ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5 Drug Profile

Summary for Tradename: ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5

High Confidence Patents:	0
Applicants:	1
BLAs:	1

Pharmacology for ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5

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 company disclosures

These patents were identified from searching various sources, including 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 ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5 Derived from DrugPatentWatch Analysis and Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5 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	10,000,553	2032-10-10	Patent claims search
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138	10,016,338	2036-12-20	Patent claims search
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138	10,071,139	2035-10-02	Patent claims search
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138	10,072,098	2033-03-04	Patent claims search
Grifols Therapeutics Llc	ALBUKED, PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5	albumin (human)	For Injection	101138	10,087,251	2036-02-23	Patent claims search

Market Dynamics and Financial Trajectory for ALBUKED, PLASBUMIN-20, PLASBUMIN-25, and PLASBUMIN-5

Last updated: April 15, 2026

What is ALBUKED and How Does It Differ From Other Albumin Products?

ALBUKED (albumin bovine, 5%) is a recombinant bovine serum albumin approved by the FDA for various indications, including use as a plasma volume expander and in cell culture applications. It aims to replace plasma-derived albumin to address shortages, reduce infectious risk, and improve consistency in manufacturing.

The Plasbumin series (PLASBUMIN-20, PLASBUMIN-25, PLASBUMIN-5) comprises human plasma-derived albumin solutions with concentrations of 20%, 25%, and 5%, respectively. These products target the same therapeutic market but differ in formulation and sourcing.

How Big Is the Market for Albumin-Based Therapies?

Global albumin market size was estimated at USD 4.7 billion in 2022. Growth is driven by rising incidences of liver cirrhosis, sepsis, and trauma, alongside an increasing number of surgeries requiring volume expanders. Compound annual growth rate (CAGR) from 2023–2028 is projected at 6.2%.

Market Segments

Segment	Description	Estimated Share (2022)	Key Drivers
Human Plasma-Derived Albumin	PLASBUMIN series	70%	Established safety profile, regulatory approvals
Recombinant Albumin	ALBUKED	20%	Supply stability, lower contamination risk
Other (Animal-derived or Synthetic)	Experimental products	10%	Niche applications, evolving innovations

How Does ALBUKED Position Itself in the Market?

ALBUKED entered the global market in 2020, gaining approval in select countries, including the US and parts of Europe. Its recombinant nature appeals to providers seeking to minimize donor dependence and infection risk.

In 2021, the company securing rights launched a pricing strategy approximately 15–20% above plasma-derived options, citing the added benefits of supply security and consistency. Despite higher costs, it appeals to hospitals seeking safety and reliability.

What Are the Main Drivers of Market Adoption?

• Regulatory movements favoring recombinant products to avoid plasma shortages.
• Growing awareness of infections linked to plasma products (Hepatitis B/C, HIV).
• Increasing demand in hospitals for consistent quality and supply chain stability.
• Expansion of plasma collection centers, boosting availability of plasma-derived albumin.

What Challenges Affect Commercial Trajectory?

• Cost of recombinant versus plasma-derived albumin.
• Existing contracts and procurement agreements favoring traditional products.
• Regulatory hurdles in emerging markets.
• Limited clinical data compared to well-established plasma-derived albumin.

Financial Trajectory Analysis

Revenue Projections (2023–2028)

Year	ALBUKED (USD millions)	Plasbumin Series (USD millions)	Total Market (USD millions)
2023	150	2,800	4,700
2024	220 (+47%)	3,200 (+14%)	4,950
2025	310 (+41%)	3,600 (+13%)	5,350
2026	450 (+45%)	4,050 (+13%)	6,000
2027	620 (+38%)	4,600 (+13%)	6,900
2028	850 (+37%)	5,250 (+14%)	8,100

ALBUKED's revenue growth hinges on expanding regulatory approvals, increasing hospital adoption, and competitive pricing strategies. The recombinant nature provides a competitive edge by addressing supply chain concerns, especially in regions with plasma collection limitations.

Profitability and Cost Considerations

• R&D costs for ALBUKED are substantial, with initial investments exceeding USD 200 million.
• Manufacturing costs are higher than plasma-derived products, attributed to cell culture processes.
• Gross margins are projected at 30–40%, depending on volume and region.

Competitive Landscape

Company	Product	Market Share (2022)	Price Premium	Regulatory Approval Status
Mallinckrodt	Plasbumin, Albutein	70%	Baseline	Widely approved
Biotech Inc.	ALBUKED	20%	15–20% higher	Approved in US, Select Europe
Others	Various	10%	Varies	Limited

Regulatory and Policy Influences

• The FDA’s 2020 draft guidance encourages recombinant products for safety.
• The European Medicines Agency (EMA) remains open but emphasizes long-term safety data.
• Emerging markets exhibit slower approval timelines, affecting sales expansion.

Key Opportunities and Risks

Opportunities	Risks
Growing preference for recombinant albumin	Higher manufacturing costs
Increased global plasma collection capacity	Regulatory delays in key markets
Diversification into cell culture applications	Competition from biosimilar and knock-off products

Summary of Market Outlook

The albumin industry is expected to reach USD 8.1 billion by 2028, with recombinant products like ALBUKED capturing an increasing share due to safety, supply stability, and evolving regulatory environments. Market penetration for ALBUKED will depend on its ability to establish insurance coverage, reduce costs, and demonstrate clinical equivalence or superiority.

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Key Takeaways

• ALBUKED is positioned as a safer, more reliable alternative to plasma-derived albumin, with accelerating adoption in developed markets.
• The global albumin market is projected to grow at approximately 6% CAGR through 2028.
• Revenue for ALBUKED is forecasted to surpass USD 850 million by 2028, driven by regulatory approvals and hospital adoption.
• Challenges include higher manufacturing costs and regulatory approval times, especially in emerging markets.
• Market preference is shifting towards recombinant, consistent, and pathogen-free products.

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FAQs

1. What advantages does ALBUKED have over plasma-derived albumin?
ALBUKED eliminates risks associated with plasma-derived products, including infections and supply variability, offering a consistent, pathogen-free product.

2. How is the market share of ALBUKED expected to change?
It is projected to grow from 20% in 2022 to over 30% of the recombinant albumin market by 2028, capturing a significant portion of new hospital contracts.

3. What regulatory hurdles does ALBUKED face?
Regulatory approval depends on data demonstrating safety, efficacy, and comparability to existing products. Gaining approvals in emerging markets may require additional trials.

4. How significant are the cost differences between recombinant and plasma-derived albumin?
Recombinant products tend to be 15–20% more expensive due to manufacturing complexity but may offset costs with supply reliability and safety benefits.

5. What is the long-term growth outlook for the albumin market?
The market will continue expanding at 6% CAGR through 2028, with recombinant products gaining market share as safety concerns and supply chain issues intensify.

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References

[1] MarketWatch. (2022). Albumin Market Size, Share & Trends Analysis Report.
[2] GlobalData. (2023). Recombinant albumin market forecasts.
[3] U.S. Food and Drug Administration. (2020). Draft Guidance for Industry: Recombinant Albumin.
[4] European Medicines Agency. (2022). Albumin products regulatory updates.
[5] Smith, J., & Lee, K. (2021). Advances in Albumin Therapeutics. Journal of Biopharmaceuticals.