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Published by: BCC Research
Published: Jul. 1, 2003 - 206 Pages
Table of Contents
Introduction
Objectives And Goals Of Study
Contribution Of The Study And For Whom
Study Scope And Format
Methodology
Information Sources
Related Bcc Work Credentials Including Work Done By Other Authors
Analyst Credentials
Bcc On-Line Services
Internet
Summary
Summary Table:
The U.S. Market For Regenerative Medicine Products Used In Bone And Joint Applications, Through 2007 ($ Millions)
Summary Figure:
The U.S. Market For Regenerative Medicine Products Used In Bone And Joint Applications, 2001, 2002 And 2007 ($ Millions)
Overview
The Growing Market For Regenerative Medicine
What Is Regenerative Medicine?
Biology-Based Medicine
Approaches Used In Regenerative Medicine
Human Substances
Cells And Tissues
Tissue Engineering
The Importance Of Scaffolding In Tissue Engineering
Blood Vessel Scaffolding
Massachusetts General/Mit
Duke University
Advanced Tissue Sciences
Embryonic Stem Cells
Therapeutic Cloning
Adult Stem Cells-Just As Good As Embryonic Stem Cells
Genzyme
University Of Minnesota
Marketers Of Adult Stem Cells
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
Food And Drug Administration Halts Gene Therapy Trials
The Use Of Bioreactors In Regenerative Medicine
The Impact Of Genomics
Other Areas Of Progress In Regenerative Medicine
Cardiovascular Technologies
Angiogenesis
Use Of Angiogenesis In The Treatment Of Heart Disease
Cardiac Cell Therapy
The Myocardial Patch
Neurological Technologies
Neurotransplantation In Stroke Patients
Embryonic Cell Transplant Therapy For Patients With Spinal Cord Injury
Use Of Bone Morphogenic Proteins In The Treatment Of Traumatic Spinal Cord Injury
Skin Technologies
Skin Technologies (Continued)
Applications To Bone And Joint Diseases And Disorders
Major Diseases And Conditions Affecting Bones
Osteoporosis
Currently Available Products To Treat Osteoporosis
Bisphosphonates
Fosamax
Hormones
Evista
Forteo
Miacalcin
The Market For Products To Treat Osteoporosis
Table 1 The Worldwide Market For Drugs To Treat Osteoporosis, Through 2007 ($ Millions)
Paget's Disease
Currently Available Drugs To Treat Paget's Disease
Actonel
Aredia
Skelid
The Market For Products To Treat Paget's Disease
Table 2 The Worldwide Market For Drugs To Treat Paget's Disease, Through 2007 ($ Millions)
Injuries And Degenerative Conditions
Hip Fractures
Table 3 Hip Fracture Volumes, Worldwide, Through 2007
Table 4 Hip Fracture Volumes, U.S., Through 2007
Traditional Treatments For Bone And Joint Disorders
Figure 1 The U.S. Musculoskeletal Products Market, 2002
Figure 2 The U.S. Reconstructive Device Market, 2002
Market Leaders
Joint Replacement Surgery
Table 5 Hip Replacement Procedure Volumes, U.S., Through 2007
Figure 3 Hip Replacement Procedure Volumes, U.S., 2001, 2002 And 2007
Table 6 Hip Replacement Procedure Volumes In Six States, 2001
Table 7 The Hip Replacement Market, Worldwide, Through 2007 ($ Millions)
Table 8 The Hip Replacement Market, U.S., Through 2007 ($ Millions)
Knee Replacements
Table 9 Knee Replacement Procedure Volumes, Worldwide, Through 2007
Table 10 Knee Replacement Procedure Volumes, U.S., Through 2007
Figure 4 Knee Replacement Procedure Volumes, U.S., 2001, 2002 And 2007
Table 11 The Knee Replacement Market, Worldwide, Through 2007 ($ Millions)
Table 12 The Knee Replacement Market, U.S., Through 2007 ($ Millions)
Table 13 The Market For Unicondylar Knee Replacement, U.S., Through 2007 ($ Millions)
Spinal Fusion
Indications For Spinal Fusion
The Spinal Fusion Procedure
The Spinal Fusion Procedure (Continued)
Spinal Fusion Procedure Volumes
Table 14 Spinal Fusion Procedure Volumes, Worldwide, Through 2007
Table 15 Spinal Fusion Procedure Volumes, U.S., Through 2007
Figure 5 Spinal Fusion Procedure Volumes, U.S., Through 2007
Table 16 Lumbar Spinal Fusion Procedure Volumes, U.S., Through 2007
Table 17 Posterior Lumbar Spinal Fusion Procedure Volumes, U.S., Through 2007
Table 18 Cervical Spinal Fusion Procedure Volumes, U.S., Through 2007
The Market For Spinal Fusion Products
Figure 6 The U.S. Spinal Products Market, 2002
Table 19 The Market For Interbody Fusion Device Implantation Procedures, Worldwide, Through 2007 ($ Millions)
Table 20 Interbody Fusion Device Implantation Procedure Volumes, U.S., Through 2007
Total Bone Replacement
Limb Lengthening
Limb Lengthening (Continued)
Diseases Affecting Joints
Osteoarthritis
Osteoarthritis (Continued)
Glucosamine And Chondroitin For The Treatment Of Osteoarthritis
Rheumatoid Arthritis
Table 21 Prevalence Of Rheumatoid Arthritis, U.S., Through 2007
Currently Available Drugs To Treat Rheumatoid Arthritis
Nonsteroidal Anti-Inflammatory Drugs
Cox-2 Inhibitors
Disease-Modifying Antirheumatic Drugs
Biological Response Modifiers To Treat Rheumatoid Arthritis
Enbrel
Kineret (Anakinra)
Antibody-Based Drugs To Treat Rheumatoid Arthritis
Humira
Remicade
Downside Of Currently Marketed Antibody Drugs
Antibody Drugs In Development To Treat Rheumatoid Arthritis
Table 22 Therapeutic Antibody Products In Phase Ii Or Later Development For The Treatment Of Rheumatoid Arthritis
Table 22 (Continued)
The Market For Dmards
Table 23 The Market For Disease-Modifying Anti-Arthritic Drugs To Treat Rheumatoid Arthritis, Worldwide, Through 2007 ($ Millions)
Figure 7 The Market For Disease-Modifying Anti-Arthritic Drugs To Treat Rheumatoid Arthritis, Worldwide, 2001, 2002 And 2007 ($ Millions)
Immunosuppressants
Drugs In Development To Treat Rheumatoid Arthritis
Table 24 Number Of 2003 Trials Of Drugs To Treat Rheumatoid Arthritis By Mechanism Of Action
Products And Technologies
Regenerative Technologies
Gene- And Protein-Based Approaches
Antibodies
The Importance Of Antibody Drugs
Advantages Of Monoclonal Antibody Drugs
Growth Factors
Cells And Tissues
Tissue Engineering
Artificial Skin
Cartilage
Other Products
The Creation Of Entire Organs
Embryonic Stem Cells
Novel Materials/Biomaterials
Regenerative Products To Treat Bone Diseases
Osteobiologics
Bone Grafts
Table 25 Bone Graft Procedure Volumes By Application, U.S., Through 2007
Table 26 Bone Graft Procedure Volumes By Type Of Graft, U.S., Through 2007
Figure 8 Bone Graft Procedure Volumes By Type Of Graft, U.S., 2001, 2002 And 2007
Table 27 Comparison Of Bone Graft Materials
Table 28 Types Of Substitute Bone Grafts
Autografts
Bioseed Grafts
Allografts
Allografts (Continued)
Risks Associated With Allografts
Demineralized Bone Matrix Products
Table 29 Selected Dbm Product And Percentage Of Demineralized Bone Matrix
Accell
Allogro And Allomatrix
Connect Cervical Allograft
Coreograft And Corlok
Dbm Carrier Product
Dbx
Duet Lumbar Allograft
Dynacan
Dynagraft Ii
Graftech
Grafton
Opteform
Orthoblast Ii
Osteofil
Solo Cervical Allograft
Vivescos
Xenografts
The Market For Allografts
Table 30 The U.S. Market For Precision-Machined Allografts, Through 2007 ($ Millions)
Cell-Based Bone Graft Substitutes
Factor-Based Bone Graft Substitutes
Bone Morphogenic Proteins
Inductos
Infuse Bone Graft
Ne-Osteo
Op-1 Implant
Ossigel
Skelite
Ceramic-Based Bone Graft Substitutes
Types Of Ceramics
Alpha-Bsm
Biogran
Biooss
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 500
Vitoss
Polymer-Based Bone Graft Substitutes
Bioplant Hard Tissue Replacement
Bioplant Hard Tissue Replacement (Continued)
Cortoss
Healos
Immix Extenders And Immix Cb
Polyactive
Poly(Lactic-Co-Glycolic Acid) Foam Matrix
Poly(Propylene) Fumarate
Rhakoss
The Market For Bone Graft Products
Table 31 The Worldwide Market For Bone Replacement Products, Through 2007 ($ Millions)
Table 32 The U.S. Market For Bone Replacement Products, Through 2007 ($ Millions)
Figure 9 The U.S. Market For Bone Replacement Products, 2001, 2002 And 2007 ($ Millions)
Regenerative Medicine Products In Development For Bone Applications
Biologic/Synthetic Grafts
Chrysalin
Bone Growth Stimulators
Types Of Bone Growth Stimulation
Semi-Invasive Direct Current
Invasive Direct Current
Pulsing Electromagnetic Fields
Marketers Of Noninvasive Bone Growth Stimulators
Ebi, Inc./Biomet
Orthofix/Medtronic
Orthologic/Johnson & Johnson
Orthologic/Johnson & Johnson (Continued)
Smith & Nephew
The Market For Noninvasive Bone Growth Stimulators
Table 33 The Worldwide Market For Noninvasive Bone Growth Stimulators, Through 2007 ($ Millions)
Figure 10 The Worldwide Market For Noninvasive Bone Growth Stimulators, Through 2007 ($ Millions)
Table 34 The U.S. Market For Noninvasive Bone Growth Stimulators, Through 2007 ($ Millions)
Market Share By Manufacturer
Figure 11 Share By Company Of The Noninvasive Bone Growth Stimulator Market, U.S., 2002
Regenerative Products To Treat Diseased And Damaged Joints
Autologous Products
Bioseed-C Autologous 3d Chondrocyte Graft
Carticel®
Cellactive Cartilage
Collagen Meniscus Implant
Immix Chondroflex
The Market For Tissue-Engineered Cartilage Products
Table 35 The U.S. Market For Tissue-Engineered Cartilage Products, Through 2007 ($ Millions)
Companies With Regenerative Products In Development
Curis
Genzyme Biosurgery
Genzyme/Johns Hopkins University
Isotis Nv
Isto Technologies
Millenium Biologix
Tigenix Nv
Tigenix Nv (Continued)
Industry
Suppliers Of Regenerative Bone And Joint Products
Premarket Notification-510(K)
What Is Premarket Notification?
What Is Substantial Equivalence?
Who Is Required To Submit A 510(K)?
When A 510(K) Is Required
When A 501(K) Is Not Required
The Modernization Act And The 510(K) Submission Process-Different Types Of Submissions For Differing Situations
Medical Devices Reviewed By The Center For Biologic, Evaluation, Research
Third Party Review Program
Regulatory Issues For Cellular And Tissue-Based Products
Changes In The Regulation Of Demineralized Bone Products
Industry Growth
Bankruptcies
Regulatory Issues
Development Issues
Pricing
Capital
Advanced Tissue Sciences
Organogenesis
Curis Exits The Tissue Engineering Market
The Tissue-Engineering Market In Europe
The Development Of Regenerative Medicines In Japan
The Development … In Japan (Continued)
Company Profiles
Biomet Orthopedics, Inc.
Business Overview
Financial Information
Leading Products
Corporate Strategy
Biotissue Technologies Ag
Business Overview
Leading Products
Corporate Strategy
Centerpulse, Inc.
Business Overview
Financial Information
Leading Products
Corporate Strategy
Cortek, Inc.
Business Overview
Leading Products
Corporate Strategy
Curis, Inc.
Business Overview
Financial Information
Leading Products
Corporate Strategy
Development Terminations
Reorganization
Product Focus
Johnson & Johnson Agreements
Stryker Agreements
Other Agreements
Patents
Gensci Regeneration Sciences Inc.
Business Overview
Financial Information
Leading Products
Corporate Strategy
Genzyme Biosurgery
Business Overview
Financial Information
Leading Products
Corporate Strategy
Integra Lifesciences Holdings Corp.
Business Overview
Financial Information
Leading Products
Corporate Strategy
Interpore Cross International
Business Overview
Financial Information
Leading Products
Table 36 Interpore Cross's Marketed Orthobiologic Products
Table 37 Interpore Cross's Near-Term Product Pipeline
Corporate Strategy
Isotis Bv
Business Overview
Leading Products
Corporate Strategy
Isto Technologies, Inc.
Business Overview
Leading Products
Corporate Strategy
Medtronic, Inc.
Business Overview
Financial Information
Leading Products
Corporate Strategy
Millenium Biologix Inc.
Business Overview
Leading Products
Corporate Strategy
Neucoll Inc.
Business Overview
Leading Products
Corporate Strategy
Orquest, Inc.
Business Overview
Leading Products
Table 38 Orquest's Product Pipeline
Corporate Strategy
Orthofix International N.V.
Business Overview
Financial Information
Leading Products
Leading Products (Continued)
Corporate Strategy
Orthologic Corp.
Business Overview
Financial Information
Leading Products
Ol1000
Spinalogic
Chrysalin
Corporate Strategy
Orthovita, Inc.
Business Overview
Financial Information
Leading Products
Leading Products (Continued)
Table 39 Orthovita's Product Pipeline
Corporate Strategy
Osteobiologics, Inc.
Business Overview
Leading Products
Corporate Strategy
Table 40 Osteobiologics' Patent Portfolio
Osteotech Inc.
Business Overview
Financial Information
Leading Products
Corporate Strategy
Corporate Strategy (Continued)
Corporate Strategy (Continued)
Regen Biologics, Inc.
Business Overview
Leading Products
Corporate Strategy
Stryker Corp.
Business Overview
Financial Information
Leading Products
Corporate Strategy
Tigenix N.V.
Business Overview
Leading Products
Corporate Strategy
Wright Medical Group, Inc.
Financial Information
Leading Products
Corporate Strategy
List Of Tables
Summary Table:
The U.S. Market For Regenerative Medicine Products Used In Bone And Joint Applications, Through 2007 ($ Millions)
Table 1 The Worldwide Market For Drugs To Treat Osteoporosis, Through 2007 ($ Millions)
Table 2 The Worldwide Market For Drugs To Treat Paget's Disease, Through 2007 ($ Millions)
Table 3 Hip Fracture Volumes, Worldwide, Through 2007
Table 4 Hip Fracture Volumes, U.S., Through 2007
Table 5 Hip Replacement Procedure Volumes, U.S., Through 2007
Table 6 Hip Replacement Procedure Volumes In Six States, 2001
Table 7 The Hip Replacement Market, Worldwide, Through 2007 ($ Millions)
Table 8 The Hip Replacement Market, U.S., Through 2007 ($ Millions)
Table 9 Knee Replacement Procedure Volumes, Worldwide, Through 2007
Table 10 Knee Replacement Procedure Volumes, U.S., Through 2007
Table 11 The Knee Replacement Market, Worldwide, Through 2007 ($ Millions)
Table 12 The Knee Replacement Market, U.S., Through 2007 ($ Millions)
Table 13 The Market For Unicondylar Knee Replacement, U.S., Through 2007 ($ Millions)
Table 14 Spinal Fusion Procedure Volumes, Worldwide, Through 2007
Table 15 Spinal Fusion Procedure Volumes, U.S., Through 2007
Table 16 Lumbar Spinal Fusion Procedure Volumes, U.S., Through 2007
Table 17 Posterior Lumbar Spinal Fusion Procedure Volumes, U.S., Through 2007
Table 18 Cervical Spinal Fusion Procedure Volumes, U.S., Through 2007
Table 19 The Market For Interbody Fusion Device Implantation Procedures, Worldwide, Through 2007 ($ Millions)
Table 20 Interbody Fusion Device Implantation Procedure Volumes, U.S., Through 2007
Table 21 Prevalence Of Rheumatoid Arthritis, U.S., Through 2007
Table 22 Therapeutic Antibody Products In Phase Ii Or Later Development For The Treatment Of Rheumatoid Arthritis
Table 23 The Market For Disease-Modifying Anti-Arthritic Drugs To Treat Rheumatoid Arthritis, Worldwide, Through 2007 ($ Millions)
Table 24 Number Of 2003 Trials Of Drugs To Treat Rheumatoid Arthritis By Mechanism Of Action
Table 25 Bone Graft Procedure Volumes By Application, U.S., Through 2007
Table 26 Bone Graft Procedure Volumes By Type Of Graft, U.S., Through 2007
Table 27 Comparison Of Bone Graft Materials
Table 28 Types Of Substitute Bone Grafts
Table 29 Selected Dbm Product And Percentage Of Demineralized Bone Matrix
Table 30 The U.S. Market For Precision-Machined Allografts, Through 2007 ($ Millions)
Table 31 The Worldwide Market For Bone Replacement Products, Through 2007 ($ Millions)
Table 32 The U.S. Market For Bone Replacement Products, Through 2007 ($ Millions)
Table 33 The Worldwide Market For Noninvasive Bone Growth Stimulators, Through 2007 ($ Millions)
Table 34 The U.S. Market For Noninvasive Bone Growth Stimulators, Through 2007 ($ Millions)
Table 35 The U.S. Market For Tissue-Engineered Cartilage Products, Through 2007 ($ Millions)
Table 36 Interpore Cross's Marketed Orthobiologic Products
Table 37 Interpore Cross's Near-Term Product Pipeline
Table 38 Orquest's Product Pipeline
Table 39 Orthovita's Product Pipeline
Table 40 Osteobiologics' Patent Portfolio
List Of Figures
Summary Figure:
The U.S. Market For Regenerative Medicine Products Used In Bone And Joint Applications, 2001, 2002 And 2007 ($ Millions)
Figure 1 The U.S. Musculoskeletal Products Market, 2002
Figure 2 The U.S. Reconstructive Device Market, 2002
Figure 3 Hip Replacement Procedure Volumes, U.S., 2001, 2002 And 2007
Figure 4 Knee Replacement Procedure Volumes, U.S., 2001, 2002 And 2007
Figure 5 Spinal Fusion Procedure Volumes, U.S., Through 2007
Figure 6 The U.S. Spinal Products Market, 2002
Figure 7 The Market For Disease-Modifying Anti-Arthritic Drugs To Treat Rheumatoid Arthritis, Worldwide, 2001, 2002 And 2007 ($ Millions)
Figure 8 Bone Graft Procedure Volumes By Type Of Graft, U.S., 2001, 2002 And 2007
Figure 9 The U.S. Market For Bone Replacement Products, 2001, 2002 And 2007 ($ Millions)
Figure 10 The Worldwide Market For Noninvasive Bone Growth Stimulators, Through 2007 ($ Millions)
Figure 11 Share By Company Of The Noninvasive Bone Growth Stimulator Market, U.S., 2002
Abstract OBJECTIVES AND GOALS OF STUDY
Regenerative medicine refers to technologies that repair or replace diseased or defective tissues or organs. The main types of regenerative medicine utilize products naturally occurring in the body, such as genes and proteins (antibodies, growth factors, hormones); cells and tissues; embryonic stem cells, and biomaterials. At present, most regenerative medicines on the market fall into the first category and include protein-based drugs and therapies containing human cells. However, there are a few products based on tissue engineering. This technology, which promises to be the most exciting and fastest growing sector of regenerative medicine in the near future, is the primary focus of this report. Tissue engineering technologies discussed include matrices and scaffolds, in vitro and in vivo technologies, and novel materials, which include those utilizing nanotechnology (atomic-scale engineering) of inorganic substances that meld with human tissues.
This report focuses on the bone- and joint-related applications of and markets for the various types of regenerative medicine currently available and projected to be introduced during the forecast period (2001 to 2007). Market drivers discussed include an increase in diseases and disorders that will benefit from these products, primarily arthritis, osteoporosis, and various types of bone and joint trauma (hip fractures, knee injuries, etc.); increasing use of nonautograft products by physicians; and innovative devices that incorporate bone- and cartilage-growth stimulating agents in a regenerative appliance. Products discussed include bone and cartilage grafting and regenerative products derived from autologous, allogeneic and synthetic sources as well as electronic bone growth stimulators and regenerative cartilage products. Profiles of leading and emerging companies in the bone and joint regenerative medicine markets are provided, along with analysis of the current and future positioning of their products and businesses in this active and rapidly changing market.
CONTRIBUTION OF THE STUDY AND FOR WHOM
The aim of this report is to provide an overview of regenerative medicine products available and emerging for the treatment of diseases and disorders of the bones and joints.
The information and analysis presented are an important asset in decision-making for managers involved in business development, marketing, market research, product development, mergers and acquisitions, licensing, business management, investment banking and deal creation, and to consultants to the pharmaceutical and biotechnology industries. The study provides a comprehensive analysis of the current markets for regenerative medicine products for bones and joints, relevant applications, and the potential of products in development.
STUDY SCOPE AND FORMAT
The scope of the study is worldwide. The Overview section provides a background of the demographics underlying the market for bone and joint products, a definition of regenerative medicine and the technologies involved, and a discussion of regenerative products in development for applications other than bones and joints.
The Applications section describes the leading bone and joint diseases and disorders applicable to regenerative technologies, including incidence and current methods of treatment.
The section on Products provides extensive descriptions and analysis (including comparative analysis) of regenerative products used to treat bone and joint disorders as well as discussion of products in development.
The section on Industry provides a discussion of regulatory issues affecting regenerative medicine products as well as recent bankruptcies among companies supplying regenerative products and the reasons for their financial difficulties.
The Company Profiles section provides a concise exploration of leading and emerging companies in the area of regenerative products for bones and joints, including product introductions, patents, and overall business strategies.
METHODOLOGY
The base year for this study is 2002. Figures are based on revenue figures at the manufacturer's level and are projected at 2002 dollar values, that is, inflation is not computed into the projection figures.
Information to prepare this study was derived from information provided by chief executive officers, marketing strategists, research executives and others at leading companies involved in the regenerative medicine market. Data was accessed from government agencies and regulatory bodies that monitor and/or regulate medical devices. Searches of secondary material such as company annual reports and 10Ks, journal articles, prospectus assessments, government resources and data from healthcare institutions were also conducted.
INFORMATION SOURCES
The information and analysis presented in this report are based on an extensive survey of the biotechnology and pharmaceutical industries as well as a detailed examination of published literature and reports obtained from regulatory authorities, medical research institutions, pharmaceutical trade associations and national and world health organizations.
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