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Global Biosimilars Market

Global Biosimilars Market

Biosimilar Market
The market was estimated to be USD XX million in 2016 and is expected to reach USD XX million by 2021, witnessing a CAGR of XX% during the forecast period.

Biosimilar is a biological product, which is almost an identical copy of the original and is expected to possess active properties, similar to what was previously licensed. Biosimilars can be made only when the patent for the original product expires. Currently, Europe holds the largest market share in the biosimilar market, followed by Asia-Pacific. The Asia-Pacific market is witnessing the highest CAGR, mainly due to the proper & consistent guidelines issued by the regulatory authority and high adoption rate. The low-cost of a biosimilar is the primary driving force of the Asia-Pacific market. In countries, such as the United States, this market is still in its nascent stage; however, with a growing approval rate, the American market is expected to expand during the forecast period.

Drivers

Several blockbuster pharmaceuticals going off-patent in the next 5 to10 years is the primary driver for this market. Patent expiry of blockbuster drugs, such as Humira, Enbrel and Remicade, which have been among the top selling drugs, globally, present a significant opportunity for new players to enter this market. Patent expiry is not specific to geographical locations but is spread across the globe, including Europe and the United States. Biosimilar’s price is close to 70-80% of the original product, and hence, the low price margin is unable to attract a major share of the customers. Next-generation model, like getting into agreement with insurance companies for better reimbursement, is further driving the market. Additionally, as global biosimilar market is still in its early phase, entry is easier, and opportunity of growth is high.

Restraints

Developing a biosimilar drug is not easy, and opening a manufacturing facility costs between USD 100-250 million. The expensive process, along with high complexity, is the major restraint for this market. Additionally, inconsistent guidelines issued by the regulatory body, within the country, and competition from biobetters are inhibiting the biosimilar market growth

Market Segmentation

The biosimilar market is segmented by product class and geography.

By product class, the global biosimilar market is further segmented as follows –

Monoclonal Antibodies (Adalimumab, Infliximab, Rituximab, Trastuzumab, Bevacizumab and others)
Recombinant Hormones (Insulin, Human Growth Hormone, Follicle Stimulating Hormone)
Recombinant Growth Factors (Granulocyte Colony Stimulating Factor, Erythropoietin and others)
Immunomodulators (Interferon Alfa, Interferon Beta and others)
Anti-Inflammatory Agents (TNF Inhibitors and others)
By geography, the market is segmented into –

North America
Europe
Asia Pacific
The Middle East & Africa
South America
Some of the key players in this market are –

Accord Healthcare
Apotex
Biocon
Bioxpress Therapeutics
Celltrion
Eli Lilly
Harvest Moon Pharmaceuticals
Hexal
Hospira
Novartis/Sandoz
Teva Pharmaceuticals
Zydus Cadila Healthcare
Key Deliverables

Market analysis for the global biosimilar market, with region-specific assessments and competition analysis.
Market definition along with the identification of key drivers, restraints opportunities and challenges.
Identification of factors instrumental in changing the market scenario, rising prospective opportunities, and identification of key companies that can influence this market on a global and regional scale.
Extensively researched competitive landscape section with company profiles of key players with the analysis of their current strategic interests and key financial information.
Identification and analysis of the macro and micro factors that affect the global biosimilar market.
Insights of the market in the regions that have the highest potential for growth and also identify the markets that are still untapped.

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1. Introduction
1.1 Report Description
1.2 Market Definition
1.3 Research Methodology
2. Executive Summary
3. Key Inferences
4. Market Overview and Industry Trends
4.1 Current Market Senario
4.1.1 Key questions that aren't yet fully answered
4.2 Market Overview
4.3 Porter's Five Forces
4.3.1 Bargaining Power of Suppliers
4.3.2 Bargaining Power of Consumers
4.3.3 Threat of New Entrants
4.3.4 Threat of Substitute Products and Services
4.3.5 Competitive Rivalry Within the Industry
5. Drivers, Restraints, Opportunities, and challenges Analysis
5.1 Market Drivers
5.1.1 Several Blockbuster Biopharmaceuticals Going Off-Patent in Next 5 to 10 Years
5.1.2 Next-Gen Business Models
5.1.3 Market Still in the Early Stage and Permits Very High Growth Rate
5.2 Market Restraints
5.2.1 Concerns Regarding Substitutability and Interchangeability
5.2.2 Regulatory Uncertainty
5.2.3 Production Complexity
5.2.4 Competition From Biobetters Combined with Consumer Brand Consciousness
5.3 Key Challenges
5.3.1 Low Price Difference Compared to Original Product
5.4 Current Opportunities in the Market
5.4.1 Local Partnerships in Emerging Markets
6. Global Biosimilars Market, by Product Class
6.1 Monoclonal Antibodies
6.1.1 Adalimumab
6.1.2 Infliximab
6.1.3 Rituximab
6.1.4 Trastuzumab
6.1.5 Bevacizumab
6.1.6 Others
6.2 Recombinant Hormones
6.2.1 Insulin
6.2.2 Human Growth Hormone
6.2.3 Follicle Stimulating Hormone
6.2.4 Others
6.3 Recombinant Growth Factors
6.3.1 Granulocyte Colony Stimulating Factor
6.3.2 Erythropoietin
6.3.3 Others
6.4 Immunomodulators
6.4.1 Interferon Alfa
6.4.2 Interferon Beta
6.4.3 Others
6.5 Anti-Inflammatory Agents
6.5.1 TNF Inhibitors
6.5.2 Others
6.6 Others
7. Global Biosimilars Market, by Geography
7.1 North America
7.1.1 United States
7.1.2 Canada
7.1.3 Mexico
7.2 Europe
7.2.1 United Kingdom
7.2.2 Germany
7.2.3 France
7.2.4 Italy
7.2.5 Spain
7.2.6 Rest of Europe
7.3 Asia-Pacific (APAC)
7.3.1 China
7.3.2 Japan
7.3.3 India
7.3.4 Australia
7.3.5 South Korea
7.3.6 Rest of APAC
7.4 Middle East & Africa (MEA)
7.4.1 GCC
7.4.2 South Africa
7.4.3 Rest of MEA
7.5 South America
7.5.1 Brazil
7.5.2 Argentina
7.5.3 Rest of Latin America
8. Competitive Landscape
8.1 Merger and Acquisition Analysis
8.2 New Product Launches
8.3 Agreements, Collaborations and Parterships
9. Key Vendor Analysis
9.1 Accord Healthcare
9.2 Apotex
9.3 Biocon
9.4 Bioxpress Therapeutics
9.5 Celltrion
9.6 Eli Lilly
9.7 Harvest Moon Pharmaceuticals
9.8 Hexal
9.9 Hospira
9.10 LG Life Sciences Limited
9.11 Mylan
9.12 Novartis/Sandoz
9.13 Samsung Bioepis
9.14 Teva Pharmaceuticals
9.15 Zydus Cadila Healthcare
10. Analyst Outlook for Investment Opportunities
11. Future Outlook of the Market

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