The global cell therapy processing market size was valued at USD 4,493.37 million in 2022. It is estimated to reach USD 40,292.87 million by 2031, growing at a CAGR of 27.60% during the forecast period (2023–2031).
Cell therapy is the injection of living cells to replace a missing cell type or to offer a continuous source of a necessary factor to achieve an effective therapeutic outcome. Cell therapy's manufacturing process requires using different products, such as cell lines. Several different types of cells may be employed as a component of therapy or treatment for several diseases and disorders with the help of new technologies, innovative products, and infinite imagination. Various forms of cell therapies are available in the market, which includes stem cell therapy, allogeneic cell therapy, and embryonic cell therapy.
As the research progresses, additional cell types will be researched for possible applications and developed into therapeutics as innovative cell therapies. The most popular cell therapy for treating a range of hematologic and blood cancers is hematopoietic stem cell transplantation, often known as a bone marrow transplant. Cell treatments may treat conditions such as cancer, autoimmune illness, urine issues, and infectious disease, repair spinal cord injuries, and treat patients with neurological diseases. They may also treat cancer, autoimmune disease, urinary difficulties, and infectious disease.
The rapid increase in stem cell and cell therapy research in lung biology and illnesses, as well as in ex vivo lung bioengineering, opens up new opportunities for developing fresh possible treatment strategies for lung ailments. These preliminary findings have prompted further clinical research into endothelial progenitor cells and mesenchymal stem (stromal) cells for use in clinical trials of pulmonary hypertension and chronic obstructive pulmonary disease (COPD).
Ex vivo bioengineering of the trachea, larynx, diaphragm, and decellularized tissues has been used to treat patients with end-stage lung diseases. Moreover, progress in stem cell therapy provides further understanding of lung biology and repair after lung injuries and further scientific evidence for the therapeutic use of cell therapies and bioengineering approaches in treating lung diseases. Thus, developing stem cell therapy techniques is anticipated to stimulate market growth.
Immunotherapy utilizing T cells modified with chimeric antigen receptors has demonstrated high response rates in patients with B-cell cancers. In addition, chimeric antigen receptor T-cell therapy finds its major application in treating several hematologic and solid tumor types. Chimeric antigen receptor T cells are generated by extracting T cells from a patient's blood and engineering the cells to express the chimeric antigen receptor, reprograming the T cells to target tumor cells.
Chimeric antigen receptor (CAR) T cell therapy is a cellular therapy in which the patient's T cells are redirected to target and eliminates tumor cells specifically. CARs are fusion proteins with an antigen recognition domain derived from a monoclonal antibody and intracellular T-cell signaling and costimulatory domains. Therefore, the rise in the demand for chimeric antigen receptor (CAR) T-cell therapy for cancer treatment is estimated to enhance the development of the global market.
Insufficient financial resources coupled with poor income, fewer biotechnology companies, and lack of availability of advanced manufacturing systems hamper the growth of the market in underdeveloped countries in Asia and Africa. Similarly, inadequate support by government agencies for the adoption of cell therapy processing techniques and a shortage of trained professionals impede market growth in underdeveloped countries such as Ethiopia, Afghanistan, and Guinea.
Due to the availability of improved biotechnology industry infrastructure, a rise in the number of biotechnology industries, and an increase in demand for cell therapy processing products and services, the growth of the market is predicted to be driven by opportunities in untapped and emerging markets. Furthermore, the need for advanced manufacturing systems is surging, and the government is making considerable investments to upgrade the healthcare infrastructure. As a result, the healthcare sector in emerging nations is growing significantly. Emerging countries like China and India are the hubs of biotechnology companies, which is expected to further contribute toward the growth opportunities for this market during the forecast period.
The global market is segmented by offering type and application.
Based on offering type, the global market is bifurcated into products, services, and software.
The products segment dominates the global market and is projected to exhibit a CAGR of 27.40% over the forecast period. Products such as matrices, sera, enzymes for cell attachment, culture vessels, cytokines and media components, bags, tubing sets, and other disposables are extensively used in the market. Products like testing bags, tubing, and culture vessels for extractable and leachable are required to maintain cell growth and viability. Furthermore, the product segment includes additional processing equipment, such as single-use bioreactors for producing modified cell lines for therapeutic use. The product segment holds the majority of share in the global cell therapy processing market, owing to the extensive use of consumable and disposable products, the rise in demand for CQA- and QbD-based products, and the increase in the adoption of single-use bioreactors for the production of modified cell lines, which are majorly used in cell therapy processing.
Additionally, cell sources are the most vital products of the market. Cell sources may vary from primary fetal cells to fully differentiated cells of various types and may be obtained from in vitro expanded cell populations or primary tissues. For some manufacturing processes, cells must be pre-selected based on their phenotypic characteristics. The developmental maturity of cells used for transplantation varies depending on cell type and therapeutic needs.
Cell therapy software has been developed to enable and effectively manage cell therapy workflow. In 2018, the software segment held a significant market share and is projected to grow throughout the forecast period at a high CAGR. The software executes critical functions such as detailed trial preparation management, operations monitoring, and supply and finance. For instance, Title21 Health Solutions creates integrated cell therapy software that handles operations with scalable, robust cell therapy software. The software was developed for processing cell therapy to increase the operations bandwidth and improve overall quality through streamlined operations. Integrated cell therapy software from Title21 has workflows with embedded logic depending on clinical business operations to guide data gathering from referral via post-infusion follow-up and collect electronic signatures for approvals on the way. Furthermore, an effective software solution may assist businesses that manufacture pharmaceuticals and medical devices to adhere to regulatory norms, making it easier for them to enter new markets and fuel the segment's expansion during the projection period.
Based on application, the global market is segmented into cardiovascular devices, bone repair, neurological disorders, skeletal muscle repair, cancer, and others.
The skeletal muscle repair segment owns the highest market share and is anticipated to exhibit a CAGR of 27.70% during the forecast period. The skeletal muscle repair segment accounted for the major share of the global market. Skeletal muscle is the body's most abundant tissue and is an important locomotive. These muscles serve as the major carbohydrate and protein storage house and are one of the key heat generators. Thus, it is important to maintain muscle health properly. A severe acute loss of muscle function can be fatal, leading to the debilitating effects of chronic mobility decline. Therefore, skeletal tissue repair and maintenance must be quick and effective. Current recommendations for treating skeletal muscle lesions depend on cautious rest, ice, compression, and elevation (RICE)-based and surgical therapies for scientific implementation. However, the treatment shows minimal effectiveness in improving extreme case outcomes, stressing the need for new approaches to skeletal muscle therapy. Biomedical research is being carried out on restoring the structure and function of damaged muscles on different fronts.
Patients with brain damage tend to suffer from lifelong disability due to the limited capacity to regenerate central nervous tissues. Fetal neural tissue for cell therapy presented the first unambiguous proof that such grafts can be used to grow, evolve, and recover functional defects in rodents to varying degrees. The shortcomings associated with this technique led to the search for more robust and acceptable stem cells capable of transforming into any specific type of cell, including neurons and glia. Depending on the culture conditions, such cells may be modified using an in vivo technique to secrete the desired neurotransmitters. In addition, the stem cells capable of such transformations can be isolated from adult bone marrow and many other tissues, such as the placenta, umbilical cord blood, and amniotic fluid. Thus, ethical concerns raised against fetal or embryonic tissue use were overcome. However, these transformed adult stem cells revealed new difficulties and limited success. Neurological disorders are caused by the loss of neurons and glial cells in the central or peripheral nervous system.
Based on region, the global market is bifurcated into North America, Europe, Asia-Pacific, and LAMEA.
North America is the most significant global market shareholder and is anticipated to exhibit a CAGR of 27.70% during the forecast period. The market for cell therapy processing in North America is witnessing significant growth due to increased funding from numerous government and private organizations to cater to unmet medical needs, the increased popularity of stem cell research, and a rise in global awareness of stem cell therapies. Increasing approvals for stem cell therapy clinical trials and developing cutting-edge genomic techniques for stem cell analysis are also driving the market growth. Due to the country's established healthcare infrastructure, stronger purchasing power, and rapid uptake of cutting-edge medical procedures, the U.S. market held the largest share in 2018. Furthermore, the frequency of osteoporosis is increasing along with the number of elderly people. Given that elderly persons are more likely to develop osteoporosis, this resulted in a spike in demand in the area. The presence of the most prominent firms in the area and other factors also play a big role in the market's expansion. Likewise, factors such as the rise in R&D activities related to the launch of new therapies boost the market's growth.
Europe is estimated to exhibit a CAGR of 27.10% over the forecast period. Europe holds the second-highest position in the world's cell therapy processing market as a result of higher disposable income. Other factors that propel the development of the market in the region include a surge in the prevalence of lifestyle disorders and a rise in awareness toward the use of cell therapy processing. Due to increased research efforts and the prevalence of cardiovascular ailments, cell therapy processing has become more popular in Europe in the past few years.
Furthermore, the presence of important firms in the region facilitates the market's expansion. An increase in approvals of advanced techniques encouraged market players in this area to develop novel cell therapies for treating different diseases. For example, in 2014, the European Medicines Agency recommended the approval for use in the European Union of Holoclar, a stem cell treatment. Holoclar is used in humans with severe limbal stem cell deficiency due to eye burns. Similarly, a surge in awareness related to early diagnosis of chronic diseases is another factor that propels the market growth in the region.
Asia-Pacific offers lucrative opportunities for the market and is anticipated to register the highest growth rate during the forecast period. The countries in this region are highly populated, with China being the first and India the second most populated country. Therefore, the region possesses high growth potential owing to the presence of a huge patient base, which is anticipated to propel the Asia-Pacific cell therapy processing market growth. Moreover, an increase in research and development expenditure and a surge in the usage of products augment the market's growth. The market for cell therapy processing in the Asia-Pacific region has increased traction over the past several years. Japan serves as a hub for regenerative medicine research, mainly driven by the support from Prime Minister Shinzo Abe. He identified regenerative medicine and cellular therapy as key to Japan's strategy to drive economic growth. In addition, China, South Korea, and other Asian nations have taken measures to support cell therapy-related advancements.
In LAMEA, the market is in its nascent phase due to low research activity in the region, lack of advanced healthcare facilities, inadequate health expenditure, and insufficient health coverage. The governments of the countries in LAMEA have increased their spending for the healthcare segment to attract key players to expand their businesses in this region. Moreover, an increase in the burden of diseases in the region leads to a surge in demand for quicker healthcare services, which fuels the market's growth. LAMEA is a developing market because healthcare expenditures are projected to rise over the forecast period, generating lucrative growth opportunities for market participants. For the past few decades, this region has witnessed the highest economic growth due to economic reforms leading to improved living standards, which created various opportunities for the research and healthcare sector. All such factors together are anticipated to drive the growth of the market during the forecast period.
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