As a new method that may completely cure cancer, cell therapy has been sought after by various capitals. Large foreign pharmaceutical companies have consolidated their dominant position in the industry through investment, mergers and acquisitions, and strong alliances. Domestic listed companies have also entered the cell therapy market through investment and mergers and acquisitions to get a share of the pie. Representative companies include Yaoji Poker, Xinri Hengli, Beilu Pharmaceutical, Xiangxue Pharmaceutical, etc. This article sorts out the market overview of the stem cell therapy sector in the field of cell therapy.

Cell therapy roadmap

1. Stem cell therapy leads the regenerative medicine revolution

According to the 2010 Stem Cell Yearbook, the scale of stem cells has been growing at an average annual compound growth rate of 34%. In the next 20 years, the global market size of stem cells is expected to reach 400 billion US dollars. Stem cell therapy is to transplant or intravenously inject healthy stem cells into the patient or the body to repair diseased cells or rebuild normal functioning cells and tissues. Stem cell therapy is like injecting new vitality into the body, thereby curing the disease fundamentally.

There have always been high hopes for stem cell therapies, and scientists hope that stem cell therapies can be used to bring substantial benefits to patients suffering from diseases and injuries.Stem cell therapy has been shown to have significant curative effects in cardiovascular diseases, diabetes, Parkinson's syndrome, Alzheimer's disease, cirrhosis of the liver, joint diseases, leukemia and other diseases. Countries have listed stem cell research and application as a national key development industry.

Bone marrow transplantation can rebuild the hematopoietic system and immune system for patients. Other types of stem cell transplantation can also bring significant effects to the treatment of diseases, especially embryonic stem cells (ESC) and pluripotent induced stem cells (iPSC). Researchers are highly optimistic about the treatment of these two types of stem cells in a variety of diseases.The mesenchymal stem cell MSCs is considered to be the ideal “seed” for tissue repair, which is also valued by more and more countries.

Advantages of stem cell therapy:

(1) Safety: low toxicity (or no toxicity);

(2) It can also be applied before the exact mechanism of disease pathogenesis is fully understood;

(3) Adequate sources of treatment materials;

(4) A wide range of treatment options;

(5) It is the best vector for immunotherapy and gene therapy;

(6) Diseases that were considered “incurable” by traditional therapies now have new treatments and new hope.

Principles of stem cell transplantation for treating diseases:

Replaces and repairs dead and damaged cells

Activate dormant and suppressed cells

Paracrine effects (secreting neurotrophic factors, anti-apoptotic factors, etc.)

Immune regulation mechanism

Promote the recovery of intercellular electrical capacity and electrical conduction (such as mesenchymal stem cells secrete junction proteins to help intercellular connections and promote the opening of ion channels, etc.)

2. Industrial model of stem cell therapy

The industrial chain of the stem cell therapy industry includes upstream stem cell storage, midstream stem cell technology research and development, and downstream stem cell diagnosis and treatment. Cell storage, also known as "cell banking", is the most basic and cutting-edge business in the cell therapy industry, and it is also a resource library for the cell therapy industry. Now various companies are competing to deploy cell storage to seize the industry's resource opportunities. The downstream of the cell therapy industry chain - cell therapy, is implemented by tertiary hospitals; there are generally two models for developing downstream industries: one is for tertiary hospitals to carry out secondary business on their own, and the other is for tertiary hospitals to cooperate with enterprises, with enterprises providing technical services and technical support, and hospitals providing clinical platforms to implement treatment behaviors.

3. Stem cell research and development is rapid, and many international stem cell drugs have been approved for marketing

There are many stem cell products on the market internationally, including 3 in South Korea, 2 in the United States, 1 in Belgium, 1 in Australia, 1 in Canada, and 1 in Italy.

4. In the past 10 years, there have been zero clinical approvals for new stem cell drugs in my country.

There are currently 9 stem cell products approved internationally, but none in my country has been approved for marketing. It is understood that as early as December 2004, my country's first innovative stem cell drug, "bone marrow primitive mesenchymal stem cells" developed and applied for by the Institute of Basic Medicine of the Chinese Academy of Medical Sciences, received a Phase I clinical trial approval from the State Food and Drug Administration (CFDA); in April 2006, the drug received a Phase II clinical trial approval; in September 2008, the Phase III clinical trial approval for the drug was submitted to the CFDA, but there has been no follow-up so far.

Except for two other stem cell drugs that received clinical trial approval in 2005 and 2006, none of the other stem cell drugs applied for in China in the past 10 years have received clinical trial approval. This makes us reflect on why my country's stem cell industry is in a "sick state"? The upstream, midstream and downstream of the stem cell therapy market are all subject to policies and regulations, especially the suspension of stem cell therapy by the Ministry of Health after 2012, which has put the entire industry in a state of stagnation.

5. China's stem cell industry will enter a period of rapid development

Stem cell medical technology has been rated by magazines such as Science and Nature as the most promising technology in the field of biological science in the 21st century. It is a new medical technology that can conquer major diseases that are beyond the reach of traditional medicine.

China's stem cell therapy policy is gradually being liberalized. In March 2009, my country became the third country after the United Kingdom and the United States to announce the legalization of stem cell therapy as a Class III medical technology. In May 2015, the State Council issued the "Decision on Canceling Non-Administrative Approval Items", which included the cancellation of the approval project for hematopoietic stem cell transplantation. In July 2015, the National Health and Family Planning Commission and CFDA formulated the "Guidelines for Quality Control and Preclinical Research of Stem Cell Preparations (Trial)", and in August jointly issued China's first regulation on the stem cell industry, the "Stem Cell Clinical Research Management Measures (Trial)". In November 2015, "Stem Cell and Translational Research" was included in the National Key R&D Program Pilot Project. In March 2016, precision medicine was officially included in the "13th Five-Year Plan", and the National Health and Family Planning Commission and CFDA jointly issued the "Establishment of the National Stem Cell Clinical Research Management Leading Group" and announced the list of the group.

The continuous introduction of these policies has lit up the signal light for the development of the stem cell industry and promoted the healthy development of the stem cell industry. We are convinced that with the implementation of precision medicine and medical reform policies, China's stem cell industry will enter a stage of rapid development.