Cheryl Barton is director of PharmaVision, 

Cheryl Barton

Amyloid plaques in Alzheimer's disease | Image Credit: ©Artur -stock.adobe.com


Dementia affects more than 55 million people worldwide, with Alzheimer’s disease (AD) accounting for approximately 70% of cases.

 By 2050, it is estimated that around 130 million people could suffer from AD, driven by an ageing global population. Approximately 7% of people over age 65 have dementia, and prevalence rises sharply with age, often doubling every five to six years after age 65.

A large proportion of dementia cases remain undiagnosed; new diagnostic tests are under development that could help speed up diagnosis and patient access to approved and emerging AD treatments

 Eli Lilly has developed a telehealth platform, LillyDirect, to expand access and potentially improve early diagnosis and treatment uptake.

 AD and dementia impose enormous societal and healthcare costs worldwide, with urgent calls for better detection, treatment, and care infrastructure.

Traditional AD treatments, such as Forest Laboratories' orally active Namenda (memantine), a cholinesterase inhibitor, address the symptoms of the disease rather than slow disease progression.

 More recently, new disease-modifying therapies (DMTs), such as intravenous (IV) administered anti-amyloid β monoclonal antibodies from Biogen/Eisai’s Leqembi (lecanemab) and Eli Lilly's Kisunla (donanemab), have been approved for early stages of AD with confirmed amyloid pathology.

 However, there remains a high unmet need for safer, easy-to-use drugs and therapies targeting non-amyloid/tau pathways. In 2025, the US Food and Drug Administration (FDA) accepted the supplemental biologics licensure application (BLA) for Leqembi Iqlik (lecanemab-irmb), a subcutaneous autoinjector formulation for once-weekly maintenance dosing in the United States.

There has been significant investment in the AD space in recent years, and more than 138 drugs were investigated in 182 clinical trials in 2025. These drugs target a range of novel targets beyond amyloid and tau, including pathways affecting bioenergetics and metabolism, the endocrine system, oxidative stress, synaptic plasticity, and the vasculature (

 New Alzheimer’s disease treatments target a wide range of biological pathways. Figure courtesy of the author. 

What AD therapies are the pharma industry investing in?

At present, Biogen, Eli Lilly, and Eisai monopolise the AD market; however, many large pharma firms also run AD programs. For example, Johnson & Johnson (J&J) and Roche/Genentech are developing anti-amyloid antibodies, posdienmab and trontinemab, respectively.

 Large pharma has been active in licensing assets and co-developing innovative platforms, ranging from anti-tau antibodies to natural killer (NK) cell therapies. Meanwhile, the regulators have published guidance and established frameworks, including FDA Fast Track and European Medicines Agency (EMA) adaptive pathways, to help align drug development and investment in innovative medicines for AD and other areas of unmet medical need.

What are some European players to watch out for in the proteasome space?

Several European biotechs are evaluating next-generation anti-amyloid agents, tau and sigma inhibitors. European biotech leading the way include the following.

 is a clinical-stage biopharmaceutical company focusing on novel treatment for neurodegenerative diseases leveraging its clinically validated technology platforms, SupraAntigen and Morphomer. The company is developing a broad range of AD therapies, including ACI-35.030 (JNJ-2056), an anti-pTau active immunotherapy in phase 1b/2a targeting extracellular phosphorylated Tau (pTau), partnered with Janssen Pharmaceuticals; the company published trial data in eBioMedicine, and further data are expected in 1H26.

 ACI-24.060 targets misfolded Abeta to prevent accumulation and enhance clearance of amyloid plaques in AD and AD in Down syndrome and is currently being evaluated in the ABATE phase 1b/2 with Takeda. Results of this study are due to be released soon.

Anavex Life Science Corporation (Germany) 

focuses on novel small-molecule treatment for central nervous system diseases. Its lead candidate, blarcamesine, is a once-daily oral Sigma-1 receptor modulator that enhances autophagy. The company has filed a new drug application with EMA and FDA based on pivotal ATTENTION-AD and AD-004 trials in early AD, in which it demonstrated significant clinical benefit and slowed brain volume loss compared with the intent-to-treat population.

 In December 2025, the company requested a re-examination of the EMA's refusal of its marketing authorization because “the main study failed to demonstrate effectiveness and safety of blarcamesine in patients with early AD who do not have a mutation in the SIGMAR1 gene”.

 is a clinical-stage biotech company developing small molecules targeting tau protein aggregation. In July 2024, it completed a $100 million Series C financing round led by Novo Holdings, with new investment from EQT Life Sciences–LSP Dementia Fund, OrbiMed, and SR One, alongside existing investors M Ventures, Sofinnova Partners, GSK Equities Investments Limited and Johnson & Johnson Innovation (JJDC, Inc.).The funds were used to advance its lead asset, ASN51, an oral small-molecule drug designed to inhibit OGA, an enzyme implicated in protein aggregation in AD and Parkinson’s disease (PD).

 developed Leqembi in conjunction with Eisai, one of the first DMTs for early AD. The drug is now approved in more than 50 countries and continues to show strong sales growth. In September 2025, BioArtic received regulatory approval for monthly IV maintenance treatment in China. Eisai received US approval for Leqembi Iqlik weekly maintenance dosing, using a subcutaneous autoinjector. BioArtic signed a global out-licensing agreement with Bristol Myers Squibb (BMS) for two preclinical AD programmes: BAN1503, an antibody targeting pyroGlu Abeta, and BAN2803, an antibody targeting PyroGlu Abeta combined with BioArtic’s Brain Transporter technology.

 a UK biotechnology company, focuses on the treatment of AD by modulating retinoic acid receptor alpha (RARα), as identified in Professor Jonathan Corcoran's research at King's College London.

 has taken a different approach, targeting septin filaments, which regulate calcium entry into cells. This function is impaired in AD. In September 2025, the company published data from the phase 2a trial, which was halted prematurely due to dose-dependent elevations in liver enzymes that normalized after treatment was stopped.

 The company is developing REN392, a second-generation septin modulator that can help restore neuronal calcium balance, with an optimised safety profile and pharmacokinetic profile.

) are developing small-molecule tau aggregation inhibitors, and their lead programme is hydromethylthionine mesylate (HMTM), which has demonstrated promising results in the phase 3 LUCIDITY in the treatment of mild cognitive impairment in AD.

 is a spin-off company from the University of Cambridge (UK) and Lund University (Sweden). In January 2021, it closed a £12.4 million ($17 million) financing round; the total capital raised to date is approximately £33 million ($45 million).

 The funds have been used to advance its two misfolding small-molecule programs towards the clinic for the potential treatment of AD and PD.

Competition in the AD field is increasing, and several US biotechs—Alzheon, Annovis Bio, Alpha Cognition, Cognition Therapeutics, Longeveron, Neurodon—have R&D programs in this space and include NKGen Biotech, which is developing troculeucel, the first autologous enhanced NK cell therapy for AD.

 Asia-Pacific activity is growing, and several biotech companies—ADEL, AirBio Co. Ltd, GemVax, Shanghai Hengrui, and Therabest Korea—are developing AD agents and attracting pharma interest. In December 2025, Sanofi signed a US$1.04 billion licensing agreement with Korean biotech ADEL for ADEL-Y01, a tau-targeting antibody for AD.

Future opportunities in targeting the proteasome

Treatment for AD continues to advance, and innovative biotech companies are now looking beyond anti-amyloid and anti-tau programs to target the underlying causes of neuroinflammation and immune modulation in AD rather than focusing on symptomatic therapies.The global Alzheimer’s drugs market size was valued at US$3.52 billion in 2022 and is projected to grow from US$3.69 billion in 2023 to US$5.21 billion by 2030, exhibiting a compound average growth rate of 5.1% due to improvements in diagnosis and the emergence of new DMTs.

 Many large pharma companies, including Biogen, Bristol-Myers Squibb, Eisai, Genentech, Janssen, Roche, Sanofi, and Takeda, have already invested in the field, and several pivotal studies are due to report during the next 18 months that could stimulate further investment in this dynamic but high-risk market.

Alzheimer’s Disease Diagnosis: An Update and Review of Biomarkers and Clinical Practice

FDA OKs First Blood Test That Can Help Diagnose Alzheimer’s Disease.

Eli Lilly Announces Expanded Services to Early Diagnosis and Access Alzheimer's Disease Care.

Therapeutic Advances in Targeting the Amyloid-β Pathway for Alzheimer’s Disease.

Eisai Initiated Rolling Supplemental Biologics License Application to the US FDA for LEQEMBI IQLIK (lecanemab-irmb) as a Subcutaneous Starting Dose for the Treatment of Early Alzheimer’s Disease Under Fast Track Status.

Cummings, J.L.; Zhou, Y.; Lee, G.; et al. 

Alzheimer’s Disease Drug Development Pipeline: 2025

Alzheimer’s & Dementia: Translational Research & Clinical Interventions.

Johnson & Johnson's Posdinemab and Tau Active Immunotherapy Receive US FDA Fast Track Designations for the Treatment of Alzheimer's Disease.

Genentech and Roche Present New Insights in Alzheimer’s Disease Research Across Its Diagnostics and Pharmaceutical Portfolios at AAIC

Clinical Investigation of Medicines for the Treatment of Alzheimer's Disease–Scientific Guideline.

Sol, O.; Mermoud, J.; Hallikainen, M.; et al. 

Safety and Immunogenicity of Two Tau-targeting Active Immunotherapies, ACI-35.030 and JACI-35.054, in Participants with Early Alzheimer's Disease: A Phase 1b/2a, Multicentre, Double-Blind, Randomised, Placebo-Controlled Study

AC Immune Reports Third Quarter 2025 Financial Results and Provides a Corporate Update.

Advancing Alzheimer’s Disease Care: Convenience for Both Patients and Families with Oral Blarcamesine. 

Alzheimer Europe Presentation. Oct. 2025.

Lessons from Our Phase 2a Alzheimer’s Septin Trial.

Journal of Prevention of Alzheimer’s Disease Publishes Trial Results Showing HMTM Potentially Offers an Accessible Oral Treatment Option for Patients with Early Alzheimer’s Disease. 

Wren Therapeutics Announces £12.4 Million in Financing.

NKGen Biotech to Present on the Use of Troculeucel for Neurodegenerative Diseases at the XXVII World Congress of Neurology. 

ADEL Signs $1.04 Billion Global License Agreement with Sanofi for ADEL-Y01, a Novel Investigational Alzheimer's Disease Therapy

Fortune Business Insights. Alzheimer's Drug Market Size, Share & COVID-19 Impact Analysis. Jan. 19, 2026.


Cheryl Barton, PhD, founder and director, PharmaVision

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

Articles

Dementia prevalence is rising rapidly, with Alzheimer’s disease comprising most cases and substantial underdiagnosis persisting despite emerging biomarker-based diagnostics and telehealth-enabled access models. Symptomatic therapies remain in use, but disease-modifying anti-amyloid monoclonal antibodies now dominate early AD treatment, including movement toward subcutaneous, autoinjector maintenance dosing. The development pipeline is broadening beyond amyloid/tau into metabolism, oxidative stress, synaptic biology, vascular targets, and immune modulation. European biotechs and Asia-Pacific innovators are increasingly influential via novel mechanisms, financings, and major licensing deals.

New disease-modifying agents are being evaluated in the clinic that could change the course of treatment for Alzheimer’s disease patients.

European Biotechs Impacting Treatment of Alzheimer’s Disease


Proteasomes are molecular machines for breaking down proteins called proteolysis, only target proteins that have been marked for destruction called ubiquitin to the target protein, 3d rendering | Image Credit: ©

Momentum is building for proteolysis-targeting chimeras (PROTAC) treatments that hijack the ubiquitin-proteasome system (UPS) to catalytically degrade pathogenic proteins and eliminate disease-causing proteins.

 This approach enables scientists to target previously "undruggable" proteins and exert sustained pharmacological effects, including those responsible for difficult-to-treat childhood cancers and drug-resistant triple-negative breast cancer.

 In recent years, significant progress has been made in the selective delivery of PROTACs, potentially extending their use to a broader range of conditions.

How is the pharma industry investing in proteasome-targeting therapies?

A number of proteasome-targeting therapies have been approved in Europe and the United States, such as Amgen’s   carfilzomib (Kyprolis), Bristol Myers Squibb’s ixazomib (Ninlaro), and Johnson & Johnson/Takeda’s bortezomib (Velcade). Several Big Pharma companies—AbbVie, AstraZeneca, Eli Lilly, Merck & Co, Novartis, Pfizer, Roche, and Sanofi—have products in clinical development. Interest in this field has catalyzed some interesting acquisitions and partnerships. For instance, in 2025, Johnson & Johnson completed its acquisition of Halda Therapeutics to gain access to its novel Regulated Induced Proximity Targeting Chimaeras (RIPTACs), a protein degradation approach that connects with proteasome pathways.

 In September 2025, Novartis initiated a collaboration with US-based Monte Rose to develop novel degraders or molecular glues to treat immune-mediated diseases.

Several biotech companies in the US are developing second-generation PROTACs, including Arvinas' vepdegestrant (ARV-471). In March 2025, Pfizer and Arvinas announced positive topline results from the phase 3 VERITAC-2 clinical trial with vepdegestrant in metastatic breast cancer.

 Additionally, C4 Therapeutics and Nurix Therapeutics have protein degrader programs: cemisoldomide in phase 1/2 for multiple myeloma/non-Hodgkin lymphoma (NHL), and bexobrutideg in phase 2/3 for relapsed/refractory chronic lymphocytic leukaemia (R/R CLL), respectively.

More recently, US-based Kymera Therapeutics received fast track designation from the US FDA for KT-621, an oral signal transducer and activator of transcription 6 (STAT6) degrader for the treatment of atopic dermatitis.

In 2025, Sanofi modified its collaboration with Kymera, discontinuing development of KT-474, an Interleukin-1 receptor-associated kinase 4 (IRAK4) degrader, while continuing development of KT-485, which is in phase 2 trials for atopic dermatitis and hidradenitis suppurativa.

 Other US biotech companies working in this field include Accutar Biotech, Cleave Therapeutics, Dialectic Therapeutics, and Karyopharm Therapeutics.

Several European biotechs are evaluating a new class of inhibitors that harness the UPS, hijacking the proteasome to provide disease-specific protein degradation with a wide range of therapeutic applications from autoimmune to oncology.

has developed its proprietary next-generation targeted protein degradation (TPD) technology to develop Targeted Glues. Its lead program, AMX-883, can induce BRD9 degradation to block patient-derived tumour growth in vivo as a monotherapy, with superiority to venetoclax in acute myeloid leukaemia (AML).

focuses on developing small-molecule proteasome activators for neurodegenerative disease using its DGRADX platform. In October 2025, the company completed a US$15 million financing round led by life sciences investors Apollo Health Ventures and Novo Holding.

 Funds will be used to advance its multidisease pipeline.

focuses on the development of precision medicine using site-restricted targeted therapeutics. OncoOne’s research encompasses the development of targeted immunotherapeutics that modulate tumour degradation using its Pre-Targ-it platform. The company is exploring therapies that target the proteasome-Bcl-2 axis as novel anticancer agents.

QLi5 Therapeutics GmbH (German-Korean joint venture) 

is working on a new class of proteasome inhibitors that demonstrate strong anti-tumour and anti-inflammatory activity, offering promise in cancer, autoimmune, and inflammatory disorders.

 In September 2025, Qli5 closed a €10 million (US$12 million) Series A financing round with an international consortium of investors, including SV Investment (Korea), KHAN Technology Transfer Fund I (Germany), Atinum Investment (Korea), and DAOL Investment (formerly KTB, Korea). The proceeds will advance its pipeline of proteasome inhibitors in clinical development.

According to market research, the global proteasome inhibitor market was valued at approximately US$2.7 billion in 2024 and is projected to reach US$3.03 billion in 2024, growing to approximately US$6.1 billion by 2034, with a compound annual growth rate of 8.70% from 2025 to 2034.

 Preliminary research indicated that proteasomes may have far-reaching effects and could be used to target new immune defence mechanisms.

 Currently, companies are focusing on developing proteasome inhibitors for oncology; however, these agents may also present new opportunities to treat patients with inflammatory and autoimmune diseases. Many large pharmaceutical companies have already forged strategic partnerships with research institutions and biotech companies to advance PROATCs and UPS, either as standalone therapies or in combination with existing therapies. Several late-stage clinical trials will read out over the next 12 to 24 months, and promising results could stimulate further investment in this area.

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Lee CH, Nguyen TM, Lee Y, et al. Overcoming therapeutic resistance in triple-negative breast cancer: targeting the undrugged kinome. 

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Yang X, Wang D, Li C, et al. Nano-PROTACs for precision medicine: engineering strategies for enhanced targeting and potency. 

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 Johnson & Johnson completes acquisition of Halda Therapeutics and its novel platform to revolutionize cancer treatment and enable next-generation oral therapies. Press release. Halda Therapeutics. Published December 29, 2025. Accessed February 19, 2026. 

https://haldatx.com/johnson-johnson-completes-acquisition-of-halda-therapeutics-and-its-novel-platform-to-revolutionize-cancer-treatment-and-enable-next-generation-oral-therapies

Monte Rosa Therapeutics announces collaboration with Novartis for degraders to treat immune-mediated diseases. Press release. Monte Rosa Therapeutics. Published September 15, 2025. Accessed February 19, 2026. 

https://ir.monterosatx.com/news-releases/news-release-details/monte-rosa-therapeutics-announces-collaboration-novartis

 Arvinas presents preclinical data supporting mechanistic synergies and enhanced antitumor activity with the combination of ARV-393 and glofitamab at the 2025 American Society of Hematology Annual Meeting and Exposition. Press release. Arvinas. Published December 6, 2025. Accessed February 19, 2026. 

https://ir.arvinas.com/news-releases/news-release-details/arvinas-presents-preclinical-data-supporting-mechanistic

Cemsidomide. C4 Therapeutics. Accessed January 13, 2026. 

https://c4therapeutics.com/our-pipeline/cemsidomide/

Nurix Therapeutics outlines 2026 goals and objectives for advancing bexobrutideg and its pipeline of novel degrader-based medicines in cancer and autoimmune diseases. Press release. Nurix Therapeutics. Published January 12, 2026. Accessed January 13, 2026. 

https://ir.nurixtx.com/news-releases/news-release-details/nurix-therapeutics-outlines-2026-goals-and-objectives-advancing

Arvinas and Pfizer announce positive topline results from phase 3 VERITAC-2 clinical trial. Press release. Pfizer. Published March 11, 2025. Accessed January 13, 2026. 

https://www.pfizer.com/news/press-release/press-release-detail/arvinas-and-pfizer-announce-positive-topline-results-phase

Kymera Therapeutics announces U.S. FDA fast track designation for KT-621, a first-in-class, oral STAT6 degrader for the treatment of atopic dermatitis. Press release. Kymera Therapeutics. Published December 11, 2025. Accessed January 13, 2026. 

https://investors.kymeratx.com/news-releases/news-release-details/kymera-therapeutics-announces-us-fda-fast-track-designation-kt

Kymera Therapeutics announces Sanofi IRAK4 collaboration. Press release. Kymera Therapeutics. Published June 25, 2025. Accessed January 13, 2026 .

https://www.globenewswire.com/news-release/2025/06/25/3104958/0/en/Kymera-Therapeutics-Announces-Sanofi-IRAK4-Collaboration-Update.html

Amphista Therapeutics presents new preclinical data showing the potential of its BRD9 targeted glue, AMX-883, to transform the treatment paradigm for acute myeloid leukaemia. Press release. Amphista Therapeutics. Published December 8, 2025.  Accessed January 13, 2026. 

https://amphista.com/amphista-therapeutics-presents-new-preclinical-data-showing-the-potential-of-its-brd9-targeted-glue-amx-883-to-transform-the-treatment-paradigm-for-acute-myeloid-leukaemia

Booster Therapeutics launches to pioneer new class of proteasome activator medicines for the treatment of a range of complex diseases. Press release. Booster Therapeutics. Published October 10, 2024. Accessed January 13, 2026. 

https://www.boostertx.com/press-releases/booster-therapeutics-launches-to-pioneer-new-class-of-proteasome-activator-medicines-for-the-treatment-of-a-range-of-complex-diseases

Innovative precision cancer therapies. OncoOne.  Accessed January 13, 2026. 

Next generation proteasome inhibitors for unmet medical needs deployed by an international research & development network. QLi5 Therapeutics. Accessed January 13, 2026. 

QLi5 Therapeutics. QLi5 Therapeutics attracts EUR 10 million in Series A financing. Press release. QLi5 Therapeutics. Published September 7, 2025. Accessed January 13, 2026. 

https://qli5tx.com/qli5-therapeutics-attracts-eur-10-million-in-series-a-financing

Proteasome inhibitors market size & share report, 2025–2034. Global Market Insight. Published March 2025. 

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Proteolysis-targeting chimeras (PROTACs) are gaining momentum as they leverage the ubiquitin-proteasome system to degrade pathogenic proteins, offering potential treatments for previously "undruggable" targets, including challenging cancers. The pharmaceutical industry is heavily investing in proteasome-targeting therapies, with several companies developing and testing new drugs. European biotech firms are also advancing in this field, exploring novel inhibitors and therapeutic applications. The global proteasome inhibitor market is projected to grow significantly, with potential applications extending beyond oncology to autoimmune and inflammatory diseases.

Proteasome-targeting therapies may eliminate disease-causing proteins in a broad range of diseases.

Proteasomes: A Novel Approach to Target the Immune System

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. 

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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. 

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

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

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

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

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.