Cell and Gene Therapy (CGT) Market Size, Share & Trends Analysis Report By Therapy Type (Cell Therapy, Gene Therapy), By Indication (Oncology, Genetic Disorders, Cardiovascular & Neurological Disorders), By End-User (Hospitals & Specialty Clinics, Academic & Research Institutions, Pharmaceutical & Biotech Companies) and By Region (North America, Europe, Asia-Pacific, Latin America, The Middle East and Africa) Forecasts, 2025-2033

Market Trends

Several emerging trends are shaping the evolution of the CGT market. Mergers and acquisitions (M&A), as well as strategic collaborations, are becoming increasingly common. Large pharmaceutical companies are partnering with or acquiring innovative biotech startups to gain access to cutting-edge CGT technologies. Notable examples include collaborations involving Novartis and Gilead, which have expanded their CGT portfolios through such alliances.

Decentralized clinical trials are also gaining traction, driven by the need for more patient-centric approaches. These trials leverage digital tools and remote monitoring to allow greater geographic diversity and improved patient participation, thereby enhancing trial efficiency and data quality. Furthermore, the integration of personalized and precision medicine principles is becoming a cornerstone of CGT development. By leveraging genomic data and advanced diagnostics, therapies can be tailored to individual patient profiles, significantly improving therapeutic outcomes and minimizing adverse effects. This convergence of CGT with precision medicine is expected to redefine standards of care across multiple disease categories.

Cell and Gene Therapy (CGT) Market Growth Factors

The cell and gene therapy (CGT) market is primarily driven by the rising global burden of genetic and chronic disorders. Over 400 million people worldwide are affected by rare diseases, approximately 80% of which are genetic in nature. As diagnostic capabilities improve and awareness increases, the demand for CGTs that address the root causes of these conditions is accelerating. Regulatory support has also played a crucial role in market growth. Regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have implemented fast-track pathways, including RMAT (Regenerative Medicine Advanced Therapy) and PRIME (PRIority MEdicines) status, to expedite the development and approval of promising therapies.

Technological advancements continue to enhance the safety, precision, and scalability of CGTs. Innovations such as CRISPR-Cas9 and other genome-editing tools have revolutionized gene therapy, enabling targeted and efficient modification of genetic material. Furthermore, breakthroughs in viral and non-viral delivery systems have significantly improved the safety profile and manufacturability of these therapies. The market is further buoyed by a robust pipeline of treatments in development. As of 2024, there are over 2,000 cell and gene therapy clinical trials in progress globally, with increasing investment flowing into clinical-stage biotechs like Bluebird Bio and Orchard Therapeutics. This rich development landscape underscores the growing confidence in CGTs as viable and scalable treatment solutions.

Market Restraint

Despite its promise, the CGT market faces several restraints that could hamper its growth trajectory. One of the most pressing challenges is the exceptionally high cost of therapies. For example, Zolgensma, a gene therapy for spinal muscular atrophy, is priced at over USD 2 million per treatment, raising significant concerns around affordability, access, and reimbursement. The manufacturing process for CGTs also presents critical hurdles. Autologous therapies, which require customization to each individual patient using their own cells, are complex, time-consuming, and costly to produce, making large-scale commercialization difficult.

Regulatory challenges further complicate market expansion. While agencies in the U.S. and Europe are becoming more adaptive, regulatory frameworks remain inconsistent across regions. This lack of harmonization slows down international market entry and adds layers of compliance complexity for manufacturers aiming for global reach. These issues, if left unaddressed, could limit patient access and deter investment in the space.

Market Opportunity

Despite these constraints, the CGT market holds substantial growth opportunities, particularly in emerging markets. Regions such as Asia-Pacific and Latin America are witnessing rising healthcare investments and the development of more advanced medical infrastructure, creating favorable conditions for CGT adoption. As regulatory bodies in these regions adapt to innovative therapies, market access is expected to improve significantly.

Another key opportunity lies in the development of allogeneic, or “off-the-shelf,” therapies. Unlike autologous treatments, allogeneic CGTs use cells from a universal donor, allowing for mass production, lower costs, and quicker turnaround times. This approach could transform the scalability and commercial viability of CGTs. Additionally, the integration of artificial intelligence (AI) and big data analytics into CGT development is streamlining target identification, optimizing clinical trial design, and enhancing manufacturing efficiency. These digital innovations are poised to accelerate the development pipeline and reduce time to market for new therapies.

Therapy Type Insights

The cell and gene therapy market can be segmented by therapy type into cell therapy and gene therapy, both of which are exhibiting strong growth trajectories. Cell therapy held a market size of USD 9.2 billion in 2024 and is projected to reach USD 33.5 billion by 2030, growing at a CAGR of 23.7%. This segment includes therapies such as CAR-T (chimeric antigen receptor T-cell), TCR-T (T-cell receptor therapies), and stem cell-based treatments. The widespread adoption of CAR-T therapies, particularly for hematologic malignancies like lymphoma and leukemia, has been a major growth driver. Notable approved products like Yescarta and Kymriah have set benchmarks for efficacy in blood cancers, spurring further investment and innovation.

Gene therapy, on the other hand, accounted for USD 8.4 billion in 2024 and is expected to reach USD 31.9 billion by 2030, at a CAGR of 24.6%, slightly outpacing cell therapy. This segment comprises gene addition, silencing, and editing technologies, including CRISPR-Cas9 and AAV-mediated gene delivery. Gene therapy is gaining significant traction, especially for treating rare and inherited disorders. The growing number of regulatory approvals for gene therapies addressing conditions such as spinal muscular atrophy and hemophilia reflects increasing confidence in this modality’s clinical value.

Indication Insights

In terms of indications, oncology remains the dominant therapeutic area, accounting for approximately 58% of the total market share. The extensive use of CAR-T cell therapies in treating hematologic cancers has made oncology the largest and most mature segment within the CGT space. Strong clinical results, along with favorable regulatory pathways for cancer treatments, continue to drive innovation and investment in this area.

The genetic disorders segment is growing rapidly, fueled by advancements in gene therapy technologies and strong regulatory incentives such as orphan drug designations and market exclusivity. Diseases like spinal muscular atrophy, beta-thalassemia, and hemophilia are seeing new treatments emerge with curative potential, attracting both public funding and private investment. The promise of one-time treatments for lifelong conditions is a particularly compelling driver in this space.

Cardiovascular and neurological disorders represent a smaller but highly promising segment. Although still in the early stages of development, several trials targeting Parkinson’s disease, amyotrophic lateral sclerosis (ALS), and ischemic heart conditions are underway. As preclinical and early clinical studies yield more data, this segment is expected to grow significantly, potentially opening new markets for CGT applications.

End-User Insights

From an end-user perspective, hospitals and specialty clinics currently administer over 60% of cell and gene therapies, largely due to the specialized nature of these treatments, which require controlled environments, expert personnel, and advanced infrastructure. As more therapies receive regulatory approval and become available commercially, these facilities will continue to play a central role in treatment delivery.

Academic and research institutions are crucial stakeholders in the early phases of CGT development. These institutions drive innovation, conduct foundational research, and lead many of the early-stage clinical trials that form the backbone of CGT advancements. Collaborations between academia and industry are increasingly common, as companies seek to accelerate time-to-market through academic partnerships.

Lastly, pharmaceutical and biotech companies are pivotal to the commercialization and scale-up of CGTs. These entities are responsible for developing manufacturing capabilities, navigating regulatory pathways, and launching products globally. The role of pharma and biotech companies is expected to expand further as more therapies transition from clinical trials to commercial production, making them key drivers of market growth and accessibility.

Regional Insights

North America remains the largest regional market for cell and gene therapy, with a market size of USD 9.8 billion in 2024, projected to grow to USD 35.7 billion by 2030, at a CAGR of 23.6%. This region benefits from a highly advanced healthcare infrastructure, early adoption of breakthrough therapeutics, and the strong presence of leading market players such as Novartis and Bluebird Bio. The U.S., in particular, leads the global landscape in terms of CGT approvals, clinical trial activity, and investment. However, the region also faces notable challenges, primarily the high cost of therapies and resistance from payers regarding reimbursement. These issues could impact patient access and slow down broader adoption, despite the market's otherwise favorable conditions.

Europe Cell and Gene Therapy (CGT) Market Trends

Europe represents the second-largest market, with a 2024 market size of USD 4.2 billion and a forecasted growth to USD 15.9 billion by 2030, growing at a CAGR of 24.3%. A key strength of the European market is its supportive regulatory environment, particularly initiatives like the EMA’s PRIME (PRIority MEdicines) program, which accelerates the development of CGTs targeting unmet medical needs. In addition, government-backed funding for rare diseases and research-focused healthcare systems further bolster growth. However, the fragmented nature of healthcare reimbursement across EU member states poses a significant challenge. Variability in pricing approvals and national reimbursement policies can delay market access and complicate commercialization strategies for therapy developers.

The Asia-Pacific region is emerging as a high-growth market, valued at USD 2.3 billion in 2024 and projected to reach USD 9.7 billion by 2030, with the highest regional CAGR of 27.0%. This growth is driven by strong government initiatives in countries like Japan, China, and South Korea, where regulatory bodies are increasingly open to approving innovative therapies. The region also benefits from a rapidly expanding local biotech sector and a growing volume of clinical trials. Furthermore, the potential for localized production of CGTs, lower operational costs, and faster patient recruitment offers significant opportunities for market players. These factors position Asia-Pacific as a strategic focus for future investment and expansion.

Latin America and the Middle East & Africa (MEA) are smaller but developing markets, with a combined value of USD 1.3 billion in 2024 and a projected increase to USD 4.1 billion by 2030, reflecting a CAGR of 21.0%. While these regions are showing interest in CGT development and adoption, several critical barriers hinder rapid growth. Regulatory frameworks remain underdeveloped, and there is limited infrastructure to support the manufacturing and clinical delivery of advanced therapies. Nevertheless, as governments in these regions begin to recognize the long-term healthcare and economic benefits of CGTs, incremental progress is expected. International partnerships and capacity-building initiatives could further accelerate growth in the coming years.

1. Novartis AG
2. Gilead Sciences (Kite Pharma)
3. CRISPR Therapeutics
4. Bluebird Bio
5. Pfizer Inc.

Recent Developments

• 2023: FDA approved Lenmeldy (Orchard Therapeutics) for metachromatic leukodystrophy — one of the first gene therapies for this indication.

• 2024: CRISPR Therapeutics & Vertex received FDA approval for Casgevy, the first CRISPR-based treatment for sickle cell disease.

• 2024: Pfizer acquired Beam Therapeutics for USD 5.4 billion to enhance in-house gene editing pipeline.