Stem Cell-Based Therapeutic Delivery Challenges & Opportunities

Date: December 22, 2008
Pages: 181
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Publisher: PharmaVision
Report type: Strategic Report
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ID: SD3D8840907EN
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Stem Cell-Based Therapeutic Delivery Challenges & Opportunities
This cutting edge & insightful report can be used to interpret & assess the potential of stem cell-based medicines. It provides opinions & market projections to:
  • assess the commercial potential of stem cell-based therapies in all of the key therapeutic areas: autoimmune diseases, cardiovascular, CNS & hematological malignancies;
  • identify key pharma & delivery specialists advancing the next generation of regenerative medicines;
  • gain an in-depth understanding of the technological manufacturing & delivery issues which face companies developing stem cell-based therapies;
  • evaluate the options available for delivering stem cell-based therapies now & in the future;
  • discover which companies are tackling the technological hurdles & are in a prime position to exploit new opportunities;
  • analyzes how the market will evolve over the next decade highlighting key trends, opportunities & challenges.
KEY FINDINGS:
  • Stem cells have grabbed the attention of scientists across the globe and the pace of research has been astonishing. It is just 10 years since the first human embryonic stem cells (hESCs) were isolated and cultured; new therapies based on this research are now reaching the clinical phase of testing.
  • Many challenges have faced those aiming to develop therapies derived from stem cells including: ethical debates and funding, immune rejection, cancerous potential and issues surrounding the manufacture of stable, pure cell therapeutics.
  • It is evidence of the growing maturity of the field that many potential products have overcome these hurdles and have entered clinical testing.
  • Our research has revealed a total of 122 stem cell-derived therapeutic projects being undertaken in companies across the globe. The majority of these projects are in the earliest stages (28%) or in preclinical studies (43%). Of the projects that have reached clinical trials, only a handful have passed initial Phase 1/2 testing, with a total of eight (7%) being investigated in Phase 3 studies.
  • The market for stem cell therapeutics is forecast to grow from 2011, as the first products enter the marketplace, and is expected to generate global sales in excess of US$1.2 billion by 2015.
  • Autologous products, derived from a patient’s own tissue, will be the first to reach the market, bu ‘off-the-shelf’ allogeneic products may offer greater commercial potential. The first allogeneic product to achieve approval is likely to be Osiris Therapeutics’ Prochymal for graft versus host disease.
  • Delivery of stem cell-based therapeutics can be challenging. Osiris’ Prochymal is unique among those reviewed, as it is delivered intravenously, offering obvious commercial advantages. Other therapies are being delivered directly to the site of injury, involving state-of-the-art catheters and imaging systems. The delivery of stem cells for CNS disorders remains a challenging area.
Introduction

“Stem cell-derived therapeutics are on the brink of a new era, with a handful of therapies expected on the market within the next 2 or 3 years. Big pharma and biotech companies such as Pfizer and Genyzme have recently invested large sums in this exciting and fast-moving area, further demonstrating its growing maturity. The results of numerous Phase 1/2 clinical trials that are underway now will provide a clearer picture of the potential of stem cell-derived therapies for the future.”

Dr Sara Sleigh

The pace of stem cell research is astonishing. It is less than 30 years since the discovery of the embryonic stem cell, and less than a decade since scientists determined the right conditions under which human embryonic stem cells (hESCs)could be directed to differentiate into a variety of cell types. Within the last few years, companies have built up sufficient data to support applications to start human clinical trials based on hESCs that have differentiated into oligodendrocytes for the treatment of spinal cord injury.

Embryonic stem cells are just part of the stem cell story. Adult stem cells, and those from other sources such as umbilical cord blood, have also been the subject of intense research over the past few years. While there has been a precedent for the use of bone marrow stem cells in the treatment of hematological malignancies, the development of new therapies based on cultured, expanded populations of specific cell types opens up a vista of new possibilities.

Regenerative medicine has a wide definition covering therapies that aim to repair, replace, restore and regenerate damaged or diseased cells, tissues and organs. Innovative therapies derived from stem cells fall within this definition and will, in the coming years, provide options for the treatment of a variety of diseases including: autoimmune diseases such as diabetes, Crohn’s disease and osteoarthritis, CNS disorders and neurodegenerative diseases, heart diseases, as well as eye diseases.

Stem cell therapies are already offered at various locations across the globe, including China and Thailand, despite a lack of robust, randomized clinical trials demonstrating their safety and efficacy. The fact that stem cell therapies are available in these locations and that patients’ travel across the globe to receive them illustrates the high unmet medical need associated with some of the targets being investigated. Clinical evidence from high quality clinical trials is now imperative in order to protect these vulnerable patient populations.

The challenges facing companies developing stem cell-derived therapies are high and range from ethical discussions surrounding the use of hESCs to difficulties associated with manufacture of cell-based products at scale and proving that products lack the potential to cause an immune response or cancer in a recipient. Nevertheless a growing pool of companies is investing heavily to bring this rapidly moving science to the clinic.

KEY QUESTIONS THIS REPORT ANSWERS:
  • Which companies & academic institutes are actively involved in stem cell therapy research?
  • What are the key areas of therapeutic focus for stem cell therapeutics in the near & long-term?
  • What are the key obstacles companies & delivery technologists need to overcome to commercialize stem cell-derived therapies?
  • How will the delivery technology drive the development of innovative stem cell-derived therapies in the future?
  • Which stem cell technologies & agents are likely to win in the near-term & long-term, & why?
  • Where are the market opportunities now & in the future?
  • When are stem cell-derived medicines likely to reach the market?
  • What do we predict will be the value of the stem-cell derived therapeutics by 2015 & 2020?
Key Findings
Stem Cells & Cell-Based Delivery
The Market for Stem Cell-Based Therapies
Stem Cell-Based Therapies for Cardiovascular Disease
Stem Cell-Based Therapies for CNS Disorders
Stem Cell Therapies for Diabetes
Stem Cell Therapies for Cancer
Stem Cell-Based Therapeutics: Challenges & Opportunities
Future of Stem Cell-Based Therapeutics & Market Trends

CHAPTER 1 STEM CELLS & CELL-BASED DELIVERY

Key Points
Introduction
An introduction to stem cell science
Embryonic stem cells
Adult stem cells
Creating pluripotent cells from adult tissue
Nuclear transfer/therapeutic cloning
Combining embryonic stem cell therapy with gene therapy
Stem cell therapy – a discovery timeline
Major scientific challenges for the development of stem cell therapies
Report structure

CHAPTER 2 STEM CELL-BASED THERAPIES: PIPELINE ANALYSIS

Key Points
Key therapy areas covered by stem cell-based therapies
Product pipelines
Stem cells for drug discovery
Stem cell culture, expansion and manufacturing
Stem cell companies analysed in this report

CHAPTER 3 STEM CELL-BASED THERAPIES FOR CARDIOVASCULAR DISEASE

Key Points
Introduction
Autologous cell platforms
Case Study: MyoCell (Bioheart Inc)
Case Study: Myoblast (Advanced Cell Technology)
Case study: CardioCure (Gamida Cell Ltd)
Case Study: C-Cure (Cardio3 BioSciences)
Case Study: Celution System (Cytori Therapeutics)
Allogeneic cell platforms
Mesenchymal stem cell therapies
Case Study: Prochymal (Osiris Therapeutics)
Case study: Revascor? (Angioblast Systems Inc)
Case study: PLX-PAD (Pluristem Therapeutics Inc)
Human embryonic stem cell therapies
Case Study: ACT Cellerate (Advanced Cell Technology)
Cell delivery technologies
Our opinion on stem cell-derived therapies for CV diseases
Where the technology is now, its evolution, achievements and pitfalls
Competition
Potential future applications
Activity in the market
Major players
Winners

CHAPTER 4 STEM CELL-BASED THERAPIES FOR CNS DISEASES

Points
Introduction
Autologous cell platforms
Case Study: NurOwn (BrainStorm Cell Therapeutics Inc)
Case study: NeuroGeneration
Allogeneic cell platforms
Stem cells from donated tissue
Case Study: HuCNS-SC® (StemCells Inc)
Case Study: ReNeuron
Case Study: Neuralstem
Case study: Q-cells (Q Therapeutics Inc)
Case study: StemedicaMCT (Stemedica USA and Stemedica International)
Stem cells from umbilical cord blood
Case study: Beike Biotechnology
Human embryonic stem cells
Case Study: GRNOPC1 (Geron)
Case study: hESCs from California Stem Cell Inc
Cell delivery technologies
Our opinion on stem cell-based therapies for CNS diseases
Where the technology is now, its evolution, achievements and pitfalls
Competition
Potential future applications
Activity in the market

CHAPTER 5 STEM CELL-BASED THERAPIES FOR AUTOIMMUNE, INFLAMMATORY & OTHER CONDITIONS

Key Points
Introduction
Crohn’s disease
Case study: Prochymal for Crohn’s disease (Osiris)
Case Study: Ontaril (Cellerix)
Diabetes
Autologous stem cell transplants for diabetes
Allogeneic stem cell transplants for diabetes
Osteoarthritis
Lung diseases
Chronic obstructive pulmonary disease
Pulmonary arterial hypertension
Our opinion on stem cell-based therapies for autoimmune and other diseases
Where the technology is now, its evolution, achievements and pitfalls
Competition
Potential future applications
Major players and winners

CHAPTER 6 STEM CELL-BASED THERAPIES FOR GRAFT VERSUS HOST DISEASE, HEMATOLOGICAL MALIGNANCIES AND CANCER

Key Points
Introduction
Cancer stem cells
Stem cells as a delivery vehicle
Graft versus host disease
Expanded umbilical cord blood transplants for malignant diseases
Case Study: StemEx (Gamida Cell)
Stem cells as delivery systems
Lung cancer
Metastatic cancer and intracranial tumors
Hematological malignancy
Multi-lineage progenitor cells (BioE)
Conclusion
Our opinion on stem cell-derived therapies for GvHD, hematological malignancies and cancer
Where the technology is now, its evolution, achievements and pitfalls
Competition
Potential future applications
Activity in the market, major players and winners

CHAPTER 7 CHALLENGES & OPPORTUNITIES FOR STEM CELL-BASED THERAPIES

Key Points
Introduction
Ethical issues for stem cell research
Funding stem cell research
Intellectual property
Manufacturing stem cell-based products
Regulation
Reimbursement
Delivering stem cell-based therapies and tissue engineering
Challenges
Opportunities

CHAPTER 8 MARKET SIZE, EVOLUTION & PROSPECTS

Key Points
Key stem cell therapy companies
Recent deals and alliances
The global stem cell market 2008-2014
Analysis parameters
Market forecast 2008-2014
Global stem cell-based therapy market in 2020
Drivers and market trends
Summary & Conclusions
Acknowledgements
Bibliography & Endnotes

LIST OF TABLES:

Table 1: Pros and cons of different stem cell types
Table 2: Diseases targeted by stem cell-based therapeutics
Table 3: Stem cell therapy companies discussed in this report
Table 4: Leading companies evaluating stem cell-based CV therapies
Table 5: Leading academic institutions researching the use of stem cells to treat CV diseases
Table 6: Leading companies evaluating stem cell-based therapies for CNS diseases
Table 7: Leading institutes evaluating stem cell-based therapies for CNS diseases
Table 8: Geron’s stem cell-based product pipeline
Table 9: Leading companies evaluating stem cell therapies for autoimmune and other diseases
Table10: Leading academic institutes evaluating stem cell therapies for autoimmune and other diseases
Table 11: Leading companies evaluating stem cell therapies for GvHD and hematological malignancies
Table 12: Academic institutions with an interest in GvHD, hematological malignancies and cancer
Table 13: Other clinical trials of mesenchymal stem cells for the prevention or treatment of GVHD
Table 14: Results of Phase 1/2 trial for StemEx
Table 15: Global positions on research on embryonic stem cells derived from IVF procedures
Table 16: Current funds available from individual US states for embryonic and adult stem cell research
Table 17: Summary of leading stem cell-based therapeutics companies
Table 18: Recent licensing deals and alliances with big pharma/biotech
Table 19: Stem cell-based therapies included in the market forecast
Table 20: Forecast of pipeline stem cell therapy products 2008-2014 (US$m)
Table 21: Forecast of pipeline stem cell therapy products 2015-2020 (US$m)

COMPANIES MENTIONED:

Aastrom Biosciences, Advanced Cell technology, Aldagen, Amorcyte Inc, Angioblast, Arteriocyte Inc, AstraZeneca, Athersys, Baxter Healthcare, Beike Biotechnology, BioE, Bioheart, BrainStorm Cell Therapeutics, California Stem Cell Inc, Cardio3 BioSciences, CDI, Celegos, Celgene Cellular Therapeutics, Cell Cure Neurosciences, Cellartis, CellCyte Genetics, Cellerant Therapeutics, Cellerix, Cytori Therapeutics, EndGenitor Technologies Inc, Gamida Cell, Genzyme, Geron Corporation, GlaxoSmithKline, MaxCyte, MedCell, Neuralstem Inc, NeuroGeneration, Neuronyx, Northern Therapeutics, Novartis, Novo Nordisk, Novocell, Opexa Therapeutics, Osiris Therapeutics, Pfizer, Plureon, Pluristem Therapeutics Inc, Q Therapeutics Inc, Regenetech Inc, Reliance Life Sciences, ReNeuron, RhinoCyte, Roche, Saneron CCEL Therapeutics Inc, StemCells Inc, Stemedica, Stemnion, Teva Pharmaceuticals, Theradigm, TheraVitae, Vesta Therapeutics, ViaCord
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