In the consumer goods industry, there is a clear and easy definition of new product launch success. Any new product launched in the market is considered successful if it can still be found on store shelves after two years! Despite all the innovation discipline and stage gate processes, new product success in consumer goods is still considered to be miserably low and it is estimated that 80% of new products launched fail the 2-year survival test.
In the pharmaceutical industry, there isn't an easy definition of drug launch success. Drugs can be delisted from formularies, which would be equivalent to a consumer goods product being delisted from stores, but in reality, it’s more likely for a new drug to not get on formularies in the first place rather than be delisted from them. Most of the time, the success of a drug launch is measured by delivery against Company/Wall Street expectations or by comparing the market share of new drugs vs. competitors in the same class. Based on that measure of success, researchers have shown that a significant % of new drugs launched miss target forecasts, suggesting that drug launch success is also not great.
Source: Cha, M., Rifai, B. & Sarraf, P. (2013) Pharmaceutical forecasting: throwing darts? Nature Reviews Drug Discovery 12, 737–738 (From the Analyst’s Couch)
There are many reasons why the launch of a new drug might miss its own internal or external analyst expectations:
The easiest way to miss the forecast is if the forecast was not realistic in the first place. Despite all the time, money, and effort pharmaceutical companies invest in drug launch forecasting, pharmaceutical market research is still a challenge. It is estimated that at least one in 3 forecasts are not accurate and the real-world results of a drug launch don't meet expectations. The launch forecasting approach in the pharma industry may need an overhaul and significantly different market research as well as modeling techniques might be necessary to improve the accuracy of launch forecasts. Researchers have found that forecasting inaccuracies vary significantly depending on the type of pharma company that is launching the drug – big pharma drugs are discounted heavily pre-launch while small/specialty pharma drugs are consistently overestimated.
Source: Cha, M., Rifai, B. & Sarraf, P. (2013) Pharmaceutical forecasting: throwing darts? Nature Reviews Drug Discovery 12, 737–738 (From the Analyst’s Couch)
Typically, launch teams have 3-5 years to prepare for a drug launch, which gives them ample time to be ready. However, increasingly teams have to quickly gear up for an accelerated launch because of an unexpected breakthrough designation status by the FDA. Many pharma companies are also waiting until the last minute to make launch decisions based on phase three clinical data, which can lead to launch teams scrambling to have materials ready by the approval date. A number of drugs even launch with just the PI and don’t even have a CVA ready.
Many important assumptions are made during the launch planning process and while launch teams conduct extensive market research and data analytics to validate their assumptions, it is possible for the market to change by the time the new drug is launched in ways that were not anticipated by the team.
Under these circumstances, launch teams end up placing the wrong “strategic bets” and not accounting for unexpected competitive or market events during the strategic planning process. Launch strategy mistakes can manifest themselves in the form of brand value propositions that don't connect with customers, brand positionings that are not differentiated, pricing and reimbursement strategies that create major barriers to market access, and more!
While very few launch teams get their strategy wrong, it is more common for launch teams to not execute well on their own strategies. Since launch planning is extended over a multi-year process, it is easy for launch teams to make incremental decisions over time and slowly end up with launch executions that are not derived from their own launch strategic thinking.
The new products planning teams in pharma are responsible for very early-stage commercialization strategy for all assets in the pipeline. However, NPP teams are typically understaffed and under budgeted given the importance of the role they play in shaping the target product profile and the ultimate product design for every drug. NPP teams are the best bridge between clinical trial experts and the end customer. Without the input of NPP teams, critical early-stage decisions about clinical trial design, endpoints, etc. can be made without enough customer input, creating challenges for the launch teams later.
Much of the focus during the launch planning process is on the product - optimizing the target product profile, developing a highly differentiated product positioning, optimizing the product visit, etc.
A more customer-centric launch planning process, grounded in patient centricity, would start with why the customer needs our product in the first place and would identify all the possible reasons why the customer wouldn't be motivated to try the product despite impressive clinical data.
The current organizational structure which relies on a global launch team to develop a launch dossier that all countries including the US are supposed to follow and execute has many challenges associated with it. Despite the best efforts of the global launch team, the US team often creates its own launch strategy, plan, and executions, and in many cases repeats essential launch planning work steps. On the other hand, local country affiliates who are always deprived of resources and have no choice but to follow the global launch dossier often don't have enough tactical guidance on how to implement the launch for better global launch consistency and singular brand voice.
Whether a pharma company is launching a rare disease drug for 10,000 patients or an obesity drug for 100 million patients, the fundamentals of a successful drug launch strategy are still the same.
Since launching a drug requires planning several years ahead, best-in-class drug launch teams master the process of forward-thinking and backward planning. Simulating the market and competitive environment years in advance is not an easy task and requires innovative business intelligence and forecasting tools. Just simulating the future is only half the battle, because a successful drug launch also needs visionary people who can reverse engineer business strategies and decisions working backward from the future. Best-in-class launch planning not only requires running Monte Carlo simulations during the forecasting process but also brainstorming different launch strategies for different scenarios.
Extensive academic research done in the field of judgment and decision-making has revealed that some people are indeed super forecasters and can accurately predict future events better than everyone else.
Every drug launch team needs to utilize the science of super forecasting to build better forecasting models, to predict launch scenarios more accurately and to create the best offense/defense strategies for launch. Research done by Philip Tetlock and Dan Gardner on the topic of super forecasting has led to the development of the Good Judgment Project platform that has produced significantly better forecasts for the COVID pandemic, geopolitical events, and even commercial applications like product launches, including within a pharma commercial model.
Most launch teams have a collaborative culture which has many upsides but can also lead to democratic decision-making by committee. Successful drug launches require strong leadership to make tough marketing strategy decisions about not just what TO DO, but also what NOT TO DO during the launch. This is especially relevant since increasingly new drugs have more clinical data based on a variety of clinical endpoints that can be communicated to customers, thereby creating a psychological tendency to want to say and do it all during the launch process. Many launch drugs can fall prey to the curse of when you say too much, you say nothing at all…because nobody is willing to make the tough strategic launch decisions.
Most launch teams prepare for launch Plan A and assume they will have an opportunity to implement it. 80% of their effort goes to prepare for Plan A and often Plan B for launch is an afterthought without enough preparation.
In the real world, most launch teams end up needing a launch plan that looks closer to Plan B. An over-prepared backup plan is better than a reactive course correction plan in every high-stakes launch situation and leadership in pharma companies need to encourage launch teams to spend more time preparing for Plan B and to drive a cultural shift in the launch planning process.
Shifts in the commercialization model and ongoing digital transformation of the entire pharmaceutical value chain will drive major changes in how drugs are launched in the future.
Pharmaceutical companies have been consolidating their brand marketing infrastructure into more integrated go-to-market teams. Many companies have already combined responsibilities for primary market research, secondary market research, competitive intelligence, data analytics, forecasting, and other important business intelligence functions under one integrated team. Beyond business and market intelligence, integration is also happening in the marketing function as brand marketing, HCP Marketing, and multi-channel marketing teams are working closely together to create synergies in personal and non-personal promotion channels.
Innovations in digital technologies and AI are making the launch planning process more efficient and improving speed-to-market for drug launches.
Cloud platforms like Veeva Vault, Within3, ZAIDYN, etc. are helping launch teams analyze data, get customer insights, create and manage content, collaborate with other launch partners, etc. Digital transformation efforts are also accelerating the analysis of clinical trial data, CSA development, NDA filing, etc. thereby improving the speed to market.
In the past, drug launch teams could only map the patient's journey through primary market research studies, which was limiting. With the universal adoption of EHR systems by providers, patient journeys can now be mapped in granular detail using data analytics, and a detailed customer experience can be developed to optimize outcomes for patients and maximize the adoption of the new drug.
The adoption of any new drug will require HCPs, patients, and payers to change some or possibly many behaviors and 40+ years of research in behavioral science has shown that human behavior change is challenging.
Drug Launch teams are integrating the use of behavioral science during the launch planning process and mapping current vs. desired customer behaviors along the entire customer journey in detail. Behavioral science is also being used to create behavior change messaging and nudge intervention programs to drive customers towards desired outcomes.
Analysis of drug launches has shown that HCP engagement during the first 5 patients is critical to building confidence and customer advocacy for a launch brand. Launch teams are optimizing the early patient trial experience for HCPs with more engaging content, AI-driven customer support, and comprehensive patient support services.
As pharma companies streamline their R&D strategies and their drug pipelines, there is increasing pressure for every drug launch to be successful, both in the absolute as well as versus expectations. Drug launch teams are embracing new sources of data and pharma insights, new launch planning processes and techniques, and your go-to-market strategies to make every new launch as successful as it can be. However, the success rate continues to be low, suggesting continuing improvement and reimagination of the launch process.
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01 Feb 2024
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