Thrombin topical (recombinant) - Biologic Drug Details

Summary for thrombin topical (recombinant)

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
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1) High Certainty: US Patents for thrombin topical (recombinant) Derived from Brand-Side Litigation

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2) High Certainty: US Patents for thrombin topical (recombinant) Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for thrombin topical (recombinant) Derived from Patent Text Search

No patents found based on company disclosures

Thrombin topical (recombinant) Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Thrombin Topical (Recombinant)

Introduction to Thrombin Topical (Recombinant)

Thrombin, a crucial enzyme in the blood coagulation cascade, has been widely used as a hemostatic agent in surgical procedures. The development of recombinant thrombin has marked a significant shift in the market, offering a safer and more reliable alternative to traditional bovine-derived thrombin.

Market Definition and Scope

The thrombin market encompasses various types of thrombin products, including bovine thrombin, human thrombin, and recombinant thrombin. Recombinant thrombin, specifically, is a biologic drug produced through genetic engineering, eliminating the risks associated with animal-derived products[3].

Drivers of the Thrombin Market

Increase in Surgical Procedures and Road Accidents

The rise in the number of surgical procedures and road accidents has significantly increased the demand for effective hemostatic agents. Thrombin, particularly recombinant thrombin, plays a critical role in controlling heavy blood loss during surgeries and emergency situations[3].

Growing Prevalence of Blood Coagulation Disorders

The increasing prevalence of inherited blood coagulation diseases such as hemophilia, Von Willebrand disease, and hypercoagulable states has driven the demand for thrombin. Recombinant thrombin is preferred due to its procoagulant properties and reduced risk of antibody formation[3].

Advances in R&D and Government Initiatives

Research and development activities in the pharmaceutical sector are focused on developing new treatments for blood-related disorders. Government initiatives to improve medical facilities, especially in developing regions, have created lucrative opportunities for the thrombin market[3].

Competitive Landscape

Key Players

The thrombin market is dominated by several key players, including Johnson & Johnson, Pfizer, Inc., Mallinckrodt Pharmaceuticals, and ZymoGenetics, Inc. (now part of Bayer HealthCare). These companies are investing heavily in R&D to develop new thrombin products and expand their market share[3][5].

Product Differentiation

Recombinant thrombin, such as RECOTHROM™ approved by the FDA, stands out due to its plasma-free and recombinant nature, reducing the risk of antibody formation and coagulopathy abnormalities compared to bovine thrombin[5].

Financial Trajectory

Market Size and Growth

The global thrombin market was valued at US$ 652.2 million in 2022 and is projected to grow at a CAGR of 6.1% from 2023 to 2031, reaching US$ 1.1 billion by the end of 2031. This growth is driven by the increasing demand for recombinant thrombin in surgical and diagnostic applications[3].

Regional Market Analysis

North America was the most lucrative region in 2022, driven by advanced healthcare infrastructure and high adoption rates of recombinant thrombin. Other regions, such as Europe and Asia Pacific, are also expected to show significant growth due to increasing healthcare expenditures and government initiatives[3].

Product Segmentation

By Product Type

• Bovine Thrombin: Although still used, its market share is declining due to concerns over antibody development and coagulopathy abnormalities.
• Human Thrombin: Derived from human plasma, it is less commonly used compared to recombinant thrombin.
• Recombinant Thrombin: The fastest-growing segment, driven by its safety profile and efficacy[3].

By Dosage Form

• Powder Form: Commonly used in surgical settings.
• Solution Form: Used in various medical applications.
• Others: Includes gelatin sponge forms and other specialized formulations[3].

By End-User

• Hospitals: The primary end-users, accounting for the largest market share.
• Diagnostic Centers & Clinics: Increasingly adopting recombinant thrombin for diagnostic procedures.
• Academic & Research Institutes: Utilizing thrombin for research purposes[3].

Safety and Efficacy

Comparative Studies

Studies have shown that recombinant thrombin is as effective as bovine thrombin in controlling bleeding, with a significantly lower incidence of antibody formation. This makes it a safer option for patients, especially those at risk of developing antibodies against bovine thrombin[2][5].

Clinical Implications

The choice between bovine and recombinant thrombin often balances theoretical risks and economic considerations. However, the cost difference between these products is minimal, making recombinant thrombin a preferred choice for many healthcare professionals[2].

Market Opportunities and Challenges

Opportunities

• Rise in R&D Activities: Continued investment in research and development is expected to lead to new drug developments and treatments for blood-related disorders.
• Government Initiatives: Improvements in medical facilities, especially in developing regions, will increase the demand for thrombin products[3].

Challenges

• Regulatory Approvals: Obtaining regulatory approvals for new thrombin products can be a lengthy and challenging process.
• Cost Considerations: While the cost difference between bovine and recombinant thrombin is minimal, economic factors can still influence market dynamics[3].

Conclusion

The market for thrombin topical (recombinant) is poised for significant growth, driven by increasing demand in surgical and diagnostic applications, advances in R&D, and favorable government initiatives. As the healthcare sector continues to evolve, the preference for recombinant thrombin over traditional bovine thrombin is expected to rise due to its safety profile and efficacy.

Key Takeaways

• The global thrombin market is projected to grow at a CAGR of 6.1% from 2023 to 2031.
• Recombinant thrombin is the fastest-growing segment due to its safety and efficacy.
• North America is the most lucrative region, followed by Europe and Asia Pacific.
• Key players are investing heavily in R&D to develop new thrombin products.
• Government initiatives and increasing healthcare expenditures are driving market growth.

FAQs

What is the primary difference between bovine thrombin and recombinant thrombin?

The primary difference is that recombinant thrombin is produced through genetic engineering, eliminating the risk of antibody formation associated with bovine thrombin.

Which region is expected to dominate the thrombin market in the coming years?

North America is currently the most lucrative region and is expected to continue its dominance due to advanced healthcare infrastructure and high adoption rates of recombinant thrombin.

What are the key drivers of the thrombin market?

Key drivers include the increase in surgical procedures, rise in road accidents, growing prevalence of blood coagulation disorders, and advances in R&D activities.

Is recombinant thrombin more expensive than bovine thrombin?

The cost difference between bovine and recombinant thrombin is minimal, making economic considerations less of a factor in the choice between the two.

What is the projected market size of the thrombin market by 2031?

The global thrombin market is projected to reach US$ 1.1 billion by the end of 2031.

Sources

1. Absolute Reports: Global Topical Recombinant Thrombin Market.
2. UF Health: Medication Safety Subcommittee Oral Contraceptives.
3. Transparency Market Research: Thrombin Market Size, Share, Industry Growth & Analysis 2031.
4. Market Research Intellect: Global Topical Recombinant Human Thrombin Market.
5. BioSpace: FDA Approves ZymoGenetics, Inc.' RECOTHROM(TM) Thrombin, Topical (Recombinant).