RMB 114.2 Billion Opportunity Ahead!

China’s National Health Commission to Add “Medicine-Food Homology” Boost to FSMP

Introduction

After a decade, the Food for Special Medical Purposes (FSMP) sector is entering its second “bright” phase. FSMP refers to Foods for Special Medical Purposes, a category formally recognized in 2015 when China’s Food Safety Law reclassified FSMP under “special foods,” ending its long-standing management as a pharmaceutical product. This shift directly triggered a surge in registered products.

Ten years later, on August 1, 2025, the National Health Commission responded positively to the Proposal on Incorporating Traditional Medicinal Diets and Medicine-Food Homology Ingredients into the FSMP System. This signals that the government may promote the “Medicine-Food Homology + FSMP” niche, unlocking significant economic potential.

How Big Is the FSMP Market?

While FSMP may sound niche and distant from everyday consumers, its market size is substantial. According to Global Info Research, the global FSMP market in 2025 is valued at approximately USD 15.9 billion (RMB 114.2 billion), with a steady CAGR of 6.41%. North America holds the largest share at around 40%, followed by Asia-Pacific (34%) and Europe (25%).

*Chart 1: global FSMP market analytics by Global Info Research

In Asia-Pacific, China plays a pivotal role. Data from the China Business Industry Research Institute shows that China’s FSMP market reached RMB 23.2 billion in 2024, with a five-year CAGR of 25.34%, and is projected to grow to RMB 53.1 billion by 2029.

*Chart 2: 2020-2025 Chinese FSMP Market Size Forecast Trend

Despite this rapid growth, China’s FSMP penetration rate is only 3%—far below the U.S. (over 40%) and less than half of mature markets like Europe and Japan. As of June 2025, 232 domestic FSMP products had been approved (86% of total approvals), yet domestic brands hold less than 30% market share, with foreign brands still dominant.

*Chart3: Enteral Nutrition Usage Rates by Region

Usage rates for enteral nutrition highlight the gap: 90.9% in the U.S., 80% in the EU, but only 7.69% among hospitalized patients in China. Low clinical adoption and consumer skepticism—some dismiss FSMP as an “IQ tax”—have created a “fortress” effect, keeping FSMP from reaching end-users directly.

How “Medicine-Food Homology” Can Empower FSMP

FSMP is not exclusive to patients; it was designed to meet the special nutritional needs of people with restricted food intake, impaired digestion and absorption, metabolic disorders, or specific disease states. Essentially, it is still food—just more precisely tailored to specific health requirements.

1. Integration by Disease Type FSMP includes three categories:

• Nutritionally Complete Foods

• Nutritionally Complete Foods with Specific Formulations

• Nutritionally Incomplete Foods

* Chart4: FSMP Dosage Form Distribution

The second category often serves people with diabetes, COPD, inflammatory bowel disease, or obesity. Here, medicine-food homology ingredients can be incorporated:

• Diabetes: Astragalus, Polygonatum odoratum to help regulate blood sugar while providing nutrition.

• COPD: Almonds (to relieve cough and asthma) and Chinese yam (mucoprotein to protect lung mucosa).

• Inflammatory Bowel Disease: Dendrobium officinale, purslane, kudzu root to repair intestinal mucosa.

2. Integration by Target Population As of March 2025, there are 64 FSMP products for infants and 178 for those over one year old. FSMP spans the entire life cycle, with elderly, pregnant/postpartum women, and children as key beneficiaries.

• Infants (0–1 year): Add hawthorn or chicken gizzard lining to aid digestion, with processing to convert large molecules into infant-absorbable small molecules.

• Pregnant/Postpartum Women: Combine precise supplementation of folic acid, iron, calcium, DHA with red dates, longan, goji berries for blood nourishment, or yam, cinnamon, kudzu root to help manage gestational diabetes.

• Elderly: Add black sesame, ganoderma, astragalus to boost vitality, nourish blood, and strengthen bones.

Note: While generally safe, medicine-food homology ingredients in FSMP require strict scientific validation for dosage, compatibility, and efficacy to avoid drifting into “general health supplement” territory.

Key Focus Areas: Clinical Research, Precision Nutrition, Dosage Form Expansion

Despite favorable policies, the “Medicine-Food Homology + FSMP” track faces challenges—especially in scientific evidence and standardization.

1. Clinical Research Establish dose–effect relationships, bioavailability, and long-term safety through multi-center clinical trials and evidence-based studies to support product registration and marketing.

2. Precision Nutrition With advances in genomics, both FSMP and medicine-food homology will move from “one formula for thousands” to “one formula per person.” Genetic testing can guide FSMP formulations tailored to genotype, metabolism, and gut microbiota.

3. Dosage Form Expansion Currently, FSMP is 73.5% powder (178 products), 26% liquid (63 products), and only 1 granular product. Future opportunities include more liquid formats, semi-solid products, capsules, lozenges, and even snack-style FSMP—without compromising nutritional efficacy.

Conclusion

The integration of medicine-food homology with FSMP represents a fusion of traditional Chinese wellness wisdom and modern nutritional science—an important practice under the “Healthy China” strategy. This sector could see explosive growth in the coming years. For enterprises, success in this RMB 114.2 billion market will depend on scientific rigor and user-centric innovation. Regulators, in turn, must accelerate standards, streamline approvals, and strengthen oversight to guide the industry toward healthy, orderly, and high-quality development.

References

[1] Yuanjian Huiku, 2025 China FSMP Industry In-Depth Analysis: Policy Dividends and the Blue Ocean Behind 206 Approved Products

[2] Global Info Research, 2025 Global and China FSMP Market Status and Future Trends

[3] China Business Industry Research Institute, 2025 China FSMP Industry Market Outlook Forecast Report

[4] China Food News, FSMP in the “Dual-Track System”: Bright Prospects, Challenging Path

[5] FSMP Navigator, Latest Analysis of 242 Approved FSMP Products

Media Contact
Company Name: Sinofn (Tianjin) Pharm-Tech Co., Ltd.
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Phone: 022-24928910
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City: Tianjin, 300308
Country: China
Website: https://www.sinofnhealth.com/