The global cell therapy manufacturing market size is expected to reach a valuation of USD 4,134.48 million in 2023 and further expand at a CAGR of 14.2% from 2023 to 2033. The market is anticipated to reach a valuation of ~USD 15,634.67 million by the end of 2033. Autologous cell therapy manufacturing is leading the global market and held a share of about 56.0% in 2021.
A sophisticated gene-edited cell-based product such as chimeric antigen receptor (CAR)-T cells or tissue engineering products like Holoclar are examples of modern cell therapies that include but are not limited to blood transfusion and hematopoietic progenitor stem cell transplantation exclusively.
Quality standards have evolved in response to the continual improvement of cell therapy manufacturing processes, thereby resulting in improved product consistency, reliability, and efficacy.
Manufacturing processes need a transition from open and manual to closed and automated in order to scale up. This offers several benefits such as decreased risk of contamination, improved product uniformity, increased efficiency, and surging traceability throughout the process to assure the chain of custody.
In order to reduce risks and get ready for a high-production future, groups in both academia and industry are actively implementing novel technologies that help them build automated, scalable, and closed systems.
Key players are also working on the development of innovative technologies that assist investigators in automating their processes for success in the future.
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Rising Practice of Manufacturing Capability Outsourcing
It is challenging and time-consuming for businesses that are not familiar with the cell therapy manufacturing process to build a solid supply chain with the tools and processes required to satisfy consumer demand.
Companies that have a strong understanding of the biology of their product, but are unfamiliar with how to transition from a small, manual production to a scaled-up, automated production that serves the needs of hundreds of thousands of patients globally, quickly bridge the gap with the help of an outside organization, such as a contract manufacturing organization (CMO).
Outsourcing of manufacturing capabilities creates growth opportunities for new industry entrants to scale up their products for wide-scale distribution. Additionally, outsourcing saves manufacturers from making investments in large-scale systems and facilitates anticipation of future product delays or regulatory denials.
Manufacturers of cell therapies face certain process limitations when they aim to provide a functional and safe output from an extremely variable starting material. Increased starting material variability poses limitations on the production protocols for desired end use products.
Additionally, as different phases in the production of cell therapy require variable timespans, bottlenecks develop in a fully automated system by holding one part of equipment engaged for a longer duration of time, while the rest of the system sits idle, not utilizing resources and wasting both time & space.
The design is more efficient in a modular system as only one part of the system is engaged and the rest of the system is available for usage. Another drawback of fully automated systems is that they could bind an organization or a research team to a certain methodology.
| Attributes | Details |
|---|---|
| Cell Therapy Manufacturing Market CAGR (2023 to 2033) | 14.2% |
| Cell Therapy Manufacturing Market Size (2023) | USD 4,134.48 million |
| Cell Therapy Manufacturing Market Size (2033) | USD 15,634.67 million |
The cell therapy manufacturing industry held approximately 3.3% of the global targeted therapeutics market, which was worth ~USD 3,685.7 million in 2022. The global cell therapy manufacturing market expanded at a CAGR of 10.7% from 2018 to 2022 owing to the positive outcomes of immunotherapy.
In its most precise definition, cell therapy manufacturing starts with the patient's cell collection in a clinical (or apheresis) facility and ends with the patient receiving the finished drug at their bedside. Numerous hand-off points and activities occur between the initial raw material collection and the subsequent administration of a product.
Cell therapy manufacturing differs from more conventional pharmaceutical production due to the complexity of all these working components in a supply chain, as well as the blend of the production and delivery phases. The majority, if not all, cell therapies currently available are only meant to treat a small number of patients.
However, if they are to be made widely accessible for a variety of indications, advancements in automation, process simplification, and supply chain management are necessary to keep up with the rising demand. Owing to the aforementioned factors, the global market is expected to surge at a CAGR of 14.2% during the forecast period.
The United States dominates the North American region and held a total share of about 42.1% in 2022. The country is expected to continue to remain at the forefront throughout the forecast period.
The increasing prevalence of sickle cell disease in the country and the presence of a large number of gene & cell and tissue-based therapeutic developers are likely to drive growth. As per the Centers for Disease Control and Prevention (CDC), sickle cell disease affects nearly 100,000 Americans and it occurs among about 1 out of every 16,300 Hispanic-American births.
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The United Kingdom held approximately 26.6% of the Europe market in 2022. The country reflects a lucrative outlook toward cell therapy manufacturing. As per the European Medicines Agency, from 2018 until 2020, nearly 102% of advanced therapy classifications occurred across Europe annually.
China held a share of around 38.2% in 2021 in the East Asia cell therapy manufacturing market, finds FMI. Chinese local biotech businesses are working with industry associations to develop guidelines for maintaining high product quality and introducing new processing methods in an effort to streamline cell therapy manufacturing. China is likely to hold a market CAGR of 22.1% by 2033.
For instance, SALIAI, a leading stem cell start-up, is promoting the establishment of production and quality standards for the stem cell sector while collaborating with the China Quality Association for Pharmaceuticals.
The autologous source segment held the leading share of around 56.0% in 2022. Growth is attributed to various advantages of autologous sources in stem cell transplant. They help in promoting faster recovery of cell counts, reducing mortality rates associated with the treatment modality, and providing a shorter length of hospital stays.
Cancer is expected to showcase high growth at a CAGR of 14.8% by the end of the forecast period. As per FMI, the segment held a market share of about 31.0% in 2022. The high incidence rate of cancer, as well as the growing adoption of novel treatment models for targeted therapy, are propelling the segment in the global cell therapy manufacturing market.
For pre-clinical, clinical, and commercial scaling of cell therapy products, manufacturing processes promote adoptive standardization for each protocol. Clinical manufacturing held a high market share of around 42.0% in the global market, followed by commercial manufacturing, which accounted for a share of about 32.0% globally in 2022.
Injectables held a market share of about 44.0% in 2022 in the global market. Injectables promote greater absorption of therapeutic drugs at the target site and hence contribute to a positive outcome for disease treatment. Moreover, injections for cell therapy exhibit better cell retention at the targeted site of the disease.
The hematopoietic stem cells (HSC) segment held a share of around 25.0% in 2022 in the cell therapy manufacturing market as many malignant disorders, including leukemia and lymphoma, as well as non-malignant conditions such as sickle cell disease, are treated with HSCs in order to replace or rebuild the patient's hematopoietic system.
Hospital settings held the leading market share of around 38.1% in 2022, says FMI. This segment is emerging as a valuable end user with the advancement of point-of-care manufacturing of cell therapies in units close to hospital settings for increased accessibility of treatment, as well as to reduce treatment time and risk of contamination.
Competitive Landscape
The global cell therapy manufacturing market is fragmented with the presence of a large number of companies. They are striving persistently to build digital capabilities for cell therapy production. These efforts help them to optimize their business processes and expand their portfolios in the global market.
For instance,
Key players
The cell therapy manufacturing sector expanded at a share of USD 3,685.79 million in 2022.
The United States is set to register exponential growth in the cell therapy manufacturing market.
The increasing demand for cell therapy products and the growing number of clinical trials are expected to drive cell therapy manufacturing sales.
The rising adoption of automation and the increasing focus on personalized medicine are key trends driving the cell therapy manufacturing market.
Substantial investment in research and development and expansion into new markets are expected to provide growth prospects for the market players.
| Market Size, 2024 | USD 16.7 billion |
|---|---|
| Projected Market Size, 2034 | USD 52.1 billion |
| Value-based CAGR (2024 to 2034) | 12.1% |
| Estimated Market Share in 2023 | USD 6,365.2 million |
|---|---|
| Forecasted Market Size by 2033 | USD 12,957.8 million |
| Projected Market CAGR (2023 to 2033) | 7.4% |
| Market Estimated Size (2023) | USD 5,935.9 million |
|---|---|
| Market Forecasted Size (2033) | USD 15,735.3 million |
| Market CAGR (2023 to 2033) | 10.2% |
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