With much-awaited approval of biosimilar interchangeability by FDA, the dynamics in the much nascent US biosimilars market is about to change with long-lasting price competition. The report “Global Biosimilar Market by Classes (Insulin, Erythropoietin (EPO), Human Growth Hormone (HGH), Granulocyte- Colony Stimulating Factor (G-CSF), Monoclonal Antibody (mAb) and Interferon (IFN) & Markets (Developed & Emerging)- Industry Outlook 2020” provides an in-depth analysis of global biosimilars market focusing on key segments detailing approved and upcoming biosimilar products. Market outlook for aforementioned biosimilar classes has been provided for the period 2017-20.
The report provides comprehensive coverage on major industry drivers, restraints, and their impact on market growth during the forecast period. Furthermore, the study encompasses various market specific growth opportunities at the global and regional level. The report has been segmented as following:-
Market Segmentation by Classes
• Insulin
• Erythropoietin (EPO)
• Human Growth Hormone (HGH)
• Granulocyte- Colony Stimulating Factor (G-CSF)
• Monoclonal Antibody (mAb)
• Interferon (IFN)
Market Segmentation by Geography
• Developed Markets – Europe and the US
• Emerging Markets – China & India
Key Vendors
• Sandoz
• Hospira
• TEVA
• Celltrion
• Biocad
• Dong-A Pharmaceutical Co., Ltd.
• Stada
1. Executive Summary
2. Research Methodology
3. Introduction
4. Global Biologics Market
4.1 OVERVIEW
4.1.1 Classification of Biologics
4.2 GLOBAL BIOLOGICS MARKET ANALYSIS
1.1.1 Market Sizing (Actual & Forecasted)
5. Global Biosimilars Market
5.1 OVERVIEW
5.2 MARKET ANALYSIS
5.2.1 Market Sizing (Actual & Forecasted)
2.1.1 Market Share by Region (Actual & Forecasted)
3.1.1 Market Share by Application (Actual & Forecasted)
4.1.1 Market by Product Pipeline
6. Global Biosimilars Market Segmentation
6.1 ERYTHROPOIETIN (EPO)
6.1.1 Overview
6.1.2 Market Analysis
6.2 INSULIN
6.2.1 Overview
6.2.2 Market Analysis
6.3 HUMAN GROWTH HORMONE (HGH)
6.3.1 Overview
6.3.2 Market Analysis
6.4 GRANULOCYTE- COLONY STIMULATING FACTOR (G-CSF)
6.4.1 Overview
6.4.2 6.4.2 Market Analysis
6.4.2 6.4.2 Market Analysis
6.5 MONOCLONAL ANTIBODY (MAB)
6.5.1 Overview
6.5.2 Market Analysis
6.6 INTERFERON (IFN)
6.6.1 6.6.1 Overview
6.6.2 Market Analysis
7. Global Biosimilars Market Analysis – Developed & Emerging Nations
7.1 DEVELOPED MARKET
7.1.1Europe
7.1.2 The US
7.2 EMERGING MARKET
7.2.1 China
7.2.2India
8. Global Biosimilars – Pricing Analysis
9. Global Biosimilar Industry – SWOT Analysis
10. Global Biosimilars Market Attractiveness Index
11. Global Biosimilars Market Dynamics
11.1 INDUSTRY TRENDS & DEVELOPMENTS
11.1.1 New Biosimilars Dominated by Large Globals
11.1.2 11.1.2 Biosimilar Interchangeability Guidance by FDA
11.1.3 11.1.3 Focus on Pharmerging Markets
11.2 GROWTH DRIVERS
11.2.1 11.2.1 Biological Patent Expiries
11.2.2 11.2.2 Cost saving
11.2.3 11.2.3 Increased use for Treatment of Chronic Diseases
11.3 CHALLENGES
11.3.1 11.3.1 High Cost of Development
11.3.2 11.3.2 Regulatory Uncertainty
11.3.3 11.3.3 Lower Adoption Rate of Biosimilars
11.3.4 11.3.4 Manufacturer Skills Gap
12. Competitive Landscape
12.1 MARKET SHARE BY COMPETITORS
12.2 MARKET SHARE BY DRUGS
13. Company Profiles
13.1 SANDOZ
13.2 HOSPIRA
13.3 TEVA
13.4 CELLTRION
13.5 BIOCAD
13.6 DONG-A PHARMACEUTICAL CO., LTD
13.7 STADA
List of Tables
Table 1: Biosimilar - EPOs Approved for Marketing Globally
Table 2: Biological EPOs Patent Expiry Status
Table 3: Biosimilar EPOs in Pipeline
Table 4: Global Biosimilars - Insulins Pipeline
Table 5: Global - Biosimilar Insulin Approved for Marketing
Table 6: Global - Patent Expiry Status of Insulin
Table 7: Global - Biosimilar HGH Approved for Marketing
Table 8: Global - Biosimilar HGH in Pipeline
Table 9: Global - Biosimilar G-CSF Approved for Marketing
Table 10: Global - Biosimilar G-CSF in Pipeline
Table 11: Global - Patent Expiry Status of G-CSF
Table 12: Global - Biosimilar mAbs Approved for Marketing
Table 13: Global - Biosimilar mAbs in Pipeline
Table 14: Global - Patent Expiry Status of mAbs
Table 15: Global - Biosimilar Interferons Approved for Marketing
Table 16: Global - Biosimilar Interferons in Pipeline
Table 17: Global - Patent Expiry Status of Interferons
Table 18: Biosimilar Development Pipeline in EU and the US
Table 19: Major Biological Patent Expiries in Europe, 2010-20
Table 20: Biosimilar Drugs in Europe
Table 21: Major Biological Patent Expiries in the US, 2010-20
Table 22: Global Biosimilar Drugs Market Share by Manufacturer (2015)Table 23: Sandoz - Biosimilars Approved for Marketing
Table 24: Sandoz - Biosimilars in Pipeline
Table 25: Hospira - Biosimilars Approved for Marketing
Table 26: Hospira - Biosimilars in Pipeline
Table 27: TEVA - Biosimilars Approved for Marketing
Table 28: TEVA - Biosimilars in Pipeline
Table 29: Celltrion - Biosimilars Approved for Marketing
Table 30: Celltrion - Biosimilars in Pipeline
Table 31: Biocad - Biosimilars Approved for Marketing
Table 32: Biocad - Biosimilars in Pipeline
Table 33: Dong-A Pharmaceutical - Biosimilars Approved for Marketing
Table 34: Dong-A Pharmaceutical - Biosimilars in Pipeline
Table 35: Dong-A Pharmaceutical - Biosimilars Approved for Marketing
Table 36: Dong-A Pharmaceutical - Biosimilars in Pipeline
List of Figures
Figure 1: Research Methodology – Rockville Research
Figure 2: Classification of Biologics
Figure 3: Global Biologics Market Size and Growth, 2007-16E (US$ Billions, %)
Figure 4: Global Biologics Market Size by Value Forecasted, 2017E-22E (US$ Billions)
Figure 5: Global Biosimilars Market Size by Value, 2010-16E (US$ Billions)
Figure 6: Global Biosimilars Market Size by Value Foreacsted, 2017E-22E (US$ Billions)
Figure 7: Global Biosimilars Market Share by Region (2015)
Figure 8: Global Biosimilars Market Share by Region Forecasted (2020E)
Figure 9: Global Biosimilars Market Share by Region (2015)
Figure 10: Global Biosimilars Market Share by Region Forecasted (2020E)
Figure 11: Global Biosimilar Pipeline by Therapy Area (2015)
Figure 12: Global Biosimilar Product Pipeline by Phase, 2015
Figure 13: Global Continent-wise Biosimilar Candidates in Research Pipeline (as of Sept’16)
Figure 14: Global Erythropoietin (EPOs) Biosimilars Market Size by Value, 2014-2020E (US$ Millions)
Figure 15: Current and Projected Cases of Diabetes by Region, 2013 & 2035F
Figure 16: Global - Insulin Biosimilars Market Size by Value, 2014-2020E (US$ Millions)
Figure 17: Global - HGH Biosimilars Market Size by Value, 2014-2020E (US$ Million)
Figure 18: Global - G-CSF Biosimilars Market Size by Value, 2014-2020E (US$ Millions)
Figure 19: Global - mAb Biosimilars Market Size by Value, 2014-2020E (US$ Millions)
Figure 20: Global - Interferon Biosimilars Market Size by Value, 2014-2020E (US$ Millions)
Figure 21: Number of Biosimilars Approved in Europe, Japan and the US
Figure 22: Europe Biosimilar Market Size by Value, 2014-20E (US$ Billions)
Figure 23: Comparison of Innovator (Reference Products) and Biosimilar - ESA use in the EU27* (% of Treatment Days)
Figure 24: Comparison of Innovator (Reference Products) and Biosimilar – G-CSFs use in the EU27* (% of Treatment Days)
Figure 25: Biosimilar – Market Penetration in EU5 (% of treatment days)
Figure 26: Biosimilar (HGH, EPO, G-CSF, INFLIXIMAB) Penetration of Accessible Markets in Europe
Figure 27: Europe Top Molecules Sales (MAT 12/2015), €
Figure 28: Biosimilar Timeline in the US
Figure 29: The US Biosimilars Market Size by Value, 2014-20E (US$ Millions)
Figure 30: Biosimilar Prorducts in Chinese Market
Figure 31: China - Biosimilar Market Size by Value, 2014-20E (US$ Billions)
Figure 32: Biosimilar Prorducts in Indian Market
Figure 33: India - Biosimilar Market Size by Value, 2014-20E (US$ Millions)
Figure 34: Global Biosimilars Pricing Analysis
Figure 35: Global Biosimilars Market Attractiveness Index
Figure 36: Number of Biosimilar Products in Registration, Pre-registration, and Phase III
Figure 37: Global Biosimilars Sales at risk due to Patent Expiry, 2010-21 (US$ Bn)
Figure 38: Patent Expiry of World’s Best Selling Biologics in the US and Europe
Figure 39: Sales of Biologicals Going Off Patent
Figure 40: Development Cost Comparison of Biosimilar, Biologic & Generic
Figure 41: Global Biosimilars Market Share Competitors (2015)
Figure 42: Sandoz Sales, FY2012-FY2016 (US$ Billions)
Figure 43: Hospira Sales, FY2012-FY2016 (US$ Billions)
Figure 44: TEVA Sales, FY2012-FY2016 (US$ Billions)
Figure 45: Celltrion Sales, FY2012-FY2016 (US$ Billions)
Figure 46: Biocad Sales, FY2012-FY2016 (US$ Billions)
Figure 47: Dong-A Pharmaceutical Co., Ltd Sales, FY2012-FY2016 (US$ Billions)
Figure 48: Stada Sales, FY2012-FY2016 (US$ Billions)
Table 1: Biosimilar - EPOs Approved for Marketing Globally
Table 2: Biological EPOs Patent Expiry Status
Table 3: Biosimilar EPOs in Pipeline
Table 4: Global Biosimilars - Insulins Pipeline
Table 5: Global - Biosimilar Insulin Approved for Marketing
Table 6: Global - Patent Expiry Status of Insulin
Table 7: Global - Biosimilar HGH Approved for Marketing
Table 8: Global - Biosimilar HGH in Pipeline
Table 9: Global - Biosimilar G-CSF Approved for Marketing
Table 10: Global - Biosimilar G-CSF in Pipeline
Table 11: Global - Patent Expiry Status of G-CSF
Table 12: Global - Biosimilar mAbs Approved for Marketing
Table 13: Global - Biosimilar mAbs in Pipeline
Table 14: Global - Patent Expiry Status of mAbs
Table 15: Global - Biosimilar Interferons Approved for Marketing
Table 16: Global - Biosimilar Interferons in Pipeline
Table 17: Global - Patent Expiry Status of Interferons
Table 18: Biosimilar Development Pipeline in EU and the US
Table 19: Major Biological Patent Expiries in Europe, 2010-20
Table 20: Biosimilar Drugs in Europe
Table 21: Major Biological Patent Expiries in the US, 2010-20
Table 22: Global Biosimilar Drugs Market Share by Manufacturer (2015)Table 23: Sandoz - Biosimilars Approved for Marketing
Table 24: Sandoz - Biosimilars in Pipeline
Table 25: Hospira - Biosimilars Approved for Marketing
Table 26: Hospira - Biosimilars in Pipeline
Table 27: TEVA - Biosimilars Approved for Marketing
Table 28: TEVA - Biosimilars in Pipeline
Table 29: Celltrion - Biosimilars Approved for Marketing
Table 30: Celltrion - Biosimilars in Pipeline
Table 31: Biocad - Biosimilars Approved for Marketing
Table 32: Biocad - Biosimilars in Pipeline
Table 33: Dong-A Pharmaceutical - Biosimilars Approved for Marketing
Table 34: Dong-A Pharmaceutical - Biosimilars in Pipeline
Table 35: Dong-A Pharmaceutical - Biosimilars Approved for Marketing
Table 36: Dong-A Pharmaceutical - Biosimilars in Pipeline
Sandoz, Hospira, TEVA, Celltrion, Biocad and Dong-A Pharmaceutical Co., Ltd.
*If Applicable.
Links
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