Embarking on the journey from product development to market success in the biopharma industry is no small feat. The landscape is highly competitive with new prescription medications launching worldwide each year. However, this journey is fraught with challenges as revealed by an in-depth analysis. According to a McKinsey report, a startling 40% of biopharma products fail to meet their sales forecasts within the initial two years, prompting a critical reassessment of strategies for product launches.
The Complex Launch Environment
In an era marked by intense competition and a remarkable surge in prescription medication launches – experiencing a 60% growth from 2010 to 2019, per a CBO report – biopharma companies grapple with a host of challenges during product launches. Key stumbling blocks include payer activation and reimbursement hurdles, regulatory complexities, tepid market adoption by healthcare professionals (HCPs), field force inefficiencies, and obstacles in engaging and adopting patients.
Regulatory Approval and Payer Engagement
Securing regulatory approval with a distinct product label is pivotal for the success of a new biopharma product. Early shaping of the label during clinical trial design, risk mitigation, and avoiding approval delays are crucial for seizing a competitive advantage. Equally challenging is the landscape of payer activation and reimbursement, demanding proactive engagement with payers through effective education and data provision. Success in these aspects not only ensures strong market adoption but also positions a product favorably in the ever-evolving biopharma market.
As Indegene’s Kevin Patterson sums it up, “The pressure to access the market earlier and more efficiently has increased in importance due to the Inflation Reduction Act and other regulatory rulings. Planning for a successful launch now reaches earlier in the clinical development cycle with a significantly expanded role for the generation of market access and commercialization information at earlier stages of development. Pharma is slowly evolving in its approaches to evidence generation, but it needs to accelerate to meet the new demands for launch success.”
HCP Trust and Field Force Effectiveness
Building trust and confidence among HCPs is another critical determinant of biopharma product launch success. Traditionally, field sales representatives faced the challenge of reaching HCPs through conventional channels and the post-COVID world has heightened these difficulties. A strategic reevaluation of engagement strategies is essential. Addressing gaps in HCP coverage and engagement, coupled with optimizing field force effectiveness, and intentionally designing face-to-face (F2F) + digital + virtual experiences based on HCP preferences, is crucial to ensure HCPs are well-informed advocates for new products entering the market.
Indegene’s Nancy Phelan notes, “Reaching, engaging, and activating HCPs throughout the product development and launch lifecycle is critical to building enduring HCP advocacy. Traditional models are simply not getting the job done. Now more than ever, we need to embrace HCP-centered models that intentionally blend F2F + digital + virtual channels to achieve personalized outcomes at scale.”
Patient Engagement and Support
Beyond HCPs, the success of biopharma product launches is intrinsically tied to patient engagement strategies. Tailoring education and support programs based on product complexity and specific disease areas is paramount. Bridging the gap between manufacturers and patients not only fosters understanding but also overcomes potential barriers to adoption.
As Jeff Rothstein, CEO, CultHealth (an Indegene company), outlines, “From demand generation using tactics such as DTC, through market access and onboarding support, a holistic approach to patient engagement significantly impacts the success of biopharma product launches.”
The Blueprint for Success
In response to the identified challenges, a comprehensive blueprint has been developed to enhance biopharma product launch outcomes. This guide empowers manufacturers to proactively identify and address gaps in their launch capabilities, maximizing their chances of success in a fiercely competitive landscape. Our analysis shows that the gap between launch strategy and execution is a key factor in missed launch forecasts. Indegene and CultHealth have developed the Launch Success Accelerator to solve these challenges and boost the odds of a successful launch.
The biopharma industry finds itself at a pivotal juncture, where the success of new product launches is no longer assured. The insights gleaned from industry experiences shed light on the multifaceted challenges faced by biopharma companies, urging a strategic shift in the approach to product launches. By adopting the proposed blueprint, manufacturers can navigate the complexities of regulatory approval, payer activation, HCP engagement, and patient support, ultimately enhancing their prospects of achieving successful and sustainable product launches in an ever-evolving landscape. As the biopharma industry continues to push the boundaries of innovation, mastering the art of product launches becomes not just a strategic advantage but a necessity for survival and growth.
Click here to read the full report on achieving product launch success in the biopharma industry.
