Cell and Gene Therapy Manufacturing Market Projected to Set $22.88 Billion by 2034

Cell and Gene Therapy Manufacturing Market: Growth, Trends, and Key Companies

The cell and gene therapy manufacturing market is projected to grow from USD 5.08 billion in 2024 to USD 22.88 billion by 2034, with a compound annual growth rate (CAGR) of 16.25% from 2025 to 2034. This growth is driven by the expanding biotechnology industry, increased research in cell and gene therapies, and rising investments in these innovative treatments.

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Key Highlights of the Cell and Gene Therapy Manufacturing Market

• North America led the cell and gene therapy manufacturing market in 2024.

• The Asia-Pacific region is expected to experience the fastest growth during the forecast period.

• The allogeneic cell therapy segment held the largest market share by therapy in 2024.

• In terms of technology, somatic cell technology dominated the global market in 2024.

• Induced pluripotent stem cells were the leading source in the global market in 2024.

• The musculoskeletal application segment held the largest market share in 2024.

Overview of the Cell and Gene Therapy Manufacturing Market

Cell and gene therapy manufacturing is a highly specialized process that involves producing cell and gene therapy products at a large scale. It requires state-of-the-art facilities, equipment, and skilled expertise. Cell therapy focuses on transplanting healthy cells into patients to repair or replace damaged tissue, while gene therapy involves altering a patient's genes to treat or prevent disease. These therapies each have their unique manufacturing processes. For cell therapy, key steps include sourcing and isolating cells, activating and genetically modifying them, and expanding and culturing them. Gene therapy production involves viral vector expression, cell growth, harvesting viral vectors, and filtration and purification.

With the potential to treat serious diseases like cancer, cell and gene therapy have garnered significant attention. Due to the complexity and rapid growth of the field, many companies turn to Contract Development and Manufacturing Organizations (CDMOs) to streamline their manufacturing needs.

In August 2022, Cytiva, a subsidiary of Danaher Corporation, teamed up with Forecyte Bio, a CDMO focused on cell and gene therapy, to enhance the development and manufacturing of these therapies in both China and the U.S. Forecyte Bio will use Cytiva's Flex Factory platform to expand its CDMO services.

Factors Driving Growth in the Cell and Gene Therapy Manufacturing Market

• Rising Prevalence of Chronic Diseases: The increasing rates of chronic conditions like cancer are driving the need for CGT products, fueling market growth.

• Expanding Biotech Industry: The growing demand for biologics is pushing the growth of the biotech sector, which in turn supports the market for cell and gene therapy manufacturing.

• More Investments: Both government and private sectors are investing more into CGT research and manufacturing, accelerating the development of new therapies.

• Increase in Clinical Trials: The rising number of clinical trials for CGT products further boosts the demand for manufacturing these therapies.

How AI Can Revolutionize the Cell and Gene Therapy Manufacturing Market

Artificial intelligence (AI) is becoming increasingly important in the manufacturing of cell and gene therapy (CGT) products, offering innovative solutions to the challenges that traditional methods face. By introducing automation, AI significantly improves the efficiency, reproducibility, and scalability of the manufacturing process, ultimately reducing both time and costs. While AI and robotics are still in the early stages, they have the potential to optimize large-scale production, ensuring more consistent and uniform products with fewer variations.

In addition to enhancing the production process, AI and machine learning (ML) algorithms are also making a big impact in the research and development (R&D) phase. They can help rapidly screen and select the most promising candidates for novel CGTs, streamlining the development process. Furthermore, AI can improve the efficiency of the supply chain, ensuring that CGT products are delivered on time to larger markets.

Survey Reflects Growing Optimism in the Cell and Gene Therapy Industry

A recent survey on the cell and gene therapy industry highlights a positive shift in attitudes toward CGT. Over the past 12 to 18 months, innovators in CGT and healthcare providers have remained optimistic about the sector, with 86% and 83%, respectively, expressing a positive outlook. However, contract development and manufacturing organizations (CDMOs) were slightly less optimistic, with only 66% sharing this view. Looking ahead, the outlook is even brighter, with expectations of positive growth across all groups for the next 12-18 months. CGT innovators (93%), healthcare providers (86%), and CDMOs (83%) all foresee continued advancements, particularly in gene therapies, which are expected to see more favorable outcomes compared to cell therapies, whether autologous or allogeneic.

Market Dynamics

Key Drivers

Booming Biotechnology Sector

The rapid growth of the biotechnology sector is a major driving force behind the expansion of the cell and gene therapy manufacturing market. As the number of biotech companies increases, so does the demand for CGT products, spurring more research and development in the field. This growth is further supported by increased investment in biotech and the expansion of manufacturing facilities.
Many institutions and organizations are also hosting seminars, workshops, and conferences to raise awareness about biotech products and train new researchers. Additionally, the rise of biotech startups around the world is contributing to the overall market growth and fostering innovation in CGT product development. FDA-approved therapies are also accelerating the demand for CGT manufacturing.

Opportunities

Rising Demand for Precision Medicine

The growing demand for precision medicine presents significant opportunities for the CGT manufacturing market. With changing demographics and an increasing global population, there is a rising need for personalized treatments. Autologous cell therapies and CRISPR-based gene therapies represent a new frontier in precision medicine, offering treatments that are tailored to individual patients. Government and private organizations are providing funding and creating policies to support the development of precision medicine, further fueling the demand for CGT products. Additionally, ongoing technological advancements in CGT manufacturing are paving the way for more sophisticated and personalized treatments.

Challenges

Cost Barriers to Market Growth

Despite its potential, the high cost of cell and gene therapies remains a major barrier to widespread adoption. The price of treatments has significant financial implications for patients, healthcare providers, and insurance companies. As a result, there is pressure on companies to reduce prices in order to improve accessibility and acceptance. Addressing the high cost of these therapies will be crucial for the continued growth of the market.

Market Scope and Segmentation of the Cell and Gene Therapy Manufacturing

Market

Allogeneic Cell Therapy Leads the Market

Cell and Gene Therapy Manufacturing Market Value by Therapy Type (2017-2030)
The allogeneic cell therapy segment was valued at approximately $1.2 billion in 2022 and is projected to reach around $3.13 billion by 2030, growing at a compound annual growth rate (CAGR) of 12.8%.

In 2023, allogeneic cell therapy maintained its dominant position in the market. This therapy involves the introduction of healthy stem cells from a donor into a patient's body. These donor cells can treat multiple patients and are often used in emergency medical situations. Compared to autologous stem cells (which come from the patient themselves), allogeneic stem cells are derived from healthy, young donors, reducing the risk of disease-related co-morbidities.

Recent advancements in cell storage and availability in healthcare settings are helping to drive this segment's growth.

Somatic Cell Technology Takes the Lead

Cell and Gene Therapy Manufacturing Market Value by Technology Type (2017-2030)

The somatic cell technology segment was valued at $823.2 million in 2022 and is expected to grow to $2.35 billion by 2030, with a CAGR of 14.0%.

In 2023, somatic cell technology was the leading technique in the global market. This technology involves inserting the nucleus of a differentiated cell into an egg cell that has had its genetic material removed. This process allows for the cloning of animals with desirable traits. Stem cells derived from somatic cells are used to treat degenerative diseases. With the rise in these diseases and continuous technological advancements, this segment is expected to experience significant growth.

Induced Pluripotent Stem Cells Dominate by Source

Cell and Gene Therapy Manufacturing Market Value by Source (2017-2030)
The induced pluripotent stem cells (iPSCs) segment was valued at $1.09 billion in 2022 and is projected to reach $4.09 billion by 2030, growing at a robust CAGR of 17.9%.

Induced pluripotent stem cells were the dominant source in the market in 2023. iPSCs are derived from adult cells and have the remarkable ability to transform into any type of cell in the body. These cells are invaluable for studying human development, modeling diseases, and screening drugs. The growing prevalence of neurological and chronic diseases, combined with increased investment and technological progress, is driving the growth of this segment.

Musculoskeletal Applications Lead the Market

Cell and Gene Therapy Manufacturing Market Value by Application (2017-2030)
The musculoskeletal segment was valued at $807.3 million in 2022 and is expected to reach $2.74 billion by 2030, growing at a CAGR of 16.5%.
The musculoskeletal application held the largest market share in 2023. The rising global incidence of musculoskeletal disorders and the increasing focus on research and development in this area are fueling this growth. According to the World Health Organization, over 1.7 billion people worldwide suffer from musculoskeletal conditions. As demand for cell and gene therapies to treat these disorders increases, the segment is expected to continue expanding.

Regional Insights: Cell and Gene Therapy Manufacturing Market Share (2023)

North America Leads the Charge

In 2023, North America took the lead in the cell and gene therapy (CGT) manufacturing market, fueled by key industry players, technological innovations, and favorable government support. The U.S. Department of Health and Human Services is set to launch the Cell and Gene Therapy Access Model in January 2025, aimed at making CGT products more affordable by inviting manufacturers to offer lower-priced options. The ongoing investments in the region also suggest continued market growth. For instance, Canada's government has allocated approximately $2.2 billion between 2020 and 2024 to enhance its domestic biomanufacturing and life sciences sectors.

In addition, OmniaBio announced a significant $580 million investment to build a new biomanufacturing facility in Hamilton, Ontario. With increasing numbers of FDA-approved CGT products-41 as of December 2024-the market is expected to keep expanding. The U.S. FDA approved 12 CGTs in 2022 and 7 more in 2023, supporting growth across the sector.

Asia-Pacific Set for Rapid Growth

Asia-Pacific is predicted to experience the fastest growth in the CGT manufacturing market in the coming years. Key drivers include rising chronic disease rates, expanding manufacturing infrastructure, and growing foreign direct investment. In China, the government is encouraging foreign investment in CGT, allowing wholly foreign-owned hospitals in select cities. They are also investing heavily in research and development, particularly in Suzhou, China's biotech hub.

India is making strides too, with the government pushing for CGT advancements in the rapidly growing biotech sector. In April 2024, India launched its first domestically developed anti-cancer CAR-T cell therapy, NexCAR19. This innovative therapy, developed in partnership with the Indian Institute of Technology, Bombay, and the Tata Memorial Center, aims to improve accessibility and affordability for patients in India.

Industry Leaders' Latest Announcements

Josh Ludwig, the Global Director of Operations at ScaleReady, shared exciting news about the future direction of CGT. He emphasized that the industry is shifting from autologous to allogeneic therapies, which offer durable responses. This transition is expected to move away from using viral methods like lentivirus and retrovirus, in favor of non-viral gene editing techniques. These advancements could reduce costs and pave the way for more affordable, off-the-shelf CAR-T therapies.

Recent Developments in the Cell and Gene Therapy Manufacturing Market

• In October 2024, Cellular Origins and Fresenius Kabi announced a collaboration to integrate the latter's suite of cell therapy processing technologies within the former's CGT robotic manufacturing platform, Constellation.
• In August 2024, PHC Corporation Biomedical Division announced the launch of LiCellGrow, a new cell expansion system, to promote the development of cell and gene therapy products manufacturing process.
• In May 2024, Merck announced the acquisition of Mirus Bio for $600 million to advance its integrated offering for viral vector manufacturing using Mirus Bio's transfection reagents.

Cell And Gene Therapy Manufacturing Market Top Companies
• Bluebird Bio Inc.
• Hitachi Chemical Co., Ltd.
• Takara Bio Inc.
• Catalent Inc.
• F. Hoffmann-La Roche Ltd.
• Samsung Biologics
• Novartis AG
• Lonza
• Merck KGaA
• Wuxi Advanced Therapies
• Boehringer Ingelheim
• Cellular Therapeutics
• Miltenyi Biotec
• Thermo Fisher Scientific
• F. Hoffmann-La Roche Ltd
• Bluebird Bio Inc.

Source: https://www.towardshealthcare.com/insights/cell-and-gene-therapy-manufacturing-market-experiencing-significant-growth

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