Biosimilars in Developed Countries - Launch of Biosimilar mAbs in Europe and New Regulatory Pathways in the US to Spur Market Growth

Biosimilars in Developed Countries - Launch of Biosimilar mAbs in Europe and New Regulatory Pathways in the US to Spur Market Growth

Summary

GBI Research, the leading business intelligence provider, has released its latest report, “Biosimilars in Developed Countries - Launch of Biosimilar mAbs in Europe and New Regulatory Pathways in the US to Spur Market Growth” that provides key data, information and analysis of the major trends and issues affecting the biosimilar market in developed countries covering the US, the top five European markets and Japan. The report provides a comprehensive insight into the biosimilar market, and offers market forecasts by geography as well as biosimilar categories. It also provides the drivers and restraints affecting the biosimilars market, as well as the business environment and the key success factors in the global biosimilar industry. In addition, the report describes the regulatory environment in the US, top five European markets and Japan with respect to biosimilars. Finally, the report looks into the competitive landscape of the biosimilar industry by offering profiles of key players in the industry and the analysis of major deals that have taken place.

This report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research’s team of industry experts.

The global biosimilars industry has grown significantly over the past few years and has a great scope for future growth due to the expiry of patents for major biological drugs, pressure on the governments of developed nations to cut healthcare costs and the savings in treatment costs offered by biosimilars. The global biosimilar industry was valued at $450m in 2011 and is expected to increase to $7.5billion in 2018 at a compound annual growth rate (CAGR) of 49.6%. Access to the US market after the issuance of draft guidelines by the US Food and Drug Administration (FDA) will offer a major boost to the growth of the global biosimilar market. The establishment of guidelines for the approval of biosimilar interferons in the European Union will also drive global biosimilar market growth.

Currently, the global biosimilar market is at nascent stage. Major pharmaceutical companies including Teva Pharmaceuticals, Sandoz and Hospira have made a strong position for themselves in the European biosimilar market. However, the markets in the US and Japan have not been explored fully. Companies such as Pfizer, Mylan and Merck have shown interest in the opportunities offered by the global biosimilar market and have taken initiatives enter into it. Players such as Biocon and Celltrion from the emerging economies are collaborating with these global pharmaceutical companies to develop and market biosimilars. The market is expected to witness a large amount of strategic consolidation between these players in near future.

Scope

• Data and analysis on the biosimilar market in the leading geographies of the world – the US, the UK, Germany, France, Italy, Spain, and Japan.
• Market forecast for global biosimilar market from 2011 to 2018, by geography as well as product category.
• Key drivers and restraints that have had a significant impact on the market globally as well as at national level.
• The regulatory environment for biosimilars in the US, the EU and in Japan.
• Analysis of competitive environment in the industry and profiles of key players in the biosimilar market. The companies studied in this report are Sandoz, Teva Pharmaceuticals, Hospira, Dr. Reddy’s, Biocon, Intas, Celltrion and 3S Bio.
• Key M&A activities and Licensing Agreements that took place between 2009 up until February 2012 in the global biosimilar market.

Reasons to buy

• Make more informed business decisions from the insightful and in-depth analysis of the global biosimilar market and the factors shaping it.
• Identify the key areas of deal making through a thorough understanding of the deals landscape in the global biosimilar market.
• Build effective strategies to launch pipeline products by identifying potential geographies.
• Identify the companies from emerging nations for collaborations along with their key capabilities.
• Exploit in-licensing and out-licensing opportunities by identifying products that might fill your portfolio gaps.