year-end summary of cell industry in 2024 will usher in a full-scale outbreak in 2025

Introduction

2024 is a big year for the cell industry. Policy and technology dual wheel drive, cell industry acceleration era

From the US FDA's approval of the world's first mesenchymal stem cell drug to the market, to the issuance of the first stem cell drug production license in Beijing, to the introduction of policies to support cell therapy in many places in China, all this marks a new stage of cell and gene technology on a global scale.

According to data from Markets and Markets, the global cell therapy market has exceeded $28 billion in 2024 and is expected to reach more than $100 billion by 2030.

Driven by policy support, capital influx and technological innovation, China has gradually become an important force in the global field of cell and gene therapy.

Policy: Important policy review in 2024

In 2024, a number of landmark policies were introduced globally, and China also issued a number of documents to promote the development of the cell industry at the central and local levels.

Here are the most important policies of the year.

Global Policy: International pace for cell therapy

1. Us FDA approves first mesenchymal stem cell drug

• Background: In January 2024, the FDA approved the world's first mesenchymal stem cell drug for the treatment of complex fistulas associated with Crohn's disease.

• Significance: This decision opens the door to the commercialization of stem cell drugs and provides a reference standard for the approval of stem cell drugs in other countries.

2. European EMA launches accelerated review mechanism for cell therapy

• Background: The European Medicines Agency (EMA) launched the "Special Pathway for Innovative Cell Therapies" to reduce approval times.

• Significance: To lay the foundation for the commercialization of stem cell and gene therapies in Europe and to accelerate the entry of products to the market.

National policy: A "Chinese solution" for stem cell therapy

3. Technical Guidelines for Non-Clinical Research of Human Stem Cell Products (2024.01.12)

• Content: Clarify non-clinical research requirements for stem cell products, including biological behavior, toxic effects, and mechanisms of action.

• Significance: Promote the standardization of stem cell drug research and development, and lay a scientific foundation for clinical trials and marketing.

4. Guiding Opinions on Developing the Silver Economy and Improving the Happiness of the Elderly (2024.01.15)

• Content: Focus on supporting anti-aging and regenerative medicine technologies, and encourage the development of early detection and treatment methods related to aging health.

• Market potential: The market size of China's silver economy will exceed 5 trillion yuan in 2024, and the policy will further stimulate the growth of related industries.

5. Guidelines for On-site Inspection of Cell Therapy Products (2024.07.12)

• Content: Issued by the State Food and Drug Administration to clarify the quality management requirements for the production of cell therapy products.

• Significance: to provide standardized reference for the production process of enterprises, and to enhance product safety.

6. Implementation Plan for the Whole Chain to Support the Development of Innovative Drugs (2024.07.05)

• Content: Focus on supporting innovative drugs with breakthrough mechanisms to accelerate the transformation of cell and gene therapy technologies.

• Highlights: Policies such as rapid incorporation of truly innovative drugs into hospital processes and exemption from assessment make innovation more attractive.

7. Implementation Opinions on Promoting Future Industrial Innovation and Development (2024.01.18)

• Content: It is clear that cell and gene technology is one of the key areas of the future industry, and the direction of combining with artificial intelligence and other technologies is proposed.

• Practical effect: Promote the commercialization of cell and gene therapy technology, and accelerate the industrialization of the landing.

8. Action Plan to Steadily Promote High-level Opening Up and Make Greater Efforts to Attract and Utilize Foreign Investment (2024.03.19)

• Content: Encourage foreign investment to enter the high-end medical field, and promote international cooperation in cell and gene therapy technology.

Local policy: A comprehensive national response

9. Beijing Drug Administration issues the first stem cell drug production license (2024.02.01)

• Significance: Promote the standardized production of cell therapy drugs and fill the gap in domestic supervision.

10. Several Measures for Supporting the Development of Modern Life Science and Biotechnology Industry in Xiongan New Area (Trial) (2024.02.18)

• Content: Support biopharmaceutical enterprises and promote stem cell clinical research and international cooperation.

11. Several Policies and Measures for Promoting High-quality Development of Biomedical Industry in Guangzhou (2024.01.19)

• Content: High funding and policy support for stem cell and gene therapy.

12. Action Plan for Fostering Future Life and Health Industry Clusters in Guangdong Province (2024.02.28)

• Content: Promote the combination of cell therapy, gene technology and AI in the field of biomedicine.

13. Regulations on the Promotion of New Biomedical Technologies in Boao Lecheng International Medical Tourism Pilot Zone of Hainan Free Trade Port (2024.12.05)

• Content: Support clinical research and application of cutting-edge technologies such as cell therapy and gene therapy.

14. Beijing Action Plan to Accelerate the Innovation and Development of Synthetic Biological Manufacturing Industry (2024-2026) (2024.09.14)

• Content: Accelerate the development of synthetic biological manufacturing technology and promote the formation of industrial clusters in fields such as cell therapy.

Technology: Breakthroughs and Challenges coexist in 2024

Stem cell therapy: Milestones from basic research to clinical application

In 2024, stem cell therapies made the crucial leap from the laboratory to clinical application in multiple fields.

As a core technology in regenerative medicine, stem cells show outstanding potential in the fields of degenerative diseases, metabolic diseases and anti-aging.

1. Global focus on diabetes treatment

Diabetic foot: A Phase III clinical trial of mesenchymal stem cell therapy completed in China showed an ulcer healing rate of up to 85% in patients, significantly better than 50% in the traditional treatment group.

This treatment is expected to be approved in 2025, providing a new treatment option for diabetes patients around the world.

Type 1 diabetes: A breakthrough in functional islet like cell transplantation therapy.

Data from the trial showed a 40 percent reduction in insulin dependence and significant improvement in long-term blood sugar control.

2. Regenerative medicine application of organ repair

Cirrhosis: In clinical studies of stem cell therapy for end-stage cirrhosis, the recovery rate of liver function in patients reached more than 50%, providing new hope for patients who have failed to respond to traditional treatments.

• Myocardial infarction: Stem cell injection therapy demonstrated significant results in improving heart function, with ejection fractions increasing by an average of more than 10% in a multicenter study.

3. Advances in anti-aging technology

• Skin aging: Mesenchymal stem cell therapy demonstrated outstanding performance in delaying skin aging, with participants' skin elasticity and moisture content increased by more than 20%, and fine lines and pigmentation decreased significantly.

• Neurodegenerative diseases: Stem cell therapy trials for Alzheimer's disease have shown a 30% slowdown in cognitive decline in patients, providing breakthrough data in the field of anti-aging and neural repair.

Immune cell therapy: A new era of precision and broad treatment

Immune cell therapy is the technology star of 2024 for its high precision and lethality.

The success of CAR-T, NK, gamma delta T and other therapies in the treatment of solid tumors and hematologic tumors offers multiple possibilities for the future of cell therapy.

1. Continuous breakthrough in CAR-T therapy

• Blood tumors: CAR-T therapy achieved complete response rates of more than 80% in acute lymphoblastic leukemia (ALL) and more than 70% in multiple myeloma, continuing to consolidate its central position in the treatment of blood tumors.

Solid tumors: By 2024, the efficacy rate of dual-target CAR-T technology (EGFR in combination with HER2) in non-small cell lung cancer has reached 45%, providing a new direction to solve the problem of immunosuppression in the solid tumor microenvironment.

2. The rise of NK cell therapy

Triple negative breast cancer: Clinical trials of modified NK cell therapy have shown disease control rates of more than 60% and a 6-month extension of progression-free survival after treatment.

• Mass production: NK cell therapy is one of the most cost-effective options for immunotherapy because it does not require personalized preparation.

3. Multifunctional performance of gamma /δ T cell therapy

• Broad recognition: γ/δ T cells are able to recognize non-classical antigens and are particularly suitable for heterogeneous solid tumors. A 2024 study showed that gamma /δ T cell therapy achieved a 60% disease control rate in patients with advanced gastric cancer.

Virus-associated tumors: Gamma delta T cells are effective in clearing HPV-associated cervical cancer and Epstein-Barr virus-associated lymphoma, becoming an important breakthrough point in the treatment of virus-associated tumors.

4. Auxiliary roles of TIL and CIK

TIL therapy: TIL cells have demonstrated a high response rate in the treatment of melanoma and lung cancer, providing an effective option for solid tumors with a high mutation load.

CIK therapy: As a classic technique, CIK therapy continues to play an important role in adjuvant therapy, especially in immunoconsolidation therapy after liver cancer recurrence, which has extended disease-free survival by 12 months.

Technology convergence and future direction

In 2024, the cross-application of stem cell therapy and immune cell therapy began to emerge.

For example, the combination of stem cells and CAR-T technology opens up new possibilities for immunotherapy in the treatment of solid tumors.

The integration of these technical directions not only broadens the range of indications for cell therapy, but also further improves the overall therapeutic effect and commercialization.

Market: Dual-track development of high-end medical consumption and health

The full explosion of the anti-aging market

In 2024, the size of China's anti-aging market will reach nearly 700 billion yuan, doubling from 2020.

Consumer interest in anti-aging technology has gradually shifted from "early adoptions" to "just-needed", and high net worth individuals have listed stem cell therapy as one of the first choices for their annual health management plan.

This trend has not only driven the business growth of related enterprises, but also attracted more capital into the anti-aging field.

In addition, the application scenarios of the anti-aging market are increasingly diversified.

In addition to traditional beauty and skin management, stem cell therapy has been widely used in fields such as boosting immunity, improving metabolism, and preventing chronic diseases.

For example, in some high-end health management institutions, the price of a single course of stem cell therapy is as high as 200,000 yuan, but the appointment still needs to be made months in advance.

The dividing line between medicalization and consumerization

Two important trends are emerging in the cell therapy market:

1. Medicalization: In the treatment of spinal cord injury, diabetic foot and other diseases, the effect of cell therapy has been verified by several rounds of clinical verification, and it is gradually moving toward standardized treatment.

2. Consumerization: The combination of anti-aging therapy and health management allows cell therapy to expand from "treating disease" to "improving health status".

In 2024, more than 60% of cell therapies will be used for personalized treatments.

This trend has benefited from consumers' emphasis on health management and also benefited from the empowerment of AI technology, further driving the popularity of customized solutions based on patient genetic and cell characteristics.

Deep integration of international markets

In 2024, the internationalization of China's cell industry will accelerate.

In free trade zones such as Beijing and Shanghai, foreign companies are allowed to participate in the research and development and application of stem cell and gene therapy technologies, injecting new impetus into the industry.

Statistics show that the number of new Sino-foreign joint ventures increased by 35% year on year, and international cooperation has become an important force to promote innovation in the domestic market.

At the same time, foreign enterprises have also begun to seek in-depth cooperation with the Chinese market.

For example, the stem cell therapy research and development center set up by a multinational pharmaceutical company in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan has become a model of international cooperation.

This two-way cooperation has not only promoted technological progress in the domestic market, but also provided more successful cases for the international market.

Regional market synergies

From the policy support of Xiongan New Area to the high subsidies of Guangzhou Development Zone, the local market in 2024 has made efforts to develop the cell industry, forming a multi-point flowering situation. For example:

Xiongan New Area: Focus on supporting cutting-edge research in stem cell and gene therapy.

• Guangdong Province: Promote the combination of cell therapy and AI technology to form a complete industrial ecological chain.

The promotion of these local policies has injected vitality into the domestic market and accelerated the regional collaborative development of the cell industry.

Future: Four trends for accelerated development in 2025

1. Further optimization of policy support

In 2025, the landing of more favorable policies will create a more favorable environment for the cell industry:

• Rapid approval of innovative drugs: Policies such as the Implementation Plan to Support Innovative Drug Development across the Chain will continue to optimize access paths for innovative drugs to support high-value cell therapies.

• Expansion of medical insurance coverage: Some cell therapies may be covered by medical insurance, reducing the burden of treatment for patients.

2. Deep combination of technology and AI

Ai is becoming a powerful tool in the field of cell therapy:

R&d acceleration: The use of AI in drug target discovery and efficacy prediction has significantly improved R&D efficiency. For example, an AI-based target discovery platform has reduced the development cycle of stem cell therapies by 40 percent.

Personalized medicine: AI-driven genetic analysis and prediction of cell behavior will further improve the precision and safety of cell therapies.

3. Globalization and localization go hand in hand

In the process of internationalization, China's cell industry will continue to deepen the local market and strengthen two-way exchanges with the international market:

• International standard docking: More companies will be certified by FDA and EMA, paving the way for products to go international.

• Deep foreign participation: The number of Sino-foreign joint ventures is expected to increase by another 30% by 2025, and the flow of technology and capital will accelerate.

4. Business model innovation

In the future, the cell industry will usher in the diversified development of business models:

• Consumer products: stem cell skin care products, genetic testing kits, etc., will further enter the mass market.

Service-based medicine: Cell therapy is shifting from "one-time treatment" to "continuous health management". For example, some health authorities have begun offering annual cell therapy memberships.

Conclusion: 2025, the golden age of cell industry

Policy support, technological breakthroughs and market activity in 2024 have laid a solid foundation for the future of the cell industry.

Looking forward to 2025, with the continuous advancement of policy optimization, technological innovation, capital influx and consumption upgrading, China's cell industry will usher in explosive growth and become an important force that cannot be ignored in the global biomedical field.