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Analysis of the Anticoagulant Market
Frost & Sullivan, Dec 2011, Pages: 95
The U.S. anticoagulant market is on the verge of a potential major shift in clinical practice, from a market dominated by a single injectable anticoagulant to a highly competitive market dominated by first-in-class novel oral anticoagulants. While these novel oral agents are expected to become standard of care for stroke prevention in atrial fibrillation patients, injectable agents will likely maintain their hold on certain hospital-based critical care applications. This research service covers the U.S. anticoagulant market from 2008 to 2016, with 2010 as the base year. Included are products on the market, products in development, and patient and revenue forecasts. Market challenges, drivers and restraints are identified and assessed.
This Frost & Sullivan research service titled Analysis of the Anticoagulant Market provides an overview of industry trends and marketed product revenue forecasts. The study includes a complete analysis of key market drivers, restraints, and challenges. In this research, Frost & Sullivan's expert analysts thoroughly examine the following segments: oral (VKAs, factor Xa inhibitors, and direct thrombin inhibitors) and parenteral (indirect thrombin inhibitors, and direct thrombin inhibitors).
Market Overview
Large Atrial Fibrillation Population with Unmet Needs Will Help the U.S. Anticoagulant Market to Grow to $10 billion by 2016
Rollout of Novel Oral Anticoagulants Poised to Drastically Change the Clinical Practice Landscape
The U.S. anticoagulant market is on the verge of a major shift in clinical practice. It is transitioning from a market dominated by a single injectable anticoagulant to a highly competitive one dominated by first-in-class novel oral anticoagulants. Companies are vying with each other to introduce novel therapies that offer superior safety, efficacy, and convenience to patients and physicians. This is a medical need that has been unmet for decades. “Studies reveal that there are currently 2.7 million patients in the United States with atrial fibrillation (AF); however, this may be an underestimation as the actual figure could be as high as 4.0 million,” notes the analyst of this research service. “Lifelong anticoagulant therapy is critical for stroke prevention in these patients, resulting in substantial commercial opportunities.” Warfarin, the long-established gold standard therapy for stroke prevention in AF, carries many significant inherent risks such as bleeding, leaving a very narrow therapeutic window.
A robust growth period is expected following the launch of Pradaxa (dabigatran), an oral direct thrombin inhibitor (DTI) in late 2010, followed by a second growth period upon the anticipated launch of Eliquis (apixaban), an oral factor Xa inhibitor in late 2012 or early 2013. Edoxaban, an oral factor Xa inhibitor is also in the pipeline, and Xarelto (rivaroxaban), another oral factor Xa inhibitor which is approved for prophylaxis following orthopedic surgery, is awaiting approval for stroke prevention. These agents are poised to dominate the market for stroke prevention in AF, a very large and partially untapped market. They are also likely to grab substantial market share from the parenteral anticoagulants for prophylaxis of venous thromboembolism in orthopedic joint replacement surgery. With the approval of Pradaxa and the imminent approval of its successors, the bar has been significantly raised for the anticoagulant market. Superiority to warfarin is paramount for new drug approval and market uptake. Patient and clinician acceptance will depend on strong data showing improvements in efficacy and lower risk of bleeding.
There is a fine line between the prevention of thrombosis and uncontrollable bleeding. Most often, bleeding issues or other safety concerns may not arise until late-stage clinical trials, or only in certain patient populations, after significant investments in drug development have been made. In addition, bleeding issues or other safety concerns may surface in the future, particularly if the bleeding risk of the real-world population differs from that studied in clinical trials, leading to black-box warnings or market withdrawal.
One of the shortcomings of oral anticoagulants is the lack of a strategy for reversal in case of emergency or uncontrolled bleeding. “The oral anticoagulants are ideal for chronic therapy with their easy administration,” says the analyst. “However, the ability to quickly reverse the anticoagulant action in the event of an emergency is a critical unmet need.” Newcomers to the market that can address this issue will resolve the key shortfall of chronic anticoagulation therapy and their drugs are likely see rapid adoption into clinical practice.
Market Sectors
Expert Frost & Sullivan analysts thoroughly examine the following market sectors in this research:
- Oral (VK, factor Xa inhibitors, direct thrombin inhibitors)
- Parenteral (indirect thrombin inhibitors, and direct thrombin inhibitors
Technologies
The following technologies are covered in this research:
- Subcutaneous injection
- Oral administration
- Intravenous administration
- Coagulation monitoring
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