Global Biosimilar Market Trends & Opportunities: 2015 Edition
Scope of the Report
The report titled “Global Biosimilar Market: Trends & Opportunities (2015 Edition)” analyzes the global biologics market, with exhaustive discussion on demand of Biosimilars with increase in patent expiry of innovator drugs. The key market challenges recognized by the analysts and the major trends biosimilar market are presented in the report. Further, key manufacturers of Biosimilars like Sandoz, Teva, Hospira and Dr. Reddy’s Lab are profiled in the report.
Product Coverage
Rising budgetary pressures to reduce healthcare expenditures, patent expiries of blockbuster drugs, growing demand for cost-effective alternatives, increasing aging population, conductive government initiatives and rising incidences of various diseases are significant factors that are responsible for the growth of global biosimilar market (2013 to 2018). On the other hand stringent regulatory environment in some countries, high manufacturing complexities, costs, and presence of low priced generic drugs and high-entry barriers are considered to hinder the market growth. Emerging pharmaceutical market and less stringent government regulatory frameworks in few countries can provides some of the major opportunities for biosimilars market. In addition, increased collaboration between manufacturing companies and outsourcing of biosimilar products are key trends for biosimilars market.
The biosimilar products market is segmented into recombinant non-glycosylated proteins, recombinant glycosylated proteins, and recombinant peptides. Globally there are 280 biosimilars in pipeline and their clinical trials are increasing at a rate of 20% annually.
The report titled “The Global Biosimilar Market: Trends & Opportunities (2014-2018)” provides an in-depth analysis of the growing Biosimilar Market with detailed analysis of market sizing and growth, market share and economic impact of the industry. The report also assesses the key opportunities in the market and outlines the factors that are and will be driving the growth of the industry. Growth of the overall Biosimilars industry has also been forecasted for the period 2014-18, taking into consideration the previous growth patterns, the growth drivers and the current and future trends. Further, key players of the industry like Sandoz, Teva, Hospira and Dr. Reddy’s Lab are profiled.
The report titled “Global Biosimilar Market: Trends & Opportunities (2015 Edition)” analyzes the global biologics market, with exhaustive discussion on demand of Biosimilars with increase in patent expiry of innovator drugs. The key market challenges recognized by the analysts and the major trends biosimilar market are presented in the report. Further, key manufacturers of Biosimilars like Sandoz, Teva, Hospira and Dr. Reddy’s Lab are profiled in the report.
Product Coverage
- Recombinant Glycosylated Biosimilars (EPO,mAb,Follitropin)
- Humira, Enbrel, Remicade, Herceptin
- Recombinant Non-Glycosylated Biosimilars (Insulin,G-csf,Interferons,hGh)
- Sandoz(Novartis)
- Hospira
- Teva
- Dr. Reddy’s Lab
Rising budgetary pressures to reduce healthcare expenditures, patent expiries of blockbuster drugs, growing demand for cost-effective alternatives, increasing aging population, conductive government initiatives and rising incidences of various diseases are significant factors that are responsible for the growth of global biosimilar market (2013 to 2018). On the other hand stringent regulatory environment in some countries, high manufacturing complexities, costs, and presence of low priced generic drugs and high-entry barriers are considered to hinder the market growth. Emerging pharmaceutical market and less stringent government regulatory frameworks in few countries can provides some of the major opportunities for biosimilars market. In addition, increased collaboration between manufacturing companies and outsourcing of biosimilar products are key trends for biosimilars market.
The biosimilar products market is segmented into recombinant non-glycosylated proteins, recombinant glycosylated proteins, and recombinant peptides. Globally there are 280 biosimilars in pipeline and their clinical trials are increasing at a rate of 20% annually.
The report titled “The Global Biosimilar Market: Trends & Opportunities (2014-2018)” provides an in-depth analysis of the growing Biosimilar Market with detailed analysis of market sizing and growth, market share and economic impact of the industry. The report also assesses the key opportunities in the market and outlines the factors that are and will be driving the growth of the industry. Growth of the overall Biosimilars industry has also been forecasted for the period 2014-18, taking into consideration the previous growth patterns, the growth drivers and the current and future trends. Further, key players of the industry like Sandoz, Teva, Hospira and Dr. Reddy’s Lab are profiled.
1. EXECUTIVE SUMMARY
2. GLOBAL BIOSIMILAR MARKET
2.1 Overview of Biosimilar Market
2.1.1 History
2.1.2 Prescription of Biosimilars
2.1.3 Naming of Biosimilars
2.1.4 Determination of Biosimilarity
2.1.5 Differences between Biosimilar and Original Drugs
2.1.6 Manufacture of Biosimilars
2.1.7 Safety, Efficacy, Quality
2.1.8 Variability in Biosimilars
2.1.9Regulating Biosimilars
2.1.10 Approval Pathways of Biosimilars
2.1.11Market Segmentation by Therapeutic Area
3. GLOBAL BIOSIMILAR MARKET: SIZING AND GROWTH
3.1 Biosimilar Market Size: 2009-2013
3.2 Forecasted Biosimilar market Size : 2014-2018
4. BIOSIMILAR MARKET ANALYSIS: BY GEOGRAPHY
4.1 Asia-Pacific
4.1.1 China
4.1.2 India
4.1.3 South Korea, Taiwan, ASEAN
4.1.4 Latin America
4.1.5 Brazil
4.1.6 Mexico
4.1.7 Argentina
4.2 Europe
4.3 U.S.A
5. BIOSIMILAR MARKET: PRODUCT ANALYSIS
5.1 Recombinant Glycosylated Biosimilars
5.1.1 Market Size: 2009-2013
5.1.2 Forecasted: 2014-218
5.1.2.1 Original epoetin (EPO) products
5.1.2.2 Original follitropin product
5.1.2.3 Original Monoclonal antibodies
5.1.2.4 Following are biologic MAb drugs that are expected to become off-patent from 2013 to 2018
5.2 Recombinant non-glycosylated proteins
5.2.1 Market Size: 2009-2013
5.2.2 Forecasted Market Size: 2014-2018
5.2.2.1 Original G-CSF products:
5.2.2.2 Somatotropin Products
6. MARKET DYNAMICS OF BIOSIMILAR MARKET
6.1 Growth drivers
6.1.1 Patent expiry
6.1.2 Increase in Demand of Biologics
6.1.3 Increase demand to lower the soaring health costs
6.1.4 Focus On Therapeutic Research Areas (Diabetes, Cancer) including Monoclonal Antibody and Human Insulin
6.1.5 Increase in expenditure on biologics globally
6.2 Market Challenges
6.2.1 Efficacy issues
6.2.2 Pharmacovigilance
6.2.3 Safety issues
6.2.4 Substitution
6.2.5 Regulatory approval
6.2.6 Barriers to competition
6.3 Market trends
6.3.1 Mergers and acquisitions
6.3.2 Penetration into U.S market
7. COMPETITIVE LANDSCAPE: GLOBAL BIOSIMILAR MARKET
8. COMPANY PROFILES GLOBAL BIOSIMILAR MARKET
8.1 Sandoz-Novartis
8.1.1 Business overview
8.1.2 Financial overview
8.1.3 Business strategies
8.2 Hospira
8.2.1 Business overview
8.2.2 Financial overview
8.2.3 Business strategies
8.3 Teva
8.3.1 Business overview
8.3.2 Financial overview
8.3.3 Business strategies
8.4 Dr. Reddy’s Laboratories
8.4.1 Business Overview
8.4.2 Financial overview
8.4.3 Business strategies
2. GLOBAL BIOSIMILAR MARKET
2.1 Overview of Biosimilar Market
2.1.1 History
2.1.2 Prescription of Biosimilars
2.1.3 Naming of Biosimilars
2.1.4 Determination of Biosimilarity
2.1.5 Differences between Biosimilar and Original Drugs
2.1.6 Manufacture of Biosimilars
2.1.7 Safety, Efficacy, Quality
2.1.8 Variability in Biosimilars
2.1.9Regulating Biosimilars
2.1.10 Approval Pathways of Biosimilars
2.1.11Market Segmentation by Therapeutic Area
3. GLOBAL BIOSIMILAR MARKET: SIZING AND GROWTH
3.1 Biosimilar Market Size: 2009-2013
3.2 Forecasted Biosimilar market Size : 2014-2018
4. BIOSIMILAR MARKET ANALYSIS: BY GEOGRAPHY
4.1 Asia-Pacific
4.1.1 China
4.1.2 India
4.1.3 South Korea, Taiwan, ASEAN
4.1.4 Latin America
4.1.5 Brazil
4.1.6 Mexico
4.1.7 Argentina
4.2 Europe
4.3 U.S.A
5. BIOSIMILAR MARKET: PRODUCT ANALYSIS
5.1 Recombinant Glycosylated Biosimilars
5.1.1 Market Size: 2009-2013
5.1.2 Forecasted: 2014-218
5.1.2.1 Original epoetin (EPO) products
5.1.2.2 Original follitropin product
5.1.2.3 Original Monoclonal antibodies
5.1.2.4 Following are biologic MAb drugs that are expected to become off-patent from 2013 to 2018
5.2 Recombinant non-glycosylated proteins
5.2.1 Market Size: 2009-2013
5.2.2 Forecasted Market Size: 2014-2018
5.2.2.1 Original G-CSF products:
5.2.2.2 Somatotropin Products
6. MARKET DYNAMICS OF BIOSIMILAR MARKET
6.1 Growth drivers
6.1.1 Patent expiry
6.1.2 Increase in Demand of Biologics
6.1.3 Increase demand to lower the soaring health costs
6.1.4 Focus On Therapeutic Research Areas (Diabetes, Cancer) including Monoclonal Antibody and Human Insulin
6.1.5 Increase in expenditure on biologics globally
6.2 Market Challenges
6.2.1 Efficacy issues
6.2.2 Pharmacovigilance
6.2.3 Safety issues
6.2.4 Substitution
6.2.5 Regulatory approval
6.2.6 Barriers to competition
6.3 Market trends
6.3.1 Mergers and acquisitions
6.3.2 Penetration into U.S market
7. COMPETITIVE LANDSCAPE: GLOBAL BIOSIMILAR MARKET
8. COMPANY PROFILES GLOBAL BIOSIMILAR MARKET
8.1 Sandoz-Novartis
8.1.1 Business overview
8.1.2 Financial overview
8.1.3 Business strategies
8.2 Hospira
8.2.1 Business overview
8.2.2 Financial overview
8.2.3 Business strategies
8.3 Teva
8.3.1 Business overview
8.3.2 Financial overview
8.3.3 Business strategies
8.4 Dr. Reddy’s Laboratories
8.4.1 Business Overview
8.4.2 Financial overview
8.4.3 Business strategies
LIST OF FIGURES AND TABLES
Figure 1 : Original And Biosimilar Medicine
Figure 2 : Original And Biosimilar Medicine
Figure 3: A stir tank bioreactor
Figure 4: Biosimilars Omnitrope and Accofil
Table 1: List of Biosimilars approved by EMA
Figure 5: Global Biosimilar Market (2009-2013)-sales-U.S$ Billion
Figure 6: Biosimilar Products Market Share (2013)
Figure 7: Global Biosimilar Market Sales (2014-2018) in U.S$ Billion
Figure 8: Global biosimilar market share by geography (2013)
Figure 9: Biosimilar uptake across countries in Europe in 2013
Figure 10: Biosimilar Market - Recombinant Glycosylated Products – Sales (2009-2013) - US$ Billion
Figure 11: Biosimilar Market - Recombinant Glycosylated Products – Sales (2014-2018) - US$ Billion
Figure 12: Biosimilar Market –Epoeitin and Follitropoin– Sales (2014-2018) - US$ Billion
Figure 13: biosimilar monoclonal antibody market-2013 to 2018-U.S$ Billion
Table 2: Biosimilars of bevacizumab in development
Table 3: Biosimilars of Adalimumab in development
Table 4: Biosimilar of Entracept Approved for Development
Table 5: Biosimilar of Trastuzumab Approved or in Development
Figure 14: Biosimilar recombinant non-glycosylated Market (2009-2013)- Sales –U.S$ Billion
Figure 15: Biosimilar recombinant non-glycosylated Market (2014-2018) –Sales-U.S$ Billion
Figure 16: Biosimilar G-CSF Market (2014-2018)-Sales-U.S$ Billion
Figure 17: Blockbuster innovator drug market sales-2013-U.S$ Billion
Table 6: Blockbuster innovator drugs scheduled patent expiries
Figure 18: Global biologics sales and growth: 2009-2013
Table 7: Increase in sales of top six biologic drugs 2012-2013
Figure 19: Potential Cost Savings across Biologic Classes
Figure 20: Core Therapy Areas of biologics Sales-2013-U.S$ Billion
Figure 21: Mortality rate of cancer patients-2012
Figure 22: Global spending on biologics: 2002-2017-U.S$ Billion
Table 8: Competitive landscape of key biosimilars players
Figure 23: Global Biosimilar Players market share: 2013
Table 9: characterization of biosimilar players on basis of investmental capabilities and developmental expertise
Figure 24: Sandoz- Biosimilars net revenue: 2011-13 (US$ Million)
Figure 25: Hospira Net Revenue: 2011-13 (US$ Million)
Figure 26: Teva’s net revenue of oncology and women health products: 2011-13 (US$ Million)
Figure 27: Dr. Reddy’s Lab’s Proprietary Products Net Revenue: 2011-14 (US$ Million)
Figure 1 : Original And Biosimilar Medicine
Figure 2 : Original And Biosimilar Medicine
Figure 3: A stir tank bioreactor
Figure 4: Biosimilars Omnitrope and Accofil
Table 1: List of Biosimilars approved by EMA
Figure 5: Global Biosimilar Market (2009-2013)-sales-U.S$ Billion
Figure 6: Biosimilar Products Market Share (2013)
Figure 7: Global Biosimilar Market Sales (2014-2018) in U.S$ Billion
Figure 8: Global biosimilar market share by geography (2013)
Figure 9: Biosimilar uptake across countries in Europe in 2013
Figure 10: Biosimilar Market - Recombinant Glycosylated Products – Sales (2009-2013) - US$ Billion
Figure 11: Biosimilar Market - Recombinant Glycosylated Products – Sales (2014-2018) - US$ Billion
Figure 12: Biosimilar Market –Epoeitin and Follitropoin– Sales (2014-2018) - US$ Billion
Figure 13: biosimilar monoclonal antibody market-2013 to 2018-U.S$ Billion
Table 2: Biosimilars of bevacizumab in development
Table 3: Biosimilars of Adalimumab in development
Table 4: Biosimilar of Entracept Approved for Development
Table 5: Biosimilar of Trastuzumab Approved or in Development
Figure 14: Biosimilar recombinant non-glycosylated Market (2009-2013)- Sales –U.S$ Billion
Figure 15: Biosimilar recombinant non-glycosylated Market (2014-2018) –Sales-U.S$ Billion
Figure 16: Biosimilar G-CSF Market (2014-2018)-Sales-U.S$ Billion
Figure 17: Blockbuster innovator drug market sales-2013-U.S$ Billion
Table 6: Blockbuster innovator drugs scheduled patent expiries
Figure 18: Global biologics sales and growth: 2009-2013
Table 7: Increase in sales of top six biologic drugs 2012-2013
Figure 19: Potential Cost Savings across Biologic Classes
Figure 20: Core Therapy Areas of biologics Sales-2013-U.S$ Billion
Figure 21: Mortality rate of cancer patients-2012
Figure 22: Global spending on biologics: 2002-2017-U.S$ Billion
Table 8: Competitive landscape of key biosimilars players
Figure 23: Global Biosimilar Players market share: 2013
Table 9: characterization of biosimilar players on basis of investmental capabilities and developmental expertise
Figure 24: Sandoz- Biosimilars net revenue: 2011-13 (US$ Million)
Figure 25: Hospira Net Revenue: 2011-13 (US$ Million)
Figure 26: Teva’s net revenue of oncology and women health products: 2011-13 (US$ Million)
Figure 27: Dr. Reddy’s Lab’s Proprietary Products Net Revenue: 2011-14 (US$ Million)
