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Advances in the Stem Cell Industry: The Future Impact of Innovation, and an Evaluation of the Commercial Landscape

Scripp Business Insights, October 2009, Pages: 162

An important milestone in the development of stem cell technology occurred in 2007, when researchers induced human cells into a stem cell state using defined genetic factors. These cells are now known as induced pluripotent stem (IPS) cells; they offer an alternative to using embryonic stem cells. This report takes the implications of IPS cells and other developments into account. Some essential technologies are already in place and stem-cell based therapies have already begun to appear in the marketplace. This has enabled the author to build market estimates based on emerging commercial realities. The stem cell market is already divided into three segments—cell-based treatments, umbilical cord blood banking, and the use of stem cells to evaluate the efficacy and safety of new drugs developed by other methods. Global sales reached $410 million in 2008, and will grow to $2.68 billion by 2012. This growth will reach a projected $5.1 billion in 2014, providing a realistic and even cautious forecast of the commercial potential these segments.

The report also describes the potential for stem cell science as applied to drug discovery and toxicity testing To give a full industry perspective, the report offers profiles of a large number (approximately 50) of companies operating in this field, including all sizes and types of organisation from small start-ups based on a single technology to large concerns with established product portfolios. This report also describes the background of stem cell science and the current status of knowledge in this sphere. The approach does not shirk essential technical detail but it is written in an easily readable style and the depth of information provided is carefully assessed.

Key features of this report

- Provides current status of the stem cell market, essential in a fast-moving field where up-to-date knowledge is paramount.

- Another key quality for a report such as this is that it should be realistic. Whether one describes the glass as half-full or half-empty matters less than describing it as a half glassful. Market forecasts are refined to indicate the potential offered by this exciting new area of technology without ignoring the practical difficulties.

- The scope for medical applications of stem cell science is broad and the report attempts to give as full a picture as possible, including applications that are as yet in development as well as those which are more advanced.

- The report also describes the potential for stem cell science as applied to drug discovery and toxicity testing

- To give a full industry perspective, the report offers profiles of a large number (approximately 50) of companies operating in this field, including all sizes and types of organisation from small start-ups based on a single technology to large concerns with established product portfolios.

- The report describes the background of stem cell science and the current status of knowledge in this sphere. The approach does not shirk essential technical detail but it is written in an easily readable style and the depth of information provided is carefully assessed.

Key findings from this report

- The main focus of applied stem cell research has been to explore the possibilities of using SCs in regenerative medicine, to replace normal cells and tissues destroyed by disease or trauma.

- Primary therapeutic targets are nervous system disorders such as Parkinson’s disease and amyotrophic lateral sclerosis; cardiovascular disease including heart failure, myocardial infarction and severe peripheral arterial disease..

- Stem cell science also offers the prospect of contributing to new drug discovery, for example by providing in vitro targets that can identify promising new candidates before any in vivo work has been undertaken.

- Cell-based therapies may be divided into those using autologous cells and those using allogeneic cells. Each market has its own characteristics.

- The world market for cell-based therapies is now estimated at $600 million, but there is great growth potential, given the high prevalence of eligible patients, once appropriate products reach the marketplace.

- The US accounts for about 90% of the world market but other national markets will make inroads over the coming years, and grow faster than the US market.

- Attrition among companies and products in the regenerative medicine market indicate that this is a demanding market environment requiring care in the choice of appropriate marketing model.

Key questions answered by this report

- What are the main hitherto untreatable conditions for which stem cell therapy may provide new hope of cure?

- Are embryo or adult stem cells the best prospect for future commercialization?

- What is the present size of the global stem cell market, and how is it expected to grow?

- Which are the leading national markets for stem cell products?

- What is the nature of the ethical objection to stem cell manipulation?

- What important factors need to be taken into account when formulating a business plan for stem cell commercialization.

- Names the leading companies with stem cell products in advanced development.

- Apart from the treatment of disease, what other roles are envisaged for stem cell products?

- What are induced pluripotent stem cells, and why are they important?

Advances in the Stem Cell Industry
Executive summary
Background
Stem cell research and development: scope and status
Commercial landscape
Industry landscape

Chapter 1 Background
Summary
Introduction
The building blocks of life
About stem cells
Potency
Stem cell division
Stem cell research
Human ESCs
Current status of knowledge
Embryonic stem cells
Growth and identification of ESCs
Stimulating ESCs to differentiate
Adult stem cells
Cord blood stem cells
Induced pluripotent stem cells
Nuclear reprogramming
Ethical and regulatory issues
Situation in the US
European regulations

Chapter 2 Stem cell research and development: scope and status
Summary
Introduction
Practical applications of stem cells
Disease treatment
Amyotrophic lateral sclerosis
Parkinson's disease
Spinal cord injury
Alzheimer’s disease
Cancer
Heart disease
Peripheral arterial disease
Type 1 diabetes
Liver failure
Graft-versus-host disease
Stem cell models: applications in drug discovery
Screening studies
Toxicity studies
Practical benefits
Some skepticism remains

Chapter 3 Commercial landscape
Summary
Resisting the hyperbole
Market realities
Cell-based therapy market
Autologous SC therapy
Allogeneic SC therapy
Cord blood banks
Market drivers
Market
Global market estimates and forecasts
Global market by use
Global market by country share
Embryo vs. adult stem cells
Investment opportunities
Choosing a viable business model
Matching the model to the circumstance
Autologous therapy models
Allogeneic therapy models

Chapter 4 Industry landscape
Summary
Introduction
Company profiles
Aastrom Biosciences, Inc
Overview
Pipeline
Advanced Cell Technology, Inc
Overview
Pipeline
Collaboration
Aldagen
Overview
Pipeline
Collaboration
Angioblast Systems, Inc
Overview
Pipeline
Athersys, Inc
Overview
Pipeline
Collaboration
Financials
Bioheart, Inc
Overview
Pipeline
Bionet
Overview
Collaboration
Brainstorm Cell Therapeutics
Overview
Capricor, Inc
Overview
Pipeline
Collaboration
Cardio3 BioSciences SA
Overview
Cellcyte Genetics
Overview
Pipeline
Collaboration
Cellerix SA
Overview
Pipeline
CellGenix Technologie Transfer
Overview
Cytori Therapeutics, Inc
Overview
Entest BioMedical, Inc
Overview
ES Cell International
Overview
EvoStem Finland Oy
Overview
Fate Therapeutics, Inc
Overview
Genzyme
Collaboration
Financials
Geron
Overview
Pipeline
Healtheuniverse, Inc
Overview
Innovacell Biotechnologie AG
Overview
International Stem Cell Corporation (ISCO)
Overview
Financing
iPierian, Inc
Overview
Ixion Biotechnology, Inc
Overview
Karocell Tissue Engineering AB
Overview
MedCell Bioscience Ltd
Overview
MediStem, Inc
Overview
Pipeline
Mesoblast Limited
Overview
Nephrogenix
Overview
Neuralstem, Inc
Overview
Pipeline
Collaboration
OncoStem Pharma
Overview
Novocell, Inc
Overview
NuVasive, Inc
Overview
Osiris Therapeutics, Inc
Overview
Pipeline
Collaboration
Financials
Pharmicell Europe GmbH
Overview
PrimeGen Biotech
Overview
Opexa Therapeutics
Overview
Financing
Financials
Plureon
Overview
Pipeline
Collaboration
Proteonomix, Inc
Overview
Regenerative Sciences, Inc
Overview
ReNeuron
Overview
Pipeline
Shenzhen Beike
Overview
Stematix, Inc
Overview
StemCells, Inc
Overview
Stem Cell Therapeutics
Overview
Stem Cell Therapy International
Overview
Stemedica Cell Technologies, Inc
Overview
Stempeutics Research Pvt. Ltd
Overview
t2cure GmbH
Overview
TICEBA GmbH
Overview
Tristem
Overview

Chapter 5 Appendix
Methodology
Glossary
Index

List of Figures
Figure 1.1: Early embryonic development and later differentiation
Figure 1.2: Stem cell division
Figure 1.3: Induced pluripotent stem cells
Figure 2.4: Stem cell opportunities in disease treatment and R&D
Figure 3.5: Forces affecting the stem cell market
Figure 3.6: Key challenges faced when developing autologous therapy
Figure 4.7: Type and number of regenerative medicine organizations

List of Tables
Table 3.1: Global stem cell market ($m), 2008-14
Table 3.2: Potential US patient populations for cell-based therapies
Table 3.3: Stem cell market by main uses ($m), 2008-14
Table 3.4: Country breakdown of stem cell market ($m), 2008-14
Table 3.5: Leading cell-based regenerative medicine products

- Brainstorm
-Genzyme
- International Stem Cell Corporation
- MedCell
- MediStem
- NuVasive
- Opexa
- Osiris
- Plureon

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