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Cell Therapy and Tissue Engineering: Emerging Products

Published by: BCC Research

Published: Apr. 1, 1998 - 178 Pages


Table of Contents


Introduction

Reason For Study

Objectives Of Study

Audience For Report

Scope And Content Of The Report

Methodology And Information Sources

Analyst Credentials

Other Relevant Bcc Reports

Bcc On-Line Services

Internet

Summary

Overview

Definitions

Basic Concepts

Differentiation

Immune Reactions

Self-Recognition And Autoimmune Disease

Regeneration

Regenerative Technologies

Bioartificial Organs

Markets For Cell And Tissue Therapies

Effects Of An Aging Population On Demand

Reimbursement Issues

Regulation Of Products And Services

Medical Devices

Pharmaceuticals And Biologicals

How Therapies Are Categorized

Proposed Framework For Regulation Of Human Cellular And Tissue-Based Products.

Special Regulatory Problems Inherent In Xenogeneic Cell Therapies

Orphan Product Status

International Issues

Iso 9000

Medical Applications Of Cell Therapies And Tissue Engineering

Summation Of Revenue Forecasts

History Of Cell Therapy

Blood Components

Cell Therapies To Treat Cancer Victims

Bone Marrow Transplants

Peripheral Blood Progenitor Cell Collection

Indications For Bone Marrow Or Progenitor Cell Transplant

Purification Of Blood Stem Cells

Cellpro's Ceprate System

Isolex 300i System

Patent Litigation: Baxter Versus Cellpro

Dendreon, Inc. (Formerly Activated Cell Therapy)

Amcell Cell Selection Device

Systemix' Hematopoietic Stem Cell Product.

Aastrom Cell Production System

Purity Of Stem Cells: A Good Thing? Or Not?

Fractionation Of Bone Marrow Or Pbpc Apheresis Units Into A Variety Of Components

Market Opportunity For Hematopoietic Stem Cell Transplants

Reticence By Some Large Biomedical Companies To Pursue Hematopoietic Stem Cell Therapy.

Cytokines For Stem Cell Therapy

G-Csf And Gm-Csf

Other Stem Cell Factors

Stemgen™ (Stf)

Mobist™ (Flt-3 Ligand)

Neumega™ (Human Interleukin 11)

Market Opportunity For Cytokines Used In Hematopoietic Cell Treatments

Autologous Lymphocyte Therapies (Activated Cell Therapies) Used To Treat Cancer

Dendritic Cells

Cellcor's Alt

Rigs/Act

Market Opportunity For Autologous Lymphocyte And Activated Cell Therapies

Chronic Pain In Cancer Patients

Market Opportunity For Pain In Cancer Victims

Summary Of Cancer Therapy Projections

Aids

The Disease

The Virus

The Pandemic

Treatments

Neoprobe's Act For Aids

Cell Genesys/Hoechst—Modified Killer T-Cells

Systemix -Modified Hematopoietic Stem Cells For Aids Therapy

How Large Is The Market?

Long Term Prospects

Inducing Immune Tolerance

Allomune And Xenomune

The Market

Neurodegenerative Diseases

Parkinson's Disease

Market Opportunity For Parkinson's Disease Treatments

Huntington's Disease

Market Opportunity For Hd Cell Therapy

Multiple Sclerosis

Ms Therapy Which Kills Or Inactivates T-Cells

Market Opportunity For Multiple Sclerosis Therapies

Peripheral Nerve Regeneration

Dural Regeneration

Muscular Dystrophy

Myoblast Transfer Therapy (Mtt)

Alternatives To Mtt

Market Opportunity For Muscular Dystrophy Therapies

Diabetes

Forms Of Diabetes

Prevalence Of Diabetes

Complications Of Diabetes

Treatment Of Diabetes

Cell Therapies

Transplantation To The Liver

Where To Obtain Islets?

Encapsulation

Diabetic Cell Therapy As An Industry

Biohybrid Technologies

Desmos, Inc.

Encelle, Inc.

Circe Biomedical (Formerly Grace Biomedical)

Islet Technology Inc.

Metabolex

Neocrin Company

Vivorx

Anti-T-Cell Therapies For Diabetics

Market For Cell Therapies To Treat Diabetics

How Much Will Cell Therapy Cost?

Increase In The Number Of Diabetics In The U.S.

Cardiovascular Disease

Coronary Artery Disease And Congestive Heart Failure

Cardiocell

Mesenchymal Stem Cells

Heart Valves

Market For Tissue-Engineered Heart Valves

Vascular Grafts

Liver Failure

Circe Biomedical's Hepatassist Device

Bioartificial Liver From Hemocleanse

Direct Infusion Of Porcine Liver Cells

Market Opportunity For Liver Cell Therapies

Wound Healing

Burns

Integra's Patent Infringement Suit

Relative Costs

Use Of Alloderm And Artificial Skin In Plastic And Reconstructive Surgery

Demand For Matrix-Type Skin Regeneration Products

Skin Ulcers

Venous Stasis Ulcers

Diabetic Foot Ulcers

Decubitous Ulcers

Tissue Engineering Solutions For Skin Ulcers

Marketing Opportunities For Skin Ulcer Tissue Therapies

Bone Healing

Allografts

Demineralized Bone Matrix

Synthetics

Morphogenic Proteins

Mesenchymal Stem Cell Therapies

Market Penetration

Joint Repair

Carticel

Cartilage Regeneration By Seeding Matrix Substrates In Vitro

Cartilage Regeneration By Implanting Matrix

Market For Cartilage Repair

Products And Services

Cell Selection Devices

Amcell Stem Cell Concentrator

Bsds60 Cd34 Recovery System

Ceprate-Sc And Ceprate-Tcd

Isolex 300i

Neoprobe 1000

Cytokines And Growth Factors

Granocyte

Leukine™

Mobist™ (Flt3-Ligand)

Neupogen

Neumega

Ossigel (Basic Fibroblast Growth Factor)

Stemgen™

Autologous Cell Therapies, Purification And Expansion

Aastrom Cell Production System (Cps)

Autologous Lymphocyte Therapy (Alt) From Cellcor

Dendritic Cells From Dendreon

Carticel™

Epicel™

Hematopoietic Stem Cell Transplant Product From Systemix

Neocell™

Radioimmune Guided Surgery And Activated Cell Therapy (Rigs/Act)

T-Cells, Genetically Modified To Destroy Hiv-Infected Cells

Allogeneic Cell And Tissue Therapies, Wound Healing

Allomune™

Apligraf ™ Living Skin Equivalent

Cryopreserved Allograft Skin

Cultured Composite Skin

Dermagraft

Dermagraft-Tc

Spheramine™

Matrix Products, Cartilage Regeneration

Cartilage Repair System

Collagen Meniscus Implant

Matrix Products, Wound Healing

Alloderm

Integra™ Artificial Skin

Xenoderm™

Matrix Products, Bone Healing

Collagraft

Grafton Demineralized Bone Matrix

Healos

Pro-Osteon™ Implant 500 Coralline Hydroxyapetite Bone Void Filler

Matrix Products, Neurological

Dural Regeneration Template

Nerve Regeneration Template

Morphogenic Proteins, Bone Healing

Human Bone Morphogenic Protein-2

Osteogenic Protein-1 (Op-1)

Xenogeneic Cells, Unencapusulated

Cardiocell™

Hepatocell™

Neurocell™-Pd, Neurocell™-Hd

Xenomune™

Xenogeneic Cells, Encapsulated

Actid™

Bioartificial Pancreas

Encellin Xp

Vivorx Microencapsulated Pancreatic Cells

Xenogeneic Cells, Bioartificial Livers

Biologic-Dtpfc

Hepatassist™

Peptides That Generate T-Cell Apoptosis Or Anergy

Anergix For Multiple Sclerosis (Ms)

Mp4 For Ms

Nbi-5788 For Ms

Synergies Between Cell And Tissue Therapy And Other Emerging Technologies

Genetic Engineering

Peptide And Combinatorial Chemistry

Microelectronics

Beyond 2007

Structure Of The Industry

Biotechnology Companies Supply Ideas And Technology

Strategies Of The Multinational Life Science Companies

Cell And Tissue Therapy Companies By Category

Company Profiles

Aastrom Biosciences, Inc.

Advanced Tissue Sciences, Inc.

Alexion Pharmaceuticals

Amcell, Inc

American Home Products

Amgen

Anergen

Baxter International, Inc.

Biohybrid Technologies, Inc.

Biotransplant, Inc.

Biowhittaker, Inc

Cellex Biosciences, Inc.

Cell Genesys, Inc.

Cell Therapy Research Foundation

Cellpro, Inc.

Circe Biomedical, Inc

Collagen Corporation

Creative Biomolecules

Cryolife, Inc.

Cytogen Corporation (Cellcor Inc.)

Cytotherapeutics, Inc.

Dendreon

Desmos, Inc

Diacrin, Inc.

Encelle, Inc.

Genzyme Corporation

Hemocleanse, Inc

Immunex Corporation

Integra Life Sciences Corporation

Interpore International

Islet Technology, Inc

Lifecell Corporation

Matrix Biotechnologies, Inc

Neocrin

Neoprobe Corporation

Neurocrine Biosciences

Novartis International Ag

Organogenesis, Inc.

Orquest, Inc

Osiris Therapeutics, Inc.

Osteotech, Inc.

Regen Biologics, Inc.

Titan Pharmaceuticals, Inc.

Vimrx Pharmaceuticals

W.R. Grace & Company

Appendix I Glossary Of Terms And Abbreviations

List Of Tables

Summary Table
Projections Of Revenue From Cell Therapies And Tissue Engineering Products

1 Change In Population Structure, 1997-2007

2 Change In U.S. Population Structure By Age Group, 1997-2007

3 Projected Revenues From Cell And Tissue Therapies By Application

4 Cancer Incidence By Age, 1994

5 U.S. And Worldwide Incidence Of Selected Cancers

6 Indications For Bone Marrow Or Progenitor Cell Transplant

7 Cytokines And Growth Factors For Stem Cell Transplantation

8 Cell Therapies For Cancer

9 Prevalence Of Hiv/Aids, Worldwide, 1996

10 Cell Therapy Treatments Using Cell Selection Procedures, Projected Revenue

11 Cell Therapy To Induce Donor-Specific Immune Tolerance

12 Projected Revenues From Cell Therapies For Neurological Diseases Or Conditions

13 Matrix Solutions For Neurological Problems

14 Prevalence Of Diabetes Mellitus, Worldwide

15 Diagnosed Diabetics In The U.S. By Age

16 Prevalence Of Chronic Ischemic Heart Disease

17 Incidence Of Medical Indications For Skin Wound Repair

18 Indications For Skin Wound Tissue Therapies

19 Revenue Projections For Skin Regeneration Products

20 Sales Of Tissue Therapies For Skin Wounds

21 Annual Incidence Of Procedures Requiring Bone Regeneration

22 Surgically Reduced Fractures Requiring Support, Projected Numbers

23 Commercial Treatments For Bone Repair And Remodeling

24 Projected Number Of Knee Replacement Procedures

25 Revenues For Articular And Meniscal Cartilage Treatments

26 Projected Revenue From Cell And Tissue Therapies By Product Or Service Category

27 Cell Therapy Companies By Source Of Cells

28 Tissue Engineering Companies, By Application And Technology

29 Manufacturers Of Cytokines Or Growth Factors Used For Cell Or Tissue Therapies

30 Companies Developing T-Cell Or Anti-T-Cell Therapies

List Of Figures

1 Change In Population Structure, 1997-2007

2 Change In U.S. Population Structure By Age Group, 1997-2007

3 Projected Revenues From Cell And Tissue Therapies By Application

4 Cancer Incidence By Age, 1994

5 Prevalence Of Hiv/Aids, Worldwide, 1996

6 Prevalence Of Diabetes Mellitus, Worldwide

7 Diagnosed Diabetics In The U.S. By Age

8 Surgically Reduced Fractures Requiring Support, Projected Numbers

9 Projected Number Of Knee Replacement Procedures

Abstract

Hundreds of millions of dollars have been spent to commercialize products used for cell therapy or tissue engineering. To date, though, only a handful of these have been approved and marketed. BCC analyzes products being developed for a wide variety of applications, including cancer, cardiovascular disease, AIDS, neurological conditions, diabetes, liver failure, burns, skin ulcers, joint injuries, and bone fractures. Estimates are given of market sizes and penetration, now and a decade hence. BCC identifies and profiles over 40 companies involved in the cell therapy and tissue engineering industry. Significant patent disputes and regulatory issues are discussed.

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