By Eduardo Schur, EY
Small and midsize biotechs, defined as those with less than $1B in total sales, play a major role in industry innovation: Consider that emerging biotechs develop and launch 40% of all drugs that hit the U.S. market. But with the healthcare ecosystem in an ongoing state of change, small and midsize biotechs can no longer rely on traditional commercial models. Launching new drugs is one of the most critical phases in the product life cycle, and often these entities’ entire existence depends heavily on a successful rollout.
But drug launches are complex, and emerging issues are adding even more complexity to the process, from the rise of specialty drugs to reduced face time with physicians and the need for multichannel digital engagement with consumers and other stakeholders. To enable success in today’s dynamic marketplace, small and midsize biotechs must reimagine both launch strategies as well as overall operations.
Trends In Small And Midsize Biotech Launches
To gain insights around launch performance, we analyzed publicly available data for several biotech products introduced since January 2020. Our research found challenges across the board. More than two-thirds of the products analyzed did not meet sales expectations, while 38% of the products missed expectations by more than 50% of projected revenues.
Underwhelming launch performance, like these scenarios, can have a significant impact on a biotech’s sales, cash flows, valuations, and overall future as a company. In our experience, this type of poor performance is often the result of inefficiencies at every stage of the pre-launch phase. As such, biotech companies need to explore better strategies to bring new drugs to market more efficiently.
Small and midsize biotech leaders should also develop a deeper understanding of why subpar launch performance is so common. From our perspective, less experienced launch teams may not adhere to best practices, including engaging key opinion leaders, payors, and advocacy groups to increase product awareness and value proposition; ensuring cross-functional alignment through an agile decision-making process; or enabling information sharing across teams using single-source data management.
For emerging biotech companies embarking on their first or second launch, following several key principles can ensure they keep pace with the competition and build long-term value through the pre- and post-launch period.
1. Create Tailored And Easily Adjustable Launch Plans.
Because launch teams must perform thousands of interrelated tasks across several cross-functional groups, they should be diligent about planning launch-related activities, identifying interdependencies, and remaining coordinated throughout the launch journey. Therefore, assembling a cross-functional team that includes professionals from sales, marketing, medical, regulatory, market access, and commercial operations is essential. Attending a launch activation workshop together will enable the team to align on vision and strategy, KPIs for pre- and post-launch, timelines, and major deliverables and milestones.
Cross-functional teams also should consider how organizational benchmarks and past launch performance will inform planning in specific therapeutic areas or local regions. Each team member’s prior knowledge about patients, competitors, key opinion leaders, and other stakeholders can be leveraged to develop leading and lagging KPIs that can be embedded into launch readiness plans and monitored.
In addition, a robust launch plan should include what-if scenarios to enable the team to adjust when market conditions change (e.g., a competitor launches a product earlier than expected or regulatory or manufacturing delays impact the product launch date). This will facilitate making quick but informed decisions, even amid disruption or uncertainty. After the above milestones have been achieved, the launch plan functions as a leading indicator of variations in performance and helps the team identify cross-project acceleration and de-risking opportunities.
2. Prioritize Data Analytics To Drive Informed Decision-Making.
For small and midsize biotechs, data analytics can unlock deep launch performance insights. While many companies have access to several internal and external sources of data — from claims and competitive intelligence to social media, clinical resources, and more — they may lack the infrastructure to integrate the data to derive forward-looking, actionable knowledge. In today’s marketplace, launch teams must move beyond relying on spreadsheets and static resources and focus more on backward-looking KPIs and achieving monthly or quarterly activity milestones.
Best practices also entail continuously tracking activity plans, including use of an early warning system for risks and potential delays. This allows global and regional launch teams to access key launch information earlier, thus enabling more proactive course correction. For example, when a brand manager has access to an interactive dashboard with real-time information on the progress of the launch, they can stay up to date on each function’s progress, continuously monitoring the progress of each functional team, along with any potential impact on the launch date. When challenges arise, this model enables managers to quickly drill down further at a functional or regional level to identify issues and define actionable steps.
To that end, biotechs also should consider investing in intuitive digital collaboration technologies that consolidate data from various sources to maintain a single source of truth. This will allow the integration of information across functional teams, driving better decision support automating processes, such as building reports, and enabling teams to proactively monitor launch readiness.
3. Establish A Digitally Enabled Launch Control Team To Drive Commercial Success.
In addition to strategic planning and robust data analytics capabilities, biotechs should ensure the right team is in place to execute the launch program, align all the various cross-functional teams at the global and regional levels, and coordinate effectively with external vendors. This team can then establish a digitally enabled launch control room to support launch plan execution.
Launch teams that leverage this approach should also consider conducting readiness checks at regular intervals around key milestones and to track each function’s overall progress, the scope of activities, resourcing, budget, and performance metrics. This provides the launch team and leadership with timely visibility into potential issues and risks across all program elements, deliverables, and interconnected activities, thus helping to drive agile decision-making across the organization.
As traditional commercial launch models give way to a new healthcare paradigm, it’s now critical for small and midsize biotechs to deploy strategic thinking around product launch. The three critical success factors outlined above will enable them to execute launches in a more targeted and effective way that will increase their chances of success.
About The Author:
Eduardo Schur is the EY U.S. Health Sciences & Wellness Commercial Strategy and R&D lead. He has more than 20 years’ experience in pharma and biotech, leading product launches, due diligence products, commercial assessments, and medical and market access projects in several therapeutic areas. He holds a bachelor’s degree in marketing and finance from Fundação Getulio Vargas in São Paolo, Brazil.
The views expressed by the author are not necessarily those of Ernst & Young LLP or other members of the global EY organization