Market Dynamics and Financial Trajectory for the Biologic Drug: THROMBATE III
Overview of THROMBATE III
THROMBATE III is a human plasma-derived antithrombin III (AT-III) used primarily in patients with suspected antithrombin III-mediated heparin resistance, particularly those on extracorporeal membrane oxygenation (ECMO)[2][5].
Market Size and Growth
The global antithrombin market, which includes THROMBATE III, was valued at USD 490.4 million in 2018 and is projected to reach USD 1,028.7 million by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of 5.5% during the forecast period. This growth is driven by the increasing prevalence of antithrombin deficiency and the growing incidence of bleeding during surgical procedures[1].
Therapeutic Applications
THROMBATE III is predominantly used in therapeutic applications, which accounted for 95.7% of the market share in 2018. Its use is critical in managing venous thromboembolism (VTE) and in patients undergoing surgical procedures, especially those with low antithrombin levels. Even modest decreases in antithrombin levels significantly increase the risk of VTE, emphasizing the importance of this drug[1][5].
Regional Analysis
The Asia Pacific region is expected to emerge as the fastest-growing market for antithrombin products, including THROMBATE III, due to the growing prevalence of congenital antithrombin III deficiency and increasing demand for reducing surgical mortality rates. Europe also holds significant potential, with countries like Germany, the UK, and France showing considerable adoption of human antithrombin-based products[1].
Competitive Landscape
Key players in the antithrombin market include Shire, CSL Behring, and Grifols, which collectively hold a significant market share. These companies are focused on developing robust distribution networks and strong market penetration, particularly in Europe. Other notable companies in the market are LFB USA, Kedrion S.p.A., Octapharma AG, Lee Biosolutions, and Scripps Laboratories Inc[1].
Cost and Utilization
The cost of THROMBATE III is substantial, with each unit costing approximately $4.66. A study at The Johns Hopkins Hospital revealed that out of 326 doses administered to 65 patients, 54% were potentially unnecessary, resulting in significant waste and costs. Implementing restriction criteria and alternative dosing strategies could lead to estimated annual savings of $556,000[2].
Mechanism of Action and Manufacturing
THROMBATE III is prepared from pooled units of human plasma and undergoes rigorous virus inactivation and removal steps, including heat treatment and nanofiltration. This ensures the product's safety by effectively removing viruses and reducing the infectivity of transmissible spongiform encephalopathy agents[5].
Market Drivers
Several factors drive the growth of the antithrombin market, including:
- Increasing Incidence of Coagulation Disorders: Conditions such as venous thromboembolism (VTE) and inherited thrombophilia contribute to the demand for antithrombin products[4].
- Advancements in Drug Technology: New therapeutics like Fitusiran (ALN-AT3) and ATryn Antithrombin (Recombinant) are in various stages of clinical trials, expanding the treatment options for antithrombin deficiency and related disorders[4].
- Combination Therapy with Heparin: The use of antithrombin in combination with heparin, especially in cases of heparin resistance during cardiac surgery, is a significant growth driver[4].
Market Restraints
Despite the growth potential, the market faces some restraints:
- Regulatory Challenges: Increasing regulations on animal testing and stringent approval processes can impede the development and manufacturing of new antithrombin products[4].
- High Costs: The high cost of antithrombin products, coupled with the potential for unnecessary utilization, can be a significant barrier to widespread adoption[2].
Financial Trajectory
The financial trajectory of THROMBATE III and the broader antithrombin market is positive, driven by increasing demand and advancements in therapeutic applications. Here are some key financial insights:
- Market Size: The global antithrombin market is projected to grow from USD 490.4 million in 2018 to USD 1,028.7 million by 2032[1].
- CAGR: The market is expected to grow at a CAGR of 5.5% during the forecast period[1].
- Cost Savings: Implementing efficient dosing strategies and restriction criteria can lead to significant cost savings, as seen in the study at The Johns Hopkins Hospital[2].
Key Takeaways
- The global antithrombin market, including THROMBATE III, is expected to grow significantly due to increasing prevalence of antithrombin deficiency and growing surgical procedures.
- Asia Pacific and Europe are key regions driving market growth.
- Major players like Shire, CSL Behring, and Grifols dominate the market.
- Efficient use and cost-saving strategies are crucial to maximize the benefits of antithrombin products.
- Advancements in drug technology and combination therapies with heparin are driving market growth.
FAQs
What is the primary use of THROMBATE III?
THROMBATE III is primarily used in patients with suspected antithrombin III-mediated heparin resistance, especially those on extracorporeal membrane oxygenation (ECMO).
How is THROMBATE III manufactured?
THROMBATE III is prepared from pooled units of human plasma and undergoes rigorous virus inactivation and removal steps, including heat treatment and nanofiltration.
What are the key drivers of the antithrombin market growth?
Key drivers include the increasing incidence of coagulation disorders, advancements in drug technology, and the use of antithrombin in combination with heparin.
What are the potential cost savings in the use of THROMBATE III?
Implementing restriction criteria and alternative dosing strategies can lead to estimated annual savings of $556,000.
Which regions are expected to drive the growth of the antithrombin market?
The Asia Pacific and Europe regions are expected to be the fastest-growing markets for antithrombin products.
Sources
- Fortune Business Insights: Antithrombin Market Size, Share, Trends & Growth | Global Report
- Johns Hopkins University: Identification of cost-saving opportunities for the use of antithrombin
- FTC: Biologics Market Dynamics: Setting the Stage for Biosimilars
- Coherent Market Insights: Antithrombin Market - Share, Size and Industry Analysis
- THROMBATE III Resources: hATd Resources | THROMBATE III (antithrombin III [human])
