Cover Image
市場調查報告書

生技仿製藥 (生技學名藥) 世界市場 2016年∼2026年:MAb、融合蛋白、胰島素、G-CSF、紅血球生成素、干擾素、成長荷爾蒙、生育賀爾蒙

Biosimilars and Follow-On Biologics Trends, R&D and Revenue Forecasts 2016-2026: Assess Prospects for MAbs, Fusion Proteins, Insulin, G-CSF, Erythropoietin, Interferons, Growth and Fertility Hormones

出版商 Visiongain Ltd 商品編碼 204743
出版日期 內容資訊 英文 319 Pages
商品交期: 最快1-2個工作天內
價格
Back to Top
生技仿製藥 (生技學名藥) 世界市場 2016年∼2026年:MAb、融合蛋白、胰島素、G-CSF、紅血球生成素、干擾素、成長荷爾蒙、生育賀爾蒙 Biosimilars and Follow-On Biologics Trends, R&D and Revenue Forecasts 2016-2026: Assess Prospects for MAbs, Fusion Proteins, Insulin, G-CSF, Erythropoietin, Interferons, Growth and Fertility Hormones
出版日期: 2016年02月24日 內容資訊: 英文 319 Pages
簡介

本報告針對生技仿製藥 (生技學名藥) 市場提供生技仿製藥概要、市場發展過程、市場成長促進因素、阻礙因素分析、先進國家市場與新興國市場動向、主要藥劑區分分類動向分析與收益預測、SWOT分析、專家訪問、未來展望。

第1章 報告概要

第2章 介紹:生技仿製藥與生技仿製藥的開發

  • 生物製藥是什麼?
  • 生技仿製藥是什麼?
  • 生技仿製藥開發過程
  • 同質的生物製藥與生技仿製藥差異
  • 生技仿製藥市場主要區分

第3章 世界生技仿製藥市場預測

  • 世界生技仿製藥市場
  • 生物製藥市場全體生技仿製藥定位
  • 世界生技仿製藥市場預測
  • 生技仿製藥市場今後成長促進因素
  • 生技仿製藥市場販售成長阻礙因素
  • 成長促進因素、阻礙因素摘要
  • 生技仿製藥市場預測:區分分類

第4章 主要先進市場生技仿製藥展望

  • 主要國家市場
  • 國家分類市場預測
  • 世界市場地區構成變化預測
  • 美國市場預測
  • EU市場預測

第5章 新興市場生技仿製藥展望

  • 中國、印度:生技仿製藥收益居冠
  • 主要新興市場預測
  • 中國生技仿製藥市場預測
  • 印度生技仿製藥市場預測
  • 韓國確立生技仿製藥規範
  • 俄羅斯生技仿製藥市場預測
  • 巴西生技仿製藥相關法規

第6章 單株抗體 (MAb) 生技仿製藥:區分分類預測與臨床實驗

  • 生物製藥市場全體MAb定位
  • MAb:數10億美元收益與生物製藥市場最大區分
  • MAb生技仿製藥市場全體與區分分類市場預測
  • MAb生技仿製藥市場成長促進因素
  • MAb生技仿製藥市場成長阻礙因素
  • 生技仿製藥開發主要標的預測
  • Rituximab生技仿製藥
  • Infliximab生技仿製藥
  • Trastuzumab生技仿製藥
  • Adalimumab生技仿製藥
  • Bevacizumab生技仿製藥

第7章 融合蛋白生技仿製藥:區分分類預測與臨床實驗

  • 科學的背景
  • 融合蛋白區分
  • 生物製藥市場全體融合蛋白定位
  • 融合蛋白生技仿製藥市場預測
  • Etanercept生技仿製藥預測
  • EYLEA (Aflibercept 生技仿製藥)
  • 恩瑞舒(Abatacept生技仿製藥)

第8章 胰島素生技仿製藥:區分分類預測

  • 生物製藥市場全體胰島素定位
  • 糖尿病診斷者數量預測
  • 認可的胰島素生技仿製藥
  • Abasaglar、Basaglar、胰島素Glargine BS:先進市場初次承認的胰島素生技仿製藥
  • EMA:發表胰島素生技仿製藥規範最終決定
  • Basaglar:在美國延遲
  • 人體胰島素生技仿製藥部門預測
  • 類胰島素生技仿製藥部門預測
  • 甘精胰島素生技仿製藥部門預測
  • 賴脯胰島素生技仿製藥

第9章 紅血球生成素生技仿製藥:區分分類預測

  • 3種產品主導生物學EPO藥市場
  • 紅血球生成素刺激劑在安全性上的擔憂
  • 口服治療的競爭
  • 慢性腎臟病患者的貧血治療:EPO藥的主要用途
  • 歐洲紅血球生成素生技仿製藥被承認
  • 歐洲市場的Epoetin Alfa臨床實驗
  • 歐洲生技仿製藥紅血球生成素引進動向
  • 美國Epoetin Alfa臨床實驗
  • 日本紅血球生成素生技仿製藥
  • 韓國紅血球生成素生技仿製藥
  • 印度、中國紅血球生成素生技仿製藥
  • 第2世代EPO生技仿製藥
  • Mircera生技仿製藥臨床開發:尚未進行
  • 生技仿製藥EPO市場預測

第10章 G-CSF生技仿製藥:區分分類預測

  • Amgen:在生物G-CSF品牌藥市場居冠
  • Teva:進入長期效用Pegfilgrastim 市場
  • 被世界承認的主要非格司亭生技仿製藥
  • 生技仿製藥G-CSF市場預測

第11章 干擾素生技仿製藥:區分分類預測

  • 干擾素:長年的主要抗病毒劑、多發性硬化症治療藥
  • 主要干擾素品牌藥
  • 多發性硬化症市場競爭:與干擾素Beta治療藥的競爭
  • 干擾素Alfa治療藥:與口服治療藥的競爭
  • 沒有被先進市場承認的生技仿製藥
  • 生技仿製藥干擾素市場預測
  • 生技仿製藥干擾素Alfa
  • 生技仿製藥干擾素Beta

第12章 重組賀爾蒙生技仿製藥:區分分類預測

  • 人體成長賀爾蒙概略
  • 生物學的成長賀爾蒙市場:Novo Nordisk、Pfizer獨佔
  • 成長賀爾蒙生技仿製藥
  • 世界可用的複數生技仿製藥
  • 受孕賀爾蒙

第13章 生技仿製藥:定性分析、產業動向

  • SWOT分析

第14章 專家訪問

  • PROBIOMED
  • Ralph Warsinsky博士 (Executive Director of Product Communications, Boehringer Ingelheim)

第15章 總結

  • 受到期待的急速成長高潛力市場
  • 單株抗體生技仿製藥:最快速成長與受期待部門
  • 受各種因素需求刺激
  • 生技仿製藥開發與上市面對的課題

圖表

本網頁內容可能與最新版本有所差異。詳細情況請與我們聯繫。

目錄
Product Code: PHA0091

Biosimilars - Discover Revenue Predictions from 2016, Benefiting Your Authority

Do you want to find sales potentials of biosimilar drugs? If so, our new analysis gives you revenue forecasts to 2026 at overall world market, therapeutic class and national level.

See what is possible. For those therapies you explore sales data, R&D, opportunities and commercial prospects. Those emerging medicines hold great potential to benefit patients, healthcare providers and pharma companies.

Visiongain's updated study gives you revenue predictions for those follow-on biological drugs from 2016, helping you stay ahead. You also explore trends, technologies and expected products, benefiting your reputation for insight.

Data to help your research, plans, decisions and influence

Why struggle to find data on biosimilars, losing time and missing out? Instead help your research, analyses, plans, proposals and presentations. Avoid wasted time, struggle and missed opportunities.

Discover, in our new study, the promising future for biosimilars. Those agents include follow-on biologics (FOB) and subsequent entry biologics (SEB).

Read on, then, to explore what shapes that market, also seeing predicted revenue.

Forecasts and other analyses show you the most promising sales opportunities

That updated, expanded report shows revenue forecasting to 2026, recent results, growth rates and market shares. There you explore quantitative and qualitative analyses. That way you assess research and development, news and opportunities. Explore what the future holds, staying ahead.

Our analysis gives you 122 tables, 66 charts and two interviews with companies. With that study you assess clinical, technological and commercial trends, results and potentials. There explore issues such as these:

  • Why will the biosimilars market expand fast - with predicted doubling in size many times from 2016 to 2026 - and what revenues are possible?
  • When will that worldwide industry achieve overall sales in tens of billion dollars?
  • What compounds give the most promise for developers, producers and sellers?
  • Who are the best-placed companies in that healthcare industry from 2016?
  • Where are the most promising countries for selling those biological drugs?
  • How will biosimilar producers serve regulators, doctors, patients and payers?

Many opportunities exist for those competitors of original biologics. You investigate what segments are most likely to prosper, seeing from 2016 potential sales.

See there what the future holds for follow-on protein products. The following sections explain how our study helps your work.

Predictions for that world market and submarkets - see potentials for sales growth

Along with revenue prediction for the overall world market for biosimilars, our investigation shows forecasts to 2026 for eight individual therapeutic submarkets:

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

That report also shows revenue forecasts to 2026 for 12 individual submarkets within those segments:

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

Our report shows sales potentials of those biopharmaceuticals, helping you find ways to develop your business. Benefit your authority on those treatments for cancer, diabetes, autoimmune diseases and other disorders, expanding your reputation for commercial knowledge.

You also find what stimulates and restrains sales of those subsequent entry biologics. Explore that industry, seeing what products can achieve the most success. So discover what revenues are possible, hearing how companies can gain.

That study also divides its overall world market forecast into geographical segments.

National markets for those therapeutic proteins - where will highest sales and growth occur?

Developments worldwide will influence that follow-on biologics market, raising demand for biosimilars in developed and developing countries. See what is possible.

Our analyses show you individual revenue forecasts to 2026 for 12 national markets:

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

In our work you discover progress and outlooks. There you assess the biosimilar industry's future - needs, developments and demands. Our work explains, exploring issues affecting those biological drug companies, influencing their results.

Forces affecting that rising industry - what shapes its present and future?

Our new report discusses pressures, opportunities and other events affecting the biosimilars industry and market from 2016, including these influences:

  • Strategies for developing biosimilars - needs, demand, challenges and opportunities
  • Guidelines from regulators (FDA, EMA and others) and what they mean for those drug developers and producers - assess recent progress
  • 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.

Our study also discusses other aspects of those successor biologics, including these forces:

  • Economics stimulating demand for cheaper biological medicines
  • Outlooks for the overall biologics market - effects of biosimilar competition
  • Biobetters and other next-generation biologics as rivals to biosimilars - technological races and battles
  • Collaborations for those biopharmaceutical molecules - assess deals
  • Outsourcing - using contract manufacturing organisations (CMOs) - to gain expertise in pharma biotechnology, production efficiencies and cost savings.

With our report you assess that industry's strengths, weaknesses, opportunities and threats. You explore what restricts and stimulates companies, seeing the progress and sales possible.

From 2016 discover what the future holds for those drugs and their producers.

Companies and 2020 market value - what overall revenue potential?

From 2016, product launches hold great potential for investments, demand and sales. Our study predicts the world market for biosimilars and related biologics will reach $18.42 billion in 2020, multiplying in size many times from 2016 to 2026.

See how high revenues can go. With our study you assess what biosimilar technologies, products and companies hold most potential. Our analyses cover these firms and other developers, producers, marketers and sellers:

  • Sandoz
  • Teva Pharmaceutical Industries
  • Boehringer Ingelheim
  • Amgen
  • Pfizer.

There you also assess these biopharma specialists, among others:

  • Dr. Reddy's Laboratories
  • Intas Pharmaceutical
  • Mabion
  • Hospira
  • Celltrion.

Our work also shows you two interviews with organisations - Boehringer Ingelheim and PROBIOMED.

From 2016 many opportunities in that industry will appear. Explore, then, what the future holds, staying ahead in knowledge.

5 Ways Biosimilars and Follow-On Biologics' Trends, R&D and Revenue Forecasts 2016-2026 helps your work

In these five main ways, our new investigation helps your research, analyses, decisions, proposals and presentations:

  • Revenues for biosimilars to 2026 at overall world level and for 8 main submarkets and 12 further market divisions - discover outlooks for development, production and sales
  • Forecasts to 2026 for 12 national markets in the Americas, Europe and Asia - assess developed and developing countries for potential revenues
  • Prospects for established competitors and rising companies - explore portfolios, results, strengths, strategies and research and development
  • Analysis of what encourages and restrains biosimilar producers - investigate challenges, opportunities, regulations and competition
  • Interviews with that industry - discover what other authorities think, say and do, helping you stay ahead in technological and commercial insight.

That report, by our in-house team in the UK, gives knowledge to help your work, sparing you struggles and saving time. You gain data leading companies depend on.

Data there found nowhere else, benefiting your authority on the future of biologics

Our investigation gives independent analysis. There you gain competitive intelligence found only in our survey, seeing where prospects are most rewarding.

With our study you are less likely to fall behind in information or miss opportunity. Discover there how to help your research, analyses and decisions. Also save time and benefit your reputation for commercial insight.

So explore the future of biopharmaceuticals. In our new survey you find biosimilar results, trends, opportunities and sales predictions. Stay ahead by getting our report here now.

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 2016-2026

  • 3.1. The Global Biosimilars Market
  • 3.2. Biosimilars as a Share of the Biologics Market, 2014
    • 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, 2016-2026
  • 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, 2016-2026
    • 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, 2016-2026

  • 4.1. The Leading National Biosimilar Submarkets
  • 4.2. National Submarket Forecasts 2016-2026
  • 4.3. How will the Regional Composition of the Global Market Change from 2016-2026?
  • 4.4. US Biosimilars Market Outlook 2016-2026
    • 4.4.1. Status of the US Market in 2014 and 2015
    • 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 in August 2015
    • 4.4.4. Individual States Can Pass their Own Biosimilar Substitution Laws
    • 4.4.5. US Biosimilars Market Forecast 2016-2026
  • 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, 2016-2026
    • 4.5.4. Inflectra and Remsima in Europe - Demonstrates a Path for Other Biosimilar mAbs
    • 4.5.5. German Biosimilar Market Outlook, 2016
      • 4.5.5.1. German Biosimilar Market Forecast, 2016-2026
    • 4.5.6. French Biosimilars Market Outlook, 2016
      • 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, 2016-2026
    • 4.5.7. UK Biosimilar Market Outlook, 2016
      • 4.5.7.1. UK Biosimilar Market Forecast, 2016-2026
    • 4.5.8. Italian Biosimilars Market Outlook, 2016
      • 4.5.8.1. Italian Biosimilars Market Forecast, 2016-2026
    • 4.5.9. Spanish Biosimilars Market Outlook, 2016
      • 4.5.9.1. Spanish Biosimilar Market Forecast, 2016-2026
    • 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, 2016-2026

5. Outlook for Biosimilars in Emerging Markets, 2016-2026

  • 5.1. China and India Lead Biosimilar Revenues
  • 5.2. Leading Emerging Biosimilar Markets Forecast, 2016-2026
  • 5.3. Chinese Biosimilars Market Outlook, 2016
    • 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, 2016-2026
  • 5.4. Indian Biosimilars Market Outlook, 2016
    • 5.4.1. CDSCO Guidelines Released in 2012
    • 5.4.2. Indian Biosimilars Market Forecast, 2016-2026
  • 5.5. South Korea's Established Biosimilar Guidelines
    • 5.5.1. Currently Approved Biosimilars in South Korea, 2016
    • 5.5.2. South Korean Biosimilars Market Forecast, 2016-2026
  • 5.6. Russian Biosimilars Market Outlook and Forecast, 2016-2026
  • 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, 2016-2026

6. Biosimilar Monoclonal Antibodies: Submarket Forecast and Pipeline, 2016-2026

  • 6.1. MAbs as Part of the Overall Biologics Market in 2014
  • 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, 2016-2026
  • 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, 2016-2026
  • 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, 2016-2026
      • 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 2016-2026
  • 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, 2015-2026
      • 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 2016-2026
  • 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, 2015-2026
      • 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): Phase 3
      • 6.9.3.3. PF-05280014(Pfizer): Phase 3
      • 6.9.3.4. SB3(Samsung Bioepis) and BX2318(BioXpress Therapeutics)
    • 6.9.4. Biosimilar Trastuzumab: Revenue Forecast 2016-2026
  • 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, 2015-2026
      • 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): Phase 3 Results
    • 6.10.4. Biosimilar Adalimumab: Revenue Forecast 2016-2026
  • 6.11. Biosimilar Bevacizumab
    • 6.11.1. Avastin: High Revenues and Late Patent Expiry
    • 6.11.2. Biosimilar Bevacizumab Pipeline, 2016-2026
      • 6.11.2.1. BCD-021(Biocad)
      • 6.11.2.2. ABP 215(Amgen and Allergan): Positive Phase 3 Results
      • 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, 2016-2026

7. Biosimilar Fusion Proteins: Submarket Forecast and Pipeline, 2016-2026

  • 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, 2016-2026
  • 7.5. Biosimilar Etanercept, 2016-2026
    • 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 2016-2026
  • 7.6. Eylea and Biosimilar Aflibercept
  • 7.7. Orencia and Biosimilar Abatacept

8. Biosimilar Insulin Submarket Outlook, 2016-2026

  • 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, 2016-2026
  • 8.8. Biosimilar Human Insulin Submarket, 2016-2026
    • 8.8.1. A Submarket Mostly Restricted to Emerging Markets?
    • 8.8.2. Biosimilar Human Insulin in China
    • 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, 2016-2026
  • 8.9. Biosimilar Insulin Analogues Submarket, 2016-2026
    • 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. Biosimilar Insulin Analogue Revenue Forecast, 2016-2026
  • 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, 2016-2026
  • 8.11. Biosimilar Insulin Lispro
    • 8.11.1. One Biosimilar is Currently Available - Prandlin
    • 8.11.2. Much Smaller Pipeline than for Insulin Glargine
    • 8.11.3. Biosimilar Insulin Lispro: Revenue Forecast, 2016-2026

9. Biosimilar Erythropoietins Submarket Outlook, 2016-2026

  • 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, 2016-2026

10. Biosimilar G-CSF Submarket Outlook, 2016-2026

  • 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, 2016-2026

11. Biosimilar Interferons Submarket Outlook, 2016-2026

  • 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, 2016-2026
  • 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, 2016-2026
  • 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, 2016-2026

12. Biosimilar Recombinant Hormones Submarket Outlook, 2016-2026

  • 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, 2016-2026
  • 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 2026
    • 12.6.7. Biosimilar Fertility Hormones Market Forecast, 2016-2026

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

14. Research Interviews from Our Survey

  • 14.1. Interview with PROBIOMED
    • 14.1.1. Introduction to PROBIOMED
    • 14.1.2. PROBIOMED's Most Prominent Biosimilars and its Future Pipeline
    • 14.1.3. Withdrawal of Kikuzubam and Changes in Mexican Biosimilar Regulation
    • 14.1.4. On Standing out from the Competition
    • 14.1.5. On How the Biosimilars Market will Develop over the Next Ten Years and its Main Strengths
  • 14.2. Interview with Dr Ralph Warsinsky, Executive Director of Product Communications at Boehringer Ingelheim
    • 14.2.1. On Boehringer Ingelheim's Current Biosimilar Pipeline and its Reasons for Entering the Biosimilars Space
    • 14.2.2. On Boehringer Ingelheim's Track Record with Biopharmaceuticals and the Factors Needed to Become Successful in the Biosimilars Industry
    • 14.2.3. Advantages over Competitors and Thoughts on the US Market

15. Conclusions from Visiongain's Research and Analysis

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

List of Tables

  • Table 2.1: First Approvals for Recombinant Protein Therapies, 1982-1993
  • Table 3.1: Top Ten Best-Selling Drugs of 2014 (Wihtin the Overall Pharmaceutical Market): Revenues ($bn), Market Shares (%)
  • Table 3.2: Global Biosimilars Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2014-2020
  • Table 3.3: Global Biosimilars Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
  • Table 3.4: Patent Status for Leading Biologics within the Overall Biologics Market, 2016
  • Table 3.5: Biosimilars Market Forecast by Submarket (Insulin, EPO, G-CSF, Growth Hormones, mAbs): Revenue ($bn), AGR (%), CAGR (%), Market Shares (%), 2014-2020
  • Table 3.6: Biosimilars Market Forecast by Submarket (Interferons, Fusion Proteins, Fertility Hormones, Other Biosimilars): Revenue ($bn), AGR (%), CAGR (%), Market Shares (%), 2014-2020
  • Table 3.7: Biosimilars Market Forecast by Submarket (Insulin, EPO, G-CSF, Growth Hormones, mAbs): Revenue ($bn), AGR (%), CAGR (%), Market Shares (%), 2021-2026
  • Table 3.8: Biosimilars Market Forecast by Submarket (Interferons, Fusion Proteins, Fertility Hormones, Other Biosimilars): Revenue ($bn), AGR (%), CAGR (%), Market Shares (%), 2021-2026
  • Table 4.1: Global Biosimilars Market by Region: Revenues ($bn), Market Share (%), 2014
  • Table 4.2: Global Biosimilars Market Forecast Segmented by Nation (China, EU, India, US, South Korea, Japan): Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2014-2020
  • Table 4.3: Global Biosimilars Market Forecast Segmented by Nation (Russia, Brazil, Other): Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2014-2020
  • Table 4.4: Global Biosimilars Market Forecast Segmented by Nation (China, EU, India, US, South Korea, Japan): Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2021-2026
  • Table 4.5: Global Biosimilars Market Forecast Segmented by Nation (Russia, Brazil, Other): Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2021-2026
  • Table 4.6: US Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2014-2020
  • Table 4.7: US Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2021-2026
  • Table 4.8: European Biosimilar Approvals: Monoclonal Antibodies and Insulin
  • Table 4.9: European Biosimilar Approvals: G-CSF
  • Table 4.10: European Biosimilar Approvals: EPO
  • Table 4.11: European Biosimilar Approvals: Growth Hormones and Fertility Hormones
  • Table 4.12: European Biosimilars Market Segmented by Leading Nations: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2014-2020
  • Table 4.13: European Biosimilars Market Segmented by Leading Nations: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2021-2026
  • Table 4.14: German Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2014-2020
  • Table 4.15: German Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2021-2026
  • Table 4.16: French Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2014-2020
  • Table 4.17: French Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2021-2026
  • Table 4.18: UK Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2014-2020
  • Table 4.19: UK Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2021-2026
  • Table 4.20: Italian Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2014-2020
  • Table 4.21: Italian Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2021-2026
  • Table 4.22: Spanish Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2014-2020
  • Table 4.23: Spanish Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2021-2026
  • Table 4.24: Japanese Biosimilar Approvals To-Date, 2016
  • Table 4.25: Japanese Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2014-2020
  • Table 4.26: Japanese Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2021-2026
  • Table 5.1: Leading Emerging Biosimilar Markets: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2014-2020
  • Table 5.2: Leading Emerging Biosimilar Markets: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2021-2026
  • Table 5.3: Chinese Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2014-2020
  • Table 5.4: Chinese Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2021-2026
  • Table 5.5: Indian Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2014-2020
  • Table 5.6: Indian Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2021-2026
  • Table 5.7: Currently Approved Biosimilars in South Korea, 2016
  • Table 5.8: South Korean Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2014-2020
  • Table 5.9: South Korean Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2021-2026
  • Table 5.10: Russian Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2014-2020
  • Table 5.11: Russian Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2021-2026
  • Table 5.12: Brazilian Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2014-2020
  • Table 5.13: Brazilian Biosimilars Market: Revenue ($bn), AGR (%), CAGR (%), Market Share (%), 2021-2026
  • Table 6.1: The Best-Selling mAbs of 2014: Revenue ($bn), 2014
  • Table 6.2: Biosimilar Monoclonal Antibodies Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2014-2020
  • Table 6.3: Biosimilar Monoclonal Antibodies Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
  • Table 6.4: Biosimilar Monoclonal Antibodies Market and Submarkets Forecast: Revenue ($bn), AGR (%), CAGR (%), 2014-2020
  • Table 6.5: Biosimilar Monoclonal Antibodies Market and Submarkets Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
  • Table 6.6: Patent Status of Five Leading mAbs, 2016
  • Table 6.7: Types of Next-Generation Antibody Therapy, 2016
  • Table 6.8: Past and Present GP2013 (Sandoz) Clinical Trials, 2016
  • Table 6.9: Ongoing BI 695500 (Boehringer Ingelheim) Clinical Trials, 2015
  • Table 6.10: Ongoing CT-P10 (Celltrion) Clinical Trials, 2016
  • Table 6.11: Past and Present PF-05280586 (Pfizer) Clinical Trials, 2016
  • Table 6.12: Biosimilar Rituximab Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2014-2020
  • Table 6.13: Biosimilar Rituximab Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
  • Table 6.14: Biosimilar Infliximab Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2014-2020
  • Table 6.15: Biosimilar Infliximab Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
  • Table 6.16: Ongoing PF-05280014 (Pfizer) Clinical Trials, 2016
  • Table 6.17: Biosimilar Trastuzumab Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2014-2020
  • Table 6.18: Biosimilar Trastuzumab Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
  • Table 6.19: Recent ABP 501 (Amgen and Allergan) Clinical Trials, 2016
  • Table 6.20: Ongoing BI 695501 (Boehringer Ingelheim) Clinical Trials, 2016
  • Table 6.21: Biosimilar Adalimumab Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2014-2020
  • Table 6.22: Biosimilar Adalimumab Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
  • Table 6.23: Recent BCD-021 (Biocad) Clinical Trials, 2016
  • Table 6.24: Biosimilar Bevacizumab Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2014-2020
  • Table 6.25: Biosimilar Bevacizumab Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
  • Table 7.1: Biosimilar Fusion Proteins Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2014-2020
  • Table 7.2: Biosimilar Fusion Proteins Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
  • Table 7.3: Amgen's US Patents and Expiry Dates for Enbrel
  • Table 7.4: Ongoing CHS-0214 (Coherus Biosciences and Baxter) Clinical Trials, 2016
  • Table 7.5: Biosimilar Etanercept Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2014-2020
  • Table 7.6: Biosimilar Etanercept Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
  • Table 8.1: Diabetes Prevalence in Leading National Markets, 2012
  • Table 8.2: Selected Insulin Biosimilars which have been Approved and Launched
  • Table 8.3: Biosimilar Insulin Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2014-2020
  • Table 8.4: Biosimilar Insulin Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
  • Table 8.5: Biosimilar Insulin Submarket Forecasts: Revenue ($bn), AGR (%), CAGR (%), 2014-2020
  • Table 8.6: Biosimilar Insulin Submarket Forecasts: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
  • Table 8.7: Biosimilar Human Insulin Submarket Forecast: Revenue ($bn), AGR (%), CAGR (%), 2014-2020
  • Table 8.8: Biosimilar Human Insulin Submarket Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
  • Table 8.9: Approved Insulin Analogues Marketed Worldwide, 2016
  • Table 8.10: Biosimilar Insulin Analogues Submarket Forecast: Revenue ($bn), AGR (%), CAGR (%), 2014-2020
  • Table 8.11: Biosimilar Insulin Analogues Submarket Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
  • Table 8.12: MK-1293 (Merck / Samsung Bioepis) Recent Clinical Trials, 2016
  • Table 8.13: Insulin Glargine Biosimilar (Mylan and Biocon) Ongoing Clinical Trials, 2016
  • Table 8.14: Biosimilar Insulin Glargine Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2014-2020
  • Table 8.15: Biosimilar Insulin Glargine Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
  • Table 8.16: Biosimilar Insulin Lispro Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2014-2020
  • Table 8.17: Biosimilar Insulin Lispro Revenue Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
  • Table 9.1: Ongoing ASP1517 (Astellas Pharma) Clinical Trials, 2016
  • Table 9.2: Binocrit / HX575 (Novartis) Clinical Trials, 2016
  • Table 9.3: Selected EPO Biosimilars Approved in India
  • Table 9.4: Biosimilar EPO Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2014-2020
  • Table 9.5: Biosimilar EPO Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
  • Table 10.1: Selected Filgrastim Biosimilars Approved Worldwide
  • Table 10.2: Biosimilar G-CSF Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2014-2020
  • Table 10.3: Biosimilar G-CSF Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
  • Table 11.1: Types of Interferon Used Therapeutically, 2016
  • Table 11.2: Approved Branded Interferon Therapies, 2016
  • Table 11.3: Biosimilar Interferons Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2014-2020
  • Table 11.4: Biosimilar Interferons Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
  • Table 11.5: Selected Interferon Alfa Biosimilars Approved Worldwide, 2016
  • Table 11.6: Chronic Hepatitis B and C: Global Prevalence by Region, 2014
  • Table 11.7: Biosimilar Interferon Alfa Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2014-2020
  • Table 11.8: Biosimilar Interferon Alfa Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
  • Table 11.9: Selected Interferon Beta Biosimilars Approved Worldwide
  • Table 11.10: Biosimilar Interferon Beta Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2014-2020
  • Table 11.11: Biosimilar Interferon Beta Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
  • Table 12.1: Biosimilar Growth Hormone Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2014-2020
  • Table 12.2: Biosimilar Growth Hormone Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
  • Table 12.3: Recent Bemfola / Afolia (Finox Biotech) Clinical Trials, 2016
  • Table 12.4: Biosimilar Fertility Hormone Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2014-2020
  • Table 12.5: Biosimilar Fertility Hormone Market Forecast: Revenue ($bn), AGR (%), CAGR (%), 2021-2026
  • Table 13.1: Expected Biologic Patent Expiries, 2016-2029
  • Table 13.2: Typical Models of Collaboration for Biosimilar Development

List of Figures

  • Figure 1.1: Main Segments and Sub-Segments of the Biosimilars Market, 2016
  • Figure 3.1: Biosimilars Market as Share of the Overall Biologics Market: Revenue ($bn), Market Share (%), 2014
  • Figure 3.2: Global Biosimilars Market Forecast: Revenue ($bn), 2014-2026
  • Figure 3.3: Drivers and Restraints for the Biosimilars Market, 2016
  • Figure 3.4: Global Biosimilars Market Forecasts by Submarket: Revenue ($bn), 2014-2026
  • Figure 3.5: Composition of the Biosimilars Market in 2014: Market Shares (%)
  • Figure 3.6: Composition of the Biosimilars Market in 2020: Market Shares (%)
  • Figure 3.7: Composition of the Biosimilars Market in 2026: Market Shares (%)
  • Figure 4.1: Regional Composition of the Biosimilars Market in 2014: Market Shares (%)
  • Figure 4.2: Global Biosimilars Market Forecast Segmented by Region: Revenue ($bn), 2014-2026
  • Figure 4.3: Market Shares (%) for the Major Regional Markets, 2014-2026
  • Figure 4.4: Regional Composition of the Biosimilars Market in 2020: Market Shares (%)
  • Figure 4.5: Regional Composition of the Biosimilars Market in 2026: Market Shares (%)
  • Figure 4.6: US Biosimilars Market Forecast: Revenue ($bn), 2014-2026
  • Figure 4.7: European Biosimilars Market Breakdown: Revenue ($bn), 2014
  • Figure 4.8: European Biosimilars Market Breakdown: Revenue ($bn), 2020
  • Figure 4.9: European Biosimilars Market Breakdown: Revenue ($bn), 2026
  • Figure 4.10: European Biosimilars Market Segmented by Leading Nations: Revenue ($bn), 2014-2026
  • Figure 4.11: German Biosimilars Market: Revenue ($bn), 2014-2026
  • Figure 4.12: French Biosimilars Market: Revenue ($bn), 2014-2026
  • Figure 4.13: UK Biosimilars Market: Revenue ($bn), 2014-2026
  • Figure 4.14: Italian Biosimilars Market: Revenue ($bn), 2014-2026
  • Figure 4.15: Spanish Biosimilars Market: Revenue ($bn), 2014-2026
  • Figure 4.16: Japanese Biosimilars Market: Revenue ($bn), 2014-2026
  • Figure 5.1: Leading Emerging Nations Biosimilar Market Shares: Revenues ($bn), 2014
  • Figure 5.2: Leading Emerging Nations Biosimilar Market Shares: Revenues ($bn), 2020
  • Figure 5.3: Leading Emerging Nations Biosimilar Market Shares: Revenues ($bn), 2026
  • Figure 5.4: Leading Emerging Nations Biosimilar Market Shares: Revenues ($bn), 2014-2026
  • Figure 5.5: Chinese Biosimilars Market: Revenue ($bn), 2014-2026
  • Figure 5.6: Indian Biosimilars Market: Revenue ($bn), 2014-2026
  • Figure 5.7: South Korean Biosimilars Market: Revenue ($bn), 2014-2026
  • Figure 5.8: Russian Biosimilars Market: Revenue ($bn), 2014-2026
  • Figure 5.9: Brazilian Biosimilars Market: Revenue ($bn), 2014-2026
  • Figure 6.1: Monoclonal Antibodies as a Percentage of the Total Biologics Market: Revenue ($bn), Market Share (%), 2014
  • Figure 6.2: The Best-Selling mAbs of 2014 as a Percentage of the Total Biologics Market: Revenue ($bn), Market Share (%), 2014
  • Figure 6.3: Biosimilar Monoclonal Antibodies Market Forecast: Revenue ($bn), 2014-2026
  • Figure 6.4: Biosimilar Monoclonal Antibody Market Forecast, Split by Product: Revenue ($bn), 2014-2026
  • Figure 6.5: Biosimilar Rituximab Revenue Forecast: Revenue ($bn), 2014-2026
  • Figure 6.6: Biosimilar Infliximab Revenue Forecast: Revenue ($bn), 2014-2026
  • Figure 6.7: Biosimilar Trastuzumab Revenue Forecast: Revenue ($bn), 2014-2026
  • Figure 6.8: Biosimilar Adalimumab Revenue Forecast: Revenue ($bn), 2014-2026
  • Figure 6.9: Biosimilar Bevacizumab Revenue Forecast: Revenue ($bn), 2014-2026
  • Figure 7.1: Fusion Proteins as a Percentage of the Total Biologics Market: Revenue ($m), Market Share (%), 2014
  • Figure 7.2: Biosimilar Fusion Proteins Market Forecast: Revenue ($bn), 2014-2026
  • Figure 7.3: Biosimilar Etanercept Market Forecast: Revenue ($bn), 2014-2026
  • Figure 8.1: Diabetes Prevalence in Leading National Markets, 2012
  • Figure 8.2: Biosimilar Insulin Market Forecast: Revenue ($bn), 2014-2026
  • Figure 8.3: Biosimilar Insulin Submarket Forecasts: Revenues ($bn), 2014-2026
  • Figure 8.4: Drivers and Restraints for the Biosimilar Insulin Market, 2016
  • Figure 8.5: Biosimilar Human Insulin Submarket Revenue Forecast: Revenue ($bn), 2014-2026
  • Figure 8.6: Biosimilar Insulin Analogues Submarket Forecast: Revenue ($bn), 2014-2026
  • Figure 8.7: Biosimilar Insulin Glargine Revenue Forecast: Revenue ($bn), 2014-2026
  • Figure 8.8: Biosimilar Insulin Lispro Revenue Forecast: Revenue ($bn), 2014-2026
  • Figure 9.1: Biosimilar EPO Market Forecast: Revenue ($bn), 2014-2026
  • Figure 10.1: Biosimilar G-CSF Market Forecast: Revenue ($bn), 2014-2026
  • Figure 11.1: Biosimilar Interferons Market Forecast: Revenue ($bn), 2014-2026
  • Figure 11.2: Chronic Hepatitis B: Global Prevalence Share (%) by Region, 2014
  • Figure 11.3: Chronic Hepatitis C: Global Prevalence Share (%) by Region, 2014
  • Figure 11.4: Biosimilar Interferon Alfa Market Forecast: Revenue ($bn), 2014-2026
  • Figure 11.5: Biosimilar Interferon Beta Market Forecast: Revenue ($bn), 2014-2026
  • Figure 12.1: Biosimilar Growth Hormone Market Forecast: Revenue ($bn), 2014-2026
  • Figure 12.2: Biosimilar Fertility Hormone Market Forecast: Revenue ($bn), 2014-2026
  • Figure 13.1: Strengths and Weaknesses of the Biosimilars Market, 2016-2026
  • Figure 13.2: Opportunities and Threats for the Biosimilars Market, 2016-2026
  • Figure 13.3: Biosimilar Development Costs by Stage, 2016
  • Figure 13.4: Typical Biosimilar Development Timeline

Companies Listed

  • Allergan
  • Allozyne
  • Alteogen
  • Alvogen
  • Amarey Novamedical
  • Amega Biotech
  • Amgen
  • Apotex
  • Argentine Ministry of Health
  • 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
  • Cardiovascular and Renal Drugs Advisory Committee
  • Cardiovascular Drugs Advisory Committee
  • CCL Pharmaceuticals
  • CCM Duopharma
  • Celltrion
  • Centers of Medicare and Medicaid Services (CMS)
  • Centocor Ortho Biotech
  • Central Drugs Standard Control Organisation
  • Centre for Drug Evaluation (CDE)
  • China Food and Drug Administration
  • Chong Kun Dang
  • Chugai
  • CinnaGen.
  • Coherus BioSciences
  • Comisión Federal para la Protección contra Riesgos Sanitarios
  • Committee for Medicinal Products for Human Use
  • Compass Biotechnologies
  • Cristália
  • CT Arzneimittel
  • Cyplasin
  • Daiichi Sankyo
  • Department of Biotechnology (India)
  • Dong-A Pharmaceutical
  • Dr. Reddy's Laboratories
  • Egis Pharmaceuticals
  • Eisai
  • Eli Lilly
  • Elpen Pharmaceutical
  • Emcure Pharmaceuticals
  • EMS
  • Epirus
  • Eurofarma
  • European Generic Medicines Association (EGA)
  • European Medicines Agency (EMA)
  • 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
  • Intellectual Property Appellate Board (IPAB)
  • International Clinical Trials Registry Platform (ICTRP)
  • inVentiv Health
  • JCR Pharmaceuticals
  • Johnson & Johnson
  • Kabi
  • Kemwell Biopharma
  • Kissea
  • Koçak Farma
  • Korea Food and Drug Administration
  • 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
  • Mexican Supreme Court
  • Minapharm
  • Ministry for Health Labour and Welfare (MHLW)
  • Mitsubishi Tanabe
  • Mochida Pharmaceutical
  • Momenta Pharmaceuticals
  • Mycenax Biotech
  • Mylan
  • National Health Service (NHS)
  • National Institute for Health and Care Excellence (NICE)
  • Nichi-Iko
  • Nippion Kayaku
  • Norwegian Ministry of Health
  • Novartis
  • Novo Nordisk
  • Nuron Biotech
  • Oncobiologics
  • Ortho Pharmaceutical
  • Orygen
  • Pan American Health Organization
  • PanGen Biotech
  • Pfenex
  • Pfizer
  • Pharmaceuticals and Medical Devices Agency (PMDA)
  • 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
  • Russian Ministry of Health
  • Samsung Bioepis
  • Samsung BioLogics
  • Sandoz
  • Sanofi
  • SciGen
  • Scottish Medicines Consortium (SMC)
  • Shandong Kexing Pharma
  • Shanghai Celgen Biopharmaceutical
  • Shanghai CP Guojian
  • Shanghai Fosun
  • Shantha Biotechnics
  • Shinogi
  • Sicor Biotech
  • Sothema Laboratories
  • Spectrum Pharmaceuticals
  • STADA Arzneimittel
  • Stanford University
  • State Employees' Social Security and Social Services Institute (ISSSTE)
  • Stragen Pharma
  • Strides Arcolab
  • Syngene International
  • Synthon Biopharmaceuticals
  • Takeda
  • Teva
  • 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
  • Tianjin Hualida Biotechnology
  • Tonghua Dongbao
  • Toronto University
  • TSH Biopharm Corp
  • UK Medicines and Healthcare Products Regulatory Agency (MHRA)
  • União Química
  • 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
  • USV Biologics
  • Virchow Biotech
  • Wanbang Biopharmaceuticals
  • Wockhardt
  • World Health Organization (WHO)
  • Xiamen Amoytop Biotech
  • Zenotech
  • Zhejian Huahai Pharmaceutical
  • Zuventus
  • Zydus Biovation
  • Zydus Cadila
Back to Top