Across the pharmaceutical industry, the likelihood of developing a product, receiving approval, and then achieving commercial success is currently 3%. This slim but high-potential possibility, alongside forecasts that new launches will create up to 80% of the industry’s revenue by 2021, is prompting companies to upgrade their launch excellence capabilities. Established tactics can no longer be relied upon as changing dynamics are shaking up the market, with a growing emphasis on speciality therapies, cost, and improved outcomes. Three professionals share their insights on the future of product launch.
What market specific dynamics are affecting the future of product launch?
Scheuer: What has been affecting us, and will continue to affect us, is the expectation from payers (public and private) for us to deliver better value to patients and society. We came from an environment that was willing to pay for incremental innovation in a one-size-fits-all model. Now, and even more so in the future, with better understanding of diseases at a molecular level and more precise drug technologies, we will be able to treat more targeted patient segments and move closer towards cure or permanent alleviation of symptoms for severely affected patients with high unmet need. Commercially, this will continue to challenge our ability to create a value proposition for more targeted patient segments.
Forlin: In addition to the challenge presented by squeezed timelines, there are three main dynamics affecting the future of product launch: the increasing pressure on healthcare cost containment resulting in tightening constraints on market access, new ways to assess pricing, reimbursement focussed on clinical benefits, and health economics assessments; the digital transformation with the social-media-empowered patient voice; and the increased need to offer additional value beyond the pill. Therefore, having a great R&D function and developing innovative products, without addressing these points, isn’t enough to lead to a successful launch.
Luna: Multiple variables influence launch and one of the dynamics that will increase overtime is the value proposition offered to the customers, particularly in highly competitive environments. Markets demand stronger value propositions to ensure true cost-effectiveness. This implies that companies should develop differentiated market access and commercial strategies that support the value of the drug. This includes developing a clear and deeper understanding of the market and existing therapies, the economic and social impact of the unmet need in the specific market and ensuring the early engagement of key customers and experts to proactively prepare the market for the new product.
With more large companies developing rare disease medicines, what are the strategic essentials in preparing the market for speciality launch?
Scheuer: Deep understanding of science, sophisticated capabilities to generate market insights, and cost-efficient customer engagement are imperatives for success. If we assume that we are addressing a relevant unmet need with a highly efficacious new treatment, then it is essential to develop an ‘an organisation that works effectively and efficiently across functions, globally and locally, because the decision-making process for speciality and rare disease medicine is more complex. Then, organisational size is not a key factor; however, access to capital is vital to access technology and generate data.
Forlin: Launch must begin with a deep understanding of the customer and patient journey, followed by a cross-functional analysis across all critical nodes to truly understand the gap between the current versus desired experience. This analysis includes a deep understanding of the marketplace to identify the most appropriate actions. Early market access assessment, pre-marketing activities, close collaboration with patient advocacy groups, and disease awareness tactics are all essential activities, especially in speciality launches.
Luna: There are approximately 7,000 rare diseases identified today. Of those, approximately 95% do not have FDA approved treatment. This represents a great opportunity for pharma; however, success in rare disease is not easy and requires specialised approaches. The strategic essentials include the understanding of the disease and patient journey through close collaboration with patients and patient organisations; identification and mapping of HCPs involved in the management of patients with rare diseases; and, very importantly, ensuring early payer engagement together based on a ‘blue ocean strategy’ in market access. The last point is crucial since scrutiny has increased from the payer’s perspective regarding pricing and reimbursement.
Why is the focus and alignment of an organisation important for commercial success?
Scheuer: Organisational alignment is needed because a complex buying system needs to be engaged in order to reach the patients. Reaching more targeted patient segments, with more advanced drug technologies at price points that can be perceived as high, requires an aligned organisation to deliver a coherent and credible value proposition to the market. Focus is important because it is always required for execution and because a few markets make up >80% of the market potential, which is important to realise because cost consciousness does matter in a market under cost pressure.
Forlin: Alignment across the organisation is essential to achieve commercial success. In order to succeed at brand building and effectively communicate the value proposition to customers, it is imperative that all functions, communication channels, and tactics are aligned, resulting in one voice in the marketplace. Launch excellence teams are an effective solution to ensure alignment on launch preparation for commercial success.
Luna: Commercial success is derived from the aligned efforts of every member of the brand team. A shared vision supported by SMART objectives and clear roles and responsibilities substantiate the formula for success. Today’s world is faced with something we can call ‘the differentiation challenge’, which implies that every project, product, or approach should provide a relative value added that justifies its commercialisation. This is nothing new, but it is the reality that pharma faces day by day. In specialised markets, focussed strategies are required to ensure the specific opportunity is understood and maximised. Behind the existence of new methods and technologies is every team member that will contribute to the success or failure of every project.
From this discussion, it appears that, to adapt to the multiple forces simultaneously influencing launch, organisational alignment remains key for generating a shared vision, ensuring that an individualised, credible value proposition is offered. At the same time, reaching a more targeted patient segment and gaining in-depth disease awareness specific to individual patients will provide a differentiating factor for companies, enabling greater market share in speciality segments.