Abstract
This cutting edge and insightful report can be used to interpret and assess the real potential of stem cell-based medicines
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.
In March 2009, President Obama relaxed federal restrictions on ESC research in
the US and this is likely to fuel further uptake of this technology in the
developed world. Meanwhile, stem cell therapies are already offered at various
locations across the globe, including China and Thailand, despite a lack of
robust, randomised 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 and investment is growing
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 the 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.
"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."
A FAST GROWING SECTOR WITH GREAT PROMISE
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.
KEY FINDINGS IN THE REPORT SHOW
- 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, but ' 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.
THIS REPORT PROVIDES REAL INSIGHTS...
For executives working in industry and commerce, the need to understand the
issues, players and products in this sector of high growth potential is
essential. That is why Espicom is making this report available, published by
UK pharma consultancy PharmaVision.
In over 180-pages, Stem Cell-Based Therapeutic Delivery: Challenges &
Opportunities (published December 2008) summarises some of the latest
developments and analyses some of the most promising solutions which companies
are providing to address the use of stem cells in key areas of unmet clinical
need. Packed with facts, statistics and case studies, the report is the most
comprehensive study on this sector of great clinical and commercial potential.
This report answers key business questions
- 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 commercialise 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?
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