Cell and Gene Therapy (CGT) is reshaping the future of medicine with its potential to treat, prevent or cure diseases that were previously incurable.
Globally, the CGT market is witnessing rapid growth due to rising incidences of cancer, genetic disorders and chronic diseases, alongside an increasing number of positive clinical trials (1). The rise of advanced technologies is driving greater support for CGT, with faster clinical trials and drug approvals fuelling stronger industry momentum worldwide (2).
Challenges of Cell and Gene Therapy Development
As the CGT landscape continues to expand, it offers unprecedented opportunities for companies while also presenting unique challenges.
Scalability
Many CGT developments fail to advance beyond early development, primarily due to manufacturing challenges and the inherent difficulties of scaling up. The high variability of cell types and gene-editing techniques complicates the streamlining of production, making it challenging to establish a standardised and reproducible process (3). This presents significant challenges in transitioning through clinical phases to GMP-Compliant commercialisation.
Diverse Regulatory Framework across regions
Differences in regulatory framework worldwide remain a key hurdle, hindering the global approval process for CGT. Although Europe and the U.S. each have centralised regulatory bodies, global alignment in CGT remains limited due to differences in definitions, approval pathways and commercialisation requirements (4).
Beyond Europe and the U.S., the regulatory environment in the Asia Pacific adds another layer of complexity for developers, due to the lack of harmonisation across countries. Each country has its own regulatory framework and requirements for CGT products, making it challenging to navigate clinical trial approvals and manufacturing standards across borders (5).
As such, global regulatory landscape for CGT remains fragmented, making cross-border development and commercialisation a major challenge.
Supply Chain Vulnerabilities
CGT manufacturing depends heavily on a wide range of specialty raw materials, from cell culture media and growth factors to purification resins, with each playing a critical role in ensuring the safety and therapeutic efficacy of the final product. For developers and manufacturers, any disruptions to this supply chain can result in delays in clinical trials and jeopardise patient access to therapies.
Recent global events, including the COVID-19 pandemic, highlight the necessity of diversifying raw material sourcing and partnering with suppliers who can ensure uninterrupted supply and preserve the integrity of the supply chain.
Our solutions for Cell and Gene Therapy Success
IMCD Biopharmaceuticals provides a comprehensive portfolio of specialty raw materials and process solutions to help biopharmaceutical companies navigate the complexity of CGT manufacturing. Combining regulatory insight, technical expertise, and reliable supply chain capabilities, we help ensure compliance and consistency across every stage of development.
Our offerings include:
- Buffers, Salts, Minerals, Water For Injection (WFI), Reagents
- Cell culture media and feeds
- Chromatography resins
- Critical nutrients
- Cryopreservation additives
- Fill-finish solutions
- Growth factors
- Sera
Please contact your local IMCD representative or fill in the form to request an detailed portfolio overview.
By integrating these solutions into upstream and downstream processes, we enable our partners to enhance product quality and safeguard supply chain resilience. Connect with us today to unlock greater efficiency and long-term stability in your operations.
References
1. Gene Therapy Is Developing Rapidly in Asia-Pacific. Genetic Engineering & Biotechnology News, 2024.
Available at: https://www.genengnews.com/topics/genome-editing/gene-therapy-is-developing-rapidly-in-asia-pacific/
2. Cell and Gene Therapy Market Size Rapidly Approaching USD 117.46 Billion by 2034. BioSpace, n.d.
Available at: https://www.biospace.com/press-releases/cell-and-gene-therapy-market-size-rapidly-approaching-117-46-billion-by-2034
3. 2025 Cell and Gene Challenges: Scalability, Supply Chain and Manufacturing. Cell & Gene Therapy Review, 2025.
4. Overcoming Regulatory Challenges in APAC Cell and Gene Therapy Development. IQVIA, 2025.
5. p, K. A Regulatory Roadmap for Cell and Gene Therapy Developers in Asia-Pacific. ISCT Global – Telegrafthub (2025). Available at: https://www.isctglobal.org/telegrafthub/blogs/ken-ip1/2025/05/28/a-regulatory-roadmap-for-cell-and-gene-therapy-dev