Venous thromboembolism (VTE), comprising deep vein
thrombosis (DVT) and pulmonary embolism (PE), represents a significant public
health and financial burden. The impending expansion of the treatment labels of
the four nonmonitored, fixed-dose oral anticoagulants into the treatment and
secondary prophylaxis of VTE will address the need for more-convenient
alternatives to current standards of care, and these agents will drive market
growth during the forecast period. However, opportunities remain in other underserved
VTE indications, including primary prophylaxis of VTE in acute medically ill
and ambulatory cancer patients.
Questions Answered in This Report:
The oral anticoagulant rivaroxaban (Bayer/Janssen’s Xarelto) is
the first of the novel agents to gain approval for the acute treatment and
secondary prophylaxis of VTE, with dabigatran etexilate (Boehringer Ingelheim’s
Pradaxa), apixaban (Bristol-Myers Squibb/Pfizer’s Eliquis), and edoxaban
(Daiichi Sankyo’s Lixiana) expected to follow soon. How do thought leaders
perceive each of these drugs and their differentiating features? How will
uptake of these agents in the market impact on current market-leading
therapies? Which agents will be most successful and why?
The VTE primary prophylaxis market encompasses several
different patient populations, with the novel oral anticoagulants only gaining
approval in the orthopedic surgery setting. What lessons can be learned from
negative clinical trial results in VTE primary prophylaxis populations outside
of the orthopedic surgery setting? Which patient subpopulations have the
greatest remaining unmet need and commercial potential?
The pipeline of new VTE therapies appears relatively bare in
the near term, following recent anticoagulant drug approvals and drug
discontinuations. However, exciting developments are being made for new
therapeutic targets. What do thought leaders think of these alternative
approaches? Have there been any recent improvements in the understanding of VTE
disease pathophysiology and discoveries of potential new drug targets?
Markets covered: United States, France, Germany, Italy,
Spain, United Kingdom, Japan.
Primary research: 23 country-specific interviews with
Epidemiology: Number of DVT events; number of PE events;
number of hospitalization events (orthopedic surgery, major non-orthopedic
surgery, minor nonorthopedic surgery, nonsurgical) eligible for VTE acute
primary prophylaxis; number of prevalent cases of cancer patients eligible for
VTE primary prophylaxis.
Population segments in market forecast: Primary
prophylaxis indications (major orthopedic surgery, non-orthopedic surgery,
nonsurgical patients, cancer patients eligible for prophylaxis); acute DVT
treatment and secondary prophylaxis; acute PE treatment and secondary
Emerging therapies: Phase II: 1 drug; Phase
III/preregistration/registration: 6 drugs. Coverage of select preclinical and
Phase I products.
Market forecast features: Using a patient-based model,
we forecast drug sales for two market segments: for VTE acute
treatment/secondary prophylaxis and VTE primary prophylaxis through 2022.