Market Overview

The Europe gene therapy market was valued at USD 2.78 Billion in 2025 and is projected to reach USD 7.41 Billion by 2034, growing at a CAGR of 11.5% during the forecast period from 2026 to 2034. This rapid expansion is driven by rising incidences of rare genetic disorders and chronic diseases, alongside regulatory support from the European Medicines Agency and significant investments in research and development. Precision medicine approaches, including CAR T-cell and CRISPR-based therapies, are key growth drivers transforming oncology and inherited condition treatments.

Study Assumption Years

• Base Year: 2025
• Historical Year/Period: 2020-2025
• Forecast Year/Period: 2026-2034

Europe Gene Therapy Market Key Takeaways

• The market size was valued at USD 2.78 Billion in 2025, with a CAGR of 11.5% forecasted through 2026-2034.
• Antigen leads the gene type segment with a 16% market share in 2025, driven by its role in cancer immunotherapy and targeted vaccines.
• Viral vector dominates with 68% share due to superior gene delivery efficiency, clinical record, and regulatory experience.
• In-vivo gene therapy holds 61% market share owing to demand for direct patient administration and lower production costs.
• Oncological disorders account for 40% share, reflecting Europe's cancer burden and CAR T-cell therapy successes.
• Germany commands the largest country market share at 28%, supported by its pharmaceutical concentration and biotechnology investments.

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Market Growth Factors

The increasing prevalence of rare genetic disorders is a driving force for this market. The European Medicines Agency estimate that 36 million people in the European Union have a rare disease with 600,000 new cases each year. About 80% of all rare diseases are caused by genetic mutations. Genetic screening and diagnostics have increased eligibility for gene therapies, yet few therapies have been developed for such patients. Patient advocacy and clinician education are believed to also have helped trial enrollment and treatment uptake, with European healthcare systems appearing to have been more willing to reimburse novel gene therapies with high unmet needs.

The market is driven by advancements in gene editing tools, improvements in manufacturing process scalability and increased precision of mutation targeting, leading to improved efficacy and safety of gene editing therapies, as well as improved vector designs and automation. By using contract development and manufacturing organizations to scale, investing to modular facilities and digitally controlling quality can speed up the process and help to regulatory compliance. Localized manufacturing strengthens supply chain resilience and responsiveness.

Supportive regulations like flexible and rapid approval programs, orphan drug designations, early access to medicines schemes such as conditional authorizations and scientific advice on regulatory issues can reduce uncertainties and support innovation. Clear procedures for clinical trial conduct and safety monitoring define regulatory certainty for investors and developers for regulators. Public funding programs, cross-border initiatives and government investments in biotech clusters improve infrastructure and talent access. Reimbursement dialogue systems along with outcome-based payment models will create a sustainable cost environment, an attractive pipeline, and a commercial environment on a global scale.

Market Segmentation

Gene Type:

• Antigen: Dominates with 16% share in 2025, crucial for cancer immunotherapy. These therapies engineer cells or viral vectors to express tumor-specific antigens, enhancing immune recognition and tumor destruction. Extensive CAR T-cell therapy research targets CD19 and BCMA antigens mostly in hematological cancers. Advances in neoantigen discovery expand applications to solid tumors while reducing production costs.

Vector Type:

• Viral Vector: Leads with 68% market share in 2025 due to high transduction efficiency and safety. Adeno-associated viruses offer tissue targeting and long-term expression without genome integration. Lentiviral vectors are key in ex-vivo CAR T-cell engineering, ensuring stable transgene integration. Expanded manufacturing capacity and regulatory familiarity accelerate commercial adoption. Innovations in capsid engineering and vector design improve payload and safety.

Delivery Method:

• In-Vivo Gene Therapy: Holds 61% share in 2025, favored for simplified protocols eliminating cell extraction and reinfusion. Enables treatment of previously inaccessible tissues including CNS and cardiac. Lipid nanoparticle systems are growing for liver-targeted applications. The approval of clinical trials in the UK and development of in-vivo CRISPR therapeutics highlight advanced pipelines.

Application:

• Oncological Disorders: Account for 40% market share in 2025, driven by Europe's cancer burden and breakthroughs in CAR T-cell immunotherapies with superior outcomes in relapsed hematological malignancies. Biomarker-driven patient selection and combination therapies improve durability. Expanding treatment centers and reimbursement schemes support wider adoption.

Country:

• Germany: Represents 28% of the market in 2025. The country's pharmaceutical concentration, advanced infrastructure, and government biotech investments underpin leadership. The National Strategy for Gene and Cell Therapies fosters partnerships and foreign investments. Roche's €90 million gene therapy center investment highlights robust support. Germany offers comprehensive reimbursement and strong regulatory expertise.

Regional Insights

Germany dominates the Europe gene therapy market with a 28% share in 2025, driven by its dense pharmaceutical presence, advanced research infrastructure, and significant government biotech funding. Strategic initiatives catalyze public-private partnerships and foreign investments, while reimbursement frameworks facilitate patient access. These strengths position Germany as a preferred hub for gene therapy commercialization within Europe.

Recent Developments & News

In February 2025, the European Medicines Agency approved marketing authorization for Vyjuvek (beremagene geperpavec), the first topical gene therapy in the European Union for dystrophic epidermolysis bullosa, targeting wound management across all ages. In March 2024, Roche invested €90 million to establish a gene therapy development center near Munich, supported by Germany's strategic biotech initiatives. Also, in March 2024, iECURE, Inc. received UK MHRA approval to extend its Clinical Trial Authorization for in-vivo gene editing therapies addressing liver disorders.

Key Players

• Roche
• iECURE, Inc.

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