engineering Industry Overview
    • Defining Tissue Engineering
    • Regenerative Medicine
    • Excluded Technologies
    • Classification of Technologies
    • In Vitro Tissue Engineering
    • Tissue Engineering Process Components
    • Tissue Engineering: An Historical Perspective

2. Demographics: Description of Industry, Potential Disease Modalities

  • Tissue Engineering Technologies
    • Potential Disease Modalities
  • Skin Tissues
    • Skin Therapies
    • Autografts vs. Allografts
    • Natural Skin Wound Healing
    • Skin Replacements
    • Skin Transplantation: Autograft
    • Skin Transplantation: Allograft
    • Tissue engineered Skin Products
    • Decellularized Skin
    • Skin Substitutes: Autologous Cells
    • Skin Substitutes: Allogeneic Cells
    • Indications
  • Bone Tissues
    • Clinical Orthopedics
    • Orthopedic Tissue-Basic Biology
    • Synthetic Bone Grafts
  • Cartilage Tissues
    • Articular Cartilage
    • Repairing Meniscus Cartilage
    • Hyaluronase Polymers (Synvisc®, Hyalgan®)
    • Advances in Cartilage Technology
    • Companies Involved in Cartilage Tissue Engineering
  • Circulatory—Heart Muscles, Veins
    • Heart Attacks
    • Vascular Arterial Damage
    • Stroke
    • Coronary Vascular Graft
    • Muscle Tissue Engineering for Cardiac Patch
    • Biomaterials for Mechanical Heart Valve Prostheses
  • Bladder and Urinary Tract
    • Controlling Urine Flow
    • Treatments
    • Tissue Engineered Bulking
    • Bladder Augmentation
    • Clinical Challenges in the Genitourinary System
  • Tissue Engineering—Diagnostic and Toxicology Applications
    • Toxicity Testing
    • Battlefield Threats
    • Tissue-Based Biosensors
  • Tissue Culture Systems
  • Liver
    • Liver Assist Devices
    • Current Liver Therapies
    • Research
    • Liver Research in Japan
  • Pancreas
    • Functional Genomics and Developmental Biology Platforms
    • Islet Cell Transplantation
    • Definitions
    • Potential Problems With the Bio-Artificial Pancreas
    • Islet Sheet
    • Use of Bioartificial Pancreas
  • Other Engineered Tissues—Oral Tissues
    • Soft Oral Tissue—Saliva Glands
    • Soft Tissue and Salivary Glands
    • Development of Artificial Salivary Glands
  • Other Engineered Tissues--Muscle
  • Other--Spinal Cord, Nerves
    • Areas of Research
    • Promoting Nervous System Regeneration
    • Scaffolds for Neural Tissue Engineering
    • Neural Stem Cell Regeneration

3. Products on the Market and in Clinical Development

  • Background
  • Products in Development
    • Skin—First Tissue Engineered Products
    • Tissue Engineered Cartilage Products
    • The First Tissue Engineered Organs
    • Tissue Information and the Material Interface
    • Products in the Pipeline or at the Bedside
  • Company Involvement in Product Research and Development
    • Bone/Soft Tissue Repair and Synthetic Bone Substitutes
    • Bone/Soft Tissue Repair Biologic Products, Allograft
    • Bone/Soft Tissue Repair Biologic Products, Chondrocyte Transplantation
    • Bone/Soft Tissue Repair, Growth Factors/Osteoinductives
    • Bone/Soft Tissue Repair, Bovine
    • Bone/Soft Tissue Repair Soft Tissue Repair/Replacement
    • Potential for Gene Therapy Products
    • Potential for Stem Cell Therapy Products
    • Bone Substitute Sources

4. Market Forecasts and Market Share

  • Tissue Engineering Industry
  • Tissue Engineering Demographics
  • Tissue Engineering Industry General Trends
    • Size of the Potential Engineered Tissue Market
    • Where Will the First Products Be?
    • Sales of FDA-Approved Tissue Engineering Products
  • Challenges Facing the Tissue Engineering Industry
    • Funding Alternatives
    • Challenges Due to Regulatory Issues
    • Staffing Issues Impacting Commercial Success
    • Education Issues Impacting Commercial Success
  • Market Estimates
    • Transplant Market
  • Market Trends
    • Too Many Companies Researching the Same Product Areas
  • Biotechnology Industry Overview
  • Market Opportunities: Autograft vs Allograft
  • Market Forecast—Skin
    • Wound Care
    • Burns, Skin—Acute Care
    • Ulcers, Skin—Chronic Care
  • Market Forecast—Cartilage
  • Market Forecast—Bone
  • Market Forecast—Cardiovascular
    • Tissue Engineered Small Diameter Blood Vessels
    • Stroke
  • Market Forecast—Liver Disease
  • Market Forecast—Diabetes
  • Market Forecast—Oral Mucosa
  • Market Forecast—Diagnostics and Toxicology Testing

5. International Tissue Engineering Activity


    1) Differences in Funding Sources
    2) Autologous vs. Allogeneic Cell Usage
    3) Cell Technology Advances in Europe and Japan
    4) Cross Disciplinary Environments—Linking Basic
    Biology and Materials Sciences
    5) Genomics and Informatics
    6) Novel Bioreactor Design—Europe Following U.S. Lead
  • International Markets and Activities
  • Europe
    • Selected German Tissue Engineering Organizations
    • Selected United Kingdom Tissue Engineering Organizations
    • Selected Swiss Tissue Engineering Organizations
    • Selected French Tissue Engineering Organizations
    • Selected Dutch Tissue Engineering Organizations
  • Japan

6. Overview of Tissue Engineering Companies and Organizations

  • Commercial Organizations
    • Trends in Company Activities
    • Advanced Tissue Sciences, Inc.
    • Anika Therapeutics, Inc.
    • Biora AB
    • BioTissue Technologies, AG.
    • Chondros, Inc.
    • Circe Biomedical, Inc.
    • Co.don AG
    • Collagenesis, Inc.
    • Curis, Inc.
    • Encelle, Inc.
    • ETEX, Corp.
    • Fibrogen, Inc.
    • GenSci Regeneration Sciences, Inc.
    • Genzyme Biosurgery, Inc.
    • Innogenetics, NV
    • Integra LifeSciences Corp.
    • IsoTis NV
    • Isto Technologies, Inc.
    • LifeCell Corporation
    • Modex Therapeutics, Ltd.
    • Organogenesis, Inc.
    • Ortec International, Inc.
    • Protein Polymer Technology, Inc.
    • Tutogen Medical, Inc.
  • Academic Organizations and Associations in Tissue Engineering
  • BioMedical Engineering Departments and Programs at U.S. and
  • Canadian Universities
  • Government Activities and Interests
    • Relationship to Agency Mission
    • Synergies
    • Funding
  • Federal Agency Activities
  • Other Companies, Enabling Technologies

7. Strategic Issues in Tissue Engineering

  • Competition
  • Skin Product Competitors
    • Bone
    • Liver: Hepatic Diseases, Liver Assist Devices
    • Cartilage
    • Pancreas
    • Enabling Technologies
  • Regulatory
    • Agencies
    • Guidelines
    • FDA Market Approvals
    • Cost of Additional Regulations
    • Tissue Regulation
    • Process for Drug and Biologics Approvals
    • Cellular-Based Products
    • Funding to Survive Clinical Trials
    • Regulatory Issues in Europe and Japan
  • Reimbursement
    • Reimbursement Issues
  • Emerging Technologies
    • Tissue Engineering Technology
    • Role of Academic Institutions
    • Key Strategies: Development of Product Platform Technologies
    • Key Factors in Future Development
    • Bioreactors
    • Cell Types Used in Tissue Engineering
    • Microscopy
    • Use of Tissue Engineered Products in Toxicology and Diagnostics
    • Tissue Engineering Technological Challenges
  • Standards Development
    • Standards Development in the U.S.
    • World-Wide Standards Development
    • Performance Standards
    • International Standards Activities
    • Standards for Biomaterials
  • Industry Social and Political Aspects
    • Tissue Engineering and Cloning
    • Private Sector Cloning
    • Xenotransplantation

8. Summary and Conclusions

  • Future of Tissue Engineering
  • Industry Opportunities
    • Wound Healing, Orthopedics
    • Vascularization
    • Bioreactors
    • Informatics and Tissue Engineering
    • Dental Markets
    • Marketing Opportunities: Acute (Allogeneic) vs.
    • Chronic (Autologous) Markets
  • Industry Challenges
    • Time to Market
    • Lack of Commercial Successes—Funding Issues
    • Need for Tissue Engineers
    • Academic Activities
    • Government Support
    • Technical Challenges
    • Regulatory Challenges
  • Tissue Engineering Trends
    • General Tissue Engineering Industry Trends
    • Trends in Biomaterials
    • International Trends
    • General Biotechnology Industry Trends
    • Healthcare Trends

Appendix: Tissue Engineering Websites and Links

List of Exhibits
Table 1-1: Components of Regenerative Medicine
Table 1-2: Tissue Engineered Medical Products
Table 2-1: Advantages and Disadvantages of Various Bone Therapies
Table 2-2: Comparison of Cartilage Therapies
Table 3-1: Tissue Engineering Products in the Pipeline or Currently Marketed
Table 3-2: Commercially Available Bone Substitutes For Orthopedic Reconstruction
Table 4-1: Growth of Tissue Engineering in the U.S.
Table 4-2: Tissue Engineering Statistics
Table 4-3: Type of Transplant
Table 4-4: Incidence of Organ and Tissue Deficiencies in the U.S. Indication, Procedures or Patients/Year
Table 4-5: Burns U.S. Annually
Table 4-6: Burns Worldwide Annually
Table 4-7: Chronic Skin Wound Care Market Estimates
Table 4-8: Cartilage Markets
Table 4-9: Bone Repair and Implant Markets
Table 4-10: Market Estimates, Vascular Arterial Damage
Table 4-11: Diabetics Prevalence, 1995
Table 4-12: Cases of Oral Mucosa Replacement Therapy
Table 5-1: Selected European, Japanese and Australian Organizations Involved in Tissue Engineering Research and Development
Table 5-2: Comparisons Among U.S., Japanese, and European Tissue Engineering Research and Development
Table 6-1: Biomedical Engineering Departments and Programs at U.S. and Canadian Universities
Table 6-2: Participating Mates Agencies
Table 6-3: NIST/ATP Extramural Awards in Tissue Engineering Competition, (1991-2000)
Table 6-4: NOST/ATP Awards in Tissue Engineering (1991 - 2000) - Extramural
Table 6-5: Atp Awards in Tissue Engineering (1991-2000)
Table 7-1: Skin Competitors
Table 7-2: Other Organizations With Skin Technologies or Capabilities of Developing Skin Products
Table 7-3: Competitive Activities in Bone Technology

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