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生物製剤API (原薬) 製造サービス - 世界の産業・市場展望 (~2029年) :哺乳類細胞培養・微生物発酵・ヒト成長ホルモン・インスリン・インターフェロン・モノクローナル抗体・ワクチン

Biological Drug API Manufacturing Services World Industry and Market Forecast to 2029: Mammalian Cell Cultures, Microbial Fermentations, Human Growth Hormones, Insulin, Interferons, Monoclonal Antibodies, Vaccines, Others

発行 Visiongain Ltd 商品コード 927103
出版日 ページ情報 英文 211 Pages
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1GBP=136.53円で換算しております。

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生物製剤API (原薬) 製造サービス - 世界の産業・市場展望 (~2029年) :哺乳類細胞培養・微生物発酵・ヒト成長ホルモン・インスリン・インターフェロン・モノクローナル抗体・ワクチン Biological Drug API Manufacturing Services World Industry and Market Forecast to 2029: Mammalian Cell Cultures, Microbial Fermentations, Human Growth Hormones, Insulin, Interferons, Monoclonal Antibodies, Vaccines, Others
出版日: 2019年11月07日 ページ情報: 英文 211 Pages
概要

生物製剤API (原薬) 製造市場は、予測期間の前半に9.5%のCAGRで成長すると推定されています。 2018年において、哺乳類細胞培養システムは、生物製剤API製造産業における最大のサブマーケットとなりました。

当レポートでは、世界の生物製剤向けAPI (医薬品有効成分) 受託製造サービス市場について分析し、市場の基本構造や最新情勢、主な市場促進・抑制要因、世界全体および分野別・地域別の市場動向見通し 、主要企業のプロファイルと事業戦略、業界の求心力 (SWOT分析)、今後の技術開発・市場成長の方向性といった情報を取りまとめてお届けいたします。

第1章 レポートの概要

第2章 生物製剤API (原薬) 製造サービス:イントロダクション

  • 生物製剤API (原薬) 製造サービスとは何か?
    • 生物製剤APIの生産:製造工程の概略
    • 生物製剤API製造市場の定義
    • API製造のための様々な発現系
  • 生物製剤APIの製造上の課題
  • アウトソーシング:生物製剤API製造サービスの一般的な傾向
  • 生物製剤API製造サービス市場の今後の動向

第3章 生物製剤API (原薬) 製造サービス:世界市場の展望・予測

  • 生物製剤API受託製造サービス市場の業績 (最新値)
    • 業績予測
  • 生物製剤API製造サービス市場の促進・抑制要因
    • 市場促進要因
    • 市場抑制要因
  • 生物製剤API製造サービス市場の将来展望:需要の拡大

第4章 生物製剤API製造サービスのサブマーケット - 世界市場の展望・予測:発現システム

  • サブマーケット
    • 哺乳類細胞培養
    • 微生物発酵
    • そのた開発中のAPI発現システム
  • 本章のサマリー:市場のプラス成長

第5章 生物製剤API製造サービス市場:生物製剤API受託製造の主要部門の展望

  • 抗体療法:生物製剤API受託製造の最大部門 (概略)
    • モノクローナル抗体API受託製造部門:市場予測
    • モノクローナル抗体API受託製造部門:将来展望
  • ワクチンAPI受託製造:CMOにとって有望な市場機会
    • ワクチンAPI受託製造市場:展望と予測
    • ワクチン製造上の課題
  • インスリン療法:市場概略と、API受託製造市場の展望
    • インスリンアナログAPIの受託製造市場の予測
    • インスリンアナログ市場の予測:内製はインスリン治療薬API受託製造市場の成長を抑制
    • インスリンAPI受託製造市場の発展動向
  • インターフェロン治療薬:イントロダクション・API受託製造市場の展望
    • インターフェロン治療薬API受託製造市場の予測
    • 市場機会の見通し
  • 成長ホルモン:イントロダクション・API受託製造市場の展望
    • 成長ホルモンAPIの受託製造市場の予測
    • 現在は内製が大半
    • 長時間作用型治療薬がアウトソーシングへ機会を提供
  • 本章のサマリー:主な生物製剤製品のアウトソーシングの見通し

第6章 主要国の生物製剤API受託製造サービス市場

  • 世界の生物製剤API製造サービス市場:地域別の内訳
  • 北米
  • EU
  • 北米
  • BRIC
  • その他の主要国
  • 本章のサマリー

第7章 生物製剤API製造サービス市場:主要CMO (医薬品製造受託機関)

  • 上位4社が市場を牽引
  • 主要企業:生産能力別
    • 小規模な企業が大半を占める
    • 主な市場参入障壁
  • FDA (米国食品医薬品局) がバイオシミラー市場の障壁を取り除く
  • Boehringer Ingelheim BioXcellence
    • 戦略展望:アジア市場の強化
  • Celltrion:アジアの生物製剤市場のリーダー
    • パートナーシップと合弁事業の道筋をたどる
  • Patheon NV:合併および買収をターゲットに
  • Lonza:世界最大の細胞培養能力
    • 成長戦略としての生物製剤分野のコアコンピテンシー
  • その他の注目すべき企業
    • Samsung BioLogics:バイオシミラーの強化
    • Cytovance Biologics:事業拡張計画
    • Fujifilm Diosynth Biotechnologies:将来的な設備・サービス拡充
  • CMO部門を運営している代表的なバイオ医薬品企業
    • AbbVie Contract Manufacturing:企業買収を通じた競争力強化
    • GSK Biopharmaceuticals
    • Sandoz:生物製剤・バイオシミラーの専業企業
    • Rentschler Biotechnologie:昨今の事業拡張の動き
    • Teva:生物製剤市場における将来有望な企業
    • Catalent:事業提携を通じた、新たなプラットフォームの提供
  • 本章のサマリー:主要企業の動向見通し

第8章 生物製剤API製造サービス市場の産業動向:定性分析

  • SWOT分析:生物製剤API製造サービス市場の長所と短所
  • STEP分析
  • 生物製剤の開発動向
    • バイオシミラー:CMOにとって重要な市場機会
    • 次世代型抗体の開発に投資するCMO
    • 希用薬・個別化医療:バッチの小型化の傾向
    • 使い捨て型 (シングルユース) API製品の市場の将来展望
    • 生物製剤API製造のアウトソーシングの傾向
  • 生物製剤API製造サービスへの規制とその影響
  • 本章のサマリー

第9章 結論

  • 市場
  • 市場展望
  • 市場成長

付録

図表

List of Tables

  • Table 2.1: Contract API Manufacturing: Revenues ($bn) and Market Share (%) by Sector, 2018
  • Table 3.1: Contract Biological Drug API Manufacturing Services Market: Overall Revenue Forecast ($bn), AGR (%), CAGR (%), 2018-2029
  • Table 4.1: Contract Biological Drug API Manufacturing Services Market Revenue Forecasts by Expression Systems Submarket ($bn), AGR (%), CAGR (%), 2018-2029
  • Table 4.2: Contract Biological Drug API Manufacturing Services Market Revenue Forecasts for Mammalian Cell Culture Submarket ($bn), AGR (%), CAGR (%), 2018-2029
  • Table 4.3: ADC Pipeline 2019
  • Table 4.4: Recent ADC's Investment
  • Table 4.5: Contract Biological Drug API Manufacturing Services Market Revenue Forecasts for Microbial Fermentation Submarket ($bn), AGR (%), CAGR (%), 2018-2029
  • Table 4.6: Contract Biological Drug API Manufacturing Services Market Revenue Forecasts for Other APIs Expression Systems Submarket ($bn), AGR (%), CAGR (%), 2018-2029
  • Table 5.1: Top Ten Best-Selling Drugs in 2018: Revenue ($bn)
  • Table 5.2: Contract API Biological Drug Revenue Forecasts ($bn), AGR (%), CAGR (%), by Therapeutic Area, 2018-2029
  • Table 5.3: Monoclonal Antibody Types and Sources
  • Table 5.4: Contract Biological Drug API Manufacturing Services Market Revenue Forecasts for Monoclonal Antibodies Submarket ($bn), AGR (%), CAGR (%), 2018-2029
  • Table 5.5: The Four Classes of Next- Generation Antibody Therapies
  • Table 5.6: Contract Biological Drug API Manufacturing Services Market Revenue Forecasts for Vaccines Submarket ($bn), AGR (%), CAGR (%), 2018-2029
  • Table 5.7: Comparison between biomanufacturing platforms for Vaccine Production: VLP
  • Table 5.8: Contract Biological Drug API Manufacturing Services Market Revenue Forecasts for Insulin Analogues Submarket ($bn), AGR (%), CAGR (%), 2018-2029
  • Table 5.9: Contract Biological Drug API Manufacturing Services Market Revenue Forecasts for Interferon Therapies Submarket ($bn), AGR (%), CAGR (%), 2018-2029
  • Table 5.10: Contract Biological Drug API Manufacturing Services Market Revenue Forecasts for Growth Hormones Submarket ($bn), AGR (%), CAGR (%), 2018-2029
  • Table 5.11: Selected Long-Acting Growth Hormones in Development, 2018
  • Table 6.1: Contract Biological Drug API Manufacturing Market: Revenues ($bn) and Market Shares (%) by Region, 2018
  • Table 6.2: Contract Biological Drug API Manufacturing Market: Revenues ($bn) and Market Shares (%) by Submarket, 2018
  • Table 6.3: Contract API Biological Drug Revenue Forecasts ($bn), AGR (%), CAGR (%), by Region, 2018-2029
  • Table 6.4: Contract Biological Drug API Manufacturing Market: Leading Nationals Revenue Shares (%), 2018, 2024 & 2029
  • Table 6.5: EU and Switzerland Contract Biological Drug API Manufacturing: Revenue Forecasts ($bn), GAGR (%), AGR (%), 2018-2029
  • Table 6.6: EU and Switzerland Contract Biological Drug API Manufacturing: Revenues ($bn) and Shares (%) by Leading Country, 2018
  • Table 6.7: Germany Contract Biological Drug API Manufacturing Revenue Forecast ($bn), GAGR (%), AGR (%), 2018-2029
  • Table 6.8: UK Contract Biological Drug API Manufacturing Revenue Forecast ($bn), GARG (%), AGR (%), 2018-2029
  • Table 6.9: France Contract Biological Drug API Manufacturing Revenue Forecast ($bn), GARG (%), AGR (%), 2018-2029
  • Table 6.10: Switzerland Contract Biological Drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2018-2029
  • Table 6.11: Spain Contract Biological Drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%),2018-2029
  • Table 6.12: Italian Contract Biological Drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2018-2029
  • Table 6.13: North America Contract Biological Drug API Manufacturing: Revenue Forecasts ($bn), GAGR (%), AGR (%), 2018-2029
  • Table 6.14: US Contract Biological Drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2018-2029
  • Table 6.15: Canada Contract Biological Drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2018-2029
  • Table 6.16: Mexico Contract Biological Drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2018-2029
  • Table 6.17: Contract Biological Drug API Manufacturing Market: BRIC National Revenue Forecasts ($bn), CAGR (%), AGR (%), 2018-2029
  • Table 6.18: BRIC Markets: API Revenues ($bn) and Market Shares (%), 2018
  • Table 6.19: Contract Biological Drug API Manufacturing Market: BRIC National Revenue Forecasts ($bn), CAGR (%), AGR (%), 2018-2029
  • Table 6.20: Chinese Contract Biological Drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2018-2029
  • Table 6.21: India Contract Biological Drug API Manufacturing Revenue Forecast ($bn), GAGR (%), AGR (%) 2018-2029
  • Table 6.22: Russia Contract Biological Drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2018-2029
  • Table 6.23: Brazilian Contract Biological Drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2018-2029
  • Table 6.24: Contract Biological Drug API Manufacturing Market: Other Leading Nationals Revenue Forecasts ($bn), CAGR (%), AGR (%), 2018-2029
  • Table 6.25: Japanese Contract Biological Drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2018-2029
  • Table 6.26: South Korean Contract Biological Drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2018-2029
  • Table 6.27: Selected Biotechs and Pharmaceutical Companies with Manufacturing Facilities in Singapore, 2019
  • Table 6.28: Singaporean Contract Biological Drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2018-2029
  • Table 7.1: Leading Biological drug API CMOs: Mammalian Cell Culture and Microbial Fermentation Manufacturing Scale, 2018
  • Table 7.2: Selected Other Biological drug API CMOs: Mammalian Cell Culture and Microbial Fermentation Manufacturing Scale, 2018
  • Table 7.3: Boehringer Ingelheim BioXcellence: Manufacturing Capacity, 2018
  • Table 7.4: Boehringer Ingelheim BioXcellence: Revenue ($bn), 2016-2018
  • Table 7.5: Celltrion Revenue ($bn), 2016-2018
  • Table 7.6: Lonza Pharma & Biotech Revenue ($bn), 2016-2018
  • Table 7.7: Samsung BioLogics CMO Revenue ($bn), 2016-2018
  • Table 7.8: Sandoz Biosimilar Pipelines: Selected Biosimilars, 2019
  • Table 8.1: Contract Biological Drug API Manufacturing Market: Strengths and Weaknesses, 2018
  • Table 8.2: Contract Biological Drug API Manufacturing Market: Opportunities and Threats, 2018-2029
  • Table 8.3: Biological Drug API Manufacturing Services Market: STEP Analysis, 2018
  • Table 8.4: Selected EU-Approved Biosimilars: Manufacturers and Companies, 2018
  • Table 8.5: Key Approved Next-Generation Antibody Therapies, 2018
  • Table 9.1: Contract Biological Drug API Manufacturing Market: Revenue Forecasts ($bn) by Expressions Submarket, 2019, 2021, 2023, 2025, 2027 and 2029
  • Table 9.2: Contract Biological Drug API Manufacturing Market: Revenue Forecasts ($bn) by Region, 2019, 2021, 2023, 2025, 2027 and 2029

List of Figures

  • Figure 1.1: Biological Drug API Manufacturing Services Submarkets 2018
  • Figure 2.1: Steps for Biological Drug Manufacturing, 2018
  • Figure 2.2: Contract API Manufacturing: Market Shares by Sector (%), 2018
  • Figure 2.3: Future Trends in the Biological Drug API Manufacturing Market, 2018-2029
  • Figure 3.1: Contract Biological Drug API Manufacturing Services Market: Revenue Forecast ($bn), AGR (%), 2018-2029
  • Figure 3.2: Contract Biological Drug API Manufacturing: Market Drivers
  • Figure 3.3: Contract Biological Drug API Manufacturing: Market Restraints
  • Figure 4.1: Contract Biological Drug API Manufacturing: Market Shares (%) by Expression Systems Submarket, 2018
  • Figure 4.2: Mammalian Cell Culture Submarket Forecast: Revenue ($bn), AGR (%), 2019-2029
  • Figure 4.3: Mammalian Cell Culture Submarket: Drivers and Restraints
  • Figure 4.4: Microbial Fermentation Submarket Forecast ($bn), AGR (%), 2019-2029
  • Figure 4.5: Microbial Fermentation Submarket: Drivers and Restraints, 2019
  • Figure 4.6: Other Expression Systems Submarket Forecast ($bn), AGR (%), CAGR (%), 2018-2029
  • Figure 5.1: Contract Biological Drug API Manufacturing: Market Shares (%) by Therapeutic Area Submarket, 2018
  • Figure 5.2: Monoclonal Antibodies Submarket Forecast: Revenue ($bn), AGR (%), 2018-2029
  • Figure 5.3: Vaccines Submarket Forecast, Revenue ($bn), AGR (%), 2018-2029
  • Figure 5.4: Insulin Analogues Submarket Forecast: Revenue ($bn), AGR (%), 2018-2029
  • Figure 5.5: Interferon Therapies Submarket Forecast, Revenue ($bn), AGR (%), 2018-2029
  • Figure 5.6: Growth Hormones Submarket Forecast, Revenue ($bn), AGR (%), 2018-2029
  • Figure 6.1: Contract Biological Drug API Manufacturing: Market Shares (%) by Region, 2018
  • Figure 6.2: Contract Biological Drug API Manufacturing: Market Shares by Leading Nationals (%), 2018
  • Figure 6.3: Contract Biological Drug API Manufacturing: Market Shares by Leading Nationals (%), 2024
  • Figure 6.4: Contract Biological Drug API Manufacturing: Market Shares by Leading Nationals (%), 2029
  • Figure 6.5: EU and Switzerland Contract Biological Drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2018-2029
  • Figure 6.6: EU Contract Biological Drug API Manufacturing: Leading National Revenue Shares (%), 2018
  • Figure 6.7: Germany Contract Biological Drug API Manufacturing Revenue Forecast ($bn), 2018-2029
  • Figure 6.8: UK Contract Biological Drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2018-2029
  • Figure 6.9: France Contract Biological Drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2018-2029
  • Figure 6.10: Switzerland Contract Biological Drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2018-2029
  • Figure 6.11: Spanish Contract Biological Drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2018-2029
  • Figure 6.12: Italian Contract Biological Drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2018-2029
  • Figure 6.13: North America Contract Biological Drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2018-2029
  • Figure 6.14: US Contract Biological Drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2018-2029
  • Figure 6.15: Canada Contract Biological Drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2018-2029
  • Figure 6.16: Mexico Contract Biological Drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2018-2029
  • Figure 6.17: Contract Biological Drug API Manufacturing Market: BRIC National Revenue Forecasts ($bn), AGR (%), 2018-2029
  • Figure 6.18: Biologics Market: BRIC Revenue Shares (%), 2018
  • Figure 6.19: Chinese Contract Biological Drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2018-2029
  • Figure 6.20: India Contract Biological Drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2018-2029
  • Figure 6.21: Russia Contract Biological Drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2018-2029
  • Figure 6.22: Brazilian Contract Biological Drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2018-2029
  • Figure 6.23: Japanese Contract Biological Drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2018-2029
  • Figure 6.24: South Korean Contract Biological Drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2018-2029
  • Figure 6.25: Singaporean Contract Biological Drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2018-2029
  • Figure 7.1: Leading Biological drug API CMOs: Mammalian Cell Culture Manufacturing Scale, 2018
  • Figure 7.2: Leading Biological drug API CMOs: Microbial Fermentation Manufacturing Scale, 2018
  • Figure 7.3: Boehringer Ingelheim BioXcellence: Revenue ($bn), 2016-2018
  • Figure 7.4: Celltrion Revenue ($bn), 2016-2018
  • Figure 7.5: Patheon N.V.: Revenue ($bn), 2014-2016
  • Figure 7.6: Lonza Pharma & Biotech Revenue ($bn), 2016-2018
  • Figure 7.7: Samsung BioLogics CMO Revenue ($bn), 2016-2018
  • Figure 9.1: Contract Biological Drug API Manufacturing Market: Revenue Forecasts ($bn) by Expressions Submarket, 2018-2029
  • Figure 9.2: Contract Biological Drug API Manufacturing Market: Revenue Forecasts ($bn) by Region, 2019, 2021, 2023, 2025, 2027 and 2029

COMPANIES LISTED:

  • Abasria
  • AbbVie
  • Accord Healthcare
  • Acquired Cedarburg Pharmaceuticals
  • Actavis Generics
  • Adaptimmune Therapeutics
  • Agensys
  • Althera Technologies
  • Altus Pharmaceuticals
  • Amgen
  • Apotex
  • Aptuit
  • arGEN-X
  • Ascendis Pharma A/S
  • Asterion
  • Astra Zeneca
  • Avid Bioservices Inc
  • Bakhu Pharma.
  • Banner Life Sciences
  • Basaglar
  • Baxalta
  • Baxter
  • Bayer
  • Bever Pharmaceutical
  • Biocad
  • Biocon
  • Biogen
  • Biogen Idec
  • BMS
  • Boehringer Ingelheim
  • Boehringer Ingelheim BioXcellence
  • Bolder BioTechnology
  • Calico Life Science
  • Caspugel
  • Catalent Biologics
  • Celgene
  • Celldex Therapautics
  • Celltrion
  • Cinfa
  • CMC Biologics
  • CMIC Holdings Co. Ltd.
  • CMO Relthy Laboratórios
  • Cook Pharmica
  • Critical Pharmaceuticals
  • CT Arzneimittel
  • Cytos Biotechnology
  • Cytovance Biologics
  • DPx Fine Chemicals
  • DPx Holdings B.V.
  • DSM Biologics
  • DSM Sinochem Pharmaceuticals
  • Eli Lily
  • EMD Millipore
  • FDA
  • Ferring Pharmaceuticals
  • Filnox Biotech
  • Fresenius
  • Fujifilm Diosynth Biotechnologies
  • Gallus BioPharmaceuticals,
  • GE Healthcare
  • Genentech
  • GeneScience Pharmaceuticals Co., Ltd.
  • Genexine and Handok
  • Genmab
  • Genzyme
  • Germany's Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG)
  • Gilead Sciences, Inc.
  • GSK
  • Hanmi Pharmaceutical Co.
  • Hexal
  • Index Ventures
  • Infarco
  • Infinity Pharmaceuticals
  • Inno Biologics
  • Innovation Network Corporation of Japan (INCJ),
  • Japanese Ministry of Health, Labour and Welfare
  • Johnson and Johnson
  • Johnson Matthey
  • JSR Corporation
  • Kalon Biotherapeutics
  • KBI Biopharma, Inc.
  • Kemwell
  • Kyowa Hakko Kirin
  • Labrys Biologics Inc,
  • Laureate Biopharma
  • LG Life Sciences, Ltd.
  • Lonza
  • Matrix Laboratories
  • Merck
  • Mitsubishi Gas Chemical Company
  • Mylan
  • Neopharm
  • NHS
  • NICE
  • Nikon
  • Nippon kayaku
  • Norbitec
  • Novartis
  • Novasep
  • Novo Nordisk
  • Nuron Biotech
  • Nycomed
  • Opko Health
  • Patheon
  • PelChem
  • Peregrine Pharmaceuticals
  • Perrigo
  • Pfizer
  • Pharmstandard
  • Phyton Biotech
  • Piramal Healthcare
  • Precision Biologics
  • Progenics
  • Quintiles
  • Rebtschler Biotechnologie
  • Recepta Biopharma
  • Redwood Bioscience
  • Rentschler
  • Rentschler Biotechnologie
  • Roche
  • RoYal DSM
  • SAFC
  • Samsung BioLogics
  • Sanofi
  • SCM Pharma
  • Seattle Genetics
  • ShangPharma
  • SICOR Biotech
  • Sigma-Aldrich Corporation
  • Stada
  • SunShine Biopharma
  • SynCo BioPartners
  • Takeda
  • Teva
  • Therapure Biopharma
  • Thermo Fisher
  • Toyobo Biologics
  • Transgene SA
  • Versartis
  • Vertex
  • Vida Pharma
  • VTU
  • WHO
  • WuXi Biologics,
  • WuXi PharmaTech
  • Zhangjiang Biotech
  • Zhejiang Jiang Yuan Tang Biotechnology
  • ZJ Base
目次
Product Code: PHA0550

The biological drug API manufacturing market is estimated to grow at a CAGR of 9.5% in the first half of the forecast period. In 2018, Mammalian cell culture systems submarket represents the largest submarket within the biological drug API manufacturing industry.

How this 211-page report delivers:

Biological Drug API Manufacturing Services market forecast to 2029

Biological Drug API Manufacturing Services market forecast to 2029 by Expression Systems:

  • Mammalian cell culture
  • Microbial fermentation
  • Other expression platforms

Biological Drug API Manufacturing Services market forecast to 2029 by Therapeutic Area:

  • Monoclonal antibody (mAb) therapies
  • Vaccines
  • Insulin therapies
  • Interferon therapies
  • Growth hormones
  • Other Therapeutic Areas

Biological Drug API Manufacturing Services market forecast to 2029 by Regional and National Market:

  • North America: US, Canada
  • Europe: Germany, France, the UK, Switzerland, Spain, Italy, Rest of Europe
  • BRIC: Brazil, Russia, China, India
  • Japan
  • South Korea
  • Singapore
  • RoW

Profiles leading companies that offer biotech API manufacturing services to the pharmaceutical industry. Leading CMOs profiled in this report are:

  • Abbvie
  • Boehringer Ingelheim BioXcellence
  • Catalent
  • Celltrion
  • Cytovance Biologics
  • Fujifilm Diosynth Biotechnologies
  • GSK
  • Lonza
  • Patheon N.V.
  • Rentschler Biopharma
  • Samsung BioLogics
  • Sandoz
  • Teva

Provides qualitative analysis: SWOT and STEP Analysis of the biological drug API manufacturing market.

Key questions answered by this report:

  • How is the biological drug API manufacturing services market evolving?
  • What is driving and restraining the biological drug API manufacturing services market?
  • What are the market shares of each main segment of the overall biological drug API manufacturing services market in 2018?
  • How will each main biological drug API manufacturing services submarket grow over the forecast period and how much revenue will these submarkets account for in 2029?
  • How will the market shares for biological drug API manufacturing services submarkets develop from 2019 to 2029?
  • What will be the main drivers for the overall market from 2019 to 2029?
  • How will political and regulatory forces influence the regional markets and submarkets?
  • Will leading national biological drug API manufacturing services markets broadly follow the macroeconomic dynamics, or will individual national markets outperform others?
  • How will the market shares of the national markets change by 2029 and which countries will lead the market in 2029?
  • Who are the leading companies and what are their prospects?
  • What are the predictions for M&A activity, consolidation for existing players and the potential prospects for new market entrants?
  • How will the industry evolve during the period 2019 to 2029, and which trends will be important?

Visiongain's study is intended for anyone requiring commercial analyses for the biological drug API manufacturing market. You find data, trends and predictions.

Buy our report today Biological Drug API Manufacturing Services World Industry and Market Forecast to 2029: Mammalian Cell Cultures, Microbial Fermentations, and Other Expression Systems; Human Growth Hormones, Insulin, Interferons, Monoclonal Antibodies, Vaccines, and Others Therapeutic Areas.

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Table of Contents

1. Report Overview

  • 1.1. Contract Biological Drug API Manufacturing: World Market Review 2018
  • 1.2. Benefits of this Report
    • 1.2.1. How This Report Delivers
    • 1.2.2. Main Questions Answered by This Analytical Report
  • 1.3. Who is This Report For?
  • 1.4. Methods of the Study
  • 1.5. Frequently Asked Questions (FAQ)
  • 1.6. Associated Reports
  • 1.7. About Visiongain

2. Introduction to Biological Drug API Manufacturing Services

  • 2.1. What are Biological Drug API Manufacturing Services?
    • 2.1.1. Producing Biological drug API: An Overview of the Manufacturing Process
    • 2.1.2. Defining the Biological Drug API Manufacturing Market
    • 2.1.3. Differing Expression Systems to Manufacture APIs
  • 2.2. Challenges in Manufacturing Biological drug API
  • 2.3. Outsourcing: A Common Trend in Biological Drug API Manufacturing Services
  • 2.4. Future Trends for the Biological Drug API Manufacturing Services Market

3. Biological Drug API Manufacturing Services: World Market Outlook and Forecast 2019-2029

  • 3.1. The Contract Biological Drug API Manufacturing Services Market Performance, 2018
    • 3.1.1. Contract Biological Drug API Manufacturing Services: Forecast 2018-2029
  • 3.2. Drivers and Restraints in the Biological Drug API Manufacturing Services Market
    • 3.2.1. Drivers in the Biological Drug API Manufacturing Market
      • 3.2.1.1. The Ageing Population is a Driver for Growth
      • 3.2.1.2. The Patent Cliff Effect Will Stimulate Biologics and Biosimilar Development
      • 3.2.1.3. Outsourcing as a Driver for Growth
      • 3.2.1.4. Opportunities from the Long Pipeline Will Drive Growth
      • 3.2.1.5. Increased Investment in Orphan Drugs from Companies
      • 3.2.1.6. Emerging Markets Will Grow and Influence the Market
      • 3.2.1.7. Technological Changes: Single-Use Technology Will Become Essential in the Next 10 Years
    • 3.2.2. Restraints on Growth in the Biological Drug API Manufacturing Services Market
      • 3.2.2.1. Pricing Pressures Will Limit Market Growth
      • 3.2.2.2. Regulatory Restrictions Will Increase
      • 3.2.2.3. Overcapacity Will Be Adverse to Market Growth for CMOs
      • 3.2.2.4. Complexity of API Production is a Challenge
  • 3.3. Outlook for the Outsourced Biological drug API Services: Increased Demand

4. Biological Drug API Manufacturing Services Submarket by Expression Systems: World Market Outlook and Forecasts 2019-2029

  • 4.1. Submarkets for the Biological Drug API Manufacturing Services Industry
    • 4.1.1. The Mammalian Cell Culture Submarket
      • 4.1.1.1. The Mammalian Cell Culture Submarket Forecast 2018-2029
      • 4.1.1.2. ADCs and Next-Generation Antibodies Will Drive Growth 2018-2029
    • 4.1.2. The Microbial Fermentation Submarket
      • 4.1.2.1. The Microbial Fermentation Submarket Forecast 2018-2029
      • 4.1.2.2. Increase in Demand for Insulin Will Drive Growth 2018-2029
    • 4.1.3. Other APIs Expression Systems Are Still in Development
      • 4.1.3.1. Plant-Made Pharmaceuticals
      • 4.1.3.2. Yeast Cell Expression Systems
      • 4.1.3.3. Insect Cell Expression Systems
      • 4.1.3.4. Other Expression Systems Submarket Forecast 2018-2029
  • 4.2. Chapter Summary: Positive Growth for the Market

5. Biological Drug API Manufacturing: Outlook for Leading Biological Drug Contract API Sectors: 2019-2029

  • 5.1. Antibody Therapies: An Introduction to the Largest Contract API Biological Drug Sector
    • 5.1.1. Contract API Monoclonal Antibody Manufacturing Forecast 2018-2029
    • 5.1.2. Outlook: Outsourced Manufacturing for Monoclonal Antibody APIs Will Increase
  • 5.2. Contract API Vaccine Manufacturing: A Promising Opportunity for CMOs
    • 5.2.1. Contract API Vaccine Market: Outlook and Forecast 2018-2029
    • 5.2.2. Challenges in Manufacturing Vaccines
  • 5.3. Introduction to the Insulin Therapies Market and Outlook for the Contract API Insulin Therapies Market
    • 5.3.1. Contract API Insulin Analogues Forecast 2018-2029
    • 5.3.2. Insulin Analogues: In-House Production Restrains Contract API Insulin Therapies Market Growth
    • 5.3.3. Development Trends in the Contract API Insulin Market 2018 to 2029
  • 5.4. Introduction to the Interferon Therapy Market and Outlook for the Contract API Interferon Therapy Market
    • 5.4.1. Contract API Interferon Market Forecast 2018-2029
    • 5.4.2. Unlikely to be Opportunities in the Contract API Interferon Market
  • 5.5. Introduction to the Growth Hormone Market and Outlook for the Contract API Growth Hormone Manufacturing Market
    • 5.5.1. Contract API Growth Hormone Market Forecast 2018 to 2029
    • 5.5.2. Most Manufacturing is In-House for Growth Hormone Production
    • 5.5.3. Long-Acting Therapies Provide Opportunity for Outsourcing
  • 5.6. Chapter Summary: Outsourcing for Key Biological Products 2018-2029

6. Leading National Markets for Contract Biological Drug API Manufacturing Services Market Forecast to 2029

  • 6.1. Regional Breakdown of the World Biological Drug API Manufacturing Services Market
    • 6.1.1. North America and EU Dominate Growth for Leading National Submarkets 2018-2029
    • 6.1.2. National Revenue Shares by 2029: Emerging Market Growth
  • 6.2. Contract Biological Drug API Manufacturing in EU Market 2018-2029
    • 6.2.1. Strong Growth for the EU Revenue Forecasts 2018-2029
    • 6.2.2. Forecasts for Switzerland and Leading EU National Revenues 2018-2029
      • 6.2.2.1. Germany Leads the EU Biotech Market with Strong Growth
      • 6.2.2.2. UK: Strong Research Sector Will Drive Market Growth
      • 6.2.2.3. France: Strong Vaccine Development Industry
      • 6.2.2.4. Switzerland: Headquarters for Leading Companies
      • 6.2.2.5. Spain: Numerous Biotech Companies
      • 6.2.2.6. Italy: Outlook and Forecast 2018-2029
  • 6.3. Contract Biological Drug API Manufacturing in North America Market 2018-2029
    • 6.3.1. Forecasts for North America Leading National Revenues 2018-2029
    • 6.3.2. US: A Market Leader in Biological Drug API Manufacturing
    • 6.3.3. Canada: A Market Leader in Biological Drug API Manufacturing
    • 6.3.4. Mexico: A Market Leader in Biological Drug API Manufacturing
  • 6.4. BRIC Market: Contract Biological Drug API Manufacturing Services Market 2018-2029
    • 6.4.1. Emerging Nations May Develop a Presence in the Biologics Market
    • 6.4.2. Increased Demand for Biosimilars and Biological Drugs 2018-2029
    • 6.4.3. China is Poised for Growth: Forecast for 2018-2029
    • 6.4.4. India Offers a Lower-Cost Advantage for Biological Drug API Manufacturing Services: Forecast 2018-2029
    • 6.4.5. Brazilian and Russian Governments Promoting Domestic Biotech Development
      • 6.4.5.1. Russian Biological Drug API Manufacturing Services Forecast: 2018-2029
      • 6.4.5.2. Brazilian Biological Drug API Manufacturing Services Forecast: 2018-2029
  • 6.5. Forecasts for the Other Leading Nationals Revenues 2018-2029
    • 6.5.1. Japan: A Less Mature Contract Manufacturing Market
    • 6.5.2. Leading CMOs Celltrion and Samsung BioLogics Drive the Market in South Korea: Market Forecast, 2018-2029
    • 6.5.3. Singapore: Market Forecast, 2018-2029
  • 6.6. Summary of Chapter: Outlook for Leading National Submarkets 2018-2029

7. Leading CMOs in the Biological Drug API Manufacturing Services Market

  • 7.1. Four Companies Led the Market in 2018
  • 7.2. Leading Companies by Capacity
    • 7.2.1. Small-Scale Biopharmaceutical Manufacturing is a Common Trend
    • 7.2.2. Barriers to Market Entry 2018-2029
      • 7.2.2.1. The High Cost of Facilities: Acquisition as a Cheaper Alternative
  • 7.3. FDA Opens Barriers for the Biosimilars Market
  • 7.4. Boehringer Ingelheim BioXcellence
    • 7.4.1. Strategic Outlook: Expanding into the Asian Market
  • 7.5. Celltrion: Biologics Leader in Asia
    • 7.5.1. Celltrion: Following Partnerships and Joint Ventures Path
  • 7.6. Patheon N.V.: Target for Mergers and Acquisitions
  • 7.7. Lonza Has the Largest Worldwide Cell Culture Capacity
    • 7.7.1. Lonza: Biopharmaceutical Core Competency as a Strategy for Growth
  • 7.8. Other Market Players of Interest in 2018
  • 7.9. Samsung BioLogics: Focusing on Biosimilars
    • 7.9.1. Samsung BioLogics: Partnership Strategy for Future Expansion
  • 7.10. Cytovance Biologics: Plans to Expand
  • 7.11. Fujifilm Diosynth Biotechnologies
    • 7.11.1. Facility and Service Expansion for the Future
  • 7.12. Leading Biopharma Companies Operate CMO Divisions
  • 7.13. AbbVie Contract Manufacturing: Strength through Acquisition
  • 7.14. GSK Biopharmaceuticals
  • 7.15. Sandoz: Expertise in Biologics and Biosimilars
  • 7.16. Rentschler Biopharma: Recent Expansions
  • 7.17. Teva: A Future Player in the Biologics Market
  • 7.18. Catalent: Follows Acquisition and Investment Strategy for Expansion

8. Biological Drug API Manufacturing Services Market Industry Trends: Qualitative Analysis

  • 8.1. SWOT Analysis: Strengths and Weaknesses of the Biological Drug API Manufacturing Services Market 2018
    • 8.1.1. Strength: Biopharmaceutical Demand for Outsourcing is increasing
    • 8.1.2. Weakness: A Fragmented Market with a Costly and Difficult Manufacturing Process
    • 8.1.3. Opportunities for the Biological Drug API Manufacturing Services Market 2018-2029
    • 8.1.4. Threats for the Biological Drug API Manufacturing Services Market 2018-2029
  • 8.2. STEP Analysis of the Biological Drug API Manufacturing Services Market
    • 8.2.1. Social Factors: Drug Pricing Pressures to Meet Demand for an Increasing Ageing Population
    • 8.2.2. Technological Factors: Advances Will Drive Growth
      • 8.2.2.1. Single-Use Technology: A Vital Trend for the Future
    • 8.2.3. Economic Factors: The High Cost of Manufacturing Will Lead to Outsourcing
    • 8.2.4. Political Factors: Regulatory Requirements Need to Be Met
  • 8.3. Trends in Biological Drug Development 2018-2029
    • 8.3.1. Biosimilars Will Be an Important Opportunity for CMOs
    • 8.3.2. CMOs are investing in Next-Generation Antibody Development
    • 8.3.3. Orphan Drugs and Personalised Medicine: Trend for Smaller Batches
    • 8.3.4. Outlook for Single-Use Technologies in Biological Drug API Manufacturing 2018-2029
      • 8.3.4.1. Future Direction: Single-Use Systems will be Essential
    • 8.3.5. Outsourcing Trends for Biological Drug API Manufacturing 2018-2029
      • 8.3.5.1. Biopharma Companies Continue to Invest in In-House Facilities
      • 8.3.5.2. Off-shoring Biological Drug API Manufacturing to Emerging Markets: Not a Trend for this Decade?
      • 8.3.5.3. Overcapacity is a Risk for the Biotech CMO Industry
      • 8.3.5.4. Future Trends: Strategic Partnering
      • 8.3.5.5. Alternative Expression Methods
  • 8.4. Regulations and Effects on the Biological Drug API Manufacturing Services Industry
    • 8.4.1. Effect on the Emerging Biological Drug API Manufacturing Services Market 2018-2029
    • 8.4.2. Regulations in Other Countries in the Biological drug API Market
  • 8.5. Chapter Summary: Industry Trends for Contract Biological Drug API Manufacturing to 2028

9. Conclusions

  • 9.1. The Contract Biological Drug API Manufacturing Services Market
  • 9.2. Outlook for the Biological Drug API Manufacturing Services Market
    • 9.2.1. Mammalian Cell Culture is the Leading Expression Platform for Outsourced Biological Drug API Manufacturing
    • 9.2.2. The US and EU Markets Lead for the Global Biological Drug API Manufacturing Services Market in 2017
    • 9.2.3. Single-Use Technology Will Become Indispensable for Success in the Market
  • 9.3. Growth in the Market 2018-2029
    • 9.3.1. The Future of the Biological Drug API Manufacturing Services Marketplace

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