The rapid consumer adoption of wearable devices for the collection of health data has inspired the next revolution in clinical trial operations. The integration of wearable health monitors with smartphones has opened up several fronts in clinical research. These integrated device-app-database systems can increase the frequency and accuracy of data collection, improve operational efficiencies, and achieve greater patient engagement in the clinical trial process.
Direct oral anticoagulants were introduced in the market to simplify the anticoagulation treatment and eventually, replace warfarin. As previously discussed, these new agents have some advantages over warfarin. One of those advantage is that all DOACs are administered in fixed doses, only adjusted for specific factors like renal functions (in some cases). Since 2008, the US and EU regulatory bodies have approved several DOACs for specific indications based on their clinical trials demonstrating non-inferiority to warfarin. The availability of DOACs have changed the way stroke prevention in AF is managed.
In the recent years, several new classes of Cardiology drugs have emerged. Notable among them are anticoagulants that are used in several secondary indications associated with the diseases of the heart and the vasculature. In this four-part series of articles, we analyze and provide an overview of the market leading anticoagulants, indicated for stroke prevention in Atrial Fibrillation and for primary and secondary prevention of Thromboembolism.
The white paper attempts to infer the biosimilar play of India-based biosimilar developers. It explores plausible scenarios for Indian developers entering the lucrative US and EU biosimilar market based on the current situation analysis of major biosimilar developers.
Biologics have a growing share in the pharma pipeline and increased usage as nutraceuticals. The increasing demand for biologic products has attracted huge investments in capacity and capability build-up. There remains huge opportunity for service providers/CMOs to be leveraged by providing flexibile, high-quality product delivery with customer centricity.
This paper attempts to present situation analysis of the current marketplace of Oncology biosimilars specially with respect to the industry’s micro-environment. The research and analysis herein, intends to identify positive forces and interactions that are shaping an attractive biosimilar industry in both US and EU markets.