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Last Updated: April 27, 2025

Albumin (human) - Biologic Drug Details


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Summary for albumin (human)
Recent Clinical Trials for albumin (human)

Identify potential brand extensions & biosimilar entrants

SponsorPhase
King's College LondonPhase 4
Juvenile Diabetes Research FoundationPhase 4
Glostrup University Hospital, CopenhagenPhase 4

See all albumin (human) clinical trials

Recent Litigation for albumin (human)

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
GENENTECH, INC. v. DR. REDDYS LABORATORIES, INC.2023-11-17
Genentech, Inc. v. Biogen MA Inc.2023-07-13
Genentech, Inc. v. Samsung Bioepis Co. Ltd.2020-06-28

See all albumin (human) litigation

PTAB Litigation
PetitionerDate
Apotex Inc.2017-11-09
Apotex Inc. et al.2017-11-09
Cipla Ltd. et al.2017-11-09

See all albumin (human) litigation

Pharmacology for albumin (human)
Ingredient-typeSerum Albumin
Mechanism of ActionOsmotic Activity
Physiological EffectIncreased Intravascular Volume
Increased Oncotic Pressure
Established Pharmacologic ClassHuman 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
  2. 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.

  3. General brand-side disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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 Company Disclosures

No patents found based on company disclosures

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

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Human Albumin

Market Size and Growth Projections

The global albumin market, particularly the segment focused on human albumin, is experiencing significant growth. As of 2022, the market size was valued at $5.4 billion and is projected to reach $9.9 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 6.2% from 2023 to 2032[1].

Another estimate suggests that the global albumin market was valued at $6.35 billion in 2023 and is expected to grow to $10.19 billion by 2032, with a CAGR of 5.6% during the forecast period[5].

Key Growth Drivers

Several factors are driving the growth of the human albumin market:

Increasing Prevalence of Diseases

The rise in diseases such as hypoalbuminemia, burns, trauma, liver cirrhosis, and cardiac surgeries significantly propels the demand for albumin. For instance, approximately 11 million individuals suffer from burn wounds annually, highlighting the critical role of albumin in addressing these medical conditions[1].

Blood Donation Awareness

Initiatives aimed at raising awareness about blood donation have a positive impact on the supply of human plasma, a key source of albumin. This increased supply supports the growing demand for albumin in various medical and pharmaceutical applications[1].

Pharmaceutical Applications

Albumin's versatile properties make it a valuable component in pharmaceutical formulations, enhancing drug stability and delivery. The pharmaceutical industry's focus on developing innovative medications further amplifies the demand for albumin[1][3].

Recombinant Human Albumin

There is a burgeoning interest in recombinant human albumin as a substitute for plasma-derived albumin. This shift offers advantages such as reduced costs, consistent quality, and diminished contamination risks associated with blood products[3].

Market Segmentation

By Type

The albumin market is segmented into human serum albumin, bovine serum albumin, and recombinant albumin. Human serum albumin accounted for the largest share in 2022 and is expected to register the fastest CAGR during the forecast period due to its widespread and diverse applications in medical interventions[1].

By Application

Albumin is used in various applications, including pharmaceuticals, culture media ingredients, diagnostics, and medical coatings. The pharmaceutical segment, particularly the use of albumin in drug formulations and as a culture media ingredient, holds a significant market share[3].

By Sales Channel

The market is segmented into business-to-business (B2B) and business-to-consumer (B2C) sales channels. The B2B segment dominated the market in 2022 and is expected to maintain its lead, while the B2C segment is anticipated to register the fastest CAGR due to direct sales enhancing market accessibility and customer engagement[1].

By Region

The global albumin market is segmented geographically, with North America holding a major share. The region is expected to witness significant growth due to the presence of key market players, rising cancer cases, and increased research and development activities[3].

Financial Trajectory

Revenue Projections

The albumin market is estimated to grow from $6.57 billion in 2024 to $10.19 billion by 2032, exhibiting a CAGR of 5.6% during the forecast period. The U.S. market alone is projected to reach an estimated value of $2.00 billion by 2032[5].

Regional Growth

North America, with a market share of 37.04% in 2024, is expected to witness a CAGR of 7.53% over the forecast period. Emerging markets, particularly in Asia-Pacific and parts of Africa, are also experiencing an increase in demand for albumin-based treatments[3].

Industry Dynamics

Chronic Diseases and Trauma

The increasing prevalence of chronic diseases such as liver cirrhosis, kidney disorders, and cancer, along with the rise in global trauma and burn cases, surges the demand for albumin. Albumin plays a pivotal role in novel treatments for these diseases and in blood plasma protein therapies[3].

Innovative Applications

Albumin is finding expanded applications in drug formulations for targeted delivery and innovative treatments such as immunotherapy. The use of albumin in these applications further drives market growth[3].

Regulatory and Production Challenges

Despite the growth opportunities, the market faces challenges such as high production costs, regulatory hurdles, and market competition. These factors need to be addressed to sustain the growth trajectory of the albumin market[3].

Clinical Significance and Outcomes

Hypertension Risk

Studies have shown that high stable trajectories of serum albumin concentrations are significantly associated with a reduced risk of hypertension. This underscores the importance of maintaining optimal serum albumin levels for cardiovascular health[2].

Mortality Rates in Sepsis

In sepsis patients, those with persistently low albumin levels have higher mortality rates and worse clinical outcomes. Conversely, patients with stable high or increasing albumin levels exhibit a reduced risk of mortality, highlighting the prognostic value of albumin levels in critical care[4].

Key Takeaways

  • The global albumin market is driven by increasing medical needs, pharmaceutical applications, and advancements in recombinant technology.
  • Human serum albumin dominates the market due to its extensive use in therapeutic treatments.
  • North America and emerging markets in Asia-Pacific are key regions driving market growth.
  • The market faces challenges such as high production costs and regulatory hurdles but offers substantial opportunities for innovation and expansion.

FAQs

Q: What is the projected market size of the global albumin market by 2032? A: The global albumin market is projected to reach $9.9 billion by 2032, growing at a CAGR of 6.2% from 2023 to 2032[1].

Q: What are the primary drivers of the human albumin market? A: The primary drivers include the increasing prevalence of diseases such as hypoalbuminemia, burns, and liver cirrhosis, along with growing pharmaceutical applications and awareness about blood donation[1].

Q: How does recombinant human albumin impact the market? A: Recombinant human albumin offers advantages such as reduced costs, consistent quality, and diminished contamination risks, making it a promising substitute for plasma-derived albumin[3].

Q: What is the significance of serum albumin levels in clinical outcomes? A: High stable trajectories of serum albumin concentrations are associated with reduced risks of hypertension and mortality in critical care patients, highlighting the prognostic value of albumin levels[2][4].

Q: Which region is expected to dominate the albumin market in the forecast period? A: North America is expected to maintain its lead in the albumin market, driven by the presence of key market players and increasing research and development activities[3].

Cited Sources

  1. Allied Market Research: Albumin Market Size, Share | Growth Drivers | Forecast- 2032
  2. Frontiers in Cardiovascular Medicine: Association between serum albumin concentration change trajectory ...
  3. Mordor Intelligence: Albumin Market Size Analysis and Growth Report
  4. Frontiers in Nutrition: Associations between serum albumin level trajectories and clinical ...
  5. Fortune Business Insights: Albumin Market | Key products, Applications, End-users [2032]

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