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バイオシミラー (バイオ後続品) の世界市場 2018年〜2028年:MAb・融合タンパク質・インスリン・エリスロポエチン・G-CSF・インターフェロン・成長ホルモン・受胎能ホルモン

Global Biosimilars and Follow-On Biologics Market 2018-2028: Monoclonal Antibodies (mAbs), Fusion Proteins, Insulin, Erythropoietins, Granulocyte Colony-Stimulating Factor (G-CSF), Interferons, Growth Hormones, Fertility Hormones

発行 Visiongain Ltd 商品コード 204743
出版日 ページ情報 英文 335 Pages
納期: 即日から翌営業日
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本日の銀行送金レート: 1GBP=149.17円で換算しております。

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バイオシミラー (バイオ後続品) の世界市場 2018年〜2028年:MAb・融合タンパク質・インスリン・エリスロポエチン・G-CSF・インターフェロン・成長ホルモン・受胎能ホルモン Global Biosimilars and Follow-On Biologics Market 2018-2028: Monoclonal Antibodies (mAbs), Fusion Proteins, Insulin, Erythropoietins, Granulocyte Colony-Stimulating Factor (G-CSF), Interferons, Growth Hormones, Fertility Hormones
出版日: 2018年06月01日 ページ情報: 英文 335 Pages
概要

世界のバイオシミラー (バイオ後続品) 市場は、2017年に77億米ドルとなりました。同市場では、バイオシミラーモノクローナル抗体が支配的な地位を占めており、そのシェアは2022年までに24%となることが予測されています。

当レポートでは、世界のバイオシミラー (バイオ後続品) の市場を取り上げ、バイオシミラーの概要、市場の発展の経緯、市場成長の推進因子・阻害因子の分析、先進国市場および新興国市場における動向、主要薬剤区分別の動向分析および収益予測、SWOT分析、将来の展望などをまとめています。

第1章 レポート概要

第2章 イントロダクション:バイオシミラーとバイオシミラー製剤の開発

  • 生物学的製剤とは?
  • バイオシミラーとは?
  • バイオシミラーの開発の経緯
  • 同質の生物学的製剤とバイオシミラーの違い
  • バイオシミラー市場の主な区分

第3章 世界のバイオシミラー市場の予測

  • 世界のバイオシミラー市場
  • 生物学的製剤市場全体に占めるバイオシミラーのシェア
  • 世界のバイオシミラー市場の予測
  • バイオシミラー市場の成長推進因子
  • バイオシミラー市場の売上成長を阻む要因
  • 世界のバイオシミラー市場における成長推進因子・阻害因子のサマリー
  • 世界のバイオシミラー市場の予測:2次区分別

第4章 主要先進市場におけるバイオシミラーの展望

  • 主要国のバイオシミラー2次市場
  • 国別の2次市場予測
  • 世界市場の地域構成の変化の見通し
  • 米国のバイオシミラー市場展望
  • EUのバイオシミラー市場:歴史・現況

第5章 新興市場におけるバイオシミラーの展望

  • 中国・インドはバイオシミラー収益をリード
  • 主要な新興市場の予測
  • 中国のバイオシミラー市場の展望
  • インドのバイオシミラー市場の展望
  • 韓国の確立されたバイオシミラーガイドライン
  • ロシアのバイオシミラー市場の展望・予測
  • ブラジルのバイオシミラー関連法規制

第6章 モノクローナル抗体 (MAb) のバイオシミラー:区分別の予測とパイプライン

  • 生物学的製剤市場全体におけるMAbの位置付け
  • MAb:数10億ドルの収益をもたらす最大の生物学的製剤市場区分
  • MAbバイオシミラー市場・2次市場の予測
  • MAbバイオシミラー市場の成長推進因子
  • MAbバイオシミラー市場の成長阻害因子
  • バイオシミラー開発の主な標的の予測
  • リツキシマブバイオシミラー
  • インフリキシマブバイオシミラー
  • トラスツズマブバイオシミラー
  • アダリムマブバイオシミラー
  • ベバシズマブバイオシミラー

第7章 融合タンパク質のバイオシミラー:区分別の予測とパイプライン

  • 科学的背景
  • 融合タンパク質の区分
  • 生物学的製剤市場全体における融合タンパク質の位置付け
  • 融合タンパク質バイオシミラー市場の予測
  • エタネルセプトバイオシミラーの予測
  • EYLEA およびアフリベルセプトバイオシミラー
  • オレンシアおよびアバタセプトバイオシミラー

第8章 インスリンバイオシミラー:区分別の予測

  • 生物学的製剤市場全体におけるインスリンの位置付け
  • 2030年までに3000万人が糖尿病と診断される見込み
  • 承認済みインスリンバイオシミラー
  • Abasaglar・Basaglar・インスリングラルギンBS:先進市場で初めて承認されるインスリンバイオシミラー
  • EMA:インスリンバイオシミラーガイドラインの最終決定を発表
  • Basaglar:米国で遅れ
  • インスリンバイオシミラー市場・2次市場の予測
  • ヒトインスリンバイオシミラー部門の予測
  • インスリンアナログバイオシミラー部門の予測
  • インスリングラルギンバイオシミラー部門の予測
  • インスリンリスプロバイオシミラー

第9章 エリスロポエチンバイオシミラー:区分別の予測

  • 3種の製品が生物学的EPO薬市場を主導
  • エリスロポエチン刺激剤の安全性上の懸念
  • 経口治療との競合
  • 慢性腎臓病 (CKD) 患者の貧血の治療:EPO薬の主な用途
  • 欧州でのエポエチンバイオシミラーの承認
  • 欧州市場に向けたエポエチンアルファのパイプライン
  • 欧州でのバイオシミラーエポエチンの導入動向
  • 米国に向けたエポエチンアルファのパイプライン
  • 日本でのエポエチンバイオシミラー
  • 韓国でのエポエチンバイオシミラー
  • インド・中国でのエポエチンバイオシミラー
  • 第2世代EPOバイオシミラー
  • ミルセラバイオシミラーの臨床開発:行われていない
  • バイオシミラーEPO市場の予測

第10章 G-CSFバイオシミラー:区分別の予測

  • Amgen:生物学的G-CSFのブランド薬市場をリード
  • Teva:長時間作用性ペグフィルグラスチムを市場投入
  • 世界で承認されている主なフィルグラスチムバイオシミラー
  • バイオシミラーG-CSF市場の予測

第11章 インターフェロンバイオシミラー:区分別の予測

  • インターフェロン:長年の主要な抗ウイルス剤・多発性硬化症治療薬
  • 主なインターフェロンブランド薬
  • 多発性硬化症市場での競合:インターフェロンベータ治療薬との競合
  • インターフェロンアルファ治療薬:すべての経口治療薬と競合に
  • 先進市場で承認されたバイオシミラーはない
  • バイオシミラーインターフェロン市場の予測
  • バイオシミラーインターフェロンアルファ
  • バイオシミラーインターフェロンベータ

第12章 組換えホルモンバイオシミラー:区分別の予測

  • ヒト成長ホルモンの概歴
  • 生物学的成長ホルモン市場:Novo Nordisk・Pfizerが独占的立場
  • 成長ホルモンバイオシミラー
  • 世界で利用可能な複数のバイオシミラー
  • 成長ホルモンバイオシミラー市場の予測
  • 受胎能ホルモン

第13章 バイオシミラー:定性分析・産業動向

  • SWOT分析
  • 強み
  • 弱み
  • 機会
  • 脅威
  • 製品パイプライン

第14章 総論

  • 急成長が期待される潜在性の高い市場
  • モノクローナル抗体バイオシミラー:最速成長と期待される部門
  • 様々な要因が需要を刺激
  • バイオシミラーの開発と上市に残される課題
図表

List of Table

  • Table 2.1: First Approvals for Recombinant Protein Therapies, 1982-1993
  • Table 3.1: Top Ten Best-Selling Drugs of 2017 (in the Overall Pharmaceutical Market): Revenues ($bn), Market Shares (%)
  • Table 3.2: Global Biosimilars Market Forecast: Revenue ($bn), AGR (%),CAGR (%), 2016-2022
  • Table 3.3: Global Biosimilars Market Forecast: Revenue ($bn), AGR (%),CAGR (%), 2023-2028
  • Table 3.4: Patent Status for Leading Biologics within the Overall Biologics Market, 2018
  • Table 3.5: Biosimilars Market Forecast by Submarket (Insulin, EPO, G-CSF, Growth Hormones, mAbs): Revenue ($bn), AGR (%), CAGR (%), Market Shares (%), 2016-2022
  • Table 3.6: Biosimilars Market Forecast by Submarket (Interferons, Fusion Proteins, Fertility Hormones, Other Biosims): Revenue ($bn), AGR (%),CAGR (%), Market Shares (%), 2016-2022
  • Table 3.7: Biosimilars Market Forecast by Submarket (Insulin, EPO, G-CSF, Growth Hormones, mAbs): Revenue ($bn), AGR (%),CAGR (%), Market Shares(%), 2023-2028
  • Table 3.8: Biosimilars Market Forecast by Submarket (Interferons, Fusion Proteins, Fertility Hormones, Other Biosims): Revenue ($bn), AGR (%),CAGR (%), Market Shares (%), 2023-2028
  • Table 4.1: Global Biosimilars Market by Region: Revenues ($bn), Market Share (%), 2018
  • Table 4.2: Global Biosimilars Market Forecast Segmented by Nation (China, EU, India, US, South Korea, Japan): Revenue ($bn), AGR (%),CAGR (%),Market Share(%), 2016-2022
  • Table 4.3: Global Biosimilars Market Forecast Segmented by Nation (Russia, Brazil, Other): Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2016-2022
  • Table 4.4: Global Biosimilars Market Forecast Segmented by Nation (China, EU, India, US, South Korea, Japan): Revenue ($bn), AGR (%),CAGR (%),Market Share(%) 2023-2028
  • Table 4.5: Global Biosimilars Market Forecast Segmented by Nation (Russia, Brazil,Other): Revenue ($bn), AGR (%), CAGR (%), Market Share(%), 2023-2028
  • Table 4.6: U.S. Biosimilar Approvals To-Date, 2018 Table 4.7 US Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2016-2022
  • Table 4.8: US Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2023-2028
  • Table 4.9: European Biosimilar Approvals: Monoclonal Antibodies and Insulin
  • Table 4.1: European Biosimilar Approvals: G-CSF
  • Table 4.11: European Biosimilar Approvals: EPO
  • Table 4.12: European Biosimilar Approvals: Growth Hormones and Fertility Hormones
  • Table 4.13: European Biosimilars Market Segmented by Leading Nations: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2016-2022
  • Table 4.14: European Biosimilars Market Segmented by Leading Nations: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2023-2028
  • Table 4.15: German Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2016-2022
  • Table 4.16: German Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2023-2028
  • Table 4.17: French Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2016-2022
  • Table 4.18: French Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2023-2028
  • Table 4.19: UK Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2016-2022
  • Table 4.20: UK Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2023-2028
  • Table 4.21: Italian Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2016-2022
  • Table 4.22: Italian Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2023-2028
  • Table 4.23: Spanish Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2016-2022
  • Table 4.24: Spanish Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2023-2028
  • Table 4.25: Japanese Biosimilar Approvals To-Date, 2018
  • Table 4.26: Japanese Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2016-2022
  • Table 4.27: Japanese Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2023-2028
  • Table 5.1: Leading Emerging Biosimilar Markets: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2016-2022
  • Table 5.2: Leading Emerging Biosimilar Markets: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2023-2028
  • Table 5.3: Chinese Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2016-2022
  • Table 5.4: Chinese Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2023-2028
  • Table 5.5: Indian Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2016-2022
  • Table 5.6: Indian Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2023-2028
  • Table 5.7: Currently Approved Biosimilars in South Korea, 2016
  • Table 5.8: South Korean Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2016-2022
  • Table 5.9: South Korean Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2023-2028
  • Table 5.10: Russian Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2016-2022
  • Table 5.11: Russian Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2023-2028
  • Table 5.12: Brazilian Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2016-2022
  • Table 5.13: Brazilian Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2023-2028
  • Table 6.1: The Best-Selling mAbs of 2017: Revenue ($bn), 2017
  • Table 6.2: Biosimilar Monoclonal Antibodies Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2022
  • Table 6.3: Biosimilar Monoclonal Antibodies Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2023-2028
  • Table 6.4: Biosimilar Monoclonal Antibodies Market and Submarkets Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2022
  • Table 6.5: Biosimilar Monoclonal Antibodies Market and Submarkets Forecast: Revenue ($bn), AGR (%), CAGR (%), 2023-2028
  • Table 6.6: Patent Status of Five Leading mAbs, 2018
  • Table 6.7: Types of Next-Generation Antibody Therapy, 2018
  • Table 6.8: Past and Present GP2013 (Sandoz) Clinical Trials, 2018
  • Table 6.9: Ongoing BI 695500 (Boehringer Ingelheim) Clinical Trials, 2018
  • Table 6.10: Ongoing CT-P10 (Celltrion) Clinical Trials, 2018
  • Table 6.11: Past and Present PF-05280586 (Pfizer) Clinical Trials, 2018
  • Table 6.12: Biosimilar Rituximab Revenue Forecast: Revenue ($bn), AGR (%),CAGR (%), 2016-2022
  • Table 6.13: Biosimilar Rituximab Revenue Forecast: Revenue ($bn), AGR (%),CAGR (%), 2023-2028
  • Table 6.14: Biosimilar Infliximab Revenue Forecast: Revenue ($bn), AGR (%),CAGR (%), 2016-2022
  • Table 6.15: Biosimilar Infliximab Revenue Forecast: Revenue ($bn), AGR (%),CAGR (%), 2023-2028
  • Table 6.16: Ongoing PF-05280014 (Pfizer) Clinical Trials, 2018
  • Table 6.17: Biosimilar Trastuzumab Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2022
  • Table 6.18: Biosimilar Trastuzumab Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2023-2028
  • Table 6.19: Recent ABP 501 (Amgen and Allergan) Clinical Trials, 2018
  • Table 6.20: Ongoing BI 695501 (Boehringer Ingelheim) Clinical Trials, 2018
  • Table 6.21: Biosimilar Adalimumab Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2022
  • Table 6.22: Biosimilar Adalimumab Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2023-2028
  • Table 6.23: Recent BCD-021 (Biocad) Clinical Trials, 2018
  • Table 6.24: Biosimilar Bevacizumab Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2022
  • Table 6.25: Biosimilar Bevacizumab Revenue Forecast: Revenue ($bn), AGR (%),CAGR (%), 2023-2028
  • Table 7.1: Biosimilar Fusion Proteins Market Forecast: Revenue ($bn), AGR (%),CAGR (%), 2016-2022
  • Table 7.2: Biosimilar Fusion Proteins Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2023-2028
  • Table 7.3: Amgen's US Patents and Expiry Dates for Enbrel
  • Table 7.4: Ongoing CHS-0214 (Coherus Biosciences and Baxter) Clinical Trials, 2018
  • Table 7.5: Biosimilar Etanercept Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2022
  • Table 7.6: Biosimilar Etanercept Market Forecast: Revenue ($bn), AGR (%),CAGR (%), 2023-2028
  • Table 8.1: Diabetes Prevalence in Leading National Markets, 2012
  • Table 8.2: Selected Insulin Biosimilars which have been Approved and Launched
  • Table 8.3: Biosimilar Insulin Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2022
  • Table 8.4: Biosimilar Insulin Market Forecast: Revenue ($bn), AGR (%),CAGR (%), 2023-2028
  • Table 8.5: Biosimilar Insulin Submarket Forecast: Revenue ($bn), AGR (%),CAGR (%), 2016-2022
  • Table 8.6: Biosimilar Insulin Submarket Forecast: Revenue ($bn), AGR (%),CAGR (%), 2023-2028
  • Table 8.7: Biosimilar Human Insulin Submarket Forecast: Revenue ($bn), AGR (%),CAGR (%), 2016-2022
  • Table 8.8: Biosimilar Human Insulin Submarket Forecast: Revenue ($bn), AGR (%),CAGR (%), 2023-2028
  • Table 8.9: Approved Insulin Analogues Marketed Worldwide, 2018
  • Table 8.10: Other Biosimilar Insulin Analogues Submarket Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2022
  • Table 8.11: Other Biosimilar Insulin Analogues Submarket Forecast: Revenue ($bn), AGR (%),CAGR (%), 2023-2028
  • Table 8.12: MK-1293 (Merck / Samsung Bioepis) Recent Clinical Trials, 2018
  • Table 8.13: Insulin Glargine Biosimilar (Mylan and Biocon) Ongoing Clinical Trials, 2018
  • Table 8.14: Biosimilar Insulin Glargine Revenue Forecast: Revenue ($bn), AGR (%),CAGR (%), 2016-2022
  • Table 8.15: Biosimilar Insulin Glargine Revenue Forecast: Revenue ($bn), AGR (%),CAGR (%), 2023-2028
  • Table 8.16: Biosimilar Insulin Lispro Revenue Forecast: Revenue ($bn), AGR (%),CAGR (%), 2016-2022
  • Table 8.17: Biosimilar Insulin Lispro Revenue Forecast: Revenue ($bn), AGR (%),CAGR (%), 2023-2028
  • Table 9.1: Ongoing ASP1517 (Astellas Pharma) Clinical Trials, 2018
  • Table 9.2: Binocrit / HX575 (Novartis) Clinical Trials, 2018
  • Table 9.3: Selected EPO Biosimilars Approved in India
  • Table 9.4: Biosimilar EPO Market Forecast: Revenue ($bn), AGR (%), CAGR (%),2016-2022
  • Table 9.5: Biosimilar EPO Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2023-2028
  • Table 10.1: Selected Filgrastim Biosimilars Approved Worldwide
  • Table 10.2: Biosimilar G-CSF Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2022
  • Table 10.3: Biosimilar G-CSF Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2023-2028
  • Table 11.1: Types of Interferon Used Therapeutically, 2018
  • Table 11.2: Approved Branded Interferon Therapies, 2018
  • Table 11.3: Biosimilar Interferons Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2022
  • Table 11.4: Biosimilar Interferons Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2023-2028
  • Table 11.5: Selected Interferon Alfa Biosimilars Approved Worldwide, 2018
  • Table 11.6: Chronic Hepatitis B and C: Global Prevalence by Region, 2014
  • Table 11.7: Biosimilar Interferon Alfa Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2022
  • Table 11.8: Biosimilar Interferon Alfa Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2023-2028
  • Table 11.9: Selected Interferon Beta Biosimilars Approved Worldwide
  • Table 11.10: Biosimilar Interferon Beta Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2022
  • Table 11.11: Biosimilar Interferon Beta Market Forecast: Revenue ($bn), AGR (%),CAGR (%), 2023-2028
  • Table 12.1: Biosimilar Growth Hormone Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2022
  • Table 12.2: Biosimilar Growth Hormone Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2023-2028
  • Table 12.3: Recent Bemfola / Afolia (Finox Biotech) Clinical Trials, 2018
  • Table 12.4: Biosimilar Fertility Hormone Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2016-2022
  • Table 12.5: Biosimilar Fertility Hormone Market Forecast: Revenue ($bn),AGR (%), CAGR (%), 2023-2028
  • Table 13.1: Expected Biologic Patent Expiries, 2016-2029
  • Table 13.2: Typical Models of Collaboration for Biosimilar Development
  • Table 13.3: Biosimilars product pipeline
  • Table 14.1: Biosimilars and Follow-On Biologics Market: Revenue ($bn) and Market Share (%) by Sector, 2018, 2022 and 2028
  • Table 14.2: Biosimilars and Follow-On Biologics Market: Revenue ($bn) and Market Share (%) by Region, 2018, 2022 and 2028

List of Figure

  • Figure 1.1: Main Segments and Sub-Segments of the Biosimilars Market, 2018
  • Figure 3.1: Biosimilars Market as Share of the Overall Biologics Market: Revenue ($bn), Market Share (%), 2017
  • Figure 3.2: Global Biosimilars Market Forecast: Revenue ($bn), 2016-2028
  • Figure 3.3: Drivers and Restraints for the Biosimilars Market, 2018
  • Figure 3.4: Global Biosimilars Market Forecasts by Submarket: Revenue ($bn), 2016-2028
  • Figure 3.5: Composition of the Biosimilars Market in 2018: Market Shares (%)
  • Figure 3.6: Composition of the Biosimilars Market in 2022: Market Shares (%)
  • Figure 3.7: Composition of the Biosimilars Market in 2028: Market Shares (%)
  • Figure 4.1: Regional Composition of the Biosimilars Market in 2018: Market Shares (%)
  • Figure 4.2: Global Biosimilars Market Forecast Segmented by Region: Revenue ($bn), 2016-2028
  • Figure 4.3: The Market Shares (%) for the Major Regional Markets 2016-2028
  • Figure 4.4: Regional Composition of the Biosimilars Market in 2022: Market Shares (%)
  • Figure 4.5: Regional Composition of the Biosimilars Market in 2028: Market Shares (%)
  • Figure 4.6: US Biosimilars Market Forecast: Revenue ($bn), 2016-2028
  • Figure 4.7: European Biosimilars Market Breakdown: Revenue ($bn), 2018
  • Figure 4.8: European Biosimilars Market Breakdown: Revenue ($bn), 2022
  • Figure 4.9: European Biosimilars Market Breakdown: Revenue ($bn), 2028
  • Figure 4.10: European Biosimilars Market Segmented by Leading Nations: Revenue ($bn), 2016-2028
  • Figure 4.11: German Biosimilars Market: Revenue ($bn), 2016-2028
  • Figure 4.12: French Biosimilars Market: Revenue ($bn), 2016-2028
  • Figure 4.13: UK Biosimilars Market: Revenue ($bn), 2016-2028
  • Figure 4.14: Italian Biosimilars Market: Revenue ($bn), 2016-2028
  • Figure 4.15: Spanish Biosimilars Market: Revenue ($bn), 2016-2028
  • Figure 4.16: Japanese Biosimilars Market: Revenue ($bn), 2016-2028
  • Figure 5.1: Leading Emerging Nations Biosimilar Market Shares: Revenues ($bn), 2018
  • Figure 5.2: Leading Emerging Nations Biosimilar Market Shares: Revenues ($bn), 2022
  • Figure 5.3: Leading Emerging Nations Biosimilar Market Shares: Revenues ($bn), 2028
  • Figure 5.4: Leading Emerging Nations Biosimilar Market Shares: Revenues ($bn), 2016-2028
  • Figure 5.5: Chinese Biosimilars Market: Revenue ($bn), 2016-2028
  • Figure 5.6: Indian Biosimilars Market: Revenue ($bn), 2016-2028
  • Figure 5.7: South Korean Biosimilars Market: Revenue ($bn),2016-2028
  • Figure 5.8: Russian Biosimilars Market: Revenue ($bn), 2016-2028
  • Figure 5.9: Brazilian Biosimilars Market: Revenue ($bn), 2016-2028
  • Figure 6.1: Monoclonal Antibodies as a Percentage of the Total Biologics Market: Revenue ($bn), Market Share (%), 2016
  • Figure 6.2: The Best-Selling mAbs of 2017 as a Percentage of the Total Biologics Market: Revenue ($bn), Market Share (%), 2017
  • Figure 6.3: Biosimilar Monoclonal Antibodies Market Forecast: Revenue ($bn), 2016-2028
  • Figure 6.4: Biosimilar Monoclonal Antibody Market Forecast, Split by Product: Revenue ($bn), 2016-2028
  • Figure 6.5: Biosimilar Rituximab Revenue Forecast: Revenue ($bn), 2016-2028
  • Figure 6.6: Biosimilar Infliximab Revenue Forecast: Revenue ($bn), 2016-2028
  • Figure 6.7: Biosimilar Trastuzumab Revenue Forecast: Revenue ($bn), 2016-2028
  • Figure 6.8: Biosimilar Adalimumab Revenue Forecast: Revenue ($bn),2016-2028
  • Figure 6.9: Biosimilar Bevacizumab Revenue Forecast: Revenue ($bn), 2016-2028
  • Figure 7.1: Fusion Proteins as a Percentage of the Total Biologics Market: Revenue ($m), Market Share (%), 2016
  • Figure 7.2: Biosimilar Fusion Proteins Market Forecast: Revenue ($bn), 2016-2028
  • Figure 7.3: Biosimilar Etanercept Market Forecast: Revenue ($bn), 2016-2028
  • Figure 8.1: Diabetes Prevalence in Leading National Markets, 2012
  • Figure 8.2: Biosimilar Insulin Market Forecast: Revenue ($bn), 2016-2028
  • Figure 8.3: Biosimilar Insulin Submarket Forecasts: Revenue ($bn), 2016-2028
  • Figure 8.4: Drivers and Restraints for the Biosimilar Insulin Market, 2018
  • Figure 8.5: Biosimilar Human Insulin Submarket Revenue Forecast: Revenue ($bn), 2016-2028
  • Figure 8.6: Other Biosimilar Insulin Analogues Submarket Forecast: Revenue ($bn), 2016-2028
  • Figure 8.7: Biosimilar Insulin Glargine Revenue Forecast: Revenue ($bn),2016-2028
  • Figure 8.8: Biosimilar Insulin Lispro Revenue Forecast: Revenue ($bn), 2016-2028
  • Figure 9.1: Biosimilar EPO Market Forecast: Revenue ($bn), 2016-2028
  • Figure 10.1: Biosimilar G-CSF Market Forecast: Revenue ($bn), 2016-2028
  • Figure 11.1: Biosimilar Interferons Market Forecast: Revenue ($bn), 2016-2028
  • Figure 11.2: Chronic Hepatitis B: Global Prevalence (%) by Region, 2014
  • Figure 11.3: Chronic Hepatitis C: Global Prevalence (%) by Region, 2014
  • Figure 11.4: Biosimilar Interferon Alfa Market Forecast: Revenue ($bn), 2016-2028
  • Figure 11.5: Biosimilar Interferon Beta Market Forecast: Revenue ($bn), 2016-2028
  • Figure 12.1: Biosimilar Growth Hormone Market Forecast: Revenue ($bn), 2016-2028
  • Figure 12.2: Biosimilar Fertility Hormone Market Forecast: Revenue ($bn), 2016-2028
  • Figure 13.1: Strengths and Weaknesses of the Biosimilars Market, 2016-2028
  • Figure 13.2: Opportunities and Threats for the Biosimilars Market, 2016-2028
  • Figure 13.3: Biosimilar Development Costs by Stage, 2018
  • Figure 13.4: Typical Biosimilar Development Timeline
  • Figure 14.1: Biosimilars and Follow-On Biologics Market: Revenue ($bn), by Sector, 2018, 2022 and 2028
  • Figure 14.2: Biosimilars and Follow-On Biologics Market: Revenue ($bn), by Region, 2018, 2022 and 2028

COMPANIES LISTED

  • Allergan
  • Allozyne
  • Alteogen
  • Alvogen
  • Amarey Novamedical
  • Amega Biotech
  • Amgen
  • Apotex
  • Astellas Pharma
  • AstraZeneca
  • Avesthagen
  • Baxter
  • Bayer
  • Beijing Four Rings
  • Beijing SL Pharmaceutical
  • Biocad
  • Bioceuticals
  • Biogen
  • BioGenomics
  • Biolab
  • Bionovis
  • BioPartners
  • Biosidus
  • Bioton
  • BioXpress Therapeutics
  • Boehringer Ingelheim
  • Bristol-Myers Squibb
  • Cambridge Antibody Technology
  • CCL Pharmaceuticals
  • CCM Duopharma
  • Celltrion
  • Centocor Ortho Biotech
  • Chong Kun Dang
  • Chugai
  • CinnaGen.
  • Coherus BioSciences
  • Compass Biotechnologies
  • Cristália
  • CT Arzneimittel
  • Cyplasin
  • Daiichi Sankyo
  • Dong-A Pharmaceutical
  • Dr. Reddy's Laboratories
  • Egis Pharmaceuticals
  • Eisai
  • Eli Lilly
  • Elpen Pharmaceutical
  • Emcure Pharmaceuticals
  • EMS
  • Epirus
  • Eurofarma
  • Express Scripts
  • FibroGen
  • Finox Biotech
  • Fuji Pharma
  • Gan & Lee
  • Genetech
  • Genexine
  • Gennova
  • GenSci
  • Genzyme
  • Geropharm
  • Gilead Sciences
  • GlaxoSmithKline
  • Hangzhou Jiuyuan Gene Engineering Co.
  • Hanmi Pharmaceutical
  • Hanwha Chemical
  • Haselmeier
  • Health Canada
  • Helius Biotech
  • Hexal
  • Hindustan Antibiotic
  • Hospira
  • Hualida Biotech
  • Hypermarcas
  • IGES Institute
  • Intas Biopharmaceuticals
  • inVentiv Health
  • JCR Pharmaceuticals
  • Johnson & Johnson
  • Kabi
  • Kemwell Biopharma
  • Kissea
  • Koçak Farma
  • Kwizda Pharma
  • Kyowa Hakko Kirin
  • Landsteiner Scientific
  • LG Life Sciences
  • Libbs
  • LKM SA
  • Lonza
  • Mabion
  • Marvel Life Sciences
  • MEDICE Arzneimittel Pütter
  • Merck (MSD)
  • Merck KGaA
  • Merck Serono
  • Minapharm
  • Mitsubishi Tanabe
  • Mochida Pharmaceutical
  • Momenta Pharmaceuticals
  • Mycenax Biotech
  • Mylan
  • Nichi-Iko
  • Nippion Kayaku
  • Novartis
  • Novo Nordisk
  • Nuron Biotech
  • Oncobiologics
  • Ortho Pharmaceutical
  • Orygen
  • PanGen Biotech
  • Pfenex
  • Pfizer
  • Pharmapark
  • Pharmstandard
  • PRA International
  • Pro Generika
  • PROBIOMED
  • Qilu Pharmaceutical
  • Quintiles
  • Ranbaxy Laboratories
  • RAND Corporation
  • Ratiopharm
  • Regeneron Pharmaceuticals
  • Reliance GeneMedix
  • Reliance Life Sciences (RLS)
  • Rentschler Biotechnologie
  • Roche
  • Samsung Bioepis
  • Samsung BioLogics
  • Sandoz
  • Sanofi
  • SciGen
  • Shandong Kexing Pharma
  • Shanghai Celgen Biopharmaceutical
  • Shanghai CP Guojian
  • Shanghai Fosun
  • Shantha Biotechnics
  • Shinogi
  • Sicor Biotech
  • Sothema Laboratories
  • Spectrum Pharmaceuticals
  • STADA Arzneimittel
  • Stragen Pharma
  • Strides Arcolab
  • Syngene International
  • Synthon Biopharmaceuticals
  • Takeda
  • Teva
  • Tianjin Hualida Biotechnology
  • Tonghua Dongbao
  • TSH Biopharm Corp
  • União Química
  • USV Biologics
  • Virchow Biotech
  • Wanbang Biopharmaceuticals
  • Wockhardt
  • Xiamen Amoytop Biotech
  • Zenotech
  • Zhejian Huahai Pharmaceutical
  • Zuventus
  • Zydus Biovation
  • Zydus Cadila

List of Organisations Mentioned in the Report:

  • Argentine Ministry of Health
  • Cardiovascular and Renal Drugs Advisory Committee
  • Cardiovascular Drugs Advisory Committee
  • Centers of Medicare and Medicaid Services (CMS)
  • Central Drugs Standard Control Organisation
  • Centre for Drug Evaluation (CDE)
  • China Food and Drug Administration
  • Comisión Federal para la Protección contra Riesgos Sanitarios
  • Committee for Medicinal Products for Human Use
  • European Generic Medicines Association (EGA)
  • European Medicines Agency (EMA)
  • Intellectual Property Appellate Board (IPAB)
  • Korea Food and Drug Administration
  • Mexican Supreme Court
  • Ministry for Health Labour and Welfare (MHLW)
  • National Health Service (NHS)
  • National Institute for Health and Care Excellence (NICE)
  • Norwegian Ministry of Health
  • Pan American Health Organization
  • Pharmaceuticals and Medical Devices Agency (PMDA)
  • Russian Ministry of Health
  • Scottish Medicines Consortium (SMC)
  • Stanford University
  • State Employees' Social Security and Social Services Institute (ISSSTE)
  • The Brazilian Ministry of Health
  • The Drug Regulatory Authority of Pakistan
  • The Ministry of Food and Drug Safety (MFDS)
  • The National Conference of State Legislatures (US)
  • The United Laboratories (TUL)
  • Therapeutic Goods Administration
  • Toronto University
  • UK Medicines and Healthcare Products Regulatory Agency (MHRA)
  • University of California, San Francisco
  • University of Tokyo
  • US Center for Disease Prevention and Control (CDC)
  • US Court of Appeals
  • US Food and Drug Administration (FDA)
  • US Patent and Trademark Office
  • World Health Organization (WHO)
目次
Product Code: PHA0315

The global biosimilars and follow-on biologics market is estimated to have reached $7.70bn in 2017 and expected to grow at a CAGR of 23.8% in the first half of the forecast period. The market is dominated by Biosimilar Monoclonal Antibodies, this submarket is estimated to hold 24% share of this market by 2022.

How this report will benefit you

Read on to discover how you can exploit the future business opportunities emerging in this sector.

In this brand new 335-page report you will receive 131 tables and 68 figures- all unavailable elsewhere.

The 335-page report provides clear detailed insight into the global biosimilars and follow-on biologics market. Discover the key drivers and challenges affecting the market.

By ordering and reading our brand-new report today you stay better informed and ready to act.

Report Scope

Global Biosimilars and Follow-on Biologics Market forecasts from 2018-2028

Along with revenue prediction for the overall world market for biosimilars, our investigation shows forecasts to 2028 for 8 individual therapeutic submarkets:

  • Monoclonal antibodies (mAbs)
  • Fusion proteins
  • Insulin
  • Erythropoietin (EPO)
  • Granulocyte colony-stimulating factor (G-CSF)
  • Interferons
  • Growth hormones
  • Fertility hormones

This report also shows revenue to 2028 for 12 individual submarkets within the above segments:

  • Rituximab, infliximab, trastuzumab, adalimumab and bevacizumab
  • Human insulin, insulin analogues, insulin glargine and insulin lispro
  • Interferon alfa and interferon beta
  • Etanercept

Our analyses show individual revenue forecasts to 2028 for 12 national markets:

  • US
  • Japan
  • Germany, France, UK, Italy and Spain
  • China, India, South Korea, Russia and Brazil

Our study provides a SWOT analysis of the biosimilars and follow-on biologics market.

Our study discusses pressures, opportunities and other events affecting the biosimilars industry and market, including these influences:

  • Strategies for developing biosimilars - needs, demand, challenges and opportunities
  • Guidelines from regulators (FDA, EMA and others)
  • Patent challenges and data exclusivity for biopharmaceuticals
  • Needs and opportunities in developing biosimilar mAbs, including rising incidence of cancers and increasing demand for lower-cost biologicals
  • Developments in technology and operations for biosimilar drug production.

Visiongain's study is intended for anyone requiring commercial analyses for the biosimilars and follow-on biologics market. You find data, trends and predictions.

Buy our report today Global Biosimilars and Follow-On Biologics Market 2018-2028: Monoclonal Antibodies (mAbs), Fusion Proteins, Insulin, Erythropoietins, Granulocyte Colony-Stimulating Factor (G-CSF), Interferons, Growth Hormones, Fertility Hormones.

Visiongain is a trading partner with the US Federal Government.

Table of Contents

1. Report Overview

  • 1.1. Biosimilars Overview
  • 1.2. Biosimilars Market Segmentation
  • 1.3. Why You Should Read this Report
  • 1.4. How this Report Delivers
  • 1.5. Main Questions Answered by this Report
  • 1.6. Who is this Report for?
  • 1.7. Research and Analysis Methods
  • 1.8. Frequently Asked Questions (FAQ)
  • 1.9. Some Associated Reports
  • 1.10. About Visiongain

2. An Introduction to Biosimilars and Biosimilar Drug Development

  • 2.1. What are Biologics?
    • 2.1.1. Biologics can be Very Effective but also Very Expensive
    • 2.1.2. Brief History of Biological Drug Development
    • 2.1.3. Why are Biologics the Most Lucrative Products in the Global Pharmaceutical Market?
  • 2.2. What are Biosimilars?
  • 2.3. Brief History of Biosimilars
  • 2.4. What are Interchangeable Biological Products and how do They Differ from Biosimilars?
    • 2.4.1. FDA Guidelines on Prescription of Interchangeables vs Biosimilars
    • 2.4.2. Where does the EMA Stand with Regard to Interchangeables?
    • 2.4.3. Where do the EU5 and other European Countries Stand with Regard to Automatic Substitution?
    • 2.4.4. Why Would Nations Oppose Automatic Substitution of Reference Biologics with Biosimilars?
  • 2.5. Main Segments of the Overall Biosimilars Market

3. The Global Biosimilars Market 2018-2028

  • 3.1. The Global Biosimilars Market
  • 3.2. Biosimilars as a Share of the Biologics Market, 2017
    • 3.2.1. Seven of the Top Ten Best-Selling Drugs are Biologics
    • 3.2.2. Outlook for the Overall Biologics Market
  • 3.3. Global Biosimilars Market Forecast, 2016-2028
  • 3.4. What will Drive Growth in the Biosimilars Market?
    • 3.4.1. Biosimilars Can Bring about Savings of Billions - $44bn for the US by 2024 and $33bn for Europe by 2020
    • 3.4.2. Over $67bn Worth of Biologic Patents due to Expire by 2020
    • 3.4.3. US Approves First Biosimilar - Zarxio. Will this Open the Floodgates? Interchangeability Can Also Drive Growth
    • 3.4.4. Other Developed and Emerging Markets Will also Provide Opportunities for Growth
    • 3.4.5. Competitive Landscape Emerging for Biosimilars
  • 3.5. What Factors Can Restrain Sales Growth in the Biosimilars Market?
    • 3.5.1. Complexity of Biologics Means that Biosimilar Development Faces Many Challenges
    • 3.5.2. Opposition from Originator Companies and Patent Issues
    • 3.5.3. Fragmentation in the Market as Many Companies Chase the Same Targets
    • 3.5.4. The Threat of Biobetters and Next-Generation Biologics
  • 3.6. Summary of the Drivers and Restraints for the Global Biosimilars Market
  • 3.7. Global Biosimilars Market Forecast by Submarket, 2016-2028
    • 3.7.1. Leading Segments in the Biosimilars Market
    • 3.7.2. How Will the Composition of the Market Change Over the Next Ten Years?

4. Outlook for Biosimilars in Leading Developed Markets, 2016-2028

  • 4.1. The Leading National Biosimilar Submarkets
  • 4.2. National Submarket Forecasts 2016-2028
  • 4.3. How will the Regional Composition of the Global Market Change from 2016-2028?
  • 4.4. US Biosimilars Market Outlook 2016-2028
    • 4.4.1. Status of the US Market in 2014-2018
    • 4.4.2. FDA Finalises Three New Guidelines on 351(k) Applications in April 2015
      • 4.4.2.1. The History of the US' Biosimilar Guidelines
    • 4.4.3. FDA Finally Releases Guidance on Biosimilar Naming
    • 4.4.4. Individual States Can Pass their Own Biosimilar Substitution Laws
    • 4.4.5. US Biosimilars Market Forecast 2016-2028
  • 4.5. The EU Biosimilar Market: History and Current Status
    • 4.5.1. History of EMA Guidelines and Updates
    • 4.5.2. Biosimilar Uptake in the Europe Varies between Nations
    • 4.5.3. European Biosimilars Market Forecast, 2016-2028
    • 4.5.4. Inflectra and Remsima in Europe - Demonstrates a Path for Other Biosimilar mAbs
    • 4.5.5. German Biosimilar Market Outlook, 2018
      • 4.5.5.1. German Biosimilar Market Forecast, 2016-2028
    • 4.5.6. French Biosimilars Market Outlook, 2018
      • 4.5.6.1. Biosimilar Substitution Passed but Requires Decrees to Come into Effect, Expected Sometime This Year
      • 4.5.6.2. French Biosimilar Market Forecast, 2016-2028
    • 4.5.7. UK Biosimilar Market Outlook, 2018
      • 4.5.7.1. UK Biosimilar Market Forecast, 2016-2028
    • 4.5.8. Italian Biosimilars Market Outlook, 2018
      • 4.5.8.1. Italian Biosimilars Market Forecast, 2016-2028
    • 4.5.9. Spanish Biosimilars Market Outlook, 2018
      • 4.5.9.1. Spanish Biosimilar Market Forecast, 2016-2028
    • 4.5.10. Biosimilar Regulation in Japan and Currently Approved Biosimilars
      • 4.5.10.1. Differences between the European and Japanese Guidelines
      • 4.5.10.2. Currently Approved Biosimilars in Japan
      • 4.5.10.3. Japanese Biosimilar Market Forecast, 2016-2028

5. Outlook for Biosimilars in Emerging Markets, 2016-2028

  • 5.1. China and India Lead Biosimilar Revenues
  • 5.2. Leading Emerging Biosimilar Markets Forecast, 2016-2028
  • 5.3. Chinese Biosimilars Market Outlook, 2018
    • 5.3.1. China Publishes Final Guidelines for Biosimilars
    • 5.3.2. Biosimilars Account for less than Half of Biotech Revenues in China
    • 5.3.3. Chinese Biosimilars Market Forecast, 2016-2028
  • 5.4. Indian Biosimilars Market Outlook, 2018
    • 5.4.1. CDSCO Guidelines Released in 2012
    • 5.4.2. Indian Biosimilars Market Forecast, 2016-2028
  • 5.5. South Korea's Established Biosimilar Guidelines
    • 5.5.1. Currently Approved Biosimilars in South Korea, 2018
    • 5.5.2. South Korean Biosimilars Market Forecast, 2016-2028
  • 5.6. Russian Biosimilars Market Outlook and Forecast, 2016-2028
  • 5.7. Brazilian Biosimilar Regulation
    • 5.7.1. Government Eager to Promote Biosimilar Development, and Two Major Conglomerates, Bionovis and Orygen, are Racing to Produce Biosimilars
    • 5.7.2. Brazilian Biosimilars Market Forecast, 2016-2028

6. Biosimilar Monoclonal Antibodies: Submarket Forecast and Pipeline, 2016-2028

  • 6.1. MAbs as Part of the Overall Biologics Market in 2018
  • 6.2. Monoclonal Antibodies (mAbs): Largest Biologic Submarket, with Individual Drugs Accumulating Multi-Billion Dollar Revenues
  • 6.3. Biosimilar Monoclonal Antibodies Market and Submarkets Forecast, 2016-2028
  • 6.4. Drivers for the Biosimilar Monoclonal Antibodies Market
    • 6.4.1. New Launches of Biosimilar mAbs in Developed and Emerging Markets
    • 6.4.2. Rising Incidence of Cancer Will Drive Demand
    • 6.4.3. The Need for Lower Cost Therapies
    • 6.4.4. Partnering to Launch Biosimilar mAbs
  • 6.5. Restraints for the Monoclonal Antibodies Market
    • 6.5.1. Novel mAb Developers Choosing to Develop Biobetters and Next-Generation Therapies in Face of Biosimilar Competition
  • 6.5.1.1. Hope for Biosimilars when Competing Against Next-Generation Therapies
    • 6.5.2. Challenges in Antibody Development and Manufacturing
    • 6.5.3. Patent Issues, Market Fragmentation and Perception of Biosimilars
  • 6.6. Leading Targets for Biosimilar Development, 2016-2028
  • 6.7. Biosimilar Rituximab
    • 6.7.1. Rituxan: The First Anti-Cancer mAb
    • 6.7.2. Approved Biosimilars and Rituxan Patent Expiry
      • 6.7.2.1. Reditux (Dr. Reddy's Laboratories): First Biosimilar Rituximab
      • 6.7.2.2. MabTas (Intas Pharmaceutical): Another Indian Biosimilar
      • 6.7.2.3. AcellBia (Biocad): The Leading Biosimilar Rituximab
      • 6.7.2.4. Kikuzubam (PROBIOMED) - Faced Challenges
    • 6.7.3. Biosimilar Rituximab Pipeline, 2016-2028
      • 6.7.3.1. Terminated Developments
      • 6.7.3.2. GP2013 (Sandoz): One of the Biggest Names in the Biosimilar Industry Throws its Hat into the Ring with Advanced Stage Candidate
      • 6.7.3.3. BI 695500 (Boehringer Ingelheim)
      • 6.7.3.4. MabionCD20 (Mabion): Focusing on Markets with High Demand
      • 6.7.3.5. CT-P10 (Celltrion)
      • 6.7.3.6. PF-05280586 (Pfizer)
    • 6.7.4. Biosimilar Rituximab: Revenue Forecast 2016-2028
  • 6.8. Biosimilar Infliximab
    • 6.8.1. Remicade: Second Only to Humira
    • 6.8.2. Approved Biosimilars and Remicade Patent Expiry: Uncertainty in the US after FDA Rejection
      • 6.8.2.1. Inflectra and Remsima (Hospira and Celltrion)
      • 6.8.2.2. Celltrion Speeds Ahead with US FDA Filing, and Inflectra Approved in Australia and Canada
      • 6.8.2.3. Inflimab and BOW015 (Epirus Biopharmaceuticals and Ranbaxy Laboratories)
    • 6.8.3. Biosimilar Infliximab Pipeline, 2016-2028
      • 6.8.3.1. SB2 (Samsung Bioepis): Has been Filed for EU Approval and Shows Positive Phase 3 Results
      • 6.8.3.2. NI-071 (Nichi-Iko): Advanced Stages
      • 6.8.3.3. ABP 710 (Amgen) and BX2922 (BioXpress Therapeutics)
    • 6.8.4. Biosimilar Infliximab: Revenue Forecast 2016-2028
  • 6.9. Biosimilar Trastuzumab
    • 6.9.1. Herceptin: Another Jewel in Roche's Cancer mAb Portfolio
    • 6.9.2. Approved Biosimilars and Herceptin Patent Expiry
      • 6.9.2.1. Hertraz and CanMab (Mylan and Biocon): The First to Win Approval
      • 6.9.2.2. Herzuma (Celltrion)
    • 6.9.3. Biosimilar Trastuzumab Pipeline, 2016-2028
      • 6.9.3.1. BCD-022 (Biocad): Leading Biosimilar Rituximab Developer Tries its Hand at Trastuzumab
      • 6.9.3.2. ABP 980 (Amgen and Allergan): CHMP Approval
      • 6.9.3.3. PF-05280014 (Pfizer): FDA halts approval
      • 6.9.3.4. SB3 (Samsung Bioepis) and BX2318 (BioXpress Therapeutics)
    • 6.9.4. Biosimilar Trastuzumab: Revenue Forecast 2016-2028
  • 6.10. Biosimilar Adalimumab
    • 6.10.1. Humira - The World's Best-Selling Prescription Drug
    • 6.10.2. Approved Biosimilars and Humira Patent Expiry
      • 6.10.2.1. Exemptia (Zydus Cadila): The First Biosimilar Adalimumab
    • 6.10.3. Biosimilar Adalimumab Pipeline, 2016-2028
      • 6.10.3.1. ABP 501 (Amgen and Allergan): Positive Phase 3 Results Released
      • 6.10.3.2. GP2017 (Sandoz): Phase 3
      • 6.10.3.3. BI 695501 (Boehringer Ingelheim)
      • 6.10.3.4. SB5 (Samsung Bioepis)
    • 6.10.4. Biosimilar Adalimumab: Revenue Forecast 2016-2028
  • 6.11. Biosimilar Bevacizumab
    • 6.11.1. Avastin: High Revenues and Late Patent Expiry
    • 6.11.2. Biosimilar Bevacizumab Pipeline, 2016-2028
      • 6.11.2.1. BCD-021 (Biocad)
      • 6.11.2.2. ABP 215 (Amgen and Allergan): Approved
      • 6.11.2.3. BI 695502 (Boehringer Ingelheim): Phase 3
      • 6.11.2.4. PF-06439535 (Pfizer): Phase 3
    • 6.11.3. Biosimilar Bevacizumab: Revenue Forecast, 2016-2028

7. Biosimilar Fusion Proteins: Submarket Forecast and Pipeline, 2016-2028

  • 7.1. Scientific Background
  • 7.2. Differentiating Fusion Proteins
  • 7.3. Fusion Proteins as Part of the Overall Biologics Market
  • 7.4. Biosimilar Fusion Proteins Market Forecast, 2016-2028
  • 7.5. Biosimilar Etanercept, 2016-2028
    • 7.5.1. Enbrel is the Leading Fusion Protein
    • 7.5.2. Enbrel Granted Extended Patent Protection in the US, Patent has Expired in EU
    • 7.5.3. Multiple Biosimilars Available in Emerging Markets
      • 7.5.3.1. Brenzys / SB4 (Merck and Samsung Bioepis): First Product Approval to Result from Biosimilar Collaboration
      • 7.5.3.2. Yi Sai Pu (Shanghai CP Guojian Pharmaceutical) and Qiangke (Shanghai Celgen Biopharmaceutical)
      • 7.5.3.3. Etacept (Cipla) and Intacept (Intas Pharmaceuticals)
      • 7.5.3.4. Davictrel / HD-203 (Hanwha Chemical and Merck KGaA)
    • 7.5.4. Biosimilar Etanercept Pipeline
    • 7.5.5. GP2015 (Sandoz)
      • 7.5.5.1. Sandoz Goes in Early: FDA Accepts Application for GP2015, Despite the Fact that Enbrel Patents are not due to Expire any time Soon
    • 7.5.6. SB4 (Samsung Bioepis): EMA Accepts Application
      • 7.5.6.1. Samsung Bioepis Releases Positive Phase 3 Data for SB4
    • 7.5.7. CHS-0214 (Coherus Biosciences and Baxter)
    • 7.5.8. TuNEX / ENIA11 (Mycenax Biotech / TSH Biopharm Corp): Phase 3 in Taiwan
    • 7.5.9. LBEC0101 (LG Life Sciences): Phase 3
    • 7.5.10. Biosimilar Etanercept: Revenue Forecast 2016-2028
  • 7.6. Eylea and Biosimilar Aflibercept
  • 7.7. Orencia and Biosimilar Abatacept

8. Biosimilar Insulin Submarket Outlook, 2016-2028

  • 8.1. Insulin as Part of the Biological Drug Sector
  • 8.2. 30 Million People Expected to be Diagnosed with Diabetes by 2030
  • 8.3. Approved Insulin Biosimilars
  • 8.4. Abasaglar / Basaglar / Insulin Glargine BS - The First Insulin Biosimilars to be Approved in Developed Markets
  • 8.5. EMA Releases Finalised Insulin Biosimilars Guideline
  • 8.6. Basaglar Delayed in the US until End of 2016
  • 8.7. Biosimilar Insulin Market and Submarkets Forecast, 2016-2028
  • 8.8. Biosimilar Human Insulin Submarket, 2016-2028
    • 8.8.1. A Submarket Mostly Restricted to Emerging Markets?
    • 8.8.3. Biosimilar Human Insulin in India
      • 8.8.3.1. Wockhardt and Biocon - Given up on their Desire to Target the US and Europe?
    • 8.8.4. Biosimilar Human Insulin in Russia
    • 8.8.5. Biosimilar Human Insulin Submarket Forecast, 2016-2028
  • 8.9. Biosimilar Insulin Analogues Submarket, 2016-2028
    • 8.9.1. Available Biologic Insulin Analogues - Sanofi's Lantus Tops Revenues
    • 8.9.2. Insulin Glargine in the Main Biosimilar Target
      • 8.9.2.1. Limited Development for the Other Targets
    • 8.9.3. Insulin Market Leaders are Developing Ultra-Rapid Acting Insulin Analogues
      • 8.9.3.1. Ultra-Long Acting Insulin also in Development
    • 8.9.4. Mylan Partners with Biocon for Insulin Analogues
    • 8.9.5. Other Biosimilar Insulin Analogue Revenue Forecast, 2016-2028
  • 8.10. Biosimilar Insulin Glargine
    • 8.10.1. Biosimilars in India and China
    • 8.10.2. Biosimilar Insulin Glargine Pipeline
      • 8.10.2.1. MK-1293 (Merck / Samsung Bioepis)
      • 8.10.2.2. Mylan's Insulin Glargine (Mylan and Biocon)
    • 8.10.3. Biosimilar Insulin Glargine: Revenue Forecast, 2016-2028
  • 8.11. Biosimilar Insulin Lispro
    • 8.11.1. Currently Available Biosimilars
    • 8.11.2. Much Smaller Pipeline than for Insulin Glargine
    • 8.11.3. Biosimilar Insulin Lispro: Revenue Forecast, 2016-2028

9. Biosimilar Erythropoietins Submarket Outlook, 2016-2028

  • 9.1. Three Products Lead the Biologic EPO Therapy Market
  • 9.2. Safety Concerns for Erythropoietin-Stimulating Agents
  • 9.3. The Challenge from Oral Therapies is Coming
  • 9.4. Treating Anaemia in Patients with CKD - the Leading Use of EPO Therapies
  • 9.5. Biosimilar Epoetin Approvals in Europe
  • 9.6. Epoetin Alfa Pipeline for the European Market
  • 9.7. Trends in Uptake for Biosimilar Epoetins in Europe
  • 9.8. Epoetin Alfa Pipeline for the US - Companies Preparing for Launch
    • 9.8.1. Pfizer's Retacrit Delayed after Response Letter from FDA
    • 9.8.2. Binocrit / HX575 has Completed Trials
  • 9.9. Biosimilar Epoetin in Japan
  • 9.10. Biosimilar Epoetin in South Korea
  • 9.11. Biosimilar Epoetin in India and China
  • 9.12. Second-Generation EPO Biosimilars
  • 9.13. No Mircera Biosimilars in Clinical Development
  • 9.14. Biosimilar EPO Market Forecast, 2016-2028

10. Biosimilar G-CSF Submarket Outlook, 2016-2028

  • 10.1. Amgen Leads the Branded Biologic G-CSF Market
  • 10.2. Teva Launches Long-Acting Pegfilgrastim
  • 10.3. Selected Filgrastim Biosimilars Approved Worldwide
    • 10.3.1. The European G-CSF Biosimilars Market
      • 10.3.1.1. Trends in Biosimilar Uptake Across Europe
    • 10.3.2. Tevagrastim (Teva): The First Biosimilar in Europe, Launched as Granix in the US
    • 10.3.3. Nivestim (Hospira - Pfizer)
    • 10.3.4. Zarzio (Sandoz): The Most Prescribed Biosimilar Therapy in Europe
    • 10.3.5. Zarxio Becomes the First Biosimilar to be Approved in the US, Launched in September
    • 10.3.6. Apotex: FDA has Accepted Applications for both its Biosimilar Filgrastim, and its Biosimilar Pegfilgrastim
    • 10.3.7. Multiple Launches in Japan in Recent Years
    • 10.3.8. Biosimilar Filgrastim and Pegfilgrastim in India
    • 10.3.9. Biosimilars in Russia, China and Other Emerging Markets
  • 10.4. Biosimilar G-CSF Market Forecast, 2016-2028

11. Biosimilar Interferons Submarket Outlook, 2016-2028

  • 11.1. Interferons: Key Antiviral and MS Therapies Since the 1990s
  • 11.2. Leading Interferon Brands
  • 11.3. Competition for the Multiple Sclerosis Market - Challenges for Interferon Beta Therapies
  • 11.4. All-Oral Regimens will Challenge Interferon Alfa Therapy
    • 11.4.1. However Oral Therapies will be Expensive
  • 11.5. There are no Approved Biosimilars in Developed Markets
  • 11.6. Biosimilar Interferon Market Forecast, 2016-2028
  • 11.7. Biosimilar Interferon Alfa
    • 11.7.1. Biosimilar Interferon Alfa - a Common Target in Developing Countries, Leading to Fragmented Markets
    • 11.7.2. Biosimilar Peginterferon Alfa
    • 11.7.3. Hepatitis Treatment Rates are Low
    • 11.7.4. Biosimilar Interferon Alfa Submarket Forecast, 2016-2028
  • 11.8. Biosimilar Interferon Beta
    • 11.8.1. Biosimilars are Well-Established in Emerging Markets
    • 11.8.2. Biosimilar Interferon Beta Pipeline
    • 11.8.3. EMA Guidance
    • 11.8.4. Long-Acting Interferon Beta
    • 11.8.5. Biosimilar Interferon Beta Submarket Forecast, 2016-2028

12. Biosimilar Recombinant Hormones Submarket Outlook, 2016-2028

  • 12.1. Human Growth Hormone: First Extracted in 1958
  • 12.2. Biologic Growth Hormone Market in 2014 - Novo Nordisk and Pfizer Dominate
    • 12.2.1. Novo Nordisk Aiming to Retain Dominance Through FlexPro Device and NN8640 Somatropin Candidate
  • 12.3. Biosimilar Growth Hormones
    • 12.3.1. Omnitrope - Well Established in Developed Markets
  • 12.4. Multiple Biosimilars Available Worldwide
    • 12.4.1. Biosimilars Growth Hormones Outside of Asia
    • 12.4.2. Biosimilar Growth Hormones in Asia
    • 12.4.3. Biosimilar Uptake Varies by Region
  • 12.5. Biosimilar Growth Hormones Market Forecast, 2016-2028
  • 12.6. Fertility Hormones
    • 12.6.1. Two Products Lead the Branded Fertility Hormone Market
    • 12.6.2. Long-Acting Follicle Stimulating Hormone (FSH)
    • 12.6.3. Branded Fertility Hormones Market Outlook
    • 12.6.4. Available Biosimilar Fertility Hormones
    • 12.6.5. Biosimilars Approved in Europe
      • 12.6.5.1. Ovaleap (Teva)
      • 12.6.5.2. Befomla (Finox Biotech) Approved in Europe, Undergoing Phase 3 for US
    • 12.6.6. Rising Infertility to Drive Demand to 2028
    • 12.6.7. Biosimilar Fertility Hormones Market Forecast, 2016-2028

13. Biosimilars: Qualitative Analysis and Industry Trends

  • 13.1. SWOT Analysis of the Biosimilars Market
  • 13.2. Biosimilars Market: Strengths
    • 13.2.1. Biosimilars Can Offer Huge Cost Savings
    • 13.2.2. The US has Finally Joined the Global Biosimilars Market
    • 13.2.3. Biosimilars are Already Well-Established in Many National Markets
    • 13.2.4. Outsourcing Offers the Chance for Further Cost Savings
  • 13.3. Biosimilars Market: Weaknesses
    • 13.3.1. Biosimilars are High Cost to Develop and Manufacture
    • 13.3.2. Complexity Means that Development Timelines are Long
    • 13.3.3. Uptake for Biosimilars Varies and is Low in Some Regions
  • 13.4. Biosimilars Market: Opportunities
    • 13.4.1. Blockbuster Biologics Face Patent Expiry
    • 13.4.2. Rising Disease Prevalence
    • 13.4.3. Licensing Agreements for Biosimilars
  • 13.5. Threats
    • 13.5.1. Biobetters and Next-Generation Biologics
    • 13.5.2. Patent Issues and Product Life Cycle Management from Originator Companies
    • 13.5.3. Fragmentation in the Market
    • 13.5.4. Long Market and Data Exclusivity Periods
    • 13.5.5. Biosimilars Require Marketing and Education
  • 13.6. Biosimilars Product Pipeline

14. Conclusions from Visiongain's Research and Analysis

  • 14.1. Rapid Growth Expected for this High-Potential Market
  • 14.2. Biosimilar Monoclonal Antibodies to be the Fastest Growing Segment
  • 14.3. A Range of Factors Will Stimulate Demand
  • 14.4. Challenges Remain in Developing and Successfully Launching Biosimilars
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