On 12 May 2026, the European Commission (EC) welcomed the landmark policy agreement on the Critical Medicines Act (CMA).

 The proposed EC CMA is one of the most significant industrial policy measures in the European pharmaceutical sector in recent decades. Launched in March 2025 as part of the larger European Health Union initiative, the CMA seeks to improve the availability, manufacturing, and supply security of essential medicines throughout the European Union (see 

 The initiative was launched in reaction to ongoing medicine shortages, geopolitical unrest, and insights gained from the COVID-19 pandemic, highlighting Europe’s reliance on external providers for APIs and essential medicines.

The CMA significantly shifts the strategic focus of pharmaceutical manufacturing in Europe. Traditionally, procurement processes in many European Union countries emphasized low costs, often favouring large-scale offshore production in Asia, especially in China and India.

 The new framework emphasizes supply security, resilience, diversification, and regional manufacturing capacity. During the next 5-10 years, this policy shift is likely to impact pharmaceutical development strategies, manufacturing sites, procurement approaches, and investment decisions throughout the European life sciences sector.

From Cost Efficiency to Supply Resilience

A key transformation in the CMA is shifting from procurement systems focused mainly on price competition. The CMA now includes resilience-related criteria, enabling EU governments to prioritize suppliers that have diversified and secured manufacturing networks, contingency capacity, and production within Europe.

 This change is likely to impact pharmaceutical economics throughout Europe. Manufacturers that once relied on highly centralized production outside Europe might now experience strategic pressure to regionalize parts of their manufacturing processes. Companies producing antibiotics, sterile injectables, insulin, vaccines, and other essential medicines may need to invest more in European API synthesis, fill-finish processes, and packaging to stay competitive in EU tenders.

The policy also promotes “strategic projects” that benefit from expedited regulatory processes, simplified access to financing, and possible state aid.

 These incentives could greatly reduce obstacles for manufacturers aiming to set up domestic or regional production in Europe. In practical terms, this suggests that the pharmaceutical sector might favour more modular manufacturing approaches instead of depending on a few large global production centres.

Implications for Decentralized and Distributed Manufacturing

The CMA might significantly accelerate investment in decentralized or distributed pharmaceutical manufacturing systems. Traditionally, pharmaceutical production has favoured very large central facilities to maximize economies of scale. Yet these plants are susceptible to supply disruptions, transport delays, trade conflicts, pandemics, and regional political instability. Distributed manufacturing offers an alternative, with smaller, modular facilities located closer to demand centres. These facilities can quickly adjust production levels and switch products during emergencies. Within the CMA framework, this flexibility is strategically important because resilience delivers economic and regulatory benefits.

According to Carol Houts, CEO of Germfree, Belgium/US, “The CMA signals a shift in how Europe thinks about pharmaceutical manufacturing. In the past, strategies have predominantly focused on cost optimization, global sourcing, and consolidated supply chains. The CMA is really moving towards resilience, regional capacity, supply security, and the ability to respond when global systems are disrupted.”

Advanced continuous manufacturing technologies are especially important here.

 They reduce plant size, lower inventory needs, and enable flexible production scaling. Unlike traditional batch methods, modular continuous systems can usually be set up more quickly and duplicated across different sites.

 In the coming decade, Europe is likely to see heightened investment in modular API production facilities, portable fill-finish systems, and hybrid digital manufacturing networks. This trend corresponds with wider European industrial policy aims centred on “strategic autonomy.”

 Policymakers are increasingly concerned that over 80% of certain antibiotic APIs used in Europe are sourced from Asia.

 A manufacturing network spread across multiple locations can help reduce risks linked to export bans, shipping delays, or regional emergencies.

Modular Manufacturing and Rapid Deployment Capacity

The CMA’s focus on preparedness and supply continuity highlights the potential benefits of modular and quickly deployable manufacturing facilities. Modular manufacturing uses prefabricated units that can be installed, expanded, or relocated more quickly than conventional pharmaceutical plants. These systems could be particularly useful during health emergencies or supply shortages. Modular manufacturing platforms are currently under consideration for vaccines, sterile injectables, biologics, and advanced therapy medicinal products (ATMPs). Looking ahead, the CMA might encourage public-private partnerships to invest in additional manufacturing infrastructure spread across multiple EU member states.

 These facilities could operate at reduced capacity during regular times but quickly ramp up production in emergencies.

Digitalization will play a key role in this transformation. Technologies such as automation, process analytical technologies (PAT), and AI-driven quality monitoring can help smaller facilities achieve regulatory compliance similar to large centralized plants.

 This approach may lower operational risks and support distributed production across different locations. The advantages go beyond just resilience. Decentralized manufacturing has the potential to shorten lead times, cut transportation emissions, and enhance medicine availability in smaller or underserved European markets. Nevertheless, implementing these systems will require significant harmonization of regulatory oversight, workforce training, cybersecurity infrastructure, and quality assurance frameworks across EU member states.

The CMA also encourages collaborative procurement and cross-border cooperation among member states.

 This collaborative approach could expand into manufacturing ecosystems that include pharmaceutical firms, contract development and manufacturing organizations (CDMOs), hospital networks, academic institutions, and regional health systems. These collaborative approaches could be particularly vital for advanced therapies, personalized medicines, and niche critical drugs, where production volumes are low but clinical need is urgent. Regional manufacturing clusters might integrate local production with shared logistics, digital infrastructure, and clinical services.

“Over the next 5 to 10 years, we'll see a shift as European manufacturers and health systems start to work more collaboratively, geographically,” Houts agrees. “Global supply chain issues are not necessarily confined to a single region, and challenges may differ across regions worldwide. It's going to require strong support from countries and initiatives to bring these manufacturing capabilities to fruition, particularly in APIs. APIs are quite inexpensive to produce at scale in places like India and China, but reproducing them in Europe or the United States is extremely expensive.”

For instance, collaborations between pharmaceutical companies and hospital-based manufacturing centres can facilitate decentralized production of cell and gene therapies. Because these treatments typically have very short shelf lives and require highly personalized manufacturing, producing them closer to patients could help minimize transport delays and maintain product quality. The CMA may promote the creation of resilient manufacturing ecosystems instead of standalone production facilities.

 In this approach, pharmaceutical resilience relies not just on physical plants but also on collaborative networks that can quickly coordinate supply, demand forecasting, and emergency response.

Implications for Advanced Therapies and Point-of-Care Production

Over the next decade, the CMA could serve as a key driver for advanced manufacturing technologies and point-of-care pharmaceutical production. Cell and gene therapies are already challenging traditional centralized manufacturing models, as they are often patient-specific, time-sensitive, and logistically complex. Point-of-care manufacturing refers to the creation of therapies directly within or near hospitals and treatment centres. The CMA’s focus on regional resilience and localized production could naturally support this growing approach. Europe might increasingly invest in small, automated manufacturing systems designed to produce autologous cell therapies near the patient’s bedside.

Similarly, modular manufacturing systems for small molecules could involve providing mini factories, in which highly automated facilities generate essential medicines on demand at regional levels.

 These systems might heavily depend on continuous flow chemistry, robotics, and digital quality management. Regulatory frameworks will need to adapt accordingly. The European Medicines Agency is already emphasising manufacturing resilience and digital innovation.

Upcoming European regulations might become more flexible, supporting decentralized manufacturing validation, remote monitoring, and real-time release testing. Importantly, the CMA does not suggest Europe achieve total pharmaceutical self-sufficiency. International collaborations continue to be a component of the strategy.

 Nonetheless, there is a notable move towards diversification and less reliance on single external suppliers.

The CMA represents a significant strategic change in European pharmaceutical policy. Instead of seeing medicines merely as market commodities, the EU now considers them vital public health resources that need a robust regional infrastructure. In the coming 5-10 years, this transition is expected to boost investments in European manufacturing capacity, decentralized production systems, modular facilities, and collaborative pharmaceutical networks.

“I think that distributed manufacturing, whether through regional manufacturing hubs or point-of-care, is going to be necessary to address both drug shortages and expand access,” says Houts.

For pharmaceutical manufacturers, the CMA could fundamentally reshape the basis of competitive advantage. Factors such as supply resilience, geographic diversification, digital manufacturing capabilities, and regional integration might become as vital as manufacturing cost efficiency. Companies that integrate advanced manufacturing technologies with flexible regional supply networks are likely to gain a competitive edge in the evolving European regulatory and procurement landscape. At the same time, the CMA could accelerate the adoption of modular manufacturing, continuous processing, and point-of-care production technologies, particularly for advanced therapies and essential medicines. If implemented effectively, the CMA could position Europe as a global leader in resilient pharmaceutical manufacturing, enhancing long-term medicine security for European patients.

EMA. EMA welcomes political agreement on the Critical Medicines Act

12 May 2026. https://ec.europa.eu/commission/presscorner/detail/en/ip_26_1017

 11 March 2025. https://health.ec.europa.eu/publications/proposal-critical-medicines-act_en

Critical Medicines Act: Council agrees its position on new rules to tackle shortages

 2 December 2025. https://www.consilium.europa.eu/en/press/press-releases/2025/12/02/critical-medicines-act-council-agrees-its-position-on-new-rules-to-tackle-shortages/pdf

Critical Medicines Act: Council and Parliament reach provisional deal

https://www.consilium.europa.eu/en/press/press-releases/2026/05/12/critical-medicines-act-council-and-parliament-reach-provisional-deal/pdf

EU announces plans to cut reliance on Asia for antibiotics and critical drugs

https://www.reuters.com/business/healthcare-pharmaceuticals/eu-announces-plans-cut-reliance-asia-antibiotics-other-critical-drugs-2025-03-11

https://health.ec.europa.eu/medicinal-products/critical-medicines-act_en

EU agrees draft deal to tackle essential medicine shortages

https://www.reuters.com/sustainability/boards-policy-regulation/eu-reaches-provisional-deal-address-shortage-essential-medicines-2026-05-12

Modular and reconfigurable factories for continuous production innovation in pharmaceutical manufacturing.

https://doi.org/10.1080/00207543.2025.2575844

Regulatory perspectives on continuous pharmaceutical manufacturing

https://doi.org/10.1016/j.xphs.2017.06.015

Schaber S.D., et al. Economic analysis of integrated continuous and batch pharmaceutical manufacturing: a case study.

 2011;50(17):10083-10092. https://www.research.ed.ac.uk/en/publications/economic-analysis-of-integrated-continuous-and-batch-pharmaceutic/

Future of pharmaceutical industry in Europe: Addressing strategic autonomy, API production, affordable medicines and unmet needs.

https://www.eesc.europa.eu/en/our-work/opinions-information-reports/opinions/future-pharmaceutical-industry-europe-addressing-strategic-autonomy-api-production-affordable-medicines-and-unmet-needs/related-links-ccmi-212

New CMA proposals to drive growth, investment and business confidence. Competition and Markets Authority

. Blog. 13 February 2025. https://competitionandmarkets.blog.gov.uk/2025/02/13/new-cma-proposals-to-drive-growth-investment-and-business-confidence/

Regulatory and quality considerations for continuous manufacturing

The Industrial Forum. Advanced Manufacturing at the heart of a resilient, sustainable and competitive Europe. Recommendations by the EU Industrial Forum. 12 June 2023. 

tf5-report-final-version--12.06.2023-3.pdf

Modulus: Redefining Biopharma Manufacturing

. 8 October 2025. Accessed 25 May 2026. https://www.sanofi.com/en/magazine/ai-in-healthcare/modulus-redefining-the-future-of-biopharma-manufacturing

. 18 June 2025. Accessed 25 May 2026. https://www.eesc.europa.eu/en/our-work/opinions-information-reports/opinions/critical-medicines-act

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

Articles

The EU’s Critical Medicines Act signals a major industrial-policy pivot from lowest-cost sourcing to supply security for essential medicines. Resilience criteria in procurement, coupled with incentives for “strategic projects,” are expected to drive investment in European API, fill-finish, and packaging capacity. The framework favors decentralized and modular manufacturing, continuous processing, and digitally enabled quality oversight to improve agility during disruptions. Cross-border collaboration and manufacturing ecosystems may expand, with particular relevance for vaccines, antibiotics, sterile injectables, and point-of-care cell and gene therapies.

Regulatory Watch

The CMA will improve Europe’s manufacturing resilience and lead to greater diversification and reduced reliance on single external suppliers.

The Critical Medicines Act’s Impact on Pharmaceutical Manufacturing and Supply Resilience in Europe

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 innovation hubs that leverage artificial intelligence (AI) to streamline CGT production and automate batch recording and data analysis.

 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 T-cell (CAR T) therapies, gene-edited medicines, and regenerative therapies (see 

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.

 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.

 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.

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.

 For CAR T treatments, manufacturing costs alone can exceed €60,000 per patient, depending on the production model.

 At the same time, global manufacturing capacity has fallen dramatically short of demand.

 Bridging this gap will require creative and innovative delivery models, such as increased automation, closed processes, decentralized manufacturing, and point-of-care solutions.

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 (

). 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.

The commercialization of these life-changing medicines remains a challenge, in part due to their high production costs, regulatory complexities, and limited scalability.

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

, 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.

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.

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.

 was founded by Syncona Ltd in June 2018. It focuses on process optimization and quality-by-design manufacturing methods.

 The company is leveraging its pioneering Foxp3 Phenotype-Locked technology, multimodular 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).

 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.

was founded in 2007 and is a market leader in cell-free enzymatic manufacturing. It uses its synthetic DNA platform, dbDNA technology, 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), GSK (2024), LenioBio (2024), and Ceva Animal Health (2025).

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.

 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-Stem for Vertex’s type 1 diabetes programme.

 In May 2025, TreeFrog secured €30 million in financing from the European Investment Bank to accelerate the development of its CGT platform.

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

: 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.

. 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.

 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.

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.

 Reforms to European pharmaceutical laws and biotech policy also aim to streamline trials, facilitate the use of AI, and improve manufacturing competitiveness.

 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.

 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.

While European companies have excelled in discovery and engineering, advances in manufacturing and commercialization are essential if Europe is to maintain its competitive edge. The future of Europe’s CGT sector depends on industrialising innovation. Europe has started to centre on health care resilience and advanced manufacturing capabilities to reduce CoGs, expand patient access, and maintain its leadership in next-generation biomedical technologies.

 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.

Europe cell and gene therapy market government funding and EMA approvals.

 20 April 2026. https://www.towardshealthcare.com/insights/europe-cell-and-gene-therapy-market-sizing

European CGT commercialisation gap: challenges in cell & gene therapy Europe.

 23 April 2026. https://www.phacilitate.com/insights-resources/european-cgt-commercialisation-gap

2025 cell and gene challenges: Scalability, supply chain and manufacturing.

 3 February 2025. https://www.cellgenetherapyreview.com/3975-Featured-Articles/617533-2025-cell-and-gene-challenges-Scalability-supply-chain-and-manufacturing/

Weltin AL, De Graaf Y, Goudarzi A, et al. 

Industrializing CAR-T cell therapy: impact of automation on cost and space efficiency of manufacturing facilities.

Liberthal RD, Buontempo P, Harmon B, Omosule A, Washabaugh M, Whittaker A. 

Cost of goods sold analysis for manufacturing mRNA-based cell and gene therapie

https://www.medrxiv.org/content/10.64898/2026.05.04.26352406v2

2025 22nd Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production

. 2025. Accessed 22 May 2026. https://www.bioplanassociates.com/22nd/

Why flexibility and commercial viability must be built-in early for scaling CGTs.

https://www.biopharminternational.com/view/why-flexibility-and-commercial-viability-must-be-built-in-early-for-scaling-cgts

Cell and gene therapy manufacturing challenges to persist in 2025.

 23 December 2024. https://www.pharmamanufacturing.com/all-articles/article/55251398/cell-and-gene-therapy-manufacturing-challenges-to-persist-in-2025

First two CAR-T cell medicines recommended for approval in the European Union

. News Release. European Medicines Agency; 29 June 2018. https://www.ema.europa.eu/en/news/first-two-car-t-cell-medicines-recommended-approval-european-union

Oribiotech, Cell Therapies and AdAlta join forces to tackle cell therapy manufacturing challenges.

 News release. Oribiotech; 21 April 2026. https://oribiotech.com/press-releases/oribiotech-cell-therapies-and-adalta-join-forces-to-tackle-cell-therapy-manufacturing-challenges

Ori Biotech and Fresenius Kabi collaborate to advance modular, scalable manufacturing of cell and gene therapies. News release. Ori Biotech; 10 December 2024. https://oribiotech.com/press-releases/ori-biotech-and-fresenius-kabi-collaborate-to-advance-modular-scalable-manufacturing-of-cell-and-gene-therapies

WuXi AppTec completes acquisition of OXGENE to strengthen cell and gene therapy service offerings.

 News Release. 2 March 2026. https://www.wuxiapptec.com/news/wuxi-news/4493

AskBio and Touchlight restructure joint venture. News release. AskBio; 8 February 2022. https://www.askbio.com/askbio-and-touchlight-restructure-joint-venture/

Vertex and TreeFrog Therapeutics announce licensing agreement and collaboration to optimize production of Vertex’s cell therapies for type 1 diabetes

. News release. Vertex Pharmaceuticals; 23 April 2024. https://investors.vrtx.com/news-releases/news-release-details/vertex-and-treefrog-therapeutics-announce-licensing-agreement

Oxford Biomedica completes acquisition of ABL Europe.

 News release. Oxford Biomedica; 29 January 2024. https://oxb.com/news/oxford-biomedica-completes-acquisition-of-abl-europe/

AstraZeneca to acquire EsoBiotec to advance cell therapy ambition.

 News release. AstraZeneca; 17 March 2025. https://www.astrazeneca.com/media-centre/press-releases/2025/astrazeneca-to-acquire-esobiotec.html

 Accessed May 2026. https://www.autolus.com/about-us/our-partners/

Ori Biotech raises over $100 million in Series B funding to launch innovative cell and gene therapy manufacturing platform.

 News release. Ori Biotech; 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

Transforming lives in immune mediated disease.

 Accessed May 2026. https://www.quell-tx.com/?part=manufacturing

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. News release. Quell Therapeutics; 3 March 2026. 

https://www.quell-tx.com/news/quell-therapeutics-initiates-chill-phase-1-2-trial

 Accessed 22 May 2026. https://touchlight.com/news-events/

France: Treefrog Therapeutics secures €30 million from EIB marking a significant milestone in the company’s journey to accelerate the field of cell therapy.

 European Investment Bank; 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

. 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/

https://ct.catapult.org.uk/facilities?facility=stevenage

. Accessed 22 May 2026. https://necstgen.com/

Regulation of advanced therapies in Europe: are we on the right track?

. 2023;30(8): 1013-1016. doi: 10.1016/j.stem.2023.07.004

 December 2025. https://health.ec.europa.eu/medicinal-products/reform-eu-pharmaceutical-legislation_en

 March 2025. https://health.ec.europa.eu/medicinal-products/critical-medicines-act_en

Europe is scaling investment in regenerative medicine.

 12 May 2026. www.sorosgabinete.com/insights/europe-is-scaling-investment-in-regenerative-medicine

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

Europe is positioning itself as a next-generation CGT manufacturing center, underpinned by dense research networks, public–private partnerships, and innovation hubs deploying AI for process control and data automation. Despite strong ATMP trial activity, commercialization lags the US and faces intensifying cost competition from Asia. High CoGs—often 55%–70% of total therapy costs—and constrained capacity are driving investment toward automation, closed systems, decentralized/point-of-care models, and scalable vector/DNA platforms. Regulatory modernization and industrial policy may improve resilience and competitiveness.

European Frontrunners

European biotechnology companies are increasing patient access to innovative cell and gene therapies through decentralized next-generation manufacturing platforms. 

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

Click here to read the PharmTech Europe June 2026 issue.