Global Stem Cell Manufacturing market is estimated to witness high growth owing to rising demand and increasing legalization
The Global Stem Cell Manufacturing Market is estimated to be valued at USD 12.8 Bn in 2024 and grow at a CAGR of 13% over the forecast period 2024-2031. The market is witnessing high growth due to the increasing advancements in regenerative medicine and the discovery of new applications of stem cells in treating chronic diseases such as cancer and neurological disorders. Furthermore, the increasing R&D investments by public and private organizations and favorable government regulations are also fueling the market growth.
Market Dynamics:
The growth of the Global Stem Cell Manufacturing Market is driven by increasing approval of stem cell clinical trials and advancement in stem cell research. Over 600 clinical trials involving stem cells are currently active. The rising number of preclinical and clinical research projects involving cell-based therapeutics will create significant demand for stem cell manufacturing. substantial impact on the market's expansion. For Instance, in September 2021, LifeCell International Pvt. Ltd secured an investment of INR 225 crore (USD 27.2 million) from OrbiMed Asia Partners IV, acquiring a minority stake. This investment is expected to empower the company to venture into additional sectors such as fertility health and cell-based therapeutics.
Increasing Prevalence of Chronic Diseases is Driving the Demand for Stem Cell Therapies
One of the major drivers of the global stem cell manufacturing market is the rising prevalence of chronic diseases globally. Diseases like cancer, diabetes, cardiovascular diseases, neurological disorders are becoming increasingly common. Stem cell therapies offer promise for treating many of these conditions. For example, stem cells are being studied for their potential in regenerating insulin-producing cells for diabetes treatment and repairing damaged heart tissues after heart attacks. The growing patient pool of chronic diseases is fueling demands for new therapeutic options, driving investments in stem cell research.
Advances in Stem Cell Research and Technologies are Enabling New Applications
Significant advancements in stem cell research and emerging technologies are enabling the commercialization of new stem cell-based applications and products. Scientists are gaining better understanding of how stem cells can be isolated, cultured, characterized, and differentiated. Novel techniques like induced pluripotent stem cell generation are allowing researchers to generate patient- and disease-specific stem cells. Technologies like microfluidics, 3D bioprinting are helping optimize stem cell cultures. These advances are supporting the translation of stem cell therapies from lab to the market. It is allowing stem cells to target an increasing number of diseases. The growing stem cell applications are expected to create new revenue streams for manufacturers.
High Cost of Establishing Stem Cell Manufacturing Facilities is a Key Restraint
One of the major market restraints is the high capital requirement for setting up GMP-compliant stem cell manufacturing facilities. Stem cell production involves complex biological and technological processes that must meet stringent regulatory standards. It necessitates significant investments in specialized equipment, cleanrooms, skilled workforce and quality control systems. Additionally, ongoing operational costs of maintaining cell cultures, regulatory compliance and logistics also remain high. This high barrier to entry poses challenges, especially for new market entrants. It may also restrict the expansion of the existing small stem cell companies. The high production costs ultimately increase the price of stem cell products, limiting their widespread adoption.
Stringent Regulatory Framework Creates Uncertainties
The stem cell therapy landscape is heavily regulated as it involves human tissues and cells. Regulatory policies continue to evolve with advancing science. Different markets have varying regulations around stem cell collection, processing, distribution and use. This regulatory complexity leads to delays in approval processes. It also poses challenges for global harmonization efforts. The stringent policies and uncertainties around new regulations discourage investments. It hampers the timely commercialization of new and promising stem cell applications. Additionally, regulatory hurdles increase the clinical development timelines and costs. This acts as a market restraint in the short term.
Personalized Medicine is Creating Opportunities
One of the major market opportunities is the increasing shift towards personalized and precision medicine approaches. Stem cells offer potential for developing patient-specific, disease-modifying therapies. Technologies to generate induced pluripotent stem cells from adult somatic cells are enabling the production of personalized stem cells. These personalized stem cells can then be differentiated into various cell types relevant for regenerative therapies customized to an individual's genetics, disease profile, and treatment needs. The growing personalized medicine sector will create opportunities for stem cell-based diagnostic assays, drug testing models, and personalized regenerative therapies.
Link: https://www.coherentmarketinsights.com/market-insight/stem-cell-manufacturing-market-5381
Key Development
- On 29 May 2024, REPROCELL, a Biotechnology company announces the launch of Master Cell Bank (MCB) manufacturing services for Human Induced Pluripotent Stem Cells (hiPSCs) and Human Mesenchymal Stem Cells (hMSCs) intended for therapeutic applications. Utilizing strict donor recruitment processes and adhering to global regulatory standards, REPROCELL employs a proprietary footprint-free RNA reprogramming method to produce clinically relevant hiPSCs. Enhancing their capabilities, REPROCELL has integrated the Cytocentric Xvivo System model 2 from BioSpherix into their GMP Biomanufacturing Facility.
- In August 2022, Applied Stem Cell, Inc. (ASC), a Contract Research Organization (CRO) and Contract Development and Manufacturing Organization (CDMO) specializing in cell and gene therapy, augmented its Current Good Manufacturing Practice (cGMP) facility. ASC, dedicated to supporting the research community and biotechnology sector in developing and manufacturing cell and gene products, expanded its existing cGMP suite. The expansion entails the construction of four additional cGMP cleanrooms, cryo-storage facilities, process development areas, and quality control/quality assurance spaces.
- In December 2020, Sartorius AG, international pharmaceutical company entered into an agreement with Israeli cell culture media developer and manufacturer, Biological Industries, to acquire a significant stake, thereby expanding the company’s cell culture media product portfolio.
- In February 2020, Becton, Dickinson and Company revealed its strategic partnership with Babson Diagnostics for the collection of small volume blood samples in retail pharmacies.
- In May 2020, Lonza Group announced a collaboration with Moderna for the production of Moderna’s COVID-19 vaccine (mRNA-1273).
Key Players:
Sartorius, Becton, Dickinson and Company, Fujifilm Holdings Corporation (Cellular Dynamics), Lonza Group, Stemcell Technologies, Corning Incorporated, Merck Group, Thermo Fisher Scientific, Pluristem Therapeutics Inc., Miltenyi Biotec, Takeda Pharmaceutical Company Limited, DAIICHI SANKYO COMPANY, LIMITED, AbbVie Inc., Bristol-Myers Squibb Company (US), GlaxoSmithKline Plc, Danaher Corporation, Accegen, Cellular Engineering Technologies,
