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Last Updated: April 9, 2025

OCTAPLAS Drug Profile


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

Identify potential brand extensions & biosimilar entrants

SponsorPhase
University College, LondonPhase 2
Octapharma
University of IcelandPhase 2

See all OCTAPLAS 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 OCTAPLAS Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

No patents found based on company disclosures

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

These patents were obtained by searching patent claims
Showing 1 to 3 of 3 entries

Market Dynamics and Financial Trajectory for Octaplas

Introduction

Octaplas, a pooled plasma product developed by Octapharma, is a critical component in the treatment of various medical conditions, including coagulopathy and thrombotic thrombocytopenic purpura. This article delves into the market dynamics and financial trajectory of Octaplas, highlighting its performance, cost-effectiveness, and the broader market context.

Market Context: Plasma-Derived Therapies

The market for plasma-derived therapies is growing, driven by increasing demand for safe and effective treatments for rare and life-threatening diseases. Octapharma, a key player in this market, has seen significant growth in recent years, with sales reaching €3.266 billion in 2023, a 14.4% increase over the previous year[1][2].

Product Overview: Octaplas

Octaplas is a solvent/detergent-treated plasma product that offers a reduced risk of transmitting lipid-enveloped viruses compared to standard fresh frozen plasma (FFP). It is used in various clinical settings, including surgical procedures and the treatment of bleeding disorders.

Cost-Effectiveness Analysis

Studies have evaluated the cost-effectiveness of Octaplas compared to standard FFP. A comprehensive economic analysis revealed that while Octaplas is associated with a minimal reduction in disease burden, it comes at a higher cost. The incremental cost per quality-adjusted life-year (QALY) gained was estimated to be $934,000, and the incremental cost per life-year gained was $1.3 million[4].

Budget Impact Analysis

The budget impact analysis suggests that replacing standard FFP with Octaplas would result in significant additional costs to the healthcare system. For instance, if Octaplas replaced all forms of FFP, the healthcare system would incur a yearly net loss of about C$13.5 million. However, this could also lead to savings from reduced purchases of intravenous immunoglobulin (IVIg) and albumin[4].

Financial Performance of Octapharma

Octapharma's financial performance is closely tied to the success of its products, including Octaplas. Here are some key financial metrics:

Sales and Revenue

In 2023, Octapharma's sales rose to €3.266 billion, driven by increased plasma collection and strong demand for its products. This represents a 14.4% increase over the previous year[1][2].

Operating Income

Operating income for 2023 was €436 million, slightly lower than the €522 million recorded in 2022. This decrease is attributed to higher production and material costs, as well as increased investment in research and development and market expansion[1][2].

Cost of Sales and Gross Margins

The cost of sales increased by 21.4% to €2.332 billion, reflecting higher production and material costs. Despite this, gross profit marginally increased to €934 million, though gross margins declined to 28.6% from 32.7% in 2022[1].

Market Expansion and Regulatory Approvals

Octapharma's growth strategy includes expanding into new markets and obtaining regulatory approvals for its products. For example, the FDA approval of Balfaxar® (marketed as octaplex® in other regions) and the expanded approval for wilate® in the USA have boosted the company's growth plans[2].

Regulatory Inspections

Successful regulatory inspections by the FDA at Octapharma's production sites have been crucial for maintaining high production standards and expanding market presence. These inspections are vital for ensuring compliance with stringent regulatory requirements[2].

Investment in Research and Development

Octapharma has been investing heavily in research and development to enhance its product portfolio and meet growing global demand. These investments are part of the company's ambitious strategy to increase production by up to 50% by 2028[1][2].

Talent Attraction and Retention

To support its growth plans, Octapharma is focusing on attracting and retaining talent. The company aims to remain an employer of choice in the industry by enhancing its working environment and offering competitive opportunities[1][2].

Future Outlook

The future outlook for Octaplas and Octapharma is promising, driven by robust inventories of raw plasma, ongoing investments in production capacity, and a strong pipeline of new products. The company's strategy to expand its donor centers and improve donor experience is expected to further support growth[1][2].

Key Takeaways

  • Growing Demand: Increasing demand for plasma-derived therapies is driving the growth of Octaplas.
  • Cost-Effectiveness: While Octaplas offers safety benefits, it is more costly than standard FFP, with significant incremental costs per QALY and life-year gained.
  • Financial Performance: Octapharma's sales and revenue have seen significant growth, though operating income has been affected by higher costs.
  • Market Expansion: Regulatory approvals and successful FDA inspections are key to Octapharma's market expansion.
  • Investment in R&D: Heavy investment in research and development is crucial for future growth and product innovation.
  • Talent Management: Attracting and retaining talent is essential for executing Octapharma's growth strategy.

FAQs

What is Octaplas?

Octaplas is a solvent/detergent-treated plasma product used to treat various medical conditions, including coagulopathy and thrombotic thrombocytopenic purpura.

How does Octaplas compare to standard FFP in terms of cost-effectiveness?

Octaplas is more costly than standard FFP, with an incremental cost per QALY gained estimated at $934,000 and an incremental cost per life-year gained at $1.3 million[4].

What were Octapharma's sales and operating income in 2023?

In 2023, Octapharma's sales rose to €3.266 billion, and operating income was €436 million[1][2].

What are the key drivers of Octapharma's growth strategy?

Octapharma's growth strategy includes increasing plasma collection, expanding into new markets, investing in research and development, and enhancing production capacity to meet growing global demand[1][2].

How is Octapharma positioned for future growth?

Octapharma is well-positioned for future growth due to robust inventories of raw plasma, ongoing investments in production capacity, and a strong pipeline of new products. The company's focus on attracting and retaining talent also supports its growth plans[1][2].

What are the regulatory milestones achieved by Octapharma in recent years?

Octapharma has achieved successful FDA inspections at its production sites and obtained key regulatory approvals, such as the FDA approval of Balfaxar® and the expanded approval for wilate® in the USA[2].

Sources

  1. Octapharma Group. Delivering strong performance in 2023. Retrieved from https://www.octapharma.com/news/corporate-news/2024/financial-review-2023
  2. Octapharma Group. Annual Report 2023. Retrieved from https://www.octapharma.com/api/download/x/df5a28c67e/annual-report-2023_english.pdf
  3. Samsung Bioepis. Biosimilar Market Report Q1 2024. Retrieved from https://www.samsungbioepis.com/upload/attach/SB+Biosimilar+Market+Report+Q1+2024.pdf
  4. Canada's Drug Agency. An Economic Analysis and Budget Impact Analysis. Retrieved from https://www.cda-amc.ca/sites/default/files/pdf/Economic_Analysis_March%202011.pdf

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