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市場調查報告書
大型製藥公司：2009年第2季的主要動向和活動
Biopharma Quarter: Key Trends and Events of the Second Quarter of 2009
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大型製藥公司：2009年第2季的主要動向和活動 是由出版商Decision Resources, Inc.在2009年09月所出版的。
這份英文市場調查報告書包含49 Pages 價格從美金4600起跳。
本報告書內容包括:第0相治驗及FDA改革、孤兒藥資金等2009年第2四半期所發生的各種活動、大型製藥公司的H1N1及幹細胞研究為主題的交易動向、日本的生物學名藥動向等、內容綱要摘記如下:
實施摘要
介紹
活動預測
交易預測
- H1N1在第二四半期交易契約所帶來的影響
- M&A
- 產品交易
- 治療領域
- 技術聯盟
- 幹細胞研究
非專利藥品預測
- 日本首度生物學名藥認可
- 2008年的主要非專利的廠商
- 大型製藥公司在非專利藥品上的遺留
- Ranbaxy的第二影響
- 非專利藥品補助策略的各種結果
策略的預測：H1N1流行病
- 豬流感：第一輪
- 全球的危機
- 經濟及健康困境
- 免疫學的背景
- 病毒的特徵
- 醫療對應
- 檢測出
- 預防
- 治療
- 豬流感：何謂第2輪
専家建言
圖表
Abstract
“Last quarter, we included Vanda Pharmaceuticals in our list of
companies struggling for survival in the midst of the economic downturn. This
quarter, we note Vanda' s success, not only because it signals a comeback but
also because the company' s resurrection, made possible by the FDA' s approval
of the company' s Fanapt brand of iloperidone, is a victory in the move toward
personalized medicine. Vanda prevailed in its quest for Fanapt' s approval
based on pharmacogenetically stratifi ed research showing the effi cacy of the
drug in particular subgroups of patients; companion diagnostics to guide the
use of Fanapt might reach the market as well. Personalized medicine is a
pending new paradigm for healthcare and one of the trends that companies in
the biopharma sector must monitor and consider in formulating their
strategies.”- Catherine Cuddihee, M.S., Principal Director.
Introduction
The first Phase 0 trial results, the first fruits of Japan' s biosimilar
pathway, the first straightforward use of the social marketing tool Twitter
to advance a drug franchise, the first moves of the EU to regulate
third-party mentions of pharmaceuticals, the first encounter with the H1N1
strain of infl uenza. These firsts of the second quarter of 2009 are among
the developments that companies in the biopharma sector should consider in the
context of their business strategies. This report provides biopharma players
with event- and trend-related alerts, explanations, and models to heed.
Questions Answered in This Report
- Voices call for a healthcare paradigm shift toward personalized medicine.
What does the approval of Vanda' s Fanapt teach contenders in this space?
What hobbles the paradigm shift?
- Drug development is stymied by a variety of factors. How is the FDA
transforming to facilitate R&D? How are scrutiny and regulation of the
industry changing in major-market regions? What are the opportunities in niche
diseases?
- Novo Nordisk took a big step in the social marketing arena with the launch
of a Twitter-based campaign. How is the company using this medium? How does
the campaign relate to conventional marketing wisdom? What are the related
regulatory issues?
- Pharma industry dealmaking continues at a relatively steady state. What
companies are among the big players? What are the notable deals of the second
quarter of 2009? How has the H1N1 fl u pandemic infl uenced dealmaking?
- National governments have enacted measures to drive use of generics and
biosimilars. What results have been recorded in the United States? In
Japan? What effect has this focus had on the fortunes of generics
companies?
Scope
- Events Perspective: Phase 0 trials, iloperidone approval, warfarin
payment decision, FDA reform, orphan drug funding, DTC advertising,
regulation, social marketing, Twitter.
- Deals Perspective: Deals compared with prior time periods; deals by
company, therapeutic area, technology; deals focusing on H1N1 and stem cell
technologies.
- Generics Perspective: Japanese biosimilars, leading generics
companies, generics dealmaking, generics-based healthcare savings.
- Strategy Perspective: Focus on the H1N1 fl u (swine fl u) pandemic.
- Expert commentaries: Implications of Phase 0 clinical trials for
oncology, orphan drug development strategies, opportunities for makers of infl
uenza diagnostics.
Table of Contents
- Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Introduction
- Events Perspective
- On the Personalized Medicine Front: Steps Forward and Back
- Fanapt Approval
- Bristol-Myers Squibb' s Coumadin
- On the Drug Development Front
- FDA' s Improved Image
- First Phase 0 Oncology Trial
- Support for Rare Diseases
- On the Marketing Front and the Regulatory Front
- Social Marketing Push
- Confi dentiality of Prescriber-Identifi able Data
- Further Restrictions on DTC Advertising
- Deals Perspective
- H1N1' s Infl uence on Dealmaking in the Second Quarter
- Notable M&As
- Notable Product Deals
- Therapy-Area Deals
- Technology Deals
- Focus on Stem Cells
- Generics Perspective: Consistent Growth in a Key Sector
- First Biosimilar Approval in Japan
- Leading Generics Companies of 2008
- Big Pharma Gains a Bigger Footprint in Generics
- Fallout at Ranbaxy
- Data Report: Mixed Results for Generics Initiatives
- Strategy Perspective: Focus on the H1N1 Pandemic
- Swine Flu: Round One
- A Global Crisis
- Economic and Public Health Dilemma
- Epidemiological Background
- Virus Characteristics
- Medical Response to Flu
- Detection
- Prevention
- Treatment
- Swine Flu: Round Two?
Expert Commentaries
- Phase 0 Trials: Implications for Cancer Drug Development
- What Are the Benefi ts of Orphan Drug Status?
- H1N1 Flu Pandemic: Expanding Opportunities for Infl uenza Screening
Tables
- 1. Emerging Diagnostic Profi le Acceptable to 88% of Surveyed
Psychiatrists: Genetic Theranostic to Predict Atypical Antipsychotic Effi cacy
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- 2. Orphan Drug Policies in the United States, Europe, and Japan
- 3. Select Findings from Decision Resources' Coverage of Orphan Drug
Indications
- 4. Top Company Dealmaking Activity, Q2 2009
- 5. Deals Related to the H1N1 Outbreak, Q2 2009
- 6. Select Deals by Therapeutic Area, Q2 2009
- 7. Collaborations Focused on Stem Cell Technologies, Q2 2009
- 8. Top Ten Infl uenza Vaccines by Revenue, 2008
- 9. Top Five Antivirals for the Treatment of Infl uenza by Revenue, 2008
Figures
- 1. Q2 2009 U.S. Drug Approval Tallies and Highlights
- 2. Number of Q2 Deals, 2006-2009
- 3. Number of Deals Valued at More Than $100 Million in the Second Quarter
of Each Year, 2006-2009
- 4. Three Deals, More Than $150 Billion Spent: Pfi zer/Wyeth,
Roche/Genentech, and Merck & Co./Schering-Plough, Q1 2009
- 5. Select Mergers and Acquisitions Valued at More Than $50 Million, Q2 2009
- 6. Select Product-Related Deals Valued at More Than $100 Million, Q2 2009
- 7. Percentage of Deals by Therapeutic Area, Q2 2009
- 8. Percentage of Technology-Focused Deals by Technology Type, Q2 2009
- 9. 2008 Revenue of Leading Generics Companies
- 10. Revenue and Profi t for Select Ranbaxy Subsidiaries, 2008
- 11. Growth in the Savings to the U.S. Healthcare System as a Result of
Generic Drugs, 2000-2008
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