Advances in the Stem Cell Industry: The future impact of innovation, and an evaluation of the commercial landscape

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?



Companies mentioned in the report

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

Report Highlights

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Table of Contents
Advances in the Stem Cell Industry
Executive summary 10
Background 10
Stem cell research and development: scope and status 10
Commercial landscape 11
Industry landscape 12
Chapter 1 Background 16
Summary 16
Introduction 17
The building blocks of life 17
About stem cells 18
Potency 20
Stem cell division 21
Stem cell research 21
Human ESCs 23
Current status of knowledge 24
Embryonic stem cells 24
Growth and identification of ESCs 25
Stimulating ESCs to differentiate 26
Adult stem cells 26
Cord blood stem cells 29
Induced pluripotent stem cells 30
Nuclear reprogramming 31
Ethical and regulatory issues 33
Situation in the US 33
European regulations 34
Chapter 2 Stem cell research and development: scope and status 38
Summary 38
Introduction 39
Practical applications of stem cells 39
Disease treatment 40
Amyotrophic lateral sclerosis 40
Parkinson's disease 43
Spinal cord injury 44
Alzheimer’s disease 46
Cancer 48
Heart disease 49
Peripheral arterial disease 52
Type 1 diabetes 55
Liver failure 59
Graft-versus-host disease 60
Stem cell models: applications in drug discovery 61
Screening studies 61
Toxicity studies 63
Practical benefits 64
Some skepticism remains 65
Chapter 3 Commercial landscape 68
Summary 68
Resisting the hyperbole 69
Market realities 70
Cell-based therapy market 70
Autologous SC therapy 71
Allogeneic SC therapy 71
Cord blood banks 71
Market drivers 72
Market 73
Global market estimates and forecasts 74
Global market by use 75
Global market by country share 76
Embryo vs. adult stem cells 77
Investment opportunities 78
Choosing a viable business model 79
Matching the model to the circumstance 80
Autologous therapy models 80
Allogeneic therapy models 83
Chapter 4 Industry landscape 86
Summary 86
Introduction 87
Company profiles 89
Aastrom Biosciences, Inc. 89
Overview 89
Pipeline 90
Advanced Cell Technology, Inc. 90
Overview 91
Pipeline 91
Collaboration 92
Aldagen 92
Overview 92
Pipeline 92
Collaboration 93
Angioblast Systems, Inc. 93
Overview 93
Pipeline 94
Athersys, Inc. 95
Overview 95
Pipeline 95
Collaboration 96
Financials 96
Bioheart, Inc. 97
Overview 97
Pipeline 97
Bionet 98
Overview 99
Collaboration 99
Brainstorm Cell Therapeutics 99
Overview 100
Capricor, Inc. 101
Overview 101
Pipeline 101
Collaboration 102
Cardio3 BioSciences SA 102
Overview 102
Cellcyte Genetics 103
Overview 103
Pipeline 103
Collaboration 104
Cellerix SA 104
Overview 104
Pipeline 105
CellGenix Technologie Transfer 105
Overview 106
Cytori Therapeutics, Inc. 107
Overview 107
Entest BioMedical, Inc. 107
Overview 108
ES Cell International 108
Overview 109
EvoStem Finland Oy 109
Overview 110
Fate Therapeutics, Inc. 110
Overview 110
Genzyme 112
Collaboration 113
Financials 113
Geron 113
Overview 113
Pipeline 114
Healtheuniverse, Inc. 114
Overview 115
Innovacell Biotechnologie AG 115
Overview 116
International Stem Cell Corporation (ISCO) 116
Overview 116
Financing 118
iPierian, Inc. 118
Overview 118
Ixion Biotechnology, Inc. 119
Overview 119
Karocell Tissue Engineering AB 120
Overview 120
MedCell Bioscience Ltd 121
Overview 121
MediStem, Inc. 122
Overview 122
Pipeline 123
Mesoblast Limited 124
Overview 125
Nephrogenix 126
Overview 126
Neuralstem, Inc. 127
Overview 127
Pipeline 128
Collaboration 128
OncoStem Pharma 128
Overview 128
Novocell, Inc. 129
Overview 129
NuVasive, Inc. 130
Overview 130
Osiris Therapeutics, Inc. 131
Overview 131
Pipeline 131
Collaboration 132
Financials 133
Pharmicell Europe GmbH 133
Overview 133
PrimeGen Biotech 134
Overview 135
Opexa Therapeutics 136
Overview 136
Financing 136
Financials 137
Plureon 137
Overview 137
Pipeline 138
Collaboration 138
Proteonomix, Inc. 139
Overview 139
Regenerative Sciences, Inc. 140
Overview 140
ReNeuron 140
Overview 141
Pipeline 141
Shenzhen Beike 143
Overview 143
Stematix, Inc. 143
Overview 144
StemCells, Inc. 145
Overview 145
Stem Cell Therapeutics 146
Overview 147
Stem Cell Therapy International 147
Overview 147
Stemedica Cell Technologies, Inc. 148
Overview 148
Stempeutics Research Pvt. Ltd. 149
Overview 150
t2cure GmbH 150
Overview 151
TICEBA GmbH 152
Overview 152
Tristem 153
Overview 153
Chapter 5 Appendix 154
Methodology 154
Glossary 155
Index 162


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Table 3.1: Global stem cell market ($m), 2008-14 74
Table 3.2: Potential US patient populations for cell-based therapies 75
Table 3.3: Stem cell market by main uses ($m), 2008-14 76
Table 3.4: Country breakdown of stem cell market ($m), 2008-14 77
Table 3.5: Leading cell-based regenerative medicine products 79
Figure 1.1: Early embryonic development and later differentiation 19
Figure 1.2: Stem cell division 21
Figure 1.3: Induced pluripotent stem cells 31
Figure 2.4: Stem cell opportunities in disease treatment and R&D 40
Figure 3.5: Forces affecting the stem cell market 73
Figure 3.6: Key challenges faced when developing autologous therapy 83
Figure 4.7: Type and number of regenerative medicine organizations 87
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