Cheryl Barton is director of PharmaVision, 

Cheryl Barton

Stockholm old town city skyline, cityscape of Sweden | Image Credit: ©f11photo -stock.adobe.com

Sweden continues as a leader in early-stage life science innovation.

 The country is recognized for its dynamic, venture-supported biotech companies that target a diverse range of therapeutic areas and diagnostic solutions, including central nervous system (CNS) and neurology (AlzeCure Pharma, BioArtic AB), cell and gene therapies (Anocca AB, Asgard Therapeutics), immuno-oncology (Aligator Biosciences, Neogap Therapeutics AB), and rare diseases (Calliditas Therapeutics AB, Swedish Orphan Biovitrum AB). Since June 2025, investment in Swedish biotechs has surged, with a heavy focus on out-licensing, rights issues, and collaborations with strategic pharma partners including Eli Lilly, Foundation Medicine (Roche), and QuantumCell, amongst others (

Swedish Biotech Companies that Have Recently Attracted Venture Capital and Pharmaceutical Investments

Sweden Has a Strong R&D Base and Thriving Life Science Sector

According to the Royal Swedish Academy of Engineering Sciences, Sweden has a strong research and development (R&D) base.

 Long-term investments in research infrastructure such as SciLifeLab, MaxIV, and the European Spallation Source (ESS) offer valuable opportunities for research in life sciences and related fields. These facilities are also a key strength in attracting talented researchers to Sweden.

 AstraZeneca has a major presence in Sweden, has a large impact on the Swedish economy, and accounted for 5% of Sweden’s total product exports in 2023. 

What Are Some Swedish Biotechs to Watch Out for?

Sweden's life sciences industry is thriving. More than 150 small- to medium-sized companies are actively developing pharmaceuticals for human use and have products in clinical development.

Several biotechs have products in late-stage clinical trials, including Affibody Medical AB, BioArtic AB, Camurus, Diamyd Medical Aktiebolag, Dilafor AB, Dizlin Pharmaceuticals AB, Ilya Pharma AB, Infant Bacterial Therapeutics AB, Immedica Pharma AB, Sarcomed AB, Swedish Orphan Biovitrum (Sobi) AB and Vivesto AB.The Swedish pipeline is broad and spans various modalities (eg, advanced therapy medicinal products [ATMPs], biomolecules, and small molecules) and therapeutic areas (eg, autoimmune/immunology, cardiovascular, endocrinology/metabolism, infection, oncology, and neurology/CNS) (

 Swedish Drug Discovery and Development Project, by Stage and Modality, 2025 (Figure courtesy of the author)

Figure 2: Swedish drug discovery and development project, by therapy area and modality, 2025 (Figure courtesy of the author)

The following are some Swedish biotech companies to keep an eye on.

is a clinical-stage radiopharmaceutical company working on next-generation radioligand therapies (RLTs) to target tumors precisely. The company has created novel small (6 kDa) therapeutic proteins, called Affibody molecules, which specifically bind to target cells. In May 2026, the company published positive phase 2b/3 data from its lead programme with Izokibep in psoriatic arthritis, and it dosed the first patient in its phase 1 trial with ABY-271, a RLT targeting HER2-positive metastatic breast cancer.

 On February 17, 2026, Affibody’s licensee Rallybio Corporation announced positive results from its phase 1 confirmatory study with RLYB116, a once-weekly, small-volume, subcutaneously injected complement factor 5 (C5) inhibitor, based on the Affibody platform

 is a biotech firm specializing in oncology. It halted development of mitazalimab in 2026 due to it non-commercial viability in the pancreatic cancer market. The company will now concentrate on HLX22, an HER2-targeting antibody in phase 3 trials for breast cancer and other solid tumors. Additionally, at AACR 2026, they reported encouraging data on HLX49, a HER2 biparatopic antibody-drug conjugate that contains HER2 binding domains from HLX22.

 In August 2024, the company announced a rights issue of SEK 125.6 million (UD$13 million) and entered into bridge loan agreements totaling SEK 19 million (US$2 million) to secure near-term liquidity.

 is a private biopharmaceutical company developing drugs for heart failure. Founded on research from Karolinska Institutet, it aims to improve heart muscle contractility. Its lead program, AC01, is an oral calcium-sensitizing agent licensed from Helsinn and is now in development for heart failure. A phase 1b/2a study showed proof of concept in HFrEF patients, supporting further development of this promising drug.

 The company has raised more than US$40 million (SEK 432 million) across multiple funding rounds, attracting investment from Novo Holdings, Pureos Bioventures, and Sound Bioventures, Flerie, Industrifonden, and others to develop its product pipeline.

was founded in 2014 and is a clinical-stage biopharmaceutical company developing T cell receptor-modified T cell therapy (TCR-T) immunotherapies. It has created a pipeline of T-cell immunotherapies by combining its novel approach to T-cell biology, cutting-edge biotechnologies, and integrated software. In August 2025, the company raised SEK440 million (US$166 million) in Series D financing, attracting investment from AMF, Mellby Gård, and Ramsbury to advance the development of its pancreatic cancer candidate, ANOC-001, the first non-viral, gene-edited TCR-T cell therapy targeting KRAS G12V mutations in pancreatic ductal adenocarcinoma (PDAC).

 In June 2026, the company initiated its Phase I VDAR trial. It has forged a strategic platform licensing agreement for cell engineering technology with MaxCyte and competes with Moderna and Jazz Pharmaceuticals in the genetic engineering space.

, founded in 2018, is a private biotech company specializing in cell reprogramming technologies. Its flagship program, AT-108, is an off-the-shelf gene-based cancer immunotherapy designed to reprogram tumor cells into cDC1-like antigen-presenting cells. This approach aims to work synergistically with immune checkpoint blockade (ICB) to generate a robust anti-tumor response. The therapy has demonstrated promising results in murine animal models.

The company has received funding from the Eurostars-2 joint program, with co-funding from EUREKA member countries and the European Union Horizon 2020 Framework Programme, and from the EIC Women in Tech program, with funding from the Horizon Europe program.

was established in 2003 and focuses on improving treatment for neurodegenerative diseases by enhancing delivery across the blood-brain barrier (BBB). The company developed Leqembi, which uses its proprietary Brain Transporter technology. In June 2026, BioArctic signed a US$30 million collaboration with Eli Lilly to apply its Brain Transporter technology to one of Lilly’s neurodegenerative drug candidates

In July 2026, Eisai received FDA approval for Leqembi (lecanemab), a weekly subcutaneous injection indicated for early Alzheimer’s disease. The medication utilizes BioArtics BrainTransporter technology and is scheduled for launch in August 2026.

Founded in 2008 by Dr Karl Tryggvason and his son, Dr Kristian Tryggvason, the company focuses on developing animal-free laminin-based cell culture tools that support the growth of pluripotent stem cells and other primary cells. In September 2025, it partnered with Cell X Technologies to integrate its laminin reagents (Biolaminin) with Cell X’s Celligent platform, enhancing the reproducibility of iPSC production.

 In April 2026, the EIB provided the company with a €20 million loan to further develop laminin technologies, supporting the advancement of next-generation cell therapies.

 In May 2026, Biolamina partnered with Cytochroma to leverage its technology to create iPSC-derived cells for drug discovery and disease modelling, supporting regulatory efforts to reduce animal testing and encourage new approach methodologies (NAMs).

 was founded in 2004 and focuses in creating specialized pharmaceuticals. Its main product candidate, nefecon (sold as Kinpeygo /Tarpeyo), is a delayed-release form of budesonide designed to treat IgA nephropathy (IgAN), an inflammatory kidney disease. The firm is also researching setanaxib, a NOX1/NOX4 inhibitor for solid tumors and fibrotic diseases, where early results are promising. Calliditas has partnered with Everest Medicines and gained approval from China’s NMPA to use nefecon for primary IgAN in at-risk adults. Moreover, Viatris Japan, its partner, announced a phase 3 trial for nefecon in Japan, starting July 4, 2024. The company has also collaborated with TADA Arzneimittel AG and filed with the MHRA to upgrade Kinpeygo from conditional to full marketing authorization. It has raised SEK 324 million (US$ 34 million) and secured a US$75 million loan from Kreos Capital.

founded in 1991, is a global biopharmaceutical firm dedicated to creating and marketing innovative, long-acting medicines for patients with severe and chronic conditions. It uses its proprietary FluidCrystal technology—a lipid-based drug delivery system—to develop injectable depots that deliver sustained medication levels over days to months. The company has partnered with Eli Lilly to develop and commercialize four long-acting incretins, and with Gubra to create a long-acting treatment for hypoparathyroidism

founded in 2017, specializes in developing anti-inflammatory and pain-relief drugs. In October of that year, it acquired the OX-MPI development program from Orexo AB, which included several selective and potent microsomal prostaglandin E synthase-1 (mPGES-1) inhibitors, such as vipoglanstat (GS-248), originating from Boehringer Ingelheim. In March 2019, the company acquired additional mPGES-1 inhibitors from Acturum Real Estate AB, and advanced 1 of these agents, GS-073 (which originated from AstraZeneca), to phase 1 clinical trials in 2020. Recently, Gesynta decided to focus on developing vipoglanstat for endometriosis. The company has completed 3 funding rounds and raised more than SEK 607 million (US$229 million), attracting investments from Hadean Ventures, Innovestor Life Science, Industrifonden, and Linc to support its product pipeline. Gesynta Pharma has received support from Karolinska Institutet Innovation AB, Novo Nordisk Foundation, Swelife, and VINNOVA–Sweden’s Innovation Agency.

was established in 2020 and operates as a privately owned biotechnology company. It focuses on creating advanced brain-targeting treatments, leveraging its proprietary VHH antibodies capable of crossing the BBB. In June 2025, the company signed a licensing deal with Chiesi to use its BBB technology for developing CNS-targeted enzyme replacement therapies for lysosomal storage disorders.

 In February 2026, it formed a strategic partnership with OliX Pharmaceuticals to develop further siRNA delivery for central nervous system (CNS) disorders.

is a clinical-stage biotech company focused on creating personalized cancer immunotherapies that use the patient’s own cells. Their method is based on 2 proprietary technologies: PIOR and EpiTCer. PIOR combines patient DNA sequencing data with machine learning to identify tumor-specific mutations, while EpiTCer expands T cells that recognize and attack these specific tumor features. In February 2026, the company raised SEK87 million (US$9.6 million) in funding led by Society funds. These funds will support the development of its pTTL (personalized Tumor Trained Lymphocytes) therapy for patients with advanced colorectal cancer.

 It has also received a grant from Medtech4Health to advance its autoimmune research.

) is a global biopharma company that is developing life-saving therapies for people living with rare diseases. It has a broad portfolio of drugs targeting hematology and immunology. In February 2026, it completed the acquisition of US-based Arthrosi Therapeutics to strengthen its gout franchise and gain access to pozdeutinurad (AR882), an investigational next-generation, once-daily oral URAT1 inhibitor currently being evaluated in 2 fully recruited global phase 3 clinical studies for the potential management of progressive and tophaceous gout, with results expected to read out in 2026

Sobi has forged various partnerships, including entering into a licensing deal with Innate Pharma to initiate the TELLOMAK-3 confirmatory phase 3 study in cutaneous T-cell lymphoma (CTCL) with lacutamab.

 In August 2026, it repurchased all issued Class C shares, paying SEK122 million (US$13 million); the company will convert these shares to common shares.

Future Opportunities for Investment in Swedish Biotechs

Sweden’s Life Science industry, with annual sales of about SEK 474 billion (US$50 billion), has become one of the nation's leading engines of growth (see 

). Recently, government investments have increased, bolstered by a vibrant private sector that makes up about three-quarters of the country's R&D expenditure.

 In April 2026, the Swedish government initiated a national project called Swe Trial to establish a unified framework for clinical trials. The goal is to simplify the process, boost capacity and reduce barriers to enhance the country's competitiveness in healthcare, research, and industry. Biobank Sweden has provided SEK10 million (US$1.1 million) to fund the project, and the Swedish Medical Products Agency (Läkemedelsverket) will supervise it.

Swedish biotech companies have a strong and wide-ranging product pipeline, providing pharma with considerable opportunities to invest in early-stage startups and innovative technologies. This can help pharma grow its own pipeline and create the next wave of groundbreaking therapies.

Swedish Biotech Companies to Keep an Eye On.

SwedenBIO. The Swedish Drug Discovery and Development Pipeline 2026. SwedenBio. 2026.

https://swedenbio.se/wp-content/uploads/2025/10/lowres-the-swedish-drug-discovery-and-development-pipeline-2026.pdf

Johansson A, et al. Swedish Science Barometer 2025/26. Vetenskap & Allmänhet. 2026. Accessed September 8, 2026. 

https://vetenskapallmanhet.se/wp-content/uploads/2026/02/varapport2025_4-English.pdf 

Government Offices in Sweden. A concerted effort for excellence, long-term competitiveness, and increased patient benefit: National life sciences strategy. New objectives. 2026. Accessed September 8, 2026. 

government.se/contentassets/79e61ed6d1334ebba5a1a8bd5bb295f3/a-concerted-effort-for-excellence-long-term-competitiveness-and-increased-patient-benefit/

Positive 52-week phase 2b/3 data of Izokibep in psoriatic arthritis to be presented at EULAR 2026. Press release. Affibody Medical AB.May 21, 2026. 

https://www.affibody.se/press/positive-52-week-phase-2b-3-data-of-izokibep-in-psoriatic-arthritis-to-be-presented-at-eular-2026/

First patient dosed in part b of phase 1 study with affibody’s radioligand therapy candidate ABY-271 in HER2-positive metastatic breast cancer. Press release. Affibody Medical AB. May 28, 2026. 

https://www.affibody.se/press/first-patient-dosed-in-part-b-of-phase-1-study-with-affibodys-radioligand-therapy-candidate-aby-271-in-her2-positive-metastatic-breast-cancer/

Affibody’s licensee Rallybio announces positive data for RLYB116 phase 1 study demonstrating complete and sustained inhibition of terminal complement. Press release. Affibody Medical AB. February 17, 2026. 

https://www.affibody.se/press/affibodys-licensee-rallybio-announces-positive-data-for-rlyb116-phase-1-study-demonstrating-complete-and-sustained-inhibition-of-terminal-complement/

Alligator Bioscience comments on Henlius presentation of HLX49 preclinical data at AACR 2026 . Press release. Alligator Bioscience. April 23, 2026. 

https://alligatorbioscience.se/en/mfn_news/alligator-bioscience-comments-on-henlius-presentation-of-hlx49-preclinical-data-at-aacr-2026/

Alligator Bioscience shares crash 73% after dropping key drug program By Investing.com. Press release

https://uk.investing.com/news/stock-market-news/scott-bizily-4d-molecular-therapeutics-chief-legal-officer-sells-8176-93CH-4858908

AnaCardio´s phase 1b/2a GOAL-HF1 study in patients with heart failure and reduced ejection fraction (HFrEF) published in 

.Press release. AnaCardio. June 24, 2026. 

https://anacardio.com/anacardios-phase-1b-2a-goal-hf1-study-in-patients-with-heart-failure-and-reduced-ejection-fraction-hfref-published-in-the-lancet/

AnaCardio raises USD 19 million to advance first-in-class drug candidate AC01 for heart failure. Press release.AnaCardio. January 9, 2025. 

https://anacardio.com/anacardio-secures-usd-19-million-to-advance-ac01-development-for-heart-failure-and-shares-positive-result-from-phase-1b-study/

Anocca raises SEK 440 million to advance clinical trial targeting pancreatic cancer. Press release.Anocca. September 29, 2025.

https://www.anocca.com/company/news/anocca-raises-sek-440-million-to-advance-clinical-trial-targeting-pancreatic-cancer

Asgard Therapeutics announces oral presentation at ASGCT 2026, showcasing advanced preclinical data on AT-108 – its first-in-class, off-the-shelf, gene-based cancer immunotherapy. Press release. April 28, 2026. 

https://www.asgardthx.com/asgard-therapeutics-announces-oral-presentation-at-asgct-2026-showcasing-advanced-preclinical-data-on-at-108-its-first-in-class-off-the-shelf-gene-based-cancer-immunotherapy/

European Innovation Council Transition–accelerating 40 groundbreaking technologies from lab to market readiness. Press release. European Innovation Council. January 22, 2025. 

https://eic.ec.europa.eu/news/european-innovation-council-transition-accelerating-40-groundbreaking-technologies-lab-market-2025-01-22_en

BioArctic and Lilly sign research and collaboration agreement combining Lilly compound with BioArctic’s BrainTransporter technology. Press release. BioArctic. June 22, 2026. 

FDA approves Leqembi Iqlik® (lecanemab-irmb) subcutaneous injection as a starting dose for early Alzheimer’s disease. Press release. BioArtic. July 13, 2026. 

https://www.bioarctic.com/en/fda-approves-leqembi-iqlik-lecanemab-irmb-subcutaneous-injection-as-a-starting-dose-for-early-alzheimers-disease/

Cell X Technologies and BioLamina enter a collaboration to advance standardization in iPSC-based therapeutics. Press release. BioLamina. September 29, 2025.

https://biolamina.com/newsroom/cell-x-technologies-and-biolamina-enter-a-collaboration-to-advance-standardization-in-ipsc-based-therapeutics/

Swedish company BioLamina to enable next-generation cell therapies for serious chronic diseases with €20 million EIB commitment. Press release. BioLamina. April 16, 2026. 

https://biolamina.com/newsroom/swedish-company-biolamina-to-enable-next-generation-cell-therapies-for-serious-chronic-diseases-with-e20-million-eib-commitment/

BioLamina and Cytochroma partner to accelerate reliable New Approach Methodologies aligned with FDA Modernization Act 2.0 Press release. BioLamina. May 28, 2026. 

https://biolamina.com/newsroom/biolamina-and-cytochroma-partner-to-accelerate-reliable-new-approach-methodologies-aligned-with-fda-moderniziation-act-2-0/

Camurus announces expansion of Lilly collaboration. Press release. Camurus. June 1, 2026. 

https://www.camurus.com/media/press-releases/2026/camurus-announces-expansion-of-lilly-collaboration/

Camurus and Gubra enter into a collaboration and license agreement to develop a long-acting treatment for hypoparathyroidism. Press release. Camurus. June 1, 2026. 

https://www.camurus.com/media/press-releases/2025/camurus-and-gubra-enter-into-a-collaboration-and-license-agreement-to-develop-a-long-acting-treatment-for-hypoparathyroidism/

Gesynta Pharma announces second closing of Series B now totaling SEK 347m - HealthCap and Hadean Growth Fund join strong investor syndicate. Press release. Gesynta Pharma. July 22, 2026 

https://www.gesynta.se/news-media/press-releases/?slug=gesynta-pharma-announces-second-closing-of-series-b-now-tota-98931

Chiesi Group enters into worldwide licensing agreement with Key2Brain AB to advance blood-brain barrier-crossing therapies for lysosomal storage disorders. Press release. Key2brain. June 11, 2025. 

https://www.key2brain.com/blog/key2brain-ab-enters-into-worldwide-licensing-agreement-with-chiesi-group

Key2Brain and OliX Pharmaceuticals enter a strategic evaluation and option agreement to advance CNS-targeted siRNA delivery. Press release. Key2Brain. June 11, 2025. 

https://www.key2brain.com/blog/key2brain-and-olix-pharmaceuticals-enter-a-strategic-evaluation-and-option-agreement-to-advance-cns-targeted-sirna-delivery

Neogap secures SEK 87 million to advance clinical development of its personalized immunotherapy. Press release. NEOGAP. February 11, 2026. 

https://neogap.se/news/neogap-secures-sek-87-million-to-advance-clinical-development-of-its-personalised-immunotherapy/

Sobi completes acquisition of Arthrosi Therapeutics, strengthening pipeline for the potential treatment of gout. Press release. February 9, 2026. 

https://www.sobi.com/en/press-releases/sobi-completes-acquisition-arthrosi-therapeutics-strengthening-pipeline-potential-treatment-gout-2424540

Sobi enters strategic partnership with Innate Pharma to license lacutamab in T-cell lymphoma. Press release. Sobi. August 10, 2026. 

https://www.sobi.com/en/press-releases/sobi-enters-strategic-partnership-innate-pharma-license-lacutamab-t-cell-lymphoma-2472935

Sobi has completed an issue of class C shares. Press release. Sobi. August 31, 2026. 

https://www.sobi.com/en/press-releases/sobi-has-completed-issue-class-c-shares-2478017

Stockholm Science City. Life Science.2025. 

https://ssci.se/en/what-we-do/life-science

SweTrial launched to boost clinical trials in Sweden. Press release. ATMP Sweden. August 11, 2025. 

https://atmpsweden.se/news-article/swetrial-clinical-trials-sweden/

Articles

Sweden is reinforcing its position as a European hub for early-stage life science, supported by deep R&D infrastructure (SciLifeLab, MaxIV, ESS) and a strong industrial anchor in AstraZeneca. Since mid-2025, financing and deal activity have accelerated, emphasizing out-licensing, rights issues, and strategic collaborations with large pharma and diagnostics partners. A broad, modality-diverse pipeline spans CNS, immuno-oncology, ATMPs, and rare disease assets, with multiple late-stage programs. Government-backed SweTrial aims to streamline and scale national clinical-trial execution.

Swedish biotech companies have a broad and varied product pipeline that is attracting attention from venture capitalists and pharmaceutical companies.

Sweden, a Powerhouse for Early Stage Innovation

Image Credit: ©Monika Huňáčková -stock.adobe.com

Since July 2026, the European Union (EU) has shifted its focus from legislative reforms to practical applications, prioritizing supply-chain resilience, preventing medicine shortages, streamlining regulations, artificial intelligence (AI) governance, and introducing innovative approaches for nonclinical drug development.

Key updates for pharma and biotech include implementing the AI Act, expanding regulatory reliance on postauthorization changes (PACs), implementing new pharmaceutical regulations, and addressing medicine shortages and supply-chain robustness. Additionally, the European Medicines Agency (EMA) continues to promote regulatory reliance and faster clinical development pathways, supported by a new pilot program for New Approach Methodologies (NAMs).

Enforcement of the AI Act began on August 2, 2026, creating a framework and implementing new transparency standards for specific generative, interactive AI systems and AI-produced content.

 Additional regulations for other high-risk applications will take effect in December 2027, with further high-risk requirements postponed until August 2, 2028, under the AI Omnibus.

This delay significantly affects the pharmaceutical sector’s AI usage in areas such as research and development (R&D) (including AI-supported drug discovery and diagnostics), manufacturing and process optimization (covering generative AI in regulated workflows and quality systems), pharmacovigilance (such as regulatory intelligence and medical information), and clinical development (AI-enabled decision-support tools, clinical trial recruitment, and optimization). The pharma industry must continue to focus on establishing governance, transparency, and accountability for AI systems across the entire value chain.

EMA Expands Regulatory Reliance for Postauthorization Changes

On August 13, 2026, the EMA released updated guidance for industry regarding the reliance pilot for PACs, including a mid-pilot review.

 The aim is for EU regulators to leverage evaluations already conducted by trusted authorities elsewhere, preventing redundant assessments. This approach could lower administrative burdens for multinational firms, accelerate review timelines, reduce duplicated efforts across jurisdictions, and ease overall regulatory workloads. The PAC pilot initiative is a component of a wider strategy to foster international regulatory convergence and reliance. For global pharmaceutical companies, this could significantly streamline their supply chain, manufacturing processes, and postapproval life cycle management.

Prioritizing Medicine Shortages and Strengthening Supply-Chain Resilience

On August 31, 2026, the EMA released a new Shortage Prevention Plans (SPP) template and revised its industry guidance on SPP implementation.

This development is crucial because the upcoming EU pharmaceutical framework will focus more on manufacturers and marketing-authorization holders proactively identifying and addressing vulnerabilities to prevent shortages. The SPP approach urges pharma companies to systematically consider factors such as alternative manufacturing options, API and raw material risks, business continuity plans, logistical vulnerabilities, dependencies on manufacturing sites, mitigation strategies, and potential supply chain vulnerabilities.

EU regulators increasingly view manufacturing diversification as a regulatory and public health goal. For manufacturers, reliance on a single API source or manufacturing location is becoming a more significant regulatory factor. The EMA's initiatives support the broader EU Critical Medicines Act, which seeks to increase production capacity, diversify supply chains, and reduce dependence on particular suppliers.

On September 1, 2026, the EMA launched a pilot program, Voluntary Data Submission, to collect data on NAMs.

These include techniques such as organoids, microphysiological systems, computational models, and other innovative in vitro methods, including integrated approaches. Companies, clinical research organizations, labs, and method developers can submit NAM data independently of marketing applications for nonbinding regulatory feedback. The pilot will help the EMA gain experience in evaluating these technologies before wider regulatory use. If this pilot succeeds, it could impact pharma R&D by accelerating the use of organoid models, reducing animal testing, and potentially improving preclinical data and predictions, while encouraging more funding for biotech, cell therapies, computational biology, and innovative drug firms.

In July 2026, the EMA published the nonclinical requirements concept paper for severe diseases.

 The consultation for this program concludes on September 30, 2026, and a reflection paper will be released afterwards to align nonclinical development and facilitate earlier access to life-saving medicines. The paper will emphasize the 3Rs—replacing, reducing, and refining animal models whenever feasible.

Faster Multinational Clinical-Trial Assessment

EU regulators acknowledge that making the Clinical Trials Regulation (CTR) faster and more predictable is essential for Europe to stay competitive in innovative clinical research. In July 2026, the EMA held a Clinical Trials Information System (CTIS) training session on how to use the new annual safety reporting (ASR) module, which will become the mandatory channel for submitting and managing ASRs from go-live.

 Earlier in the year, the Heads of Medicines Agencies launched the Facilitating and Accelerating Strategic Clinical Trials European (FAST-EU) pilot to expedite the evaluation of multinational clinical trials under the EU CTR.

 This program provides a coordinated fast-track review process designed to reduce timelines and enhance predictability among Member States.

The EU’s largest pharma regulatory overhaul in 2 decades is nearing adoption. It consists of a new regulation and a new directive, which will replace the current framework (Directive 2001/83/EC and Regulation (EC) No 726/2004). In December 2025, the Council and European Parliament (CEP) reached a political agreement on a new pharmaceutical framework, which is now moving forward in the legislative process.

Although not yet officially in effect, the legislation covers regulatory protections, market access, shortages, antimicrobial resistance, orphan and pediatric medicines, and regulatory procedures. As a result, companies should start preparing for upcoming changes in regulatory incentives, supply obligations, procedures, and market access, as well as the link between EU regulatory approval and actual market availability. The revised framework is expected to become fully operational around 2028, at least for the main provisions.

In September 2026, the European Commission (EC) proposed a new European Innovation Act to support the development, funding, and scaling of Europe’s most innovative ideas.

To strengthen the EU innovation system, the proposal addresses 2 main challenges. First, it seeks to boost access to funding for innovative businesses by providing up to €10.2 billion (US$11.85 billion) extra each year and reducing about €35 million (US$40.67 million) in administrative costs. Secondly, it will create a unified framework for R&D procurement, enhancing legal clarity. This will help technologists bring products to market more efficiently and make it easier for EU buyers to participate in joint R&D procurement. As a result, companies could see an increase of €25.92 billion (US$30.12 billion) in annual profits, and public buyers could save €1 billion (US$1.16 billion) annually.

Future Outlook of EU Regulation on the Pharma Industry

Between July and September 2026, the EU’s pharma and biotech regulation landscape emphasized digitalization and AI, fostering innovation through regulation, enhancing regulatory efficiency, and strengthening supply chains. The emphasis has moved from a primarily product-focused regulatory approach to prioritizing EU competitiveness, resilience, and strategic independence. Additionally, upcoming guidance on the AI Act will delineate the distinctions among general-purpose AI, medical devices, and AI integrated into regulated products. The EMA’s NAM pilot program will evaluate whether organoids, computational models, and other alternatives can gain wider regulatory approval. Furthermore, FAST-EU performance data are expected to speed up clinical trial assessments.

During the next 12 months, the industry will integrate the EU Pharma Package and new pharmaceutical regulations into its operations. For innovative biotech firms, key changes will involve FAST-EU, NAM, and regulatory reliance initiatives. Meanwhile, established pharmaceutical companies are likely to face significant operational changes related to shortage prevention, pharmacovigilance, and implementing the EU Pharma Package.

Commission starts enforcing AI Act rules and new transparency requirements on 2 August

. European Commission. July 31, 2026. Accessed September 10, 2026. 

https://digital-strategy.ec.europa.eu/en/news/commission-starts-enforcing-ai-act-rules-and-new-transparency-requirements-2-august

Guidelines on transparency obligations for providers and deployers of certain AI systems

. European Commission. July 20, 2026. Accessed September 10, 2026. 

https://digital-strategy.ec.europa.eu/en/library/guidelines-transparency-obligations-providers-and-deployers-ai-systems

The enforcement framework of the AI Act

. European Commission. August 24, 2026. Accessed September 10, 2026. 

https://digital-strategy.ec.europa.eu/en/policies/enforcement-ai-act

Regulation (EU) 2026/1744 of the European Parliament and of the Council amending Regulations (EU) 2024/1689, (EU) 2018/1139 and (EU) 2023/1230 as regards the simplification of the implementation of harmonised rules on artificial intelligence (Digital Omnibus on AI).

 European Commission. July 8, 2026. Accessed September 10, 2026. 

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=OJ:L_202601744

Transparency obligations under Article 50 of the AI Act

. European Commission. July 24, 2026. Accessed September 10, 2026. 

https://digital-strategy.ec.europa.eu/en/faqs/transparency-obligations-under-article-50-ai-act

Reliance pilot for post-authorisation changes: guidance for industry and mid-pilot review

. European Medicines Agency. 2026. Accessed September 10, 2026. 

https://www.ema.europa.eu/en/documents/report/reliance-postauthorisation-changes-pacs-mid-pilot-review_en.pdf

Guidance for industry on shortage prevention plans

. European Medicines Agency. July 17, 2026. Accessed September 10, 2026. 

https://www.ema.europa.eu/system/files/documents/regulatory-procedural-guideline/guidance-industry-implementing-shortage-prevention-plans-en.pdf

. European Commission. March 11, 2025. Accessed September 10, 2026. 

https://ec.europa.eu/commission/presscorner/detail/en/ip_25_733

Voluntary data submission pilot to advance innovative alternatives to animal testing

. European Medicines Agency. September 1, 2026. Accessed September 10, 2026. 

https://www.ema.europa.eu/en/news/voluntary-data-submission-pilot-advance-innovative-alternatives-animal-testing

Concept paper on the development of a reflection paper on the non-clinical requirements for severely debilitating or life-threatening diseases

. European Medicines Agency. July 30, 2026. Accessed September 10, 2026. 

https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-development-reflection-paper-non-clinical-requirements-severely-debilitating-or-life-threatening-diseases_en.pdf

Presentation CTIS training environment: updated access process and safety module instructions.

 European Medicines Agency. July 23, 2026. Accessed September 10, 2026. 

https://www.ema.europa.eu/en/documents/presentation/presentation-ctis-training-environment-updated-access-process-safety-module-instructions-ornela-ademi_en.pdf

European Medicines Agency. March 3, 2026. Accessed September 10, 2026. 

https://ec.europa.eu/newsroom/ema/items/925543/en

. European Commission, Directorate-General for Health and Food Safety. European Commission. December 2025. Accessed September 10, 2026. 

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

The EU Pharma Package is finally here – here’s the settled position on key areas.

 Herbert Smith Freehills Kramer. Global law firm. April 26, 2026. Accessed September 10, 2026. 

https://www.hsfkramer.com/notes/ip/2026-04/the-eu-pharma-package-finally-here-what-it-changes-and-what-it-means

Commission proposes new European Innovation Act to help innovative European ideas grow and compete globally. European Commission. News release. September 9, 2026. Accessed September 10, 2026. 

https://ec.europa.eu/commission/presscorner/detail/en/ip_26_1810

EU pharma policy in mid-2026 pivoted toward implementation: AI Act enforcement, reliance pathways for post-authorization changes, shortage-prevention obligations, and pilots to modernize non-clinical evidence. EMA guidance strengthens governance for generative AI while deferring high-risk requirements to 2027–2028. Reliance on trusted foreign assessments aims to compress PAC timelines and reduce duplication. New Shortage Prevention Plan templates and the Critical Medicines Act elevate diversification and business continuity expectations. NAM voluntary submissions and CTR accelerators (CTIS ASR module, FAST-EU) target faster, more predictable development ahead of the 2028 pharma package.

The EU is focused on strengthening supply-chain resilience, avoiding medicine shortages, simplifying regulations, and implementing new approach methodologies. 

European Regulators Prepare the Pharma Industry for Future Changes as Legislation Is Formalized

3D bioprinting is the utilization of 3D printing to combine cells and growth biomaterials to make biomedical parts | Image Credit: ©luchschenF -stock.adobe.com

Biomedical technology has been revolutionized by advances in computer-aided design and manufacturing, often referred to as three-dimensional (3D) printing. As 3D printers become more accessible and easier to use, researchers are finding new ways to incorporate this technology into their work.

 3D bioprinters using natural, synthetic, and hybrid biocompatible materials have successfully been deployed in tissue engineering and regenerative medicine, creating artificial corneas, cartilage, 3D cell culture scaffolds, implantable grafts, and wound patches.

3D printing technology is increasingly applied in drug discovery to produce artificial organs, organoids, and microfluidic systems for organ-on-a-chip (OOC) applications, enabling high-throughput screening of pharmaceutical compounds. For instance, Sweden-based BICO has developed a range of 3D cell culture and bioprinting technologies, including CELLINK’s Bionova X for direct in-well printing and Cellenion’s spheroOne for automated sorting and isolation of spheroids and organoids, enabling the generation of 3D in vitro models for toxicity testing.

In addition, several companies have explored the role of 3D printing in producing customized drugs. GSK and Merck have evaluated 3D printing to produce drugs for clinical use before moving to commercial-scale manufacturing.

 FABRX, based in the United Kingdom, has created the M3DIMaker ecosystem, enabling the production of personalized medicines tailored to the patient based on the shape, flavor, color, dose, and release profile. It also supports polypills, which combine multiple drugs into a single pill. FABRX has been collaborating with AstraZeneca, Evonik Industries, Losan Pharma, Pfizer, and leading academic institutes and hospitals to develop and distribute this technology to improve patient outcomes.

Advancements in high-resolution printing and technology have enabled scientists to develop complex, large-scale heterocellular constructs. A variety of fabrication methods have been developed, including extrusion-based bioprinting (EBB), inkjet, laser-induced forward transfer (LIFT), two-photon polymerization (2PP), and vat photopolymerization (VP), which offer high-resolution and biofunctionalization solutions.

Currently, EBB is the most widely used bioprinting technology and employs a mechanical or pneumatic system to extrude bioink materials through a micronozzle. This method is commonly used to create human tissue, from small vessels to whole organs, for surgical use.

 Inkjet-based bioprinting was one of the first to be developed. It is a non-contact method that uses print heads to eject single drops of ink from a reservoir. This technology has been used to produce tissue scaffolds because it offers high precision and resolution at low cost, but challenges remain in achieving heterogeneous structures.

Conversely, LIFT uses a laser to deposit cells or bioinks onto a substrate accurately. This method allows for the construction of intricate 3D structures with high precision and good cell survival rates. LIFT has been extensively used to produce biomolecule microarrays and different tissue types, including skin, blood vessels, and bone.

 For instance, France-based Poietis Biosystems has teamed up with Servier to use its next-generation LIFT technology to produce liver tissues to improve the detection of drug-induced liver lesions.

VP and 2PP bioprinting potentially offer the highest resolution and can generate micro- and nanostructures using ultraviolet/visible light or a laser beam, respectively. VP is the second most widespread 3D bioprinting technology and comprises 3 main types: digital light processing (DLP), liquid crystal display, and stereolithography. This technology has been used in digital dentistry, surgical planning, and medical devices; however, VP is not widely used to print scaffolds for implantation, though it is useful for investigating cell-scaffold interactions.

Leading European Biotechs Working in the 3D Printing Space

Advances in 3D printing materials and technologies have attracted investor interest, with France-based Healshape completing a US$6.8 million (€6 million) Series A funding round to develop bioprinted breast tissue implants that are personalized and resorbable.

 In addition, several high-profile acquisitions have been announced, including Anzu Partners' €20 million deal with Germany-based EnvisionTEC in August 2025.

Several pharma companies have forged strategic alliances with 3D printing companies, including AstraZeneca/FABRX, Eli Lilly and Company/Triastek, Servier/Poietis Biosystems, and Pfizer/FABRX.

Several European biotech companies are pushing the frontiers of 3D bioprinting technologies forward through the development of bioinks, high-resolution bioprinting hardware, and platforms for medical-device bioprinting 

Table: Leading European Biotechs Working in the 3D Printing Space

A bioink is a printable material made from living cells encapsulated in a supportive hydrogel, designed specifically for 3D bioprinters that build living tissue layer by layer.

 Bioink formulations use hydrogels and polymers to create live organs and 3D scaffolds to treat wounds; repair muscle, bone, and tissues; and deliver drugs. 

Three-dimensional printing is moving from prototyping into biomedical production, spanning tissue engineering, regenerative implants, organoids, and organ-on-a-chip platforms for drug screening, particularly within oncology and rare-disease pipelines. Multiple bioprinting modalities—extrusion, inkjet, LIFT, vat photopolymerization, and two-photon polymerization—trade throughput for micrometre-to-nanometre resolution and biofunctionality. European innovation centers on advanced bioinks, high-resolution hardware, and device platforms, supported by funding, acquisitions, and pharma collaborations. Growth is strong, but vascularization, cell survival, scale-up, and regulation remain limiting; EMA guidance is clarifying GMP expectations for 3D-printed oral dosage forms.

European biotechs are advancing bioinks and high-resolution bioprinting for medical devices and regenerative tissues.