CITIC Construction Investment: Domestic Albumin Batch Release Share Increases, New Product Development Continues to Advance

In 2025, the domestic blood products industry will maintain steady growth in the issuance of batches for albumin, immune globulin, and fibrinogen, with a year-over-year increase in the proportion of domestically produced albumin batch approvals. The issuance of Factor VIII and PCC batches is growing rapidly, while rabies and tetanus immune globulin batches continue to see good growth. Due to centralized procurement and other factors, some domestic companies have adjusted the winning bid prices for products like albumin and Factor VIII, which is favorable for volume expansion through price competition and boosts product sales. In terms of R&D pipelines, companies are continuously advancing the development of recombinant products and new immunoglobulins (including chromatography-based immune globulin and subcutaneous immunoglobulin). For 2026, industry recommendations focus on the expansion of plasma stations, M&A and industry consolidation trends, and progress in new product R&D. Attention is advised on leading companies in the industry that are expected to expand plasma station resources through organic growth and acquisitions, ensuring sustained growth in blood product businesses.

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Overview of the Blood Products Industry in 2025: Increased Domestic Albumin Batch Approvals, Continued R&D of New Products

In 2025, the domestic blood products industry will maintain steady growth in the issuance of batches for albumin, immune globulin, and fibrinogen, with a year-over-year increase in the proportion of domestically produced albumin batch approvals. The issuance of Factor VIII and PCC batches is growing rapidly, while rabies and tetanus immune globulin batches continue to see good growth. Due to centralized procurement and other factors, some domestic companies have adjusted the winning bid prices for products like albumin and Factor VIII, which is favorable for volume expansion through price competition and boosts product sales. In terms of R&D pipelines, companies are continuously advancing the development of recombinant products and new immunoglobulins (including chromatography-based immune globulin and subcutaneous immunoglobulin). For 2026, industry recommendations focus on the expansion of plasma stations, M&A and industry consolidation trends, and progress in new product R&D. Attention is advised on leading companies in the industry that are expected to expand plasma station resources through organic growth and acquisitions, ensuring sustained growth in blood product businesses.

Investment Recommendations: Focus on leading companies in the industry that are expected to expand plasma station resources through organic growth and acquisitions, ensuring continuous growth in blood product businesses.

Industry Batch Approvals: In 2025, the proportion of domestically produced albumin increased, with factor products maintaining good growth. 1) Human serum albumin: total batch approvals reached 5,565 (up 2.9%), with domestic varieties accounting for 1,923 batches (up 7.2%), representing 34.6%, showing a year-over-year increase. 2) Intravenous immunoglobulin (pH 4): total approvals reached 1,457 (up 9.1%), maintaining steady growth. 3) Human coagulation factor VIII: total approvals reached 706 (up 23.9%), with good growth. Eight domestic companies received approval. 4) Human fibrinogen: total approvals reached 305 (up 5.2%), steadily increasing. Approved for nine companies. 5) Human prothrombin complex concentrate (PCC): total approvals reached 363 (up 38.5%), with nine domestic companies approved. 6) Rabies immune globulin: total approvals reached 130 (up 14.5%), with nine companies approved. 7) Tetanus immune globulin: total approvals reached 169 (up 19.9%), with eight companies approved. 8) Hepatitis B immune globulin: total approvals reached 28 (up 7.7%), with seven companies approved. 9) Human immunoglobulin: total approvals in 2025 were 45 (down 47.1%), with six companies approved. 10) Other products: in 2025, domestic histamine human immunoglobulin approvals reached 61 (up 3.4%), human fibrin sealant approvals 29 (up 61.1%), human coagulation factor IX approvals 137 (up 16.1%), and human thrombin approvals 5 (up 66.7%).

Blood Product Industry Pipeline: Some products are expected to face pricing pressures; attention should be paid to new product development progress. 1) Human serum albumin: many manufacturers, with the lowest bid prices decreasing in 2025; He Yuan Biotech’s recombinant albumin approved and became the first domestically produced. 2) Chromatography-based immune globulin: three domestic products approved, with multiple companies investing in R&D; subcutaneous formulations have promising prospects. 3) Coagulation factors: some products’ bid prices adjusted, benefiting penetration; numerous pipeline projects include long-acting Factor VIII and FVIII/vWF complexes. 4) Fibrinogen: multiple domestic products launched, with several companies developing fibrin sealants. 5) PCC: mainly used for coagulation factor deficiency, with limited pipeline R&D. 6) Special immunoglobulins: various types mainly targeting infectious diseases.

Risk Warnings:

• Lower-than-expected batch approval progress: Blood products in China follow a batch approval system. If approval speed falls short of expectations, it could negatively impact sales and company performance and valuation.
• Product safety and compliance risks: Due to their biological nature, blood products are subject to stricter regulation and broader management. Safety issues or violations could adversely affect individual companies and cause industry-wide fluctuations.
• R&D and approval delays: Several pipeline products are in development or application stages. Delays or failures could impact future revenue, profitability, and valuation of related companies.

Note: Batch approval data only reflect samples approved by the China National Medical Products Administration (NMPA) and do not represent actual sales volumes.