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市場調查報告書
暢銷藥專利失效的情況及未來非專利藥品市場
Blockbuster Patent Expirations and the Future of the Generics Market
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本報告已在2011年12月21日停止出版。
2006年將近有90種藥品取得暢銷藥的地位，創下了2000億美元以上的營業總額，佔了全球藥品市場的3成。
專門於醫療產業相關廣泛調查的美國市調公司Decision Resources Inc. （總公司：美國Massachusetts洲），針對暢銷藥專利失效的情況及未來非專利藥品市場進行調查分析，並系統整理調查結果後出版報告書 "Blockbuster Patent Expirations and the Future of the Generics Market" 。
本報告書內容包括：新暢銷藥開發相關製藥企業的課題、主要7大市場中暢銷藥的未來動向、與非專利藥品的競爭、未來發展前景等。內容綱要摘記如下：
實施概要
概要
專利失效預定表
與非專利藥品競爭時的障礙
患者對非專利藥品的支持
醫藥產業未來的發展前景及影響
表
- 暢銷處方藥：2006年
- 2006年暢銷藥專利即將失效的預定表
- 2007年至2017年間專利即將失效的主要製藥企業的暢銷藥在主要7大市場的營業額
- 對美國增加處方箋藥補助的策略的看法：2005年
圖
- 2007年至2021年間專利即將失效的暢銷藥在美國的營業額
- 2007年至2019年間專利即將失效的暢銷藥在法國的營業額
- 2007年至2019年間專利即將失效的暢銷藥在德國的營業額
- 2007年至2019年間專利即將失效的暢銷藥在義大利的營業額
- 2007年至2019年間專利即將失效的暢銷藥在西班牙的營業額
- 2007年至2019年間專利即將失效的暢銷藥在英國的營業額
- 2007年至2018年間專利即將失效的暢銷藥在日本的營業額
- 2007年至2019年間專利即將失效的暢銷藥在主要7大市場的營業額
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
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