Despite a promising product pipeline, mass manufacturing capacity does not exists for proper commercialization, finds Frost & Sullivan Transformational Health Team
MOUNTAIN VIEW, California, June 21, 2016 /PRNewswire/ -- The fast-growing cell therapy market is attracting government and private funds, positioning disruption throughout the pharmaceutical landscape. Stem cell therapy, the largest segment, has an impressive number of clinical trials worldwide. Furthermore, combination therapies are showing great curative potential. As evidence of the safety and efficacy of numerous products emerge, large pharmaceutical companies such as Pfizer, Novartis and Juno Therapeutics are entering the market. This will foster new partnerships, mergers and acquisitions to quicken the pace of development.
Recent analysis from Frost & Sullivan, Future of Cell Therapy in the Regenerative Medicine Market (http://utm.io/256555), finds the overall cell therapy market is close to $4 billion and is expected to grow at a compound annual growth rate of 20.1 percent between 2015 and 2020. Cell therapy holds 60 percent of the regenerative medicine market and covers cell-based immunotherapy, stem cell therapy, cell-gene therapy and stem cell-gene therapy. Currently, the U.S. dominates the market despite stringent regulations due to increased funding from the private sector. However, new opportunities exist in the Asia-Pacific region, especially in Japan who has an expedited approval process, which is fuelling U.S.-Japan corporate partnerships.
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"The surge of late stage hybrid therapies promising positive results at clinical stages, such as cell-gene and stem cell-gene, can disrupt commercialization in the mainstream market," confirmed Frost & Sullivan Transformational Health Industry Analyst Aish Vivekanandan. "Furthermore, a main opportunity lies in allogeneic therapies due to the scalability and cost-efficiency for both manufactures and patients when compared to autologous cell therapies."
Oncology is a key focus area, accounting for close to 50 percent of the pipeline therapies. Cardiovascular and neurology too are vibrant segments unlike more mature dermatology and musculoskeletal cell therapies. However, large-scale manufacturing of autologous cell therapy and combination therapies, without affecting the efficiency and quality of products, remains a challenge.
"If a tenth of the pipeline therapies reach the market, there will be no viable manufacturing infrastructure capable of supporting mass production to meet demand," explained Vivekanandan. "Companies dealing with live cells must have a quick turn-around time when isolating and processing immune cells. Sustainable models to develop strategic facilities and automated machinery to scale up may offer a solution."
Over the next five years, social healthcare and the need for less expensive therapies to treat the growing global aging population will continue to drive adoption. Cell therapy based models will be used for drug screening, efficacy as well as the subsequent discovery of new molecules, biologics and stem cell products.
"Numerous governments are implementing legislative policies favoring the establishment of centers of excellence, manufacturing infrastructure and research networks," added Vivekanandan. "This changing environment, in terms of regulatory oversight, will make the market more prominent, especially in regions with value-based healthcare."
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Future of Cell Therapy in the Regenerative Medicine Market is part of the Life Sciences Growth Partnership Service program. The study not only looks at basic drivers and restraints and environmental factors that affect commercialization of products, it also give a 360 degree view on the cell therapy market in terms of manufacturing and funding opportunities available for companies. In addition to analysis of the drug pipeline, the research offers strategic advice on existing business models for new entrants and companies that are looking to launch products into the mainstream market. Other recent topics covered under the subscription include: Analysis of the Cardiac Biomarker Diagnostics Market and A Product and Pipeline Analysis of the Global Immunoglobulin Market.
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Future of Cell Therapy in the Regenerative Medicine Market
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SOURCE Frost & Sullivan