Stem Cell Manufacturing Market Size

Global Stem Cell Manufacturing Market Overview

The Stem Cell Manufacturing Market Size was valued at USD 10.64 billion in 2021 and is projected to grow from USD 12.02 billion in 2022 to USD 33.3 billion by 2032, exhibiting a compound annual growth rate (CAGR) of 13.4% during the forecast period (2023 - 2032). The driving factors that are boosting market growth are growing awareness regarding the usage of stem cells for treating various diseases and the increasing prevalence of rare diseases.

Source Secondary Research, Primary Research, MRFR Database and Analyst Review

The rising occurrence of rare illnesses and rising familiarity with stem cells as a treatment option are two factors fueling market expansion. The worldwide stem cell manufacturing industry is expanding at a dizzying rate, largely due to a growing public understanding of the therapeutic potential of stem cell products. At the same time, there are tremendous developments in stem cell research, and innovative approaches are revealed virtually year. This has resulted in a large influx of new workers into the industry, which has helped the stem cell manufacturing business explode.

In July 2023, Pluristyx, Inc. announced the sealed deal with Stem Genomics. Under this partnership, Stem Genomics will use its iCS-digital PSC assay to assess Pluristyx’s Pluripotent Stem Cell (PSC) lines for genomic stability.
Similarly, Cordlife Hong Kong Limited (Cordlife) and Hong Kong Regen MedTech Limited (HKRM), both partner companies of Hong Kong Science and Technology Parks Corporation (HKSTP), entered into a collaboration agreement in July 2023 aimed at improving stem cell therapy. The project’s target is to have a joint launch of an MSCs-based medical initiative.

For example, in June 2023, FUJIFILM Cellular Dynamics launched its human iPSC-derived iCell Blood-Brain Barrier Isogenic Kit geared towards neuroactive drug researchers. It has been manufactured with integrity of barrier function as well as can be used in discovering drugs as well as developing them, and doing medical research on CNS disorders.

Take the case of Canada's Stem Cell Network (SCN), which launched IGNITE 2022-2025 in April 2022 using USD45m from Budget 2021 commitment by the Canadian government. SCN’s three-year strategic plan called IGNITE 2022-2025 is built upon three core pillars –research, training and knowledge mobilization, which are central to SCN’s efforts to position Canadian scientists and experts as leaders in RM worldwide.

A case example is Vertex Pharmaceuticals, which received the FDA grant for VX-880 with fast-track designation as a human stem cell-derived therapy for Type I diabetes patients in March 2021. With regards to controlling glucose levels through restoring patients’ normal pancreatic islet cell functions, including insulin production, VX-880 represents a new class of allogenic fully differentiated cellular therapy comprised of transplanted ex vivo cultured cells made from human embryonic stem cells.

Additionally, ExCellThera Inc. completed the patient enrollment for its first Ph2 studies in leukemias at high risk and myelodysplastic syndromes (MDS) in November 2022. These unique UM171-expanded stem cell transplants are produced by using the proprietary molecule UM171, together with an optimized culture system that permits the application of small cord blood units without compromising engraftment. The different phases of trials have positive results.

Stem Cell Manufacturing Market Trends

• Growing awareness regarding the usage of stem cells for treating various diseases boosts market growth

Stem cells help treat a wide range of incurable diseases such as acquired immune deficiency syndrome (AIDS), for which the treatments were previously unknown. Stem cell therapy also helps treat cardiovascular diseases, neurodegenerative diseases, autoimmune diseases, orthopedic conditions, and healing incisions & wounds. They are increasingly being utilized for replacing damaged neurons caused by spinal cord injuries, Parkinson's disease, Alzheimer's disease, and other neurological problems. They also produce insulin that supports in treatment of patients with diabetes and weak heart muscle and replaces the damaged tissue or the injured or diseased organ.

Moreover, rare diseases affect a small percentage of the population and are often neglected conditions whose treatments are often not considered profitable due to their cost to develop and limited patient population. Rare diseases include rare cancers, genetic diseases, infectious tropical diseases, and degenerative diseases. According to the data published by Food and Drug Administration (FDA) in February 2020, there were around 7,000 rare diseases, more than half of which affect children, and only 5% have FDA-approved treatments. Hence, increasing awareness associated with the usage of stem cells in treatment of various diseases and rising incidences of rare diseases propelling the growth of the market.

Stem Cell Manufacturing Market Segment Insights

Stem Cell Manufacturing Product Insights

The Market segments of Stem Cell Manufacturing, based on product, includes stem cell lines, instruments, culture media, and consumables. The stem cell lines segmented into mesenchymal stem cells (MSCs), induced pluripotent stem cell (iPSC), embryonic stem cell (ESC), hematopoietic stem cells (HSCs), and others moreover, instruments further segmented into bioreactors, incubators, cell sorters, and others. The stem cell lines segment accounted for the largest market share in 2021. The advent of stem cell research unveiled the therapeutic potential of stem cells and their derivatives and increased the awareness of the same in the public and scientific community. The successful manufacturing of stem cells and their derivatives has positively impacted medical sciences owing to its ever-expanding therapeutic solutions for patients is boosting the segment growth during the forecast period.

April 2021 Bristol-Myers Squibb Company (US) expands its business by building a new cell therapy manufacturing unit in the Netherlands. This expansion has given Bristol new opportunities.

Stem Cell Manufacturing Application Insights

The Stem Cell Manufacturing Market data has been segmented, based on application, by research, target identification, stem cell-based therapy, and cell & tissue banking. The stem cell-based therapy segment was anticipated to reach USD 4.84 billion by 2021. The stem cell based further bifurcated into autologous and allogeneic. Autologous stem cell therapy provides high compatibility with the human immune system, as the patients are their own donors of stem cells. For instance, in March 2021, Novadip Biosciences (Belgium) received approval from US FDA for the company’s Investigational New Drug (IND) application for its autologous cell therapy product NVD-003. Therefore, strategic alliances are propelling the growth of the segment.

October 2021 Bristol-Myers Squibb Company (US) announced positive topline results from phase 3 transform trial evaluating breyanzi versus chemotherapy followed by stem cell transplant in second-line relapsed or refractory large b-cell lymphoma.

Figure 2 Stem Cell Manufacturing Market, by Application, 2021 & 2030 (USD Billion)Source Secondary Research, Primary Research, MRFR Database and Analyst Review

Stem Cell Manufacturing End User Insights

Based on end user, the global market of stem cell is segmented into hospitals, pharmaceutical, and biotechnology companies, stem cell banks, and others. The pharmaceutical, and biotechnology companies accounted for the largest market share in 2021. Pharmaceutical & biotechnology companies have taken an increased interest in stem cell biology. The use of stem cells as research tools has expanded, with most major pharmaceutical companies using embryonic stem cells (ESCs) or adult stem cells for internal drug discovery programs. These internal efforts are often enhanced through the expertise of external partnerships with academics or biotech companies which is bolstering the growth of the segment.

In June 2023, Bit.bio, a synthetic biology firm with a primary focus on human cells, has made significant progress in human cell manufacturing in June 2023. Bit.bio's induced pluripotent stem cell (iPSC)-derived cell products have attained a new level of accuracy and consistency thanks to their opti-oxTM 1-based transcription factor reprogramming technique. In order to produce the mature cell types, samples of cells were picked from various production lots and time periods, and the opti-ox reprogramming phase was performed by various users. Fewer than one percent of genes were found to have changed expression levels in bulk mRNA sequencing investigations comparing various batches of production. This breakthrough improves upon previous methods of producing human cells in the lab.

In July 2023, SCG Therapy was a forerunner in Singapore's Manufacturing 2030 Vision by opening a cell therapy manufacturing plant and research and development center. SCG's state-of-the-art cell therapy manufacturing and commercially available human induced Pluripotent Stem Cell (iPSC) technologies will be put to use and expanded upon at the new facility. SCG's state-of-the-art cell therapy manufacturing and commercially available human induced Pluripotent Stem Cell (iPSC) technologies will be put to use and expanded upon at the new facility. The facility will also serve as a distributor for cell therapy goods to hospitals in the Americas, Asia, and Europe.

In May 2023, StemCures, located in the United States, will open the largest stem cell production plant in India at its new facility in Telangana, India. The proposed facility would utilize cutting-edge American technology and know-how to produce high-quality stem cell products at competitive prices for the treatment of a wide range of life-threatening diseases. Currently, StemCures is finishing up Phase-1 lab trials for its stem cell line at the University of Hyderabad's Aspire Bionest.

Stem Cell Manufacturing Regional Insights

By Region, the study segments the market into North America, Europe, Asia-Pacific, and Rest of the World. North America stem cell manufacturing market accounted for the largest market share in 2021, due to increasing prevalence of chronic diseases such as cancer, cardiovascular disorders, neurological disorders, gastrointestinal diseases, other chronic conditions. In 2020, as per the National Cancer Institute, the National Institutes of Health forecasted an estimated 1,806,590 new cases of cancer to be diagnosed in the US, with about 606,520 deaths reported as a result of the disease.

Further, the major countries studied are The US, Canada, Germany, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

Figure 3 STEM CELL MANUFACTURING MARKET, BY REGION 2021 & 2030 (USD Billion)

Source Secondary Research, Primary Research, MRFR Database and Analyst Review

Europe stem cell manufacturing market accounts for the second-largest market share due to the accessibility to advanced treatment facilities, support by government bodies for the development of the healthcare sector, the rising geriatric population, and the growing number of cases suffering from chronic and neurological disorders. Furthermore, the Germany market of stem cell manufacturing held the largest market share in 2021, and the UK market of stem cell manufacturing was the fastest growing market in the Europe region.

The Asia-Pacific stem cell manufacturing market is expected to grow at a significant share from 2022 to 2030 due to the factors such as improving healthcare infrastructure, growing adoption of stem cell therapy treatments, availability of contract manufacturers, and rising prevalence of cancer in the region, which are likely to drive the market’s growth. Moreover, China market of stem cell manufacturing held the largest market share, and the India market of stem cell manufacturing was the fastest growing market in the Asia-Pacific region.

Stem Cell Manufacturing Key Market Players & Competitive Insights

Major market players are spending a lot of money on R&D to increase their product lines, which will help the stem cell manufacturing market grow even more. Market participants are also taking a range of strategic initiatives to grow their worldwide footprint, including new product launches, contractual agreements, mergers and acquisitions, increased investments, and collaboration with other organizations. Competitors in the stem cell manufacturing industry must offer cost-effective items to expand and survive in an increasingly competitive and rising market environment.

Fujifilm Holdings Corporation (US) is the holding company of the Fujifilm Group, whose main business is in photographic films. Fujifilm has three operating companies headquartered in Japan Fuji Xerox Co., Ltd, FUJIFILM Corporation, and Toyama Chemical Co., Ltd. In January 2022, the company acquired a cell therapy manufacturing facility from Atara Biotherapeutics, Inc. (US), a leading allogeneic T-cell immunotherapy company, for USD 100 million. This acquisition is helping to Fujifilm Holdings Corporation (US) to expand its biosciences business.

Key Companies in the market of stem cell manufacturing includes.

• Fujifilm Holdings Corporation (US)


• AbbVie, Inc. (US)


• Bio-Rad Laboratories, Inc. (US)


• Thermo Fisher Scientific, Inc. (US)


• Lonza Group (Switzerland)


• Bristol-Myers Squibb Company (US)


• GlaxoSmithKline Plc (UK)


• Sartorius AG (Germany)


• Becton, Dickinson, and Company (US)


• Merck KGaA (Germany)

Stem Cell Manufacturing Industry Developments

January 2022 Thermo Fisher Scientific Inc. (US) acquired PeproTech, Inc., (US), with a total cash purchase price of USD1,850 million. Cell & gene therapies and other cell culture applications utilize recombinant proteins in their development and manufacture.

March 2021 Fujifilm Holdings Corporation (US) contract development and manufacturing organization (CDMO), the US-based subsidiary, and Fujifilm Diosynth Biotechnologies (US) expanded its new manufacturing site with USD 2000 million cell culture facility in the North America region.

July 2020 Thermo Fisher Scientific Inc. (US) and Lyell Immunopharma (US) partnered to develop manufacturing procedures that resulted in more effective cell treatments for cancer patients. The company's major purpose is to improve T cell fitness and gain access to and knowledge of developing technologies.

Stem Cell Manufacturing Market Segmentation

Stem Cell Manufacturing Product Outlook

• Stem Cell Lines
  
  
  
  • Mesenchymal Stem Cells (MSCs)
  
  
  • Induced Pluripotent Stem Cell (iPSC)
  
  
  • Embryonic Stem Cell (ESC)
  
  
  • Hematopoietic Stem Cells (HSCs)
  
  
  • Others
  
  
  
  


• Instruments
  
  
  
  • Bioreactors
  
  
  • Incubators
  
  
  • Cell Sorters
  
  
  • Others
  
  
  
  


• Culture Media


• Consumables

Stem Cell Manufacturing Application Outlook

• Research


• Target Identification


• Stem Cell-Based Therapy
  
  
  
  • Autologous
  
  
  • Allogenic
  
  
  
  


• Cell & Tissue Banking

Stem Cell Manufacturing End User Outlook

• Pharmaceutical & Biotechnology Companies


• Hospitals


• Stem Cell Banks


• Others

Stem Cell Manufacturing Regional Outlook

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  North America

  
  
  
  
  • US
  
  
  • Canada
  
  
  
  


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  Europe

  
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


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  Asia-Pacific

  
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • South Korea
  
  
  • Australia
  
  
  • Rest of Asia-Pacific
  
  
  
  


• 
  

  Rest of the World

  
  
  
  
  • 
    

    Middle East

    
    
  
  
  • 
    

    Africa

    
    
  
  
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    Latin America