Introduction

Launching a new biopharmaceutical product has always been a challenge for manufacturers. Regardless of organizational size or product disease area, launches can be challenging for many reasons, including competitive environment, organizational size/agility, shortening time horizons, and regulatory hurdles. A manufacturer’s ability to objectively monitor and access their Market Access environment is critical to successfully launch a product. Several key trends indicate that the Market Access environment continues to be increasingly challenging, such as:

  • Manufacturers launch novel products or expand indications for existing products more frequently with smaller launches¹
  • Increasingly rapid pace of branded and generic competitor entry with minimal clinical differentiation – which results in newer products launching at lower-than-expected prices to gain access parity with established brands
  • Manufacturers seek and receive faster approvals in the US¹
  • Manufacturers plan for shorter product lifecycles due to increased competition
  • Payers consider evolving types of evidence when gathering data for formulary decision-making for novel products

Based on Herspiegel Consulting’s experiences advising clients and interviewing stakeholders, we have identified the below external factors and internal capabilities that drive success for Manufacturers launching their products in this challenging Market Access environment:

1. External Factors: • Payer trends • Competitor trends • Policy trends 2. Internal Capabilities: • Alignment of internal stakeholders • Objective & comprehensive understanding of Market Access environment • Understand & prepare for the evolving complexity of stakeholder engagement While these activities seem obvious, our clients often struggle to manage them all effectively and can result in sub-optimal launch uptake. Efficiently managing these external factors and internal capabilities are critical to driving launch success in an increasingly challenging and evolving Market Access launch environment.