Market Report Source

Overview

Stem cell transplants are routinely used to treat patients with cancers and other disorders of the blood and the immune system and may hold the key to repairing or replacing tissue cells damaged in many devastating diseases. Thus, proven and potential clinical benefit underpins the vast interest in stem cell research. Stem cells have both the capacity to self-renew (by cell division) and differentiate into mature, specialized cells. Differentiation describes a process of development with an increase in the level of organisation or complexity of a cell, accompanied with a more specialized function. During differentiation, certain genes become activated and other genes become inactivated in an intricately regulated fashion. As a result, a differentiated cell develops specific structures and performs certain functions.

Table of Contents

Table of Contents

Opportunities in Stem Cell Research and

Commercialization

Executive Summary

Introduction to stem cells

Regulatory and ethical issues

Technologies and strategies

Market analysis

Adult stem cell programs

Embryonic and fetal stem cell programs

Patents in stem cell research

Trends and opportunities

Chapter 1 Introduction to stem cells

Summary

Introduction

Stem cell types

Differentiated cell types

Major milestones in stem cell research

Characteristics of embryonic and adult stem cells

Current uses of stem cells

Potential uses of stem cells

Chapter 2 Regulatory and ethical issues

Summary

Introduction

Regulation of cell and tissue therapies (USA)

iv

Ethical issues in embryonic stem cell research

Global embryonic stem cell policies

USA

Europe

Israel, Russian Federation and Asian nations

Canada and Australia

Chapter 3 Technologies and strategies

Summary

Introduction

Culture of adult stem cells

Isolation and identification of stem cells

Ex vivo expansion

Prevention of differentiation in culture

Preservation and scale-up

Examples of adult stem cell cultures

Hematopoietic stem cells

Mesenchymal stem cells

Neural stem cells

Culture of mouse ESCs

Culture of human ESCs

Single cell cloning

Challenges

Tissue engineering

Chapter 4 Market analysis

Summary

Introduction

The regulation of cellular therapy

Human embryonic stem cells (hESCs)

Human mesenchymal stem cells (MSCs)

Human hematopoietic stem cells (HSCs)

Stem cell mobilization

Stem cell expansion

Stem cell therapy and tissue engineering products

Commercial applications

Bone/cartilage regeneration

Myocardial and vascular regeneration

v

Pancreatic beta-cell regeneration

Neuronal regeneration

Skin replacement and wound healing

Drug screening

Embryonic and fetal stem cell programs

Potential markets

Overview of stem cell market forecasts

The stem cell market, 2005-2010

Preliminary observations

Quantitative forecasts

Stem cell competitive landscape

Therapeutic stem cells and research/services

Cord blood banks

Cytokines

Chapter 5 Adult stem cell programs

Summary

Introduction

Hematopoietic stem cell (HSC) transplantation

Established clinical applications

HSC mobilization products

Emerging clinical applications

Purification of HSCs for transplantation

Harvesting of HSCs from cord blood

HSC-based gene therapy

Ex vivo expansion systems

Mesenchymal stem cells for GvHD

In vivo stem cell activation

Stem cells for tissue repair/regeneration

Tissue repair products

Bone/cartilage regeneration

Myocardial and vascular regeneration

Beta-cell regeneration

Neuronal regeneration

Skin replacement and wound healing

Other applications

Novel approaches

Stem cells for drug testing applications

vi

Chapter 6 Embryonic and fetal stem cell programs

Summary

Introduction

Human embryonic stem cell (hESC) lines

hESC lines derived from blastocyst embryos

Other approaches to derivation of hESC lines

Somatic cell nuclear transfer

Fusion technologies

Single-cell embryo biopsy

Other approaches

Harnessing the power of ESCs

Tissue repair/regeneration

Initial challenges

Directed differentiation of ESCs

Nascent therapies

Drug screening and discovery

Miscellaneous applications

Human fetal stem cell therapies

Chapter 7 Patents in stem cell research

Summary

Introduction

Patent systems in Europe and the US

Overview

Post-issue challenges to patent validity

Patent litigation

Patenting of stem cells

Survey of US stem cell patents

Methodology

Patent activity analysis

Competitive analysis

Most frequently cited patents

Most prolific patent assignees

Chapter 8 Trends and opportunities

Summary

Slow beginnings, big promise

vii

Ensuring a strong proprietary position

Exploiting accessible sources of adult stem cells

Regenerative medicine takes shape

Commercializing stem cells for drug screening

Embracing embryonic stem cell research

Chapter 9 Appendix

Specialist stem cell companies

Companies with adult stem cell programs

Companies with fetal and embryonic stem cell programs

Cord blood banks around the world

The top 30 stem cell patent citations

Abbreviations

Technical Terms

Regulatory Terms

Index

viii

List of Figures

Figure 1.1: History of stem cell research

Figure 4.2: Commercial focus of 106 stem cell companies by type of stem cell program

Figure 4.3: Geographic location of 106 specialized stem cell companies

Figure 4.4: Ownership status of 106 specialized stem cell companies

Figure 4.5: Cord blood banks by region

Figure 7.6: US stem cell patents, filed 1980-2005

Figure 7.7: Patent activity analysis for types of Stem cells, filed 1980-2005

Figure 7.8: Top 30 US stem cell patents: types of stem cell and technology areas

Figure 7.9: Top 30 US stem cell patents: therapy area

Figure 7.10: Top 30 US stem cell patents by FCN, filed 1980-2005

List of Tables

Table 4.1: Potential US patient populations for cell-based therapies, 2005

Table 4.2: Annual direct expenditures in the US for selected diseases, 2005

Table 4.3: Stem cell market forecasts by technology and product type, 2005-2010

Table 4.4: Stem cell market forecasts by region, 2005-2010

Table 7.5: Top 30 stem cell patents by forward citations (US filings), 1980-2005

Table 7.6: Top 30 assignees for US stem cell patents (US filings 1980-2005)

Table 8.7: Specialist companies with proprietary adult stem cells or proprietary technogies

Table 8.8: Specialist companies developing autologous and allogeneic therapies for tissue

regeneration/repair

Table 9.9: 106 specialist stem cell companies

Table 9.10: 106 specialist stem cell companies (cont.)

Table 9.11: Commercial exploitation of adult stem cells for blood cancers and other blood diseases

Table 9.12: Commercial exploitation of adult stem cells for tissue repair/regeneration

Table 9.13: Commercial exploitation of adult stem cells for tissue repair/regeneration (cont.)

Table 9.14: Commercial exploitation of adult stem cells: miscellaneous research/services

Table 9.15: Programs utilizing human fetal stem cells

Table 9.16: Programs utilizing human embryonic stem cells

Table 9.17: Programs utilizing animal embryonic stem cells

Table 9.18: Cord Blood Banks in the US and Canada

Table 9.19: Cord Blood Banks in Mexico, Central and South America

Table 9.20: Cord Blood Banks in the UK and rest of Europe

Table 9.21: Cord Blood Banks in the Middle East, Asia, Africa, Australia and New Zealand 190