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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.

Table Of Contents

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

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