Evidence has never been more central to commercial success. Payers demand it before reimbursement. HTA
bodies are raising the bar with sweeping new frameworks, most significantly the EU’s Joint Clinical Assessment
process, which launched in January 2025 as a major step toward harmonising clinical evidence requirements
across all EU member states.1 Furthermore, regulators are signalling that the era of selective disclosure is over. An FDA study found that sponsors omitted 85% of the agency’s safety and efficacy concerns in public announcements, a transparency gap that has since prompted the FDA to begin publishing complete response letters that companies had historically kept confidential.2
Yet, according to McKinsey, only 20% of leading pharmaceutical companies currently develop an integrated
evidence generation plan across the full lifecycle of a product, with most leaders still generating evidence in silos rather than for the needs of the wider organisation and its stakeholders.3 Indeed, the vast majority are still building their evidence base reactively. Commissioning studies after payer rejections, scrambling to answer regulatory questions or plugging gaps that should have been identified years earlier.
In biopharma’s new evidence era, this approach to what is a vital element of commercialisation strategy development no longer cuts it. What’s needed instead is a fundamental rethink. One in which evidence generation is not a downstream activity delegated to HEOR or medical affairs, but a strategic, cross-functional and proactive discipline. This must be built on the foundations of a clear winning aspiration, confidence in where to play and how to win there, and deliberate prioritisation of the evidence needed to deliver for regulators, patients, payers and providers.
