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

Platform Innovation, Regulatory Maturity, and Global Capacity Expansion Are Catalyzing the Next Wave of Growth in Cell and Gene Therapy

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(R), Roctavian(R), Vyjuvek(R), 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.

Report Summary: Cell And Gene Therapy Market

The global Cell & Gene Therapy Market size was estimated at USD 9.98 billion in 2024 and is projected to reach USD 51.37 billion by 2030, growing at a CAGR of 31.4% from 2025 to 2030. Rapid clinical translation, increasing approvals of gene-modified cell therapies, and expanding adoption of in vivo gene therapies are driving sustained growth across the cell and gene therapy (CGT) market.

Key Market Trends & Insights

• North America accounted for the largest revenue share of the global Cell And Gene Therapy Market in 2024, supported by accelerated regulatory pathways, strong venture funding, and early adoption of outcomes-based reimbursement models.
• In the United States, increasing approvals of CAR-T, gene-editing, and in vivo gene therapies are accelerating commercialization across oncology and rare genetic disorders.
• By therapy type, gene-modified cell therapies held the dominant position in 2024, reflecting strong uptake in hematologic malignancies and expanding second-line treatment approvals.
• The Gene therapy market is witnessing rapid momentum in vivo delivery platforms, driven by advancements in viral vectors, lipid nanoparticles, and genome-editing technologies.
• Asia Pacific is emerging as the fastest-growing region, supported by accelerated regulatory frameworks in Japan and China and increasing domestic manufacturing investments.

Market Size & Forecast

• 2024 Market Size: USD 9.98 Billion
• 2030 Projected Market Size: USD 51.37 Billion
• CAGR (2025-2030): 31.4%
• North America: Largest Market in 2024
• Asia Pacific: Fastest-Growing Market

The rapid evolution of manufacturing automation, smart factories, and digital quality systems is further strengthening the scalability of the CGT therapeutics market. As regulatory clarity improves and reimbursement models mature, the cell and gene therapy (CGT) market is expected to transition from niche innovation to a mainstream therapeutic pillar by the end of the forecast period.

Market Overview & Trends: Cell & Gene Therapy Market

The Cell & Gene Therapy Market is transitioning from experimental innovation to an integrated therapeutic ecosystem built on platform scalability, regulatory convergence, and commercial readiness. Historically constrained by high costs, manufacturing complexity, and reimbursement uncertainty, the cell and gene therapy (CGT) market is now benefiting from structural shifts that support broader adoption.

One of the most significant trends shaping the CGT therapeutics market is the shift from autologous, batch-based manufacturing toward automated, closed-system platforms. Smart factories, digital batch records, and AI-driven process analytics are reducing production timelines, improving consistency, and lowering cost of goods. These advancements are enabling developers to move beyond ultra-rare indications and address larger patient populations.

Another defining trend in the Gene therapy market is the rapid growth of in vivo delivery platforms, including AAV and lipid nanoparticle-based systems. These approaches reduce logistical complexity and expand treatment accessibility compared to ex vivo therapies. Concurrently, hybrid models combining cell and gene engineering are emerging as next-generation innovation zones within the Cell And Gene Therapy Market.

Regulatory frameworks are also evolving. Agencies such as the FDA, EMA, and PMDA are refining guidance on comparability, long-term follow-up, and accelerated approvals. Programs such as RMAT, PRIME, and Sakigake are compressing development timelines by 12-18 months, improving capital efficiency across the cell and gene therapy (CGT) market.

On the commercial front, reimbursement models are shifting toward outcomes-based agreements and annuity-style payments. These mechanisms are addressing payer concerns around high upfront costs while enabling sustainable access. Collectively, these trends are redefining the operating model of the CGT therapeutics market, positioning it for sustained long-term growth.

Scope of Analysis: Cell and Gene Therapy Market

This analysis examines the global Cell And Gene Therapy Market with a comprehensive assessment of industry structure, technology evolution, and commercial dynamics. The study period spans 2021-2030, with 2024 as the base year and 2025-2030 as the forecast period. All market values are expressed in US dollars.

The scope covers therapeutic modalities within the cell and gene therapy (CGT) market, including non-genetically modified cell therapies, gene-modified cell therapies, and gene therapies. DNA- and RNA-based therapeutics outside regenerative medicine frameworks are excluded. The CGT therapeutics market assessment includes approved products and advanced pipeline assets expected to reach commercialization during the forecast horizon.

Geographic coverage includes North America, Europe, Asia-Pacific, Latin America, and the Middle East, reflecting both mature and emerging adoption cycles in the Gene therapy market. Regional analysis focuses on regulatory maturity, reimbursement readiness, and ecosystem development rather than segment-level revenue attribution.

Methodologically, the Cell & Gene Therapy Market evaluation integrates primary expert interviews, pipeline tracking, regulatory analysis, and secondary data from clinical trial databases, financial disclosures, and industry associations. Revenue forecasting incorporates product lifecycle assumptions, approval probabilities, and pricing evolution, while excluding granular segment-level revenue splits to maintain consistency and reliability.

Revenue & Spending Forecast: Cell And Gene Therapy Market

The global Cell & Gene Therapy Market is exhibiting a steep and sustained growth trajectory, driven by accelerating commercialization of advanced therapies, expanding clinical pipelines, and improving regulatory and reimbursement clarity. According to the revised forecast, global market revenue increased from USD 5.73 billion in 2022 to USD 9.98 billion in 2024, reflecting rapid early-stage adoption across oncology and rare genetic disorders.

During the forecast period, the cell and gene therapy (CGT) market is expected to scale sharply, reaching USD 51.37 billion by 2030, expanding at a robust compound annual growth rate (CAGR) of 31.4%. This growth curve highlights the transition of the CGT therapeutics market from pilot-scale commercialization toward broader clinical and geographic penetration.

Revenue acceleration is primarily supported by rising approvals of gene-modified cell therapies, increasing uptake of in vivo gene therapies, and growing confidence in outcomes-based reimbursement models. As therapies move from ultra-rare indications into larger patient populations, spending momentum across the Gene therapy market is expected to intensify.

Investment activity across manufacturing automation, viral vector capacity expansion, and digital quality systems is further reinforcing long-term revenue growth. Overall, the Cell And Gene Therapy Market is positioned to evolve into a core pillar of advanced therapeutics by the end of the forecast period, with revenue growth reflecting both clinical maturity and ecosystem scalability.

Market Segmentation Analysis: Cell & Gene Therapy Market

The Cell & Gene Therapy Market is segmented based on therapeutic modality, therapeutic area, delivery approach, and geography, reflecting the multidimensional nature of the cell and gene therapy (CGT) market ecosystem.

By therapeutic modality, the CGT therapeutics market includes non-genetically modified cell therapies, gene-modified cell therapies, and gene therapies. Gene-modified cell therapies, particularly CAR-T and TCR-based platforms, currently represent the most commercially mature segment, supported by strong oncology uptake. Gene therapies delivered via viral and non-viral vectors are expanding rapidly as in vivo approaches gain regulatory and clinical validation.

Therapeutic area segmentation highlights oncology as the dominant focus within the Gene therapy market, accounting for the largest share of pipeline activity and commercial approvals. Hematologic malignancies remain central; however, solid tumors, neurological disorders, cardiovascular diseases, and inherited metabolic conditions are increasingly targeted. This diversification is broadening the addressable market for the Cell And Gene Therapy Market.

From a delivery perspective, ex vivo therapies continue to dominate approved products, but in vivo delivery is gaining momentum due to simplified logistics and scalability advantages. Hybrid in vivo-ex vivo platforms are emerging as innovation frontiers within the cell and gene therapy (CGT) market.

Geographically, North America leads in commercialization and reimbursement innovation, while Europe emphasizes structured access through managed entry agreements. Asia-Pacific is witnessing accelerated regulatory approvals and localized manufacturing investments. Overall, segmentation trends indicate a gradual shift toward scalable, platform-based solutions across the CGT therapeutics market.

Growth Drivers: Cell & Gene Therapy Market

The Cell & Gene Therapy Market is propelled by multiple structural growth drivers shaping the evolution of the cell and gene therapy (CGT) market.

First, rapid innovation in genome-editing tools, viral vectors, and delivery platforms is accelerating clinical success rates. These advancements are expanding the therapeutic reach of the Gene therapy market beyond rare diseases into more prevalent conditions.

Second, regulatory acceleration mechanisms such as RMAT, PRIME, and conditional approvals are significantly reducing development timelines. This regulatory support enhances capital efficiency and improves return on investment across the CGT therapeutics market.

Third, manufacturing transformation through automation and digitalization is addressing historical scalability constraints. Smart factories and AI-enabled process control are reducing variability and enabling consistent commercial output within the Cell And Gene Therapy Market.

Fourth, evolving reimbursement models-including outcomes-based agreements and installment payments-are mitigating payer resistance to high upfront costs. These frameworks are unlocking broader access and stabilizing long-term demand in the cell and gene therapy (CGT) market.

Finally, increasing venture funding and strategic partnerships are fueling pipeline expansion and ecosystem maturity, reinforcing sustained growth momentum across the CGT therapeutics market.

Growth Restraints: Cell & Gene Therapy Market

Despite strong momentum, the Cell & Gene Therapy Market faces several constraints that temper near-term growth in the cell and gene therapy (CGT) market.

High therapy prices remain a primary challenge, particularly for one-time curative treatments. Even with evolving reimbursement models, affordability concerns continue to limit adoption in cost-sensitive healthcare systems within the Gene therapy market.

Manufacturing complexity and capacity constraints also persist. While automation is improving scalability, technology transfer risks, workforce shortages, and quality control challenges still impact the CGT therapeutics market.

Regulatory heterogeneity across regions creates uncertainty for global commercialization. Differences in evidence requirements and long-term follow-up obligations slow market entry for the Cell And Gene Therapy Market in certain geographies.

Finally, long-term safety and durability concerns necessitate extended post-marketing surveillance, increasing development costs and payer scrutiny. Addressing these barriers is essential for sustaining long-term growth in the cell and gene therapy (CGT) market.

Competitive Landscape: Cell & Gene Therapy Market

The Cell & Gene Therapy Market features a dynamic and fragmented competitive environment comprising large pharmaceutical companies, specialized biotechnology firms, and CDMOs. Market leaders are leveraging platform-based strategies to scale across multiple indications within the CGT therapeutics market.

Major players focus on expanding portfolios through targeted acquisitions, licensing agreements, and strategic collaborations. M&A activity increasingly emphasizes next-generation delivery platforms, in vivo gene editing, and automated manufacturing capabilities, reflecting evolving priorities in the Gene therapy market.

Biotechnology firms continue to drive innovation, particularly in gene-modified cell therapies and novel vector technologies. Meanwhile, CDMOs are transitioning from service providers to integrated partners offering regulatory-ready capacity, digital manufacturing, and logistics support across the cell and gene therapy (CGT) market.

Competitive differentiation is increasingly defined by manufacturing readiness, regulatory execution, and payer engagement capabilities rather than clinical innovation alone. As competition intensifies, ecosystem collaboration will remain critical to sustaining leadership in the Cell and Gene Therapy Market.