Market Dynamics and Financial Trajectory for the Biologic Drug: CROSSEAL, EVICEL
Introduction
Biologic drugs, including fibrin sealants like CROSSEAL and EVICEL, are a significant segment of the pharmaceutical market, known for their complex composition and high efficacy in specific medical applications. This article delves into the market dynamics and financial trajectory of these biologic drugs, focusing on their clinical use, market position, and the impact of broader industry trends.
Clinical Use and Efficacy of CROSSEAL and EVICEL
Haemostatic Properties
CROSSEAL and EVICEL are fibrin sealants used as supportive treatments in surgery to control bleeding when standard surgical techniques are ineffective or impractical. These products consist of human clottable protein (predominantly human fibrinogen) and human thrombin, which form a stable fibrin clot to achieve haemostasis[1][2].
Comparative Efficacy
Clinical studies have shown that CROSSEAL and EVICEL are highly effective in various surgical settings. For instance, CROSSEAL was found to be significantly more effective than standard haemostatic agents in achieving haemostasis in patients undergoing liver resection. Similarly, EVICEL outperformed manual compression in vascular surgery and was more effective than Surgicel in retroperitoneal or intra-abdominal surgeries[1].
Mechanical and Biochemical Properties
The mechanical properties of EVICEL, such as its tensile strength and resistance to stretching, are superior to those of other fibrin sealants like TISSEEL. This is largely due to the presence of factor XIII in EVICEL, which enhances clot stability and strength[4].
Market Position and Growth
Biologics Market Overview
The biologics market has experienced significant growth, with revenues increasing by 70% over the last five years to reach $232 billion. This growth is driven by strong launches in high-unmet-need indications, particularly in oncology, autoimmune diseases, and diabetes[3].
Competitive Landscape
CROSSEAL and EVICEL operate within a competitive landscape dominated by other fibrin sealants such as TISSEEL, TISSUCOL, and TACHOSIL. Each of these products has its own set of adhesive and haemostatic properties, making the choice of product dependent on the specific surgical procedure and patient needs[4][5].
Market Share and Revenue
While specific revenue figures for CROSSEAL and EVICEL are not publicly disclosed, they are part of the broader biologics market that is expected to continue growing. The absence of off-patent competition in their therapy areas has contributed to their market position, although the emergence of biosimilars could impact future growth[3].
Impact of Biosimilars
Market Dynamics
Biosimilars are a significant factor in the biologics market, offering cheaper alternatives to original biologic products. As major biologic products face biosimilar competition, prices are expected to decrease, which could impact the revenue of products like CROSSEAL and EVICEL. However, this competition also opens up opportunities for wider access to biologics and potential growth in other therapeutic areas[3].
Pricing and Access
The introduction of biosimilars will lead to increased competition and discounting within indications. While this may reduce the revenue of original biologic products, it also enables better value for patients and potentially increases volume growth before prices stabilize at lower levels[3].
Financial Trajectory
Current Trends
The financial trajectory of CROSSEAL and EVICEL is closely tied to the overall biologics market. With continued investment in biologic pipelines, particularly in oncology and other high-growth areas, the market is expected to remain robust. However, the impact of biosimilars will be a key factor in shaping the financial future of these products[3].
Future Prospects
Despite the challenges posed by biosimilars, the long-term prospects for biologic growth remain positive. The rise in oncological treatments, including immuno-oncology and antibody-drug conjugates, is expected to drive significant growth. For CROSSEAL and EVICEL, maintaining their position through continued innovation and demonstrating value to payers will be crucial[3].
Regulatory and Safety Considerations
Regulatory Approval
CROSSEAL and EVICEL have undergone rigorous clinical trials and have been approved for use in various surgical settings. The removal of tranexamic acid from EVICEL's formulation, for example, allowed for an expanded indication and reduced the risk of neurotoxicity[1][2].
Safety Profile
These products have generally been well tolerated in clinical studies, with adverse event profiles similar to those of comparator groups. However, specific studies have highlighted the need for careful monitoring of tissue reactions and inflammatory responses, particularly in neurosurgical applications[1][2].
Conclusion
CROSSEAL and EVICEL are highly effective biologic drugs that play a critical role in surgical haemostasis. Their market position is influenced by the broader dynamics of the biologics market, including the impact of biosimilars and the ongoing investment in biologic pipelines. To maintain their financial trajectory, these products must continue to demonstrate clinical value and adapt to the evolving market landscape.
Key Takeaways
- Clinical Efficacy: CROSSEAL and EVICEL are highly effective in achieving haemostasis in various surgical settings.
- Market Growth: The biologics market is growing, driven by strong launches in high-unmet-need indications.
- Biosimilar Impact: The emergence of biosimilars will impact pricing and access to biologic products.
- Regulatory Considerations: These products have undergone rigorous clinical trials and have been approved for use in various settings.
- Safety Profile: Generally well tolerated, but with specific considerations for tissue reactions and inflammatory responses.
FAQs
Q: What are CROSSEAL and EVICEL used for?
A: CROSSEAL and EVICEL are fibrin sealants used as supportive treatments in surgery to control bleeding when standard surgical techniques are ineffective or impractical.
Q: How do CROSSEAL and EVICEL compare to other fibrin sealants?
A: CROSSEAL and EVICEL have superior mechanical properties, such as tensile strength and resistance to stretching, compared to other fibrin sealants like TISSEEL.
Q: What is the impact of biosimilars on the market for CROSSEAL and EVICEL?
A: Biosimilars will lead to increased competition and potentially lower prices, affecting the revenue of original biologic products but also enabling wider access to biologics.
Q: Are CROSSEAL and EVICEL safe for use in neurosurgery?
A: While generally well tolerated, the use of CROSSEAL and EVICEL in neurosurgery requires careful consideration due to potential tissue reactions and inflammatory responses.
Q: What are the long-term prospects for the financial growth of CROSSEAL and EVICEL?
A: The long-term prospects remain positive due to continued investment in biologic pipelines, particularly in oncology, but will depend on adapting to market changes and demonstrating value to payers.
Sources
- Fibrin sealant (evicel® [quixil®/crosseal™]): a review of its pharmacological properties, clinical efficacy and tolerability. PubMed.
- Australian public assessment for Fibrin haemostatic agent/sealant. TGA.
- Disruption and maturity: The next phase of biologics. IQVIA.
- Comparison of the mechanical, kinetic, and biochemical properties of fibrin clots produced using EVICEL Fibrin Sealant (Human) and TISSEEL Fibrin Sealant. Science.gov.
- Comparison of a New Fibrin Sealant With Standard Topical Hemostatic Agents. JAMA Surgery.
