The path forward for small and midsize biotechs
Considering the conditions described above, we recommend that small and midsize biotech focus on the following five key pillars to prepare for and enable a successful launch.
1. Design an operating model that drives executional effectiveness.
From market access to sales, supply chain, and regulatory, a cross-functional mindset is essential for a successful biotech launch. This involves building out a launch team with diverse skill sets and capabilities early on, particularly for biotechs launching a product for the first time with limited resources. Collaboration, accountability, and diversity of thinking inform a wide variety of critical launch-related activities, including pricing, marketing spend, and salesforce deployment.
Without proper planning and prioritization around key activities and resources, the launch team likely will find it difficult to execute an effective launch due to significant challenges in catching up on related tasks that require long lead times. It is critical for organizations to develop execution plans, to include associated investment that enable the launch team to build a deep understanding of the market and strategically position the company’s products for success.
2. Execute an effective and fit-for-purpose go-to-market plan.
Commercialization budgets are typically large, and their front spend is not at risk, assuming regulatory approval. Biotech companies have to utilize a fit-for-purpose, prioritized, and smaller budget, and yet they need to be able to execute competitively in the marketplace. Emerging biotechs should take advantage of the increasing role of medical affairs, advocacy, and potential provider partnerships in their go-to-market strategy. Innovative and effective plans to activate key opinion leaders prior to launch are fundamental to support a robust product introduction.
Relationships with advocates and influencers are essential in bolstering the clinical need and health-economic value of a new product relative to the standard of care or other interventions in the market. In addition to conveying a compelling value story, emerging companies should engage payers early to understand the drivers and potential barriers for product uptake, including non-traditional payers such as retail stakeholders.
Moreover, the COVID-19 pandemic has accelerated the shift beyond traditional face-to-face interactions to more digitally enabled communications. As such, biotech companies need to plan, build, and implement both an omnichannel engagement model to interact with customers and an end-to-end positive patient experience. It’s also important for these companies to understand which targeted stakeholders to engage, when to engage them, and which channel is most appropriate. This mindset is essential to drive a product’s success and penetration in the market upon launch.
3. Be strategic about market access and pricing.
Another key pillar for successful launch, this approach involves carefully developing estimates for potential product value by applying risk scoring to assess pricing and guide strategic choices, building robust forecasting models, and establishing a methodology to evaluate the probability of technical, regulatory, and market access success for each product. It’s critical for the launch team to develop an early understanding of how diverse stakeholder groups will perceive a product. This will enable the team to anticipate and plan for any potential obstacles or challenges that may arise during launch. The impact of not doing so can be significant, including underperformance and missed first-year forecasts.
Small and midsize biotechs also need to understand the payer perspective on unmet need, comparators, and coverage and reimbursement processes early in the planning process so that the company can plan for and generate the appropriate evidence ahead of launch. The launch team also needs to assess the budget impact in the context of the treatment paradigm and outcomes when they establish the list price, net price, and coverage goal for the product. And because many of these tasks must be completed virtually, many companies also need to evaluate which payers to engage and how to engage them, including the pre-launch exchange of information, to articulate the value proposition of the product and potential negotiations at launch.
4. Prioritize data foundation, analytics, and monitoring.
Strategically collecting, analyzing, and monitoring data is essential in establishing a solid foundation to deploy a smarter, more efficient go-to-market strategy with limited resources. Small and midsize biotech companies should leverage their internal data and external datasets to uncover market insights as well as physician and patient preferences and behaviors. Additionally, biotech companies are now applying machine learning and predictive analytics to a wide range of commercial use cases, including the identification of drivers for uptake and predictions on how providers, patients, and payers are likely to react to the entry of a new product. Using predictive analytics also can help launch teams anticipate pricing and reimbursement hurdles and understand how to improve patient access.
Advanced and predictive analytics can provide sales and marketing functions with real-time insights into content and channel preference based on the historical behavior of physicians and patients, increasing the likelihood that the right message will get to the right stakeholder through the optimal method. To maximize the effectiveness of the field force, organizations rely on clean and accurate customer data and performance metrics to properly align territories and incentivize sales representatives. All of these capabilities need to be “baked” into the strategic planning of any launch from the very beginning, as delayed decision-making around data and analytics considerations is a common industry pitfall that ultimately creates significant challenges in the later stages of product launch.
Implementing the foundation for a robust analytics and omnichannel model early will improve the quality of the insights extracted from data, increase overall organizational agility and establish effective closed-loop feedback mechanisms, resulting in quick adaption of messaging to customer preferences and seamless redeployment of resources. In addition, monitoring performance using consistent metrics across the product portfolio will help teams navigate a rapidly evolving landscape by identifying potential issues and enabling the team to course-correct early in the launch process.
5. Conduct market-shaping activities early.
Leveraging a multi-stakeholder approach to support market-shaping activities and increase awareness and adoption of new therapeutics begins far before launch. Collaborating with influential health and patient advocacy organizations, community leaders, and market influencers is especially important for new therapeutic indications, as shaping an unmet need with novel products in novel landscapes can take considerably longer than it does in previously established markets. To be successful at launch, it is essential that biotechs understand the nuances of the landscape, evaluate the market, and effectively communicate value and unmet needs throughout launch engagements.
Most successful companies begin these activities during the clinical development phase to transform disease perception and adjust the product profile before launch. The launch team will need to begin by forming strong partnerships and engaging early with patients, caregivers, and advocacy groups to understand their journey and the obstacles they may face in accessing treatment and help to address value gaps. Patient advocacy groups are tremendously influential in accelerating funding and access for innovative treatments by conveying their patients’ pressing needs to regulators, policymakers, and budget holders to drive maximum impact.
In addition, building valuable relationships, deploying disease-state education programs, and priming the market can help stakeholders analyze data to source a stronger, more nuanced understanding of market and unmet patient needs. If market-shaping activities are executed effectively, biotechs will be able to transform existing market structures to improve therapy awareness and maximize patient access and uptake upon launch.
