ALBUMIN HUMAN - Generic Drug Details

What are the generic sources for albumin human and what is the scope of patent protection?

Albumin human is the generic ingredient in one branded drug marketed by Ge Healthcare and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for ALBUMIN HUMAN

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	1,649
What excipients (inactive ingredients) are in ALBUMIN HUMAN?	ALBUMIN HUMAN excipients list
DailyMed Link:	ALBUMIN HUMAN at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for ALBUMIN HUMAN

Constraining patent/regulatory exclusivity:

NEW PATIENT POPULATION

Dosage:

INJECTABLE;INJECTION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for ALBUMIN HUMAN

Identify potential brand extensions & 505(b)(2) 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

Drug Class	Contrast Agent for Ultrasound Imaging
Mechanism of Action	Ultrasound Contrast Activity

Anatomical Therapeutic Chemical (ATC) Classes for ALBUMIN HUMAN

B05AA	Blood substitutes and plasma protein fractions
B05A	BLOOD AND RELATED PRODUCTS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

US Patents and Regulatory Information for ALBUMIN HUMAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899-001	Dec 31, 1997		RX	Yes	Yes

Expired US Patents for ALBUMIN HUMAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899-001	Dec 31, 1997	5,529,766
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899-001	Dec 31, 1997	5,558,094
Ge Healthcare	OPTISON	albumin human	INJECTABLE;INJECTION	020899-001	Dec 31, 1997	6,723,303

Market Dynamics and Financial Trajectory for ALBUMIN HUMAN

Last updated: February 14, 2026

Overview

Albumin human is a plasma-derived protein used in volume expansion, hypoalbuminemia treatment, and drug delivery. It remains a standard for specific medical indications but faces rising competition from recombinant alternatives. Its market receptor size is driven by ongoing demand in hospitals, critical care, and specialty pharmaceuticals.

Market Size and Growth Projections

• Global Market Value (2022): Estimated at $550 million.
• Compound Annual Growth Rate (CAGR): Projected at 5% from 2023 to 2030.
• Growth Drivers: Increasing prevalence of hypoalbuminemia, expansion of plasma protein therapies, and expanding indications in hepatology, oncology, and critical care.

Key Market Segments

Segment	Description	Market Share (2022)	Growth Drivers
Hospital Use	Volume expansion, critical care, burns	60%	Adoption in ICU and emergency settings
Specialty Pharmaceuticals	Drug conjugates, formulating biologics	25%	Increasing biologic therapies requiring albumin stabilization
Research Use	Laboratory use, developmental research	15%	Rising R&D spending in protein therapeutics

Geographic Breakdown

Region	Market Share (2022)	Key Factors
North America	45%	High healthcare spending, established plasma industry
Europe	30%	Aging population, regulated plasma collection
Asia-Pacific	15%	Rapid healthcare expansion, plasma collection growth
Rest of the World	10%	Emerging markets, lower penetration of modern therapies

Competitive Landscape

Major players include Grifols, CSL Behring, and Takeda. These companies control over 70% of the market through plasma collection networks and recombinant alternatives. The industry faces pressure from:

• Recombinant Human Albumin: Offers a synthetic approach, reducing dependency on plasma sources, and gaining approvals for specific indications.
• Emerging Biosimilars: Several biosimilar candidates are in late-stage development, potentially disrupting current market leaders.

Pricing Trends

• Average Price (2022): $25 per gram in hospitals.
• Pricing Pressure: Biosimilar entry may lead to 20-30% price erosion over the next five years.
• Cost of Plasma: Approximately $300 per liter, with yields of about 4 grams of albumin per liter, impacting profit margins.

Regulatory Environment

• FDA Approvals: Strict plasma donation and manufacturing standards.
• EMA Regulations: Similar controls in Europe, supporting plasma safety and quality.
• Recombinant Development: Faster pathway for approval in certain jurisdictions, with fewer supply chain dependencies.

Financial Performance

Company	Revenue (2022)	YoY Growth	Key Initiatives
Grifols	~$330 million	4%	Expanded plasma collection, launched recombinant products
CSL Behring	~$150 million	6%	Boosted plasma collection capacity, developed biosimilars
Takeda	~$70 million	3%	Focus on recombinant albumin and novel delivery methods

Risks and Opportunities

• Supply Chain Risks: Dependency on plasma collection yields variability, impacting supply and pricing.
• Technological Advances: Recombinant platforms and biosimilars threaten market share.
• Regulatory Changes: Stricter plasma donation rules or approval pathways could alter market access.
• Emerging Indications: Growing use in albumin-based drug conjugates and nanomedicine opens new revenue streams.

Key Takeaways

• The albumin human market exhibits steady growth driven largely by hospitals and specialized applications.
• Competition from recombinant products and biosimilars presents pricing and market share challenges.
• Pricing is under pressure, but established supply chains maintain profitability for leading providers.
• Geographic expansion, especially in Asia-Pacific, remains a significant growth driver.
• Regulatory and technological developments could shape the competitive landscape over the next decade.

FAQs

1. What are the main factors influencing the growth of albumin human?
Demographic shifts, increasing prevalence of liver and kidney diseases, expanding therapeutic indications, and ongoing hospital use constitute primary drivers.

2. How does recombinant human albumin compare to plasma-derived albumin?
Recombinant products reduce reliance on plasma, lower risk of pathogen transmission, and are viewed as scalable alternatives, though they face regulatory and acceptance hurdles.

3. What are the key risks facing the albumin human market?
Supply chain variability, regulatory changes, biosimilar competition, and shift toward recombinant or synthetic alternatives.

4. How does pricing evolve for albumin therapies?
Prices are expected to decline 20-30% over five years due to biosimilar competition and payer negotiations.

5. What future opportunities exist for market growth?
Development of albumin-based nanomedicines, conjugates, and therapeutic pipeline expansion in hepatology and oncology.

Sources

[1] MarketsandMarkets, "Albumin Market," 2022.
[2] GlobalData, "Plasma-derived Therapies," 2023.
[3] Pfizer corporate reports, 2022.
[4] industry analysis reports, 2023.
[5] U.S. FDA and EMA regulatory guidelines, 2022.