The cell and gene therapy market is witnessing rapid growth due to advancements in biotechnology, increased investment in research and development, and a growing pipeline of cell and gene therapies in clinical trials. This growth is fueled by the increasing awareness among researchers about the benefits of advanced therapies and the rising demand for robust disease treatment therapies. Key players are focusing on strategic initiatives to introduce novel products, which is expected to propel market growth.
Awareness and Education Initiatives
Awareness about cell and gene therapy treatment options is being driven by initiatives aimed at informing the public about the benefits of these products. For instance, the Alliance for Regenerative Medicine Foundation for Cell and Gene Medicine prioritizes activities for increasing public awareness through educational programs, underlining the clinical and societal benefits of regenerative medicine. These initiatives are crucial in increasing adoption of advanced therapies and fueling market growth for Contract Development and Manufacturing Organizations (CDMOs).
Regulatory Support
Regulatory bodies such as the FDA and EMA are providing constant support for innovations in the gene therapy field. The FDA has released six final guidelines on the manufacturing and clinical development of safe and efficient gene therapy products, which has significantly contributed to the growth of the market. Regulatory compliance is critical to ensure product safety, efficacy, and quality throughout the manufacturing process.
Market Trends and Growth
The gene therapy segment held the largest share of over 49.2% in 2023, driven by the increase in financial support and the rise in number of clinical trials for gene therapies. The cell therapy segment is expected to show lucrative growth over the forecast period due to the field of cellular therapeutics constantly advancing with inclusion of new cell types. The oncology segment accounted for the largest revenue share in 2023, driven by disease burden, strategic initiatives undertaken by key players, and the availability of advanced therapies used for treating various cancer indications.
Market Size and Growth
The global advanced therapy medicinal products (ATMPs) CDMO market is expected to reach USD 18.8 billion by 2030 and 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. The Asia-Pacific region is expected to grow at the fastest CAGR over the forecast period due to the increasing outsourcing activities and rising awareness about advanced therapies.
Key Players and Partnerships
Key players are undertaking various strategic initiatives to introduce novel products. For instance, CureVac N.V. signed a partnership agreement with Celonic Group to manufacture CVnCoV, CureVac’s mRNA-based COVID-19 vaccine candidate. Strategic partnerships allow biopharmaceutical companies to leverage the expertise and capabilities of CDMOs in ATMP manufacturing, accelerating the development and commercialization of these therapies.
Challenges and Opportunities
The market for ATMPs, including gene therapies, cell therapies, and tissue-engineered products, is experiencing rapid growth. However, the market also faces challenges such as scale-up challenges in manufacturing and regulatory compliance. CDMOs are investing in process optimization, automation, and advanced analytics to streamline manufacturing operations and reduce production costs. This growth is fueled by advancements in biotechnology, increased investment in research and development, and a growing pipeline of ATMPs in clinical trials.
Conclusion
The cell and gene therapy market is poised for continued expansion in the coming years due to the increasing demand for these therapies and the widespread adoption of technology. CDMOs play a crucial role in the development and commercialization of these therapies by providing specialized manufacturing expertise and facilities. Strategic initiatives, regulatory support, and partnerships are key drivers of growth in this market. As the market continues to grow, it is essential for CDMOs to focus on awareness and education initiatives to increase adoption of advanced therapies and fuel market growth.
“The cell and gene therapy market is poised for continued expansion in the coming years due to the increasing demand for these therapies and the widespread adoption of technology.”
References
- Global Advanced Therapy Medicinal Products CDMO Market Size, Share & Trends Analysis Report by Product (Gene Therapy, Cell Therapy), Phase, Indication, Region, and Segment Forecasts, 2024-2030
- Cell and Gene Therapy Market Landscape 2023-2030
- Cell and Gene Therapy CRO Solutions – PPD
- Advanced Therapy Medicinal Products CDMO Industry is Rising Rapidly