Growth Opportunities in Cell and Gene Therapeutics Market, Forecast to 2030

The global CGT therapeutics market is transitioning from a niche, high-complexity segment into a mainstream, high-growth therapeutic class. Driven by scientific breakthroughs, accelerated regulatory pathways, and the entry of next-generation platforms—including in vivo CRISPR gene editing, allogeneic “off-the-shelf” cell therapies, and automated smart-factory bioprocessing—the market is projected to cross $50 billion by 2030 and reflect a greater than 30% CAGR between 2024 and 2030. This growth aligns with the expanding global disease burden: oncology indications continue to dominate CGT development, while rare genetic, neurological, hematologic, and ophthalmologic disorders fuel diversification into new high-value segments.

Pipeline momentum is unprecedented. In 2025, oncology remains the largest therapeutic focus, with hematologic malignancies accounting for the majority of trials and solid-tumor programs accelerating through improved tumor-microenvironment targeting and next-generation vectors. Rare diseases continue to anchor the CGT landscape—over two-thirds of rare-disease trials target rare cancers, while new programs are broadening into genetically linked common diseases such as Alzheimer’s, cardiovascular disease, arthritis, and HIV. Approvals of CASGEVY™, Lyfgenia™, Elevidys™, Ryoncil™, Hemgenix®, Roctavian®, Vyjuvek®, and emerging CNS and ophthalmology therapies demonstrate durable evidence that ex vivo and in vivo modalities offer curative potential across multiple disease categories.

Major scientific and operational inflection points are reshaping the sector. In vivo gene editing is rapidly progressing—Intellia’s NTLA-2002 entered Phase III, Interius initiated the first in vivo CAR-T clinical pathway, and YolTech advanced LNP-delivered gene-editing into human studies. Parallel advances in automated manufacturing (e.g., Cellares Cell Shuttle™ receiving FDA AMT designation) and the rise of regional “IDMO Smart Factories” in the United States, Europe, and Japan signal a decisive move toward scalable, closed system, digitally orchestrated CGT production. Manufacturing readiness (MRL), AMT-qualified platforms, and cloud-enabled QA are becoming as important as clinical data for asset valuation.
Globally, the regulatory landscape is evolving in support of innovation.

North America leads with outcomes-based reimbursement models (CMS CGT Access Model with more than 33 states on board), accelerated approvals, and growing manufacturing capacity.

Europe advances through managed entry agreements and national value-based reimbursement, while APAC remains the fastest-growing geography, driven by Japan’s expedited pathways, China’s maturing NMPA frameworks, and South Korea’s Rare Disease Act.

LATAM and the Middle East show early regulatory traction, led by the UAE and Saudi Arabia, though broad access remains limited.

Investment and M&A activity reflect a strategic focus on scalable platforms and next-generation delivery. The sector has shifted from megadeals to mid-sized “string-of-pearls” acquisitions—exemplified by Roche–Poseida, AbbVie–Capstan, Lilly–Verve, and Gilead–Interius—focused on in vivo editing, allogeneic CAR-T, and improved vector technologies. While venture investments have cooled relative to 2021 peaks, capital remains available for differentiated AAV capsids, LNPs, base/prime-editing technologies, and automated manufacturing platforms.

This research service provides a 6-year revenue forecast (2025 to 2030) and a comprehensive market evaluation across North America, Europe, APAC, MENASA, and Latin America, covering pipeline evolution, technology trends, regulatory and reimbursement models, strategic partnerships, and emerging GTM strategies. The analysis spans in vivo gene therapy, ex vivo gene therapy, gene-modified cell therapy, non-genetically modified cell therapy, and hybrid ex/in vivo modalities, each experiencing high double-digit growth. It identifies next-generation areas—such as allogeneic iPSC-derived therapies, base-editing, smart-factory automation, and in vivo CAR-T—as future growth engines.

Overall, the CGT therapeutics market is entering a period of accelerated commercialization, underpinned by robust late-stage pipelines, regulatory innovation, outcomes-based reimbursement, and transformative manufacturing technologies. Stakeholders that invest early in automated platforms, vector innovation, real-world evidence frameworks, and integrated global access strategies will be best positioned to capture growth in this rapidly expanding, high-impact therapeutic domain. Show more