Introduction:
The market for cellular therapies is poised for rapid
expansion over the next decade and is attracting high interest from large
biomedical companies. The emergence of novel, costly cellular products and
continuous uptake of already marketed therapies will fuel expansion, while
restricted uptake, complex manufacturing and delivery logistics, and
reimbursement hurdles will pose the greatest challenges to drug developers. To
provide a comprehensive view of the market for cellular therapies, we provide
up-to-date analysis on the clinical and commercial potential of marketed
products and more than 40 emerging therapies.
Questions Answered in This Report:
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Currently marketed cellular therapies have recorded
disappointing sales.
What are the main drawbacks of available cellular
treatments? Are second-generation products likely to have stronger uptake? Why
or why not?
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The development of cellular therapies is fundamentally
different from that of other biologics or small-molecule therapies.
What are
the biggest risks and challenges in the manufacturing and delivery process for
cellular therapies? What cellular therapies are best positioned to
overcome key manufacturing and commercialization hurdles and why?
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The first cellular therapies were developed in an unclear
regulatory environment, but emerging cellular products will need to comply with
stricter regulations.
What is the current regulatory landscape in Europe and
in the United States? Which cellular therapies will face the highest regulatory
burdens? What are the implications of the centralized European regulations for
advanced therapy medicinal products that take effect at the end of 2008?
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We expect at least 15 cellular products to launch over the next
decade.
Which therapies will become the market- and patient-share leaders?
Which companies are poised to carve out the largest share of the market for
cellular therapies?
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Because of cellular therapies’ complex manufacturing and
anticipated uptake in later lines of treatment, their prices are likely to be
very high and, in many cases, to exceed those of other biologics.
What is
the reimbursement coverage of currently marketed cellular therapies? What will
be the main drivers for adoption of emerging cellular therapies by U.S. payers?
Which types of cellular therapies are likely to have more favorable
reimbursement and why?
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Emerging cellular therapies are targeting a wide range of
indications, and some products are undergoing trials in as many as six
different diseases.
Which indications present the greatest opportunity for
manufacturers of cellular therapies? Which indications have the most
advanced pipelines? Which targeted indications are unlikely to benefit from the
launch of a cellular therapy over the next ten years and why?
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Stem-cell-based therapies are considered the best hope for
patients with chronic and degenerative diseases.
Which are the most advanced
stem cell therapies, what is their efficacy, and how soon will they reach the
market? Which early stem cell therapies pose the highest risk to
investors?
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The development of cellular therapies has faced significant
ethical, funding, and legal hurdles.
What is the current legal and
intellectual property landscape in the United States and Europe? What are the
prospects for increased funding from government and from private investors in
this field?Scope:
Primary research: We interviewed 10 U.S. and European
thought leaders on the current use of cellular therapies, the anticipated
adoption of emerging cellular therapies, and the key challenges faced by
companies entering this field. We also surveyed 50 U.S. managed care
organization (MCO) pharmacy and/or medical directors.
Markets covered: Base-year sales are provided for the
United States and Europe. Specific market forecasts are provided for the United
States.
Market forecast features: Using therapy-specific
assumptions on launch price, average size of the eligible patient population,
patient share, and dosing frequency, we forecast the sales of 14 cellular
products in their targeted indications in 2012 and 2017 in the United States.
We also provide competitive commercial analysis of another 30 emerging cellular
products that have limited clinical data available at this time.
Types of cellular therapies covered: Marketed and clinical-phase
therapies or devices based on the following cell types: somatic cells,
embryonic stem cells (ESCs), adult stem cells, immune cells used for active and
passive immunotherapy or immunoprophylaxis, and cell-based gene therapy.