Albumin (human) - Biologic Drug Details

Summary for albumin (human)

Tradenames:	8
High Confidence Patents:	0
Applicants:	10
BLAs:	10
Suppliers: see list	8
Recent Clinical Trials:	See clinical trials for albumin (human)

Recent Clinical Trials for albumin (human)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Nextrast, Inc.	PHASE1
Agios Pharmaceuticals, Inc.	PHASE2
Tianjin Medical University Cancer Institute and Hospital	PHASE4

See all albumin (human) clinical trials

Pharmacology for albumin (human)

Ingredient-type	Serum Albumin
Mechanism of Action	Osmotic Activity
Physiological Effect	Increased Intravascular Volume Increased Oncotic Pressure
Established Pharmacologic Class	Human Serum Albumin

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for albumin (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for albumin (human) Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Kedrion, S.p.a.	KEDBUMIN	albumin (human)	Injection	125384		2038-03-08	DrugPatentWatch analysis and company disclosures
Kedrion, S.p.a.	KEDBUMIN	albumin (human)	Injection	125384		2039-10-10	DrugPatentWatch analysis and company disclosures
Kedrion, S.p.a.	KEDBUMIN	albumin (human)	Injection	125384		2028-10-24	DrugPatentWatch analysis and company disclosures
Kedrion, S.p.a.	KEDBUMIN	albumin (human)	Injection	125384		2027-03-21	DrugPatentWatch analysis and company disclosures
Kedrion, S.p.a.	KEDBUMIN	albumin (human)	Injection	125384		2028-11-11	DrugPatentWatch analysis and company disclosures
Kedrion, S.p.a.	KEDBUMIN	albumin (human)	Injection	125384		2030-11-01	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for albumin (human) Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138		2032-10-10	Patent claims search
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138		2036-12-20	Patent claims search
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138		2035-10-02	Patent claims search
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138		2033-03-04	Patent claims search
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138		2036-02-23	Patent claims search
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138		2037-05-19	Patent claims search
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138		2037-10-24	Patent claims search

International Patents for albumin (human)

Country	Patent Number	Estimated Expiration
Japan	2020100633
United Kingdom	2488077
Brazil	112013028536
Canada	2890766
Russian Federation	2414925
World Intellectual Property Organization (WIPO)	2014072481
European Patent Office	2635598

Albumin (human) Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are the Market Dynamics for Human Albumin (Biologic)?

Global demand for human albumin, a plasma-derived protein used in medical conditions such as shock, burns, and liver disease, is driven by increasing healthcare needs and expanding indications. The industry faces supply constraints owing to reliance on plasma donations, which are limited and regionally uneven.

Market Size and Growth Rate

The global human albumin market was valued at approximately $2.1 billion in 2021. It is projected to grow at a compound annual growth rate (CAGR) of around 4.5% from 2022 to 2028, reaching roughly $3.0 billion. Drivers include aging populations, rising incidence of acute medical conditions requiring albumin therapy, and improvements in plasma fractionation techniques.

Regional Breakdown

• North America: Largest market, approx. 40% of global sales in 2021. Growth driven by high healthcare expenditure and extensive use in hospital settings.
• Europe: Second-largest, about 30%, with demand driven by similar factors and increasing adoption in clinical applications.
• Asia-Pacific: Fastest-growing, current CAGR of approximately 6%. Population growth, expanding healthcare infrastructure, and increasing awareness contribute.

Key Market Players and Competition

Major companies include CSL Behring, Grifols, and Japan Blood Products Organization. These firms dominate plasma procurement and fractionation, with minimal direct competition from recombinant alternatives due to label restrictions and cost considerations.

Indications and Usage Patterns

Albumin is primarily used for:

• Volume expansion in hypovolemic shock
• Treatment of burns
• Liver cirrhosis management
• Acute respiratory distress syndrome (ARDS)

Its utilization has increased as new clinical guidelines endorse albumin's role in resuscitation and critical care.

Supply Chain Challenges

Plasma collection is constrained by donor availability and collection infrastructure, impacting manufacturing scalability. Synthetic or recombinant albumin alternatives are under development but face regulatory hurdles and higher costs.

What Is the Financial Trajectory for Human Albumin?

Revenue Trends and Forecasts

Revenue growth has been steady, with an incremental increase of around 4-5% annually. Price per unit varies but has shown resilience despite pressure from biosimilars and generics, due to the complex process required for plasma-derived protein production.

Cost Structure and Profit Margins

Manufacturing costs are high, driven by plasma collection, fractionation, and quality controls. Gross margins are estimated at 20-30%. Economies of scale and improved collection efficiencies could enhance profitability.

Regulatory Environment Impact

Regulation governing plasma-derived products emphasizes safety (e.g., prion transmission prevention). Stringent standards limit rapid market entry of biosimilars or recombinant alternatives, reinforcing pricing power for established suppliers.

R&D and Investment Trends

Investments in plasma collection technologies and recombinant albumin—although still limited—are increasing. Companies allocate capital toward improving yield, reducing costs, and exploring novel delivery mechanisms to expand indications.

Licensing and Reimbursement Policies

Reimbursement rates vary globally, with high-income countries providing coverage aligned with hospital and critical care practices. Changes in healthcare policies could influence utilization and revenues.

How Do Market Dynamics and Financial Trajectory Interact?

The limited supply of plasma and slow development of biosimilar alternatives sustain market prices and profit margins for existing players. Growth hinges on expanding indications and geographic reach. Rising healthcare budgets in Asia-Pacific and regulatory barriers for biosimulants bolster future revenue stability.

Key Takeaways

• The human albumin market is projected to grow at a CAGR of approximately 4.5%, driven by clinical demand and demographic shifts.
• Regional variations influence revenue distribution, with North America and Europe leading, while Asia-Pacific shows faster growth.
• Market players maintain pricing power amid supply constraints, with ongoing R&D focusing on alternatives and process efficiencies.
• Supply chain limitations and regulatory standards sustain high production costs, constraining market expansion but supporting profit margins.
• Policy changes and healthcare innovation could impact the future landscape, especially regarding biosimilar development and reimbursement.

FAQs

1. What factors most influence the price of human albumin?
   Supply limitations, manufacturing costs, and regulatory standards primarily determine prices. Demand stability and lack of biosimilar competition also support pricing.

2. Are biosimilar or recombinant albumin products likely to replace plasma-derived albumin?
   They face regulatory, safety, and cost barriers. While development continues, widespread adoption is unlikely in the short term due to these hurdles.

3. How will demographic shifts impact future demand?
   Aging populations and increasing prevalence of chronic liver diseases and critical care admissions will sustain or elevate demand.

4. What regulatory changes could affect the market?
   Relaxation of standards for biosimilars or recombinant proteins could introduce new competition. Stricter safety protocols reinforce current suppliers' positions.

5. What investment opportunities exist within this market?
   Opportunities include plasma collection technology innovations, process efficiency improvements, and development of recombinant alternatives.

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Sources:
[1] Markets and Markets, "Human Albumin Market," 2022.
[2] Grand View Research, "Albumin Market Size," 2021.
[3] CSL Behring Annual Reports, 2022.
[4] Grifols Investor Relations, 2022.
[5] U.S. FDA, "Plasma Protein Therapeutics," 2022.