Development Pipeline Analysis/Competitive Intelligence
For any given indication, there are usually a multiplicity of therapies being developed. This is the development pipeline, and this is your competition.
Conduct competitive intelligence to identify your pipeline competition. If you have been working in this space for years, you have likely crossed paths with other innovators in your space – at conferences, in literature reviews, and in other professional settings. None-the-less, there is work to be done. At a first pass, searches for similar products in development can be conducted leveraging open access platforms such as PubMed, NIH Reporter, ClinicalTrials.gov, google scholar, and even google itself. Depending on your asset, it will be helpful to categorize your competition into subgroups, e.g., similar mechanism of action (MoA) but different indication, alternative MoA but different indication, etc. As previously stated, it is important to cast a wide net and not focus solely on competition with the same MoA and indication – you will have many other competitors than that! Some indications have unique/new competitors to consider, such as biosimilars. Once you have identified the major pipeline competitors, it is time to understand each’s strengths and weaknesses (e.g. SWOT analyses – Strengths, Weaknesses, Opportunities, Threats). Are they ahead of you in their development timeline? Do they have a team with a successful track-record of bringing therapeutics to the market? How does their efficacy and safety data stack up against yours? What is the route of administrations? Predicted dosing schedule?
Competitive intelligence is important to start early and is never finished. As with any industry, newcomers are continuously entering the field.
For successful development and ultimate commercialization, your therapeutic must not only rise above the standard of care in efficacy/safety, but also must be superior to pipeline competition.
Conduct rigorous competitive intelligence and create a strategy for continued updating.