PUBLISHER: The Business Research Company | PRODUCT CODE: 1810821
PUBLISHER: The Business Research Company | PRODUCT CODE: 1810821
Advanced therapy medicinal products are medicines derived from genes, cells, or tissue engineering that provide innovative treatments for a variety of diseases and injuries. These therapies function by repairing, replacing, or regenerating human cells, tissues, or organs to restore normal function.
The main types of advanced therapy medicinal products include somatic cell therapy medicinal products, tissue-engineered medicinal products, and gene therapy medicinal products. Somatic cell therapy medicinal products involve treatments using cells from the human body (excluding reproductive cells) that are manipulated or processed to treat, prevent, or cure diseases by repairing or replacing damaged tissues or cells. These therapies employ various technologies such as gene editing, viral vector technology, stem cell technology, and automation and artificial intelligence-driven processes. They are used in treating conditions including muscular dystrophies, Alzheimer's, hemophilia, cystic fibrosis, among others. Distribution channels include hospital pharmacies, retail pharmacies, and online pharmacies, serving a wide range of end users such as hospitals, specialty clinics, and other healthcare providers.
Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.
The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the pharmaceutical companies contend with tariffs on APIs, glass vials, and lab equipment inputs with few alternative sources. Generic drug makers, operating on razor-thin margins, are especially vulnerable, with some reducing production of low-profit medicines. Biotech firms face delays in clinical trials due to tariff-related shortages of specialized reagents. In response, the industry is expanding API production in India and Europe, increasing inventory stockpiles, and pushing for trade exemptions for essential medicines.
The advanced therapy medicinal products market research report is one of a series of new reports from The Business Research Company that provides advanced therapy medicinal products market statistics, including advanced therapy medicinal products global market size, regional shares, competitors with advanced therapy medicinal products market share, detailed advanced therapy medicinal products market segments, market trends and opportunities, and any further data you may need to thrive in the advanced therapy medicinal products industry. The advanced therapy medicinal products market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.
The advanced therapy medicinal products market size has grown rapidly in recent years. It will grow from $42.85 billion in 2024 to $51.34 billion in 2025 at a compound annual growth rate (CAGR) of 19.8%. The growth during the historic period can be attributed to the increasing number of clinical trials for gene and cell therapies, the rising incidence of rare and genetic disorders, growing demand for curative treatments rather than chronic disease management, improving success rates of early-phase clinical studies, and the increasing prevalence of chronic and age-related conditions.
The advanced therapy medicinal products market size is expected to see rapid growth in the next few years. It will grow to $104.43 billion in 2029 at a compound annual growth rate (CAGR) of 19.4%. The growth in the forecast period can be attributed to the increasing demand for personalized and precision medicine approaches, a rising pipeline of chimeric antigen receptor T-cell and gene-editing therapies, growing adoption of precision medicine and genomics, increasing healthcare expenditure in emerging markets, and a heightened focus on decentralized clinical trial models. Key trends during the forecast period include the development of allogeneic off-the-shelf therapies, advancements in non-viral gene delivery vectors, integration of digital twins in therapy simulation, implementation of blockchain in supply chain tracking, and innovations in 3D bioprinting for tissue engineering.
The increasing demand for personalized medicine is anticipated to drive the growth of the advanced therapy medicinal products market in the coming years. Personalized medicine is a healthcare approach that customizes treatment and prevention strategies based on an individual's unique genetic profile, lifestyle, and environment. This rising demand is largely due to the growing prevalence of chronic diseases, as personalized treatments improve patient outcomes and minimize side effects. Advanced therapy medicinal products support personalized medicine by providing tailored treatments such as gene, cell, and tissue-engineered therapies that specifically target the unique genetic and biological characteristics of individual patients. In February 2024, the Personalized Medicine Coalition, a US-based nonprofit organization, reported that the FDA approved 16 new personalized treatments for rare disease patients in 2023, up from six in 2022. These approvals also included seven cancer drugs and three treatments for other diseases and conditions. Thus, the growing demand for personalized medicine is fueling the expansion of the advanced therapy medicinal products market.
Key players in the advanced therapy medicinal products market are concentrating on innovative therapies like new CAR-T cell therapies to enhance treatment outcomes for cancer and other severe diseases. CAR-T cell therapies are advanced cancer treatments that use a patient's own T cells, genetically modified to identify and destroy cancer cells. For example, in May 2022, Novartis AG, a Switzerland-based pharmaceutical company, received FDA approval for Kymriah, a CAR-T cell therapy intended for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more prior systemic therapies. This treatment involves genetically engineering the patient's T cells to express a chimeric antigen receptor (CAR) that targets the CD19 protein, enabling the T cells to recognize and eliminate malignant B cells. Kymriah also includes a 4-1BB costimulatory domain, which supports T cell expansion and persistence, resulting in prolonged antitumor effects from a single infusion.
In May 2024, Tri-Tech Forensics Inc., a US-based forensic company, acquired SAM Medical Products for an undisclosed sum. This acquisition is expected to help Tri-Tech Forensics broaden its emergency medical product portfolio and reinforce its market position. SAM Medical Products is a US-based firm specializing in the development, manufacturing, and marketing of orthopedic splints, wound care devices, and medical service products designed for various healthcare professionals.
Major players in the advanced therapy medicinal products market are F. Hoffmann-La Roche Limited., Novartis AG, Bristol-Myers Squibb Company, Takeda Pharmaceutical Company Limited., Lonza Group AG, Catalent Inc., BioMarin Pharmaceutical Inc., AGC Biologics Inc., ViaCyte Inc., Rentschler Biopharma SE, JCR Pharmaceuticals Co. Ltd., Vericel Corporation, UniQure N.V., Fate Therapeutics Inc., WuXi Advanced Therapies Inc., Celonic Group AG, Pharmicell Co. Ltd., Magenta Therapeutics Inc, MEDIPOST Co. Ltd., and Kolon TissueGene Inc.
North America was the largest region in the advanced therapy medicinal products market in 2024. Asia Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in advanced therapy medicinal products report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.
The countries covered in the advanced therapy medicinal products market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.
The advanced therapy medicinal products market consists of revenues earned by entities by providing services such as cell and gene therapy development services, viral vector production and characterization, regulatory and clinical trial support, analytical testing and quality control services, and process development and scale-up services. The market value includes the value of related goods sold by the service provider or included within the service offering. The advanced therapy medicinal products market also includes sales of gene therapy vectors, engineered tissue scaffolds, bioengineered skin substitutes, and encapsulated cell therapies. Values in this market are 'factory gate' values; that is, the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.
The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).
The revenues for a specified geography are consumption values and are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.
Advanced Therapy Medicinal Products Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.
This report focuses on advanced therapy medicinal products market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.
Where is the largest and fastest growing market for advanced therapy medicinal products ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The advanced therapy medicinal products market global report from the Business Research Company answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.
The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.