New Developments in Biomaterials


Market Analysis

This report provides a detailed examination of the biomaterials marketplace. It highlights the fastest growing applications of biomaterials technology and gives a comprehensive overview of mature sectors in the industry.

New Developments in Biomaterials investigates the latest product developments in tissue engineering, orthopaedics, stroke management, cardiology, wound care, urology, neurosurgery, plastic surgery/dermatology and ophthalmology. Research into device coating technology, biocompatibility and biostability is also provided. Materials covered are:

The report also takes a strategic perspective examining how companies are taking advantage of growth opportunities in emerging disciplines. New Developments in Biomaterials concludes with a detailed investigation of the top 20 companies in each field.

This report will enable you to:

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PUBLISHED: OCTOBER 2000
PAGES: 150+
REF: CBS860E

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CONTENTS

Chapter 1 Biomaterials and their applications
Introduction
Biomaterials

Chapter 2 The global market for biomaterials and biomaterial-based products
Market overview
Market trends and opportunities
The total biomaterials market

Chapter 3 Biomaterials in research and development
R&D in biomaterial engineering
Biomaterial-based product R&D

Chapter 4 The US market for biomaterials
Market overview
Market opportunities and growth areas

Chapter 5 The Asian market for biomaterials
Market overview

Chapter 6 The European market for biomaterials
Market overview
Market opportunities and growth areas
UK biomaterials partnership

Chapter 7 Biomaterial companies
AcryMed Inc
Advanced Tissue Sciences, Inc
Aortech International plc
Angiotech Pharmaceuticals Inc
Bausch & Lomb
Baxter Healthcare
Biocompatibles Ltd
Biomatrix Inc
Biomet Inc
BIONX Implants Inc
CR Bard Inc
Creative BioMolecules Inc/Curis Inc
DePuy/Johnson & Johnson Inc
GenSci Regeneration Sciences Inc
Genzyme
Implant Sciences Corporation
Interpore Cross International
IsoTis
Organogenesis Inc
Orthovita

CONTENTS
LIST OF TABLES
LIST OF FIGURES
EXECUTIVE SUMMARY

ES.1 Scope and Methodology
ES.1.1 Background
ES.2 Objectives of the report
ES.3 Methodology
ES.4 Boundaries of the report
ES.5 Exchange Rates
GLOSSARY AND ABBREVIATIONS

CHAPTER 1 BIOMATERIALS AND THEIR APPLICATIONS
1.1 Introduction
1.1.1 Biomaterials: past and present
1.1.2 Functions and applications
1.2 Problems associated with biomaterials
1.3 Biomaterials
1.3.1 Collagen
1.3.1.1 Collagen enzymes
1.3.1.2 Gelatin
1.3.2 Composites
1.3.3 Glass
1.3.4 Heparin
1.3.5 Hyaluronic acid
1.3.6 Hydrocolloids
1.3.7 Hydrogels
1.3.8 Hydroxyapatite
1.3.9 Polymers
1.3.10 Synthetic and artificial tissues
1.3.11 Other
1.3.11.1 Bioadhesives
1.3.11.2 Drug delivery systems
1.3.11.3 Brachytherapy

CHAPTER 2 THE GLOBAL MARKET FOR BIOMATERIALS AND BIOMATERIAL-BASED PRODUCTS
2.1 Market overview
2.2 Market trends and opportunities
2.3 The total biomaterials market
2.3.1 The global markets for biomaterials and biomaterial-based products
2.3.2 The global biomaterials market
2.3.2.1 Collagen and gelatin
2.3.2.2 Hyaluronic Acid
2.3.2.3 Hydrocolloids and hydroactive gels
2.3.2.4 Polymers
2.3.3 The global biomaterial-based product market
2.3.3.1 Cardiovascular medicine
2.3.3.2 Cosmetic surgery
2.3.3.3 Dentistry and oral surgery
2.3.3.4 Drug delivery
2.3.3.5 Ophthalmology
2.3.3.6 Orthopaedics
2.3.3.7 Radiotherapy
2.3.3.8 Soft tissue implants
2.3.3.9 Surgical
2.3.3.10 Tissue engineering
2.3.3.11 Urology
2.3.3.12 Wound care

CHAPTER 3 BIOMATERIALS IN RESEARCH & DEVELOPMENT
3.1 Introduction
3.2 R&D in biomaterial engineering
3.2.1 Collagen and gelatin
3.2.1.1 FibroGen (US)
3.2.1.2 Tissue Science Laboratories (UK) and Dundee University (UK)
3.2.2 Hyaluronic acid
3.2.2.1 Biomatrix Inc (US)
3.2.2.3 LifeCore (US)
3.2.3 New biomaterials
3.2.3.1 Davitech (US)
3.2.3.2 Semorex Inc (US), Hebrew University School of Pharmacy of Jerusalem (Israel) and Heinrich Heine University, Dusseldorf (Germany)
3.2.3.3 Seoul National University and Ewha Womans University (Korea)
3.2.3.4 North Carolina State University (US)
3.2.3.5 University of Texas (US)
3.2.4 Medical Device Coating Technology
3.2.4.1 Angiotech Pharmaceuticals (Canada)
3.2.4.2 Biocompatibles (UK)
3.2.4.3 BTG (UK)
3.2.4.4 Desmos (US), Baxter (US) and Guidant (US)
3.2.4.5 Focal (US)
3.2.4.6 Hydromer (US) and Symbiotech Medical (Canada)
3.2.4.7 Implant Sciences (US)
3.2.4.8 Implemed (US)
3.2.4.9 IsoTis (The Netherlands)
3.2.4.10 Lawrence Berkeley National Laboratory (US) and University of California (US)
3.2.4.11 PolyBioMed (UK)
3.2.4.12 Smith & Nephew (UK)
3.2.4.13 Spire Biomedical (US)
3.2.4.14 STS BioPolymer (US)
3.2.4.15 University of Bradford (UK)
3.2.4.16 University of Munich (Germany)
3.2.4.17 Engineered Biomaterials Center, University of Washington (US)
3.3 Biomaterial-based product R&D
3.3.1 Recent developments
3.3.2 Opportunities for new biomaterial-based products
3.3.3 Biomaterial-based therapeutics: cardiovascular
3.3.3.1 Aortech (UK)
3.3.3.2 Baxter Healthcare (US)
3.3.3.3 CardioTech International (US)
3.3.3.4 MedNova (US)
3.3.3.5 Shiga Medical Centre (Japan)
3.3.3.6 St Jude Medical (US)
3.3.3.7 Thoratec Laboratories (Canada)
3.3.3.8 Thoraxcenter, University of Rotterdam (the Netherlands)
3.3.4 Biomaterial-based therapeutics: cosmetic
3.3.4.1 Protein Polymer Technologies Inc (US)
3.3.5 Biomaterial-based therapeutics: dental
3.3.5.1 Abmin Technologies (US)
3.3.5.2 Atrix Laboratories (US)
3.3.6 Biomaterial-based therapeutics: drug delivery
3.3.6.1 ALZA (US)
3.3.6.2 Alkermes (US)
3.3.6.3 Bausch & Lomb (US)
3.3.6.4 Biocompatibles (UK)
3.3.6.5 Guilford Pharmaceuticals (US)
3.3.6.6 Inex (US)
3.3.6.7 Drug delivery and hydroxyapatite
3.3.6.8 Drug delivery and polymers
3.3.7 Biomaterial-based therapeutics: ophthalmology
3.3.7.1 Anamed (US)
3.3.7.2 Instituto Oftamologico de Alicante (Spain)
3.3.7.3 KeraVision (US)
3.3.7.4 Queen's Medical Centre, Nottingham (UK)
3.3.7.5 Staar Surgical (US)
3.3.8 Biomaterial-based therapeutics: orthopaedics
3.3.8.1 Corin Medical (UK)
3.3.8.2 IsoTis (the Netherlands)
3.3.8.3 OrthoLogic (US)
3.3.8.4 ReGen Biologics (US)
3.3.8.5 Smith & Nephew (UK)
3.3.8.6 Spine Solutions (US)
3.3.8.7 Bioactive Glass
3.3.8.8 Composites
3.3.8.9 Hyaluronic acid
3.3.8.10 Hydrogels
3.3.8.11 Hydroxyapatite
3.3.8.12 Polymers
3.3.9 Biomaterial-based radiotherapeutics
3.3.9.1 Acusphere (US)
3.3.9.2 Boston Scientific (US)
3.3.9.3 Implant Sciences (US)
3.3.9.4 Johnson & Johnson/Cordis and Best Medical (US)
3.3.9.5 Novoste (US)
3.3.9.6 Syncor International Corporation (US)
3.3.10 Biomaterial-based therapeutics: surgical
3.3.10.1 Haemostats
3.3.10.2 Bioadhesives and sealants
3.3.10.3 Anti-adhesion products
3.3.11 Microtechnology and bionic engineering
3.3.11.1 IBM Research (US) and Institute of Basle (Switzerland)
3.3.11.2 University of Southern California (US)
3.3.11.3 Tissue engineering and bionic devices
3.3.12 Biomaterials and tissue engineering
3.3.12.1 Advanced Tissue Sciences (US)
3.3.12.2 Baylor College of Medicine, Houston (US)
3.3.12.3 BioSphere Medical Inc (US)
3.3.12.4 Boston Children's Hospital and Harvard Medical School (US)
3.3.12.5 California Institute of Technology (US)
3.3.12.6 Duke University (US)
3.3.12.7 Emory University, Georgia (US)
3.3.12.8 Encelle (US)
3.3.12.9 Reprogenesis (US)
3.3.12.10 University of Connecticut (US)
3.3.12.11 OrthoLogic (US)
3.3.12.12 Tissue engineering and orthopaedics
3.3.12.13 Opportunities for tissue-engineering orthopaedic products
3.3.12.14 Organ engineering
3.3.12.15 Skin substitutes
3.3.13 Biomaterial-based therapeutics: urology
3.3.13.1 Advanced Uroscience (US)
3.3.13.2 Protein Polymer Technologies Inc (US)
3.3.13.3 Reprogenesis (US)
3.3.13.4 Uroplasty Inc (US)
3.3.13.5 Urosurge (US)
3.3.14 Biomaterial-based therapeutics: wound care
3.3.14.1 AcryMed (US)
3.3.14.2 Carrington Laboratories (US)
3.3.14.3 Electrosols Ltd (UK)
3.3.14.4 FibroGen Inc (US)
3.3.14.5 IsoTis (the Netherlands)
3.3.14.6 Protein Polymer Technologies Inc (US)

CHAPTER 4 THE US MARKET FOR BIOMATERIALS
4.1 Market overview
4.2 Market opportunities and growth areas
4.2.1 Collagen, hyaluronic acid and polymers
4.2.2 Soft tissue implants
4.2.3 Tissue engineering
4.2.3.1 Artificial skin
4.2.4 Arterial puncture site closure
4.3 Market outlook
4.3.1 Imports and exports of medical devices
4.3.1.1 Leading manufacturers
4.4 Company activities
4.4.1 Edwards LifeSciences Corporation
4.4.2 Wright Medical (US) and Cremascoli Ortho (Italy and France)
4.4.3 Health Industry Manufacturers' Association, the US Government and Japan

CHAPTER 5 THE ASIAN MARKET FOR BIOMATERIALS
5.1 Market overview
5.2 Market territories
5.2.1 Japan
5.2.1.1 Market outlook
5.2.1.2 Leading manufacturers
5.2.2 Australia
5.2.2.1 Market outlook
5.2.2.2 Leading manufacturers
5.2.3 South Korea
5.2.4 Taiwan
5.2.5 China
5.3 Company activities
5.3.1 CardioTech International (US)
5.3.2 USBiomaterials (US)

CHAPTER 6 THE EUROPEAN MARKET FOR BIOMATERIALS
6.1 Market overview
6.1.1 New technology assessments - a barrier to market entry?
6.2 Market opportunities
6.3 Market territories
6.3.1 France
6.3.1.1 Market outlook
6.3.1.2 Leading manufacturers
6.3.2 Germany
6.3.2.1 Market outlook
6.3.2.2 Leading manufacturers
6.3.3 Italy
6.3.3.1 Market outlook
6.3.3.2 Leading manufacturers
6.3.4 Spain
6.3.4.1 Market outlook
6.3.4.2 Leading manufacturers
6.3.5 United Kingdom
6.3.5.1 Market outlook
6.3.5.2 Market opportunities
6.3.5.3 Leading manufacturers
6.3.5.4 UK Biomaterials Partnership
6.3.5.5 National Institute for Clinical Excellence

CHAPTER 7 BIOMATERIAL COMPANIES
7.1 AcryMed Inc
7.1.1 Company overview
7.1.2 Product portfolio
7.1.3 Company activities
7.2 Advanced Tissue Sciences Inc
7.2.1 Company overview
7.2.2 Product portfolio
7.2.3 Company activities
7.2.3.1 R&D
7.2.3.2 Joint ventures
7.2.4 Company finances
7.2.4.1 R&D Expenditure
7.3 Aortech International Plc
7.3.1 Company overview
7.3.2 Product portfolio
7.3.3 Company activities
7.3.3.1 R&D
7.3.3.2 Joint ventures
7.3.4 Company finances
7.4 Angiotech Pharmaceuticals Inc
7.4.1 Company overview
7.4.2 Product portfolio
7.4.2.1 R&D
7.4.2.2 Joint ventures
7.4.3 Company finances
7.5 Bausch & Lomb
7.5.1 Company overview
7.5.2 Product portfolio
7.5.2.1 Vision care
7.5.2.2 Surgical
7.5.2.3 Pharmaceuticals
7.5.3 Company activities
7.5.3.1 R&D
7.5.4 Company finances
7.6 Baxter Healthcare
7.6.1 Company overview
7.6.2 Product portfolio
7.6.2.1 Blood division
7.6.2.2 Renal division
7.6.2.3 Intravenous products
7.6.3 Company activities
7.6.3.1 R&D
7.6.4 Company finances
7.7 Biocompatibles Ltd
7.7.1 Company overview
7.7.2 Product portfolio
7.7.3 Company activities
7.7.3.1 R&D
7.7.3.2 Joint ventures and acquisitions
7.7.4 Company finances
7.8 Biomatrix Inc
7.8.1 Company overview
7.8.2 Product portfolio
7.8.3 Company activities
7.8.3.1 R&D
7.8.4 Company finances
7.9 Biomet
7.9.1 Company overview
7.9.2 Product portfolio
7.9.3 Company activities
7.9.3.1 R&D
7.9.3.2 Joint ventures
7.9.4 Company finances
7.10 Bionx Implants Inc
7.10.1 Company overview
7.10.2 Product portfolio
7.10.3 Company activities
7.10.3.1 R&D
7.10.3.2 Joint ventures
7.10.4 Company finances
7.11 CR Bard Inc
7.11.1 Company overview
7.11.2 Product portfolio
7.11.2.1 Vascular products
7.11.2.2 Urology products
7.11.2.3 Oncology products
7.11.2.4 Surgical products
7.11.3 Company activities
7.11.3.1 R&D
7.11.3.2 Joint ventures
7.11.4 Company finances
7.12 Creative BioMolecules Inc/Curis Inc
7.12.1 Company overview
7.12.2 Product portfolio
7.12.2.1 R&D
7.12.3 Company activities
7.12.3.1 Joint ventures
7.12.4 Company finances
7.13 DePuy/Johnson & Johnson Inc
7.13.1 Company overview
7.13.2 Product portfolio
7.13.2.1 DePuy Orthopaedics
7.13.2.2 DePuy ACE Medical
7.13.2.3 DePuy OrthoTech Inc
7.13.2.4 DePuy AcroMed Inc
7.13.2.5 DePuy CMW
7.13.3 Company finances
7.14 GenSci Regeneration Sciences Inc
7.14.1 Company overview
7.14.2 Product portfolio
7.14.3 Company activities
7.14.3.1 R&D
7.14.3.2 Joint ventures
7.14.4 Company finances
7.15 Genzyme
7.15.1 Company overview
7.15.2 Product portfolio
7.15.2.1 Hyaluronic acid
7.15.2.2 Wound care
7.15.3 Company activities
7.15.3.1 R&D
7.15.4 Company finances
7.16 Implant Sciences Corporation
7.16.1 Company overview
7.16.2 Product portfolio
7.16.2.1 Ion implantation
7.16.2.2 Thin film coatings
7.16.2.3 Ion beam texturing
7.16.3 Company activities
7.16.3.1 R&D
7.16.3.2 Joint ventures
7.16.4 Company finances
7.17 Interpore Cross International
7.17.1 Company overview
7.17.2 Product portfolio
7.17.2.1 Pro Osteon
7.17.2.2 Autologous Growth Factors
7.17.2.3 Synergy Spinal System
7.17.3 Company activities
7.17.3.1 R&D
7.17.4 Company finances
7.18 IsoTis
7.18.1 Company overview
7.18.2 Product portfolio
7.18.2.1 R&D
7.18.2.2 Joint ventures
7.19 Organogenesis Inc
7.19.1 Company overview
7.19.2 Product Portfolio
7.19.3 Company activities
7.19.3.1 R&D
7.19.3.2 Joint ventures
7.19.4 Company finances
7.20 Orthovita
7.20.1 Company overview
7.20.2 Product portfolio
7.20.2.1 R&D
7.20.3 Company activities
7.20.3.1 Business Development
7.20.3.2 Joint ventures
7.20.4 Company finances

REFERENCES

LIST OF TABLES
Table 1.1 Basic properties of biomaterials
Table 1.2 Applications of biomaterials by medical discipline
Table 1.3 Current applications of collagen
Table 1.4 Advanced uses for collagen
Table 1.5 Applications of HA
Table 1.6 Advantages and disadvantages of hydrocolloids
Table 1.7 Applications for hydrogels
Table 1.8 Applications of biopolymers
Table 1.9 Clinical applications for bioadhesives and surgical sealants
Table 2.1 Global market for biomaterial-based products by application, 1999-2003 ($ million)
Table 2.2 Global biomaterial-based products market by territory, 1999-2003 ($ million)
Table 2.3 Global cardiovascular biomaterial-based product market by application, 1999-2003 ($ millions)
Table 2.4 Global cardiovascular biomaterial-based product market by territory, 1999-2003 ($ million)
Table 2.5 Global cosmetic surgery biomaterials-based product market by territory, 1999-2003 ($ millions)
Table 2.6 Global dental implant biomaterial-based product market by territory, 1999-2003 ($ million)
Table 2.7 Global market for injection depots, implants and other drug delivery biomaterial-based products by territory, 1999-2003 ($ million)
Table 2.8 Global ophthalmological biomaterial-based product market by application, 1999-2003 ($ millions)
Table 2.9 Global market for ophthalmic biomaterial-based products by territory, 1999-2003 ($ million)
Table 2.10 Value of orthopaedics biomaterial-based market, 1999-2003 ($ billion)
Table 2.11 Global orthopaedic biomaterial-based market by application, 1999-2003 ($ million)
Table 2.12 Global orthopaedic biomaterial-based market share by application, 1999-2003 (% share)
Table 2.13 Global orthopaedics biomaterial-based market by territory, 1999
Table 2.14 Global market for orthopaedic biomaterial-based products, by territory, 1999-2003 ($ millions)
Table 2.15 Global market share of artificial skin biomaterial-based substitutes by territory, 1999-2003 ($ million)
Table 2.16 Global market for urological biomaterial-based STI*, 1999-2003 ($ million)
Table 2.17 Global market for wound care biomaterial-based market by territory, 1999-2003 ($ million)
Table 2.18 Global market for wound care biomaterials-based products, 1999-2003 ($ million)
Table 3.1 Biomaterial-based R&D activities of major biotechnology companies, 2000
Table 3.2 Potential product opportunities using biomaterials, 2000
Table 4.1 Estimated US biomaterial-based market by application, 1999-2003 ($ million)
Table 4.2 Estimated US biomaterial-based market share by application, 2000 and 2003 (%)
Table 4.3 Leading biomaterial-based medical device manufacturers in the US, 2000
Table 5.1 Estimated Japanese biomaterial-based market by application, 1999-2003 ($ million)
Table 5.2 Estimated Japanese biomaterial-based market share by application, 2000 and 2003 (%)
Table 5.3 Leading biomaterial-based medical device manufacturers in Japan, 2000
Table 5.4 Leading domestic biomaterial-based medical device manufacturers in Australia, 2000
Table 6.1 Estimated European biomaterial-based market by application, 1999-2003 ($ million)
Table 6.2 Estimated European biomaterial-based market share by medical application, 2000 and 2003 (%)
Table 6.3 Leading biomaterial medical device manufacturers in France, 2000
Table 6.4 Leading biomaterial medical device manufacturers in Germany, 2000
Table 6.5 Leading biomaterial medical device manufacturers in Italy, 2000
Table 6.6 Leading domestic biomaterial medical device manufacturers in Spain, 2000
Table 6.7 Leading biomaterial medical device manufacturers in the UK, 2000
Table 7.1 Advanced Tissue Sciences' financial figures, 1997-1999 ($ million)
Table 7.2 Advanced Tissue Sciences' R&D expenditure, 1995-1998 ($ million)
Table 7.3 Aortech's financial figures, 1999 and 2000 (� million)
Table 7.4 Angiotech's financial figures, 1997-1999 ($ million)
Table 7.5 Bausch & Lomb's financial figures, 1997-1999 ($ million)
Table 7.6 Baxter's financial figures, 1997-1999 ($ million)
Table 7.7 Biocompatibles' financial figures, 1998 and 1999 (¥ million)
Table 7.8 Biomatrix's financial figures, 1997-1999 ($ million)
Table 7.9 Biomet's financial figures, 1997-1999 ($ million)
Table 7.10 Bionx Implants' financial figures, 1998 and 1999 ($ million)
Table 7.11 CR Bard's financial figures, 1997-1999 ($ million)
Table 7.12 Creative BioMolecule's financial figures, 1996-1998 ($ million)
Table 7.13 Johnson & Johnson's financial figures, 1997-1999 ($ million)
Table 7.14 GenSci Regeneration Sciences' financial figures, 1997-1998 (Can$ millions)
Table 7.15 Genzyme's financial figures, 1996-1999 ($ million)
Table 7.16 Implant Science's financial figures, 1998-1999 ($ million)
Table 7.17 Interpore Cross' financial figures, 1997-1999 ($ million)
Table 7.18 Organogenesis' financial figures, 1997-1999 ($ million)
Table 7.19 Orthovita's financial figures, 1997-1999 ($ thousand)

LIST OF FIGURES
Figure 2.1 Estimated global market share for the biomaterials market, 2000
Figure 2.2 Estimated global biomaterial-based product market by territory, 2000
Figure 2.3 Estimated global market share for cardiovascular biomaterial-based products, 2000
Figure 2.4 Global market share of cosmetic surgery biomaterial-based products, 1999
Figure 2.5 Estimated global market share of dental implant biomaterial-based products by territory, 2000
Figure 2.6 Estimated market share of dental implant biomaterial-based products by US company, 2000
Figure 2.7 Global market share of drug delivery biomaterial-based products by territory, 2000
Figure 2.8 Estimated market size for biomaterials-based drug delivery products by application, 2000
Figure 2.9 Global market share for ophthalmological biomaterial-based products by territory, 2000
Figure 2.10 Estimated global share for orthopaedics biomaterial-based market by territory, 2000
Figure 2.11 Estimated global market share of artificial skin biomaterial-based substitutes, 2000
Figure 2.12 Global incidence of fibrotic lesions, 1999
Figure 2.13 Global market share for urological biomaterial-based products by territory, 2000
Figure 2.14 Global incidence of chronic ulcers, 1999
Figure 2.15 Global estimation of biomaterial-based components used in wound care products, 2000
Figure 2.16 Market share of wound care biomaterial-based products by territory, 1999
Figure 2.17 Estimates of low-technology wound care products within the total wound care market, 2001
Figure 2.18 Predicted growth rates for synthetic wound care dressings, 2002
Figure 4.1 Estimated US biomaterial-based market share by application, 2000 (%)
Figure 5.1 Estimated European biomaterial-based market share by application, 2000 (%)
Figure 5.2 Leading cardiovascular intervention product manufacturers in Japan
Figure 6.1 Estimated European biomaterial-based market share by application, 2000 (%)

EXECUTIVE SUMMARY
The biomaterials landscape is flourishing, and the market is poised to dramatically impact the global healthcare markets over the next decade, as the seeds of technological innovation bear their fruits over the next 5-10 years by way of novel therapeutics. Recently, progress in medical and scientific research has been astounding; in particular, the elucidation of the human genome brings hope to the many sufferers of incapacitating diseases or terminal illnesses, and potentially catapults modern medicine to new stratospheric levels of miracle working through gene therapy. However, the application of knowledge from the genome project to eradicate disease and cure all ills is a long way off. Until that milestone arrives, biotherapeutic devices have a hugely important role in pushing back the frontiers of medical science, and supplying doctors and surgeons with a continuous supply of sophisticated, bioreactive and biocompatible tools with which to repair and rebuild the human body.

The biomaterials field is a dynamic and exciting domain and is based on the convergence of many disciplines. Creating biomaterials is no simple feat and involves the complex process of combining the many principles of materials science, bioengineering, molecular biology, genetics and human biochemistry. The application of knowledge from these distinct fields has led to the emergence of new biomaterial-based technologies, allowing scientists the potential to: for example, recreate new organs and tissues; to implant radioactive materials to destroy cancer tissues; to deliver drugs inside the body in a controlled and localised manner; create artificial blood and skin; and finally, to aspire to the creation of bionic limbs - integrating body tissue with robotic technology. Biomaterials are enabling these goals to be achieved, and what was once realised as fantastical science fiction in medical science is fast becoming a reality as science fact.

Biotechnology and biomaterial companies, mainly concentrated in the USA and Europe, are the champions of a new 'Biomaterials Age'. Decades of R&D and millions of dollars of capital investment are being rewarded by the advent of innovative biomaterial-containing devices that have created a high growth market, valued in excess of $40 billion, within the estimated total medical devices industry, valued at over $150 billion. Product innovation, driven by longer life expectancy with its consequential increased risk of organ failure and bone/tissue defects in later years of life and patent expiry of key drugs over the next 5 years, has already impacted on the bioscience industry, resulting in multi-million dollar strategic collaborations between pharmaceutical and biotechnology companies to bring new products to market.

Collective R&D pipeline biomaterial devices are numerous, this report alone provides a snapshot of over 100 global R&D activities that might result in thousands of commercial medical and surgical products. This decade will be an exciting time for the medical products industry, and the wave of innovative therapeutics likely to hit the market over the next 5-10 years will undoubtedly create new markets, new trends in healthcare, and impact on medical and surgical practices worldwide.

Current applications for biomaterials are immense. They are used in almost all medical and surgical disciplines as, for example, fixation devices or bone defect implants in orthopaedics, as collagen-based augmentation products used in reconstructive surgery, as healing hydrogels in wound care, or as polymer matrices for tissue engineering. Key product areas include cardiovascular medicine, orthopaedics, drug delivery, cosmetic and reconstructive surgery, general surgery, wound care, ophthalmology, urology and tissue engineering.

This report discusses all of these product sectors relative to the global biomaterials market. It aims to inform and up-date the reader on the status of the global biomaterial industry by discussing innovative research, market values, market divisions and emerging opportunities and strategies, in addition to product pipelines and alliances within the industry. It also forecasts values for subsectors of the market to 2003 and predicts growth rates for many therapeutic areas.

The Scope and Methodology (Section ES.1) introduces the reader to the background of biomaterials and explains the objectives and boundaries of this report.

In Chapter 1, a general overview of biomaterials is given, covering history, composition, functionality and application to medicine. Also discussed are the limitations of biomaterials and the challenges that scientists face in creating the perfect biocompatible material. This chapter includes descriptions of collagen and gelatin, composites, bioactive glasses, heparin, hyaluronic acid, hydrocolloids and hydrogels, hydroxyapatite, polymers, drug delivery systems and radiotherapeutic implants.

The global biomaterial and biomaterial-based product markets are discussed in Chapter 2. The chapter distinguishes between a biomaterial-only product market (eg collagen, gelatin, hydrogel) and a product market where the biomaterial (a coating or matrix for example) is an essential component of a medical device (eg cardiac catheter, drug delivery implant). The chapter also identifies global market trends, market sizes, opportunities for therapeutic areas, growth strategies, and subsector divisions that are high growth areas. High revenue, key product areas are shown and include cardiovascular medicine, orthopaedics, drug delivery, and wound care. Emerging markets are also discussed and include urology, ophthalmology, and subsectors such as spinal injury in orthopaedics, and varicose veins in cardiovascular medicine. Geographical segmentation of the markets are shown in Chapters 4-6, which highlight the US, Asian and European markets, respectively.

There are many biomaterial R&D programmes in progress. Chapter 3 attempts to highlight the diversity of research themes in over 100 research institutions worldwide. Bioengineering is documented in addition to biomaterial-containing medical device initiatives. The chapter also offers an insight into research trends, product and market opportunities, and recent developments that may change the course of product development. Proprietary technologies are also highlighted to show the basis of product range possibilities. Data is also presented from the 4th Annual Biomaterials of the Future Conference held in San Francisco, US, 26-27 June 2000, to show up-to date industry research, technology, and close-to-market product development.

Chapter 7 lists 20 key companies that are active in the biomaterials domain. They represent a mix of biotechnology, biopharmaceutical, medical device, and tissue engineering companies that have a strong R&D focus and pipeline product range. It also provides a snapshot of the diversity and size of the individual company, its products, corporate activities, and financial situation within the whole biotechnology industry.

ES.1 Scope and Methodology
ES.1.1 Background

'Biomaterials' is a broad term that encompasses a wide variety of disciplines, such as materials science, bioengineering, and molecular biology. The science of biomaterials involves creating substances, such as organic tissue, synthetic material, or engineered tissue substitutes, that perform anatomical functions or facilitate normal physiological functions within the human body at sites of damage or disease.

Biomaterials are evolving and advancing in parallel with high-technology, and as such, the industry has observed several trends. In particular, biomaterials are moving away from the older, metal-based, inert, implantable devices towards bioactive, responsive, resorbable plastics and synthetic materials, which are more structurally and functionally advanced than their previous counterparts. Microsystems and nanotechnology are also entering the field to add further sophistication to these materials - 'biochips' or biological microsensors have a huge potential in diagnostics and monitoring.

Other trends are noted in the use of animal-derived tissue (xenotransplantation) and bioactive molecules such as growth factors, which have a role in wound care and drug delivery. Another growing trend is in tissue engineering technology, where there is an increased use of skin, tissue sealants and bioadhesives for surgical applications. Finally, most, if not all, newer technologies are shifting toward using resorbable materials with profound healing properties.

Biomaterials is a growing industry. Market drivers include: demand for biocompatible therapeutics for an ageing population; innovation; demand for cost-effective medical and surgical products; and commercial gains for investment firms, to name but a few. Leaders in the industry have realised the importance of their work and new societies and organisations have sprung up over the past few years in an attempt to promote the industry by encouraging cooperative research, education, clinical applications and the introduction of professional standards in the field. Organisations such as the European Biomaterials Network, the UK Tissue and Cell Engineering Society, the US Biomaterials Society and the website www.biomateria.com, have all contributed in the campaign to create awareness for the industry.

The future for biomaterials looks very optimistic. Millions of dollars of investment capital are continuously ploughed into R&D, and biotechnology companies are flourishing under such conditions. The industry has also witnessed the emergence of numerous start-ups worldwide specialising in the discovery of small-molecule drugs, gene therapy, cell therapy, tissue replacement, drug delivery, diagnostics, and other markets. These companies and the larger multinationals will no doubt associate in the form of strategic alliances, partnerships, and licensing agreements - sustaining market leadership will be crucial for continued growth in competitive environments.

ES.2 Objectives of the report
The objectives of this report are to give a broad but comprehensive account of the global biomaterials industry including the markets, R&D programmes, and leading innovative companies. The report also aims to provide an account of the biomaterial and its application to medical and surgical practices, and reveals their important role in medicine in the 21st century. The report is an update to the previous Clinica Report, The World Market for Advanced Biomaterial-Based Products, published in 1996 (CBS 565).

ES.3 Methodology
The contents of this report have been compiled with the assistance of:

ES.4 Boundaries of the report
The report discusses the biomaterials industry in relation to: its application to global medical and surgical product markets; R&D programmes of selected institutions and organisations; and widely publicised commercial activities of companies operating in the field.

Owing to time limitations for data analysis, all figures, except for company financial data taken from annual reports, are estimated either from trend information or are pooled data taken from other sources. The nature of the biomaterial-based product market prevents accurate assessments of each market division and the elucidation of subsectors further complicates this task. The author has relied on statistical averages based on trend data to quantify markets where true data is missing, of limited meaning, or is misleading. All data used to forecast values are, where possible, the most recently available from publicly available industry information. The author acknowledges that some figures presented in this report may be grossly underestimated or grossly overestimated based on lack of consistent market analyst estimates for this field. Readers should therefore view these figures as estimations only and not as accurate, actual market figures.

All other information presented in this report, excluding data analysis related information, was taken from sources during the preparation of this manuscript and is believed to be accurate at the time of publication.

ES.5 Exchange Rates
The following rates are used for currency conversions to the US dollar (Financial Times, 18 July 2000).

© PJB Publications Ltd. 2001
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