Plasma protein fraction (human) - Biologic Drug Details

Summary for plasma protein fraction (human)

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for plasma protein fraction (human)

Recent Clinical Trials for plasma protein fraction (human)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of Leeds	PHASE2
Ain Shams University	PHASE1
Chang Gung Memorial Hospital	NA

See all plasma protein fraction (human) clinical trials

Pharmacology for plasma protein fraction (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 plasma protein fraction (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for plasma protein fraction (human) Derived from DrugPatentWatch Analysis and Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for plasma protein fraction (human) Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Plasma Protein Fraction (Human)

Last updated: February 16, 2026

What Is Plasma Protein Fraction (Human) and Its Market Role?

Plasma protein fraction (PPF) refers to a blood product derived from plasma, focused mainly on immunoglobulins, albumins, and other plasma proteins. It is used for various indications including immune deficiencies, infections, and autoimmune disorders. PPF is marketed primarily as intravenous immunoglobulin (IVIG) and albumin products.

What Are the Key Market Drivers?

1. Expanding Clinical Applications
   Growing use in immune deficiencies, autoimmune diseases, and neurological disorders increases demand. Immunoglobulin therapy, in particular, has seen widespread adoption in primary immunodeficiency diseases (PID), with compounded annual growth rates (CAGR) of 8-10% over the past five years [1].

2. Aging Population
   An increasing population over 65 years old, more susceptible to immunodeficiency and autoimmune conditions, propels market growth. The global aging population is projected to reach 1.5 billion by 2050 [2].

3. Rising Prevalence of Autoimmune Diseases
   Conditions like multiple sclerosis, myasthenia gravis, and Guillain-Barré syndrome drive higher IVIG utilization.

4. Advancements in Manufacturing & Supply
   Improvements in plasma collection and fractionation processes have increased yields, reduced costs, and improved safety profiles, boosting market accessibility.

What Are the Challenges?

1. Supply Constraints
   Dependence on plasma donations limits production growth potential. Donor availability and plasma collection centers are critical bottlenecks.

2. High Cost & Reimbursement Pressures
   Treatments are expensive. Reimbursement policies vary globally, pressuring profit margins and limiting patient access in certain markets.

3. Regulatory Landscape
   Stringent approval processes in regions such as the U.S. and Europe delay product launches and impact market expansion strategies.

4. Emergence of Biosimilars
   Biosimilar versions of immunoglobulin products are under development, threatening market share of branded formulations.

What Is the Current Market Size and Financial Trajectory?

Market Size (2022)

• Estimated global market value for plasma protein fractions, primarily IVIG, approximated at USD 16 billion [3].
• North America dominates with around 45% market share, followed by Europe and Asia-Pacific.

Growth Forecast (2023-2028)

• CAGR projected at 7-9%, driven by expanding indications and aging demographics.
• By 2028, market value expected to approach USD 25-27 billion based on current trendlines.

Revenue by Product Type

Product Type	2022 Market Share	Growth Rate (2023-2028)	Key Players
Intravenous Immunoglobulin (IVIG)	75%	7-9%	CSL Behring, Grifols, Takeda
Albumin	15%	2-3%	Baxter, BPL, CSL
Hyperimmune Globulins	10%	8-10%	Kedrion, Beijing Kinghorse

Geographic Trends

• North America accounts for >45% of revenues, driven by high disease prevalence and advanced healthcare infrastructure.
• Europe holds 30%, with growth fueled by regulatory approvals and aging demographics.
• Asia-Pacific exhibits the highest CAGR (~10%), reflecting increasing healthcare access and plasma collection capacity.

How Are Industry Players Positioned?

Major competitors include CSL Behring, Grifols, Takeda, BPL, and Kedrion. These organizations prioritize innovation, plasma collection expansion, and strategic partnerships.

• CSL Behring leads with ~40% market share, utilizing its extensive plasma donation network.
• Grifols emphasizes geographic expansion and biosimilar development.
• Takeda invests significantly in R&D for new immunoglobulin formulations.

What Are the Future Financial and Market Trends?

• Increased investments in plasma collection infrastructure, such as in India and China, aim to alleviate supply constraints.
• Deployment of pathogen inactivation and recombinant technologies enhances product safety, supporting regulatory approval.
• Biosimilar development poses both a threat and a growth opportunity; although biosimilars currently have limited approval, their market entry may erode margins for some branded products.

What Are the Implications for Stakeholders?

• Investors should monitor plasma supply capacity expansion, regulatory environments, and biosimilar pipelines.
• Manufacturers must balance between innovation, quality improvement, and cost management.
• Healthcare providers will need to adapt to evolving treatment protocols and reimbursement models.

Key Takeaways

• The plasma protein fraction market is growing at a compound annual rate of approximately 8%, driven by expanding clinical uses and demographic shifts.
• Supply limitations from plasma donation bottlenecks threaten to constrain growth, compelling investments in plasma collection infrastructure.
• A focus on biosimilar development, safety innovations, and geographic expansion will shape industry competitiveness.
• High treatment costs and regulatory variability influence access and profitability.

FAQs

1. Which regions are expected to see the fastest growth in plasma protein fraction demand?
Asia-Pacific exhibits the highest CAGR (~10%) over the next five years due to increasing healthcare infrastructure and plasma collection capacity.

2. How do biosimilars impact the plasma protein fraction market?
Biosimilars present a competitive threat by potentially lowering prices; however, their limited approval and development pipelines means branded products currently dominate.

3. What are the primary clinical indications for plasma protein fractions?
Immune deficiencies, autoimmune diseases, neurological disorders (e.g., multiple sclerosis), and hemorrhagic conditions such as burns and shock.

4. What are key factors affecting supply in this market?
Plasma donation rates, donor pool size, collection infrastructure, donor eligibility criteria, and geopolitical factors.

5. How might regulatory changes influence market growth?
Stricter regulatory standards can delay product approvals and increase compliance costs; conversely, streamlined regulations may accelerate market entry.

References

[1] MarketsandMarkets, “Intravenous Immunoglobulin Market,” 2022.
[2] United Nations Department of Economic and Social Affairs, “World Population Aging,” 2022.
[3] Grand View Research, “Plasma Protein Fraction Market Size, Share & Trends,” 2023.