Advanced Therapy Medicinal Products CDMO Market Size, Share & Trends Analysis Report By Product (Gene Therapy, Cell Therapy), By Phase, By Indication, By Region, And Segment Forecasts, 2024 - 2030

Advanced Therapy Medicinal Products CDMO Market Size, Share & Trends Analysis Report By Product (Gene Therapy, Cell Therapy), By Phase, By Indication, By Region, And Segment Forecasts, 2024 - 2030

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, according to a new report by Grand View Research, Inc. The market is expected to register a CAGR of 18.92% from 2024 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

• The gene therapy segment held the largest share of over 49.2% in 2023. Increase in financial support and rise in number of clinical trials for gene therapies are driving demand for the gene therapy segment.
• The cell therapy segment is expected to show lucrative growth over the forecast period. The field of cellular therapeutics is constantly advancing with inclusion of new cell types, which, in turn, provides ample opportunities for companies to enhance their market positions.
• The oncology segment accounted for the largest revenue share in 2023. The segment’s dominance is attributed to disease burden, strategic initiatives undertaken by key players, and availability of advanced therapies used for treating various cancer indications.
• The phase I segment dominated the market in 2023 due to growing R&D activities and increasing number of human trials for advanced therapies.
• North America dominated the overall market share of 49.0% in 2023. This can be attributed to increasing outsourcing activities and rising awareness about advanced therapy.
• The Asia Pacific region is expected to grow at the fastest CAGR over the forecast period due to the increasing demand for novel ATMPs and rising R&D activities to develop novel therapies.

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