Pharmaceutical product launches have always been complex, but recent developments in the industry have made these rollouts even more challenging. New modalities, such as cell and gene therapies, are complicating the biopharma landscape; competition is increasingly sophisticated, especially for multi-indication drugs and treatments in immunology and oncology; fast-growing markets such as China are seeing an increasing share of global sales; and shifts in go-to-market models are accelerating under pressure from the COVID-19 pandemic.
Now more than ever, a launch’s success depends on capable and experienced leadership—yet many of the people involved in launching a drug are doing so for the first time. For instance, among the executives taking part in a recent launch roundtable, more than a third had no prior launch experience.
And the same applies to companies; many promising biotechs have yet to launch a drug themselves.
In this article, we consider why launch is becoming more challenging, identify the five sets of capabilities most critical to a successful launch, and propose novel learning approaches to help individuals and organizations build their skills.
Why is launch more complex than ever?
A number of new factors has made the launch environment more challenging over the past few years:
- Access to healthcare professionals has become more limited. Since the onset of the pandemic, meetings with physicians have largely gone remote. According to a recent McKinsey survey, in-person interactions have fallen by 75 percent in Europe, and doctors expect that two-thirds of their contacts with reps will continue to take place via virtual channels.
Three out of four American healthcare professionals believe that restrictions on reps’ visits are here to stay.
These limitations could hamper companies’ efforts to keep doctors informed about new drugs that may elevate the standard of care, which in turn would delay better outcomes for some patient populations.
- Inexperienced players are taking on an outsize role, and veterans are venturing into new territories. McKinsey analysis shows that first-time launchers, which are expected to account for more than half of “blockbuster” launches between 2021 and 2025, have a significantly lower chance of success than their more experienced peers.
In addition, even veteran launchers may need to venture beyond their established areas of expertise when addressing rare or harder-to-treat illnesses. Eighteen of the top 20 pharma companies have gene therapies in development, and 36 percent of launches, up from less than 5 percent in 2019, are expected to involve new modalities by 2025.
- Launches in multi-indication therapeutic areas are rising. Global oncology launches rose from 150 in 2011–15 to 174 in 2016–20, while immunology launches increased from 16 to 23 over the same period. Launching a therapy with multiple indications means additional challenges related to co-positioning, pricing, the sequencing of indication expansion, the prioritization of field-team resources, the orchestration of internal collaboration, and so on.
- China is becoming a more important healthcare market. Reforms at China’s National Medical Products Administration have led to a dramatic increase in approvals, from seven in 2016 to 69 in 2021, for innovative drugs. With a growing population of patients in need, China’s pharma market is now second in size only to the United States (although generics and out-of-patent therapies still account for a significant share of the Chinese market).
Launch leaders will need a good understanding of the country, a local footprint, and the right partners for this important market.
- Launches in highly competitive markets often yield disappointing results. In markets where multiple comparable drugs are available, 60 percent of launches fail to meet prelaunch expectations.
As competition intensifies across the industry, with 40 percent more therapies per indication in 2019 than in 2006,
the number of crowded markets will only increase.
- Healthcare data are exploding. According to projections, healthcare data will increase at a CAGR of 36 percent between 2018 and 2025.
Biopharma companies must process, interpret, and act on the flood of data so they can better serve the healthcare needs of patients around the globe. We estimate they spend more than $20 billion a year on data and analytics in the United States alone.
- Ensuring patient access to therapies is becoming more challenging. Some countries are introducing price freezes or mandatory rebates; others are creating assessment bodies like the Institute for Clinical and Economic Review in the United States. These mechanisms, while helping to keep healthcare costs under control, make it more challenging for launches. Globally, real-world evidence is becoming a factor in regulatory and reimbursement decisions. Other novel sources of evidence, such as synthetic trial arms, are opening up new opportunities for pharma companies to bring the best treatments to patients and differentiate their offerings from those of competitors.
Against such a complex backdrop, pharma companies that lack highly developed strategic, digital and analytics, and functional capabilities will struggle to compete.
What capabilities do you need for an effective launch?
We identified five functional capabilities that pharma companies need to hone for a successful launch, and a corresponding set of leadership skills for the top launch team to build.
Connect the dots: use advanced research techniques to understand multistakeholder journeys, derive insights to shape the launch, and build a cross-functional market perspective as part of an integrated strategy that not only covers the drug itself but also maximizes its value in serving the most patients.
Effective launch leaders are adept at using both quantitative data and qualitative insights to shape their strategic decisions. They communicate with a range of stakeholders, ask thoughtful questions, and listen carefully to the answers. In discussion with key opinion leaders (KOLs), for instance, they balance advocacy (conveying their own point of view) with inquiry (asking for the KOL’s conclusion, reasoning, and feelings so as to understand underlying beliefs).
At the enterprise level, connecting the dots requires expertise in analyzing data from a diverse range of sources to generate early insights. For instance, a commercial team seeking to understand patients’ pain points along the treatment journey may want to examine structured data from their customer relationship management database alongside real-world evidence from electronic medical records.
Think strategically: identify what matters most, find innovative solutions to emerging launch challenges, and actively manage uncertainty.
Effective launch leaders use creative problem-solving skills to identify and address the very small number of big decisions that will most affect the launch. Instead of relying on perceived wisdom about markets or therapies, they conduct diagnostics to challenge consensus views. Rather than accept a competing therapy at face value, they consult healthcare professionals to understand how it is used in clinical practice and how effective it is perceived to be. They address issues as they occur and take a methodical approach to recognizing and prioritizing problems, planning remedial work, and developing and recommending solutions.
For the wider organization, thinking strategically involves assessing healthcare professionals’ knowledge of the therapeutic landscape, tailoring medical engagement accordingly, and developing education programs to fill any gaps. It also involves identifying pain points in treatment journeys, designing services to resolve them, and finding ways to improve the overall experience for both patients and clinicians. By segmenting physician and patient groups according to the specific pain points or problem areas they encounter, launch teams can personalize their approach to meet a wide range of different needs.
Find the edge: craft compelling narratives to position the new product distinctively with external and internal stakeholders.
Effective launch leaders develop a value proposition that addresses the important considerations—clinical, health economics, and stakeholder experience—and will also resonate with their priority audience, whether patients, physicians, or payers, such as a compelling narrative and memorable imagery to capture their audience’s attention.
A distinctive and compelling narrative that engages patients must also address emotional as well as rational concerns. For instance, the greatest value of human papillomavirus (HPV) vaccines lies not so much in preventing HPV itself as in protecting patients against the risk of various forms of cancer associated with it. However, as HPV is classed as a sexually transmitted disease, vaccinating children proved controversial for some parents. Their concerns had to be addressed to ensure they were comfortable consenting to their children’s treatment.
Telling a compelling story is not just about conveying the right message but also choosing the right format, channel, and time for the intended audience, which in turn requires a detailed understanding of their preferences and needs.
Inspire and mobilize: act as a role model and secure the support and engagement of internal and external stakeholders.
Great launch leaders articulate a clear identity and purpose for the new treatment. Inspired by the impact a new drug can have on improving patients’ lives, launch leaders are instrumental in creating the energy behind the launch and setting the tone both within the company and beyond. In addition, they are quick to detect and assess changes in the external environment and are nimble in correcting course as new clinical data become available or competitors respond to the launch. They use pulse checks to gauge internal understanding, insights from field reps to monitor their decisions’ efficacy, and sprint-based initiatives and empowered teams to put their launch strategy into action.
For multinational pharma companies, mobilizing the organization behind the launch involves securing the support of the countries’ leaders. These leaders’ contributions will vary from company to company, but typically involve developing KOLs, planning pricing and reimbursement, and ensuring compliance with local requirements for clinical trials. Market access teams will play a key role in synchronizing global and local plans to enable other functions, such as marketing and sales, to execute their plans effectively.
Get things done: maximize personal impact by setting priorities, deciding what to do in-house, and classifying other tasks as “delegate,” “defer,” or “delete.”
Planning and executing a typical pharma launch takes three to four years, involves hundreds of deliverables across multiple functions, and demands discipline and perseverance. Effective launch plans start with strategic activities at the global level and gradually transition to country-level tactics in the 18 months prior to launch. Particular expertise is required for planning handoffs between functions and identifying where collaboration adds value (such as the synchronization of data generation between access and clinical teams) and where it is unhelpful or proscribed (such as the exchange of account-level information between medical and commercial teams).
Moreover, great leaders aren’t rigid; they remain flexible when new information emerges. They will focus on rallying their organization around key impact areas, which differ from therapy to therapy, rather than blindly following a predetermined launch plan step by step. For instance, if evidence emerges that initiating early treatment with a new drug could prolong patients’ lives, the launch leader might charge the access team with gathering evidence that could affect reimbursement decisions, the medical team with educating clinicians about the importance of timely treatment, and the commercial team with raising awareness of the drug’s impact on survival rates.
Great leaders also avoid a few common pitfalls. One is spending so much time revising strategy that implementation teams must rush and improvise on the ground. Another is allowing execution to be compromised by bureaucracy, for example, endless information requests from global teams to affiliates with no feedback loop. If the central team doesn’t create a comprehensive and global plan for research, planning, and tracking the information flow, country teams may try to fill gaps themselves, creating unnecessary costs and inefficiencies, inconsistent approaches, and potentially even risk. Another common error is not tracking performance frequently enough or using inadequate metrics or mechanisms, such as relying exclusively on third-party monthly reports. (These reports are important, but they are equally accessible to all competitors and do not provide a competitive advantage on insights.) Leaders can avoid such pitfalls by setting up a “launch situation room” that is not just a physical space where teams collaborate across functions but also a virtual infrastructure and work flow that helps speed decision making and execution.
Great launch leaders articulate a clear identity and purpose for the new treatment. Inspired by the impact a new drug can have on improving patients’ lives, launch leaders are instrumental in creating the energy behind the launch and setting the tone both within the company and beyond.
How do you build launch capabilities effectively?
To be effective, a capability-building program should provide an engaging educational experience for leaders and their teams. It must cater to different learning styles and preferences by using established pedagogical methods:
- Traditional lectures and application: discussions of new concepts and case studies combined with hands-on experience via simulations and on-the-job application.
- Field and forum: self-directed workplace learning and workshops in which teams study successful launches and complete interactive exercises.
- Senior challenge: sessions in which teams apply what they have learned and present their plans to launch leaders to gain direct feedback and guidance.
- Digital classroom: webinars, self-study modules, quizzes, and other virtual elements that will synchronize with the launch calendar, support ongoing learning, and provide opportunities to update or refresh knowledge.
- Gamification: a chance to experience realistic launch situations and decisions in a risk-free environment, allowing participants to compete with peers, explore trade-offs, and build experience more rapidly than they could in the real world.
- Simulation workshops: replications of real-life decision making between leaders from multiple functions, regions, and business units that allow team members to analyze potential pitfalls.
Most successful capability-building efforts use a carefully tailored mix of these and other learning methods. One company planning a series of oncology launches set up a course of lectures for its top ten markets. Each lecture was followed by a working session so team members could apply their theoretical learning to the context of a specific country launch. Local teams were asked to commit to a vision (such as agile launch) and immediate actions (“things to try out next Monday”). General managers and regional leaders attended the sessions to encourage other staff members to participate and adopt new ideas.
Some companies have embraced wider changes to better position themselves for future launches. For example, a team could target a capability like agile marketing in the context of a specific launch, tailor the capability to fit the company’s culture, and gradually institutionalize it across the organization. Or a company preparing a series of innovative drugs could set up a launch academy to provide training across functions at a global level and then refine techniques for each local application.
New capabilities may require new personnel, systems, and facilities. For example, companies seeking to master launch analytics will need access to data sources, people skilled at converting analytical findings into actionable insights, and an analytics center of excellence to roll out the new capability.
A launch offers a pharma company a golden opportunity not only to maximize a drug’s chances of success but also to transform the company’s capabilities for the future. A well-managed rollout creates a sense of purpose as well as the prospect of immediate returns. Great launch leaders will capitalize on that sense of urgency by piloting new capabilities, establishing necessary enablers, and accelerating learning across the whole organization.