Why Germany is falling behind in Cell and Gene Therapeutics (CGT) and how we can turn it around

Maintaining Germany as a central hub for pharmaceutical innovation and manufacturing in CGT

Rebuilding Germany’s role in Cell and Gene Therapy: Key actions for faster approvals, manufacturing innovation, and a stronger global position

Germany has been a global leader in biotech and pharma for over a century, with pioneers like Bayer and Merck shaping the industry through groundbreaking drug development and chemical innovations. We played a key role in advancing vaccine technology, from early serum therapies to the mRNA revolution led by BioNTech. The strong research infrastructure, coupled with a robust manufacturing base, continues to make Germany a central hub for pharmaceutical innovation and bioprocessing excellence.

Complex bureaucracy and extensive documentation slow down scalability

In recent years, Germany’s role in biotech has evolved, particularly in cell and gene therapy manufacturing, where its strong GMP expertise is both an asset and a challenge. While Germany remains a key hub for innovation, complex bureaucracy, extensive documentation requirements, and rigid GMP standards have made scaling advanced therapies slow and costly. Compared to other countries, approval timelines for manufacturing facilities are often longer due to stringent regulatory oversight and multi-layered compliance checks. Instead of streamlining processes, the implementation of the EU Clinicial Trials Regulation (CTR) led to increased document burden, conflicting application requirements, and technical hurdles that are making the regulatory processes of new therapies complicated and slow. Ultimately, this leads to prolonged approval timelines, which are especially critical in evolving outbreaks (1). This has led some companies to seek faster pathways in other jurisdictions while keeping R&D in Germany.

Here are some practical examples for a Clinical First-in-Class First-In-Human Trial comparing USA and Germany (2):

Trial aspects	USA	Germany
Documentation for Clinical Trial Phase 1/2a	<60 pages	>500 pages
GMP requirements	Process description sufficient	Manufacturing authorization required
Time to approval	<6 months	>3-4 years

Addressing the key bottlenecks for CGT developments

But there’s good news! Germany still has the potential to reclaim its competitive edge in Cell and Gene Therapy (CGT) manufacturing - but only if we act now. The global biotech landscape is evolving rapidly, and while Germany has fallen behind in some areas, its scientific excellence, strong manufacturing expertise, and innovation-driven ecosystem provide a solid foundation for change. By addressing key bottlenecks and implementing targeted reforms, Germany can once again position itself as a leader in both CGT innovation and production.

Here are six key fields of action to start with:

• Streamline Approvals – Reduce bureaucracy and align timelines with global leaders by introducing fast-track pathways and simplifying documentation.
  

• Flexible GMP Standards – Adopt a risk-based approach, allowing process descriptions instead of full manufacturing authorization for early-stage trials.
  

• Speed up approvals and ensure pragmatic oversight.
  

• Boost Manufacturing Incentives – Offer tax breaks, grants, and funding to offset high compliance costs and attract investment.
  

• Advance Manufacturing Innovation – Invest in novel automation, closed systems, and scalable bioprocessing technologies to improve efficiency and reduce costs in CGT production.
  

• Harmonize EU Regulations – Work with European regulators to streamline approvals and create a more competitive market.
  

While policymakers urgently need to drive digitalization, streamline regulatory pathways, and reduce bureaucratic barriers, manufacturers and developers of CGTs also play a crucial role. By selecting partners with scalable, innovative solutions and advocating for more flexible regulatory frameworks, they can accelerate change from within the industry. Investors and financial stakeholders can further support the transformation by directing capital toward manufacturing innovation and infrastructure development. Achieving a globally competitive CGT ecosystem in Germany will require coordinated action across these groups, with each taking responsibility for the levers they can influence.

At Green Elephant Biotech, we are eager to play our part in achieving these goals. By developing a new generation of automated, scalable bioreactors for adherent cells, we contribute directly to making CGT manufacturing more efficient and cost-effective. Beyond technology, we are committed to building networks, supporting CGT companies and academia, and helping drive the broader changes needed to keep Germany at the forefront of biomanufacturing.

References

(1) Patrick-Brown TDJH, Bourner J, Kali S, Trøseid M, Yazdanpanah Y, Olliaro P, Olsen IC. Experiences and challenges with the new European Clinical Trials Regulation. Trials. 2024 Jan 2;25(1):3. doi: 10.1186/s13063-023-07869-x. PMID: 38167484; PMCID: PMC10759753.

(2) Reinke, Petra -2025 RedMedForum Keynote “CGT – challenges for academic research, development and translation into the clinic”, Charité