Delray Beach, FL, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Rapid innovation, expanding clinical pipelines, and rising demand for curative treatments position gene therapy as a transformative growth engine across healthcare markets
The global gene therapy market, valued at US$7.21 billion in 2023, stood at US$8.85 billion in 2024 and is projected to advance at a resilient CAGR of 19.4% from 2025 to 2032, culminating in a forecasted valuation of US$36.55 billion by the end of the period. This advancement underscores the increasing demand for curative and precision-based therapies addressing genetic disorders, rare diseases, and specific cancer types, alongside a strong surge in clinical research investments and technology breakthroughs.
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A Transformational Market Driven by Demand for Curative Solutions
What is driving this growth? The industry is witnessing unprecedented momentum as biotechnology companies, pharmaceutical leaders, and research institutions race to deliver long-term disease modification and one-time treatment cures. Approximately 19 new gene therapy products are expected to launch between 2026 and 2032, contributing nearly 25% of the total projected market value by 2032.
The rise of next-generation technologies—including CRISPR-based genome editing tools and novel vector delivery platforms—continues to reshape the therapeutic landscape. In November 2024, iotaSciences, a pioneering single-cell biology firm, introduced a rapid single-cell cloning platform specifically engineered for gene therapy, exemplifying innovation accelerating clinical deployment.
Market Barriers: High Cost and Regulatory Complexity
Despite accelerated progress, what challenges could slow market penetration? Gene therapy remains among the most expensive therapeutic categories due to the complexity of manufacturing, small patient cohorts, and stringent regulatory pathways. Research suggests that developing a single gene therapy can cost up to USD 5 billion—significantly higher than conventional pharmaceuticals.
Recent product pricing reflects the challenge:
- Pfizer’s Beqvez for Hemophilia B: approx. USD 3.5 million
- Orchard Therapeutics’ Lenmeldy for Metachromatic Leukodystrophy (MLD): approx. USD 4.25 million
These pricing structures constrain accessibility, particularly in lower-income regions, reinforcing cost and reimbursement models as central barriers to global market scaling.
Strategic Momentum Through Precision Medicine
Why does gene therapy matter now for global healthcare leaders? The rise of precision medicine—tailoring interventions to genetic and lifestyle profiles—is creating significant opportunity. Between 1998 and January 2024, the FDA approved 217 cancer drugs, including 181 targeted therapies and 94 precision oncology treatments, signaling strong regulatory support and clinical adoption.
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Manufacturing Challenges and Innovation Opportunities
How will the industry scale? Manufacturing remains a critical bottleneck. Viral vector production faces issues with cost, yield, storage, and regulatory compliance. Emerging technologies such as AI-optimized bioprocessing, continuous manufacturing systems, and single-use bioreactors are expected to define the next growth phase.
Global Market Landscape and Segment Outlook
- Viral vectors represented the largest and fastest-growing vector segment in 2023 due to high efficacy and broad clinical application.
- Neurology was the leading therapeutic segment in 2023, driven by gene therapies targeting neuromuscular diseases such as Spinal Muscular Atrophy and Duchenne Muscular Dystrophy.
- North America remained the largest regional market, supported by strong regulatory infrastructure, leading biotech presence, and accelerated product approvals.
Competitive Environment
The global gene therapy market remains highly consolidated, led by:
Biogen Inc. (US), Novartis AG (Switzerland), Alnylam Pharmaceuticals (US), Sarepta Therapeutics (US), Jazz Pharmaceuticals (Ireland), and others including Pfizer Inc., Johnson & Johnson, Daiichi Sankyo, BioMarin, UniQure, and Amgen.
Recent Strategic Developments Strengthening Market Momentum
- Amgen announced a USD 1B manufacturing expansion in North Carolina.
- Ferring B.V. secured US FDA approval for ADSTILADRIN, an adenovirus vector therapy for bladder cancer.
- PTC Therapeutics received breakthrough approval for KEBILIDI, the first gene therapy administered directly to the brain.
- Novartis acquired Kate Therapeutics for USD 1.1B, securing proprietary capsid engineering platforms.
- Pfizer received dual U.S. and European approvals for BEQVEZ for Hemophilia B.
- Orchard Therapeutics gained US FDA approval for LENMELDY treating early-onset MLD.
- Ginkgo Bioworks and Biogen partnered to enhance AAV production platform efficiency.
Why This Matters for Business Leaders
Gene therapy is poised to transform care delivery models, reshape cost-benefit economics, and redefine competitive positioning across pharma and healthcare. Executives should expect:
- Increased M&A and licensing strategies to secure platform IP
- Rising pressure to innovate pricing models and reimbursement systems
- Strategic shifts toward precision medicine ecosystems
- Manufacturing capacity as a primary competitive differentiator
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