Advanced Therapy Medicinal Products CDMO Market Size, Share & Trends Analysis Report By Product, By Phase, By Indication, By Region And Segment Forecasts, 2023 - 2030

NEW YORK, March 1, 2023 /PRNewswire/ --

Advanced Therapy Medicinal Products CDMO Market Size, Share & Trends Analysis Report By Product (Gene Therapy, Cell Therapy, Tissue Engineered), By Phase, By Indication, By Region, And Segment Forecasts, 2023 - 2030

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Advanced Therapy Medicinal Products CDMO Market Growth & Trends

The global advanced therapy medicinal products CDMO market size is expected to reach USD 18.8 billion by 2030. The market is expected to register a CAGR of 18.8% from 2023 to 2030, owing to rising clinical trials for advanced therapy medicinal products and the increasing awareness among researchers about the benefits of advanced therapies, driving the advanced therapy medicinal products (ATMP) CDMO market growth. Tissue engineering has greatly benefited in recent years from technological development. The damaged tissues and organ function are replaced or restored using this technique. Similarly, gene and cell therapy are attracting a lot of patients for the treatment of rare diseases, whose incidence is rising globally.

With rising demand for robust disease treatment therapies, key players have focused their efforts to ramp up research and development for effective gene therapies that target the cause of disorder at a genomic level. According to ASGCT, the number of cell and gene therapies in the U.S. pipeline programs (phase I-III trials) increased from 483 in 2021 to 529 in 2022. Furthermore, the FDA delivers constant support for innovations in the gene therapy field via a number of policies with regard to product manufacturing. In January 2020, the agency released six final guidelines on the manufacturing and clinical development of safe & efficient gene therapy products.

Moreover, awareness about ATMP treatment options is being driven by initiatives aimed at informing the public about the benefits of these products, which, in turn, is leading to increased adoption of advanced therapies and fueling market growth for CDMOs. For instance, Alliance for Regenerative Medicine Foundation for Cell and Gene Medicine prioritizes activities for increasing public awareness through educational programs, underlining the clinical & societal benefits of regenerative medicine.

Increasing clinical trial activity along with new product launches generates growth opportunities for the market.As of 2022, there are 1451 ATMPs in preclinical stages and 535 are being studied in Phase 1 to 3 studies.

Since August 2020, EMA has approved six of these additional ATMPs, and five more will be approved by 2023. In the UK, there were approximately 168 advanced therapy medicinal product trials underway in 2021, up from the 154 studies reported the year before, which is a 9% increase. 2021 saw a 32% increase in phase 1 trials, indicating a significant shift from experimental medicines to first-in-human studies.

On the other hand, key players are undertaking various strategic initiatives to introduce novel products, which is expected to propel market growth. For instance, in March 2021, CureVac N.V. signed a partnership agreement with Celonic Group, engaged in the manufacture of CVnCoV, CureVac's mRNA-based COVID-19 vaccine candidate. CureVac's COVID-19 vaccine candidate is manufactured at Celonic's commercial manufacturing unit for ATMPs and biologics in Heidelberg, Germany. Under the terms of the commercial supply agreement, the Celonic facility could produce over 100 million doses of CVnCoV.

Advanced Therapy Medicinal Products CDMO Market Report Highlights

• By product, gene therapy accounted for a major share of market space due to increasing clinical trials for gene therapies. Moreover, collaborative efforts for the development of novel gene therapies and the resultant expansion in gene therapy applications are factors expected to drive the volume of manufacturing
• Cell therapy is expected to account for a significant market share in the coming years. A rise in research interests and the adoption of advanced cell therapies are attracting increased investments. The segment is being driven by CDMOs attracting investments to keep up with growing commercial markets and support their growth and diversification prospects
• By phase, the phase I segment dominated the market revenue share in 2022. This is attributed to the growing number of human trials for advanced therapies and rising R&D activities
• By indication, the oncology segment held a major share of the market in 2022 due to the increasing number of cancer patients and increasing cell and gene therapy research related to cancer. Moreover, technological advancements, such as the development of cancer vaccines, are expected to further support segment growth
• North America dominated the global market in 2022, owing to increasing healthcare expenditure and the presence of key players. Companies such as Novartis AG, Sanofi, Johnson & Johnson Services, Inc., and Viatris are positively influencing market growth
• For instance, in June 2022, Novartis AG launched Dimethyl fumarate HEXAL for the treatment of patients with Relapsing-Remitting Multiple Sclerosis (RRMS) in Germany. This strategic launch was aimed at commercializing Hexal in Germany
• The Asia Pacific region is expected to expand considerably in the future. China is one of the major markets in the region. The market growth can be attributed to increasing government investments and reforms in policies related to the manufacturing of pharmaceutical products. China ranked second in the world for cell & gene therapy development with more than 1,000 clinical trials conducted in the country

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