Regenerative medicine mainly covers tissue and cell repair, stem cell therapy, and immune cell therapy.
Global Regenerative Medicine Market:
In recent years, the global regenerative medicine market has continued to expand, and the compound annual growth rate of the global regenerative medicine market from 2020 to 2024 will reach 20%. The output value of the global regenerative medicine market will reach 130 billion euros in 2025, and the compound annual growth rate will reach 33%.
With the aging of the global population, in addition to traditional drug treatment, emerging regenerative medicine has become a treatment method that has attracted much attention. Especially during the global COVID-19 epidemic, the field of regenerative medicine continues to develop. In the first half of 2021, 1,195 companies around the world invested in the development of the regenerative medicine industry.
The application of regenerative medicine has become one of the most popular areas in the development of the biomedical industry in recent years and is favored by investors. Not only has the global fundraising amount in the first half of 2020 exceeded that of the whole year of 2019, but the whole year of 2020 has set a record high, which shows that the epidemic has increased the public's demand for the biomedical industry and stimulated the growth of the biomedical capital market.
Introduction to Regenerative Medicine Industry Chain:
Upstream manufacturers in the regenerative medicine industry are responsible for the collection and preservation of stem cells, midstream manufacturers are engaged in the development of various types of stem cells, and downstream manufacturers are responsible for clinical experiments, transplantation technology, and disease treatment. Regenerative medicine is a new concept in the medical field that only appeared in the late last century. It is different from the existing concepts of therapeutic medicine and preventive medicine in the medical field, so it is also called the third type of medicine.
Regeneration refers to the production of functional and vital body organs and tissues to repair or replace unhealthy organs and tissues in the body caused by aging, illness, and damage, or to stimulate the regeneration of body tissues or organs in other ways. Regenerative medicine includes two major fields: tissue engineering and stem cell therapy. Tissue engineering uses the regeneration function of cells to form organs, while stem cell therapy uses the potential functional properties of under-differentiated and regenerating various tissues and organs to treat diseases.
Upstream of the Regenerative Medicine Industry Chain:
The upstream industry of regenerative medicine is a manufacturer engaged in the collection and preservation of stem cells. The collections include neonatal umbilical cord blood (hematopoietic stem cells), umbilical cord (mesenchymal stem cells), deciduous tooth stem cells, and fertilized eggs (spermatogonia stem cells), bone marrow, placenta, fat, skin, etc. Item storage. Its production process starts from stem cell collection and goes through a series of processes such as separation, inspection, frozen storage, storage safety maintenance, and customer withdrawal management. If the sampling and storage conditions are up to standard, the viability of adult stem cells in umbilical cord blood can be maintained for decades.
The umbilical cord and umbilical cord blood of newborns are the most important sources for obtaining adult stem cells, and mesenchymal stem cells, which are used for adult stem cells, are widely used. There are many cords blood banks with technical capabilities in Asian countries, all of which have development potential in their respective countries, and can achieve a certain degree of cooperation and resource sharing with each other, such as Taiwan, Singapore, Malaysia, Japan, South Korea, and Hong Kong. The "Asian Cord Blood Bank Alliance" jointly established by the industry not only connects the cord blood databases in the entire Asian region but also connects the international medical resources.
In recent years, the collection and storage of peripheral blood stem cells have also emerged. Its advantage is that it can be collected from adult bone marrow and used to replace general anesthesia for bone marrow surgery. At present, the medical applications of peripheral blood stem cells are mainly stem cell transplantation and cancer adjuvant therapy. and immune system and other diseases, and in the future, as more and more in-vitro medical research results come to the market, the diseases suitable for this kind of treatment will continue to increase.
Midstream of the Regenerative Medicine Industry Chain:
The midstream industry of regenerative medicine is engaged in the development of hematopoietic stem cells, embryonic stem cells, umbilical cord mesenchymal stem cells, dental stem cells, etc. The production process includes database search and matching mechanism, transnational stem cell frozen sample delivery process and control, stem cell thawing technology and operating procedures development, Establishment of stem cell transplantation models, quality appraisal of transplant recipients, and application for becoming a qualified cell supplier.
Umbilical cord blood (hematopoietic stem cells) is mainly used to rebuild blood, such as hyperplasia of red blood cells, platelets, and the improvement of immune function, such as hyperplasia of white blood cells, which can replace bone marrow for the treatment of various diseases such as cancer and anemia.
Umbilical cord (mesenchymal stem cells) is obtained from the viscous mesoderm in the umbilical cord instead of cord blood. They have excellent self-renewal and proliferation capabilities. They can be cultivated in vitro to increase the number of stem cells and can differentiate into bone, cartilage, muscle, fat, nerves, liver, etc. In addition, hematopoietic stem cells, such as autologous platelets, are used to treat or repair various tissues. By stimulating cell differentiation and life, wound healing, bone growth and cartilage regeneration can be achieved. Embryonic stem cells can make more red blood cells to treat blood diseases, and differentiate heart cells to repair damaged tissue.
Stem cells of deciduous teeth have the functions of differentiation and repair, and their medical applications include the repair of periodontal disease, skin, nerve, bone, and diabetes. Bone marrow stem cells can cure blood cancer, drug-resistant tuberculosis, liver cirrhosis, etc. Skin stem cells can repair skin scars and are mostly used in beauty and maintenance.
Downstream of the Regenerative Medicine Industry Chain:
The downstream industry of regenerative medicine is responsible for the development and treatment of stem cells. Companies engaged in the development of stem cell therapy are roughly divided into adult stem cells and embryonic stem cells according to the types of stem cells they focus on. Adult stem cells first started from hematopoietic stem cells for bone marrow transplantation, and now developed umbilical cord mesenchymal stem cells, dental stem cells, neural stem cells, pancreatic stem cells, adipose stem cells, etc., which are used in the treatment of Alzheimer's disease and Huntington's dance. In the fields of diseases, age-related macular degeneration, diabetes, stroke, orthopedic injury, surgical reconstruction surgery, and medical cosmetology, there are current results that have entered clinical trials or are close to commercialization.
With the continuous research and development of cell therapy, stem cell products have been expanded to new application fields, such as the treatment of complex genetic diseases, cancer, plastic surgery, and beauty. There are three major fields of stem cell application in the biotechnology and pharmaceutical industry, including transplant surgery, drug development, and basic research. At present, stem cells are used in culturing autologous stem cells to repair damaged tissues, such as myocardial regeneration in myocardial infarction. In addition, many applications for symptoms such as Parkinson's disease, Alzheimer's disease, diabetes, stroke, and multiple sclerosis have entered the clinical trial stage.
In the part of drug development, stem cells are cultured in vitro to differentiate into specific tissues, providing high-end medical materials such as protein dressings, screening, and R&D platforms for good drugs, or using stem cells to perform autologous or allogeneic transplantation to cooperate with cancer treatment, etc. Get initial results. The method of producing mesenchymal stem cells from human differentiated somatic cells developed, is expected to solve the problem of insufficient availability of clinical mesenchymal stem cells. The rise of new protein drugs has also greatly increased the demand for stem cells in the pharmaceutical field, and manufacturers have successively entered the ranks of stem cell preparation pharmaceutical companies that comply with PIC/S GMP standards.
In basic research, stem cells can help to understand cell development, gene expression, disease role, and impact, and then develop therapeutic methods. As new technologies and research continue to be pioneered, Taiwan's regenerative medicine industry continues to expand its business scope from stem cell or cord blood preservation to cell preservation and treatment, tissue engineering, and biomedical materials that can promote tissue regeneration or repair, such as the use of stem cell culture. The new cells repair burnt skin or damaged macula and customize the patient's autologous stem cell drugs to treat stroke, etc. The largest proportion of Taiwan's regenerative medicine output value is cell therapy, followed by tissue engineering-related regenerative medical materials. The new development direction will be towards the fields of cancer and immune system treatment.
The safety of stem cell therapy has been demonstrated by multiple studies and clinical trials of induced pluripotent stem cells (iPSCs), making stem cell therapy a big step forward. Cell therapy is now mostly used in skin and musculoskeletal applications. It is expected that the new application trend of induced pluripotent stem cells in the future will be directed toward clinical medical treatment and drug research and development, including treatment technologies for in vivo diseases such as cancer and the immune system. With the increasingly fruitful research and development of iPSC, the direction is moving from autologous cell therapy to allogeneic cell therapy. With laws and regulations in place, Taiwan will be able to reach a higher level in the field of cell therapy.
Clinical applications related to immune cell therapy are also rapidly progressing, such as the treatment of complex genetic diseases, cancer, plastic surgery, etc. Recently, many manufacturers have invested in cell therapy, and progress has been made in the safety of cell therapy and shortening the manufacturing and production time. The research results of some Taiwanese manufacturers have been affirmed in overseas markets and obtained licensing fees.
With the continuous advancement of biotechnology, the discussion of gene and cell therapy-related issues is getting higher and higher. Through cross-border cooperation, shareholding or mergers and acquisitions, licensing alliances, etc., emerging application technologies or services are gradually increasing in the industry, and the development of the industry can be expected through mutual benefit and symbiosis.
At present, all countries in the world have listed biomedical policies as a key national development industry. In addition to formulating forward-looking policies, they also speed up the sound development of the biomedical industry by revising laws and regulations, providing tax concessions and other measures, and benefiting more patients in Taiwan. patients are treated. The demand for stable quality cell manufacturing equipment and storage management has led to the introduction of intelligence into this field.
At present, cell therapy is still the most used in cancer treatment, but the number of applicable disease treatments is also gradually increasing. For example, the use of stem cell drugs can be used to treat acute myocardial infarction, cerebral stroke, or to repair damaged spinal cord cells, lung cells, etc. Recently, the repairing function of cell therapy has also been applied to the treatment of COVID-19 patients, with preliminary results. In the face of a promising market, emerging technologies attract the technology and biomedical industries to invest in the research and development of new technologies or new platforms, or obtain related products or technologies through commercial mergers and acquisitions or investments.
The global cell therapy and gene therapy market has reached US$12.3 billion in 2020. With the vigorous development of the global biotechnology market, the prospects for cell/gene therapy are promising, and it will be one of the main axes of biomedical development in the future. Taiwan has recently achieved good results in the research and development of cell therapy, biosimilar drugs, and related technology platforms. Related products or services have successively obtained domestic and foreign patents or drug certificates, which has brought great assistance to market development at home and abroad.
With the growing popularity of the cell therapy and gene therapy markets, the related commissioned development and manufacturing biomedical companies have also attracted market attention. Optimistic about the future development of the CDMO market, related trading activities are becoming more and more active. The recent increase in cases of investment, joint venture, or fundraising in CDMO factories in Taiwan shows that more and more manufacturers are investing in the CDMO industry. In addition, the government also attaches great importance to the development of the CDMO industry. The recently passed "Biotechnology and Pharmaceutical Industry Development Regulations" include CDMOs in the scope of application of industrial incentives. It is expected that in addition to promoting the development of the CDMO market, it will enhance the global biomedical industry of Taiwanese companies. Importance of the industrial supply chain.