市場調査レポート

世界のワクチン生産(トレンド、技法、主要企業、推定支出額、予測)

Vaccine Production (Trends, Techniques, Key Players, Spending Estimates and Forecasts)

発行 Kalorama Information 商品コード 230301
出版日 ページ情報 英文 180 Pages
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世界のワクチン生産(トレンド、技法、主要企業、推定支出額、予測) Vaccine Production (Trends, Techniques, Key Players, Spending Estimates and Forecasts)
出版日: 2012年02月01日 ページ情報: 英文 180 Pages
概要

過去10年にわたるワクチン市場の大幅成長は、その生産量および製法を産業復興に適応すべく見直すことの必要性を示唆しています。

当レポートでは、ワクチン製造・生産技術市場における現行の生産工程と開発中の製法に注目するなか、2010-2015年の推定生産量、設備投資、完成品市場・売れ筋カテゴリー、受託生産の市場性、主要企業の市場シェア、各カテゴリーの生産課題、細胞・昆虫・植物による生産の論点、近年のインフルエンザワクチン生産トレンド、薬剤承認への課題、主要メーカーのプロフィール、主要受託製造メーカーのプロフィール、一般的ワクチンの製法などについての最新分析情報を集めて、概略以下の構成でお届けします。

第1章 エグゼクティブサマリー

  • 調査の範囲と方法
    • 生産技術
      • 従来技術
      • 新技術
    • 製造
      • 開発企業と大手製薬会社
      • 受託製造機関
    • ワクチン産業の収益性
    • 主要ワクチンメーカー
    • 結論
    • 範囲と方法

第2章 ワクチン産業:トレンド、主要企業、市場

  • 概要
  • ワクチンの種類
  • 主要ワクチンメーカー
  • ワクチンの承認プロセス
  • ワクチン調達のサイクル
  • 公共・民間の提携関係
  • 生産量、価格ほかの収益性考察

第3章 ワクチン生産:支出、技術革新、課題

  • ワクチンの推定生産量
    • 主要ワクチンの種類
    • 改質ワクチン
    • インフルエンザワクチン生産
    • WHO(世界保健機構)のインフルエンザワクチン年間指針
    • 世界的流行
    • 歴史と欠乏問題
    • HIN汎流行
    • ワクチン産業の役割
    • 汎流行対策の10年間
    • WHO汎流行インフルエンザワクチンの製法と時間軸
    • 監督官庁の活動 - 規制認可
    • 哺乳類細胞培養
    • 背景
    • 細胞 - 哺乳類
    • 細胞培養インフルエンザワクチン
    • 優位点
    • 生産に理想的な細胞株
    • 特殊な細胞株
    • MDCK(イヌ腎臓尿細管上皮細胞)
    • ベロ細胞
    • PER.C細胞
    • DNAワクチン
    • 問題点
    • NovartisとMedicagoが型破りなワクチン事業を開始
    • ワクチンの流通
    • ワクチン生産支出の推定額
    • 受託ワクチン製造
    • 受託製造市場

第4章 企業プロフィール

  • GlaxoSmithKline Biopharmaceuticals
  • Sanofi-Aventis
  • Merck KgaA
  • Pfizer-Pfizer CenterSource
  • Novartis AG
  • Baxter International
  • Teva
  • Crucell(Johnson &Johnson)
  • CSL Biotherapies
  • Intercell
  • MedImmune/Astra Zeneca
  • MassBioLogics

第5章 ワクチン受託製造企業

  • Lonza
  • Boehringer Ingelheim
  • Fujifilm Diosynth Biotechnology
  • Catalent Pharma Solutions
  • Patheon
  • DSM Pharmaceutical
  • Cambrex(Lonza)
  • IDT Biologika
  • Charles River Biopharmaceutical Services(BPS)
目次
Product Code: KLI6420063

The considerable revenue growth in the vaccine market over the past ten years suggests the amount of vaccine production and the techniques of vaccine production will need to adapt to match a revived industry.

This report, Vaccine Production (Trends, Techniques, Key Players, Spending Estimates and Forecasts) examines the market for vaccine manufacturing and production technologies. The focus is on current production methods and new methods in development. While there may be some overlap for technologies in development, the emphasis of the report is process rather than product development.

As part of its analysis of vaccine manufacturing, the report includes:

  • Doses Produced: 2010-2015
  • Estimates of Vaccine Production Spending
  • Finished Vaccine Markets and Top Selling Categories
  • Market Potential for Contract Vaccine Manufacturing
  • Top Vaccine Companies Market Share
  • Production Challenges for Categories of Vaccines
  • Discussion of Cell, Insect and Plant Production
  • Recent Influenza Production Trends
  • Vaccine Approval Challenges
  • Profiles of Major Vaccine Marketers
  • Profiles of Major Contract Manufacturers
  • Production Methods for Common Vaccines (Oral polio, Tetanus, Measles, Influenza, Diphtheria, Pertussis, BCG, Hep. B, Hib, MMR)

As part of Kalorama Information's coverage, several profiles are included of vaccine manufacturers and contract manufacturing organizations (CMOs).

The following companies are profiled:

  • GlaxoSmithKline Biopharmaceuticals
  • Sanofi-Aventis
  • Merck KgaA
  • Pfizer-Pfizer CenterSource
  • Novartis AG
  • Baxter International
  • Teva
  • Crucell (Johnson &Johnson)
  • CSL Biotherapies
  • Intercell
  • MedImmune/Astra Zeneca
  • MassBioLogics
  • Lonza
  • Boehringer Ingelheim
  • Fujifilm Diosynth Biotechnology
  • Catalent Pharma Solutions
  • Patheon
  • DSM Pharmaceutical
  • Cambrex (Lonza)
  • IDT Biologika
  • Charles River Biopharmaceutical Services (BPS)

Sales estimates for the vaccine market and for market segment represent global revenues and are expressed in current dollars. Spending also represents global spending and expressed in current dollars.

Information for this report was gathered from a wide variety of published sources including company reports and filings, government documents, legal filings, trade journals, newspapers and business press, analysts' reports and other sources. Interviews with company representatives and other experts were conducted to capture the perspectives from industry participants' point of view and assess trends, and form the basis of the forecasting and competitive analysis.

Table of Contents

CHAPTER ONE: EXECUTIVE SUMMARY

  • Scope and Methodology
    • Production Technology
      • Legacy Technologies
      • Innovative Technologies
    • Manufacturing
      • Originator and Big Pharma
      • Contract Manufacturing Organizations
    • Profitability of The Vaccine Industry
    • Major Vaccine Manufacturers
    • Conclusions
    • Scope and Methodology

CHAPTER TWO: THE VACCINE INDUSTRY: TRENDS, MAJOR PLAYERS AND MARKETS

  • Overview
    • Types of Vaccines
      • Attenuated (Weakened) Live Viruses
      • Killed (Inactivated) Viruses
      • Toxoid Vaccines
      • Genetically Engineered/Modified Vaccines
      • Subunit Vaccines
      • Conjugate Vaccines
      • DNA Vaccination
    • Major Vaccine Manufacturers
    • Vaccine Approval Process
      • Government and NGO Investment
      • Manufacturing and Infrastructure Building
      • Centers for Innovation in Advanced Development and Manufacturing
      • BARDA Influenza & Emerging Disease Program
      • WHO
    • The cycle of Vaccine Procurement
    • Public/Private Partnerships
      • Bush Administration/Homeland Security
      • Project GreenVax
      • Vaccine Research Center Production Programs
    • Production, Prices and Other Profit Considerations
      • Negotiated Prices
      • Production Expenses
      • Sales and Marketing Expenses

CHAPTER THREE: VACCINE PRODUCTION: SPENDING, INNOVATIONS, AND CHALLENGES

  • Vaccine Production Estimates
    • Main Vaccine Types
      • Inactivated Vaccines or Live attenuated vaccines
      • Acellular / Component Vaccines
      • Live, Attenuated Vaccines
      • Toxoid Vaccines
      • Analogue Vaccines
      • Vaccines through Genetic Engineering
    • Reformulation
      • Thiomersal
    • Influenza Vaccine Production
    • Influenza Vaccine Production
      • Egg Production
      • Unique Aspects of Manufacturing Influenza Vaccine
      • Rate-Limiting Steps in the Seasonal Vaccine Process
      • Cellular Production
    • WHO Annual Flu Vaccine Guidelines
    • Pandemics
    • History and Shortages
    • HIN Pandemic of /
    • The Vaccine Industry's Role
    • A Decade of Pandemic Preparations
    • WHO Pandemic Influenza Vaccine Manufacturing Process and Timeline
    • Activities at regulatory agencies - regulatory approval
    • Mammalian Cell Culture
    • Background
    • Cell - Mammalian
    • Cell Culture Influenza Vaccines
    • Advantages
    • Ideal cell lines for production
    • Specific Cell Lines
    • Madin Darby Canine Kidney (MDCK)
    • Vero Cells
    • PER.C cells
    • DNA Vaccines
    • Concerns
    • Novartis and Medicago Open Non-Traditional Vaccine Operations
    • Vaccine Distribution
    • Estimates of Vaccine Production Spending
    • Contract Vaccine Manufacturing
    • Contract Manufacturing Market

CHAPTER FOUR: COMPANY PROFILES

  • GlaxoSmithKline Biopharmaceuticals
  • Sanofi-Aventis
  • Merck KgaA
  • Pfizer-Pfizer CenterSource
  • Novartis AG
  • Baxter International
  • Teva
  • Crucell (Johnson &Johnson)
  • CSL Biotherapies
  • Intercell
  • MedImmune/Astra Zeneca
  • MassBioLogics

CHAPTER FIVE: VACCINE CONTRACT MANUFACTURERS

  • Lonza
  • Boehringer Ingelheim
  • Fujifilm Diosynth Biotechnology
  • Fujifilm Diosynth Biotechnology
  • Catalent Pharma Solutions
  • Patheon
  • DSM Pharmaceutical
  • Cambrex (Lonza)
  • IDT Biologika
  • Charles River Biopharmaceutical Services (BPS)

LIST OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

  • Table 1-1: The Major Vaccine Development Categories
  • Table 1-2: World Vaccines Market (Pediatric and Adult)
  • Table 1-3: Technologies with the Greatest Promise for Producing Vaccines, 2011
  • Figure 1-1: Vaccine Industry Production Spending, 2008-2015
  • Figure 1-2: Discount for Selected Vaccines (ActHIB, Havrix, Tripedia, Fluarix, FluMist, Twinrix, Afluria, Decavac, MMRII, Zostravix, ENGERIX-B, Ceravix, Gardasil, Prevnar)
  • Table 1-4: Largest Vaccine Manufacturers

CHAPTER TWO: THE VACCINE INDUSTRY: TRENDS, MAJOR PLAYERS AND MARKETS

  • Table 2-1: Top Vaccine Sellers, 2011: Revenues in US$ millions
  • Table 2-2: Vaccine-Preventable Diseases, August 2011
  • Table 2-3: World Vaccines Market Manufacturer's Market Shares, 2009
  • Table 2-4: Major Vaccine Merger & Acquisition Activity
  • Table 2-5: Vaccines Approved by FDA for US Sales, July, 2011
  • Table 2-6: HHS/ BARDA Vaccine Advanced Development Milestones
  • Table 2-7: Documents Required to Determine Eligibility for WHO Prequalification
  • Table 2-8: Private Sector Price versus Negotiated Price For Selected Vaccines (ActHIB, Havrix, Tripedia, Fluarix, FluMist, Twinrix, Afluria, Decavac, MMRII, Zostravix, ENGERIX-B, Ceravix, Gardasil, Prevnar)
  • Figure 2-1: Private Sector Price versus Negotiated Price ( cost in US dollars)
  • Figure 2-2: Discount for Selected Vaccines (ActHIB, Havrix, Tripedia, Fluarix, FluMist, Twinrix, Afluria, Decavac, MMRII, Zostravix, ENGERIX-B, Ceravix, Gardasil, Prevnar)
  • Figure 2-3: Vaccine Companies vs. Traditional Pharma: Production and Sales Costs

CHAPTER THREE: VACCINE PRODUCTION: SPENDING, INNOVATIONS, AND CHALLENGES

  • Figure 3-1: Doses of Vaccine Produced Worldwide, 2010-2015
  • Table 3-1: Vaccine Classes and Associated Industrial Challenges (Oral Polio, Rabies, Acellular pertussis, Pneumococcal, Hepatitis B, Japanese encephalitis)
  • Table 3-2: Production Methods for Common Vaccines (Oral polio, Tetanus, Measles, Influenza, Diphtheria, Pertussis, BCG, Hep. B, Hib, MMR)
  • Table 3-3: Inactivated or Attenuated Vaccine Examples
  • Table 3-4: Acelluar/Component Vaccine Examples
  • Table 3-5: Attenuated Vaccine Examples
  • Table 3-6: Toxoid Vaccine Examples
  • Table 3-7: Thiomersal Content of Vaccines Routinely Recommended for Children
  • Table 3-8: Preservatives Used in U.S. Licensed Vaccines
  • Table 3-9: Annual Influenza Statistics
  • Table 3-10: Cell-based Vaccine Advantages
  • Table 3-11: Activities at WHO Collaborating Centers
  • Table 3-12: Activities at Vaccine Manufacturers
  • Figure 3-1: Vaccine Approval Timeline
  • Table 3-13: Advantages of Cell Culture Vaccines
  • Figure 3-2: Spending on Vaccine Production, Estimated (2008-2015) (billions of US Dollars Spent)
  • Table 3-14: Top Vaccine Contract Manufacturers, 2011
  • Figure 3-3: Estimated Outsourcing Market for Vaccines (2008-2015)
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