Last updated: December 31, 2024
Introduction to Dabigatran Etexilate
Dabigatran etexilate, a precursor to the active moiety dabigatran, is a direct thrombin inhibitor used as an oral anticoagulant. It is primarily indicated for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, as well as for the prevention of thrombus and embolus formation after major orthopedic surgery[1][4].
Market Overview
Global Market Size and Growth
The global dabigatran etexilate mesylate market was valued at USD 5.2 billion in 2023 and is projected to reach USD 12.7 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 13.61% during the forecast period of 2024-2030. This growth is driven by the increasing incidence of thromboembolic diseases and the aging population, along with a shift towards oral anticoagulants and innovative therapy alternatives[3].
Chinese Market
In China, the market for dabigatran etexilate has seen significant developments. The drug was approved in China in March 2013 under the trade name Taibiquan for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation. Despite its approval, the sales value of dabigatran etexilate in China declined to approximately CNY329 million (USD50.6 million) in 2020 due to the impact of COVID-19[1][4].
Key Players and Market Share
Dominance of Boehringer Ingelheim
Before 2020, Boehringer Ingelheim International GmbH dominated the Chinese dabigatran etexilate market, holding more than 99% of the market share in terms of sales value. However, with the approval of generic versions by companies such as Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Jiangsu Hansoh Pharmaceutical, and Chengdu Easton Bio Pharmaceuticals in 2020 and 2021, Boehringer Ingelheim's market share is expected to decline as more generic products become available[1][4].
Emerging Generic Manufacturers
The entry of generic manufacturers is set to increase competition in the market. Companies like Chia Tai Tianqing, Jiangsu Hansoh Pharmaceutical, and Chengdu Easton Bio Pharmaceuticals have already received approvals for their generic dabigatran etexilate capsules. This competition is likely to drive down prices and increase market accessibility[1][4].
Sales Volume and Value
Historical Sales Data
From 2016 to 2020, the sales value and volume of dabigatran etexilate in China have been tracked. The sales value peaked globally at USD1.60 billion in 2013 but declined subsequently due to the launch of other competitive anticoagulants like rivaroxaban and apixaban. In China, the sales value declined significantly in 2020 due to the COVID-19 pandemic[1][4].
Regional Sales
The sales volume and value of dabigatran etexilate in China vary by region. The market research provides detailed insights into the regional distribution of sales, highlighting areas with higher demand and potential for growth[1][4].
Sales Price Analysis
Pricing Trends
The sales price of dabigatran etexilate in China has been influenced by the introduction of generic versions. Boehringer Ingelheim's Pradaxa, the original branded version, has historically been priced higher. However, with the entry of generic competitors like Chia Tai Tianqing's Anershun, prices are expected to decrease, making the drug more affordable for a wider patient population[1][4].
Impact of COVID-19
The COVID-19 pandemic had a significant impact on the sales of dabigatran etexilate in China, leading to a decline in sales value to approximately CNY329 million (USD50.6 million) in 2020. This decline was due to disruptions in healthcare services, reduced hospital visits, and delayed diagnoses and treatments[1][4].
Prospects and Forecast
Market Drivers and Opportunities
The market for dabigatran etexilate is expected to grow driven by several factors:
- Increasing Incidence of Thromboembolic Diseases: The rising prevalence of non-valvular atrial fibrillation and other thromboembolic conditions will drive demand.
- Aging Population: An aging population is more susceptible to these conditions, further increasing demand.
- Shift to Oral Anticoagulants: The preference for oral anticoagulants over traditional warfarin due to their ease of use and reduced monitoring requirements will continue to drive market growth[3].
Market Threats and Challenges
Despite the positive outlook, the market faces several challenges:
- Competition from Other Anticoagulants: The presence of other competitive anticoagulants like rivaroxaban and apixaban may continue to impact market share.
- Regulatory Environment: Changes in regulatory policies and reimbursement lists can affect market dynamics.
- Economic Factors: Economic downturns, such as those caused by the COVID-19 pandemic, can impact healthcare spending and drug sales[1][4].
Cost-Effectiveness
Economic Evaluation
Studies have shown that dabigatran etexilate is cost-effective compared to warfarin and other alternatives. For example, a UK-based study found that dabigatran etexilate had lower rates of ischemic strokes and intracranial hemorrhages compared to warfarin, with incremental cost-effectiveness ratios (ICERs) indicating it is a cost-effective option, especially for patients under 80 years old[2].
Key Takeaways
- Global Market Growth: The global dabigatran etexilate mesylate market is projected to grow significantly, driven by increasing incidence of thromboembolic diseases and an aging population.
- Chinese Market Dynamics: The Chinese market is transitioning with the introduction of generic versions, which is expected to reduce prices and increase market share competition.
- Impact of COVID-19: The pandemic had a significant negative impact on sales in 2020, but the market is expected to recover as healthcare services normalize.
- Cost-Effectiveness: Dabigatran etexilate is shown to be cost-effective compared to traditional anticoagulants like warfarin.
FAQs
What are the primary indications for dabigatran etexilate?
Dabigatran etexilate is primarily indicated for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation and for the prevention of thrombus and embolus formation after major orthopedic surgery.
How has the COVID-19 pandemic affected the sales of dabigatran etexilate in China?
The COVID-19 pandemic led to a decline in sales value to approximately CNY329 million (USD50.6 million) in 2020 due to disruptions in healthcare services and reduced hospital visits.
Who are the major manufacturers of dabigatran etexilate in China?
Boehringer Ingelheim International GmbH has historically dominated the market, but generic manufacturers such as Chia Tai Tianqing Pharmaceutical Group Co., Ltd., Jiangsu Hansoh Pharmaceutical, and Chengdu Easton Bio Pharmaceuticals are gaining market share.
What is the forecasted growth of the global dabigatran etexilate mesylate market?
The global market is expected to grow from USD 5.2 billion in 2023 to USD 12.7 billion by 2030, with a CAGR of 13.61%.
Is dabigatran etexilate cost-effective compared to other anticoagulants?
Yes, studies have shown that dabigatran etexilate is cost-effective compared to warfarin and other alternatives, particularly in reducing the incidence of ischemic strokes and intracranial hemorrhages.
Sources
- Research Report on China's Dabigatran Etexilate Market, 2021-2025. ResearchAndMarkets.com.
- Cost-effectiveness of dabigatran etexilate for the prevention of stroke and systemic embolism in UK patients with atrial fibrillation. Heart, 98(7), 573.
- Dabigatran Etexilate Mesylate Market Size, Growth & Trends. Verified Market Reports.
- China Dabigatran Etexilate Market Research Report 2021. Business Wire.
