CLINICAL TRIALS PROFILE FOR PLASMA PROTEIN FRACTION (HUMAN)

All Clinical Trials for plasma protein fraction (human)

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00126503 ↗	Sorafenib Tosylate and Bevacizumab in Treating Patients With Advanced Kidney Cancer	Completed	National Cancer Institute (NCI)	Phase 1/Phase 2	2005-05-01	This phase I/II trial studies the side effects and best dose of sorafenib tosylate and bevacizumab and to see how well they work in treating patients with advanced kidney cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as bevacizumab, can block tumor growth by targeting certain cells. Bevacizumab and sorafenib tosylate may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving sorafenib tosylate together with bevacizumab may kill more tumor cells.
NCT00182091 ↗	Effects of Growth Hormone Administration on Cardiovascular Risk in Cured Acromegalics With Growth Hormone Deficiency	Completed	Massachusetts General Hospital	N/A	2004-08-01	The purpose of the study is to evaluate the effects of growth hormone (GH) replacement in men and women with a history of acromegaly and who are now growth hormone deficient. We will compare them to persons with a history of acromegaly who have normal GH levels. Acromegaly results when an area in the brain, called the pituitary, produces too much growth hormone. When an individual is cured of acromegaly, the growth hormone levels may be normal or low (that is GH deficiency). Growth hormone deficiency means the body no longer produces as much growth hormone because the pituitary/hypothalamic region was damaged by a tumor or by treatment received. We will study the effects of growth hormone replacement on the health of the heart and blood vessels of GH deficient persons by looking to see if this therapy: 1. has effects on cardiovascular risk markers (special blood tests which indicate how healthy your heart and arteries are) 2. affects the stiffness of the arteries 3. affects your heart rate and the capacity of your heart to respond to changes in body position 4. has different effects depending on whether you are taking estrogen / testosterone. We will assess these measures of health on one occasion in persons with cured acromegaly and normal GH levels and in persons with cured acromegaly who have GH deficiency and a contraindication to receiving GH. GH deficient individuals with no contraindication to receiving GH, will participate in the study for 12 months. Individuals with normal GH levels, or who are GH deficient and have a contraindication to receiving GH, will be asked to return for one more visit (without any interventions).
NCT00223704 ↗	Bradykinin Receptor Antagonism During Cardiopulmonary Bypass	Completed	Vanderbilt University	Phase 2/Phase 3	2006-05-01	Each year over a million patients worldwide undergo cardiac surgery requiring cardiopulmonary bypass (CPB). CPB is associated with significant morbidity including the transfusion of allogenic blood products, inflammation and hemodynamic instability. In fact, approximately 20% of all blood products transfused are associated with coronary artery bypass grafting procedures. Transfusion of allogenic blood products is associated with well-documented morbidity and increased mortality after cardiac surgery. Enhanced fibrinolysis contributes to increased blood product transfusion in the perioperative period. The current proposal tests the central hypothesis that endogenous bradykinin contributes to the hemodynamic, fibrinolytic and inflammatory response to CPB and that bradykinin receptor antagonism will reduce hypotension, inflammation and transfusion requirements. In SPECIFIC AIM 1 we will test the hypothesis that the fibrinolytic and inflammatory response to CPB differ during ACE inhibition and angiotensin II type 1 receptor antagonism. In SPECIFIC AIM 2 we will test the hypothesis that bradykinin B2 receptor antagonism attenuates the hemodynamic, fibrinolytic, and inflammatory response to CPB. In SPECIFIC AIM 3 we will test the hypothesis that bradykinin B2 receptor antagonism reduces the risk of allogenic blood product transfusion in patients undergoing CPB. These studies promise to provide important information regarding the effects of drugs that interrupt the RAS and generate new strategies to reduce morbidity in patients undergoing CPB.
NCT00223704 ↗	Bradykinin Receptor Antagonism During Cardiopulmonary Bypass	Completed	Vanderbilt University Medical Center	Phase 2/Phase 3	2006-05-01	Each year over a million patients worldwide undergo cardiac surgery requiring cardiopulmonary bypass (CPB). CPB is associated with significant morbidity including the transfusion of allogenic blood products, inflammation and hemodynamic instability. In fact, approximately 20% of all blood products transfused are associated with coronary artery bypass grafting procedures. Transfusion of allogenic blood products is associated with well-documented morbidity and increased mortality after cardiac surgery. Enhanced fibrinolysis contributes to increased blood product transfusion in the perioperative period. The current proposal tests the central hypothesis that endogenous bradykinin contributes to the hemodynamic, fibrinolytic and inflammatory response to CPB and that bradykinin receptor antagonism will reduce hypotension, inflammation and transfusion requirements. In SPECIFIC AIM 1 we will test the hypothesis that the fibrinolytic and inflammatory response to CPB differ during ACE inhibition and angiotensin II type 1 receptor antagonism. In SPECIFIC AIM 2 we will test the hypothesis that bradykinin B2 receptor antagonism attenuates the hemodynamic, fibrinolytic, and inflammatory response to CPB. In SPECIFIC AIM 3 we will test the hypothesis that bradykinin B2 receptor antagonism reduces the risk of allogenic blood product transfusion in patients undergoing CPB. These studies promise to provide important information regarding the effects of drugs that interrupt the RAS and generate new strategies to reduce morbidity in patients undergoing CPB.

Clinical Trial Conditions for plasma protein fraction (human)

Condition Name

Condition Name for plasma protein fraction (human)
Intervention	Trials
Myeloma-Multiple	3
Myeloma, Plasma-Cell	3
Ductal Breast Carcinoma In Situ	2
Infection, Bacterial	2

Condition MeSH

Condition MeSH for plasma protein fraction (human)
Intervention	Trials
Diabetes Mellitus	5
Neoplasms, Plasma Cell	4
Multiple Myeloma	4
COVID-19	4

Clinical Trial Locations for plasma protein fraction (human)

Trials by Country

Trials by Country for plasma protein fraction (human)
Location	Trials
United States	39
Canada	8
Argentina	5
Egypt	3
Belgium	2

Trials by US State

Trials by US State for plasma protein fraction (human)
Location	Trials
Maryland	6
Illinois	4
Texas	3
Tennessee	3
Pennsylvania	3

Clinical Trial Progress for plasma protein fraction (human)

Clinical Trial Phase

Clinical Trial Phase for plasma protein fraction (human)
Clinical Trial Phase	Trials
PHASE4	2
PHASE2	2
PHASE1	1

Clinical Trial Status

Clinical Trial Status for plasma protein fraction (human)
Clinical Trial Phase	Trials
Completed	29
Recruiting	15
Not yet recruiting	9

Clinical Trial Sponsors for plasma protein fraction (human)

Sponsor Name

Sponsor Name for plasma protein fraction (human)
Sponsor	Trials
National Cancer Institute (NCI)	9
Assaf-Harofeh Medical Center	2
National Institute on Drug Abuse (NIDA)	2

Sponsor Type

Sponsor Type for plasma protein fraction (human)
Sponsor	Trials
Other	71
NIH	13
Industry	9

Clinical Trials Update, Market Analysis, and Projection for Plasma Protein Fraction (Human)

Last updated: October 31, 2025

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Introduction

Plasma Protein Fraction (Human), commonly known as human plasma protein, plays a critical role in treating a range of medical conditions, including immune deficiencies, coagulation disorders, and burn injuries. As the healthcare landscape evolves with advancements in biopharmaceuticals, the clinical development, regulatory landscape, and commercial potential of plasma protein products are dynamic and significant. This report provides a comprehensive update on clinical trials, market analysis, and future projections surrounding plasma protein fraction (human).

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Clinical Trials Landscape

Current Clinical Trial Status

The development pipeline for plasma protein products continues to be active worldwide, particularly focusing on immunoglobulin therapies, albumin, and other clotting factor concentrates. As of 2023, over 30 clinical trials are registered globally, spanning phases I through III, primarily centered on novel formulations, enhanced safety profiles, and expanded indications.

Key ongoing trials are examining:

• Improved Immunoglobulin Therapies: New formulations aim to optimize efficacy and minimize adverse reactions in immunodeficiency patients. Notably, multiple phase III trials are evaluating subcutaneous versus intravenous administration routes, seeking enhanced patient compliance and quality of life.
• Albumin Expansion: Novel recombinant strategies are in early phases to address supply constraints and immunogenicity concerns associated with plasma-derived albumin. These include recombinant human serum albumin (rHSA) candidates undergoing phase I and II trials.
• Coagulation Factor Products: Enhanced clotting factor concentrates with longer half-lives and reduced immunogenicity are advancing through trial phases, aiming to improve management of hemophilia A and B.

Regulatory and Development Trends

The COVID-19 pandemic’s impact temporarily slowed some trial activities, but regulatory agencies, notably the FDA and EMA, have issued guidelines to ensure safety and accelerate approval timelines for plasma-derived products. Additionally, several companies leverage advanced biomanufacturing techniques, such as plasma fractionation optimized via chromatography and affinity purification, to expedite development.

Emerging Innovations

• Recombinant Plasma Proteins: Efforts accelerate the replacement of plasma-derived products with recombinant proteins (e.g., recombinant albumin), reducing pathogen transmission risks.
• Nanoparticle-Enhanced Delivery: Investigative trials are exploring conjugated plasma proteins with nanocarriers for targeted delivery, promising improved bioavailability.

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Market Dynamics

Market Size and Growth Drivers

The global plasma protein therapeutics market was valued at approximately USD 14.2 billion in 2022 and is projected to grow at a CAGR of 6.3% through 2030, driven by:

• Rising prevalence of immunodeficiency disorders, including primary immunodeficiency (PID) and secondary immune suppression due to chemotherapy or HIV/AIDS.
• Increasing aging populations with comorbidities requiring plasma protein therapies.
• Advances in manufacturing, making plasma protein products more accessible and affordable.

Regional Market Analysis

• North America: Dominates the market, accounting for over 40% of sales, thanks to robust healthcare infrastructure, high diagnosis rates, and advanced regulatory approval processes. The U.S. remains the largest consumer, with Moderna and CSL Behring among leading suppliers.
• Europe: Represents roughly 30% of the market, with significant demand in Germany, France, and the UK. Stringent regulatory standards, however, influence market access.
• Asia-Pacific: Exhibits the highest growth potential — CAGR estimated at 8.4% — fueled by increasing healthcare investments, expanding healthcare coverage, and rising awareness. Countries like China and India are witnessing rapid adoption of plasma therapies.

Key Market Players

Leading manufacturers include CSL Behring, Grifols S.A., Takeda Pharmaceutical Company, and Octapharma AG, which dominate through extensive plasma collection networks and advanced manufacturing. Emerging biotech firms focus on recombinant technologies and personalized plasma-based therapies, potentially disrupting traditional market dynamics.

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Market Projections

Future Outlook (2023-2030)

The plasma protein fraction market is poised for sustained growth, driven by:

• Innovative Formulations: Next-generation products with improved safety and administration profiles will expand therapeutic applications.
• Expanding Indications: Beyond traditional uses, exploring applications in neurological, infectious, and regenerative medicine broadens demand.
• Recombinant Alternatives: Transition from plasma-derived to recombinant-based products is anticipated, reducing reliance on donor plasma and expanding supply stability.
• Regulatory Approvals: Increased approvals of novel plasma proteins will facilitate market expansion, especially in emerging economies.

Forecasts predict the market will reach approximately USD 25.4 billion by 2030, with North America and Asia-Pacific leading growth segments.

Impact of Technological Advancements

Developments such as plasma fractionation automation, gene editing for recombinant protein production, and bioprocess optimization will lower costs and enhance product quality, further accelerating market proliferation.

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Regulatory and Ethical Considerations

Stringent regulations surrounding plasma collection, pathogen safety, and traceability govern the industry. International standards, like those from the WHO and pharmacopoeias, mandate rigorous donor screening and viral inactivation steps. Ethical sourcing and donor compensation remain sensitive topics, influencing supply chain sustainability.

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Key Takeaways

• Active Clinical Pipeline: Over 30 ongoing clinical trials focus on improving efficacy, safety, and administration of plasma protein therapies, with translational potential for broader indications.
• Growing Market: The global market is poised for substantial growth (CAGR of over 6%), driven by aging populations, technological innovation, and expanding indications.
• Geographic Leadership & Opportunities: North America leads, while Asia-Pacific offers exceptional growth prospects due to healthcare expansion.
• Innovation & Competition: Recombinant plasma proteins and advanced biomanufacturing techniques threaten to disrupt traditional plasma-derived product markets.
• Regulatory Trends: Enhanced safety standards and accelerated approval pathways are facilitating modernization and expansion of plasma protein therapies.

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FAQs

Q1: What are the primary therapeutic indications for plasma protein fractions?
A1: The main uses include immune deficiencies (immunoglobulin therapy), coagulation disorders like hemophilia (clotting factors), and volume expansion in burns and shock (albumin).

Q2: How is recombinant technology impacting the plasma protein market?
A2: Recombinant proteins offer reduced pathogen transmission risk, higher supply consistency, and potential cost reductions, challenging traditional plasma-derived products.

Q3: What are the key challenges facing plasma protein therapeutics development?
A3: Challenges include plasma supply limitations, high manufacturing costs, stringent regulatory requirements, and ethical considerations related to plasma donation.

Q4: Which regions are expected to see the fastest growth in plasma protein therapy adoption?
A4: The Asia-Pacific region is expected to outpace others, driven by expanding healthcare infrastructure and increased awareness.

Q5: How do recent clinical trials influence future market growth?
A5: Successful trials demonstrating improved efficacy and safety expand therapeutic indications and patient base, supporting market expansion and innovation investments.

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Conclusion

The plasma protein fraction (human) market is undergoing a transformative phase characterized by active clinical development, technological innovation, and expanding geographic reach. The ongoing clinical trials target improved safety and expanded applications, setting the stage for robust future growth. Market projections underscore a promising outlook through 2030, catalyzed by recombinant technologies and increased global demand. To capitalize on these trends, industry stakeholders must navigate regulatory landscapes, innovate continuously, and address ethical and supply chain challenges proactively.

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References

1. [1] Global Plasma Protein Therapeutics Market Size & Trends Report, 2023-2030.
2. [2] ClinicalTrials.gov. "Plasma Protein Fraction (Human) Clinical Trials."
3. [3] World Health Organization. Guidelines on plasma-derived medicines.
4. [4] MarketWatch. "Plasma Protein Market Outlook."
5. [5] European Medicines Agency (EMA). Regulatory Framework for Plasma-Derived Products.