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  • To Be Published : May 2024
  • Code : CMI1101
  • Formats :
      Excel and PDF
  • Industry : Biotechnology

Advanced Therapy Medicinal Products (ATMPs) are innovative therapies that comprises cell therapy, gene therapy, and tissue engineered products. Cell therapy products include cellular immunotherapies and autologous and allogeneic cells for certain therapeutic indications including adult and embryonic stem cells. Whereas, Human gene therapy refers to products that introduce genetic material into individuals DNA to replace faulty or missing genetic material, thus treating a disease or abnormal medical condition. These are a novel class of medicines that offer potential treatment opportunities for diseases that have currently limited or no therapeutic options such as hemophilia, cystic fibrosis, metabolic disorders, muscular dystrophies, skin burns, Alzheimer, and cancer. Although majority of ATMPs are in an early stage of development, consolidated trial stage and the chances to cure chronic conditions signify that ATMPs may achieve the market sooner than standard treatments. Furthermore, advanced therapy medicinal products are regulated and authorized for marketing by the Food and Drug Administration (FDA) in the U.S. and by European Medicines Agency (EMA) in the Europe.

Rising incidences of Alzheimer’s is expected to foster the growth of advanced therapy medicinal products market

The factors that are contributing the growth of advanced therapy medicinal products market are rising prevalence of Alzheimer’s disease. According to Alzheimer’s disease International in 2017, around 50 million people were estimated to suffer from Alzheimer’s disease across the globe. Furthermore, rising demand for gene therapies used in the treatment of ocular, neurodegenerative diseases, and several cancers accompanied by technological advancements in genetic engineering tool such as RNAi  are the factors that are expected to boost the growth of advanced therapy medicinal products market. However, the factors that are hindering the growth of advanced medicinal therapy products market are inadequate transparency, lack of funds, and regulatory guidance for biopharmaceutical companies to manufacture these therapies and products.

On the basis of geography, the global advanced medicinal therapy products are segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. North America is expected to hold a dominant position in the global advanced medicinal therapy products market, owing to the development in the field of cell and gene therapy. For instance, the innovative gene therapy known as CAR-T or chimeric antigen receptor T-cell therapy harnesses the body’s own immune cells to recognize and attack malignant cells. The T-cells are harvested and modified with a new gene. The new gene contains a protein that directs the T-cells to target and kill leukemia cells that have a specific antigen on the surface. Moreover, Food and Drug Administration (FDA) approved first gene therapy in the U.S. in 2017, leading a new approach to the treatment of cancer and other serious and life-threatening diseases.  Moreover, Kymriah a cell based gene therapy has also been approved by FDA in 2017 in the U.S. for the treatment of patients with a form of acute lymphoblastic leukemia. Europe is also showcasing lucrative growth in advanced medicines therapy market, owing to new product approval in the region. For instance, in June 2019, bluebird bio has received marketing authorization from European Commission for ZYNTEGLO™ (autologous CD34+ cells encoding βA-T87Q-globin gene) gene therapy for patients 12 years and older with Transfusion-Dependent β-Thalassemia. ZYNTEGLO is the first gene therapy product approved for transfusion-dependent β-thalassemia. Furthermore, Asia Pacific is expected to be the fastest growing region for the global advanced therapy medicinal products market mainly due to rising number of skin burns cases and cancer diseases.

Strategic acquisitions by Pfizer to develop gene therapies for the treatment of neuromuscular conditions to enhance the competitive environment

The key players are focusing on strategic mergers and acquisition and development of innovative products. For instance, Pfizer acquired Bamboo Therapeutics, a biotechnology company focused on developing gene therapies for the treatment of patients with diseases related to neuromuscular conditions and the diseases affecting central nervous system. The acquisition is expected to significantly expand Pfizer’s expertise in gene therapy by providing clinical and pre-clinical assets to balance the rare disease portfolio of company with advanced recombinant Adeno Associated Virus vector design and production technology, which is fully functional phase I/II gene therapy with manufacturing facilities. Furthermore key players operating in the market are focusing on transformation of medicines with artificial intelligence (AI). For instance in October 2019, Novartis is collaborated with Microsoft to transform medicine with artificial intelligence. With this collaboration the Novartis AI innovation lab and Microsoft as its strategic AI and data-science partner bolster Novartis AI capabilities. This would help Novartis to commercialization and help accelerate the discovery and development of transformative medicines for patients worldwide.

The key players operating the advanced therapy medicinal products market include Uniqure, Pfizer, Bluebird Bio Inc., BioMarin Pharmaceutical, Novartis AG, GE Healthcare, Shire Biotechnology, and Kite Pharma.

Advanced Therapy Medicinal Products Market Taxonomy:

Advanced therapy medicinal products are segmented on the basis of therapy, diseases, and geography

On the basis of products, the global advanced therapy medicinal products market are segmented into:

  • Somatic Cell Therapy Medicinal Products
  • Tissue Engineered Medicinal Products
  • Gene Therapy Medicinal Products

On the basis of diseases, the global advanced therapy medicinal products market are segmented into:

  • Alzheimer’s
  • Cystic Fibrosis
  • Muscular Dystrophies
  • Hemophilia

On the basis of region, the global advanced therapy medicinal products market is segmented into:

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East
  • Africa

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