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市場調査レポート

世界の生物製剤API (原薬) 製造サービス産業・市場の展望 (2018年〜2028年):哺乳類細胞培養・微生物発酵・その他の発現系、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 Predictions 2018-2028: Mammalian Cell Cultures, Microbial Fermentations, Other Expression Systems, Human Growth Hormones, Insulin, Interferons, Monoclonal Antibodies, Vaccines

発行 Visiongain Ltd 商品コード 333982
出版日 ページ情報 英文 209 Pages
納期: 即日から翌営業日
価格
本日の銀行送金レート: 1GBP=139.15円で換算しております。

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世界の生物製剤API (原薬) 製造サービス産業・市場の展望 (2018年〜2028年):哺乳類細胞培養・微生物発酵・その他の発現系、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 Predictions 2018-2028: Mammalian Cell Cultures, Microbial Fermentations, Other Expression Systems, Human Growth Hormones, Insulin, Interferons, Monoclonal Antibodies, Vaccines
出版日: 2018年07月06日 ページ情報: 英文 209 Pages
概要

世界の生物製剤API製造サービス市場は、今後5年間に9.0%のCAGR (複合年間成長率) で成長していく、と見られています。

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 (今後12年間分)、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 調査概要

第2章 生物製剤API製造サービスの概略

  • 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将来展望

第3章 生物製剤API製造サービス:世界市場の展望と予測 (今後12年間分)

  • 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 (今後12年間分)
  • 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
      • 人口高齢化、「特許の崖」、長期的な製品パイプライン、希用薬への投資拡大、技術進歩など
    • 市場抑制要因
      • 価格圧力、規制強化、過剰設備、API生産工程の複雑性
  • 生物製剤API製造サービス子女の将来展望:需要の拡大

第4章 生物製剤API製造サービス市場:分野別の展望と予測

  • 生物製剤API製造サービス産業の内訳
    • 哺乳類細胞培養の市場
    • 哺乳類細胞培養市場の予測 (今後12年間分)
    • ADC (抗体薬物複合体) および次世代型抗体
    • 微生物発酵市場
    • 微生物発酵市場の予測 (今後12年間分)
      • インスリンの需要増大に伴う成長促進
    • その他のAPI発現系:未だ開発の途上
      • 植物性医薬品
      • 酵母細胞・昆虫細胞などの発現系
  • 分析結果概略: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将来展望

  • 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 (今後12年間分)
    • 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 (今後12年間分)
    • 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 (今後12年間分)
    • インスリンアナログ市場の見通し (内製/外注)
    • インスリンAPI受託製造市場の発展動向 (今後12年間分)
  • インターフェロン治療薬:市場概略と、API受託製造市場の将来展望
    • インターフェロン治療薬API受託製造市場の予測 (今後12年間分)
    • 市場機会の見通し
  • 成長ホルモン:市場概略と、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 (今後12年間分)
    • 内製/外注の傾向:現在は内製が大半
    • 持効性治療薬の開発に伴う、外注生産の市場機会
  • 分析結果概略:主な生物製剤製品の外注化の見通し (今後12年間分)

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
    • 米国・欧州が今後の市場成長を主導
    • 国別市場シェア:新興国の上昇傾向
  • 主要国・地域の生物製剤API製造サービス市場 (今後12年間分)
    • 地域別の市場成長の見通し
    • EU諸国・スイス市場の予測 (ドイツ、英国、フランス、スペイン、イタリア、スイス)
    • 米国市場の予測
    • 日本市場の予測
    • BRIC諸国市場の予測 (ブラジル、ロシア、インド、中国)
    • 韓国市場の予測
    • シンガポール市場の予測
  • 分析結果概略:主要国の市場動向の見通し (今後12年間分)

第7章 生物製剤API製造サービス市場:代表的なCMO (医薬品製造受託機関)

  • 上位4社が市場を牽引
  • 代表的企業: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 (生産設備コストの高さ、など)
  • 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
    • アジア市場の強化
  • Celltrion:アジアの生物製剤市場のリーダー
    • 企業合併・買収 (M&A) 強化の兆し
  • DSM Biologics:生産能力の戦略的な拡張
  • 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
  • 分析結果概略:主要企業の動向見通し (今後12年間分)

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 (今後12年間分)

  • SWOT分析:生物製剤API製造サービス市場の強みと弱み
    • 生物製剤分野の外注化需要の増大
    • 細分化された市場と、コストが高く扱いが難しい製造工程
  • 生物製剤API製造サービスの市場機会 (今後12年間分)
  • 生物製剤API製造サービスへの脅威 (今後12年間分)
  • STEP分析:生物製剤API製造サービス市場の場合
    • 社会的要因:人口高齢化に伴う薬価引き上げ圧力
    • 技術的要因:技術進歩による成長促進
    • 経済的要因:製造コストの高さと、外注化の促進
    • 政治的要因:規制適合の必要性
  • 生物製剤の開発動向 (今後12年間分)
    • 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:パ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製造の外注化の傾向
      • バイオ医薬品企業:内製用設備への投資を継続
      • 新興国でのオフショア生産への移行:もう流行っていないのか?
      • 生産能力過剰:バイオテクノロジーCMOの業界にとっての脅威
      • 代替的な発現系
  • 生物製剤API製造サービスへの規制とその影響
    • 新興国市場への影響
    • その他の国々での規制動向
  • 分析結果概略:生物製剤API製造サービス産業の今度の動向見通し

第9章 結論

  • 生物製剤APIの受託製造サービス市場
  • 生物製剤API製造サービス市場の将来展望
    • 哺乳類細胞培養:代表的な発現系プラットフォームとなる
    • 米国・欧州市場が世界を主導
    • 使い捨て型技術が、市場の成長に不可欠となる
  • 市場成長の予測 (今後12年間分)
    • 生物製剤API製造サービス市場の将来展望
  • 付録
  • 用語一覧
図表

List of Tables

  • Table 2.1: Contract API Manufacturing: Revenues ($bn) and Market Share (%) by Sector, 2017
  • Table 3.1: Contract Biological drug API Manufacturing Services Market: Overall Revenue Forecast ($bn), AGR (%), CAGR (%), 2017-2028
  • Table 4.1: Contract Biological drug API Manufacturing: Overall World Market and Main Submarket Revenue Forecasts ($bn), AGR (%), CAGR (%), 2017-2028
  • Table 4.2: ADC Pipeline 2017
  • Table 4.3: Mammalian Cell Culture Submarket: API Revenue Forecast ($bn), AGR (%), CAGR (%), 2017-2028
  • Table 4.4: Selected CMOs Investing in Biological API Manufacturing Capacity, 2017
  • Table 4.5: Microbial Fermentation: API Submarket Revenue Forecast ($bn), AGR (%), CAGR (%), 2017-2028
  • Table 4.6: Other Expression Systems Submarket Two-Year Forecast Revenues ($bn), AGR (%), 2017-2028
  • Table 5.1: Top Ten Best-Selling Drugs in 2017: Revenue ($bn)
  • Table 5.2: Contract API Biological Drug Revenue Forecasts ($bn), AGR (%), CAGR (%), by Therapeutic Area, 2017-2028
  • Table 5.3: Monoclonal Antibody Types and Sources
  • Table 5.4: Monoclonal Antibody Market: Contract API Revenue Forecast ($bn), CAGR (%), AGR (%), 2017-2028
  • Table 5.5: The Four Classes of Next- Generation Antibody Therapies
  • Table 5.6: Vaccines Market: Contract API Revenue Forecast ($bn), GAGR (%), AGR (%) 2017-2028
  • Table 5.7: Insulin Therapies Market: Contract API Revenue Forecast ($bn), AGR (%), CAGR (%), 2017-2028
  • Table 5.8: Interferon Therapies Market: Contract API Revenue Forecast ($bn), CAGR (%), AGR (%), 2017-2028
  • Table 5.9: Growth Hormones Market: Contract API Revenue Forecast ($bn), CAGR (%), AGR (%), 2017-2028
  • Table 5.10: Selected Long-Acting Growth Hormones in Development, 2017
  • Table 6.1: Contract Biological drug API Manufacturing Market: Revenues ($bn) and Market Shares (%) by Region, 2017
  • Table 6.2: Contract Biological drug API Manufacturing Market: Leading Regional and National Revenue Forecasts ($bn), CAGR (%), AGR (%), 2017-2028
  • Table 6.3: Contract Biological drug API Manufacturing Market: National Revenue Two Year Shares (%), 2017-2028
  • Table 6.4: EU and Switzerland Contract Biological drug API Manufacturing: Revenue Forecasts ($bn), GAGR (%), AGR (%), 2017-2028
  • Table 6.5: EU and Switzerland Contract Biological drug API Manufacturing: Revenues ($bn) and Shares (%) by Leading Country, 2017
  • Table 6.6: Germany Contract Biological drug API Manufacturing Revenue Forecast ($bn), GAGR (%), AGR (%), 2017-2028
  • Table 6.7: UK Contract Biological drug API Manufacturing Revenue Forecast ($bn), GARG (%), AGR (%), 2017-2028
  • Table 6.8: France Contract Biological drug API Manufacturing Revenue Forecast ($bn), GARG (%), AGR (%), 2017-2028
  • Table 6.9: Switzerland Contract Biological drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2017-2028
  • Table 6.10: Spain Contract Biological drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%),2017-2028
  • Table 6.11: Italian Contract Biological drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2017-2028
  • Table 6.12: US Contract Biological drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2017-2028
  • Table 6.13: Japanese Contract Biological drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2017-2028
  • Table 6.14: Contract Biological drug API Manufacturing Market: BRIC National Revenue Forecasts ($bn), CAGR (%), AGR (%), 2017-2028
  • Table 6.15: BRIC Markets: API Revenues ($bn) and Market Shares (%), 2017
  • Table 6.16: Chinese Contract Biological drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2017-2028
  • Table 6.17: India Contract Biological drug API Manufacturing Revenue Forecast ($bn), GAGR (%), AGR (%) 2017-2028
  • Table 6.18: Russia Contract Biological drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2017-2028
  • Table 6.19: Brazilian Contract Biological drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2017-2028
  • Table 6.20: South Korean Contract Biological drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2017-2028
  • Table 6.21: Selected Biotechs and Pharmaceutical Companies with Manufacturing Facilities in Tuas, 2015
  • Table 6.22: Singaporean Contract Biological drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2017-2028
  • Table 7.1: Leading Biological drug API CMOs: Mammalian Cell Culture and Microbial Fermentation Manufacturing Scale, 2017
  • Table 7.2: Selected Other Biological drug API CMOs: Mammalian Cell Culture and Microbial Fermentation Manufacturing Scale, 2017
  • Table 7.3: Boehringer Ingelheim BioXcellence: Manufacturing Capacity, 2017
  • Table 7.4: Boehringer Ingelheim BioXcellence: Revenue ($bn), 2014-2016
  • Table 7.5: Celltrion: Revenue ($bn), CAGR (%), AGR (%), 2015-2017
  • Table 7.6: Lonza: Pharmaceutical Contract Manufacturing Revenue ($bn), CAGR (%), AGR (%), 2013-2014
  • Table 7.7: Sandoz Biosimilar Pipelines: Selected Biosimilars, 2017
  • Table 8.1: Contract Biological drug API Manufacturing Market: Strengths and Weaknesses, 2017
  • Table 8.2: Contract Biological drug API Manufacturing Market: Opportunities and Threats, 2017-2028
  • Table 8.3: Biological drug API Manufacturing Services Market: STEP Analysis, 2017
  • Table 8.4: Selected EU-Approved Biosimilars: Manufacturers and Companies, 2017
  • Table 8.5: Approved Next-Generation Antibody Therapies, 2017
  • Table 9.1: Contract Biological drug API Manufacturing Market: Revenue Forecasts ($bn) by Sector, 2018, 2020, 2022, 2024, 2026 and 2028
  • Table 9.2: Contract Biological drug API Manufacturing Market: Revenue Forecasts ($bn) by Region, 2018, 2020, 2022, 2024, 2026 and 2028

List of Figures

  • Figure 1.1: Biological Drug API Manufacturing Services Submarkets 2017
  • Figure 2.1: Steps for Biological Drug Manufacturing, 2017
  • Figure 2.2: Contract API Manufacturing: Market Shares by Sector (%), 2017
  • Figure 2.3: Future Trends in the Biological drug API Manufacturing Market, 2017-2028
  • Figure 3.1: Contract Biological drug API Manufacturing Services Market: Revenue Forecast ($bn), AGR (%), 2017-2028
  • Figure 3.2: Contract Biological drug API Manufacturing: Market Drivers, 2017-2028
  • Figure 3.3: Contract Biological drug API Manufacturing: Market Restraints, 2017-2028
  • Figure 4.1: Contract Biological drug API Manufacturing: Market Shares (%) by Sector, 2017
  • Figure 4.2: Mammalian Cell Culture Submarket Forecast, Revenue ($bn), AGR (%), 2017-2028
  • Figure 4.3: Mammalian Cell Culture Submarket: Drivers and Restraints, 2017-2028
  • Figure 4.4: Microbial Fermentation Submarket Forecast($bn), AGR (%), 2017-2028
  • Figure 4.5: Microbial Fermentation Submarket: Drivers and Restraints, 2017
  • Figure 4.6: Forecast for Other Expression Systems Submarket Forecast ($bn), AGR (%), CAGR (%), 2017-2028
  • Figure 5.1: Leading Contract API Biological Drug by Sector, 2017
  • Figure 5.2: Monoclonal Antibody Market: Contract API Revenues Forecast ($bn), AGR (%), 2017-2028
  • Figure 5.3: Vaccines Market: Contract API Revenues Forecast ($bn), AGR (%) 2017-2028
  • Figure 5.4: Comparison between biomanufacturing platforms for Vaccine production: VLP
  • Figure 5.5: Insulin Therapies Market: Contract API Revenues Forecast ($bn), AGR (%), 2017-2028
  • Figure 5.6: Interferon Therapies Market: Contract API Revenues Forecast ($bn), AGR (%), 2017-2028
  • Figure 5.7: Growth Hormones Market: Contract API Revenues Forecast ($bn), AGR (%), 2017-2028
  • Figure 6.1: Contract Biological drug API Manufacturing: Market Shares by Region (%), 2017
  • Figure 6.2: Contract Biological drug API Manufacturing: Market Shares by Region (%) 2020
  • Figure 6.3: Contract Biological drug API Manufacturing: Market Shares by Region (%) 2028
  • Figure 6.4: EU and Switzerland Contract Biological drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2017-2028
  • Figure 6.5: EU Contract Biological drug API Manufacturing: Leading National Revenue Shares (%), 2017
  • Figure 6.6: Germany Contract Biological drug API Manufacturing Revenue Forecast ($bn), 2017-2028
  • Figure 6.7: UK Contract Biological drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2017-2028
  • Figure 6.8: France Contract Biological drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2017-2028
  • Figure 6.9: Switzerland Contract Biological drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2017-2028
  • Figure 6.10: Spanish Contract Biological drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2017-2028
  • Figure 6.11: Italian Contract Biological drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2017-2028
  • Figure 6.12: US Contract Biological drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2017-2028
  • Figure 6.13: Japanese Contract Biological drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2017-2028
  • Figure 6.14: Contract Biological drug API Manufacturing Market: BRIC National Revenue Forecasts ($bn), AGR (%), 2017 -2028
  • Figure 6.15: Biologics Market: BRIC Revenue Shares (%), 2017
  • Figure 6.16: Chinese Contract Biological drug API Manufacturing Revenue Forecast ($bn), CAGR (%), AGR (%), 2017-2028
  • Figure 6.17: India Contract Biological drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2017-2028
  • Figure 6.18: Russia Contract Biological drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2017-2028
  • Figure 6.19: Brazilian Contract Biological drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2017-2028
  • Figure 6.20: South Korean Contract Biological drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2017-2028
  • Figure 6.21: Singaporean Contract Biological drug API Manufacturing Revenue Forecast ($bn), AGR (%), 2017-2028
  • Figure 7.1: Leading Biological drug API CMOs: Mammalian Cell Culture Manufacturing Scale, 2017
  • Figure 7.2: Leading Biological drug API CMOs: Microbial Fermentation Manufacturing Scale, 2017
  • Figure 7.3: Boehringer Ingelheim BioXcellence: Revenue ($bn), 2014-2016
  • Figure 7.4: Celltrion: Revenue ($bn), 2015-2017
  • Figure 7.5: DSP: Pharmaceutical Biotech Manufacturing Revenue ($bn), 2011-2015
  • Figure 7.6: Lonza: Pharmaceutical Contract Manufacturing Revenue ($bn), 2013-2017
  • Figure 9.1: Contract Biological drug API Manufacturing Market: Revenue Forecasts ($bn) by Sector, 2017 - 2028
  • Figure 9.2: Contract Biological drug API Manufacturing Market: Revenue Forecasts ($bn) by Region, 2018, 2020, 2022, 2024, 2026 and 2028

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
  • Ferring Pharmaceuticals
  • Filnox Biotech
  • Fresenius
  • Fujifilm Diosynth Biotechnologies
  • Gallus BioPharmaceuticals,
  • GE Healthcare
  • Genentech
  • GeneScience Pharmaceuticals Co., Ltd.
  • Genexine and Handok
  • Genmab
  • Genzyme
  • Gilead Sciences, Inc.
  • GSK
  • Hanmi Pharmaceutical Co.
  • Hexal
  • Index Ventures
  • Infarco
  • Infinity Pharmaceuticals
  • Inno Biologics
  • Innovation Network Corporation of Japan (INCJ),
  • 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
  • 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
  • WuXi Biologics,
  • WuXi PharmaTech
  • Zhangjiang Biotech
  • Zhejiang Jiang Yuan Tang Biotechnology
  • ZJ Base

List of Organisations Mentioned in the Report:

  • FDA
  • Germany's Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen (IQWiG)
  • Japanese Ministry of Health, Labour and Welfare
  • NHS
  • NICE
  • WHO
目次
Product Code: PHA0322

The biological drug API manufacturing market is estimated to grow at a CAGR of 9.0% in the first half of the forecast period. In 2017, Mammalian cell culture systems submarket represents the largest submarket within the biological drug API manufacturing industry.

How this 209-page report delivers:

Provides qualitative and quantitative analysis of the leading submarkets the period 2018-2028. Visiongain forecasts revenues and their growth for these submarkets:

  • Mammalian cell culture
  • Microbial fermentation
  • Other expression platforms

Provides qualitative and quantitative analysis of the leading contract API biological drug applications for the period 2018-2028. Visiongain forecasts contract API drug revenues to 2028 for these individual segments:

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

Find forecasts of the leading national markets from 2018 to 2028:

  • The EU, including the five leading markets (UK, Germany, France, Italy and Spain).
  • The US
  • Japan
  • Switzerland
  • Emerging markets such as the BRIC (Brazil, Russia, India, and China) countries, South Korea and Singapore.

Profiles leading global and national companies that offer biotech API manufacturing services to the pharmaceutical industry. For each company, current services offered, recent developments and outlooks are discussed. Leading CMOs profiled in this chapter are:

  • Boehringer Ingelheim BioXcellence
  • Celltrion
  • DSM Biologics
  • Lonza
  • Samsung BioLogics
  • Cytovance Biologics
  • Fujifilm Diosynth Biotechnologies
  • Operations of leading biopharma companies, such as AbbVie, GSK and Novartis.

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

Discover the regulatory outlook for biotech API manufacturing in leading regional and national markets in 2017, as well as predicted developments for the period to 2028.

Identify important drug development and technology trends that will affect CMOs, their clients and other market participants from 2017. The report also contains SWOT and STEP analysis of the industry and market.

Find profiles for leading CMOs offering biological drug API manufacturing services to pharmaceutical companies.

103 charts unavailable elsewhere.

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 Predictions 2018-2028: Mammalian Cell Cultures, Microbial Fermentations, Other Expression Systems, Human Growth Hormones, Insulin, Interferons, Monoclonal Antibodies, Vaccines’.

Visiongain is a trading partner with the US Federal Government.

Table of Contents

1. Report Overview

  • 1.1. Contract Biological Drug API Manufacturing: World Market Review 2017
  • 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. Some 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 2017-2028

  • 3.1. The Contract Biological drug API Manufacturing Services Market Performance, 2017
    • 3.1.1. Contract Biological drug API Manufacturing Services: Forecast 2017-2028
  • 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 Submarkets: World Market Outlook and Forecasts 2017-2028

  • 4.1. Submarkets for the Biological drug API Manufacturing Services Industry
    • 4.1.1. The Mammalian Cell Culture Submarket
    • 4.1.2. The Mammalian Cell Culture Submarket Forecast 2017-2028
    • 4.1.3. ADCs and Next-Generation Antibodies Will Drive Growth 2017-2028
    • 4.1.4. The Microbial Fermentation Submarket
    • 4.1.5. The Microbial Fermentation Submarket Forecast 2017-2028
      • 4.1.5.1. Increase in Demand for Insulin Will Drive Growth 2017-2028
    • 4.1.6. Other APIs Expression Systems Are Still in Development
      • 4.1.6.1. Plant-Made Pharmaceuticals
      • 4.1.6.2. Yeast Cell Expression Systems
      • 4.1.6.3. Insect Cell Expression Systems
      • 4.1.6.4. Other Expression Systems Submarket Forecast 2017-2028
  • 4.2. Chapter Summary: Positive Growth for the Market

5. Biological drug API Manufacturing: Outlook for Leading Biological Drug Contract API Sectors: 2017-2028

  • 5.1. Antibody Therapies: An Introduction to the Largest Contract API Biological Drug Sector
    • 5.1.1. Contract API Monoclonal Antibody Manufacturing Forecast 2017-2028
    • 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 2017-2028
    • 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 2017-2028
    • 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 2017 to 2028
  • 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 2017-2028
    • 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 2017 to 2028
    • 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 2017-2028

6. Leading National Markets for Contract Biological drug API Manufacturing Services 2017-2028

  • 6.1. Regional Breakdown of the World Biological drug API Manufacturing Services Market
    • 6.1.1. US and EU Dominate Growth for Leading National Submarkets 2017-2028
    • 6.1.2. National Revenue Shares by 2028: Emerging Market Growth
  • 6.2. Contract Biological drug API Manufacturing in EU Market 2017-2028
    • 6.2.1. Strong Growth for the EU Revenue Forecasts 2017-2028
    • 6.2.2. Forecasts for Switzerland and Leading EU National Revenues 2017-2028
      • 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 2017-2028
    • 6.2.3. US: A Market Leader in Biological drug API Manufacturing
    • 6.2.4. Japan: A Less Mature Contract Manufacturing Market
    • 6.2.5. BRIC Market: Outlook and Forecasts for Emerging Markets 2017 - 2028
      • 6.2.5.1. Emerging Nations May Develop a Presence in the Biologics Market
      • 6.2.5.2. Increased Demand for Biosimilars and Biological Drugs 2017-2028
      • 6.2.5.3. China is Poised for Growth: Forecast for 2017-2028
      • 6.2.5.4. India Offers a Lower-Cost Advantage for Biological drug API Manufacturing Services: Forecast 2017-2028
      • 6.2.5.5. Brazilian and Russian Governments Promoting Domestic Biotech Development
      • 6.2.5.6. Russian Biological drug API Manufacturing Services Forecast: 2017-2028
      • 6.2.5.7. Brazilian Biological drug API Manufacturing Services Forecast: 2017-2028
    • 6.2.6. South Korea: Market Forecast, 2017-2028
      • 6.2.6.1. Leading CMOs Celltrion and Samsung BioLogics Drive the Market
    • 6.2.7. Singapore: Market Forecast, 2017-2028
  • 6.3. Summary of Chapter: Outlook for Leading National Submarkets 2017-2028

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

  • 7.1. Four Companies Led the Market in 2017
  • 7.2. Leading Companies by Capacity
    • 7.2.1. Small-Scale Biopharmaceutical Manufacturing is a Common Trend
    • 7.2.2. Barriers to Market Entry 2017-2028
      • 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: Likely Target for Mergers and Acquisitions?
  • 7.6. DSM Biologics: Strategically Increasing Capacity
  • 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 2017
    • 7.8.1. Samsung BioLogics: Focusing on Biosimilars
    • 7.8.2. Cytovance Biologics: Plans to Expand
    • 7.8.3. Fujifilm Diosynth Biotechnologies
      • 7.8.3.1. Facility and Service Expansion for the Future
  • 7.9. Leading Biopharma Companies Operate CMO Divisions
    • 7.9.1. AbbVie Contract Manufacturing: Strength through Acquisition
    • 7.9.2. GSK Biopharmaceuticals
    • 7.9.3. Sandoz: Expertise in Biologics and Biosimilars
    • 7.9.4. Rentschler Biotechnologie: Recent Expansions
  • 7.10. Teva: A Future Player in the Biologics Market
  • 7.11. Catalent Offers a New Platform through Partnership
  • 7.12. Chapter Summary: Leading Companies 2017-2028

8. Biological drug API Manufacturing Services Market Industry Trends 2017-2028: Qualitative Analysis

  • 8.1. SWOT Analysis: Strengths and Weaknesses of the Biological drug API Manufacturing Services Market 2017
    • 8.1.1. Biopharmaceutical Demand for Outsourcing is increasing
    • 8.1.2. A Fragmented Market with a Costly and Difficult Manufacturing Process
  • 8.2. Opportunities for the Biological drug API Manufacturing Services Market 2017-2028
  • 8.3. Threats for the Biological drug API Manufacturing Services Market 2017-2028
  • 8.4. STEP Analysis of the Biological drug API Manufacturing Services Market
    • 8.4.1. Social Factors: Drug Pricing Pressures to Meet Demand for an Increasing Ageing Population
    • 8.4.2. Technological Factors: Advances Will Drive Growth
      • 8.4.2.1. Single-Use Technology: A Vital Trend for the Future
    • 8.4.3. Economic Factors: The High Cost of Manufacturing Will Lead to Outsourcing
    • 8.4.4. Political Factors: Regulatory Requirements Need to Be Met
  • 8.5. Trends in Biological Drug Development 2017-2028
    • 8.5.1. Biosimilars Will Be an Important Opportunity for CMOs
    • 8.5.2. CMOs are investing in Next-Generation Antibody Development
    • 8.5.3. Orphan Drugs and Personalised Medicine: Trend for Smaller Batches
    • 8.5.4. Outlook for Single-Use Technologies in Biological drug API Manufacturing 2017-2028
    • 8.5.5. Outsourcing Trends for Biological drug API Manufacturing 2017-2028
      • 8.5.5.1. Biopharma Companies Continue to Invest in In-House Facilities
      • 8.5.5.2. Off-shoring Biological drug API Manufacturing to Emerging Markets: Not a Trend for this Decade?
      • 8.5.5.3. Overcapacity is a Risk for the Biotech CMO Industry
      • 8.5.5.4. Future Trends: Strategic Partnering
      • 8.5.5.5. Alternative Expression Methods
  • 8.6. Regulations and Effects on the Biological drug API Manufacturing Services Industry
    • 8.6.1. Effect on the Emerging Biological drug API Manufacturing Services Market 2017-2028
    • 8.6.2. Regulations in Other Countries in the Biological drug API Market
  • 8.7. 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 2017-2028
    • 9.3.1. The Future of the Biological drug API Manufacturing Services Marketplace
  • Appendices
  • Glossary
  • Some Associated Reports
  • Visiongain Report Sales Order Form
  • About Visiongain
  • Visiongain Report Evaluation Form
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