Venous thromboembolism (VTE) refers to the formation of a thrombus (blood clot) within a vein, which subsequently blocks blood flow. VTE is the third most common form of vascular disease following stroke and heart attack. Because VTE is associated with greater morbidity and mortality, early diagnosis and treatment is essential. The most common causes of VTE include cancer, recent surgery, hospitalization, and immobilization.

Key Takeaways

• Datamonitor Healthcare estimates that in 2018, there were approximately 2.3 million incident cases of deep vein thrombosis (DVT) and 1.2 million incident cases of pulmonary embolism (PE) worldwide, and forecasts that these numbers will increase to 2.6 million incident cases of DVT and 1.3 million incident cases of PE by 2027.
• Approved drugs in the venous thromboembolism (VTE) space focus on a wide variety of targets. These drugs are commonly administered via the subcutaneous route, with some products being available in oral and intravenous formulations.
• Industry-sponsored drugs in active clinical development for VTE are spread evenly across Phase I and Phase II. Therapies in active clinical development for VTE focus on a wide variety of targets. The majority of the pipeline drugs are administered via the intravenous route, with the remainder being oral and subcutaneous formulations.
• The overall likelihood of approval of a Phase I VTE asset is 18.9%, and the average probability a drug advances from Phase III is 70%. Drugs, on average, take 10.8 years from Phase I to approval, compared to 9.3 years in the overall hematology space.
• The distribution of clinical trials across Phase I–IV indicates that the majority of trials for VTE have been in the late phases of development, with 72% of trials in Phase III–IV, and 28% in Phase I–II.
• The US has a slight lead in the number of VTE clinical trials globally, while Germany leads the major European markets. Clinical trial activity in the VTE space is dominated by completed trials. Bayer has the highest number of completed clinical trials for VTE, with 37 trials.
• Bayer leads the industry sponsors with the highest overall number of clinical trials for VTE.