Europe Gene Therapy Market to hit US$ 8,780.77 Million by 2033 | Major Compnies 2026 - Alnylam Pharmaceuticals Inc., NOVARTIS AG, Sarepta Therapeutics Inc. | Exclusive report by DataM Intelligence

Leander, Texas and Tokyo, Japan - Jan.08.2026
As per DataM intelligence research report" Europe Gene Therapy Market reached US$ 1,030.70 Million in 2024 and is expected to reach US$ 8,780.77 Million by 2033, growing at a CAGR of 24.9 % during the forecast period 2025-2033." Regulatory support and breakthroughs in rare disease treatment are boosting gene therapy adoption.

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Europe: Recent Industry Developments

✅ In November 2025, The EMA approved a new gene therapy for hemophilia B with a value-based payment model The approval allows member states to pay in installments based on patient outcomes It addresses the budget impact of high-cost curative therapies in European healthcare

✅ In October 2025, CRISPR Therapeutics opened a new manufacturing center in Belgium The facility serves as the hub for producing gene-edited cell therapies for the EU market It strengthens Europe's position in the global cell and gene supply chain

✅ In September 2025, A French biotech firm received "PRIME" designation for a gene therapy for vision loss The designation expedites the regulatory review process for promising medicines It highlights Europe's focus on treating rare genetic eye diseases

✅ In August 2025, The UK MHRA approved the first in vivo gene editing therapy for amyloidosis The therapy uses lipid nanoparticles to edit liver cells directly inside the body It marks a milestone for non-viral gene delivery in the UK

United States Recent Industry Developments

✅ In December 2025, Vertex Pharmaceuticals expanded its U.S. launch of the first CRISPR therapy for sickle cell The rollout includes a network of authorized treatment centers across the country It validates the commercial viability of gene editing in the U.S.

✅ In November 2025, The FDA released new guidance on long-term follow-up for gene therapy patients The guidance mandates 15 years of monitoring to detect potential delayed adverse events It ensures the long-term safety of the U.S. gene therapy population

✅ In October 2025, Bluebird Bio secured a major reimbursement deal with U.S. payers for its thalassemia therapy The agreement ensures patient access despite the high list price It stabilizes the financial outlook for gene therapy developers in the U.S.

✅ In September 2025, A U.S. research institute launched a "Gene Therapy for All" initiative The program aims to simplify manufacturing to lower costs for ultra-rare diseases It democratizes access to advanced therapies for underserved U.S. patients

europe gene therapy Market: Drivers
Europe Gene Therapy
The Europe gene therapy market is growing due to strong regulatory support and research infrastructure. Rising prevalence of rare genetic disorders drives demand for advanced therapies. Government funding and academic collaborations accelerate innovation. Technological advancements improve vector design and delivery efficiency. Expanding clinical trial activity strengthens market growth. Patient advocacy and awareness enhance adoption.

Market growth is reinforced by approvals of breakthrough gene therapies. Pharmaceutical and biotech investments increase manufacturing capacity. Emerging European markets adopt advanced genetic medicine. Integration with personalized healthcare models boosts demand. Regulatory harmonization supports cross-border innovation. Europe remains a global leader in gene therapy development.

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europe gene therapy Market: Major Players
Alnylam Pharmaceuticals, Inc., NOVARTIS AG, Sarepta Therapeutics, Inc., Krystal Biotech, Inc., CSL, Bluebird Bio, Inc., SPARK THERAPEUTICS, INC., Ferring, Vertex Pharmaceuticals Incorporated, Amgen, Inc., Orchard Therapeutics Plc, CRISPR Therapeutics, BioMarin Pharmaceutical Inc., MeiraGTx Holdings plc, and PTC Therapeutics, Inc. among others.

Segment Covered in the europe gene therapy Market:
By Approach
The market is segmented into in-vivo gene therapy 65% and ex-vivo gene therapy 35%, with in-vivo approaches dominating due to simpler delivery, reduced manufacturing complexity, and growing approvals for directly administered therapies. Ex-vivo gene therapy is expanding steadily, particularly in hematological and rare genetic disorders, supported by advances in cell processing and personalized treatment models.

By Vector Type
Based on vector type, the market includes viral vectors 75% and non-viral vectors 25%. Viral vectors dominate due to higher transfection efficiency and long-term gene expression, especially adeno-associated viruses (AAVs) and lentiviral vectors. Non-viral vectors are gaining attention owing to improved safety profiles, lower immunogenicity, and ongoing research into lipid- and nanoparticle-based delivery systems.

By Technique
Technique segmentation comprises gene addition 45%, gene silencing 30%, and gene editing 25%. Gene addition leads due to its widespread use in treating monogenic disorders and established clinical evidence. Gene silencing is growing with RNA-based technologies, while gene editing is gaining momentum driven by CRISPR-based advancements and strong R&D investment across Europe.

By Application
Application-wise, the market includes rare diseases 35%, blood disorders 20%, oncology 18%, ophthalmology 12%, musculoskeletal conditions 10%, and others 5%. Rare diseases dominate due to favorable regulatory pathways, orphan drug incentives, and strong patient advocacy. Blood disorders and oncology segments show rapid growth supported by ongoing clinical trials and expanding therapeutic pipelines.

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