Cell And Gene Therapy Market

The global Cell And Gene Therapy Market is valued at USD 20.5 Billion in 2024 and is projected to reach a value of USD 128.8 Billion by 2035 at a CAGR (Compound Annual Growth Rate) of 18.2% between 2025 and 2035. Cell and gene therapies (CGTs) represent significant progress in patient care, offering treatments or potential cures for diseases that were previously untreatable by traditional small molecule and biologic medicines. Over the past two decades, the FDA has approved more than 20 CGTs, with many of these one-time treatments priced between US$37,500 and US$2 million per dose.

Key Highlights

• Based on the Therapy Type, the Cell Therapy category accounted for significant market share in Cell And Gene Therapy market industry for 85.6% in 2024
• In 2024, by Therapeutic class, Infectious Disease dominated the Cell And Gene Therapy market share of 13.4%
• By Delivery Method, in vivo dominated the Cell And Gene Therapy market industry with market share
• In 2024, Based on End-Users, Cancer Care Centers dominated the Cell And Gene Therapy market with market share of 78.5%
• North America dominated the Cell And Gene Therapy market industry with 47.8% Cell And Gene Therapy market share in 2024
• Asia Pacific region is anticipated to grow at the highest CAGR during the forecast period in Cell And Gene Therapy market industry

Therapy Type Overview

​The Therapy Type segment is divided into Cell Therapy, Gene Therapy. The Cell Therapy segment held the Cell And Gene Therapy market size of 85.6% in 2024.

The Cell Therapy led the Cell And Gene Therapy market industry in 2024, capturing over 85.6% of revenue. Cell therapy involves the transplantation of living cells, sourced either from a donor (allogeneic) or the patient themselves (autologous), to treat various conditions. The widespread application of cell-based treatments, such as stem cell therapies and CAR-T therapies, which are being increasingly used to treat various diseases, including cancers and genetic disorders.

Gene therapy is a medical approach aimed at modifying the genetic composition of cells to treat or potentially cure diseases by repairing or replacing defective genetic material. It is applied across various fields, including oncology, dermatology, musculoskeletal disorders, and more. These therapies are utilized in diverse settings such as hospitals, ambulatory surgery centers, cancer treatment centers, wound care clinics, and other healthcare facilities.

Therapeutic class Overview

​The Therapeutic class segment is divided into Cardiovascular Disease, Cancer, Genetic Disorder, Rare Diseases, Oncology, Hematology, Ophthalmology, Infectious Disease, Neurological Disorders, Others. The Infectious Disease segment held the dominant share in 2024, accounting for significant Cell And Gene Therapy industry share of 13.4%.

The Infectious Disease segment led the global Cell And Gene Therapy industry in 2024 and expected to grow at the fastest rate in the coming years driven by advancements in gene-editing technologies, increasing prevalence of infectious diseases, and rising demand for innovative treatment options. The segment benefits from the development of therapies targeting conditions such as HIV, hepatitis, and emerging viral infections, leveraging breakthroughs like CRISPR-Cas9 and viral vector technologies. Growing investments in R&D, coupled with supportive regulatory frameworks, have further accelerated the commercialization of novel therapies, positioning the Infectious Disease segment as a key driver of growth in the Cell And Gene Therapy market.

End User Overview

​The End User segment is divided into Hospitals, Cancer Care Centers, Others. The Cancer Care Centers segment held the dominant share in 2024, accounting for significant Cell And Gene Therapy industry share of 78.5%.

The Cancer Care Centers segment led the global Cell And Gene Therapy industry in 2024 and expected to grow at the fastest rate in the coming years driven by the rising prevalence of cancer and the increasing adoption of advanced cell and gene therapies as standard treatment options. These centers are at the forefront of delivering cutting-edge therapies such as CAR-T cell therapy and gene-modified immunotherapies, supported by growing investments in specialized infrastructure and skilled healthcare professionals. Enhanced patient access to clinical trials, partnerships with biotechnology firms, and favorable reimbursement policies further bolster the segment's growth in Cell And Gene Therapy market, solidifying its critical role in advancing cancer treatment outcomes.

Regional Overview

In 2024, the Cell And Gene Therapy market size of the North America is USD 9.7 Billion.

North America Cell And Gene Therapy industry report is driven by the presence of advanced healthcare infrastructure, significant investments in R&D, and favorable regulatory frameworks that support the development and commercialization of innovative therapies. North America Cell And Gene Therapy market leads in the number of gene therapy clinical trials, with over 400 companies in the region actively involved in developing cell and gene therapy products targeting various disorders.

U.S. Cell And Gene Therapy Market Analysis

In 2024, the U.S. led the North American Cell And Gene Therapy Market, driven by the rapid adoption of advanced therapeutic solutions, a robust biotechnology ecosystem, and substantial government and private sector funding. The country’s leadership in clinical trials and approvals for novel therapies further bolsters its Cell And Gene Therapy market dominance.

Asia Pacific Cell And Gene Therapy Market Analysis

The Asia Pacific Cell And Gene Therapy industry report is set for significant growth with over the forecast period fueled by factors such as increasing healthcare expenditures, growing awareness of advanced therapies, and rising prevalence of chronic and genetic diseases. Strategic collaborations and expanding manufacturing capabilities in the region also contribute to the Cell And Gene Therapy market's expansion.

China Cell And Gene Therapy Market Analysis

China's Cell And Gene Therapy market is poised for significant growth due to the government's supportive policies, increasing investments in biotechnology, and a growing pipeline of clinical trials. The country’s focus on local production and international partnerships further accelerates its Cell And Gene Therapy market development.

Europe Cell And Gene Therapy Market Analysis

Europe are expected to see Cell And Gene Therapy industry growth during the forecast period driven by an increase in regulatory approvals, strong research initiatives, and rising adoption of advanced therapies in countries like Germany, the UK, and France. Collaborative efforts between academic institutions and biotech companies further enhance the region's market potential.

Based on the provided market data, Vantage Market Research offers customizations in the reports to meet the specific needs of clients.

Cell And Gene Therapy Market Trends

• Advancements in CRISPR and Gene Editing Technologies: The development of more precise and efficient gene-editing tools, like CRISPR-Cas9, is revolutionizing the ability to treat genetic disorders and enhancing the potential for personalized medicine
• Growth of Cell-Based Therapies: The increasing use of cell-based therapies, such as CAR-T (chimeric antigen receptor T-cell) therapies, is gaining traction in treating cancers and other diseases, offering new hope for patients with previously untreatable conditions
• Personalized and Targeted Therapies: There is a growing shift toward personalized medicine, where therapies are tailored to an individual’s genetic profile, enabling more effective and targeted treatments, particularly in rare genetic diseases
• Regenerative Medicine: Stem cell therapy and regenerative approaches are increasingly being explored to repair or replace damaged tissues and organs, offering new treatment options for degenerative conditions
• Increasing Collaborations and Partnerships: The market is seeing a rise in strategic collaborations between biotech firms, pharmaceutical companies, and academic institutions, aimed at accelerating the development and commercialization of gene and cell therapies
• Focus on Rare and Underserved Diseases: Companies are focusing on developing therapies for rare and genetic diseases, with a particular emphasis on conditions that have limited treatment options, opening new market opportunities
• Regulatory Advancements and Approvals: The progress in regulatory frameworks, including expedited approval pathways for gene and cell therapies, is facilitating faster market access and increasing the adoption of these therapies

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Market Dynamics

Market Drivers for Cell And Gene Therapy Market

Rising demand for innovative therapies

The increasing prevalence of genetic disorders, cancers, and chronic diseases has led to a growing demand for innovative treatments. Cell and gene therapies offer targeted solutions that can potentially cure or significantly improve the outcomes of diseases that were previously difficult to treat. As patients and healthcare providers seek more effective and personalized treatment options, the demand for these advanced therapies continues to rise, driving market growth.

Market Restraints for Cell And Gene Therapy market

High development costs and stringent regulations

The complex processes involved in gene editing, manufacturing, and clinical trials require significant investment. Additionally, the regulatory frameworks for these therapies are stringent, with lengthy approval processes and rigorous safety and efficacy standards. These factors can delay the commercialization of new therapies and increase costs, limiting the growth potential for some companies.

Market Opportunities for Cell And Gene Therapy market

Advancements in gene-transfer technologies and growing focus on rare disease treatments present significant growth potential

The development of more efficient and precise gene-transfer technologies, such as CRISPR and viral vectors, presents significant opportunities for the market. These advancements can improve the effectiveness and safety of gene therapies, making them more accessible and viable for a broader range of diseases. Additionally, there is an increasing focus on rare diseases, which often lack effective treatments. Gene therapies have the potential to address these unmet needs, offering significant growth potential as companies develop targeted therapies for these conditions.

Competitive Landscape

The Cell And Gene Therapy market industry report is characterized by the presence of established pharmaceutical companies, innovative biotech firms, and academic institutions driving research and development. Key players such as Novartis, Gilead Sciences, and Bluebird Bio are leading the market with approved therapies and robust pipelines. Collaboration and partnerships are prevalent, with companies focusing on advancing technologies like CRISPR, viral vectors, and CAR-T therapies. Startups and regional players also contribute by targeting niche indications and leveraging local expertise. Intense competition, coupled with significant investment in R&D, is accelerating innovation and expanding the therapeutic potential of cell and gene therapies globally.

The key players in the global Cell And Gene Therapy market report include - Alnylam Pharmaceuticals Inc., Amgen Inc., Biogen Inc., CORESTEM Inc., Dendreon Pharmaceuticals LLC., Helixmith Co. Ltd., JCR Pharmaceuticals Co. Ltd., Kolon TissueGene Inc., Novartis AG, Pfizer Inc. among others.

Recent Market Developments

Alexion Acquires LogicBio's Technology to Enhance Gene Therapy for Rare Diseases

• In October 3, 2022, Alexion's Genomic Medicines announced the acquisition of LogicBio's technology. This acquisition aims to integrate LogicBio's expertise in preclinical development and rare disease research and development. LogicBio has developed various systems for gene delivery to address genetic disorders and will also help enhance the creation of viral vectors through their platform

Merck Exercises Option to Co-Develop Moderna’s mRNA-4157/V940 for High-Risk Melanoma

• In October 12, 2022, Moderna revealed that Merck (MSD) had exercised its $250 million option to co-develop and commercialize the PCV mRNA-4157/V940 vaccine. Currently undergoing a Phase II clinical trial, the vaccine is being tested as an adjuvant therapy for high-risk melanoma patients, in combination with pembrolizumab, Merck's PD-1 antibody

Pfizer Acquires Biohaven Pharmaceuticals to Expand Migraine Treatment Options

• In October 3, 2022, Pfizer announced the successful acquisition of Biohaven Pharmaceuticals, a company specializing in migraine drugs. Biohaven's NURTEC ODT (rimegepant), approved for acute therapy and episodic migraine prevention in adults, will expand Pfizer's offerings, providing more treatment options for migraine patients globally

The global Cell And Gene Therapy market can be categorized as Therapy Type, Therapeutic class, Delivery Method, End-Users and Region.