The global advanced therapy medicinal products (ATMP) market size was valued at USD 8.40 billion in 2022. It is estimated to reach USD 20.63 billion by 2031, growing at a CAGR of 10.5% during the forecast period (2023–2031).
Advanced therapy medicinal products (ATMPs) are a novel class of heterogeneous biopharmaceuticals driven by research. They are being developed with the help of the European Union (EU) and the US. ATMPs are regulated as biological products in both zones, establishing the legal foundation for their creation. While there are four major groups of advanced therapies in the EU—gene therapy, somatic cell therapy, tissue-engineered therapies, and combined advanced therapies—the sub-classification of these therapies varies by region.
The European Union (EU) Commission established the legal and regulatory framework for ATMPs in the EU in 2007 (Regulation EC No. 1394/2007), which was implemented for the first time in December 2008. The European Medicines Agency's Committee for Advanced Therapies (CAT) is tasked with evaluating marketing authorization (MA) requests for ATMPs and making scientific recommendations for the categorization of ATMPs, among other duties. It plays a significant role in the regulatory oversight of these products.
ATMPs can cure diseases by addressing their root cause rather than symptomatic treatment. Long-term usage of ATMPs can significantly improve patients' health and quality of life with life-threatening diseases. They are used particularly for diseases with few or no alternative treatments. ATMPs have also benefitted patients who undergo invasive procedures regularly for symptom relief. Therefore, using ATMPs can help improve patient health and quality of life, benefiting caregivers, families, and society by relieving physical, emotional, and financial burdens.
Additionally, the transformative impact of ATMPs on treatment requirements and health outcomes for various chronic conditions can offer significant cost savings for health systems. ATMPs can eliminate the need for expensive procedures, such as blood transfusion and enzyme replacement therapy, thereby reducing investments in equipment and training of healthcare personnel and nursing staff undertaking these complicated procedures. In addition, patients treated with ATMPs tend to suffer lesser comorbidities that require expensive therapies and support. Such advantages offered by ATMPs are estimated to fuel market growth.
Recent ATMPs approvals have prompted an unprecedented expansion of its market. Pharmaceutical companies that produce conventional drugs are vying for a competitive edge because they see ATMPs as a potential income stream for future healthcare systems. Currently, this market is very active, and companies are investing significantly in clinical trials of ATMPs post the success of approved products. Moreover, companies are adopting various operation models to accelerate the product manufacturing process.
Some have undertaken in-house production of therapies, and many players prefer third-party service providers, including contract manufacturing organizations. On the other hand, several companies have marked their presence in the market by acquiring small and emerging CAR T-cell therapy developers. After Luxturna, Yescarta, and Kymriah's clearance, this market saw several acquisitions by organizations looking to enter or grow their current businesses in this industry. Some notable and recent examples include the purchases of Kite Pharma by Gilead Life Science, AveXis by Novartis, and Juno Therapeutics by Celgene. Therefore, the factors above boost the market growth.
In the case of ATMP development, standard Randomized Clinical Trials (RCTs) designed to characterize a medicinal product's safety profile and efficacy might not always be viable. This is due to technical intricacies, such as those associated with autologous therapies, ethical considerations, and the condition's rarity. As a result, products might secure regulatory approval based on open-label, single-arm, and small-scale trials. In addition, market regulators are accepting these studies based on the risk/benefit ratio rather than on the exact effect/size of new products, which is the prime focus of payers. This can create uncertainty about the impact of ATMPs on patients, hampering the market growth.
An increase in financing and investments in ATMPs is expected to provide ample growth opportunities in the market. For instance, in July 2019, Bayer provided USD 215 million to Century Therapeutics, a U.S.-based biotechnology startup, to develop therapies for solid tumors and blood cancer. Funding was further increased to USD 250 billion via a USD 35 million contribution from Versant Ventures and Fujifilm Cellular Dynamics. Similarly, Allogene Therapeutics, a California-based biotechnology company, raised over USD 300 million for its allogeneic product pipeline in 2018. The company develops CAR T-cell therapies for solid tumors and blood cancer.
Additionally, T-cell therapies are supported financially by grants awarded to university hospitals. In 2018, California Institute for Regenerative Medicine awarded USD 9.28 million to the City of Hope Medical Center for a clinical trial to evaluate CAR T-cell therapy for HER2-positive breast cancer patients. Similarly, in 2019, Cancer Prevention and Research Institute (U.S.) awarded USD 8.7 million to Cell Medica Ltd., a UK-based biotech company, to enhance its off-the-shelf CAR T-cell therapy for solid tumors and blood cancer.
The global advanced therapy medicinal products (ATMP) market is segmented by therapy type.
Based on therapy type, the global advanced therapy medicinal products (ATMP) market is segmented into cell therapy, gene therapy, CAR-T therapy, and tissue-engineered product.
The tissue-engineered product segment owns the highest market share and is predicted to exhibit a CAGR of 6.5% during the forecast period. Tissue engineering has been in practice for several years. However, the number of successful commercially engineered tissue products is less than the number of research studies conducted on tissue engineering. Engineered tissues are used across various applications, including testing cosmetics and other consumer goods, drug screening, personalized medicine, regenerative medicine, cell-based biosensors, food and other animal products, and aesthetics. Autologous tissue transplantation is restricted due to the patient's limited availability of healthy tissues. Moreover, this type of tissue transplantation is not recommended for young patients, wherein tissues are in the development phase.
Additionally, allogeneic tissue transplantation has effectively addressed the abovementioned challenges with autologous transplantation. Preparation of allogenic implants in the form of biostatic implants at tissue banks requires highly specialized procedures, such as sterilization and implant fixing. Examination of the donor tissue is required to eliminate the risk of disease transmission. These factors have boosted the revenue generation in this segment.
In cell therapies, companies are now more interested in industrialization than commercialization. Several organizations are trying to achieve this by developing standardized quality assurance practices, well-designed supply chains, and long-term outcomes. Investment in technological advancements for decentralizing cell therapy manufacturing can aid in revenue growth for this segment. For instance, Miltenyi Biotec is one of the companies that has contributed to the decentralization of cell therapy manufacturing through its CliniMACS Prodigy device. The device is an all-in-one automated manufacturing system capable of producing various cell types. Cellular therapeutics are constantly advancing with the inclusion of new cell types, providing ample opportunities for companies to reinforce their market positions. In addition, increased funding from government and private organizations to support cell therapy clinical trials, the introduction of effective guidelines for cell therapy manufacturing, and the proven effectiveness of products are some of the primary drivers of the market.
Recent approvals of gene therapies have significantly accelerated the clinical trials in this segment. Currently, the number of approved gene therapy is limited; however, many products are anticipated to receive market approvals in the coming years. Growing R&D activities in gene therapy trials have also resulted in an increase in market activities by key stakeholders operating in the market. For instance, in April 2019, Catalent announced acquiring Paragon Bioservices to grow its business footprint in the gene therapy arena. In addition, market players are marking their presence in the market through different business modalities, such as contract services for vector manufacturing.
CAR T therapies are considered revolutionary cancer therapies owing to their curing efficiency, representing a paradigm shift in cancer treatment. The notable approvals of Yescarta and Kymriah in 2017 by the U.S. FDA and subsequent geographic expansion over 2018-2019 in Europe and Japan has accelerated the development in this field. The sales of approved products in this segment are growing slowly yet steadily. This has encouraged investors to support ongoing R&D programs in this field. In addition, there have been consistent advancements in this region over the past few years. Researchers are investing in assessing CAR T-cells' safety and efficacy profiles with novel technologies and concepts.
Based on region, the global advanced therapy medicinal products (ATMP) market is bifurcated into North America, Europe, Asia-Pacific, and the Rest of the World.
North America is the most significant global advanced therapy medicinal products (ATMP) market shareholder and is anticipated to exhibit a CAGR of 12.6% during the forecast period. Factors such as a strong regulatory framework for promoting cellular therapy development, the high cost of therapies in the U.S., and the presence of a substantial number of companies in the region have resulted in North America's leading revenue share. Investments made by federal bodies in expanding advanced therapy research in the region are also anticipated to aid the growth of North America's stem cell therapy market. In addition, the market is expected to be driven by bodies such as the International Society for Cellular Therapy, a global society of technologists, regulators, clinicians, and industry partners seeking to improve the safety and effectiveness of cellular therapies to improve outcomes.
Several companies are planning to receive FDA approval over the coming years. For example, Beti-cel, also known as ZYNTEGLO® (betibeglogene autotemcel), a one-time gene therapy specifically created to treat the underlying genetic cause of beta-thalassemia and pediatric patients who need regular red blood cell (RBC) transfusions, got approved by the U.S. FDA in 2022. Such factors drive market growth.
Asia-Pacific is estimated to exhibit a CAGR of 8.2% over the forecast period. Japan, China, and South Korea have been leading the way in the recent global growth of the Asia-Pacific ATMP market. Biotech companies from other regions focus on developing innovative therapies by expanding their technologies and presence in the Asia-Pacific. For instance, in March 2019, Merck entered into a strategic alliance with China's GenScript for gene and cell therapy manufacturing. Under this collaboration, Merck would offer its manufacturing services to GenScript. Global companies are partnering up with domestic companies.
Similarly, Israel's Pluristem Therapeutics Inc. partnered with South Korea's CHA Bio. As per the partnership, CHA would perform and fund multiple PLacental eXpanded (PLX) cell-based clinical trials for the former. In addition, the stem cell therapy market has witnessed notable growth in revenue, technology, clinical development, and commercialization. For instance, in April 2015, the first trial to assess the safety of embryonic stem cell therapy in Asian patients was conducted in South Korea. These ongoing trials reflect the continuously advancing market in the Asia Pacific.
Europe accounts for a major share of the number of ongoing clinical trials. Moreover, clinical development activity continues to increase in the region. The EMA has played a crucial role in the proliferation of pipeline candidates. Furthermore, the emergence of a CMO-based business model is expected to boost revenue growth further. The UK has dominated in CMO services market within this region. The second-largest pharmaceutical market in the world is Europe, with a sizable part of medicine sales coming from Western Europe. In the upcoming years, cell therapy developers are projected to generate a sizable portion of Europe's medication sales. However, this depends on the cost-effectiveness of therapies and their approval by agencies, such as Germany's Institute for Quality and Efficiency in Healthcare (IQWIG) and the UK's National Institute for Health and Care Excellence (NICE). In addition, many academic institutes conducting early-stage cell therapy research are anticipated to boost revenue in this region.
The Rest of the World's market share is currently lower due to the small number of approved products there. However, the RoW ATMP market is expected to grow a lucrative CAGR during the forecast period, owing to the presence of emerging economies. The commercial distribution of approved products in this region, such as Vergenix FG, Vergenix-STR, CardioCel 3D, VascuCel, and CardioCel, is anticipated to propel clinical development.
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