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Last Updated: January 20, 2025

KCENTRA Drug Profile


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Summary for Tradename: KCENTRA
High Confidence Patents:0
Applicants:1
BLAs:1
Recent Clinical Trials: See clinical trials for KCENTRA
Recent Clinical Trials for KCENTRA

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Oregon Health and Science UniversityPhase 2
University of MarylandPhase 3
Kathirvel SubramaniamPhase 3

See all KCENTRA clinical trials

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 KCENTRA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for KCENTRA Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for KCENTRA Derived from Patent Text Search

No patents found based on company disclosures

Market Dynamics and Financial Trajectory for Kcentra

Introduction to Kcentra

Kcentra, a 4-factor prothrombin complex concentrate (4F-PCC), is a biologic drug used for the reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA) therapy. It is particularly crucial for patients requiring urgent surgical procedures or experiencing major bleeding.

Market Size and Growth

The global prothrombin complex concentrate (PCC) market, which includes Kcentra, has been experiencing significant growth. In 2019, the global PCC market was valued at USD 695.3 million and is projected to reach USD 2,385.3 million by 2032, with a Compound Annual Growth Rate (CAGR) of 9.6% during the forecast period[1].

Dominant Market Segment

The 4-factor PCC segment, which includes Kcentra, dominates the market. This segment accounted for the maximum portion of the PCC market share in 2019 due to its clinically proven efficacy for urgent warfarin reversal and improved penetration in emerging countries. The 4-factor PCC brands, such as Kcentra and Beriplex, have seen increased adoption, especially in regions like North America and Europe[1].

Regional Market Performance

North America

North America holds a significant share of the PCC market, with the market size valued at USD 305.9 million in 2019. The strategic presence of major manufacturers, FDA approval for 4-factor PCC, and increasing sales of Kcentra are key factors contributing to this dominance. For instance, Canada's high consumption of factor IX, as reported by the World Federation of Hemophilia, further supports the market growth in this region[1].

Europe

Europe is another key market, driven by the increasing off-label use of 4-factor PCC products like Cofact and Octaplex, and the rapid adoption of activated PCC. Grifols S.A.'s efforts to maintain plasma center operations during the COVID-19 crisis have also boosted the market in Europe[1].

Asia Pacific

The Asia Pacific region is anticipated to witness remarkable growth due to the rising prescription rate of warfarin and the increasing number of patients using Kcentra, particularly in Japan. Government measures to improve the affordability of essential therapies in China are also expected to surge the market in this region[1].

Impact of COVID-19

The COVID-19 pandemic has significantly influenced the demand for blood and plasma products, including PCC. Major manufacturers have reported changes in buying patterns that favor the prothrombin complex concentrate market. This increased demand, coupled with the higher productivity from plasma centers and the double-digit growth of Kcentra, has positively impacted the overall market[1].

Competitive Landscape

CSL Behring and Takeda are the leading players in the PCC market. CSL Behring, in particular, has a strong market position due to the higher sales of Kcentra. The launch of Kcentra in Japan in November 2017 and the subsequent increase in patient numbers have further strengthened CSL Behring's market position. Takeda's strong sales force and expanding distribution network also contribute to its prominence in the market[1].

Clinical Efficacy and Safety

Kcentra has been clinically proven to be superior to plasma in achieving effective hemostasis and early International Normalized Ratio (INR) reduction. A study by CSL Behring showed that Kcentra was more effective than plasma in patients requiring urgent surgical procedures, with 89.7% of patients on Kcentra achieving effective hemostasis compared to 75.3% treated with plasma[5].

Pricing and Accessibility

The cost of Kcentra can vary, but it is generally around $12.64 per unit for an intravenous powder for injection. Various discount programs, coupons, and copay cards are available to reduce the cost for patients, although no patient assistance programs specifically for Kcentra have been found[2].

Government Support and Regulations

Active government support, such as FDA approvals and recommendations, has been crucial for the growth of the PCC market. The FDA's approval of Kcentra in April 2013 and subsequent positive recommendations have contributed significantly to its market success. Additionally, government measures to decrease warfarin-associated adverse events and support for innovative therapies for bleeding disorders further favor the market[1].

Future Outlook

The PCC market, driven by the demand for Kcentra, is expected to continue its robust growth. The increasing prevalence of bleeding disorders, the rising prescription rate of warfarin, and the expanding distribution networks in various regions are key factors driving this growth. Significant investments in acquiring plasma centers and the ongoing support from pharmaceutical giants like CSL Behring and Takeda will also play a critical role in the market's future trajectory[1].

Key Takeaways

  • The global PCC market is projected to reach USD 2,385.3 million by 2032, with a CAGR of 9.6%.
  • The 4-factor PCC segment, including Kcentra, dominates the market due to its efficacy and penetration in emerging countries.
  • North America, Europe, and Asia Pacific are key regions driving market growth.
  • The COVID-19 pandemic has increased demand for PCC products.
  • CSL Behring and Takeda are the leading players in the market.
  • Kcentra has shown superior clinical efficacy compared to plasma.
  • Government support and regulatory approvals are crucial for market growth.

FAQs

What is Kcentra used for?

Kcentra is used for the reversal of acquired coagulation factor deficiency induced by Vitamin K antagonist (VKA) therapy, particularly in patients requiring urgent surgical procedures or experiencing major bleeding.

Who are the leading manufacturers of Kcentra?

CSL Behring is the leading manufacturer of Kcentra, with Takeda being another prominent player in the PCC market.

How has the COVID-19 pandemic affected the PCC market?

The COVID-19 pandemic has resulted in a sudden increase in the demand for blood and plasma products, including PCC, due to changes in buying patterns and increased productivity from plasma centers.

What are the key regions driving the growth of the PCC market?

North America, Europe, and Asia Pacific are the key regions driving the growth of the PCC market, with significant contributions from countries like the U.S., Canada, Japan, and China.

What is the clinical efficacy of Kcentra compared to plasma?

Kcentra has been clinically proven to be superior to plasma in achieving effective hemostasis and early INR reduction, with 89.7% of patients on Kcentra achieving effective hemostasis compared to 75.3% treated with plasma.

Sources:

  1. Fortune Business Insights, Prothrombin Complex Concentrate (PCC) Market Size, 2020-2032.
  2. Drugs.com, Kcentra Prices, Coupons, Copay Cards & Patient Assistance.
  3. Spherical Insights, Prothrombin Complex Concentrates Market Size USD 1803 Bn by 2030.
  4. FTC, Biologics Market Dynamics: Setting the Stage for Biosimilars.
  5. CSL Behring, CSL Behring Study Shows Kcentra® Superior to Plasma for Warfarin Reversal in Patients Requiring an Urgent Surgical Procedure.

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