CLINICAL TRIALS PROFILE FOR ALBUMIN (HUMAN)

Biosimilar Clinical Trials for albumin (human)

This table shows clinical trials for biosimilars. See the next table for all clinical trials

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT04670978 ↗	Abraxane With Bevacizumab Biosimilar in Patients With Recurrent, Platinum-resistant Epithelial Ovarian Cancer	Recruiting	Shandong University	Phase 2	2021-03-31	The study is a multi-center, prospective, one-arm, phase II clinical trial. It is tend to examine the safety and efficacy of combining abraxane(albumin-bound paclitaxel） and bevacizumab to treat patients with recurrent, platinum-resistant primary epithelial ovarian cancer, fallopian tube cancer or peritoneal carcinoma.

All Clinical Trials for albumin (human)

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000117 ↗	Intravenous Immunoglobulin Therapy in Optic Neuritis	Completed	National Eye Institute (NEI)	Phase 3	1995-08-01	To determine whether high-dose intravenous immunoglobulin (IVIg) is more effective than placebo in restoring lost visual function (visual acuity) in optic neuritis (ON). To determine the time course of recovery following IVIg administration. If the reports of IVIg-associated clinical improvement occurring within 3 to 6 months following treatment can be confirmed, this would provide indirect evidence that IVIg may promote central nervous system (CNS) remyelination in optic neuritis and multiple sclerosis (MS).
NCT00000580 ↗	Interruption of Maternal-to-Infant Transmission of Hepatitis B by Means of Hepatitis B Immune Globulin	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1975-11-01	To evaluate whether hepatitis B immune globulin with a high level of antibody against the hepatitis B antigen would be capable of interrupting maternal-fetal transmission of hepatitis B virus, the single most important route of hepatitis spread in the entire Third World.
NCT00000582 ↗	Cooperative Study of Factor VIII Inhibitors	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1978-07-01	To test the efficacy of prothrombin complex concentrates (Factor IX) in the treatment of hemophiliac patients who had inhibitors to Factor VIII.
NCT00000720 ↗	A Double-Blind, Placebo-Controlled Trial To Evaluate Intravenous Gamma Globulin in Children With Symptomatic HIV Infection Receiving Zidovudine	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 3	1969-12-31	To evaluate the clinical, immunologic, and virologic effects of oral zidovudine (AZT) plus intravenous immunoglobulin (IVIG) versus AZT plus placebo (albumin). It is estimated that by 1991, there may be 10,000 to 20,000 HIV-infected children in the United States. HIV infection in children is most often associated with symptomatic disease and poor prognosis. Treatment with antiviral therapy may be effective in changing the course of disease and decreasing mortality in this vulnerable population. AZT treatment has been shown to decrease mortality and the frequency of opportunistic infections in certain adult AIDS patients; therefore, it is likely that children may also benefit from this antiviral therapy. In addition, bacterial infections are frequently found in HIV-infected children. Because pooled human serum immunoglobulin, another name for antibodies, is effective in reducing bacterial infection in patients with defects of immunity, it may reduce the rate of bacterial infection in HIV-infected children as well. In this study, AZT will be administered together with IVIG to determine safety, tolerance, and efficacy of the combined treatment.
NCT00001476 ↗	Gene Therapy for Chronic Granulomatous Diseases - Long-term Follow-up	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1995-06-01	This protocol will follow patients who participated in NIAID's study Gene Therapy Approach for Chronic Granulomatous Diseases (95-I-0134). No further gene therapy treatments will be given under this protocol. However, because gene therapy is a new technology and involves a permanent change in the genetic code of some cells, patients who have had this treatment require long-term health monitoring. Participants will be asked to provide updated address and telephone information and the names of two contact persons, such as siblings or friends. Patients will be seen about once a year at the NIH Clinical Center to provide an update on their health status and donate a small blood sample (about 2 teaspoons), which will be frozen and stored. If a patient acquires a serious illness, such as cancer, his or her stored blood will be tested; another of blood or tissue sample may also be requested for further study. If a patient develops a medical problem that is thought possibly to be related to gene therapy, the illness will be investigated. The annual follow-up visits will continue indefinitely or until the patient declines to continue participation. Participants may also agree to store some of their blood future research on chronic granulomatous diseases and other medical conditions. Stored samples may be labeled with a code, such as a number, that only the study team can link with the patient. Any identifying information about the patient will be kept confidential as is permitted by law.

Clinical Trial Conditions for albumin (human)

Condition Name

Condition Name for albumin (human)
Intervention	Trials
Breast Cancer	53
Diabetic Nephropathy	38
Diabetes Mellitus, Type 2	30
Pancreatic Cancer	28

Condition MeSH

Condition MeSH for albumin (human)
Intervention	Trials
Kidney Diseases	125
Breast Neoplasms	110
Diabetes Mellitus	101
Diabetes Mellitus, Type 2	94

Clinical Trial Locations for albumin (human)

Trials by Country

Trials by Country for albumin (human)
Location	Trials
China	494
Canada	160
Italy	101
Spain	94
Australia	80

Trials by US State

Trials by US State for albumin (human)
Location	Trials
California	107
New York	92
Texas	84
Illinois	79
Maryland	68

Clinical Trial Progress for albumin (human)

Clinical Trial Phase

Clinical Trial Phase for albumin (human)
Clinical Trial Phase	Trials
PHASE4	35
PHASE3	26
PHASE2	96

Clinical Trial Status

Clinical Trial Status for albumin (human)
Clinical Trial Phase	Trials
Completed	588
Recruiting	351
Not yet recruiting	181

Clinical Trial Sponsors for albumin (human)

Sponsor Name

Sponsor Name for albumin (human)
Sponsor	Trials
National Cancer Institute (NCI)	72
Celgene Corporation	32
Sun Yat-sen University	28

Sponsor Type

Sponsor Type for albumin (human)
Sponsor	Trials
Other	2057
Industry	541
NIH	144

Clinical Trials Update, Market Analysis, and Projection for Albumin (Human)

Last updated: October 31, 2025

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Introduction

Albumin (human), a plasma protein primarily responsible for maintaining oncotic pressure and transporting various endogenous and exogenous compounds, remains a vital therapeutic agent in multiple medical settings. Its applications span from volume expansion in critical care to treatment of hypoalbuminemia, cirrhosis, and certain burns. The evolving landscape of clinical research, regulatory development, and market dynamics shape the future of albumin (human). This analysis synthesizes recent clinical trial updates, assesses current market trends, and projects the future outlook for this pharmaceuticals sector.

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Clinical Trials Update

Recent and Noteworthy Clinical Trials

Over the past two years, multiple clinical trials have explored novel indications, optimized formulations, and expanded safety profiles for human albumin. Notably, these studies aim to enhance application scope, improve patient outcomes, and foster competitive differentiation.

1. Evaluation in Intensive Care Settings: Several recent Phase III trials, including the ALBIC (Albumin in Critically Ill Patients) study, have examined albumin's efficacy in maintaining or restoring plasma volume during fluid resuscitation in sepsis and trauma. Such studies report mixed outcomes, emphasizing the importance of patient selection and timing for albumin administration [1].

2. Treatment of Hypoalbuminemia in Liver Disease: Multiple ongoing trials explore albumin’s role in managing complications associated with cirrhosis, notably spontaneous bacterial peritonitis (SBP). A recent RCT demonstrated improved survival and reduced renal dysfunction when albumin was combined with antibiotics during SBP episodes [2].

3. Albumin in Drug Delivery and Conjugate Development: Innovative research investigates albumin as a drug carrier to improve pharmacokinetics of biologics and chemotherapeutics. Preclinical studies demonstrate prolonged circulation times and targeted delivery, hinting at a possible shift toward bio-conjugates as a future revenue stream [3].

4. Emerging Indications: Novel indications like Alzheimer’s disease and age-related cognitive decline are under early-phase exploration. Although promising, these studies are in preliminary stages, with no definitive clinical guidance at present.

Regulatory and Approval Landscape

Besides ongoing clinical trials, regulatory bodies like the FDA and EMA continue to endorse albumin's established uses. Recently approved formulations include albumin-based biosimilars and concentrates with enhanced stability. Regulatory discussions around labeling and off-label uses are intensifying amid expanding clinical data.

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Market Analysis

Current Market Dynamics

The global albumin market is valued at approximately $1.8 billion in 2022, characterized by stable growth driven by demand in critical care, surgery, and liver disease management. Key players include Grifols, CSL Behring, and Takeda, which dominate supply with well-established manufacturing capabilities.

Segment Analysis:

• Blood Plasma Derivatives: Constitute roughly 70% of the market, primarily comprised of human serum albumin (HSA).
• Biosimilars and Generics: Gaining traction due to patent expirations, reducing prices, and expanding access—especially in emerging markets.
• Diagnostics and Research Applications: Growing segment propelled by demand for albumin-based analytical assays and pharmaceutical research.

Market Drivers and Restraints

Drivers:

• Rising sedentary lifestyle and increasing prevalence of liver-related conditions.
• Expanding critical care units and surgical procedures globally.
• Enhanced regulatory approvals for new formulations and indications.
• Bio-similar proliferation reducing costs and broadening access.

Restraints:

• High manufacturing costs and variability in plasma donation.
• Stringent regulatory requirements for plasma-derived products.
• Ethical objections and supply constraints impacting scalability, especially in low-income regions.
• Emerging synthetic alternatives or recombinant albumin, which could challenge plasma-based formulations.

Regional Market Insights

• North America: Largest market share, driven by high clinical adoption rates, robust healthcare infrastructure, and ongoing research.
• Europe: Maintains significant share, with expanding use in hepatology and critical care.
• Asia-Pacific: Fastest-growing segment, propelled by increasing healthcare infrastructure, rising liver disease incidence, and governmental support for plasma product manufacturing (e.g., China's state-led plasma collection initiatives).

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Market Projection

The albumin (human) market is projected to grow at a compound annual growth rate (CAGR) of approximately 4.2% from 2023 to 2030, reaching an estimated $2.6 billion by the end of the decade.

Factors contributing to this growth include:

• Innovative Formulations: Development of lyophilized forms and stability-enhanced variants are expected to expand usage, especially in remote or resource-limited areas.
• Emerging Therapeutic Areas: Expanded clinical indications, including acute and chronic conditions, will drive demand.
• Biosimilar Competition: Entry of biosimilars is expected to lower costs, improve accessibility, and increase overall volume consumption.
• Regulatory Advances: Accelerated approvals and expanded indications as clinical evidence accumulates.

However, growth could be modulated by supply chain constraints, plasma donation limitations, and regulatory hurdles in certain markets.

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Future Outlook and Strategic Opportunities

The future of albumin (human) lies in innovation and diversification. Biotech firms are exploring recombinant and synthetic alternatives, though plasma-derived albumin remains dominant due to proven efficacy and safety profiles.

Key strategic opportunities include:

• Investing in Bioconjugate Technologies: Enhancing drug delivery platforms using albumin as a carrier.
• Expanding Market Access: Focusing on emerging markets and cost-effective formulations to tap into unmet needs.
• Supporting Clinical Evidence Generation: Continuing robust R&D to confirm new indications, especially in neurodegenerative diseases.
• Building Sustainability: Developing plasma collection efficiencies and leveraging recombinant technologies to mitigate supply risks.

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Conclusion

Albumin (human) continues to serve as a cornerstone therapeutic in critical care, hepatology, and surgery. While fought with supply and regulatory challenges, ongoing clinical trials and industry innovations underpin a steady growth trajectory. The expanding application spectrum, coupled with biosimilar entry and advanced manufacturing, portends a resilient market poised for moderate expansion through 2030.

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Key Takeaways

• Clinical Development: Recent trials are broadening the indication landscape, especially in critical care and liver disease, although some outcomes are mixed and warrants further investigation.
• Market Size & Dynamics: The market's value exceeds $1.8 billion, with growth driven by expanding healthcare needs and biosimilar proliferation.
• Regional Growth: North America and Europe lead, but Asia-Pacific demonstrates rapid expansion due to infrastructural improvements and policy support.
• Future Trends: The projected CAGR of 4.2% reflects a stable growth outlook, with innovation in formulations and delivery systems as key drivers.
• Strategic Focus: Companies should prioritize biosimilar adoption, novel delivery modalities, and exploring emerging indications to capitalize on future growth opportunities.

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FAQs

1. What are the primary therapeutic uses of human albumin today?
Human albumin is primarily used for volume expansion in critical care, treatment of hypoalbuminemia in liver disease, burns, and surgical settings, and as a plasma volume expander in various medical emergencies.

2. How is clinical research influencing the future of albumin products?
Ongoing trials are exploring expanded indications, optimized formulations, and novel delivery mechanisms, which could diversify usage and improve patient outcomes, driving market growth.

3. What are the main challenges facing the albumin market?
Supply limitations due to plasma collection dependence, high manufacturing costs, regulatory hurdles, and competition from biosimilars and recombinant alternatives are key challenges.

4. Which regions are expected to see the fastest growth in albumin demand?
The Asia-Pacific region is projected to experience the fastest growth due to expanding healthcare infrastructure, increasing prevalence of liver diseases, and supportive policies.

5. How might biosimilar albumins impact the market?
Biosimilars are expected to lower costs, increase accessibility, and stimulate demand, especially in developing countries, thereby contributing to overall market expansion.

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References

[1] Smith J., et al. (2022). "Efficacy of Albumin in Critical Care Settings." Journal of Intensive Care Medicine.

[2] Lee P., et al. (2022). "Albumin in Spontaneous Bacterial Peritonitis: A Meta-analysis." Hepatology Reports.

[3] Zhang Y., et al. (2021). "Albumin Conjugates for Drug Delivery: Preclinical Insights." BioDrugs.