Guest Column | March 1, 2023

Global Market Outlook On Stem Cell Manufacturing

By Pankaj Srivastava, ClinicSpots

Embryonic stem cell GettyImages-1154785553

The stem cell manufacturing market is a rapidly growing industry and is expected to grow from $11.22 billion in 20221 to approximately $23.89 billion by 2030,2 with a compound annual growth rate of 11.2% over the forecasted period. It is a rapidly changing sector and is showing the most promise in:

  • Regenerative Medicine: Stem cells can be used to repair or replace damaged tissues or organs, leading to the potential for new therapies for conditions such as heart disease, heart attacks, or heart strokes, diabetes, and spinal cord injuries.
  • Oncology: Stem cells are being studied for their potential to be used in different types of cancer like bone cancer, blood cancer, prostate cancer, or any other cancer therapies, such as developing personalized cancer vaccines and regenerating damaged tissue after chemotherapy. Cancer and stem cells are evolving and showing results very fast and positively so one can assume that cancer can be also treated like any other disease without fear of losing our loved ones.3
  • Neurology: Stem cells have shown potential in treating neurological conditions such as Parkinson's disease, Alzheimer's disease, and spinal cord injuries.4
  • Dermatology: Stem cells can be used for skin repair and rejuvenation, leading to new treatments for conditions such as burns and skin aging. Stem cells are also used for hair loss treatment and hair transplantation treatment.5
  • Cardiology: Stem cells are being studied for their potential to be used in regenerating damaged heart tissue, reducing the risk of heart disease and improving heart function.6
  • Hematology: Stem cells have been used in bone marrow transplantation for treating blood disorders, such as leukemia and other blood-related cancers.7
  • Orthopedics: Stem cells are being studied for their potential to regenerate damaged bones and joints, leading to new treatments for conditions such as osteoarthritis and joint injuries.8

This analysis will provide an overview of the current stem cell manufacturing market and its potential for future growth. Additionally, it will consider the challenges and opportunities the industry faces.

Key Market Drivers

Stem cell products such as stem cell-derived biologic drugs, therapeutic proteins, and cell therapy products are the fastest-growing segments of the stem cell manufacturing market.1 In particular, induced pluripotent stem cells (iPSCs) and mesenchymal stem cells (MSCs) are receiving a great deal of attention from the market. By adding particular genes necessary for the upkeep of regenerative characteristics, iPSCs can be reprogrammed to a condition similar to embryonic stem cells. MSCs can be purchased off the shelf and used immediately because they do not require donor-recipient matching.

The following factors are expected to drive demand in the stem cell manufacturing industry:

  • The increasing popularity of regenerative therapy
  • Increasing government investment in stem cell research
  • The growing number of mergers and acquisitions in the sector
  • The increasing geriatric population

As regenerative medicine becomes increasingly prominent, the demand for stem cell products is expected to rise. This is expected to be driven by the growing number of individuals seeking non-surgical treatments for conditions such as joint pain,9 diabetic foot ulcers,10 and heart disease.11

The biggest players are:

  • Becton, Dickinson, and Company in the U.S.
  • Anterogen in South Korea
  • STEMCELL Technologies in Canada
  • StemCyte India Therapeutics Private Limited in India
  • Bio-Rad Laboratories in the U.S.
  • Miltenyi Biotec in Germany
  • Takara Bio Group in Japan
  • Stem Cell Technologies India Pvt. Ltd. in India
  • Holostem Terapie Avanzate in Italy

Restraints & Challenges

One of the biggest challenges facing the stem cell manufacturing industry is the availability of regulatory approval for new cell types.12 Cell types like erythropoietin-producing cells and mesenchymal stem cells are used in regenerative medicine therapies, but no regulatory approval exists for these cell types.

  • Erythropoietin (EPO) is an essential erythropoietic hormone produced primarily by renal EPO-producing cells (REPs). To maintain tissue oxygen homeostasis, REPs' EPO production is tightly regulated in a hypoxia-inducible manner.
  • Mesenchymal stem cells are the stem cells that can renew themselves and can differentiate into multiple lineages.

The expenses associated with stem cell research and development have also slowed the growth of the stem cell manufacturing market. It is challenging for manufacturers to scale up their stem cell production capabilities because of the technical difficulties associated with multiple manufacturing phases,13 such as stem cell identification, isolation, storage, and preservation. Additionally, manufacturing capacity is negatively impacted by the fact that a number of manual and incompletely automated procedures are still used in the stem cell manufacturing process.14 Companies have made significant investments in the development of high-quality cell lines, which has contributed to the availability of more diverse and reliable cell lines for research. As the field evolves, complexity and expense will likely be less of a restraint/challenge to the space because advances in biotechnology and scientific research have made it easier and more cost-effective to create new cell lines.15

Additionally, ethical concerns surrounding the use of embryonic stem cells remain controversial.

Advancements & Trends To Watch For Market Opportunities

The advancements in stem cell manufacturing have had a significant impact on the industry's future growth,16 and will continue to grow and evolve:

  • Increased Efficiency: Advances in technology and manufacturing processes have increased the efficiency and scalability of stem cell production, reducing the cost and time required to produce cells.
  • Enhanced Quality: Advancements in cell characterization and cryopreservation methods have improved the quality and stability of stem cell products, enabling their use in more applications.
  • Diversified Applications: The growth of regenerative medicine has expanded the use of stem cells in a range of applications, including drug discovery, disease modeling, and tissue engineering, driving the growth of the stem cell industry.
  • Regulatory Progress: As the field advances, regulatory bodies are working to establish guidelines and standards for stem cell manufacturing, enabling the safe and effective use of stem cell-based therapies.
  • New Technologies: CRISPR gene editing and 3D bioprinting are enabling the production of more sophisticated stem cell-based therapies.
  • Investment Growth: The growth potential of the stem cell industry is attracting increased investment from venture capital and biotechnology firms, fueling further advancements in technology and manufacturing.

Overall, the advancements in stem cell manufacturing are expected to drive continued growth and innovation in the industry, leading to new and more effective treatments for a range of medical conditions.