Dalteparin Sodium: Clinical Trials, Market Analysis, and Projections
Introduction to Dalteparin Sodium
Dalteparin sodium, marketed under the brand name FRAGMIN, is a low molecular weight heparin (LMWH) used to prevent and treat various thrombotic conditions. It is a factor Xa inhibitor and thrombin inhibitor, initially developed by Pfizer Inc.[3].
Clinical Trials and FDA Approval
FDA Approval for Pediatric Patients
In a significant milestone, the FDA approved dalteparin sodium on May 16, 2019, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients aged 1 month and older. This approval marked the first FDA-approved therapy for treating VTE in pediatric patients.
The approval was based on evidence from two prospective, single-arm, multi-center clinical trials involving 52 pediatric patients with symptomatic deep vein thrombosis and/or pulmonary embolism, with or without cancer. Patients were treated with dalteparin sodium subcutaneously twice daily for up to three months. The efficacy was determined by the achievement of therapeutic anti-Xa levels (0.5-1.0 IU/ml), and the study showed that 92% of patients achieved these levels. No patients experienced progression of the qualifying VTE, and only one patient had a recurrence of VTE[1].
Clinical Trial Phases
The clinical trials for dalteparin sodium in pediatric patients included several phases:
- Phase 2 (Pharmacodynamics Phase): This phase lasted between 1 and 7 days, during which children received their maintenance dose of dalteparin every 12 hours. Blood samples were collected to ensure anti-Xa levels were within the target range[4].
- Phase 3 (Follow-up Phase): This phase continued until the end of the study, with children receiving their maintenance dose of dalteparin every 12 hours. The study doctors monitored the children’s blood to ensure anti-Xa levels remained within the target range[4].
Adverse Reactions and Safety Considerations
In pediatric patients treated with dalteparin sodium, common adverse reactions included injection site bruising (30%), contusion (12%), and epistaxis (10%). The prescribing information includes a Boxed Warning regarding the risk of epidural or spinal hematomas in patients receiving neuraxial anesthesia or undergoing spinal puncture while anticoagulated with low molecular weight heparins or heparinoids[1].
Market Analysis
Market Size and Growth
The dalteparin sodium market is anticipated to experience significant growth due to several factors. The global market size was valued at several million dollars in 2023 and is projected to grow at a compound annual growth rate (CAGR) of XX% from 2024 to 2031[5].
Market Segmentation
The market is segmented based on type and application:
- Type: Dalteparin sodium is available in tablet and injection forms. The injection form is more commonly used for its therapeutic applications[5].
- Application: Key applications include myocardial infarction treatment, hemodialysis, and prevention of deep vein thrombosis (DVT) and pulmonary embolism. The myocardial infarction treatment segment is expected to expand significantly during the forecast period[5].
Regional Analysis
The market is analyzed across five major regions: North America, Europe, Asia-Pacific, Middle East & Africa, and Latin America. Each region is further sub-segmented by country to provide a detailed overview of the market dynamics and growth prospects[5].
Market Drivers and Restraints
The growth of the dalteparin sodium market is driven by the increasing prevalence of chronic diseases, government initiatives to enhance healthcare facilities, and increased research funding. However, stringent regulations and a lack of skilled personnel with technical expertise are expected to restrain market growth during the forecast period[2].
Competitive Landscape
Key players in the dalteparin sodium market include Pfizer Inc., Shenzhen Hepalink, Nanjing Kingfriend, SPL, Dongcheng Biochemicals, and others. These companies are focusing on expanding their product portfolios and strengthening their market presence through strategic initiatives[5].
Market Projections
Revenue Growth
The global dalteparin sodium market is forecasted to witness significant revenue growth from 2024 to 2031. The market size is expected to increase substantially, driven by the growing demand for anticoagulant therapies and the expanding patient population[5].
Application-Specific Growth
The myocardial infarction treatment segment is projected to retain its position as a significant application area throughout the forecast period, contributing substantially to the overall market growth. Other applications, such as hemodialysis and prevention of DVT and pulmonary embolism, are also expected to contribute to the market expansion[5].
Key Takeaways
- FDA Approval: Dalteparin sodium is the first FDA-approved therapy for treating VTE in pediatric patients.
- Clinical Trials: The drug has shown efficacy in achieving therapeutic anti-Xa levels and preventing VTE progression in pediatric patients.
- Market Growth: The global market is expected to grow at a significant CAGR from 2024 to 2031, driven by increasing chronic disease prevalence and government healthcare initiatives.
- Segmentation: The market is segmented by type (tablet and injection) and application (myocardial infarction treatment, hemodialysis, etc.).
- Regional Analysis: The market is analyzed across five major regions, with each region further sub-segmented by country.
FAQs
What is dalteparin sodium used for?
Dalteparin sodium is used to prevent and treat venous thromboembolism (VTE), including deep vein thrombosis (DVT) and pulmonary embolism. It is also used in combination with aspirin to prevent blood vessel complications in patients with certain types of angina or heart attack[2].
Who is the target population for dalteparin sodium?
The target population includes adults and pediatric patients aged 1 month and older with symptomatic VTE, as well as patients undergoing certain medical procedures that increase the risk of thrombosis[1].
What are the common adverse reactions associated with dalteparin sodium?
Common adverse reactions include injection site bruising, contusion, and epistaxis. There is also a risk of epidural or spinal hematomas in patients receiving neuraxial anesthesia or undergoing spinal puncture[1].
What is the market outlook for dalteparin sodium?
The market is expected to grow significantly from 2024 to 2031, driven by the increasing prevalence of chronic diseases and government initiatives to enhance healthcare facilities[5].
Who are the key players in the dalteparin sodium market?
Key players include Pfizer Inc., Shenzhen Hepalink, Nanjing Kingfriend, SPL, and Dongcheng Biochemicals, among others[5].
What are the main applications of dalteparin sodium?
The main applications include myocardial infarction treatment, hemodialysis, and prevention of deep vein thrombosis (DVT) and pulmonary embolism[5].
Sources
- FDA Approves Dalteparin Sodium for VTE in Pediatric Patients. FDA, May 16, 2019.
- Dalteparin Sodium Market Key Players Analysis 2031. The Insight Partners.
- Dalteparin Sodium - Drug Targets, Indications, Patents. Synapse.
- Clinical Trial Results - Pfizer. Pfizer, February 22, 2019.
- Dalteparin Sodium Market Report 2024 (Global Edition). Cognitive Market Research.
