市場調査レポート

バイオ医薬品およびワクチン生産の世界市場

Biopharmaceutical and Vaccine Production Markets (Mammalian Cell Production, Microbial Cell Production Market, Monoclonal Antibody Manufacturing, Other Recombinant Protein Manufacturing, Vaccine Manufacturing, Insulin Manufacturing Market)

発行 Kalorama Information 商品コード 314225
出版日 ページ情報 英文 98 Pages
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バイオ医薬品およびワクチン生産の世界市場 Biopharmaceutical and Vaccine Production Markets (Mammalian Cell Production, Microbial Cell Production Market, Monoclonal Antibody Manufacturing, Other Recombinant Protein Manufacturing, Vaccine Manufacturing, Insulin Manufacturing Market)
出版日: 2014年08月29日 ページ情報: 英文 98 Pages
概要

バイオテクノロジーは、がん、糖尿病、HIV/AIDS、自己免疫障害などに効果のある多くの新療法やワクチンを生み出しましたが、バイオ医薬品の製品化に向けた臨床薬試験の最終段階には未だ大きな困難があるため、製薬企業は米国食品医薬品局(FDA)や欧州医薬品庁(EMA)の認可を見込みながら、リスクを負って生産設備投資の時期や方法を決断することになります。過去5年の間、アナリストや製薬企業が新薬の有望性を技術的・経済的リスクと上手く折り合わせようとするなか、生物製剤に対する目算はそれぞれに大きな紆余曲折を見せてきました。

当レポートでは、バイオ医薬品およびワクチン生産の世界市場に注目し、今後5年の期間を対象に生産・販売規模やコストの推移を予測するほか、市場の動向や課題、規制問題、生産方法、競合環境、主要参入企業などに関する最新情報を集めています。

第1章 エグゼクティブサマリー

  • バイオ医薬品の主な種類
    • モノクローナル抗体
    • 組み換えタンパク
    • ワクチン
    • インスリン
    • その他の生物薬剤タンパク質
  • 承認バイオ医薬品
  • バイオ後続品

第2章 商業生産

  • 製法の概要
  • 生産システム
  • 細胞培養
    • 微生物細胞
    • 哺乳類細胞株
    • 植物細胞培養
    • 昆虫細胞
  • 遺伝子組み換え術
    • 遺伝子組み換え植物
    • 遺伝子組み換え動物
  • 無細胞タンパク質生産

第3章 予測

  • バイオ医薬品製造の総コスト

第4章 規制

  • 米国食品医薬品局生物製剤評価センター(FDA-CBER)
    • アレルギー関連
    • 血液および血液製剤
    • 細胞および遺伝子治療製品
    • 体組織および体組織製品
    • ワクチン
  • 欧州医薬品庁

第5章 競合環境

  • 原製造者と契約製造
  • 外部委託生産
    • 生物製剤製造における受託製造企業の関与形態
    • 拡大する生物製剤製造需要
    • 生物製剤製造に向けた生産力
    • 生物製剤生産の代替方法
  • 生物製剤製造へ事業拡大する契約製造組織(CMO)
    • アジアにおける生物製剤製造
    • 有力製造企業
  • 研究開発統合型製造企業
    • M&A活動
    • ライセンス供与と事業協力

第6章 特許

  • 哺乳類、酵母、昆虫、植物、遺伝子組み換えの主要特許
  • 大腸菌の特許

第7章 地域分析

第8章 企業プロフィール

  • 有力受託製造企業
  • 有力生物製剤メーカー
  • その他の受託製造企業
目次
Product Code: KLI5320705

Though biotechnology has created many new therapies and vaccines - including products to treat cancer, diabetes, HIV/AIDS and autoimmune disorders - there are still huge challenges during the final stages of clinical drug testing for new biopharmaceuticals, as manufacturers decide when and how to risk production capital to upscale while anticipating FDA or EMA approval. During the past five years, estimates for biopharmaceuticals have varied widely as analysts and producers have juggled the promise of new drugs with the technological and financial risks of manufacturing them efficiently.

Biopharmaceutical and Vaccine Production Markets examines the total biopharmaceutical manufacturing market, including in its estimates all costs related to biopharmaceutical and vaccine production. It includes the following useful information for business planning:

  • Market Forecasts and Estimates of Biopharmaceutical Manufacturing Costs
  • Vaccine Production Estimates
  • Trend Discussion
  • Production Methods
  • The Competitive Environment, including Contract Manufacturing and Outsourcing
  • Regulation of the Market
  • Company Profiles

The report contains production segmentations for the mammalian cell, microbial cell, monoclonal antibody, other recombinant protein, vaccine, and insulin manufacturing markets, with forecasts to 2018. The current competitive environment is noted, listing selected biopharmaceutical contract manufacturers, selected top-selling biopharmaceuticals, selected Asian biomanufacturing contract manufacturing organizations (CMOs), the top 10 biopharma companies based on 2012 biopharma revenues, and the top manufacturers by global biopharmaceutical manufacturing capacity.

Additional Information

Biopharmaceutical Manufacturing Services Market Reaches 36.8 Billion Kalorama

The total biopharmaceutical manufacturing market is growing, according to Kalorama Information's report, Biopharmaceutical and Vaccine Production Markets. The market research publisher includes all costs related to biopharmaceutical and vaccine manufacturing in its estimates. The total global market equaled approximately $36.8 billion in 2013, with the high expense of adding biomanufacturing capacity at commercial production levels driving demand for specialized contract manufacturing, which is expected to grow due to new drug commercialization, recovered investment funding rates for biotechnology companies, and expanding service offerings for novel therapeutics.

“At this cost level, novel technologies and outsourcing are essential to strategy,” said Bruce Carlson, Publisher of Kalorama Information. “Fortunately, this means a lot of opportunity for companies that can service these needs.”

The market research publisher's report contains production segmentations for the mammalian cell, microbial cell, monoclonal antibody, other recombinant protein, vaccine, and insulin manufacturing markets, with forecasts to 2018. Despite the proliferation of novel production technologies, commercial scale systems based on the familiar mammalian cells and E. coli are expected to continue to dominate the manufacturing scene through the end of 2018.

Biopharmaceutical and Vaccine Production Markets notes the current competitive environment, listing selected biopharmaceutical contract manufacturers, selected top-selling biopharmaceuticals, selected Asian biomanufacturing contract manufacturing organizations (CMOs), the top 10 biopharma companies based on 2012 biopharma revenues, and the top manufacturers by global biopharmaceutical manufacturing capacity. Profiles of key competitors are also included.

Table of Contents

ONE: Executive Summary

  • Major Kinds of Biopharmaceuticals
  • Monoclonal Antibodies
  • Recombinant Proteins
  • Vaccines
  • Insulins
  • Other Biopharm Protein Products
  • Approved Biopharmaceutical Products
  • Biosimilars

TWO: Commercial Production

  • Process Overview
  • Production Systems
  • Cell Culture
  • Microbial Cells
  • Mammalian Cell Lines
  • Plant Cell Cultures
  • Insect Cells
  • Transgenics
  • Transgenic Plants
  • Transgenic Animals
  • Cell-Free Protein Production

THREE: Forecasts

  • Total Biopharmaceutical Manufacturing Costs

FOUR: Regulation

  • FDA-CBER
  • Allergenics
  • Blood and Blood Products
  • Cellular and Gene Therapy Products
  • Tissue and Tissue Products
  • Vaccines
  • EMA

FIVE: Competitive Environment

  • Originator and Contract Manufacturing
  • Outsourcing
  • Types of Contractors Involved in Biomanufacturing
  • Demand for Biopharmaceutical Manufacturing Increasing
  • Production Capacity for Biopharmaceutical Manufacturing
  • Alternative Methods Of Producing Biopharmaceuticals
  • CMOs Expanding Operations to Manufacture Biologics
  • Biomanufacturing in Asia
  • Top Manufacturers
  • Integrated R&D, Manufacturing Firms
  • Merger and Acquisition Activity
  • Licensing and Collaborations

SIX: Patents

  • Select Mammalian, Yeast, Insect, Plant, and Transgenic Patents
  • E. coli Patents

SEVEN: Geography

EIGHT: Profiles

  • Major Contract Manufacturers
  • Lonza AG
  • Boehringer Ingelheim GmbH
  • FUJIFILM Diosynth Biotechnologies
  • Sandoz
  • Royal DSM
  • Rentschler Biotechnologie
  • Celonic
  • BIOMEVA GmbH
  • ProBioGen AG
  • Baxter BioPharma Solutions/Baxter Bioscience
  • Major Biologics Firms
  • Amgen
  • Genentech/Roche
  • AbbVie Inc. (Abbott)
  • Biogen Idec
  • Regeneron Pharmaceuticals
  • Alexion Pharmaceuticals
  • Crucell /Johnson & Johnson
  • GlaxoSmithKline
  • Merck & Co. Inc
  • Novartis
  • Pfizer
  • Sanofi Pasteur
  • Other Contract Manufacturers
  • AAIPharma
  • A-Bio Pharma Pte Ltd.
  • ABL, Inc.
  • Affinity Life Sciences, Inc.
  • Ajinomoto Aminoscience, LLC
  • Alliance Medical Products, Inc.
  • Alpha Biologics
  • Biotecnol
  • Boston Mountain Biotech
  • Glycobia
  • Sutro Biopharma

LIST OF EXHIBITS

ONE: Executive Summary

  • Table 1-1: Indications for Biologic Class (Erythropoietin, Interferon a, Interferon ß, Monoclonal Antibody, Colony Stimulating Factors, Glucocerebrosidase), Partial
  • Table 1-2: FDA-Approved Therapeutic Monoclonal Antibodies
  • Table 1-3: Vaccine-Preventable Diseases, 2014
  • Table 1-4: Major Vaccine Manufacturers
  • Table 1-5: 2014 Biological License Application Approvals
  • Table 1-6: 2013 Biological License Application Approvals
  • Table 1-7: 2013 Biological New Drug Application (NDA) and Abbreviated New Drug Application (ANDA) Approvals

TWO: Commercial Production

  • Table 2-1: Biopharma Manufacturing Process Overview
  • Table 2-2: Systems for the Production of Biopharmaceuticals

THREE: Forecasts

  • Table 3-1: Total Biopharmaceutical Manufacturing Market, 2012-2018
  • Table 3-2: Mammalian Cell Production Market, 2012-2018
  • Table 3-3: Microbial Cell Production Market, 2012-2018
  • Table 3-4: Monoclonal Antibody Manufacturing Market, 2012-2018
  • Table 3-5: Other Recombinant Proteins, Manufacturing Market, 2012-2018
  • Table 3-6: Vaccine Manufacturing Market, 2012-2018
  • Table 3-7: Insulin Manufacturing Market, 2012-2018

FIVE: Competitive Environment

  • Table 5-1: List of Selected Biopharmaceutical Contract Manufacturers
  • Table 5-2: Selected Top-Selling Biopharmaceuticals, 2013
  • Table 5-3: Selected Asia Biomanufacturing CMOs
  • Table 5-4: Top 10 Biopharma Companies Based on 2012 Biopharma Revenues
  • Table 5-5: Top Manufacturers by Global Biopharmaceutical Manufacturing Capacity
  • Table 5-6: Top Pharmaceutical Acquisitions in 2013

List of Exhibits

  • Table 5-7: Top Ten Pharmaceutical Acquisitions in 2012
  • Table 5-8: Biopharmaceutical Licensing and Collaboartions in 2013

SIX: Patents

  • Table 6-1: Selected Biopharmaceutical Manufacturing Patents Granted between January 1, 2013 and July 15, 2014 - Mammal
  • Table 6-2: Selected Biopharmaceutical Manufacturing Patents Granted between January 1, 2013 and July 15, 2014 - Yeast
  • Table 6-3: Selected Biopharmaceutical Manufacturing Patents Granted between January 1, 2013 and July 15, 2014 - Insect
  • Table 6-4: Selected Biopharmaceutical Manufacturing Patents Granted between January 1, 2013 and July 15, 2014 - Plant
  • Table 6-5: Selected Biopharmaceutical Manufacturing Patents Granted between January 1, 2013 and July 15, 2014 - Transgenic
  • Table 6-6: Selected Biopharmaceutical Manufacturing Patents Granted between January 1, 2013 and July 15, 2014 - E. coli

SEVEN: Geography

  • Table 7-1: Estimated Biopharmaceutical Manufacturing Capacity by Region,2014, by Revenues
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