Cheryl Barton is director of PharmaVision, 

Cheryl Barton

Fluorescent Imaging immunofluorescence of cancer cells growing in 2D with nuclei in blue, cytoplasm in red and DNA damage foci in green | Image Credit: ©drimafilm - stock.adobe.com

Live-cell imaging techniques offer dynamic, spatio-temporal insights into cellular processes and provide a comprehensive, 

cost-effective way to objectively examine drug effects across different cellular models 

(1). When used with fluorescence reporters or label-free methods alongside artificial intelligence (AI)/machine learning (ML) techniques, it can deliver detailed phenotypic screening, enabling thorough compound profiling, understanding mechanisms of action (MoA), enhancing translational predictivity, and speeding up lead optimization (

Figure 1: Key advantages of utilising live cell imaging in driving drug discovery. Source: modified from references 2,3. Figure courtesy of the author.

Which European frontrunners are leading the field in live-cell imaging technologies?

Several European biotechs, including Cellbox Labs, Evotec SE, Nanolive SA, and Salipro Biotech AB, have developed innovative high-throughput screening methods to improve 

 translation (IVIVE) and accelerate the discovery of new chemical entities (NCEs) for clinical evaluation.

was founded in 2020 by Artūrs Ābols, Gatis Mozoļevskis, and Roberts Rimša. The company focuses on developing modular “organ-on-chip” (OOC) systems to improve drug discovery, in which endothelial and epithelial layers are stacked in vertical channels separated by permeable membranes, enabling organ modelling in a controlled environment. The company has developed various OOCs, including the blood-brain barrier, kidney, gut, lung, and pancreas, to accurately predict individual responses to drugs, food, and probiotics (4). The OOCs can be mass-produced to enhance reproducibility and cost-efficiency, and can be scaled up from 8 to 24 chips, if needed.

In 2024, Cellbox raised a pre-seed round of €935,000 led by Latvian Buildit VC, with participation from LatBAN angels, ASP Asset Management AIFP, and private investor Ansis Spridzans (5). In August 2025, Cellbox attracted a further €3.3 million in funding from Tech4Cure, a state-funded Important Project of Common European Interest (IPCEI). These funds will be used to expand Cellbox’s OOC high-throughput technology and to integrate biological sensors for improved IVIVE (6). Earlier this year, Cellbox Labs began a collaboration with the Latvian Biomedical Research and Study Centre, KTH Royal Institute of Technology, Teadusmosaiik OÜ, and Fewer Moving Parts to develop a first-in-class vascularised Gut-Brain-Axis (GBA) on-chip platform, a multi-OOC model that, if successful, could have significant applications in real-world drug evaluation (7).

In August 2025, Cellbox forged a collaboration with Altis Biosystems to scale an automated, gut-on-chip model using iPSCs and patient-derived microbiota, and it plans to integrate oxygen and pH sensors directly into the OOC to provide more detailed analysis for AI-driven drug discovery (7). Cellbox is also leveraging its pancreatic islet OOC to assess and benchmark biosimilars and glucagon-like protein 1 (GLP-1) generics under dynamic flow conditions, and compare the data generated with traditional 

 animal models to help improve biosimilar testing. In addition, Cellbox Labs is working with ESQlabs and MPSlabs to develop digital twin models to enhance the predictive power of the OOC platforms for human outcomes. Overall, these next-generation OCCs could improve the translational prediction of compound effects compared to classic monolayer cultures and help de-risk and accelerate preclinical drug development (8).

using induced pluripotent stem cell (iPSC) screening

 to model human diseases and enable patient-specific drug testing. Initially, the company focused on 2D cultures to improve translational prediction and is now investigating more physiologically relevant models, including multilineage cultures, organoids, and co-cultures, to improve fidelity. The proprietary platforms integrate live-cell imaging with iPSC-derived cell types for specific conditions, including neurodegenerative and metabolic diseases (9). Evotec has leveraged its iPSC phenotypic screening and imaging platform to establish strategic collaborations with biopharma. In January 2022, Boehringer Ingelheim (BI) entered a partnership with Evotec to combine its PanOmics Platform with iPSC-based disease modelling and phenotypic screening to identify novel candidates for vision-related diseases (10). In the second quarter of 2025, Evotec reported key advancements in its neuroscience collaboration with Bristol Myers Squibb, resulting in a US$20 million research payment to the company. To date, the company has received US$75 million in programme-based payments, and two partnered assets have entered Phase II clinical trials (11).

Evotec has also established collaborations with Esperon and identified a preclinical candidate for the treatment of Primary Sclerosing Cholangitis. Another partner, Dewpoint Therapeutics, submitted an investigational new drug (IND) application for a first-in-class condensate modulator, DPTX3186, for Wnt-driven cancers, earlier this year (12). In addition, Evotec Ventures funds translational projects with academia through its Biomedical Research, Innovation & Development Generation Efficiency (BRIDGE) model. Since its establishment, it has created eight BRIDGE partnerships and made three investments in start-ups (e.g., Autobalm Labs, ArgioBio, and Extend) (13). In November 2025, the company reported strong nine-month financial results. It announced a US$650 million deal for Sandoz to acquire its Just-Evotec Biologics (JEB) EU in Toulouse and license its continuous manufacturing platform technology. The company is cash-rich and is on target to deliver its strategic objectives, enhance its live cell offerings, and build strategic partnerships with biopharma to secure future growth (11).

provides label-free live-cell holotomographic imaging platforms that measure the quantitative refractive index of cells, enabling continuous imaging of living cells over long periods without fluorescent reporters. Its proprietary LIVE Cytotoxicity Assay and LIVE T Cell Assay can be combined with AI-powered analysis to determine interaction dynamics, viability, and organelle changes (14). This technology has the potential to accelerate the discovery of chimeric antigen receptor T (CAR-T), T-cell receptor T (TCR-T), bispecific antibodies, and other immunomodulators. For example, Pagliuca 

 deployed Nanolive’s technology to monitor real-time interactions between Vγ9Vδ2 T cells and tumour cells following treatment with BTN2A1-agonist antibody, which has potential in haematological and solid tumours (15). Nanolive continues to expand its offerings and, earlier in 2025, launched its Smart Mitochondrial AssayLIVE for real-time mitochondrial analysis, enabling researchers to evaluate metabolic function, cellular stress, and drug-induced toxicity. This assay could be a helpful addition for researchers evaluating NCEs targeting mitochondrial diseases and oncology (16).

develops nanomembrane-protein stabilisation technology, Salipro DirectMX, to improve the development of therapeutic antibodies and small molecules targeting membrane proteins, such as G-protein-coupled receptors (GPCRs), ion channels, and transporters (17). This technology can be used in downstream applications such as B-cell sorting, immunisation, mass spectrometry, phage display, radioligand binding, and other processes to facilitate drug discovery. In May 2023, 

screened and identified several small-molecule binders using the Salipro and DEL (DNA encoded library) platform, successfully discovering binders against a challenging membrane protein target. This partnership provided proof-of-concept data demonstrating that Salipro’s platform enhances the discovery of new drugs targeting previously undruggable proteins (18). Salipro published a paper with Bio-Rad Laboratories, showing that Salipro platform technology, combined with Bio-Rad’s Pioneer Platform, can generate a synthetic human antibody phage display library to identify several high-affinity antibodies targeting CXC chemokine receptor type 4 (CXCR4), which play a central role in immune-oncology (19). Salipro has formed strategic partnerships with AstraZeneca, Bayer, Boehringer Ingelheim, GlaxoSmithKline, and Merck, Sharp and Dohme (MSD) to unlock drug targets for various drug development programmes. BI signed a deal to utilize Salipro’s platform technology to accelerate target discovery in therapeutic areas such as mental health and cardio-renal-metabolic diseases (20). Salipro technology complements imaging and phenotypic tools and can support drug discovery, particularly for membrane-bound protein targets that have proven challenging to study using traditional methods.

Future opportunities in live-cell imaging in drug discovery

According to market research, the global live cell imaging market is projected to reach US$3.03 billion in 2024 and grow to approximately US$6.73 billion by 2034, with a compound annual growth rate (CAGR) of 8.30% from 2024 to 2034 (21). Live-cell imaging increasingly enables phenotypically and mechanistically informed, translationally relevant screening, aiding in drug discovery and personalised medicine. Additionally, regulators aim to phase out animal testing and promote the use of new approach methodologies, including OOCs and live-cell imaging, to evaluate the safety and efficacy of new medicines during non-clinical development (22). The integration of advanced cell models, sophisticated imaging, and AI/ML analytics is creating a new generation of discovery platforms that facilitate quicker identification, validation, and progression of NCEs into clinical trials. Cellbox Labs, Evotec, Nanolive, and Salipro Biotech are leading in Europe, offering diverse approaches to accelerate drug discovery and reduce biopharma’s investment in 

 studies. Over the coming years, platforms capable of combining scale, physiological relevance, mechanistic insight, and actionable decision-making will gain momentum in the market, leading to improved target/compound selection and ultimately a higher hit-to-clinical success ratio, thereby reducing late-stage drug attrition and supporting faster go/no-go decisions.

Mimori-Kiyosue, Y.; Koizumi, T.; Washio, T. Potential of High-Spatiotemporal Resolution Live Cell Imaging for Drug Discovery and Development. In: Satoh, H., Funatsu, K., Yamamoto, H. (eds) 

Drug Development Supported by Informatics

Carreras-Puigvert, J.; Spjuth, O. Artificial Intelligence for High Content Imaging in Drug Discovery. 

Chen, B.; Yin, Z.; Ng, B.W.; et al. Label-Free Live Cell Recognition and Tracking for Biological Discoveries and Translational Applications. 

Riga-based Developer of Industrial Organ-on-Chip Technology Cellbox Labs Raised €935K

Latvian BioTech Startup Cellbox Labs Lands €3.3 million for Organ-on-Chip Innovation without Animal Testing

Cellbox Labs Kicks Off Project Developing a First-in-Class Vascularized Gut-Brain-Axis-on-Chip Platform for Accelerating Research and Drug Discovery (GBA-Connect)

Zhou, L.; Huang, J.; Li, C.; et al. Organoids and Organs-on-Chips: Recent Advances, Applications in Drug Development, and Regulatory Challenges. 

Evotec Enters Ipsc-Based Drug Discovery Partnership With Boehringer Ingelheim In Ophthalmology

Evotec SE Reports 9M 2025 Results: Continued Strong Execution On Strategic Priorities

Evotec-Partner Dewpoint Therapeutics Announces An Open IND For First-In-Class Condensate Modulator DPTX3186 For Wnt-Driven Cancers

New Gen LIVE T Cell Assay » Nanolive - A Complete Solution For Your Label-Free Live Cell Imaging

Le Floch, A.C.; Imbert, C.; Boucherit, N.; et al. Targeting BTN2A1 Enhances Vγ9Vδ2 T-Cell Effector Functions and Triggers Tumor Cell Pyroptosis. 

Automatically Quantify the Dynamics of Live Mitochondrial Assays

Salipro Biotech and DyNAbind Announce Milestone Achievement in Collaboration to Enable DEL for Membrane Proteins.

Pioneer: a synthetic human antibody phage display library for rapid therapeutic lead generation

Salipro Biotech and Boehringer Ingelheim Enter Research and License Agreement to Accelerate Multiple Boehringer Ingelheim Pipeline Programs

Live Cell Imaging Market Size, Share, and Trends 2024 to 2034

Regulatory acceptance of new approach methodologies: how to interact with EMA

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

Articles

Live-cell imaging techniques, combined with AI/ML, are revolutionizing drug discovery by providing detailed phenotypic screening and enhancing translational predictivity. European companies like Cellbox Labs, Evotec SE, Nanolive SA, and Salipro Biotech AB are at the forefront, developing innovative technologies to improve in vitro–in vivo translation and accelerate new chemical entity discovery. These advancements are crucial as the global live-cell imaging market is projected to grow significantly, driven by the need for more efficient drug discovery methods and the phasing out of animal testing in favor of new approach methodologies.

Live cell phenotypic screening can enhance translational predictability and speed up lead optimization.

Live Cell High-Content Imaging Is Driving Drug Discovery

Landkarte *** Europa | Image credit: ©beugdesign - Stock.adobe.com

In September 2025, the European Commission (EC), together with the Heads of Medicines Agencies (HMA) and the European Medicines Agency (EMA), revealed two new goals for clinical trials to ensure Europe maintains its leadership in clinical research (1). By 2030, the European Union aims to:

Increase the number of multinational clinical trials by 100 annually; currently, an average of 900 are authorized each year.

Increase the speed of patient recruitment in clinical trials; currently, about 50% of trials recruit patients within 200 calendar days or less from the application submission date. The goal is to raise this to two-thirds (66%).

In early 2025, the United Kingdom (UK) government unveiled its plans to speed up clinical trials, unlock National Health System (NHS) data for research, and improve patient access to new treatments earlier (2). The global clinical trial arena is becoming increasingly competitive, serving as a significant revenue generator. According to market research, the global clinical trials market accounted for US$59 billion (€44 billion) in 2024 and is anticipated to grow from US$62.4 billion (€54.35 billion) in 2025 to US$98.9 billion (€86.15 billion) in 2034, growing at a compound annual growth rate of 5.2% (3).

An analysis of clinical trials between 2005 and March 2025 highlights that the United States hosts the majority of clinical trials, followed by China, France, Canada, Turkey, and the UK (

). The majority of clinical trials were conducted in a limited geographical distribution. Specifically, 26% of clinical trials were conducted in multiple locations, and only 8.2% of the total clinical trials were multinational clinical trials (4). However, market research indicates that the main barriers in clinical trials are due to poor trial design, lack of inclusivity, and inadequate clinical trial infrastructure (5). Therefore, if the EU wants to be a serious contender, it needs to strengthen its clinical trial ecosystem, promote ethical research, encourage stakeholder collaboration, and implement strategic investments.

Figure 1: Distribution of clinical trials by continents and disease, 2005-2025. (Figure courtesy of the author and modified from reference 4).

How is the EU driving innovative clinical research?

These new goals are part of the EU's ongoing effort to create a more supportive environment for clinical research following the launch of the Accelerating Clinical Trials in the EU (ACT EU) initiative in January 2022, a collaboration between EC, HMA, and EMA (6). It also builds on the EU Life Science to enhance public health, create jobs, and foster innovation by 2030, positioning the EU as a global leader (7).

The EU pharmaceutical legislation continues to evolve, and the EC has started a comprehensive review to create an agile, competitive, and equitable regulatory framework. The ACT EU is one of the first steps to strengthen clinical research in Europe (8). The ACT EU initiative has launched a trial map to help patients find nearby clinical trials. Additionally, it provides guidance to clinical trial sponsors on designing effective trials and submitting successful applications for authorisation, including marketing authorization. In addition, they can provide support for the implementation of the revised International Council for Harmonisation (ICH) E6 R3, 

 guideline and assistance for non-commercial sponsors to conduct more multinational trials.

In addition, the EU has several complementary initiatives underway to help the EU meet these targets, including:

The Clinical Trials Regulation (CTR) Collaborate initiative aims to foster interaction between national authorities and ethics committees to promote harmonized procedures and reduce administrative burden (9).

The COMBINE initiative aims to understand challenges and obstacles to align the interface between the three frameworks: CTR, In Vitro Diagnostics Regulation (IVDR), and Medical Device Regulation (MDR) (10). In June 2025, the first pilot was launched to coordinate clinical and performance study assessments into a single streamlined process (11).

The MedEthicsEU is a forum of national representatives from medical research ethics committees, established by the EC, to support discussion and mutual learning between EU/EEA Member States Ethics Committees (12).

Meanwhile, the European Federation of Pharmaceutical Industries and Associations (EFPIA) has been actively promoting innovation in this area. It has launched its Clinical Trials Strategy 2030+ with the goal of re-establishing Europe as a leading hub for faster, smarter, and more patient-centric clinical trials (

) (13). EFPIA is collaborating closely with other industry associations, patient organizations, academia, and national trade bodies to engage with regulators and policymakers, to help address the challenges in the current legislative framework (e.g., CTR, IVDR, MDR) and proactively proposing solutions (14). They are involved in multiple Innovative Health Initiatives (IHIs) that focus on patient-centred clinical research, aiming to improve trial design and conduct, enhance patient engagement and experience, increase the efficiency of clinical trials, and address health disparities.

Figure 2: Clinical Trials Strategy 2030+. (Figure courtesy of the author and modified from reference 13).

What are the implications of new clinical trial targets for pharma?

These new EC trial targets present new opportunities for the pharmaceutical industry to expand the number of multinational trials, provided they can meet patient recruitment timelines and comply with the CTR. It could catalyse changes in how clinical trials are conducted and managed in the EU, and allow sponsors to include more flexible trial design and market access strategies. This will help to increase speed to market and enable European patients to receive new therapies more quickly. The EU continues to streamline the trial process and reduce administrative burdens. Pharma companies must proactively engage with regulators and stakeholders to capitalize on the EU's strategy and strengthen their position in this multi-billion-dollar arena.

EMA. New Targets for Clinical Trials in Europe. Press Release. 23 Sept 2025. 

https://www.ema.europa.eu/en/news/new-targets-clinical-trials-europe

Wise, J. UK Launches Plan to Speed Up Clinical Trials and Improve Access to New Treatments 

Clinical Trials Market Size & Share Report, 2025 – 2034

Joshi, G.; et al. The Current Landscape of Clinical Trials. 

Apr 7;14(7):2519. DOI: 10.3390/jcm14072519.

The Lancet. Clinical Trials in Global Health 2025. 25 Mar 2025. 

https://www.thelancet.com/series-do/clinical-trials

Accelerating Clinical Trials in the EU (ACT EU)

https://accelerating-clinical-trials.europa.eu/about/initiative_en

EU Regulatory Activity is Driving Comprehensive Reforms for Pharma in 2025

https://www.osborneclarke.com/insights/eu-regulatory-activity-driving-comprehensive-reforms-pharma-2025

. 16 Apr. 2014. https://eur-lex.europa.eu/eli/reg/2014/536/oj

EC. ‘COMBINE’ Initiative–The Regulatory Landscape for Combined Studies on the IVDR/MDR/CTR Interface. 

. December 2024. https://health.ec.europa.eu/document/download/44bbffa5-e61e-4056-bfaf-50a46eeecb7b_en?filename=md_combine_presentation_en.pdf

EC. COMBINE Programme Launched a Pilot Coordinated Assessment for Clinical Trials and Performance Studies. 

https://ec.europa.eu/newsroom/sante/newsletter-archives/64447

EC.Clinical Trials–MedEthicsEU–Group of National Representatives of Medical Research Ethics Committees. 

https://health.ec.europa.eu/medicinal-products/clinical-trials/medethicseu_en

clinical-trial-strategy-in-a-snapshot.pdf

EFPIA. Improving EU Clinical Trials: Proposals to Overcome Current Challenges and Strengthen the Ecosystem

efpias-list-of-proposals-clinical-trials-15-apr-2025.pdf

The European Union (EU) is setting ambitious goals to enhance its clinical trial landscape by 2030, aiming to increase multinational trials and expedite patient recruitment. This initiative is part of the Accelerating Clinical Trials in the EU (ACT EU) program, which seeks to create a supportive environment for clinical research. The EU is also implementing complementary initiatives to streamline processes and reduce administrative burdens. These efforts present opportunities for the pharmaceutical industry to expand multinational trials, improve trial design, and accelerate market access, ultimately benefiting European patients with quicker access to new therapies.

The European Union aims to become the most attractive destination for clinical research.

New Targets for Clinical Trials in the European Union

On 2 July 2025, the European Commission (EC) announced a “bold and ambitious” new life science strategy to position the European Union (EU) as the world’s most attractive place for life sciences by 2030 (1). This strategy aims to positively impact public health, create jobs, and provide access to innovative, environmentally friendly technologies, thereby enhancing the EU's strategic resilience. Previously, President Ursula von der Leyen emphasized that the strategy for European life sciences was a priority in the political guidelines for 2024–2029, stating that, “we need to put research and innovation at the heart of our economy” (2). In January 2025, the EC also published the Competitiveness Compass, focusing on how to improve research and innovation (R&I) to boost competitiveness and promote innovation in biotechnology (3).

The EC has identified several strengths, including the presence of biotech clusters and leading academic institutions that operate with freedom and encourage diversity and inclusion. Additionally, the EU ranks second behind the United States (US) in terms of global high-value patents, holding 18% share of patents compared to 39% in the US (1). The life science industry continues to invest heavily in R&I, with 15% of the world’s top firms residing in the EU (1). However, the EC also recognizes that to improve R&I it must overcome numerous barriers, such as turning scientific breakthroughs into real-world applications, improving scalability in the EU, creating a more cohesive R&D ecosystem, utilizing healthcare data and artificial intelligence (AI) more effectively, and streamlining the regulatory process to reduce complexity and duplication (1).

How will this strategy unlock Europe’s life science potential?

To overcome these issues and achieve the life science strategy goals, the EC has outlined three interconnected phases that will impact the entire life science value chain:

optimising the R&I ecosystem to achieve a globally competitive life science sector

ensuring smooth and rapid market access for life science innovations

boosting the uptake and use of life science innovation.

The EC recognizes the need to optimize the R&I ecosystem and develop a globally competitive life science sector. This can be achieved through enhanced cooperation, more efficient resource use, and a comprehensive approach that leverages data and AI, develops adequate skills, and promotes a sustainable industry. The EC will provide new incentives for long-term multi-country clinical trials and rare disease research, strengthen EU bioclusters, and establish a network of European Centres of Excellence in advanced therapy medicinal products (ATMPs) (4). The EC also aims to establish a European Life Sciences R&I Data Assembly to improve cross-regulatory collaboration and enhance the interpretation of data regulations (5).

To ensure life science innovations reach the market smoothly and quickly, the European Medicines Agency (EMA) will need to establish more innovation-friendly regulations, and the EU will need to increase investments from both private and public sectors. A number of legislative changes and regulatory reforms are underway to simplify and modernize the approval processes, such as the Biotech Act and the EU Pharma Package, and these should help make the EU’s regulatory environment more conducive to biotech innovation (5–6). For instance, the Biotech Act, announced in July 2024, seeks to tackle barriers through legislative and policy changes across five key areas: regulation, financing, scale, skills, and data (7).

The creation of new knowledge is an essential basis for a vibrant life sciences ecosystem and for the development of technologies and innovations. The EC will invest more than €10 billion (US$11.9 billion) in various programs, such as Digital Europe, EU4Health, and Horizon Europe, to help build this knowledge base (8–10). Meanwhile, Member States and stakeholders must strengthen their connection with citizens to help reduce misinformation and build trust. They also need to collaborate more closely with end-users to ensure solutions meet their specific needs. Overall, this should help accelerate the adoption and use of life science innovations (1).

What is the future outlook for EU life sciences?

Although the EU is currently in a strong R&I position, the biotechnology sector remains highly competitive. In recent years, China has increased biotech investments following regulatory reforms, improvements in domestic manufacturing, and the implementation of the Healthy China 2030 initiative (11). Additionally, the implementation of US–EU framework on an agreement for reciprocal, fair, and balanced trade has resulted in a 15% tariff on pharmaceutical raw ingredients, APIs, and completed drug products imported into the US. This has raised expenses for branded pharmaceuticals developed by multinational corporations and created market uncertainty. Private investors are concerned that potential investments may slow due to pricing pressures, and biotech companies may hesitate to invest in new projects to expand operations, given the risks associated with tariffs (12–13).

Now more than ever, the EU needs to boost its investment in the life sciences sector and tackle longstanding issues that have hindered the region’s competitiveness and limited European patients' access to the latest treatments. Plans to introduce the Biotech Act in 2025, along with enhanced support for small and medium-sized enterprises and improvements to the regulatory framework, are positive developments. The European Federation of Pharmaceutical Industries and Association (EFPIA) welcomed the news; although, Nathalie Moll, Director General of EFPIA, warned that “for Europe to truly lead, it needs to invest in medicines, attract investment, accelerate turning that investment into new treatments and economic growth, and ensure that patients across the EU have access to them at the same pace as other regions” (14).

EC. A Competitiveness Compass for the EU 

Five Facts to Know: EU Life Sciences Strategy

. https://www.edelmanglobaladvisory.com. 2 July 2025. https://www.edelmanglobaladvisory.com/insights/five-facts-know-eu-life-sciences-strategy

 May 2025. https://www.europarl.europa.eu/RegData/etudes/BRIE/2025/772866/EPRS_BRI(2025)772866_EN.pdf

The New EU “Pharma Package”: Preparing for the Trilogue

. Crowell.com. 30 June 2025. https://www.crowell.com/en/insights/client-alerts/the-new-eu-pharma-package-preparing-for-the-trilogues

European Commission Sets Out New EU Life Sciences Strategy

. 1 Aug. 2025. https://www.osborneclarke.com/insights/european-commission-sets-out-new-eu-life-sciences-strategy

EU4Health Programme 2021-2027–A Vision for a Healthier European Union

. EC.europa.eu. (accessed 30 Sept. 2025). https://health.ec.europa.eu/funding/eu4health-programme-2021-2027-vision-healthier-european-union_en

(accessed 30 Sept. 2025). https://research-and-innovation.ec.europa.eu/funding/funding-opportunities/funding-programmes-and-open-calls/horizon-europe_en

Healthy China 2030: A Vision for Health Care

. https://www.ispor.org/docs/default-source/publications/newsletter/commentary_health-care_china_2030.pdf

Assessing the Impact of Tariffs on the Pharmaceutical Industry

. https://www.pharmafocuseurope.com/articles/impact-of-tariffs-on-pharmaceutical-industry.

The Impact of Tariffs on the Life Sciences Industry - Healthcare & Life Sciences Blog

31 Mar. 2025. https://healthcarelifesciences.bakermckenzie.com/2025/03/13/the-impact-of-tariffs-on-the-life-sciences-industry/

EU Life Science Strategy: A Springboard for European Life Sciences

. Efpia.eu. 2 July 2025. https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/eu-life-science-strategy-a-springboard-for-european-life-sciences/

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

The European Commission has unveiled a comprehensive life science strategy to establish the EU as a global leader in life sciences by 2030. This initiative aims to enhance public health, create jobs, and foster innovation through environmentally friendly technologies. The strategy focuses on optimizing the research and innovation ecosystem, ensuring rapid market access for innovations, and increasing the adoption of life science advancements. Key measures include regulatory reforms, increased investments, and the establishment of European Centres of Excellence. The strategy also addresses challenges such as scalability, data utilization, and regulatory complexity.

The European Union aims to become the most attractive place for life science by 2030.

European Union Life Science Strategy

Digital composite of highlighted red painful liver of woman | Image credit: ©

Metabolic dysfunction-associated steatohepatitis (MASH) is a type of non-alcoholic fatty liver disease (NAFLD) affecting more than 250 million people worldwide, and the number of cases in advanced stages is expected to double by 2030. Underlying conditions such as obesity, type 3 diabetes, and metabolic syndrome can increase the risk of MASH. For many years, MASH has been difficult to treat, and several products have failed in clinical development, including Genfit’s peroxisome proliferator-activated receptor (PPAR) agonist elafibranor, Gilead's ASK1 inhibitor selonsertib, Intercept Pharmaceuticals' farnesoid X receptor (FXR) agonist obeticholic acid, and Novartis/Conatus' pan-caspase inhibitor emricasan.

In the past few years, significant progress has been made, and new products have entered the MASH market. In March 2024, the US Food and Drug Administration (FDA) approved Madrigal Pharmaceuticals’ orally active, selective thyroid hormone receptor (THR)-β agonist, Rezdiffra (resmetirom), for adults with MASH with moderate to advanced liver scarring (fibrosis), alongside diet and exercise (1). In June 2025, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) recommended granting conditional marketing authorization for Rezdiffra in MASH (2). On 19 Aug. 2026, the European Commission approved Rezidiffra, and the company is planning its first European launch in Germany in the fourth quarter of 2025 (3, 4).

In August 2025, Novo Nordisk received FDA approval for its injectable weight-loss drug Wegovy (semaglutide) for patients with MASH and moderate to advanced liver fibrosis, without cirrhosis, in combination with a reduced-calorie diet and exercise (5). The conditional clearance was based on Phase III results, where the glucagon-like peptide-1 receptor agonist (GLP-1RA) demonstrated improved liver scarring without worsening the condition and resolved MASH without making scarring worse (6,7). Eli Lilly is also seeking approval for its injectable dual-action gastric inhibitory polypeptide (GIP)/GLP-1RA, Zepbound (tirzepatide), based on its Phase II SYNERGY-MASH trial in patients with and without type 2 diabetes, and with stage 2 or 3 fibrosis (scarring) (8).

What investments are Big Pharma making in MASH?

MASH is seen as the next frontier in metabolic diseases, and numerous clinical trials are underway evaluating hormone analogs, receptor agonists, and enzyme inhibitors 

MASH drug development has attracted significant interest from pharma and private investors. In the GLP-1 space, Boehringer Ingelheim has teamed up with UK-based Zealand Pharma to develop survodutide. This dual glucagon/GLP-1 agonist has demonstrated a placebo-adjusted 64.8% improvement in fatty liver disease (9).

Table I. Clinical development of therapies targeting Metabolic dysfunction-associated steatohepatitis (MASH).

Table I. Clinical development of therapies targeting Metabolic dysfunction-associated steatohepatitis (MASH) (Continued).

In May 2025, GSK acquired Boston Pharmaceuticals' lead asset efimosfermin for US$1.2 billion plus US$800 million in milestone payments. Efimosfermin is a novel, once-monthly fibroblast growth factor 21 (FGF21) analog therapeutic in Phase II clinical development for the treatment of MASH (10). US-based Akero Therapeutics and 89bio are also developing FGF21 analogs, efruxifermin and pegozafermin, respectively (11, 12).

Which European frontrunners are targeting MASH?

Several European biotechs are developing innovative approaches to target the underlying cause of MASH and liver fibrosis. These include:

focuses on developing novel small-molecule therapies targeting fibrosis, lysosomal storage disorders, and oncology. Its lead program, lanifibranor (IVA337), is an orally active pan-PPAR agonist. It demonstrated promising results in a Phase IIb placebo-controlled trial in patients with active MASH, improving the resolution of MASH without worsening fibrosis (13). Lanifibranor is currently being evaluated in NATiV3, a pivotal Phase III clinical trial in patients with MASH and fibrosis stages F2 and F3; the trial is due to complete in September 2026 (14).

 is a clinical-stage biopharmaceutical company specializing in fibrolytic and anti-inflammatory diseases. Its lead compound, Vonafexor, is an orally active, non-steroidal agonist of NR1H4 (FXR, or bile acid receptor). In the Phase II LIVIFY study, Vonafexor significantly reduced liver fibrosis and inflammation markers, decreased liver fat and weight, and improved liver and kidney functions (15). In January 2024, the company raised €39 million (US$45.39 million) in Series C funding to develop Vonafexor further (16).

, is a biotechnology company focused on discovering and developing innovative peptide-based medicines. It has created several candidates targeting the metabolic brain axis, including Survodutide, a glucagon/GLP-1 dual agonist, which is being developed with Boehringer Ingelheim for MASH (Phase II) and obesity (Phase II), and petrelintide, an amylin analogue that it is co-developing with Roche. This compound could represent a new class of treatment for obesity (17).

In the United States, several biotech companies are working on MASH candidates, including MetaVia, which is developing DA-1726, a novel oxyntomodulin (OXM) analogue that functions as a glucagon-like peptide-1 receptor (GLP1R) and glucagon receptor (GCGR) dual agonist (18).

Additionally, significant progress has been made in developing biomarkers and diagnostics to identify patients at risk of MASH. For example, France-based Genfit has created a non-invasive diagnostic program that includes an 

test to detect NIS4+ and NIS2+. At the same time, Nordic Bioscience has identified biomarkers targeting neo-epitopes of collagen fragments that can be used to risk-stratify patients. (19, 20).

The global MASH market was valued at US$7.9 billion in 2024 and is forecast to grow to US$31.8 billion by 2033, with a compound annual growth rate of 17.7% from 2025 to 2033 (21). After many failed attempts, the industry has finally identified new ways to reduce liver fat buildup. While Madrigal's orally active Rezdiffra was the first to enter the US and European Union markets, it now faces competition from Novo’s injectable Wegovy, and Eli Lilly is not far behind. It will be interesting to see how the MASH landscape evolves and whether new approaches, such as oxyntomodulin analogues and gene silencing agents, can capture a share of this lucrative market in the future.

FDA Approves First Treatment for Patients with Liver Scarring Due to Fatty Liver Disease

Madrigal Receives European Commission Approval for Rezdiffra™ (resmetirom) for the Treatment of MASH with Moderate to Advanced Liver Fibrosis.

Madrigal Pharmaceuticals Reports Second-Quarter 2025 Financial Results and Provides Corporate Updates.

FDA Approves Treatment for Serious Liver Disease Known as ‘MASH’

Sanyal, A. J.; Newsome, P. N.; Kliers, I.; et al.

 Phase 3 Trial of Semaglutide in Metabolic Dysfunction-Associated Steatohepatitis

Semaglutide 2.4 mg Demonstrates Superior Improvement in Both Liver Fibrosis and MASH Resolution in the ESSENCE Trial.

Loomba, R.; Hartman, M. L.; Lawitz, E. J.; et al. (2024). T

irzepatide for Metabolic Dysfunction-Associated Steatohepatitis with Liver Fibrosis

Survodutide US FDA Breakthrough Therapy Phase 3 Trials MASH.

GSK. GSK to Acquire Efimosfermin, a Phase III-Ready Potential Best-in-Class Specialty Medicine to Treat and Prevent Progression of Steatotic Liver Disease (SLD). Press Release. 14 May 2025.

 akerotx.com/clinical-trials (accessed 20 Aug. 2025).

89bio Receives EMA PRIME Status for Pegozafermin in the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) with Fibrosis and Compensated Cirrhosis.

Francque, S. M.; Bedossa, P.; Ratziu, V.; et al.. 

A Randomized, Controlled Trial of the Pan-PPAR Agonist Lanifibranor in NASH. 

ClinicalTrials.gov. Study Details | A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 ) (accessed 21 August 2025).

Ratziu, V.; Harrison, S. A.; Loustaud-Ratti; et al. 

Hepatic and Renal Improvements with FXR Agonist Vonafexor in Individuals with Suspected Fibrotic NASH. 

ENYO Pharma. ENYO Pharma Announces a €39 Million Series C Financing and FDA Clearance to Advance Vonafexor in a Phase 2 Clinical Trial for Patients with Alport syndrome. Press Release. 3 Jan. 2024.

MetaVia Doses First Patient in the 48 mg MAD Cohort of Its Phase 1 Clinical Trial Evaluating DA-1726 for the Treatment of Obesity to Further Explore Maximum Tolerated Dose.

Nash Or Mash Treatment Market Growth Rate, Industry Insights and Forecast 2025-2033

Editor's note: The references in this article have been updated. 

Metabolic dysfunction-associated steatohepatitis (MASH), a subtype of non-alcoholic fatty liver disease, is projected to see a significant increase in advanced cases by 2030. Recent advancements include FDA and EMA approvals of Madrigal Pharmaceuticals' Rezdiffra and Novo Nordisk's Wegovy for MASH treatment. Big Pharma is heavily investing in MASH, with companies like GSK acquiring assets and others developing innovative therapies. European biotechs are also making strides with novel treatments. The MASH market is expected to grow substantially, driven by new therapeutic approaches and diagnostic advancements.

Novo Nordisk’s Wegovy will be competing with Madrigal Pharmaceuticals’ Rezdiffra in the metabolic dysfunction-associated steatohepatitis arena. 

Competition in MASH Is Heating Up as GLP-1s Gate-Crash the Party

In March 2025, the European Medicines Agency (EMA) published a three-year work plan (2025–2027) for the Good Manufacturing and Distribution Practice (GMDP) Inspectors Working Group (IWG), focusing on the Network Strategy and Regulatory Science Strategy (RSS) goals. The work plan emphasized the importance of supply chain integrity and resilience, product quality, and the potential impact of new manufacturing technologies on the supply chain(1). The overall objectives of the plan included:

Analyze the possible implications of new manufacturing technologies to regulate the new supply chains needed

Enhance inspector capacity building at the European Union and international levels

Enhance traceability, oversight, and security in the human/veterinary medicine supply chain

Encourage supply chain resilience and review long-term risks resulting from dependency on a limited number of manufacturers and sites

Reinforce the responsibility for product quality by harmonising and reinforcing guidance (1).

On 7 July 2025, the GMDP-Inspectors Working Group, in cooperation with the Pharmaceutical Inspection Co-operation Scheme (PIC/S), launched a public consultation regarding the revision of the EU’s good manufacturing practice (GMP) guidelines

, Annex 11 and Chapter 4, along with the introduction of a dedicated Annex 22 on artificial intelligence (AI) (2). The revision of Chapter 4 and Annex 11 will expand the scope of documentation requirements and raise the bar on digital system validation and oversight. Whilst the addition of Annex 22 sets clear boundaries for the safe and acceptable use of AI and machine learning (ML) in a regulated GMP environment, it will help to ensure regulatory harmonization in the manufacturing of medicines (3).

The revised Chapter 4 includes changes that emphasize the importance of documentation in GMP compliance and support the adoption of new technologies, hybrid solutions, and services for managing documentation (4). Risk-management principles are now central and integrated into the data governance system to ensure the accuracy, integrity, availability, and readability of documents in all formats. All documentation, whether in text, image, video, or audio form, must remain complete and legible throughout its lifecycle. The guideline also clarifies the requirements for managing electronic records, signatures, and data integrity, and aligns with the recent revision of Annex 11.

The revised Annex 11 establishes improved requirements for managing the entire lifecycle of computerized systems, requiring that quality risk management (QRM) principles be thoroughly applied at all stages to ensure product quality, patient safety, and data integrity. The updated provisions strengthen obligations related to defining and continuously maintaining system requirements, as well as overseeing suppliers and external service providers (5). Additionally, the Annex enhances controls for ensuring data integrity, audit trails, electronic signatures, system security, as well as backup and archiving.

The new annex on AI sets requirements for using AI/ML in manufacturing active substances and medicinal products (6). It details how to select, train, and validate AI models and places emphasis on defining the intended use of the model, establishing performance metrics, ensuring the quality of training data, and managing test data. Annex 22 requires ongoing oversight of AI systems, including change control, performance monitoring, and procedures for human review when needed. The document does not apply to generative AI and large language models, and these models should not be used in critical GMP applications.

By 2026, the updates to Chapter 4 and Annex 11, along with the introduction of Annex 22, will bring about a significant transformation in European GMP regulations for the pharmaceutical industry. These revisions could enforce tighter controls and redefine standards, setting the stage for a new era in GMP compliance.

In response to these changes, pharmaceutical companies will need to review their documentation processes and platforms and reevaluate and validate their legacy systems (such as quality control, laboratory information management systems, or commercial off-the-shelf applications) to ensure compliance with the updated traceability and audit trail requirements. Overall, organizations will need to plan for system lifecycle governance and supplier management. If activities are outsourced, they must ensure regulatory accountability remains in-house. Additionally, companies deploying AI technologies in a GMP environment will need to develop robust internal capabilities to ensure data science governance and validate AI models (3).

The pharmaceutical industry must act swiftly to align with the evolving regulatory expectations. The stakeholder consultation closes on October 7, 2025, so there is still time to submit opinions on the three documents that will shape the future of GMP in Europe (7–9).

The 3-Year Work Plan for the Inspectors Working Group 2025-2027

Stakeholders’ Consultation on EudraLex Volume 4 - Good Manufacturing Practice Guidelines: Chapter 4, Annex 11 and New Annex 22. 

Preparing for EMA's 20226 Good Manufacturing Practice (GMP) Revisions: Chapter 4, Annex 11 & Annex 22.

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

The European Medicines Agency's 2025-2027 work plan for the Good Manufacturing and Distribution Practice Inspectors Working Group focuses on supply chain integrity, product quality, and the impact of new manufacturing technologies. Key revisions include updates to GMP guidelines, emphasizing documentation, digital system validation, and AI use in manufacturing. The revised guidelines will require pharmaceutical companies to reassess documentation processes, validate legacy systems, and ensure compliance with new standards. The industry must adapt quickly to these changes, with stakeholder consultation open until October 7, 2025.

The deadline for stakeholder consultation submissions on the new and updated regulations is Oct. 7, 2025. 

Stakeholders’ Consultation on GMP Annex 11, Chapter 4, and New Annex 22 

The European Medicines Agency (EMA) is encouraging the use of new approach methodologies (NAMs) as an alternative to animal testing in the assessment of safety and efficacy of new medicines during non-clinical development (1). In the European Union (plus Norway), 8.48 million uses of animals for scientific purposes occurred in 2022 (2). In most countries, the use of animals for some safety tests is required. For instance, 

 requires marketing authorisation holders to integrate the 3Rs (replacement, reduction, refinement) and welfare standards for the treatment of animals in all aspects of the development, manufacture, and testing of medicines (3). In October 2023, EMA published a concept paper on the revision of the guideline on the principles of regulatory acceptance of 3Rs testing approaches (4). Such alternative methods as NAMs can be highly effective at modelling individual aspects of safety and efficacy and should help to reduce and/or replace animal testing in line with the 3Rs principles (5). These principles include:

Availability of a defined test methodology (protocol, endpoints)

Description of the proposed NAM context of use (i.e., the circumstances in which the NAM is applied in the development and assessment of human or veterinary medicinal products)

Establishment of the relevance within that particular context of use

Demonstration of NAM reliability and robustness (5).

The European Medicines Agency (EMA) is promoting new approach methodologies (NAMs) to reduce animal testing in drug development, aligning with the 3Rs principles of replacement, reduction, and refinement. NAMs, including high-throughput screening, in vitro assays, and in silico modeling, offer mechanistic insights into drug safety and efficacy. The European Federation of Pharmaceutical Industries and Associations (EFPIA) supports phasing out animal testing through collaboration, funding, and regulatory updates. Techniques like organ-on-a-chip and cell transformation assays are advancing, providing cost-effective, human-relevant models for pharmacokinetics and toxicity studies.

EMA is phasing out animal testing and is asking pharmaceutical companies to use new approach methodologies.