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Last Updated: February 12, 2025

Plasma protein fraction (human) - Biologic Drug Details


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Summary for plasma protein fraction (human)
Tradenames:1
High Confidence Patents:0
Applicants:1
BLAs:1
Suppliers: see list1
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

SponsorPhase
Tomsk National Research Medical Center of the Russian Academy of SciencesN/A
Leiden University Medical CenterPhase 2
University Medical Center GroningenPhase 2

See all plasma protein fraction (human) clinical trials

Pharmacology for plasma protein fraction (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 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 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)

Market Overview

The plasma protein fraction (human) market is an integral part of the broader plasma fractionation and plasma protein therapeutics markets. Here, we delve into the key market dynamics and the financial trajectory of this biologic drug.

Global Market Size and Growth

The global plasma fraction market, which includes plasma protein fraction (human), was valued at approximately $32.75 billion in 2023. This market is projected to grow to $72.86 billion by 2034, with a compound annual growth rate (CAGR) of 7.54% from 2024 to 2034[1].

Similarly, the global plasma protein therapeutics market, which encompasses plasma protein fraction, was valued at $26.5 billion in 2021 and is expected to reach $44.3 billion by 2031, growing at a CAGR of 5.2% from 2022 to 2031[3].

Drivers of Market Growth

Increasing Demand for Plasma-Derived Products

The rising demand for plasma-derived medicinal products (PDMPs) is a significant driver of the market. This demand is fueled by the need to treat various medical conditions, including immunodeficiencies, genetic defects, rabies, tetanus, shock, and trauma. The prevalence of global diseases such as immunodeficiencies and genetic disorders propels manufacturing companies to produce large quantities of high-quality medicine, thereby boosting the market[1].

Technological Advancements

Advancements in plasma fractionation technologies and the integration of recombinant DNA technology have enhanced the production and efficacy of plasma protein therapeutics. For instance, CSL's use of recombinant technology to generate improved molecules with extended half-lives has significantly benefited patients, making treatments more efficient and less frequent[2].

Expanding Applications

Plasma protein fraction (human) is used in a variety of clinical applications, including the treatment of coagulation factor deficiencies, reversing anticoagulant effects, and managing shock from plasma fluid loss. The expansion of these applications into new therapeutic areas continues to drive market growth[5].

Regional Market Dynamics

North America

North America dominates the plasma fraction market, largely due to the United States being a major exporter of plasma. The U.S. supplies about 70% of the world’s plasma, which is used for the production of PDMPs. This region is expected to continue its dominance due to increasing awareness and government initiatives promoting research activities for new plasma protein therapeutics[1][3].

Asia-Pacific

The Asia-Pacific region is expected to grow at the highest rate during the forecast period. This growth is attributed to the presence of pharmaceutical companies, increasing healthcare expenditure, and rising disposable incomes in countries like China and India. The growing prevalence of hemophilia and other bleeding disorders in this region also contributes to the market's expansion[3][4].

Financial Trajectory

Revenue Projections

The global plasma fractionation market is projected to grow from $35.21 billion in 2024 to $62.83 billion by 2032, exhibiting a CAGR of 7.5% during the forecast period. This significant growth indicates a robust financial trajectory for plasma protein fraction (human) and related products[4].

Cost and Sustainability

Despite the growth, the market faces challenges related to the high cost of plasma-derived products. The cost of plasma per liter has increased substantially, by 59.3% in Europe and 40.7% in the United States over the last five years. This increase directly impacts the sustainability of PDMP production, particularly during periods of high demand such as pandemics[1].

Market Segments

By Application

The hospital segment currently holds the largest market share due to the extensive use of plasma protein for patient treatment in hospitals. These proteins are crucial for recovering from burns, trauma, animal bites, shocks, major surgery, and various other medical conditions[1].

By Product Type

The coagulation factors segment is expected to grow at the fastest rate during the projected period. This growth is driven by the use of these factors in treating blood clotting diseases such as hemophilia and Von Willebrand’s disease[1].

Competitive Landscape

The market is characterized by the presence of several key players, including CSL, Grifols, and others. These companies are investing heavily in research and development to produce advanced and innovative plasma protein therapeutics. The competitive landscape is further shaped by the integration of new technologies and the expansion of product portfolios[2][3].

Challenges and Opportunities

High Cost and Shortages

The high cost of plasma-derived products and occasional shortages, especially during pandemics, pose significant challenges to the market. However, these challenges also present opportunities for innovation and cost reduction through technological advancements and increased donor participation[1].

Regulatory Environment

The regulatory environment plays a crucial role in the market. Products like plasma protein fraction (human) are subject to strict regulations, including those set by the FDA, which ensures the safety and efficacy of these biologics. Compliance with these regulations is essential for market growth[5].

Key Takeaways

  • The global plasma fraction market, including plasma protein fraction (human), is projected to grow significantly, driven by increasing demand for PDMPs and technological advancements.
  • North America dominates the market, but the Asia-Pacific region is expected to grow at the highest rate.
  • The high cost of plasma-derived products and occasional shortages are key challenges, but they also drive innovation.
  • The hospital segment and coagulation factors segment are critical areas of growth.
  • Regulatory compliance is essential for the safe and effective production of plasma protein fraction (human).

Frequently Asked Questions

What is the current market size of the global plasma fraction market?

The global plasma fraction market was estimated at US$ 32.75 billion in 2023[1].

What is the projected growth rate of the plasma fraction market?

The market is projected to grow at a CAGR of 7.54% from 2024 to 2034[1].

Which region dominates the plasma fraction market?

North America dominates the plasma fraction market, with the United States being a major exporter of plasma[1].

What are the primary applications of plasma protein fraction (human)?

Plasma protein fraction (human) is used to treat coagulation factor deficiencies, reverse anticoagulant effects, and manage shock from plasma fluid loss[5].

What are the main challenges facing the plasma fraction market?

The main challenges include the high cost of plasma-derived products and occasional shortages, particularly during pandemics[1].

Sources

  1. Towards Healthcare: Plasma Fraction Market Size, Shares & 7.54% CAGR by 2034
  2. YouTube: CSL Documentary: Episode 3 - Plasma Proteins
  3. Allied Market Research: Plasma Protein Therapeutics Market Size, Share | Report - 2031
  4. Fortune Business Insights: Plasma Fractionation Market Size, Share | Global Report [2032]
  5. DrugBank: Plasma protein fraction (human) - DrugBank

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