Prothrombin complex concentrate (human) - Biologic Drug Details

Summary for prothrombin complex concentrate (human)

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for prothrombin complex concentrate (human)

Recent Clinical Trials for prothrombin complex concentrate (human)

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Second Affiliated Hospital, School of Medicine, Zhejiang University	N/A
Medical University of Vienna	Phase 4
Sham Sunder Kakar	Phase 1/Phase 2

See all prothrombin complex concentrate (human) clinical trials

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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. General brand-side disclosures

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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 prothrombin complex concentrate (human) Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for prothrombin complex concentrate (human) Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for prothrombin complex concentrate (human) Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Prothrombin Complex Concentrate (Human)

Market Overview

The global market for prothrombin complex concentrates (PCCs) is experiencing significant growth, driven by several key factors. As of 2023, the market was valued at approximately USD 2.1 billion and is projected to expand substantially over the next decade[4].

Market Size and Growth Projections

• The global PCC market is expected to reach USD 1.2 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 4.1% from 2023 to 2033[1].
• Alternatively, some reports suggest a more aggressive growth rate, with the market expected to reach USD 4.7 billion by 2032, growing at a CAGR of 9.4% from 2024 to 2032[4].
• Another forecast indicates the market could reach as high as USD 1,803 billion by 2030, with a CAGR of 9.9% from 2022 to 2030[3].

Key Drivers of Market Growth

Increasing Incidence of Coagulation Disorders

The rising prevalence of bleeding disorders such as hemophilia and von Willebrand disease is a significant driver. For instance, in the United States, hemophilia affects about 20,000 people, and von Willebrand disease affects 1% of the population[1].

Emergency Medicine and Acute Bleeding

The use of PCCs in emergency settings, such as treating warfarin-induced anticoagulation with major acute bleeding or intracerebral hemorrhage, is a critical growth factor. The availability of PCCs in emergency departments and trauma centers has significantly increased demand[2].

Technological Advancements and Product Innovation

The development of novel PCC products, including non-activated PCCs and recombinant factor VIII products, has improved patient safety and efficacy. Personalized medicine approaches, tailoring products to individual patient needs, are also gaining traction[1].

Regulatory Approvals and Healthcare Policies

Approval by regulatory bodies and the introduction of new health insurance policies covering rare blood illnesses have further boosted market growth. The expansion of plasma collection centers in regions like North America also contributes to this trend[3].

Regional Market Analysis

North America

North America, particularly the United States, is a significant market for PCCs. The U.S. market was valued at USD 720.5 million in 2023 and is expected to reach USD 1.7 billion by 2032. The presence of major players and the growth in plasma collection centers are key drivers[4].

Asia Pacific

The Asia Pacific region, including countries like China and India, is expected to grow at the fastest CAGR. Increasing healthcare accessibility, the growing middle-class population, and the demand for minimally invasive medical procedures are driving this growth[3].

India and China

India, with its large population and significant number of patients with coagulation disorders (estimated 450,000 hemophilia patients), presents a lucrative market. China also offers substantial growth opportunities due to its expanding healthcare infrastructure and increasing awareness of bleeding disorders[1].

End-User Segmentation

The market is segmented into various end-users, including hospitals, ambulatory surgical centers, and others. Hospitals dominate the market, accounting for the largest share, and are expected to continue their strong growth due to increased financing for healthcare treatments and growing awareness of early diagnosis[3].

Product Type and Application Segmentation

The market is segmented into 4-factor PCC and 3-factor PCC, with the 4-factor PCC segment dominating. In terms of application, acquired coagulation factor deficiency is the leading segment, followed by congenital coagulation factor deficiency and other applications[4].

Market Challenges and Opportunities

Challenges

Despite the growth, the market faces challenges such as high production costs, stringent regulatory requirements, and the need to address side effects associated with PCCs.

Opportunities

Collaborations between manufacturers and local distributors, as well as the increasing focus on personalized medicine, offer significant opportunities for market expansion. The growing demand for plasma-related therapies and the approval of new products by regulatory bodies also present favorable conditions for growth[1][4].

Key Players and Market Share

Companies like Shire, Octapharma AG, and CSL Behring GmbH dominate the market, holding approximately 80% of the global revenue share. These companies are investing in product innovation and distribution strategies to maintain their market position[1].

Financial Trajectory

The financial trajectory of the PCC market is robust, with significant investments in research and development, distribution, and marketing. The market's growth is supported by increasing healthcare spending, government initiatives to improve healthcare infrastructure, and the expanding middle-class population in key regions[3].

Illustrative Statistics

• Market Value 2023: USD 2.1 billion[4]
• Projected Market Value 2032: USD 4.7 billion[4]
• CAGR 2024-2032: 9.4%[4]
• Prevalence of Hemophilia in the U.S.: Approximately 20,000 people[1]
• Prevalence of von Willebrand Disease in the U.S.: 1% of the population[1]
• Number of Hemophilia Patients in India: Estimated 450,000[1]

Quotes from Industry Experts

"The increasing incidence of coagulation disorders and the growing demand for plasma-related therapies are driving the growth of the prothrombin complex concentrate market globally." - Industry Analyst[4]

Highlight and Citation

"Prothrombin complex concentrate is now indicated for the urgent reversal of acquired coagulation factor deficiency, specifically in patients experiencing warfarin-induced anticoagulation with major acute bleeding, such as intracerebral hemorrhage, or those requiring emergency surgery."[2]

Key Takeaways

• The global PCC market is expected to grow significantly over the next decade, driven by increasing incidence of coagulation disorders and technological advancements.
• North America and the Asia Pacific region are key markets, with the latter expected to grow at the fastest CAGR.
• Hospitals are the dominant end-users, and 4-factor PCCs are the leading product type.
• Market challenges include high production costs and regulatory hurdles, but opportunities abound in personalized medicine and expanding healthcare infrastructure.

FAQs

Q: What is the current market size of the prothrombin complex concentrate market? A: As of 2023, the global prothrombin complex concentrate market was valued at approximately USD 2.1 billion[4].

Q: What is the projected growth rate of the PCC market from 2024 to 2032? A: The market is expected to grow at a CAGR of 9.4% from 2024 to 2032[4].

Q: Which region is expected to grow the fastest in the PCC market? A: The Asia Pacific region is expected to grow at the fastest CAGR during the forecast period[3].

Q: What are the main applications of prothrombin complex concentrates? A: The main applications include acquired coagulation factor deficiency, congenital coagulation factor deficiency, and other applications such as emergency reversal of anticoagulation[2][4].

Q: Who are the key players in the prothrombin complex concentrate market? A: Companies like Shire, Octapharma AG, and CSL Behring GmbH dominate the market, holding approximately 80% of the global revenue share[1].

Sources Cited

1. Future Market Insights, "Prothrombin Complex Concentrates Market Share Report 2033".
2. NCBI Bookshelf, "Prothrombin Complex Concentrate - StatPearls".
3. Spherical Insights, "Prothrombin Complex Concentrates Market Size, Forecast 2030".
4. Global Market Insights, "Prothrombin Complex Concentrate Market Size & Share Report, 2032".

Last updated: 2024-12-16