ブロックバスター薬の特許失効と将来のジェネリック医薬品市場

Abstract

Introduction:

Approximately 90 pharmaceuticals achieved blockbuster status in 2006, generating more than $200 billion in sales-approximately 30% of the global pharmaceutical market. However, in 2007, eight blockbuster brands- with combined 2006 sales of $13 billion in the United States alone-face patent expiration. Additionally, the future presents great challenges to the creation of new blockbuster drugs: health care payers are becoming more cost-conscious, restricting patient access to expensive, blockbuster therapies. And the upcoming expiration of patents on many current blockbuster drugs will trigger the widespread launch of generics. Finally, the prospective launch of “biosimilars” -generic versions of biologics-will present unprecedented challenges for stakeholders.

Questions Answered in This Spectrum Report:

• A key patent on simvastatin recently expired in many parts of the world. The loss of protection prompted payers in some countries to introduce measures promoting the use of generic simvastatin in place of patentprotected drugs within the same class. How has the loss of simvastatin' s patent protection affected pricing policies on patent-protected drugs?
• After many years of stagnation, the Japanese generics market is now widely expected to undergo vigorous growth. Which drug classes do Japanese physicians expect to experience the most robust growth in generics penetration?
• Despite having the largest population of any country in the European Union, Germany exhibits relatively modest spending on blockbuster pharmaceuticals. Why are German physicians wary of prescribing these popular medications?
• As more and more blockbuster products lose patent protection, payers become more and more eager to increase the rate of generics prescribing. What pharmacy benefi t management strategies have been gaining favor among employers? What strategies have been losing support?

Scope:

• U.S. employers' views on strategies to increase prescription drug benefi t values: the relative importance of generics substitution, patient compliance, cost-effective products, pharmacy deals, maximization of rebates.
• Challenges drug manufacturers face in creating new blockbuster drugs: cost-conscious health care payers; targeted therapies; the launch of generics triggered by upcoming patent expirations.
• Future patent expirations of blockbuster drugs in the seven major markets: total sales fi gures in each of the seven major markets of blockbuster drugs that lose patent protection in a given year; patent expiration timetable for 2006 blockbuster drugs; the dominant position of the United States; France as the largest European market for blockbuster drugs; Germany' s modest spending on blockbuster drugs; the impact of price cuts in Italy; Spain as the smallest European market for blockbusters; the generics prescribing culture in the United Kingdom; the absence of blockbuster brands from the Japanese market.
• Barriers to generics competition: navigating the patent maze; logistical obstacles in the manufacturing and handling of generics; the unique challenges posed by biologics.
• Payers' support for generics: U.S. employers' views of PBMs; new prescription forms, reimbursement programs, and solutions to supply defi ciencies in Japan.
• Outlook: Major changes expected; growing patient acceptance of generics; increased payer incentives for generics; increasing physician comfort with generics; the prospective launch of blockbuster biosimilars.

Table of Contents

• Executive Summary
  • Strategic Considerations
  • Stakeholder Implications
• Overview
• Schedule of Patent Expirations
• Barriers to Generics Competition
• Payers' Support for Generics
  • United States
  • Europe
  • Japan
• Outlook and Implications for the Pharmaceutical Industry

Tables

• 1. Blockbuster Prescription Drugs, 2006
• 2. Patent Expiration Timetable for 2006 Blockbuster Drugs
• 3. Total Sales in the Seven Major Markets of Leading Manufacturers' Blockbuster Drugs That Will Lose Patent Protection from 2007 to 2017
• 4. U.S. Employers' Views on Strategies to Increase Prescription Drug Benefi t Value, 2005

Figures

• 1. Total Sales in the United States of Blockbuster Drugs That Lose Patent Protection in a Given Year from 2007 to 2021
• 2. Total Sales in France of Blockbuster Drugs That Lose Patent Protection in a Given Year from 2007 to 2019
• 3. Total Sales in Germany of Blockbuster Drugs That Lose Patent Protection in a Given Year from 2007 to 2019
• 4. Total Sales in Italy of Blockbuster Drugs That Lose Patent Protection in a Given Year from 2007 to 2019
• 5. Total Sales in Spain of Blockbuster Drugs That Lose Patent Protection in a Given Year from 2007 to 2019
• 6. Total Sales in the United Kingdom of Blockbuster Drugs That Lose Patent Protection in a Given Year from 2007 to 2019
• 7. Total Sales in Japan of Blockbuster Drugs That Lose Patent Protection in a Given Year from 2007 to 2018
• 8. Total Sales in Seven Major Markets of Blockbuster Drugs That Lose Patent Protection in a Given Year from 2007 to 2019