The worldwide stem cell industry is expected to produce USD 9.38 billion in sales. From 2021 to 2028, it is predicted to increase at a compound annual growth rate (CAGR) of 8.8%. Increasing demand for biologics, technological advancements in stem cell treatments, and a growing focus on the development of tailored medications are all contributing to the growth. The market is expanding due to a growing focus on the treatment of neurological illnesses. Cerebrovascular diseases and neurological disorders account for around 7.1 percent of the overall worldwide burden of diseases, according to the World Health Organization (WHO). As a result, firms are performing fundamental research and preclinical studies to assess stem cell regeneration capacity in the treatment of neurological disorders.
Market size of stem cells in the United Kingdom, by technology, from 2017 to 2028 (USD Million)
Celavie Biosciences, for example, advanced its 5-year exploratory research on Parkinson’s disease in May 2020. The company is working on regenerative stem cell therapy to treat Parkinson’s disease and other central nervous system illnesses. Celavie Biosciences announced that their exploratory clinical trials utilising OK99 stem cells for Parkinson’s disease were successful.
Furthermore, the rising popularity of tailored medications is fueling market expansion. New procurement methods are being discovered by researchers, which can be used to manufacture tailored medicines. For example, iPSC therapies are created by reprogramming a small sample of a patient’s blood or skin cell to make new cells and tissue for transplantation. As a result, future tailored treatments can be generated using these cells.
Furthermore, companies are concentrating their efforts on creating medicines to alleviate the various stressors linked to COVID-19. For example, NoveCite and Novellus Therapeutics Limited formed a cooperation in October 2020 to research and commercialise NoveCite iPSCs for the treatment of COVID-19-related Acute Respiratory Distress Syndrome (ARDS). The method possesses multimodal immunomodulatory mechanisms of action, making it a promising treatment option for acute respiratory infections.
Adult stem cells (ASCs) dominated the market in 2020, accounting for 85.7 percent of the total. The inclusion of minimally problematic concerns addressing ethics, immune-rejection, and cancer were the key causes that contributed to the segment’s domination. The segment’s expansion can also be attributable to the use of ASCs in regenerative medicine. During the development of the ASCs bioprocessing for regenerative medicine, obstacles are expected.
Hematopoietic stem cells, mesenchymal stem cells (MSCs), neural stem cells, and epithelial/skin stem cells are all types of ASCs. Because of their potential use in autologous transplantation, large clinical trials that have demonstrated their application in the treatment of various diseases, and extensive research to explore their therapeutic applications, the MSC segment is expected to grow at the fastest CAGR during the forecast period.
Due to increased investment for developing regenerative medicines using iPSC, ensured reproducibility and maintenance, capable of differentiation into all cell types, and high proliferative ability, the induced pluripotent stem cells (iPSCs) segment is expected to grow at a significant CAGR of 9.3% from 2021 to 2028. Companies are developing services associated with iPSCs as their usefulness in the treatment of various diseases grows.
REPROCELL, for example, announced a new Personal “iPS” service in December 2020 for generating patient-specific iPSC starting in January 2021. The service will assist in the preparation and storage of an individual’s iPSCs in order to generate regenerative treatments for future illness or injury. They’re made from mature cells using RNA reprogramming technology that’s ready to utilise.
Insights into the Application
Regenerative medicine and drug discovery and development are two subcategories of the application segment. Due to increased permission for stem cell therapies clinical trials targeting various diseases, regenerative medicine retained the greatest market share of 89.1 percent in 2020. Longeveron LLC, for example, received approval from Japan’s Pharmaceutical and Medical Devices Agency (PMDA) in June 2020 to begin a Phase 2 clinical research to assess the safety and efficacy of their Mesenchymal Stem Cells (LMSCs) for treating ageing frailty.
Furthermore, numerous governments are heavily investing in the research and development of regenerative therapies. For example, in March 2020, the Canadian government committed USD 6.9 million to regenerative medicine research. The monies will be used to support four clinical trials and nine translational studies in the field of regenerative medicine. The newly created regeneration medications will aid in the treatment of a variety of heart illnesses, blood issues, vision loss, and diabetes.
From 2021 to 2028, the drug discovery and development segment is predicted to grow at a 9.4 percent CAGR. Because it is important in investigating human illness aetiology, identifying pathological mechanisms, and establishing therapeutic strategies for combating diverse diseases, market products are seeing growing penetration throughout drug discovery. Because they may imitate genetic and cellular characteristics of patients, iPSC-based models are chosen over phenotypic screening. Pharmaceutical companies can use these to evaluate predicted medication mechanisms in vitro at a low cost before starting clinical trials.
Insights into Therapy
In 2020, allogenic stem cell treatment had the highest revenue share of 58.2 percent. Because of their graft vs. cancer effect, allogeneic cells are widely used in cancer treatment. Because of this effect, the donor’s stem cells can employ their immune system cells to attack cancer cells. The donor’s immune system response is far stronger than the immune system of the recipient. Furthermore, these are frequently used to treat diseases such as lymphomas, leukemias, and myelomas.
During the projection period, autologous therapy is expected to grow at a healthy CAGR. The growth can be ascribed to benefits such as a lower risk of graft rejection, which means fewer difficulties. Other factors driving the segment’s growth include a high patient survival rate, low cost, no need for HLA typing for matching donors, low risk, and the possibility to use these cells without going through clinical trials or meeting onerous manufacturing standards.
North America held the largest market share of 52.1 percent in 2020, due to a number of factors including the presence of key players involved in stem cell therapy development, advanced healthcare infrastructure, extensive R&D, supportive reforms from healthcare organisations, and strong reimbursement policies. Because of government initiatives and a high level of research activity in the country, the United States is the leading country in the region.
For developing disorders, healthcare organisations are advocating the use of cellular treatments. For example, the US Food and Drug Administration (FDA) approved a clinical trial exploratory efficacy study using umbilical cord-derived MSCs to prevent life-threatening lung inflammation in COVID-19 patients in April 2020.
Due to the increasing development of stem cell-based therapies, government initiatives for developing regenerative medicines, the establishment of several stem cell banks, and increasing clinical trials for regenerative medicines in the region, Asia Pacific is expected to grow at the fastest CAGR of 9.0 percent during the forecast year. For example, MEDIPOST revealed the results of NEUROSTEM’s phase 1/2a trial in July 2020. It’s an experimental stem cell therapy for the treatment of Alzheimer’s disease.
Insights into Key Companies and Market Share
Companies are getting permission for their stem cell therapies one by one. Mesoblast Ltd, for example, gained FDA approval for an IND (Investigational New Drug application) for MSC product candidate remestemcel-L in April 2020. It is used to treat patients who have developed acute respiratory distress syndrome (ARDS) as a result of COVID-19. The following are some of the major players in the worldwide stem cell market:
CELGENE CORPORATION is a company based in the United States.
ReNeuron Group plc is a company based in the United Kingdom.
Virgin Health Bank is a non-profit organisation that helps people
The Biovault clan
Precious Cells International Ltd is a company that deals with precious cells.
Mesoblast Limited (Mesoblast) is a company
Seneca Biopharmaceuticals, Inc. is a biopharmaceutical company based in the United States.
Opexa Therapeutics, Inc. is a biotech company based in the United States.
Pluristem Therapeutics, Inc. is a biotech company that develops and sells
STEMCELL Technologies Inc. is a company that specialises in stem cell research and development
ThermoGenesis Holdings, Inc. is a company based in the United States.
Astellas Pharma Inc. is a pharmaceutical company based in the United States.
Technologies for Cellular Engineering
BioTime, Inc. is a company that specialises in biotechnology.