Introduction The Big Picture The Supply of Pharmaceuticals The Demand for Pharmaceuticals Pharmaceutical Prices International Price Comparisons Pharmaceutical Marketing Pharmaceutical Patents Regulatory Control of the Pharmaceutical Sector Timing of Pharmaceutical Approvals Part I. The Industry Chapter 1 The Pharmaceutical Industry The Competitive Structure of the Pharmaceutical Industry Pharmaceutical Research and Development Pharmaceutical R&D and Prices The Pharmaceutical Research and Approval Process Product Liability Increasing Private Sector Research Activity Drugs for Low-Income Countries The Role of Pharmaceutical Marketing in Prescribing Decisions Conclusions Chapter 2 The Biotechnology Industry Background What is Biotechnology? A Brief History of Modern Biotechnology Industry Factors Distinguishing the Biotechnology from the Pharmaceutical Industry Case Studies of Biotechnology Firm Growth and Failure Conclusion Chapter 3 Generics and Biosimilars Introduction A Brief History of Modern Generic Pharmaceutical Industry in the US The Structure of the Generic Pharmaceutical Industry Generic Entry and Price Competition in the Pharmaceutical Marketplace Generic Entry and Strategic Behavior Drug Shortage Economic Analysis of Drug Shortage The Emergence of Biosimilars Conclusion Chapter 4 The Global Pharmaceutical Industry Geographic Patterns of Pharmaceutical Production and Sales International Trade in Pharmaceutical Products Pharmaceutical Research and Development: An International View Does Government Drug Price Setting Influence R&D? Global Mergers and Acquisitions The Pharmaceutical Industry in Selected Countries and Regions The Chinese Pharmaceutical Industry Access to Appropriate Drugs in Developing Countries Part II. The Consumer Chapter 5 The Demand for Pharmaceuticals The Problem of Drug Expenditures How is Demand Determined? Pharmaceuticals and Other Health Services: Substitutes or Complements? The Changing Structure of the Pharmaceutical Market Conclusion Chapter 6 The Demand for Pharmaceuticals in Major International Markets Comparison of Pharmaceutical Spending across Global Markets Comparison of Pharmaceutical Consumption across Global Markets Demand for Pharmaceuticals in Japan Demand for Pharmaceuticals in China Demand for Pharmaceuticals in France and Germany Demand for Pharmaceuticals in the United Kingdom Demand for Pharmaceuticals in Canada Demand for Pharmaceuticals in Brazil Conclusion Part III. Pricing and Marketing of Pharmaceutical Products Chapter 7 Pharmaceutical Prices The Problem of Pharmaceutical Prices Pharmaceutical Prices Over Time Measuring Drug Prices: What Prices? Measuring Drug Prices: Rate of Change How Are Drug Prices Determined? Economic Models from Industrial Organization Literature Market Power, Generic Entry and Pricing Chapter 8 Economic Evaluation of New Drugs Optimizing Production of Health Cost-Benefit Analysis Cost-Effectiveness Analysis Cost-Utility Analysis Cost-Effectiveness League Table Policy Applications Conclusions Chapter 9 Pricing Pharmaceuticals in a World Environment Why Do Drug Prices Vary Across Country? Comprehensive Comparison of International Drug Prices Policy Implications Conclusion Chapter 10 Pharmaceutical Marketing Size of the Pharmaceutical Promotion Effort Pharmaceutical Promotion Directed at Healthcare Providers Pharmaceutical Promotion Aimed at Patients: Direct-to-Consumer Advertising (DTCA) Pharmaceutical Promotion to Third-Party Payers Regulation of Prescription Pharmaceutical Promotion False and Misleading Claims Off-Label Promotion Conclusion Part IV. Public Policies in the Pharmaceutical Market Chapter 11 Patent Protection Introduction Patent Law Patentability Patent Categories How Patents Are Obtained? What Protection Does a Patent Confer? Duration of Patent Protection Infringement of Patents Strategic Responses by Pharmaceutical Firms International Patent Treaties Patent Procedures under International Conventions Criticisms of the Patent System Patent and Societal Choice Chapter 12 Drug Approval Process in the United States The Drug Approval Process in the United States The Rising Cost of Pharmaceutical R&D Major Drug Legislations in the United States Annual NME Approvals by FDA since 2000 Regulatory Approval of Generic Drugs in the US Regulatory Approval of Biosimilars in the US Chapter 13 Pharmaceutical Regulation in the European Union The European Union Move Toward a Single Market History of Drug Regulation in Europe Structure and Role of the European Medicines Agency Drug Review under the European Medicines Agency EU Rules on Labeling of Medicinal Products Regulations of Drug Advertising Pharmacovigilance Approval of Generic Drugs in the European Union Approval of Biosimilars in the European Union Comparison of International Drug Approval Lags Chapter 14 Pharmaceuticals and Public Policy: A Look Ahead Industry Structure The Nascent Biosimilar Sector Personalized Medicine and Digital Healthcare Information Artificial Intelligence and Medicine Outpatient Bundled Payment Program and Pharmaceuticals Pharmaceutical Prices The FDA Conclusion

"Schweitzer and Lu's new edition provides a broad and timely overview of pharmaceutical economics and policy issues. Topics of particular current interest include biotechnology and biosimilars, international differences in drug prices and regulations, and the contricutuion and affordability of new medical advances."-Henry G. Grabowski, Professor Emeritus of Economics, Duke University " a must have if you are seriously interested in the domestic and international pharmaceutical industry." -Journal of Public Health Policy "This book is easy to read and provides an excellent overview of the pharmaceutical industry This book makes a useful contribution to anyone interested in understanding pharmaeconomic theory and the characteristics of the pharmaceutical industry." -Inquiry

Selling point: Utilizes the analytical framework of industrial economics to enhance understanding of the structure, conduct and performance of the pharmaceutical industry, including both the branded and generic manufacturers. Selling point: Investigates both the demand and supply side drivers of pharmaceuticals in the US and globally, with a heightened focus on large, emerging economies on the global market Selling point: Examines the changing landscape of drug innovation, regulatory approval, pricing and access, marketing, and competition among branded products, generics and biosimilar drugs Selling point: Provides analytical tools to assess public policies and private initiatives directed at the industry.

Stuart O. Schweitzer is Professor of Health Policy and Management at UCLA's Fielding School of Public Health. He has held other academic and research appointments at the Urban Institute and the White House Commission for a National Agenda for the Eighties. His research and consulting activities have dealt with pharmaceutical regulation and policy, health care financing, and technology assessment. Z. John Lu is Assistant Professor of Economics at the MVS School of Business and Economics, California State University, Channel Islands. Prior to this academic position, Dr. Lu was a health economist in the biopharmaceutical industry for 2 decades, including nearly 17 years at Amgen, where he was a director of global health economics and policy. Professor Lu's research interests include industrial economics and policy on pharmaceuticals, particularly in the United States and China.

Selling point: Utilizes the analytical framework of industrial economics to enhance understanding of the structure, conduct and performance of the pharmaceutical industry, including both the branded and generic manufacturers. Selling point: Investigates both the demand and supply side drivers of pharmaceuticals in the US and globally, with a heightened focus on large, emerging economies on the global market Selling point: Examines the changing landscape of drug innovation, regulatory approval, pricing and access, marketing, and competition among branded products, generics and biosimilar drugs Selling point: Provides analytical tools to assess public policies and private initiatives directed at the industry.