Navigating the evolving early commercialisation and launch landscape: eight powerful opportunities

This is a transformational time for the early commercialisation and launch landscape, with the pharma industry facing a growing array of challenges and opportunities. By acting early to understand your launch landscape and harness the collective cross-functional expertise across global to local, you can build meaningful differentiation for your brand and maximise patient benefits.

1. Multi-indication launches: The rise of multi-indication launches within and across therapy areas presents an extraordinary opportunity to reach a broader patient population. Determining the optimal launch sequence informed by engaging in early dialogue with regulatory agencies and payers is the first step. Crafting compelling value propositions for each indication built from future-proofed clinical development and evidence generation programmes is essential. To achieve ‘mega brand’ status, it is important to align on one overarching vision for the brand and demonstrate how the different indications align to this for a cohesive communications strategy.
2. Dynamic healthcare standards: The dynamic nature of healthcare and new approvals constantly challenges standards of care and often results in new market comparators emerging through the asset’s clinical development programme. Considering how the market is likely to evolve and building launch scenarios to reflect this is of paramount importance. By forming alliances with influential opinion leaders, and fostering exceptional collaboration between clinical and commercial teams, we can anticipate and plan effectively for potential scenarios through phase 3b programmes or real-world evidence generation.
3. Strategic markets: While the US remains crucial to the success of any brand globally, major ex-US markets should not be underestimated. Navigating the launch needs of diverse global markets requires a bold and confident approach. By cultivating strong partnerships internally and externally and conducting market-specific research with a particular focus on stakeholder attitudes, the patient journey and reimbursement requirements early in the clinical development and strategic planning process, we can successfully penetrate international markets and ensure our products reach patients worldwide.
4. Combination therapies: The introduction of combination therapies presents a unique opportunity to deliver enhanced patient outcomes. However, launching these therapies comes with increased complexity related to clinical trial arrangements and pricing negotiations in circumstances where distinct parts of the combination regimen span different companies. Adopting a growth mindset allows us to approach these launches with confidence, effectively navigating additional requirements with advice and support from regulatory, supply, legal and compliance functions.
5. ‘Fast to market’ launch strategies: Determining what your ‘fast to market’ strategy could be is an essential part of launch planning. Leveraging early access schemes, designing phase 2 studies with the flexibility to pivot and submit as the registration trial, accelerating the approval process through the regulatory data submission strategy and product designation are all elements that should be evaluated to expedite the approval.
6. The constant digital revolution: The digital revolution continues to disrupt traditional ‘go to market’ models, opening up immense opportunities, yet also causing a feeling of overwhelm and destabilisation. By taking advantage of digital platforms for targeted communication, engaging healthcare professionals and patients through virtual channels, and harnessing data-driven insights from clinical trials and personalised marketing efforts, we can carve a distinct path forward. Providing seamless, tailored experiences across multiple touchpoints remains a huge opportunity to set us apart in this dynamic landscape.
7. Cell and gene therapies: The emergence of cell and gene therapies represents a fantastic opportunity for patients and embodies the vision for personalised medicine. That said, it does bring with it a new set of challenges for companies: building specialised infrastructure, adhering to cold chain requirements, identifying then contracting with approved treatment centres, as well as supporting the patient through and beyond a highly complex treatment journey. Incorporating launch learnings from early cell and gene approvals into the launch strategy and starting planning and engagement with relevant stakeholders well in advance of phase 2 clinical trials is therefore paramount.
8. Companion services: Companion services, such as diagnostics, AI technologies, administration or monitoring devices, and patient support programmes, can play a vital role in our drive towards differentiated launch strategies. Offering comprehensive solutions enhances the value proposition of our brand and can sway a healthcare professional’s decision to prescribe one treatment option over another. The patient voice is becoming increasingly important and, although there are variations across therapy areas, it can influence a healthcare professional’s prescribing decision to varying degrees. Improved compliance and adherence may be achieved through wearables and patient support programmes contributing to more positive patient outcomes. By carefully selecting partners and forging strategic collaborations to develop innovative companion services aligned to launch strategies, we can be positioned at the forefront of industry advancements.