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Opportunities in Stem Cell Research and Commercialization: Technology Advances, Regulatory Impact and Key Players

Published by: Business Insights

Published: Mar. 6, 2006 - 207 Pages


Table of Contents


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)

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

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




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

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




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

Abstract

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.

Key features:
  • Growth forecasts for stem cell market sub-sectors to 2010.
  • An examination of proprietary technologies and company strategies shaping the market for adult, embryonic and fetal stem cell products.
  • Assessment of the therapeutic potential of human stem cells for tissue repair and regeneration.
  • Analysis of global regulatory issues which are dictating where and how embryonic stem cell research is being done.
Key findings:
  • The market for stem cell products and services (including cytokines) is forecast to grow almost three-fold from $24.6 billion in 2005 to $68.9 billion in 2010.
  • During the years 1980-2005, over 2,000 US patents claiming stem cell technologies and applications relevant to healthcare were published; the annual publication rate accelerated sharply in 2002.
  • The majority of adult stem cell R&D is conducted in the US, while most embryonic stem cell research is conducted outside the US due to a restrictive legislative environment.
  • In 2005, the first commercial product containing adult stem cells was launched in the US - Osiris Therapeutics Osteocel.


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