Market access professionals tell us that their role is becoming increasingly influential amid a turbulent policy environment and intense competitive landscape. This was one of the clearest results from a survey commissioned by MMIT and The Dedham Group, which we explored in a recent white paper called Working Backwards: Patient access strategy is now guiding R&D.
This short article recaps the second half of the report, focusing on the strategic role that market access occupies throughout the drug development journey. As treatments become more complex and the number of alternatives more numerous, pharma companies are investing heavily in access. And the most sophisticated decision makers are embedding access in portfolio decisions as pipelines rebalance toward a more comprehensive assessment of patient need and eventual success in the market.
Early access planning
With each passing year, the cohort of new drug approvals tends towards greater complexity. Whether in the drug itself, the disease being treated, how the treatment is administered, through to how it is reimbursed, these new launches require more planning than ever before. This is evident in our survey of market access professionals, where over 90% of respondents reported that access planning timelines have been brought forward over the last five years.
The net result is that market access work may need to begin as early as Phase I. As of today, 30% of our surveyed respondents reported that their workload includes such drugs in early clinical development, and looking forwards, 78% expect an increase in market access investment over the next five years.
Leading reasons for access timeline shift
Source: MMIT and The Dedham Group
There are around 4,000 drugs currently in Phase I, and a further 3,600 at Phase II. Many of these drugs will ultimately fail during development, so not only does access planning need to encompass a broader range of drugs, but much of it must be done at-risk.
Supporting go/no-go decisions
This growing investment in market access capabilities is not only enabling earlier planning, but also building its strategic role in shaping portfolios. Historically, only one in ten drugs that entered clinical development would eventually reach patients as an approved therapy. This has steadily fallen to the point where just one in sixteen novel drugs gain approval. This increase in attrition has been driven not only by competitive dynamics, but also by stricter requirements for new drugs to secure reimbursement.
The most sophisticated companies are embedding such analysis into their decisions around progressing drugs through the early pipeline. Success rates have fallen the most sharply at the Phase I hurdle as drug developers have become more judicious about managing R&D budgets. We expect more companies to embrace such decision making at the earliest stages, thereby prioritizing only the most promising candidates.
Evolution of R&D success rates
Source: Evaluate, Norstella
For pharma companies that are supported by large teams and consistent revenue streams, this is simply a scaling of existing resources. But for the biotechs that are discovering an increasing share of the early pipeline, a new challenge emerges. The expertise and data requirements of a biotech must grow to follow this trend towards early access planning that informs R&D decisions. Either through internal investment or external consultants, the core capabilities of a clinical-stage biotech must evolve to remain competitive and attractive to investors and potential partners.
