Cheryl Barton is director of PharmaVision, 

Cheryl Barton

Europe political map flag 3D vector individual states separate | Image Credit: 

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 non-clinical drug development.

Key updates for pharma and biotech include implementing the AI Act, expanding regulatory reliance on post-authorization 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 Post-Authorization 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 post-approval lifecycle 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, dependence on a single API source or manufacturing location is becoming a significantly more important 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 non-binding 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 non-clinical 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 non-clinical 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 ofEU 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. Press release. September 9, 2026. Accessed September 10, 2026. 

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

Articles

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. 

Belgium-based BIO INX is among Europe’s leading start-ups specializing in bioinks for bioprinting. The company has developed photopolymerizable bioinks suited for volumetric, deposition-based, DLP, and high-resolution multiphoton bioprinting, enabling the creation of complex geometries at the micrometre scale. Its biodegradable polyester resin, DEGRAD INX, functions as a biodegradable cage or scaffold around cell clusters, enhancing cell viability and extracellular matrix production to form functional tissues. This technology has been used to produce artificial corneas, cartilage, and OOC systems. Researchers at the Vienna University of Technology successfully demonstrated that injectable, DEGRAD INX, cell-based therapy facilitated the regeneration of disc tissue in patients with lower back pain caused by intervertebral disc damage.

Similarly, CELLINK (part of the BICO group) has launched CELLINK Vivoink, a medical-grade bioink specially designed for optimal printability, mechanical stability, and cell viability. Ossiform has used this technology to provide patient-matched, natural, and resorbable bone implants, resulting in improved clinical outcomes.

Vital3D Technologies, based in Lithuania and founded in 2021, has created the proprietary 2PP bioprinting platform called FemtoBrush, which offers micrometre-scale resolution within centimetre-scale build volumes. This platform has facilitated the development of a wide product range, including vascular stents, 3D organoid scaffolds, implantable grafts, wound patches, and microfluidics for OOC systems. The company's goal is to create a fully bioprinted, implantable human kidney.

To date, Vital3D has raised €2 million (US$2.34 million) and forged partnerships with pharma, biotech, clinical research organisations, medical device companies, research institutes and hospitals, as well as material and bioprinting companies. The company is collaborating on the Butterflies Project, which aims to replace conventional petroleum-based plastics in the medical and bioengineering sector. Preliminary research with chitin and chitosan-based material looks promising.

Advancements in Bioprinting Platforms for Medical Devices

EnvisionTEC, a Germany-based company, is a prominent European provider of bioprinting hardware, focusing on high-resolution printing for tissue engineering and regenerative medicine. The company produces affordable 3D printers using technologies such as DLP and Scan, Spin, and Selective Photocure, including its 3D-Bioplotter series. The EnvisionTEC 3D-Bioplotter series is used by universities, medical research centers, tissue engineering labs, and medical device manufacturers for applications such as bone regeneration, tissue engineering, organ printing, drug delivery, and advanced biomaterials research. Researchers at Northwestern University’s Feinberg School of Medicine and McCormick School of Engineering and Applied Science successfully 3D printed prosthetic ovaries and implanted them in a murine model. This innovation has contributed to the development of the US Food and Drug Administration–approved regenerative medical products, including CMFlex, a regenerative bone graft.

3D bioprinting is revolutionizing tissue engineering and regenerative medicine by allowing the development of intricate biological structures. Market research indicates that the worldwide 3D bioprinting market was valued at US$3.1 billion in 2025 and is expected to expand from US$3.5 billion in 2026 to US$6.7 billion by 2033, with a compound annual growth rate of 9.7% from 2026 to 2033.

Growth is expected to stem from improvements in biomaterials and printing methods, the demand for more precise drug testing models, and a rising need for regenerative medicines.

Although Europe’s bioprinting industry is still in its early phase, technological advancements in biomaterials and printing techniques are accelerating innovation in this field. CELLINK offers a broad array of platforms; Vital3D is known for microresolution; BIO INX leads with advanced bioinks; and Healshape focuses on implant-grade tissue bioprinting. Despite these advantages, obstacles such as vascularization, cell survival, scalability, and regulatory challenges remain significant barriers to clinical application. Looking ahead, combining artificial intelligence with innovative bioinks may enhance drug discovery and revolutionize personalized medicine, bringing new hope for organ transplants and complex tissue regeneration.

In March 2026, the European Medicines Agency published a landmark document: 

Questions & Answers on the Implementation of 3D Printing Technology (Additive Manufacturing Technology) for Solid Oral Dosage Forms

. This guidance provides greater clarity for manufacturers of solid oral dosage forms on quality and good manufacturing practice requirements and should help to drive further innovation in pharmaceutical 3D printing in personalized oncology, pediatrics, rare diseases, and community pharmacy compounding.

Savage N. Five ways 3D printing is improving lab work. 

. 2026;656(8128):783-784. doi:10.1038/d41586-026-02535-z

Vyas J, Raytthatha N, Vyas P, et al. Biomaterial-based additive manufactured composite/scaffolds for tissue engineering and regenerative medicine: a comprehensive review. 

. 2025;17(8):1090. doi:10.3390/polym17081090

Agarwal P, Arora G, Panwar A, et al. Diverse applications of three-dimensional printing in biomedical engineering: a review. 

. 2023;10(5):1140-1163. doi:10.1089/3dp.2022.0281

. BICO. Accessed August 24, 2026. https://bico.com/products/3d-cell-culture-bioprinting/

 Merck. Accessed August 25, 2026. https://www.emdgroup.com/en/research/science-space/envisioning-tomorrow/additive-manufacturing.html

Five companies personalizing treatments with 3D printed drugs

. Labiotech. Published July 28, 2022. Updated November 18, 2022. Accessed August 24, 2026. 

https://www.labiotech.eu/best-biotech/five-companies-personalizing-treatments-with-3d-printed-drugs/

Automating the future of personalized medicine

. FABRX. Accessed August 25, 2026. https://www.fabrx.co.uk/home

Kazemi M, Maralbashi S. Advances in 3D bioprinting for medical application: opportunities and challenges. 

 2025;25(1):11. doi:10.1186/s12938-025-01498-y

Sun X, Ren W, Xie L, et al. Recent advances in 3D bioprinting of tissues and organs for transplantation and drug screening. 

. 2024;19(1):e2384662. doi:10.1080/17452759.2024.2384662

Jose J, Peter A, Thajudeen KY, et al. Recent advances in the design and development of bioink formulations for various biomedical applications. 

Chang J, Sun X. Laser-induced forward transfer based laser bioprinting in biomedical applications

 2023;11:1255782. doi:10.3389/fbioe.2023.1255782

Servier and Poietis announce scientific partnership in 4D bioprinting of liver tissues. News release. Poietis Biosystems. December 19, 2018. Accessed August 25, 2026. https://www.poietis.com/servier-and-poietis-announce-scientific-partnership-in-4d-bioprinting-of-liver-tissues/

Guida L, Cavallaro M, Levi M. Advancements in high-resolution 3D bioprinting: exploring technological trends, bioinks and achieved resolutions. 

Healshape lève 6M€. News release. Healshape. June 28, 2022. Accessed August 25, 2026. https://healshape.com/healshape-leve-6millions-levee-de-fonds/

US Court approved Anzu Partners affiliate to acquire EnvisionTec, leader in 3D polymer printers and resins, providing financing and stability for operations. News release. Anzu Partners. August 13, 2025. Accessed August 25, 2026. https://www.anzupartners.com/2025/08/13/us-court-approved-anzu-partners-affiliate-to-acquire-envisiontec-leader-in-3d-polymer-printers-and-resins-providing-financing-and-stability-for-operations/

Triastek announces research collaboration with Lilly to explore the application of 3D printing technology in oral delivery of drugs

. News release. Triastek. July 13, 2022. Accessed August 25, 2026. https://www.triastek.com/detail/11.html

What is bioink and how is it used in 3D printing? Science Insights. March 26, 2026. Accessed August 25, 2026. 

https://scienceinsights.org/what-is-bioink-and-how-is-it-used-in-3d-printing/

Balasubramanian RV, Muerner M, Kopinski-Grünwald O, Grad S, Fernández-Pérez J, Ovsianikov A. 

Exploring injectable scaffolded spheroids for nucleus pulposus therapy in degenerated intervertebral discs

2026;18(7):10994-11007. doi:10.1021/acsami.5c24306

CELLINK announces CELLINK Vivoink: our first dedical-grade Bioink

. News release. CELLINK. October 18, 2023. Accessed August 25, 2026. www.cellink.com/cellink-announces-cellink-vivoink-our-first-medical-grade-bioink/

CELLINK and Ossiform enter a strategic partnership to launch Ossi Ink, a printable bioink based on Ossiform’s P3D Bone material

. News release. CELLINK. November 30, 2023. Accessed August 25, 2026. www.cellink.com/cellink-and-ossiform-enter-a-strategic-partnership-to-launch-ossi-ink-a-printable-bioink-based-on-ossiforms-p3d-bone-material/

Hybrid manufacturing for bio-intelligent future

s. Butterflies Project. Accessed August 25, 2026. https://butterfliesproject.eu/

Dimension Inx announces first surgical cases utilizing CMFlex synthetic bone graft – the first 3D-printed regenerative bone graft product cleared by the FDA

. News release. Dimension Inx. October 4, 2023. Accessed August 25, 2026. https://dimension.bio/pr-cmflex

3D bioprinting market (2026-2033). Grand View Research. March 12, 2026. Accessed August 25, 2026. 

https://www.grandviewresearch.com/industry-analysis/3d-bioprinting-market

Selvakumar M, Dhanasekar J, Nandhakumaran S, Sudhamani T. 3D bioprinting: current status and future prospects in tissue and organ regeneration. 

 2026;12:58. doi:10.1186/s43094-026-00982-z

Questions & answers on the implementation of 3DP technology (additive manufacturing technology) for solid oral dosage forms

. European Medicines Agency. March 12, 2026. Accessed August 25, 2026. 

https://www.ema.europa.eu/en/documents/other/questions-answers-implementation-3dp-technology-additive-manufacturing-technology-solid-oral-dosage-forms_en.pdf

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

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.

3D Printing Is Revolutionizing Tissue Engineering and Regenerative Medicine in Europe 

The Nordic region is among the world's leading biotechnology hubs, combining world-class academic research, robust public healthcare, experienced venture capitalists (VCs), and competitive pharmaceutical companies. Since January 2026, several large pharma companies have made strategic acquisitions or licensed Nordic assets. These include Eli Lilly’s US$1 billion licensing deal with neurology leader AlzeCure and Sobi’s US$950 million acquisition of autoimmune/inflammatory specialist Asthrosi Therapeutics.

 Meanwhile, institutional investors such as Novo Holdings, EQT, and specialized life-science funds have focused on companies with clinical-stage assets, artificial intelligence (AI)-powered drug-discovery platforms, precision medicines, and advanced biologics.

Denmark's Strategy for Life Science Towards 2030: Driving Innovation

Whilst Denmark might seem an unlikely hub for pharmaceutical production, it has a thriving life sciences ecosystem that few other countries can match. In 2024, the country unveiled its “Strategy for Life Science Towards 2030”, bringing together recommendations from a Life Science Council composed of representatives from industry, academia, patient groups, healthcare providers, and employee organizations to drive economic growth and innovation.

 The strategy's implementation seeks to improve the framework for the sector, enhance the industry as a Danish competitive edge, and provide a cohesive healthcare system for patients.

To achieve this, the government plans to support viable new companies through increased backing for innovative life science startups and to improve research and health data utilization by expanding AI and innovation for enhanced patient care. It aims to promote innovative healthcare solutions by improving access to effective, efficient, and labor-saving health services and new medicines. The strategy also involves creating competitive production and investment conditions to make Denmark more attractive for life science manufacturing and attract foreign investments. Additionally, Denmark wants to assume a more active international role by engaging in global health issues and advocating for Danish health solutions worldwide. Supporting Europe as a competitive life science region and establishing a favorable regulatory environment are also key objectives.

What Are Some Danish Biotechs to Watch Out for?

Denmark is known for its extensive manufacturing industry, including companies such as Fujifilm Biotechnologies and AGC Biologics, as well as significant pharmaceutical exports from firms such as ALK, Leo Pharma, Lundbeck, and Novo Nordisk. The country also boasts a dynamic biotech community, featuring leaders such as GenMab, a leading antibody engineering firm, and Zealand Pharma, recognized for obesity treatments. Moreover, Denmark nurtures innovative biotech start-ups, which are increasingly attracting VC and pharmaceutical interest (

Danish Biotech Companies that Have Recently Attracted Venture Capital and Pharmaceutical Investment

According to the Export and Investment Fund of Denmark (EIFO), from 2018 to 2024, 106 unique Danish life science companies attracted VC funding. More than half were biotech firms, while medtech and healthtech each accounted for about 25%.

VC investments in Danish life sciences have nearly tripled since 2018, representing over a third of the market in 2024.

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

 is a clinical-stage biotech developing next-generation antibody-drug conjugates (ADCs) to target cancer. The company is advancing three ADCs: ADCE-T02 (solid tumors), ADCE-D01 targeting uPARAP (soft tissue sarcoma), and ADCE-B05 (undisclosed target). In April 2026, the company closed an oversubscribed US$75 million Series C financing round led by Jeito Capital, with participation from numerous investors, including Novo Holdings. To date, the company has raised US$323 million in funding. In May 2026, it entered into a collaboration with MSD to evaluate ADCE-T02 in combination with Keytruda in patients with advanced solid tumors.

 In 2024, Adcendo signed a licensing agreement with Multitude Therapeutics for the worldwide development and commercialization of ADCE-T02.

is a private biotech company supported by the BioInnovation Institute and the Technical University of Denmark (DTU). It focuses on discovering highly tumor-specific antibodies that target cancer-related glycan–protein epitopes, known as combotopes. This innovative technology was developed at DTU. In June 2026, Combotrope formed a partnership with Boehringer Ingelheim to leverage Boehringer Ingelheim’s SMART-Phage platform to develop tumor-selective antibody therapies for cancer.

 is a clinical-stage techbio firm leveraging its proprietary AI-Immunology platform to develop personalized vaccines for cancer and infectious diseases. Evaxion's AI-immunology platform uses machine learning models, trained on immunological data, to predict antigens likely to trigger T-cell or antibody responses. In September 2025, it licensed its vaccine candidate EVX-B3 to MSD in a deal valued at up to US$592 million. The company also retains an option for a second vaccine candidate, EVX-B2, with the evaluation period extended, and a licensing decision anticipated in 2026.

 The company is also developing EVX-01, a personalized cancer vaccine in phase 2 trials for melanoma and EVX-B4, a bacterial vaccine candidate.

is an international biotechnology company established in 1999.It has developed a broad range of antibody-based therapeutic formats, including bispecific antibodies, ADCs, immune-modulating antibodies and other next-generation modalities. It has a strategic focus on novel drug combinations, including immune checkpoint inhibitors combined with immunomodulators such as T‑cell immunoreceptor with Ig and ITIM domains and lymphocyte activating 3 (LAG-3).

 In September 2025, GenMab acquired Netherlands-based Merus for approximately US$8 billion to expand its late-stage pipeline, gaining access to petosemtamab, an epidermal growth factor receptor (EGFR) and the leucine-rich repeat-containing G-protein-coupled receptor 5 (LGR5) bispecific antibody in phase 3 for head and neck cancer and MCLA‑145, a bispecific antibody targeting CD137 and Programmed Cell Death Protein-1 (PD-1)/Programmed Death-Ligand 1 (PD-L1) for solid tumors.

is a disease-agnostic techbio company specializing in peptide-based drug discovery and preclinical contract research services. The company leverages itsAI-powered platforms, streaMLine and Conclude, to identify and optimize peptide-based therapeutics targeting metabolic diseases. Lead obesity programs include partnered assets with AbbVie, ABBV-295 (a long-acting amylin analogue), Amylyx Pharmaceuticals, AMX0318 (GLP-1 receptor antagonist), and Boehringer Ingelheim, BI 3034701 (a triple agonist). Its internal lead candidate, GUB-UCN2, is a next-generation peptide for healthy weight loss now progressing in clinical development. In March 2025, Boehringer Ingelheim initiated a phase 2 study with BI 3034701 for the treatment of overweight and obese patients.

is a biotechnology company at the clinical stage, focused on developing therapies for blood clotting disorders. The company is building a portfolio of innovative treatments including sutacimig (HMB-001), a bispecific antibody currently in clinical trials for preventing Glanzmann thrombasthenia and Factor VII deficiency. Additionally, HMB-002, a monovalent antibody under clinical development, aims to prevent Von Willebrand Disease. In May 2026, it closed its initial public offering (IPO) generating approximately US$347 million before expenses, with an offer price of US $18 per share.

 Hemab has previously raised a total of US$310 million across 4 funding rounds, with notable investors including RA Capital Management, Novo Holdings, Access Biotechnology, and HealthCap.

 is a privately held biopharmaceutical company established in 2020 and based in Copenhagen, Denmark. It aims to treat neurodegenerative diseases by enhancing resilience to misfolded protein pathology and protecting brain functions, including cognition. Its all-in-human discovery platform identifies new targets to boost the brain’s defenses. In January 2026, the company received a US$1 million research grant from the Alzheimer’s Association to support its ongoing phase 1 trial of MNA-001. MNA-001 is a small-molecule agonist against triggering receptor expressed on myeloid cells 2 (TREM2) on microglia; TREM2 is thought to play a central role in Alzheimer's disease pathology.

,founded in 2022 by Sevan Habeshian, specializes in creating oral macrocycle therapeutics targeting validated biologic drug targets. The company leverages its proprietary nGen platform to systematically investigate macrocycle chemical space, combining automated chemistry with machine learning. So far, Orbis Medicines has secured approximately US$126 million in funding across multiple rounds, including a €90 million (US$94–$93 million) Series A in January 2025, led by New Enterprise Associates and supported by investors such as Lilly Ventures, Cormorant, Novo Holdings, and Forbion.

 focuses on developing cardiometabolic therapies and leveraging human genetics for transformative medicines.In December 2025, the company raised 700 million kroner (US$109 million) in Series A funding, with investors including Novo Holdings, Forbion, RA Capital Healthcare Fund, and Gilde Healthcare.

This funding follows a prior agreement with Shanghai Minwei Biotechnology, a subsidiary of Lepu Medical Technology. The deal grants Sidera exclusive rights outside China to MWN105, a triple agonist for obesity that targets the glucagon-like peptide-1

GLP-1)/Glucose-dependent insulinotropic polypeptide (GIP)/fibroblast growth factor-21 (FGF21) receptors.

focuses on advancing medicines for obesity and metabolic health by leveraging AI/ML technologies. Zealand Pharma's pipeline includes the amylin analogue petrelintide, which is in phase 2 clinical trials, in development with Roche, and the glucagon/GLP-receptor dual agonist survodutide, which is in phase 3 development with Boehringer Ingelheim.

 In December 2025, Zealand signed a US$2.5 billion oral cardiometabolic deal with OTR Therapeutics.

 In March 2026, it established a US research hub in Cambridge, Massachusetts, to expand its drug discovery capabilities.

Future Opportunities for Investment in Danish Biotechs

Denmark’s life science sector is a vital part of its economy, with exports hitting €25.6 billion in 2023, constituting 16.7% of the country's total goods exports. The government plans to double this to €46 billion by 2030.

 The biotech industry in Denmark exhibits strong growth potential, supported by a robust innovation ecosystem, increased venture funding, and new major funding initiatives. This growth will be further catalyzed by the implementation of the Strategy for Life Science Towards 2030. Recent investment activity indicates that Danish biotech companies are on the VC and pharma radar, and new opportunities exist to invest in early-stage startups and deep tech, and to establish cross-border collaborations.

AlzeCure Pharma enters into a collaboration and out-licensing agreement with Lilly for Alzheimer’s project. Press release. AlzeCure Pharma. Published June 9, 2026. 

https://www.alzecurepharma.se/en/alzecure-pharma-enters-into-a-collaboration-and-out-licensing-agreement-with-lilly-for-alzheimers-project/

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

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

Strategy for life. The Danish Government. Published November 2024. 

https://healthcaredenmark.dk/media/zrkgvi0v/ls2030.pdf

Danish Life Science Venture Capital - Recent trends and market outlook. EIFO. Published July 2025. 

https://eifo.dk/media/pspncjev/danish-life-science-venture-capital-market-analysis-2024.pdf

Adcendo ApS announces clinical collaboration and supply agreement with MSD to Evaluate ADCE-T02 in combination with KEYTRUDA® (Pembrolizumab) in a phase Ib study in patients with advanced solid tumors. Press release. Adcendo. Published May 26, 2026 

https://adcendo.com/adcendo-aps-announces-clinical-collaboration-and-supply-agreement-with-msd-to-evaluate-adce-t02-in-combination-with-keytruda-pembrolizumab-in-a-phase-ib-study-in-patients-with-advanced-solid-t/

Denmark is consolidating its role as a Nordic life-science investment magnet, supported by strong public-health data infrastructure, manufacturing depth, and active specialist capital. The national “Strategy for Life Science Towards 2030” targets startup formation, AI-enabled R&D and care delivery, improved access to innovative medicines, and globally competitive production and regulatory conditions. Venture funding has accelerated since 2018, with biotech dominating deal flow. High-interest companies span oncology ADCs, tumor-selective antibody discovery, AI-immunology vaccines, neurodegeneration, coagulation disorders, oral macrocycles, and cardiometabolic/obesity platforms.

Venture-based Danish biotechs are driving innovation and gaining traction with investors.