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 will grow rapidly, while rabies and tetanus immune globulin batches will 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 will boost sales. In terms of R&D pipelines, companies are continuously advancing the development of recombinant products and new types of 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 development. Attention is advised on leading companies that are expected to expand plasma station resources through organic growth and acquisitions, maintaining continuous growth in blood product businesses.

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

In 2025, the domestic blood products industry will see steady growth in batch approvals for albumin, immune globulin, and fibrinogen, with a higher proportion of domestically produced albumin approvals compared to the previous year. The issuance of Factor VIII and PCC batches will grow rapidly, while rabies and tetanus immune globulin batches will maintain 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 conducive to volume growth through price competition and will drive sales increases. Regarding R&D pipelines, companies are actively developing recombinant products and new immunoglobulin types (including chromatography-based immune globulin and subcutaneous immunoglobulin). For 2026, industry focus should be on plasma station expansion, M&A and industry consolidation trends, and progress in new product development. Companies at the industry forefront that are expected to expand plasma station resources through organic growth and acquisitions, maintaining continuous growth in blood product businesses, are recommended for attention.

Investment Advice: Focus 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.

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

Blood Products 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 minimum bid price decreasing in 2025; HeYuan Biotech’s recombinant albumin approved and becoming the first domestically produced. 2) Chromatography-based immune globulin: three domestic products approved, with multiple companies involved in R&D; subcutaneous formulations have promising prospects. 3) Coagulation factors: some products’ bid prices have been adjusted, benefiting penetration; numerous pipelines 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 treatment, with limited R&D pipelines. 6) Special immunoglobulins: various types mainly targeting infectious diseases.

Risks:

• 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 valuations.
• Product safety and compliance risks: Due to their biological nature, blood products are subject to strict regulation and broad management. Safety issues or violations could affect individual companies and cause industry-wide fluctuations.
• R&D and approval delays: Several products are in development or application stages. Delays or failures could impact future revenue, profitability, and valuation of related companies.
• Approval data only reflect samples approved by the National Medical Products Administration, not actual sales, and are for reference only.

(Source: Jiemian News)