Pooled plasma (human), solvent/detergent treated - Biologic Drug Details

Summary for pooled plasma (human), solvent/detergent treated

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

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 pooled plasma (human), solvent/detergent treated Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for pooled plasma (human), solvent/detergent treated Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAPLAS	pooled plasma (human), solvent/detergent treated	For Injection	125416	10,889,630	2037-02-10	DrugPatentWatch analysis and company disclosures
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAPLAS	pooled plasma (human), solvent/detergent treated	For Injection	125416	4,481,189	2002-04-14	DrugPatentWatch analysis and company disclosures
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAPLAS	pooled plasma (human), solvent/detergent treated	For Injection	125416	4,540,573	2003-07-14	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for pooled plasma (human), solvent/detergent treated 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
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAPLAS	pooled plasma (human), solvent/detergent treated	For Injection	125416	10,624,814	2037-06-01	Patent claims search
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAPLAS	pooled plasma (human), solvent/detergent treated	For Injection	125416	11,098,132	2037-05-16	Patent claims search
Octapharma Pharmazeutika Produktionsges.m.b.h.	OCTAPLAS	pooled plasma (human), solvent/detergent treated	For Injection	125416	4,393,133	2000-06-12	Patent claims search

International Patents for pooled plasma (human), solvent/detergent treated

Country	Patent Number	Estimated Expiration
Russian Federation	2603103
World Intellectual Property Organization (WIPO)	2017137583
Spain	2586698

Market Dynamics and Financial Trajectory for Pooled Plasma (Human), Solvent/Detergent Treated Biologic Drugs

Last updated: August 15, 2025

Introduction

Pooled plasma, especially solvent/detergent (S/D) treated human plasma, plays a critical role in the development and manufacturing of biologic drugs used to treat a range of hematological, immunological, and infectious diseases. As a vital raw material, pooled plasma provides the basis for plasma-derived medicinal products (PDMPs), including clotting factors, immunoglobulins, albumin, and other therapies. This article examines current market dynamics and forecasts the financial future of S/D treated pooled plasma-based biologics.

Market Overview

The global plasma-derived products market was valued at approximately USD 24 billion in 2022, with an expected compound annual growth rate (CAGR) of 6-8% over the next five years [1]. The increasing prevalence of genetic disorders like hemophilia, immune deficiencies, and rare autoimmune diseases Drive the demand for high-quality plasma products.

Key Drivers of Market Growth

• Growing prevalence of blood disorders: Hemophilia A and B, immune deficiencies, and immune thrombocytopenia (ITP) are on the rise globally, especially in emerging economies, fueling demand.
• Advancements in S/D processing: Solvent/detergent treatment enhances pathogen safety, enabling broader use of pooled plasma in licensed biologics by significantly reducing the risk of viral transmission.
• Regulatory embrace and safety standards: Stringent regulations mandating viral inactivation methods intensify the adoption of S/D treated plasma, fostering product safety and industry confidence.
• Biologics expansion: An expanding pipeline of plasma-derived biologics, including newer monoclonal antibody therapies, supports sustained market growth.

Market Dynamics

Technological Innovation and Product Differentiation

The S/D treatment process involves adding solvents and detergents that disrupt lipid-enveloped viruses, such as HIV, HBV, and HCV. This technology has become the standard for plasma safety, significantly decreasing viral transmission risks [2]. Innovations in plasma fractionation, such as chromatography and nanofiltration, further improve yield and product purity, increasing manufacturing efficiency.

Supply Chain and Raw Material Availability

The demand for pooled plasma hinges on reliable, large-scale plasma collection. Geographic disparities persist; high-income nations with advanced plasmapheresis infrastructure dominate supply, while emerging markets increasingly invest in collection facilities, driven by rising disease burden and market incentives. However, volatile donor recruitment, donor eligibility restrictions, and political factors can impact supply stability and cost.

Regulatory Environment

Global regulatory agencies, including the FDA (USA), EMA (Europe), and PMDA (Japan), prioritize product safety and quality. They enforce rigorous standards for plasma processing, emphasizing viral clearance and pathogen reduction. The adoption of S/D treatment is mandated or highly recommended, ensuring a competitive edge for S/D processed plasma products.

Cost Dynamics and Pricing Strategies

Processing pooled plasma into safe, high-purity biologics involves significant costs, including plasma collection, pathogen inactivation, and purification steps. While S/D treatment enhances safety, it adds to manufacturing expenses, impacting product pricing. Nevertheless, safety assurances and regulatory compliance justify premium pricing, especially for life-critical therapies.

Competitive Landscape

Major players, such as Grifols, CSL Behring, Takeda, and Octapharma, dominate the plasma-derived biologics market. They rely heavily on pooled plasma that is S/D treated for safety and quality. Innovation, capacity expansion, and strategic acquisitions shape competitive dynamics, while upcoming entrants focus on niche therapies or alternative plasma processing technologies.

Financial Trajectory Forecast

Revenue Growth Forecast

The S/D treated pooled plasma segment within the broader plasma-derived biologics market is projected to grow at a CAGR of around 6-8% over 2023–2028 [1]. This growth is supported by:

• Rising clinical demand for immunoglobulins and clotting factors.
• Expansion in emerging markets where plasma therapies are underpenetrated.
• Development of novel formulations possibly involving recombinant or synthetic alternatives, which may cannibalize some traditional plasma-derived markets but can also foster overall industry growth through pipeline diversification.

Profitability and Investment Trends

High-margin plasma products stem from economies of scale and technological efficiencies in S/D treatment, which reduce viral transmission liabilities. Companies investing in plasma collection networks and facility upgrades are expected to see revenue enhancement and improved margins.

Venture capital influx is increasingly directed towards novel plasma fractionation techniques and synthetic alternatives, which could pose future competitive threats but presently supplement existing growth trajectories.

Risks and Challenges

• Supply chain disruptions: Dependence on donor pools exposes the industry to fluctuations caused by public health crises, regulatory barriers, or donor fatigue.
• Pricing pressures: Discussions on healthcare affordability and biosimilar entry could limit pricing power.
• Regulatory shifts: Stringent standards or mandates for innovative pathogen reduction methods may increase costs or create market entry barriers.

Market Segments and Regional Outlook

North America and Europe dominate the market, accounting for approximately 60–65% share due to advanced healthcare systems, high demand for plasma-derived treatments, and mature regulatory environments [1].

Emerging Markets—notably China, India, Brazil, and parts of Southeast Asia—are experiencing rapid growth driven by increasing disease burden and infrastructure development, offering long-term revenue opportunities.

Strategic Implications

Manufacturers are focusing on expanding plasma collection, investing in advanced pathogen reduction technologies, and pursuing strategic partnerships. Regulatory harmonization initiatives, such as the ICH guidelines, facilitate global market entry and compliance.

The integration of sustainable practices, including plasma donor retention programs and environmentally friendly processing methods, is gaining importance as part of corporate social responsibility initiatives, impacting long-term financial planning.

Key Takeaways

• The global plasma-derived biologics market is set for sustained growth, driven principally by technological advancements, rising disease prevalence, and regulatory mandates for safety.
• Solvent/detergent treatment remains the gold standard for ensuring viral safety in pooled plasma, supporting industry confidence and market expansion.
• Supply chain stability is critical; expanding collection networks and integrating emerging markets offer significant upside yet pose operational risks.
• Pricing strategies will need balancing between recouping high processing costs and addressing affordability concerns, especially amidst competitive biosimilar options.
• Innovations in synthetic and recombinant therapies could reshape the landscape, prompting established players to diversify portfolios and seek technological differentiation.

Conclusion

The trajectory of pooled plasma, solvent/detergent treated, in the biologic drug space is characterized by robust growth, driven by safety enhancements, expanding indications, and evolving global demand. Industry participants must navigate supply chain complexities, regulatory hurdles, and competitive pressures through strategic investments, technological innovation, and geographic expansion.

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FAQs

1. What advantages does solvent/detergent treatment offer in plasma processing?
S/D treatment effectively inactivates lipid-enveloped viruses such as HIV, HBV, and HCV, significantly improving the safety profile of pooled plasma, fulfilling regulatory requirements, and enabling broader clinical application.

2. How does the rise of synthetic biologics affect the pooled plasma market?
Although synthetic biologics aim to replace plasma-derived products in some indications, current limitations, high efficacy of plasma therapies, and ongoing clinical needs reinforce continued demand. However, synthetic options may exert pricing pressure and influence innovation strategies.

3. What regions present the most growth opportunities for pooled plasma products?
Emerging markets like China, India, and Latin America offer substantial growth opportunities due to increasing disease prevalence, expanding healthcare infrastructure, and rising awareness of plasma therapies.

4. What are the primary risks faced by companies in this market?
Key risks include plasma supply shortages, regulatory changes, competitive biosimilar entries, and geopolitical factors affecting supply chains or market access.

5. Will future innovations replace solvent/detergent treated pooled plasma?
While advances in recombinant and synthetic therapies are promising, they currently complement rather than replace plasma-derived treatments, especially in indications requiring high antibody titers or clotting factor concentrates. The continued development of pathogen inactivation technologies ensures S/D treatment remains central to plasma processing.

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References

[1] Market Research Future, "Global Plasma Derived Medicinal Products Market," 2022.

[2] European Directorate for the Quality of Medicines & HealthCare (EDQM), "Viral Inactivation Technologies in Plasma Fractionation," 2020.