European Biotechs Developing Next-Generation Cell and Gene Therapy Manufacturing Technologies

Europe is emerging as a key player in next-generation cell and gene therapy (CGT) production, driven by collaborative research networks, public-private partnerships, and specialized hubs of innovation that leverage artificial intelligence (AI) to streamline CGT production and automate batch recording and data analysis.1 The European CGT market may exceed US$11.8 billion by 2035, delivering a compound average growth rate of 18.2% from 2025 to 2035, fuelled by the development of novel chimeric antigen receptor (CAR-T), gene-edited medicines, and regenerative therapies (see Figure).

Scaling Up CGT Production

Europe leads in research and early innovation with more than 250 advanced therapy medicinal product (ATMP) clinical trials and a strong biotech presence in the United Kingdom, Belgium, France, Germany, and Switzerland.2 However, it still trails the United States in commercialization and manufacturing, while Asia, especially China, South Korea, and Singapore, is rapidly building low-cost biomanufacturing facilities.2 Scaling up CGT production presents technical challenges, and European manufacturers have been focusing on applying advanced manufacturing techniques to meet the growing demand for innovative CGTs.3

Currently, the cost of goods (CoGs) for CGTs ranges from 55% to 70% of the total cost of a therapy, depending on material costs, consumables, capital, and labour.4,5 For CAR-T treatments, manufacturing costs alone can exceed €60,000 per patient, depending on the production model.2 At the same time, global manufacturing capacity has fallen dramatically short of demand.6 Bridging this gap will require creative and innovative delivery models, such as increased automation, closed processes, decentralized manufacturing, and point-of-care solutions.7,8

What Is the Current Investment in CGTs?

Investment activity in CGTs increased following the European Medicines Agency (EMA) approval of CAR-T therapies, Kymriah (tisagenlecleucel) and Yescarta (axicabtagene ciloleucel)to treat haematological cancers in 2018. Many major pharmaceutical companies expanded their presence through acquisitions and partnerships (Table). Funding has declined in recent years, and the European CGT sector has experienced significant consolidation and strategic alliances as biotech firms, contract development and manufacturing organizations (CDMOs), and pharmaceutical companies seek to secure manufacturing capacity, viral vector technologies, and scalable production platforms.9 The commercialization of these life-changing medicines remains a challenge, in part due to their high production costs, regulatory complexities and limited scalability.3

Leading European biotechnology companies are developing next-generation manufacturing. Several European biotechnology companies are at the forefront of this transition, including the following:

• Autolus Therapeutics, UK, develops programmable CAR-T therapies using modular engineering to enhance safety and persistence in blood cancers. Its manufacturing strategy focuses on streamlined autologous production with integrated analytics to cut turnaround times. Autolus merges clinical development with vertically integrated manufacturing, forming a hybrid biotech-commercial model. Autolus has forged numerous partnerships with industry and academic partners, including Blackstone Life Sciences (2021), Moderna (2021), Bristol Myers Squibb (2022), Cabaletta Bio (2023), BioNTech (2024), and the University College London to develop next-generation CGTs.17
• Ori Biotech, UK, focuses on manufacturing technology, leveraging its closed-loop automated CGT platform to support decentralized manufacturing. In 2022, the company raised US$100 million in Series B funding to launch its CGT manufacturing platform.18
• Oxford Biomedica, UK, is a leading European viral vector manufacturer. It provides lentiviral vector development and production to CGT developers through a CDMO model. The platform focuses on scalable, standardized vector production to maintain a reliable supply of viral vectors. In January 2024, it acquired ABL Europe to expand its viral vector footprint in Europe.15
• Quell Therapeutics, UK, was founded by Syncona Ltd in June 2018. It focuses on process optimization and quality-by-design manufacturing methods.19 The company is leveraging its pioneering Foxp3 Phenotype Lock technology, multi-modular platform, and integrated manufacturing capabilities to design and develop a pipeline of highly engineered regulatory T-cell (Treg) therapies to treat autoimmune and inflammatory diseases. In 2021, the company raised US$204 million in Series A and B financing and has since established partnerships with Cellistic (2022), AstraZeneca (2023), and AGC Biologics (2025).20 In March 2026, it initiated a phase 1/2 clinical trial with its autologous CAR-Treg therapy, QEL-005, in patients with rheumatoid arthritis and systemic sclerosis.21
• Touchlight Genetics, UK, was founded in 2007 and is a market leader in cell-free enzymatic manufacturing. Ituses its synthetic DNA platform, dbDNAtechnology, to synthesise “doggybone DNA”, an alternative to plasmid DNA. This method accelerates production, reduces contamination risks, and enhances scalability for messenger RNA (mRNA) vaccines, viral vectors, and gene editing. In March 2023, it secured £14 million from the UK government to scale up its DNA manufacturing and has signed agreements with Lonza (2022), Pfizer (2022), Voyager (2022), 20Med Therapeutics (2023), Curia (2023), GlaxoSmithKline (2024), LenioBio (2024), and Ceva Animal Health (2025).22
• TreeFrog Therapeutics, France, has developed the proprietary C-Stem technology for large-scale stem cell expansion in bioreactors. This could lower manufacturing costs for regenerative medicine and allogeneic therapies.23 It focuses on scalable allogeneic production, supporting the industry shift to off-the-shelf treatments for wider commercialization. In April 2024, TreeFrog signed a licensing deal with Vertex Pharmaceuticals for an exclusive licence to C-Stemfor the Type 1 Diabetes programme.14 In May 2025, TreeFrog secured €30 million in financing from the EIB to accelerate the development of its CGT platform.23

Emerging Trends in CGT Manufacturing

During the past five years, several trends in CGT manufacturing have emerged, such as the following:

• Automation of manufacturing processes: Companies like Ori Biotech, UK, have developed closed, automated systems to cut CoGs, ensure consistency, and enable decentralised manufacturing near hospitals. Novel manufacturing technologies are pivotal in Europe’s approach to cost-effectively and sustainably produce ATMPs, especially in autologous therapies, where production is complex and has hindered commercialization to date.
• Investment in platform technologies. Leading pharmaceutical companies and CDMOs have forged strategic alliances and acquired companies to expand their access to scalable manufacturing, vector optimization, and decentralized production, thereby supporting the simultaneous development and commercialization of multiple therapies.
• Europe is emerging as a global hub for viral vectors and DNA manufacturing. Many European countries have established CGT manufacturing innovation hubs, including the CGT Catapult Stevenage Manufacturing Innovation Centre in the UK, the DACH Region CGT Manufacturing Site in Germany, and NecstGen in the Netherlands, to drive precision manufacturing.24-26 Innovative biotechs such as Oxford Biomedica have forged strategic partnerships to leverage and advance their lentiviral vector production capabilities, while Touchlight Genetics has pioneered enzymatic DNA synthesis.
• The CGT manufacturing has become more competitive. US firms dominate CGT manufacturing; however, China is rapidly expanding its low-cost CGT infrastructure via government-backed policies. Europe has shifted from research-focused CGT to a more integrated manufacturing and commercial ecosystem, enabling Europe to build a scalable and resilient global supply chain.

To stay competitive, Europe is advancing regulatory modernization and initiatives to enhance supply chain resilience.27 Reforms to European pharmaceutical laws and biotech policy also aim to streamline trials, facilitate the use of AI, and improve manufacturing competitiveness.28 The proposed Critical Medicines Act (CMA) aims to boost European Union pharmaceutical manufacturing capacity, diversify supply chains, and promote strategic production projects via funding incentives and streamlined administrative processes.29 Although initially focused on essential medicines, the CMA may indirectly boost CGT manufacturing by aiding domestic infrastructure, reducing reliance on external suppliers, and promoting resilient procurement.

Future Competitiveness of Europe

While European companies have excelled in discovery and engineering, advances in manufacturing and commercialization are essential if Europe is to maintain its competitive edge. Europe’s CGT sector's future depends on industrialising innovation. Europe has started to centre on healthcare resilience and advanced manufacturing capabilities to reduce CoGs, expand patient access and maintain its leadership in next-generation biomedical technologies.30 During the next decade, decentralized networks, AI-driven quality systems, continuous bioprocessing, and automated platforms will help reduce costs and expand access to CGTs. With supportive regulation and coordinated industrial policy, European manufacturers could close the gap with the US and become global leaders in resilient, next-generation CGT manufacturing.

References

1. Towards Health. Europe Cell and Gene Therapy Market to Rise at 18.2% CAGR till 2035. 20 April 2026. https://www.towardshealthcare.com/insights/europe-cell-and-gene-therapy-market-sizing
2. Phacilitate, European CGT Commercialisation Gap: Challenges in Cell & Gene Therapy Europe. 23 April 2026. https://www.phacilitate.com/insights-resources/european-cgt-commercialisation-gap
3. Langhauser K. 2025 cell and gene challenges: Scalability, supply chain and manufacturing. Cell Gene Therapy Review.com. 3 February 2025. https://www.cellgenetherapyreview.com/3975-Featured-Articles/617533-2025-cell-and-gene-challenges-Scalability-supply-chain-and-manufacturing/
4. Weltin A.L. et al. Industrializing CAR-T cell therapy: impact of automation on cost and space efficiency of manufacturing facilities. Frontiers in Bioengineering and Biotechnology. 2026; 13. doi:10.3389/fbioe.2025.1612248
5. Liberthal R.D. et al. Cost of Goods Sold Analysis for Manufacturing mRNA-Based Cell and Gene Therapies. 8 May 2026. medRxiv https://www.medrxiv.org/content/10.64898/2026.05.04.26352406v2
6. Bioplan. 22nd Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production. 2025. Accessed 22 May 2026. https://www.bioplanassociates.com/22nd/
7. Mirasol F.Why flexibility and commercial viability must be built-in early for scaling CGTs. BioPharm International. 7 October 2025. https://www.biopharminternational.com/view/why-flexibility-and-commercial-viability-must-be-built-in-early-for-scaling-cgts
8. Slabodkin, S. Cell and gene therapy manufacturing challenges to persist in 2025. Pharma Manufacturing. 23 December 2024. https://www.pharmamanufacturing.com/all-articles/article/55251398/cell-and-gene-therapy-manufacturing-challenges-to-persist-in-2025
9. EMA. First two CAR-T cell medicines recommended for approval in the European Union | European Medicines Agency. 29 June 2018. https://www.ema.europa.eu/en/news/first-two-car-t-cell-medicines-recommended-approval-european-union
10. Ori Biotech, Cell Therapies and AdAlta join forces to tackle cell therapy manufacturing challenges. News release. 21 April 2026. https://oribiotech.com/press-releases/oribiotech-cell-therapies-and-adalta-join-forces-to-tackle-cell-therapy-manufacturing-challenges
11. Ori Biotech and Fresenius Kabi collaborate to advance modular, scalable manufacturing of cell and gene therapies. News release. 10 December 2024. https://oribiotech.com/press-releases/ori-biotech-and-fresenius-kabi-collaborate-to-advance-modular-scalable-manufacturing-of-cell-and-gene-therapies
12. WuXi AppTec completes acquisition of OXGENE to strengthen cell & gene therapy service offerings. News Release. 2 March 2026. https://www.wuxiapptec.com/news/wuxi-news/4493
13. AskBio and Touchlight restructure joint centure. News release. 8 February 2022. https://www.askbio.com/askbio-and-touchlight-restructure-joint-venture/
14. Vertex and TreeFrog therapeutics announce licensing agreement and collaboration to optimize production of Vertex’s cell therapies for type 1 diabetes. News release. 23 April 2024. https://investors.vrtx.com/news-releases/news-release-details/vertex-and-treefrog-therapeutics-announce-licensing-agreement
15. Oxford Biomedica completes acquisition of ABL Europe. News release. 29 January 2024 https://oxb.com/news/oxford-biomedica-completes-acquisition-of-abl-europe/
16. AstraZeneca to acquire EsoBiotec to advance cell therapy ambition. News release. 17 Mar. 2025. https://www.astrazeneca.com/media-centre/press-releases/2025/astrazeneca-to-acquire-esobiotec.html
17. Autolus. Partners. Accessed May 2026. https://www.autolus.com/about-us/our-partners/
18. Ori Biotech raises over $100 million in Series B funding to launch innovative cell and gene therapy manufacturing platform. News release. 18 January 2022. https://oribiotech.com/press-releases/ori-biotech-raises-over-100-million-in-series-b-funding-to-launch-innovative-cell-and-gene-therapy-manufacturing-platform
19. Quell Therapeutics. Transforming lives in immune-mediated disease. Accessed May 2026. https://www.quell-tx.com/?part=manufacturing
20. Quell Therapeutics. News & Media. Accessed May 2026. https://www.quell-tx.com/news
21. Quell Therapeutics initiates CHILL phase 1/2 trial of novel QEL-005 CAR Treg therapy in refractory rheumatoid arthritis and systemic sclerosis following UK CTA approval. New release. 3 March 2026. https://www.quell-tx.com/news/quell-therapeutics-initiates-chill-phase-1-2-trial
22. Touchlight. News & Events. Accessed 22 May 2026. https://touchlight.com/news-events/
23. Treefrog Therapeutics secures €30 million from EIB, marking a significant milestone in the company’s journey to accelerate the field of cell therapy. Partnerships. 27 May 2025. https://www.eib.org/en/press/all/2025-222-treefrog-therapeutics-secures-eur30-million-from-eib-eib-marking-a-significant-milestone-in-the-company-s-journey-to-accelerate-the-field-of-cell-therapy
24. LinkedIn. CGT Manufacturing in DACH: Europe's Answer to the Global CGT Challenge. 4 February 2026. https://www.linkedin.com/pulse/cgt-manufacturing-dach-europes-answer-global-challenge-imapac-grnre/
25. Facilities - Cell and Gene Therapy. Accessed 22 May 2026. https://ct.catapult.org.uk/facilities?facility=stevenage
26. NecstGen Accessed 22 May 2026. https://necstgen.com/
27. Izeta A and Cuende N. Regulation of advanced therapies in Europe: Are we on the right track? Cell Stem Cell. 30, 8, 3 August 2023. 1013-1016. doi: 10.1016/j.stem.2023.07.004
28. EMA. Reform of EU pharmaceutical legislation. ec.europea.eu. December 2025. https://health.ec.europa.eu/medicinal-products/reform-eu-pharmaceutical-legislation_en
29. European Commission. Critical Medicines Act - Public Health. ec.europea.eu. March 2025. https://health.ec.europa.eu/medicinal-products/critical-medicines-act_en
30. Soros Gabinete. Europe Is Scaling Investment in Regenerative Medicine. 12 May 2026. www.sorosgabinete.com/insights/europe-is-scaling-investment-in-regenerative-medicine

About the Author

Cheryl Barton, PhD, is founder and director of PharmaVision, Pharmavision.co.uk.