Edoxaban - Potential Game Changer in Oral Anticoagulant Market

  • ID: 2227884
  • Report
  • 58 Pages
  • MP Advisors
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FEATURED COMPANIES

  • Bayer
  • Boehringer Ingelheim
  • Boston Scientific
  • Bristol Myers Squibb
  • Daiichi Sankyo
  • Johnson and Johnson
  • MORE
Edoxaban - Potential Game changer in oral anticoagulant market

Stroke Prevention in Atrial Fibrillation represents the largest opportunity for the new generation oral anticoagulants, besides a very large prevalence, there is a very clear unmet need. There are 1.7 million patients in the US treated for non-valvular atrial Fibrillation with warfarin, in Europe the prevalence is almost twice and in Japan there are close to million patients.

About 35% of the AF patients are currently not treated with warfarin because of warfarin related constraints (drug-drug /dietary interactions, difficulty in INR control). Hypothetically assuming a 100% market share shift from warfarin/aspirin/other therapies to new generation oral anticoagulants, the annual market size works out to be $22b (at $3000 as annual cost of therapy). Besides the new generation oral anticoagulants, there is also the watchman device (currently in Phase 3) from Boston Scientific, which as well could be a major contender of market share.

The recent complete response issued by the USFDA to Eliquis was very much unexpected and has added uncertainty to the forecasts around this class. We see Daiichi Sankyo's Edoxaban and Boston Scientific's watchman device as potentially underestimated threat in the consensus forecasts for the new generation oral anticoagulants.

This report also has a market model for the new generation oral anti coagulants. The market model has been categorized into three segments

1) Warfarin Treated Patients

2) Aspirin Treated Patients

3) Patients on Dual Anti-platelet therapy / Patients on no therapy. A market model for each of these market segments has been separately prepared for the major geographies (Japan, EU and US).

The relative market share of new generation coagulants has been assigned based on

1) A thorough / detailed assessment of the pros and cons of Edoxaban success in ENGAGE AF and its expected clinical profile

2) A thorough / detailed assessment of the pros and cons of Watchman Device Success in ongoing PREVAIL trial and its expected clinical profile

3) Relative merits and demerits of the newer treatment options

4) Existing market dynamics with regard to patient's / physician propensity to switch to new generation oral anticoagulants

5) Availability of Antidotes
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FEATURED COMPANIES

  • Bayer
  • Boehringer Ingelheim
  • Boston Scientific
  • Bristol Myers Squibb
  • Daiichi Sankyo
  • Johnson and Johnson
  • MORE
Edoxaban - Potential Game changer in oral anticoagulant market

1. EXECUTIVE SUMMARY
- Market Model for Stroke Prevention in Atrial Fibrillation and DVT Treatment
- Why is Edoxaban a potential Mega Blockbuster
- Edoxaban –Market potential
Indication wise
Geography wise
Compared to other oral next generation anticoagulants
- Our view on key upcoming Milestones For Edoxaban and Factor Xa class
- Estimated launch timelines for new generation anticoagulants– Indication wise/Geographywise

2. Edoxaban in SPAF
- Background information on Edoxaban (Lixiana)
- Edoxaban PK/PD data comparision to other novel oral anticoagulant
- Expectations from ENGAGE AF study
ENGAGE AF Clinical trial design comparison to other Clinical trial designs
Analysis of chronology of events happened in completion of ENGAGE AF
- Analysis of the reported clinical trial results of Edoxaban
PhII data in Japanese Patient pool
PhII data in Global Patient Pool
PhII data in Taiwan patient pool
- Japan- PhII/III clinical data comparision of Edoxaban with other oral anticoagulants
- Relative clinical profile and Positioning of Edoxaban compared to Xarelto, Eliquis and Pradaxa in different geographies

3. Edoxaban Market Positioning in SPAF, Market Model and Peak sales Estimates based on:
- Switch From Warfarin
Warfarin continues to hold itself strong against Pradaxa and Xarelto– Will the entry of Eliquis / Edoxaban change the scenario?
- Switch from Aspirin
- Switch/Addition to those on dual antiplatelets
- Geographywise clinical data difference and different clinical practise results in different market leader/market share
- Risk to our market share Forecast

4. Factors That will restrict Adoption Of New Generation Oral Anticoagulants post launch
- Experts view on the hurdles to the adoption of new generation anticoagulants in SPAF at ESC-12
- Concomitant Medicines- Donut hole and drug-drug interaction
- Availability of antidote for novel oral anticoagulants
- Regulatory Scenario – Medicare Shared Saving program to be implemented in 2012
- Reimbursement status of PT/INR monitoring for warfarin in major countries
- Warfarin Genotype testing, its regulatory approval and its reimbursement

5. Edoxaban in VTE TREATMENT
- Market potential
Treatment duration
Geographywise Prevalence
- Edoxaban Clinical Profile compared to Other Factor Xa inhibitor in VTE treatment
Results from PhII BOTTICELI study of Eliquis
Expected data from HOKUSAI VTE study
- Pros and Cons of Edoxaban market potential in VTE treatment

ANNEXURE- 1: Analysis of the Reported pivotal clinical study results of next generation oral anticoagulants (Pradaxa, Eliquis, and Xarelto) in SPAF
- Efficacy and Safety comparision of ROCKET AF, RELY ARISTOTLE AND AVERROES
- ROCKET AF, ARISTOTLE & RELY - Cross Trial Comparison Based On CHADS2 Score
- ROCKET AF, ARISTOTLE , AVERROES & RELY – Efficacy and Safety comparison – subgroup analysis
- GEOGRAPHYWISE NET CLINICAL BENEFIT COMPARISON- Eliquis, Xarelto, Paradaxa

ANNEXURE- 2 Analysis of the reported clinical data in VTE treatment
- Prolongation of VTE treatment Duration with Xarelto and Pradaxa
- Clinical data comparison of Xarelto, Eliquis and Paradaxa in VTE treatment
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- Daiichi Sankyo
- Bayer
- Johnson and Johnson
- Boston Scientific
- Boehringer Ingelheim
- Bristol Myers Squibb
- Pfizer
- Portola
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