Cell Therapy Manufacturing Market Size, Share, and Trends 2024 to 2033

Cell Therapy Manufacturing Market Size and Growth 2024 to 2033

The global cell therapy manufacturing market size was valued at USD 4.20 billion in 2023 and is anticipated to reach around USD 16.89 billion by 2033, growing at a CAGR of 14.93% from 2024 to 2033. The rising incidence of chronic diseases such as cancer, autoimmune disorders, and degenerative conditions are key factors driving the market growth.

Cell Therapy Manufacturing Market Key Takeaways

• The North America cell therapy manufacturing market size accounted for USD 1.85 billion in 2023 and is expected to attain around USD 7.43 billion by 2033.
• North America led the market with the major revenue share of 44% in 2023.
• Asia Pacific is expected to witness the fastest growth during the forecast period.
• By therapy type, the autologous cell therapy segment has held the biggest revenue share of 59% in 2023.
• By therapy type, the allogenic cell therapy segment is projected to be the fastest-growing segment over the forecast period.
• By technology type, the somatic cell technology segment held the largest share of the market in 2023.
• By technology type, the 3D technology segment is expected to grow at the fastest rate during the projected period.
• By source, the IPSC (induced pluripotent stem cell) segment dominated the market in 2023.
• By source, the bone marrow segment is the second largest segment in the global market.
• By application, the oncology segment has contributed the largest revenue share of 35% in 2023.
• By application, the neurological segment is projected to show fastest growth during the forecast period.

Cell Therapy Manufacturing Market Size in the U.S. 2024 to 2033

The U.S. cell therapy manufacturing market size was estimated at USD 1.29 billion in 2023 and is predicted to be worth around USD 5.24 billion by 2033, at a CAGR of 15.04% from 2024 to 2033.

North America dominated the global cell therapy manufacturing market. The United States led in North America in 2023 and is expected to maintain this position in the forecast period. Factors such as the rising prevalence of sickle cell disease and the presence of numerous developers of gene, cell, and tissue-based therapeutics are driving growth. Moreover, the region benefits from many contract development organizations and local companies are expanding their manufacturing facilities.

• In May 2023, Thermo Fisher Scientific and the University of California, San Francisco (UCSF) announced a partnership to establish a new cell therapy cGMP manufacturing site. This facility will be adjacent to UCSF Medical Center's Mission Bay Campus.

Asia Pacific is expected to witness the fastest growth during the forecast period. Countries such as China, Japan, and South Korea are investing heavily in research and development and constructing state-of-the-art manufacturing facilities. The region benefits from a sizable patient population, rising healthcare spending, and government support to foster the growth and acceptance of cell therapies. Additionally, Asia Pacific is becoming a center for contract manufacturing organizations (CMOs) providing cell therapy manufacturing services.

• In April 2024, President Draupadi Murmu launched India's first indigenously developed CAR T-cell therapy for the treatment of cancer, hailing it as a "breakthrough" that provides a "new hope for humankind" in the battle against the disease.

Cell Therapy Manufacturing Market Size in Asia Pacific 2023 to 2033

The Asia Pacific cell therapy manufacturing market size was calculated at USD 970 million in 2023 and is projected to expand around USD 3,970 million by 2033, poised to grow at a CAGR of 15.13% from 2024 to 2033.

Cell Therapy Manufacturing Market Overview

The cell therapy manufacturing market comprises industries that produce therapeutic products using isolated tissue to treat disorders or wounds. Cell therapy manufacturing is essential for developing and commercializing cell-based treatments, such as CAR-T cell and stem cell therapies. It is critical to have efficient and scalable manufacturing processes to meet the increasing demand for these innovative treatments and make them available to patients around the world.

The process of cell therapy includes harvesting cells from a patient or donor, modifying or growing them in a lab, and then reintroducing them into the patient's body to improve biological functions. Manufacturing includes steps like isolating cells, expanding them, performing genetic modifications if needed, conducting quality control tests, and preparing the final product. These steps are carried out in highly controlled environments to ensure the safety, purity, and effectiveness of therapeutic cells.

Cell Therapy Manufacturing Market Growth Factors

• Ongoing research and development activities can lead to the findings of new cell therapy pathways that can drive market growth.
• Rising investment from the public and private sectors into the cell therapy market can fuel the market growth in upcoming years.
• The expansion of clinical trials across the globe can also contribute to the market expansion.
• Regulatory agencies like EMA and FDA are providing support and guidance for the development and approval of cell therapies which can boost market growth further.

Cell Therapy Manufacturing Market Scope

Cell Therapy Manufacturing Market Dynamics

Driver: Outsourcing manufacturing processes

In the cell therapy manufacturing market, businesses not well-versed in cell therapy manufacturing, establishing a robust supply chain to meet consumer demand can be daunting and time-consuming. Companies with a strong grasp of their product's biology but lack experience in transitioning from small-scale to large-scale automated production can bridge this gap with the help of external organizations like contract manufacturing organizations (CMOs).

Outsourcing manufacturing capabilities presents growth opportunities for new players in the cell therapy manufacturing market to scale up their products for widespread distribution. Moreover, it spares manufacturers from investing in extensive systems and helps them prepare for potential product delays or regulatory challenges in the future.

• In February 2024, Thermo Fisher Scientific entered into a collaboration with Multiply Labs in order to automate its instruments for cell therapy manufacturing. This partnership is expected to support large-scale manufacturing, reduce costs associated with manufacturing, and accelerate production timelines for cell therapies.

Restraint: Complex manufacturing process

The cell therapy manufacturing market is complex due to biological variations, making it difficult to standardize and ensure quality control. Moving from small-scale research to large-scale production while maintaining consistent product quality is a major hurdle. Additionally, meeting strict regulatory standards, especially for new and personalized therapies, adds further challenges, particularly concerning product safety, effectiveness, and manufacturing protocols.

Opportunity: Increasing use of allogeneic therapies 

Allogeneic cell therapies offer advantages as they produce immune cells that can target and eliminate cancer cells left behind by chemotherapy. These therapies come from healthy sources, providing a greater supply of functional cells. Moreover, allogeneic techniques allow for the creation of multiple medicines, making them a key driver of growth in the cell therapy manufacturing market. Compared to autologous therapies, allogeneic treatments are notably more cost-effective, further fueling the expansion of the market.

Despite the limited number of approvals, companies specializing in cell therapies are attracting increased funding from both private investors and government sources. Over the projected period, there has been a significant rise in private equity and capital investments in the life sciences sector. As a result, investments in the cell therapy industry play a crucial role in driving the growth of the cell therapy manufacturing market.

• In May 2024, Astellas Pharma Inc. and Poseida Therapeutics, Inc. announced that Xyphos Biosciences, Inc. and Poseida have entered into a research collaboration and license agreement to develop novel convertibleCAR® programs by combining the innovative cell therapy platforms from each of the companies.

Therapy Type Insights

The autologous cell therapy segment was the leading therapy type in the cell therapy manufacturing market in 2023. Autologous therapy is a novel treatment approach that involves using a person's own cells or tissues. These cells or tissues are treated outside the body before being re-inserted into the donor. This method is widely used in various fields of medicine, including orthopedics and dermatology, for both therapeutic and cosmetic purposes.

According to market projections, the allogenic cell therapy segment is expected to experience the highest growth rate in the cell therapy manufacturing market over the forecast period. Allogenic cell therapies involve using cells from healthy donors of the same species, as opposed to xenogeneic therapies, which use cells from different species. In this type of therapy, cells are expanded and potentially modified to treat multiple patients.

Technology Type Insights

The somatic cell technology segment held the largest share of the cell therapy manufacturing market in 2023. These benefits stem from this type of therapy. Besides advancing stem cell research and therapies, somatic cell nuclear transfer (SCNT) has the special ability to produce cells tailored to individual patients for regenerative medicine. Also, it can be used to breed transgenic animals for biomedical purposes. These factors can drive the segment growth further.

The 3D technology segment is expected to grow at the fastest rate during the projected period. This is attributed to the three-dimensional (3D) technologies, like biomaterial scaffolds, that serve various purposes. They support cell survival, prompt cell specialization, provide a surface for cell growth, aid tissue regeneration, determine tissue shape and size, deliver growth factors, and shield cell transplants from the immune system to prevent rejection. These are some important functions of 3D technologies in medical applications.

• In January 2024, Pluri, an Israel-based biotech company, launched a new business division named PluriCDMO that will offer cell therapy manufacturing services as a contract development and manufacturing organization (CDMO). The new division includes a 47,000-ft2 good manufacturing practice (GMP) cell therapy production facility.

Source Insights

The IPSC (induced pluripotent stem cell) segment dominated the cell therapy manufacturing market in 2023. Induced pluripotent stem cells (iPSCs) are viewed as an excellent option for creating ready-made allogeneic cell therapies. They can multiply indefinitely, are easily modified genetically, allow for the selection of specific clones after modification, and eliminate the need for individual cell collection.

The bone marrow segment is the second largest segment in the global cell therapy manufacturing market. A bone marrow transplant (BMT) is a specialized treatment for individuals with specific cancers or other medical conditions. It entails extracting stem cells from the bone marrow, filtering them, and reintroducing them into either the same individual (donor) or another recipient.

Application Insights

The oncology segment dominated the cell therapy manufacturing market in 2023. An oncologist is a doctor who specializes in identifying, diagnosing, and treating cancer in patients. They are trained to address various types of cancer affecting different parts of the body. The advancement of biotechnology, personalized medicine, and innovative treatment methods has elevated oncology's significance in the market.

The neurological segment is projected to show the fastest growth during the forecast period. This is because, in recent years, there has been an increasing focus on using cell transplantation or cell therapy to treat nerve injuries. This approach has gained attention for its potential in treating neurological diseases by giving new treatment options. Cell therapy in neurological diseases aims to mimic the natural process of cell repair and development in the nervous system. This can help address the root causes of the disease, improve dysfunction, and facilitate tissue repair.

• In April 2024, Aspen Neuroscience, Inc. announced that the first patient had been dosed in the ASPIRO trial, a Phase 1/2a open-label clinical trial to assess the safety and tolerability of ANPD001, an autologous, dopaminergic neuron cell replacement therapy for participants with moderate to severe Parkinson's disease. Aspen Neuroscience is a private biotechnology company developing personalized regenerative therapies.

Cell Therapy Manufacturing Market Recent Developments

• In March 2024, Cellars announced the completion of the first Cell Shuttle, an automated, cGMP-compliant cell therapy manufacturing platform to support the global demand for cell therapies while reducing the cost of manufacturing and process failure rates.
• In March 2023, Cell One Partners and the Center for Breakthrough Medicines (CBM) entered into a strategic collaboration aimed at accelerating the development and commercialization of cell and gene therapies. This collaboration brings together the expertise and resources of both organizations to drive innovation and advance the field of regenerative medicine.
• In September 2022, the Cell Therapy Manufacturing Center (CTMC) and Ori Bio collaborated to expedite the process development, commercialization, and clinical integration of cell therapies. This partnership aimed to enhance the advancement of cell-based treatments and bring them to patients more efficiently.

Cell Therapy Manufacturing Market Companies

• Merck KGaA
• Thermo Fisher Scientific
• Catalent, Inc
• Bio-Techne
• Cytiva
• Lonza
• The Discovery Labs
• Novartis AG
• Bristol-Myers Squibb Company
• Gilead Sciences, Inc.

Segments Covered in the Report

By Therapy Type

• Allogenic Cell Therapy
• Autologous Cell Therapy

By Technology Type

• Somatic Cell Technology
• Cell Immortalization Technology
• Viral Vector Technology
• Genome Editing Technology
• Cell Plasticity Technology
• 3D Technology

By Source

• IPSC (Induced Pluripotent Stem Cell)
• Bone Marrow
• Umbilical Cord
• Adipose Tissues
• Neural Stem

By Application

• Musculoskeletal
• Cardiovascular
• Gastrointestinal
• Neurological
• Oncology
• Dermatology
• Others

By Geography

• North America
• Asia Pacific
• Europe
• Latin America
• Middle East & Africa