When bringing a new drug to market, a monumental achievement is undertaken with an all-hands-on-deck approach to execute a carefully developed, data-driven market entry strategy. Specific to the Federal market, there are contracts (or modifications) prepared to remain compliant with Federal statute, pricing research conducted, and product review for formulary placement anticipated. Once the initial flurry concludes, focus, naturally, moves to new issues and light monitoring of the Federal market is the generally accepted approach. That is a mistake.
Ongoing market landscape assessments should be completed with regularity. At a minimum, product teams should integrate an assessment every two (2) years into the drug’s lifecycle management strategy for the Federal market. Key indicators that an-out-of-cycle market landscape assessment update to proactively understand changes within market dynamics that affect product positioning include: regulatory changes, new competitors entering the market, and FDA approval for new / expanded product use. This check-in process of analyzing data, understanding trends, and drawing insights is the best approach to informed decision making and can confirm current market assumptions or find pivots to existing strategies to address market shifts.
A comprehensive market landscape assessment refresh begins with an analysis of a product’s current position in the Federal market with a level-set understanding of the scope of the market size. Through data analysis of primary and secondary sources of competitor utilization, prescribing trends, and a scrutiny of how competitors are distinguishing themselves within this market, a full picture of the existing playing field emerges. The quantitative and qualitative data collected is subsequently contextualized in terms of known access barriers, health system priorities, and market changes with a focus on changes that have occurred since the last market landscape assessment. In particular, navigating the evolution in both the regulatory landscape and clinical decision-making prescribing guidance is of key importance in data interpretation. Recognizing any shifts supports justification for increased or decreased investments to internal stakeholders and uncovers any messaging or outreach adjustments necessary to maximize the product’s value proposition.
The greatest benefit of a consistent landscape assessment schedule is the resulting right-sized resource allocations to the Federal market. Not every customer base is of equal importance in recognizing revenue but ignoring even subtle shifts in the Federal market can lead to missed opportunities both within the market itself and its associated spillover into the commercial market.