Advanced Therapy Medicinal Products Market Pegged for Robust Expansion During 2025

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. 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.

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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.

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.

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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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