Specialty Pharmaceuticals: Driving Industry Growth into the Next Decade : Market Research Report

Specialty Pharmaceuticals: Driving Industry Growth into the Next Decade

Published by: CHI Insight Pharma Reports

Published: Oct. 1, 2006 - 134 Pages

CHAPTER 1. INTRODUCTION: THE ASCENDANCY OF THE PRIMARY CARE MODEL: 1.1. Background: Evolution of the Industry’s Focus on Primary Care Markets; 1.2. The Impact of the Blockbuster Model on the Current Structure and Economics of the Pharmaceutical Industry; 1.3. The Uninsurable Risk of High-Volume Drugs; 1.4. The Stirrings of a Shift
CHAPTER 2. THE EMERGING PORTFOLIO BALANCE: 2.1. Drivers behind Big Pharma’s Interest in Specialty Markets; 2.2. Hoffman-La Roche Case Study: The Big Pharma Specialist; 2.3. Other Examples from Industry
CHAPTER 3. THE WORLD OF THE SPECIALIST: 3.1. The Specialist Emerges as a Key Player in the Health Care Economy; 3.2. Specialist Practice Economics; 3.3. Detailing to Specialists; 3.4. The Specialist-Focused Strategy
CHAPTER 4. THE WORLD OF THE PATIENT: 4.1. Profile of the Specialty Care Patient; 4.2. Reaching the Specialty Care Patient; 4.3. A 3-Step Method for Reaching New Patients: A Case Study of Pegasys for Hepatitis C
CHAPTER 5. REGULATORY AND REIMBURSEMENT ISSUES: 5.1. FDA Regulatory Pathways for Specialty Care Products; 5.2. Managed Care and Specialty Drugs; 5.3. Biogen Idec’s Amevive: A Case Study in Positioning a Specialty Product for Managed Care
CHAPTER 6. ANALYSIS OF TWO SPECIALTY DISEASE MARKETS: PULMONARY ARTERIAL HYPERTENSION AND SCLERODERMA: 6.1 Pulmonary Arterial Hypertension; 6.2. Scleroderma
CHAPTER 7. CONCLUSIONS: IMPLICATIONS AND CONSIDERATIONS: 7.1. Factors Impacting the Future Commercial Vitality of Specialty Disease Markets; 7.2. Some Strategic Implications of Big Pharma’s Embrace of Specialty Products
EXPERTS INTERVIEWED FOR THIS REPORT: Thomas Bumol, PhD (Vice President of Biotechnology Discovery Research at Eli Lilly); David Caponera (former Vice President of Strategic Initiatives at TheraCom, a division of Caremark); Dan Hawkins (founding Partner of Clarion Healthcare Consulting); Kenneth Kaitin, PhD (Director of the Tufts Center for the Study of Drug Development); Sandy Lauterbach (Senior Director of Global Marketing at Genzyme); Jesus Leal (Vice President North America Infectious Diseases, Transplantation & Immunology at Novartis; former Vice President of Interferons at Roche); Paul C. Nagel (Partner at Biomedical Insights); James F. Resch, PhD (Director of Strategic Intelligence at AstraZeneca); Ramana Sonty, PhD (Senior Director of Project Management and Medical Operations at Pfizer); Debra Stern (Vice President of RxPerts); Manuel Vega, PhD (CEO of Nautilus Biotech); Eugene Williams (CEO of Cambridge Healthtech Associates; former Senior Vice President of Immune-Mediated Diseases at Genzyme)
References
Glossary
Company Index with web sites
List of Tables and Figures: Figure 1.1 Proportion of Pharmaceutical Sales from Blockbusters, 2003; Figure 2.1 Total Clinical and Approval Phase Costs by Disease Area (in millions of 2000 $); Figure 2.2 Approval Success Rates of U.S. Biopharmaceutical Products Compared with NCEs; Figure 2.3 Pricing Advantages of Specialty Products Drive Roche’s Growth; Figure 2.4 Roche’s View of the Benefits of Specialty Care: Blockbuster Potential with Low Commercial Risk; Figure 2.5 Roche’s Shifting Balance between Primary and Specialty Care, 2003 - 2009; Figure 3.1 Annual Average Cost per Patient: Acute, Chronic, and Rare Chronic Diseases; Figure 3.2 Percentage of Specialists Likely to Enroll in CAP, by Specialty Area; Figure 3.3 The Specialist-Focused Strategy As A Virtuous Circle; Figure 3.4 How Super Specialists Can Drive Patient Recruitment in Clinical Trials; Figure 4.1 The Information Flow between Patients and Specialty Healthcare Stakeholders; Figure 4.2 Amgen’s DTC Advertisement for the Anti-Neutropenia Drug Neulasta; Table 1.1 The Biologicals Pipeline by Disease Target (as of March 2004); Table 2.2 Sales of Roche’s Top 5 Products — 2004 and 2005; Table 3.1 Sector Drivers of Increased Focus on the Specialist; Table 3.2 Comparative Daily Cost of Newer Injectables vs. Prior Therapeutic Options; Table 3.3 Top 10 Medicare Part B Drugs by Percent of Expenditure and by Source, 2003; Table 3.4 Physicians’ Perceived Benefits of Conducting Clinical Trials; Table 3.5 Key Differences between Specialists and PCPs with Implications for Sales Reps; Table 3.6 Summary of Tactics and Support Services for Building Relationship Equity with Specialists; Table 4.1 Channels Whereby Manufacturers Reach Specialty Care Patients; Table 4.2 Typical Services Offered by Patient Associations; Table 5.1 Formulary Status of Biologicals at Selected Major Health Plans; Table 5.2 Selected Tactics that Plans Use to Control Utilization and Waste; Table 6.1 Recent Launches and Drugs in Development for PAH; Table 6.2 Recent Launches and Drugs in Development for Scleroderma; Table 7.1 Biogenerics: Potential Players and Products

Abstract

High-volume, big-population drugs have fueled the industry’s growth over the past 15 years. But with increasing uncertainty about the ROI of primary care drug development, big pharma is looking for additional avenues of growth. Specialty Pharmaceuticals: Driving Industry Growth into the Next Decade is a window into the complex world of specialty medicine: its stakeholders, its evolving regulatory environment, and its economics. Based on extensive thought-leader interviews, this report is both a manual and a guidebook to competing and prospering in the world of specialty pharmaceuticals. Specifically, it provides:

Strategies for:

Sustaining a specialty franchise by building relationship equity with specialists
Identifying and communicating with hard-to-reach patient populations
Generating referrals, raising awareness, working with disease associations and patient groups

Data that capture:

Cost, time, and approval rate comparisons between specialty and primary care R&D
Trends in specialty drug sales, pricing, and health care expenditures
Specifics about the large- and small-molecule specialty pipelines in big pharma

Insight into:

Pricing and uptake prospects for biogenerics and orally delivered proteins
The impact on practice economics of Medicare CAP and the shift away from buy-and-bill
Positioning specialty products for managed care

Specialty Pharmaceuticals: Driving Industry Growth into the Next Decade delivers the case studies, the recommendations, and the insider insights to help you navigate the shifting terrain of specialty markets: the gathering cost pressures, rising competitive heat, disruptive technologies, changing regulatory guidelines, new reimbursement paradigms, and more. The report also drills down into two specialty disease commercial opportunities -- pulmonary arterial hypertension and scleroderma -- detailing the epidemiology, the drugs in development, and the opportunities for improving on the current standard of treatment.

Big pharma has awakened to the specialty opportunity, and is busy filling its pipelines and aligning its organizations in order to bring to market novel drugs for small but desperately needy patient populations. Lilly currently has 14 proteins in development targeting specialty diseases, constituting about 30% of its early stage pipeline. And Pfizer’s new CEO Jeffrey Kindler boasted in his first major presentation since assuming office that Pfizer, with 35 protein projects in R&D, was on course to generate $1.5 billion in protein therapeutics in 2006, and would triple that number by 2010. Biotech companies, which already dominate most specialty disease categories, are capitalizing on the shifting momentum with the hope of vaulting into the ranks of the top 10 pharma companies. The phenomenal productivity of specialty drug R&D and the impressive commercial performance of a growing stable of specialty products beg a larger question: will big pharma be able to synergize both its specialty and primary care sales forces and to navigate the looming challenges of pricing, biogenerics, and tightening regulations in order to meet the challenge of building a prosperous specialty business?

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Specialty Pharmaceuticals: Driving Industry Growth into the Next Decade

Table of Contents

Abstract