Advanced therapy medicinal products (ATMPs) are innovative therapies
that are based on gene therapy, somatic cell therapy, and
tissue-built products. ATMPs are drug products which leverage living
cellular or active genetic materials to offer novel treatment
modalities in a range of both acute and chronic diseases. These
therapies are relied upon for vital medical advantages. The advanced
therapies are revolutionary treatments for a number of diseases or
injuries, such as skin in burns victims, Alzheimer's, cancer, or
muscular dystrophy. It has huge potential for patients and the
industry. ATMPs represent a quickly developing field of interest.
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Although the vast majority of the products are in an early stage of
development, the consolidated trial stage and the possibility to cure
serious incessant conditions indicate that ATMPs may achieve the
market sooner than standard treatments. Targeted treatments have
opened the path for new trial strategies from which ATMPs could
profit to get early access. ATMPs are regulated and authorized for
marketing by the European Medicines Agency (EMA) in the EU and the
Food and Drug Administration (FDA) in the U.S, each of which have
specific routes to market depending on the product’s legal
categorization.
Based on the type of therapy, advanced therapy medicinal products
(ATMPs) are classified as somatic cell therapy medicinal product
(SCTMP), tissue engineered medicinal product (TEP), gene therapy
medicinal product (GTMP), and combined ATMPs. Cell therapy products
like cancer vaccines are growing at a faster rate than gene therapy
like Glybera, Strimvelis, and tissue engineered medicinal products
due to the number of products advancing in clinical phase development
and more number of clinical trials in progress. In addition to
regulatory oversight of clinical studies, such as immune-oncology
study and technological advancement in genetic engineering tools like
talen, RNAi etc. boosts the market of advanced therapy medicinal
products. However, a range of issues from a lack of sustainable
funding models to insufficient transparency and regulatory guidance
for biopharmaceutical companies is still challenging the greater
uptake of these innovative treatments.
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Geographically, the advanced therapy medicinal products market can be
segmented into North America, Europe, Asia Pacific, Latin America,
and Middle East & Africa. North America held the dominant share
of the global market due to the presence of key players and the
advancement in gene and cell therapy with medical support. Moreover,
cellular and gene therapy-related research and development in the
region continue to grow at a fast rate, with a number of products
advancing in clinical development. In addition to regulatory
oversight of clinical studies, the Center for Biologics Evaluation
and Research provides proactive scientific and regulatory advice to
medical researchers and manufacturers in the area of novel product
development. In Europe in EU, regulatory framework for such products
was established with the Regulation (EC) 1394/2007, which came into
force on December 30, 2008.
The regulation established the centralized marketing authorization
procedure as the applicable route to authorize advanced therapies.
Furthermore, it established a new committee within the European
Medicines Agency (EMA), known as the Committee for Advanced Therapies
(CAT) which is responsible for assessing the quality, safety, and
efficacy of advanced therapies which helps to expand the market in
the particular region. However, opportunities for the market are
growing in Asia Pacific countries such as India, China, and Japan as
the factors driving the market are favorable in these highly
populated countries. This is attributed to rapid rise in health care
infrastructure and high level of variable diseases like cancer. In
the Middle East and African countries, the development of healthcare
projects and the economy helps to drive the market for advanced
therapy medicinal products.
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Key players in the advanced therapy medicinal products (ATMPs) market
are GSK, Uniqure, Kite Pharma, Pfizer, Adaptimmune, Bluebird Bio
Inc., BioMarin Pharmaceutical, Novartis, GE Healthcare, and Shire
Biotechnology.
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