Launching New Biopharma Products in Competitive Markets: Critical Success Factors and Failure Points

Industries Profiled:
Pharmaceutical; Biopharmaceutical; Biotech; Medical Device; Manufacturing; Consumer Products; Health Care


Companies Profiled:
Adamas Pharmaceuticals; Alkermes; Allergan; Alnylam Pharmaceuticals; AstraZeneca; Atara Biotherapeutics; BSN medical; Dicerna Pharmaceuticals; EMD Serono; F1 Oncology; Incyte; Lexicon Pharmaceuticals; Mallinckrodt; Medexus Pharmaceuticals; Novartis; PanTheryx; Inc.; Pfizer; Regeneron; Sandoz; Santhera Pharmaceuticals; Servier; Shire; Sunovion; Syros Pharmaceuticals; Takeda Pharmaceuticals; Teva Pharmaceutical Industries Ltd; UCB Pharma

Study Snapshot

Best Practices, LLC engaged 31 launch leaders from 27 companies in this research through a benchmarking survey instrument and interviews.

Key topics covered in this report include:

• Top success factors observed from launch leaders
• Current and future risks for launch
• The relative value of positioning and differentiation dimensions
• The most common failure points with leveraging efficacy and safety
• The relative value and importance of differentiation factors with different stakeholder audiences (Physicians, Payers, Patients)
• The effectiveness of engagement and education tactics across stakeholder audiences

• Investment in Sales Field Force readiness is a top launch success factor: 5th overall among all success factors, investing and initiating sales preparation early enough in the timeline is essential for producing field engagement that accelerates physician awareness and trial.

• Ensure that the right TLs are identified for engagement, in sufficient numbers: Launch leaders identified that resources for identifying the right thought leaders are the most important among TL-based launch activities. The most critical tools for TL identification are profiling and mapping – where top performing companies balance standardized processes with planning that reflects the specific product and person.

• Ensure patient education reflects their needs and wants: While the value of differentiation factors among physicians and payers has significant overlap, commercial executives indicated that patients prioritize quality of life, addressing unmet needs, safety, reduced side effects, and ease of use.

• The leading launch success factor categories
• Framework for driving successful market entry

• Creating the right positioning for new products
• Ranking of effectiveness of product traits with external stakeholders across the top 3 positioning categories

• Extremely effective efficacy dimensions for influencing the market at launch
• Advance points requisite for a new product relative to leading treatments in order to win physician trial and payer support in a therapeutic area with existing treatments
• Top efficacy pitfalls that can sink positioning, derail stakeholder support, and stymie growth for a new product entering a competitive marketplace

• Importance of various safety dimensions in encouraging physicians to try a new product that enters a competitive market
• Effectiveness of different safety dimensions (for conditions with monotherapy and combination therapies) in order to encourage physicians to try a new product entering a competitive market
• Top safety pitfalls that can sink positioning, derail stakeholder support, and stymie growth for a new product entering a competitive marketplace

• Investment level required relative to market leader for a successful market entry in a competitive marketplace
• Resource allocation for stakeholder engagement and education activities in the peri-launch period (late phase III through the first year of launch)
• Importance of educating and winning support from stakeholder groups in order to successfully enter a market
• Importance of educating and winning support from stakeholder groups in order to successfully win market share
• Importance of educating and winning support from stakeholder groups in order to successfully grow a market
• Estimated current and future risk levels of each of the listed market shaping pitfalls that can derail a new product coming into a crowded market
• Estimated current and future risk levels of each of the listed internal failure points that can derail a new product coming into a crowded market

• Effectiveness of various thought leader engagement and education strategies to create an informed and receptive marketplace at launch for a new product
• Importance of different resources for thought leader-based market entry activities
• Importance rating for thought leader identification and management approaches

• Top tier product differentiation factors for physicians at market entry
• Second tier product differentiation factors for physicians at market entry
• Effectiveness of early physician education activities in influencing market entry success
• Second tier early physician education activities to influence market entry success
• Effective methods for encouraging a physician’s initial trial with the right patient type for a new product entering a competitive marketplace
• Estimated current and future risk levels of each of the listed physician pitfalls that can derail a new product coming into a crowded market

• Top tier product differentiation factors for payers at market entry
• Second tier product differentiation factors for payers at market entry
• Effectiveness of early payer education and engagement activities in influencing market entry success
• Second tier early payer education and engagement activities to influence market entry success
• Product differentiation factors permitting superior pricing against competitors with payers
• Minimum level of superior efficacy required to charge more than a branded competitor product in a crowded marketplace
• Estimated current and future risk levels of each of the listed payer pitfalls that can derail a new product coming into a crowded market

• Top tier product differentiation factors for patients at market entry
• Second tier product differentiation factors for patients at market entry
• Effectiveness of early patient education and engagement activities in influencing market entry success
• Second tier early patient education and engagement activities to influence market entry success
• Estimated current and future risk levels of each of the listed patient pitfalls that can derail a new product coming into a crowded market