Cell and Gene Therapy Market Poised for Explosive Growth, Projected to Reach $25.78 Billion by 2031

According to The Insight Partners – The global cell and gene therapy market is on a remarkable upward trajectory, according to a comprehensive market analysis published by The Insight Partners. Valued at US$ 5.30 billion in 2024, the market is projected to reach US$ 25.78 billion by 2031, registering a compound annual growth rate (CAGR) of 25.5% over the forecast period of 2025 to 2031. This extraordinary growth underscores the rapidly shifting landscape of modern medicine, where curative and regenerative therapies are beginning to replace traditional disease management approaches.

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A Market Driven by Unmet Medical Need

At the heart of this expansion lies the growing global burden of chronic and genetic diseases. Conditions such as cancer, rare inherited disorders, and autoimmune diseases have created a pressing demand for treatments that go beyond symptom management. Cell and gene therapies — including CAR-T cell therapies and CRISPR-based gene editing — are increasingly being recognized as viable, potentially curative solutions for patients who have exhausted conventional options. This shift in therapeutic philosophy is one of the most powerful catalysts propelling market growth.

Equally significant is the rapid pace of technological innovation. Advances in gene editing tools, automated bioprocessing, and scalable manufacturing systems are not only making these therapies more effective but also more affordable and accessible. The convergence of artificial intelligence with biological research is further accelerating drug discovery and clinical development timelines.

Regulatory Tailwinds and Commercial Momentum

Supportive regulatory environments are playing a decisive role in speeding up the commercialization of these advanced therapies. Orphan drug designations, accelerated approval pathways, and breakthrough therapy designations by agencies such as the U.S. FDA are enabling faster market entry. A notable milestone came in December 2025, when the FDA approved Waskyra (etuvetidigene autotemcel) — the first cell-based gene therapy for Wiskott-Aldrich syndrome and the first such approval granted to a non-profit applicant, Fondazione Telethon ETS. This landmark decision reflects growing institutional confidence in cell and gene therapy as a legitimate treatment modality.

Outsourcing and Manufacturing Scale-Up

As the complexity of cell and gene therapy production continues to grow, pharmaceutical developers are increasingly turning to specialized Contract Development and Manufacturing Organizations (CDMOs) and Contract Manufacturing Organizations (CMOs). This outsourcing trend offers companies the dual benefits of cost efficiency and scalability, while ensuring compliance with Good Manufacturing Practice (GMP) standards. In October 2025, Lonza Group AG expanded its manufacturing portfolio with the launch of two new GMP-grade products designed to enhance the consistency and scalability of advanced therapy production, reflecting the industry's focus on commercial readiness.

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Regional Outlook

North America currently dominates the global market, supported by robust research infrastructure, deep clinical pipelines, and a favorable regulatory framework. Europe holds a substantial share as well, driven by harmonized regulatory approvals and EU-funded collaborative research. However, the Asia-Pacific region is expected to register the fastest growth over the forecast period, fueled by rising healthcare spending, government initiatives in countries like China, India, and Japan, and a surge in domestic biotech innovation. Emerging markets in South America, the Middle East, and Africa also present untapped opportunities for market expansion.

Key Players Shaping the Landscape

The competitive landscape is defined by a mix of global giants and agile innovators. Leading companies include Thermo Fisher Scientific, Merck KGaA, Lonza Group AG, WuXi AppTec, FUJIFILM Holdings, F. Hoffmann-La Roche, and Catalent. Other significant players such as Novartis AG, CRISPR Therapeutics, Bluebird Bio, and Oxford Biomedica are actively shaping clinical pipelines and strategic partnerships.

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