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
VA Office of Research and Development	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
Spain	2332846
Japan	2015512893
Japan	6703016
Australia	2008243225
United Kingdom	2512156
Mexico	2013012358
Australia	2005202654

Market Dynamics and Financial Trajectory for the Biologic Drug: Albumin (Human)

Last updated: July 29, 2025

Introduction

Human serum albumin (HSA) is a cornerstone biologic employed across diverse therapeutic and diagnostic applications. Its inherent biological properties—chiefly, maintaining plasma oncotic pressure and transporting endogenous and exogenous substances—render it invaluable in clinical contexts such as volume expansion, burn management, hypoalbuminemia, and drug delivery systems. Understanding the evolving market landscape and financial trajectory of albumin (human) informs stakeholders about investment opportunities, competitive positioning, and future growth pathways.

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Market Overview and Key Drivers

Global Market Size and Growth Trends

The global albumin market was valued at approximately USD 1.2 billion in 2022, with projections estimating a compound annual growth rate (CAGR) of around 5-6% through 2030 (source: Grand View Research). The steady expansion hinges on increasing prevalence of hypoalbuminemia, chronic liver diseases, cachexia, and extensive use in critical care settings.

Therapeutic Demand and Clinical Applications

Albumin's primary indications include volume replacement in hypovolemic states, burn management, and systemic infections. Its application in oncology, integrating albumin-bound chemotherapeutics like nab-paclitaxel, has further stimulated demand. The chemical stability, biocompatibility, and established safety profile sustain its widespread utility.

Emerging Trends and Drivers

• Aging Population and Chronic Diseases: An aging demographic amplifies the need for plasma expanders and protein replacements, bolstering albumin consumption.
• Advances in Plasma Fractionation: Innovations in plasma separation techniques enhance yield and purity, reducing manufacturing costs.
• Expanding Indications: Research into novel uses, such as drug delivery platforms and regenerative medicine, positions albumin for future utilization.
• Regulatory Support: Increased regulatory approvals and encouraging healthcare policies bolster market access.

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Market Dynamics

Supply Chain and Manufacturing

Derived predominantly through plasma fractionation, the supply of human serum albumin faces challenges related to donor pool variability, plasma collection efficiency, and manufacturing scalability. Major players like CSL Behring, Grifols, and Kedrion dominate industry dynamics, investing heavily in process optimization and capacity expansion.

Pricing and Reimbursement Landscape

Premium pricing persists due to complex production, safety standards, and limited substitutability. Reimbursement policies vary across geographies, affecting market penetration and profitability. In the US, reimbursement is influenced by Medicaid and Medicare policies, whereas in Europe, national health authorities govern procurement and pricing.

Competitive Environment

While albumin faces competition from synthetic plasma expanders and synthetic colloids (e.g., hydroxyethyl starch), concerns over safety and efficacy sustain the preferential use of human serum albumin. Biotech companies exploring recombinant and plant-based production methods, although still nascent, could disrupt traditional supply chains.

Regulatory Considerations

Meeting stringent regulatory standards—such as those outlined by the FDA, EMA, and WHO—remains critical. The advent of biosimilar albumin products, which require rigorous comparability assessments, introduces compliance complexity but also paves the way for market expansion and price competition.

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Financial Trajectory and Investment Outlook

Revenue Streams and Profitability

Major manufacturers report stable revenues, with margins reflecting manufacturing complexity and patent expirations. The high barriers to entry, anchored in proprietary plasma fractionation processes, sustain pricing power.

Research and Development Investment

Investors should monitor ongoing R&D endeavors aimed at innovative delivery systems—such as albumin-coated nanoparticles and engineered variants with enhanced stability—potentially opening new revenue streams.

Impact of Biosimilar Entry

Potential biosimilar products could catalyze price erosion and market share redistribution, especially in regions with supportive regulatory frameworks. However, biosimilar development faces scientific, clinical, and inferential hurdles, providing incumbent firms with strategic buffers.

Market Expansion and Geographic Diversification

Growth in emerging markets—Brazil, India, China—is pivotal, driven by expanding healthcare infrastructure and plasma collection capabilities. Translation of clinical guidelines to such markets will influence future revenue trajectories.

Pricing Trends and Cost Optimization

Advancements in plasma fractionation techniques and alternative production methods are expected to reduce costs, improving margins without compromising safety or efficacy.

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Future Outlook

The trajectory for human serum albumin remains cautiously optimistic. Its entrenched clinical role, especially in critical care and specialty therapeutics, underpins consistent demand. Simultaneously, technological innovations, regulatory shifts, and competitive pressures will shape pricing strategies and market share. Investment in plasma collection infrastructure and biotechnological innovations is likely to influence long-term supply stability and cost efficiencies.

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Key Takeaways

• The albumin market is characterized by stable demand driven by aging populations and expanding clinical applications.
• Manufacturing and supply chain complexities sustain high pricing, though biosimilars and innovations pose future risks and opportunities.
• Emerging production technologies and new therapeutic uses are avenues poised for growth and investment.
• Geographical expansion into emerging markets offers significant revenue potential, contingent on local regulatory and healthcare infrastructure.
• Strategic investments in process improvement and regulatory compliance remain crucial for market players to maintain competitiveness.

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FAQs

1. What factors most influence the pricing of human serum albumin?
Primarily, manufacturing complexity, donor plasma availability, regulatory hurdles, and market competition influence pricing. High production costs and safety standards sustain premium pricing, with biosimilar competition potentially reducing prices over time.

2. How does the rise of biosimilars impact the human albumin market?
Biosimilars could induce price competition and market share shifts once approved. However, the complex nature of albumin derivation and regulatory requirements pose challenges to biosimilar manufacturing and approval.

3. What are the main challenges facing the supply of human serum albumin?
Limited plasma donor pools, variability in plasma fractions, manufacturing scalability, and regulatory oversight restrict supply and can lead to price fluctuations.

4. In what new therapeutic areas could albumin see expanded use?
Potential areas include drug delivery systems, nanomedicine, regenerative medicine, and novel indications like neuroprotection or immune modulation, driven by ongoing research.

5. How will technological innovations influence future market dynamics?
Advances in recombinant production, plant-based expression systems, and improved plasma fractionation could reduce costs, mitigate supply constraints, and foster new form factors or formulations, influencing market competitiveness.

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References

1. Grand View Research. "Albumin Market Size, Share & Trends Analysis Report." 2022.
2. U.S. Food and Drug Administration (FDA). "Biologics License Application (BLA) for Albumin." 2021.
3. World Health Organization. "Plasma Fractionation: Market and Regulatory Outlook." 2020.