Biosimilars: A Global Strategic Business Report
San Jose, CA (PRWEB) April 10, 2012
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Despite the debate over whether or not biosimilars be approved to enter the US market, the US senate passed an act in March 2010 to create a pathway for approval of biosimilars in the country, as part of the Biologics Price Competition and Innovation (BPCI) Act of 2009. This led to the opening of the largest biologics market worldwide for entry of generics. The move cannot come at a more appropriate time, as several biologics are scheduled to lose patent protection through the period 2010-2015, providing huge opportunities for biosimilar companies to expand their business. The US biosimilar regulatory pathway, once fully set and established in the near future, is expected to provide a significant impetus to the global biosimilars market.
The European Union, a market presently way ahead of the US when it comes to biosimilars, in 2010, included the much awaited guidelines for biosimilar monoclonal antibodies. With this, Europe is home to a broad array of biosimilars, including epoetin alpha, Granulocyte colony-stimulating factor, and recombinant growth hormone. Monoclonal antibodies (MAbs) are likely to capture a significant share of the biosimilars market globally by the year 2015. With most of the presently available branded products in this product category nearing patent expiries, MAbs offer huge market opportunity for biogeneric manufacturers. Furthermore, as MAbs delivery involves heavy doses, they are seen as high volume products. Regionally, the US stands out to be the most lucrative market for biosimilars, followed by Europe and Japan, as stated by a new research report on Biosimilars. The US is expected to surpass Europe over the analysis period to become the largest biosimilars market.
Patent expiries of major biotechnology drugs constitute one of the key growth drivers for the biosimilars market. Several major biotech drugs such as Roche’s Herceptin and Rituxan, Sanofi’s Lantus, Amgen’s Neulasta are expected to lose patents, starting from the year 2012. This would translate into tremendous opportunities for biosimilar manufacturers in the coming years. Biosimilar manufacturers would also receive a boost for continuing efforts to curtail healthcare costs worldwide, as they show potential to offer cost savings to insurance companies, government organizations, and patients alike. The number of old and elderly people is likely to increase sharply during the coming years, not only in the US, but also in several other countries. The global aging population requires biologic drugs for the treatment of chronic and complicated conditions, such as kidney diseases or cancers, providing a major opportunity for manufacturers of biosimilar products.
Despite several positive factors taking shape on the biosimilars front, biosimilar manufacturers continue to face hurdles in their pursuit to launch biosimilars in developed markets such as Europe and the US. One major hurdle for the players is expected to come from the inclusion of 12 year exclusivity period for originator biologicals in the Trans-Pacific Partnership agreement. Additionally, bottlenecks, such as huge manufacturing and commercialization costs, uncertainty of approval as well as safety issues, indicate a scenario where only companies with substantial financial resources, legal expertise and advanced production capabilities would survive the battle. However, with the US and Europe keen on implementing various specific and effective guidelines, which are expected to emerge as a backbone for the industry, the future for the biosimilars market in short term looks bright in these regions. In addition, biosimilars have been finding increasing penetration in the emerging markets, such as India, China, Latin America and Eastern Europe, all of which have less stringent regulatory framework for biosimilars. Availability of substantial manufacturing capacities and substantial cost savings are the other principal factors driving companies towards emerging markets. Another advantage of the emerging regions is the ease at which biosimilar products can overcome regulatory barriers in these markets.
Segment-wise, biosimilar Erythropoietin (EPO) is expected to remain competitive. Teva, Stada, and Sandoz are major players in the EPO category. The insulin market is expected to remain concentrated, with generic manufacturers such as Biocon and Wockhardt holding a strong market presence. Most of the major Indian companies have generic insulin or insulin analogs as pipeline products. Granulocyte Colony Stimulating Factor (G-CSF), being a capital-efficient product, represents one of the popular product categories among manufacturers. Teva, Sandoz, and Ratiopharm are some of the major companies focusing on G-CSF products.
Major players profiled in the report includes Biocon Ltd., Biopartners GmbH, Cipla Ltd., Dr. Reddy's Laboratories Ltd., Hospira Inc., Intas Biopharmaceuticals Ltd., Sandoz International GmbH, Shantha Biotechnics Ltd., Teva Pharmaceutical Industries Ltd., Wockhardt Ltd., among others.
The research report titled “Biosimilars: A Global Strategic Business Report” announced by Global Industry Analysts Inc., provides a comprehensive review of the key biosimilars markets, regulatory framework across different regions such as Europe and US, current market trends, key growth drivers, approved biosimilars across different product categories, patent expiries of biotech drugs, recent product approvals, recent industry activity, and profiles of major/niche global as well as regional market participants. The report provides annual sales estimates and projections for biosimilars market for the years 2008 through 2017 by the following geographic markets - US, Japan, Europe, and Rest of World. The market is analyzed by the following segments- Epoetin Alpha, Granulocyte-CSF, Granulocyte Macrophage-CSF, Human Growth Hormone, Interferons, and Insulin.
For more details about this comprehensive market research report, please visit – http://www.strategyr.com/Biosimilars_Market_Report.asp
About Global Industry Analysts, Inc.
Global Industry Analysts, Inc., (GIA) is a leading publisher of off-the-shelf market research. Founded in 1987, the company currently employs over 800 people worldwide. Annually, GIA publishes more than 1300 full-scale research reports and analyzes 40,000+ market and technology trends while monitoring more than 126,000 Companies worldwide. Serving over 9500 clients in 27 countries, GIA is recognized today, as one of the world's largest and reputed market research firms.
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