Product Launch Failure & Success Study

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  • 1. % Success Factors and Failure Points in Biopharmaceutical Product Launches: An Updated Road Map for Strong Market Entry Strategic Benchmarking Research, Analysis & Recommendations
  • 2. Table of Contents
    • Background
      • Summary of Business Issue, Key Insights, Findings and Lessons Learned p.4-18
      • Universe of Learning: Research Participants, Launch Experience, Cardiology, Metabolics & Other Therapeutic Area Demographics p.19-25
    • Main Deck
      • Winning on Differentiated Product Positioning p.26-33
      • Winning a Physicians Initial Trial of a New Product p.34-35
      • Articulating Benefits that Shape Positive Market Perception p.36-38
      • New Product Pricing Strategy p.39-49
      • Thought Leader Engagement p. 50-55
      • Early Physician Education p.56-64
      • Payer Education p. 65-67
      • Patient Advocacy and Education p.68-70
      • Preparing Market Constituents p.71-75
      • Access Insights & Success Factors p.76-83
      • Winning Hospital Formulary Access p.84-85
      • Resource Allocation for Key Stakeholders in the Current & Future Marketplaces p. 86-88
      • Investment Requirements, Resource Allocation & Timing p.89-99
  • 3. Table of Contents
      • Internal Launch Readiness p.100-111
      • New Technologies for Informing Patients & Physicians p.112-115
      • Pitfalls & Stumbling Blocks p.116-130
      • Demonstrating Efficacy p.131-137
      • Rating Different Safety Dimensions p.138-144
      • Lessons Learned, Best Practices & Future Changes p.145-147
      • About Best Practices, LLC p.148
  • 4. Framework for Presenting Insights, Practices & Pitfalls The performance benchmark and field research have harvested scores of insights and observations. They have been organized into the following summary framework for discussion and planning purposes. Insights, Best Practices, Pitfalls 3. Invest in Launch & Support 4. Engage Thought Leaders 5. Educate Key Stakeholders: (Physicians, Patients, & Payers) 6. Demonstrate Value Across Multiple Fronts 2. Clearly Define Target Patient Population 7. Utilize New Technologies To Inform 1. Differentiate Your Product 8. Avoid Pitfalls & Stumbling Blocks
  • 5.
    • Differentiating Your Product - Secondary Benefits Can Be Win Themes: Differentiated positioning begins on factors established in clinical trials such as efficacy, unmet needs, safety and target patient population. Secondary positioning factors have less overall impact but can be useful in a crowded market and are often more directly influenced through Marketing. Using secondary benefits can be an effective strategy for positioning a product in a highly competitive market .
    • As one executive observed during interviews: You like to go to market with an efficacy message, thats what you want.. If you cant do efficacy, fall back to safety. If you cant do safety, you fall back to convenience. If you cant do convenience, you fall back to pricing. Secondary or even tertiary positioning factors have been win themes . Quality of life, ease of use, cost effectiveness, patient compliance, or even a celebrity spokesperson are examples. Use of secondary factors varies considerably across TAs.
    1. Differentiate Your Product In A Crowded Market Differentiation is a key factor in a new products launch success. While efficacy and safety are considered the best ways to differentiate a new product, new therapies also can use secondary benefits to gain traction at launch.
  • 6. Universe of Learning: 38 Companies Engaged Participating Companies Research participants included 44 executives and managers from 38 leading pharmaceutical, biotech and medical device companies. Laboratorios Dermatologicos Darier TGC MedTech
  • 7. Executive Interviews and Field Insights Executive Interviews Laboratorios Dermatologicos Darier More than six hours of executive interviews, in addition to field commentaries and insights from 17 executives, shed light on the market entry success and failure factors. Perspectives range from frontline prescriber to veteran pharma executive with decades of successful launch experiences. Executive Field Insights
  • 8. Vice President/Director Largest Respondent Group
    • Nearly 40 leaders in biotechnology and pharmaceutical product launches participated in this research project. A majority of respondents were either at the vice president or director levels.
    Sample Participant Titles
    • Other:
    • Founder and President
    • Principal
    • Partner
    • Coordinator, Marketing
    • Product Physician
    • Senior Consultant
    • Senior Vice President, Commercial Strategy
    • Senior Vice President, Marketing & Sales
    • Vice President, Marketing
    • Director, Health Outcomes
    • Director, Marketing
    • Director, Medical
    • Director, Strategic Planning
    • Associate Director, Managed Care Marketing
    • Senior Manager, Global Marketing
    • Manager, Business Intelligence
    • Manager, Business Unit
    • Manager, Category Marketing
  • 9. Participants Reflected on Wide Range of Therapies
    • Research participants reflected on almost 30 products, ranging from blockbusters like Januvia and Rituxan to new products like Onglyza and Victoza. The broad spectrum of products launch experiences informed the benchmark class understanding of critical success factors, stumbling blocks and failure points.
    • Metabolics
    • Cardiology
    • Central Nervous System
    • Oncology
    • Neurology
    • Pulmonary
    • Immunology
    • Gastro-enterology
    • Musculoskeletal
    • Hormonal Systems
    • HIV Infections
    • Medical Nutrition
    • Urology
    (n=33) Belatacept Cladribine (Movectro) Clivarine Enteral feeding products Levothyroxine MAb for Asthma/COPD Naproxcinod New CTC Advance catheter Taspoglutide Therapeutic Areas Products Represented by Participants Endothelin Receptor Antagonist
  • 10. Efficacy, Unmet Need Offer Best Positioning Tools
    • For respondents as a whole, efficacy and unmet need remain the most attractive positioning tools for differentiating. But participants indicated that an effective use of a tight target patient population/sub-population presents an opportunity where efficacy and unmet need may not be differentiating options for a new products launch.
    Q5. Winning On Differentiated Product Positioning : Differentiated product positioning is critical to market entry success. Rate the effectiveness of different positioning strategies and tactics for winning in the marketplace. 66% 30% 36% 18% 2% 14% Cost Effectiveness 44 68% 25% 43% 14% 7% 11% Dosing 44 70% 23% 48% 9% 9% 11% Ease-of -use/ patient compliance 44 73% 27% 45% 23% 2% 2% Tolerability 44 75% 27% 48% 16% 2% 7% Health Outcomes 44 82% 30% 52% 14% 0% 5% Safety Profile 44 86% 55% 32% 7% 5% 2% Differences from current therapies 44 88% 37% 51% 5% 2% 5% Clearly Defined Patient Population / Sub-population 43 93% 80% 14% 2% 2% 2% Unmet medical need 44 95% 60% 35% 2% 0% 2% Efficacy Profile 43 Total Effective Highly Effective Somewhat Effective Somewhat Ineffective Highly Ineffective Not Used Total Benchmark Class n =
  • 11. Lack of Differentiation Creates Domino Effect The fact that the BMS/AZ Diabetes product Onglyza had a safety and efficacy profile very similar to market leader Januvia created problems across a number of critical fronts: Payers, KOLs, Prescribers and Patients. The result - a d