Europe Eyes Leadership in Cell and Gene Therapy Advancement

Investment and Innovation Driving the Future of Medicine

Cell and gene therapies (CGTs) are rapidly reshaping medicine, offering potential cures for previously untreatable conditions. Europe is strategically positioning itself to become a leader in this innovative field, fostering investment, and developing cutting-edge treatments.

Europe’s Strategic Shift in CGT Development

The pharmaceutical industry is experiencing significant shifts in technology, regulations, and financial models, particularly concerning cell and gene therapies. As a hub for innovation, Europe is attracting interest in novel drug candidates and targets. However, there are challenges in securing investment to bring these treatments to market within the region.

The evolving global landscape has created an opportunity for Europe to highlight its strengths in developing high-value drugs. The aim is to establish a robust market, encouraging pharmaceutical businesses to invest and grow within the region.

Individual EU governments are backing companies and researchers, especially in the CGT sector. Initiatives like ATMP 2030 in Sweden are examples of this investment. Regional hubs specializing in CGT manufacturing and workforce training are also thriving.

“For Europe, the recent shift in global geopolitics… has been an opportunity to demonstrate the advantages of developing such high value drugs within the region”

—Quote from the Source

Navigating Challenges in CGT Development

The evolution of CGTs in medical practice presents unique, worldwide challenges. Scalability and manufacturing are primary concerns for developers, and the industry faces a need for flexible, risk-based strategies.

The rapid advancements in engineering, AI, and product design contrast with the pace of regulatory changes. This necessitates the introduction of new technologies, and the need for global regulators to have different viewpoints on the introduction of these technologies, such as rapid microbial methods.

Regulatory alignment and harmonization across jurisdictions are vital for global access to specialized drug products. Collaboration is essential for integrating CGTs into standard healthcare. The US FDA, Japanese PMDA, and the European Medicines Agency (EMA) are working to align requirements.

Innovative medicines such as CGTs come with high costs. Equal access across all EU member states remains a goal, which may eliminate the risk of CGTs being a premium product. The EU currently has a single regional approach to pricing. Collaboration will help deliver successful adoption, particularly when considering the current challenges.

A recent study indicates that the global cell and gene therapy market is projected to reach $13.3 billion by 2028 (Reportlinker 2024).

Key Figures

Dr. Lindsay Davies, a cell therapy expert, highlights critical factors for the broader adoption of CGTs in Europe. Dr. Davies is the Vice President Elect for Europe at the International Society for Cell & Gene Therapy (ISCT).

About the Author

Dr. Davies founded QVance, a subsidiary of NextCell Pharma, specializing in quality control analytics for advanced therapy developers. She previously worked as an Associate Professor at the Karolinska Institutet, Sweden, and the Finnish Red Cross Blood Service, and discovered a novel stem cell population within the oral cavity.

Dr. Davies has a background in biochemistry. She has also held positions at the Karolinska Institutet and the Finnish Red Cross Blood Service.