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市場調查報告書

生物醫藥品及疫苗生產的全球市場

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

出版商 Kalorama Information 商品編碼 314225
出版日期 內容資訊 英文 98 Pages
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生物醫藥品及疫苗生產的全球市場 Biopharmaceutical and Vaccine Production Markets (Mammalian Cell Production, Microbial Cell Production Market, Monoclonal Antibody Manufacturing, Other Recombinant Protein Manufacturing, Vaccine Manufacturing, Insulin Manufacturing Market)
出版日期: 2014年08月29日 內容資訊: 英文 98 Pages
簡介

生物科技創造出了許多對癌症、糖尿病、HIV/AIDS、自體免疫障礙等有效的新療法及疫苗,但由於生技醫藥品產品化的臨床藥實驗最終階段還有重大的困難,製藥公司只好一面申請美國食品藥品管理局(FDA)和歐洲藥品管理局(EMA)的認證,一面負擔風險來決定生產設備投資時期及方法。過去五年分析師和製藥企業在與新藥的潛力及技術性·經濟風險互相讓步中,對生技藥品的預估上產生了莫大的歧見。

本報告以生物醫藥品及疫苗生產的全球市場為焦點,以今後5年這段期間為對象,預測生產·銷售規模和成本的轉變,再彙整市場趨勢和課題,法規問題,生產方法,競爭環境,主要加入企業等相關最新資訊。

第1章 摘要整理

  • 生物醫藥品的主要類型
    • 單株抗體
    • 重組蛋白
    • 疫苗
    • 胰島素
    • 其他生物藥劑蛋白質
  • 核准生物醫藥品
  • 生物仿製藥

第2章 商業生產

  • 做法概要
  • 生產系統
  • 細胞培養
    • 微生物細胞
    • 哺乳類細胞株
    • 植物細胞培養
    • 昆蟲細胞
  • 基因改造
    • 基因改造植物
    • 基因改造動物
  • 無細胞蛋白質生產

第3章 預測

  • 製造生物醫藥品的整體成本

第4章 法規

  • 美國食品藥物管理局生技藥品評估中心(FDA-CBER)
    • 過敏相關
    • 血液及血液製劑
    • 細胞及基因治療產品
    • 身體組織及體組織產品
    • 疫苗
  • 歐洲藥品管理局

第5章 競爭環境

  • 原製造者與契約製造
  • 外部委託生產
    • 生技藥品製造方面,受託製造企業的參與形態
    • 生技藥品製造需求擴大
    • 製造生技藥品的生產力
    • 生產生技藥品的替代方案
  • 產業擴大到製造生技藥品的簽約製造組織(CMO)
    • 亞洲生技藥品的製造
    • 有力製造企業
  • 研究開發整合型製造企業
    • M&A活動
    • 授權與產業合作

第6章 專利

  • 哺乳類,酵母,昆蟲,植物,基因改造的主要專利
  • 大腸菌的專利

第7章 地區分析

第8章 企業簡介

  • 有力受託製造企業
  • 有力生物製藥製造商
  • 其他受託製造企業
目錄
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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