Background and Scope
Our client, a leading global bio-pharma company with engagement across pharma, biosimilars and vaccines engaged us to support decision making around continued investments in the zika vaccine program. As part of the overall portfolio decision making for a viral vaccines venture acquired, the client needed to assess overall global opportunity and investment merit in a pre-clinical stage zika vaccine.
The client engaged Sathguru to assess commercial merit of the vaccine, global competitive landscaping, evaluate the financial viability in pursuing the vaccine in different global markets and strategic implications for continued investment.
Our Approach
Sathguru performed a comprehensive assessment of both commercial landscape and regulatory considerations for a potential Zika vaccine as summarized below
Global competitive intelligence, landscaping and portfolio benchmarking
Sathguru collated information on the Zika vaccine candidates in development globally through detailed secondary research from a variety of sources: publicly available vaccine pipeline trackers, company annual reports and press releases, peer-reviewed literature published by vaccine developers, data from funding organizations and other public health stakeholders etc.
A focused competitive analysis was conducted on the identified pipeline on some key metrics: phase of development, vaccine platform type, funding or backing available to the project, pace of development of the project and commercial footprint in different markets and geographies: private vs public market in US, EU, RoW etc. The candidates were scored and benchmarked against each other based on the above metrics and the vaccine candidates presenting the most competitive threat to the client’s vaccine in different markets were identified.
Market opportunity assessment for the vaccine candidate and market sizing under various scenarios
Commercial opportunity in this case would evolve based on epidemiology and disease incidence as well as market shaping efforts by public health stakeholders. Unlike a standard market research project, the complex nature of uncertainty in this vaccine candidate, entailed the following steps to analyze the market opportunity and develop market sizing models with confidence:
A comprehensive epidemiology study for Zika disease was conducted through in-depth secondary research. In order to establish a clinical need and use-case for the vaccine, we collected and analyzed the data on historical Zika outbreaks, morbidity and mortality associated with it, with special focus on neurological complications associated with Zika presenting global public health threat.
In addition to the clinical need assessment, we searched for and identified both explicit and implicit indications from public health authorities, country governments towards the need for a vaccine and their support towards Zika vaccine development to assess commercial merit and adoption potential in public market.
Market sizing: Based on the identified need of the vaccine in different population segments and geographic spread of the disease, we quantified the market opportunity in both private and public markets based on different scenarios of vaccine adoption as observed through a qualitative analysis of advocacy and opinion literature by government and public health stakeholders.
Assessing technical and regulatory risks and way forward
A qualitative analysis of regulatory landscape was performed to identify the data requirements and challenges specific for vaccine development and licensure. A detailed review of literature published by US FDA, EMA, WHO was performed and both drivers and challenges to vaccine licensure were identified. Based on our findings and analysis, we recommended a way forward for the client based on pre-clinical and clinical study data package requirements and strategic implications of the clinical development timeline on market entry.
Weighing commercial and financial merit of investment
Synergy of Zika vaccine with the client’s existing operations in different geographies was assessed and the client’s strengths that were crucial to market value realization were analyzed. Based on the size of the market opportunity and the associated technical and regulatory risks, we assessed the financial feasibility of pursing the Zika candidate and recommended way forward for continued investment.
Project Output
Based on our comprehensive findings and analysis, we advised the client on the merit in pursuing the development of the Zika vaccine. Recommendations were designed around the criticality of timing the clinical development and strategies to de-risk the clinical development. Our detailed report formed the basis of the investment decision of the management in the vaccine project.