It is said that the first biosimilar drugs hit the Indian market first. Biosimilars are different from the original drugs but the active substance of the biosimilar medicinal product remains similar to the biological reference medicinal product. The biosimilar drug may also contain different inactive ingredients. The pharmaceutical industry, however, remains divided over the issue of immunogenicity of biosimilars. Immunogenicity is the product's ability to provoke an immune response within the body. Since biosimilars are copies of the original drug and not exact replicas, there is a debate over how they will be recognized by the body and whether or not it will produce the specific antibodies. The primary concern remains the lack of knowledge about the ability of biosimilars to cause an immune response in the body.
The global biosimilars industry is expected to reach a value of nearly USD 5 billion by 2016. Since biosimilars are priced nearly 20-30% lower than the branded product, patients are often encouraged to switch over from the branded product in order to save cost. In an era where healthcare costs are spiraling out of control, biosimilars are being seen as a welcoming intervention, making pharmaceutical drugs affordable for the general population. Europe is leading the global biosimilar industry with 13 biosimilar drugs already, followed by Japan where the first biosimilar drug was approved in June 2009.
The United States and France, Germany, Italy, Spain and the United Kingdom remain the major markets for biosimilars around the world and in 2014, these biosimilar markets combined had a market size of USD 150 million. Out of these six developed markets, Germany was the biggest biosimilar market in 2014, followed by the US. The US saw sales of Tev-Tropin and Omnitrope lead the biosimilar market in 2014.
The significant potential of growth in the biosimilars market has attracted the attention of global generic giants such as Teva Pharmaceuticals as well as traditional branded pharmaceutical players like Merck.
Though an emerging industry, there is no doubt that the biosimilar market is poised for exponential growth in the coming years. Taiyou Research takes this opportunity to analyze this growing market in its report Global Biosimilars Industry 2015. The report covers the following:
An analysis of what are biosimilars.
Emergence of biosimilars and the role of the Biologics Price Competition and Innovation (BPCI) Act. Issue of data exclusivity is touched upon.
Biosimilars are defined and their specificity is analyzed. We look at categories of biologics, importance of biosimilars, comparison of biosimilars with generics is carried out and a branded product business model is also included.
An overview of the biopharmaceutical industry includes a market profile and the manufacturing process of biopharmaceuticals.
Analysis of the global biosimilars industry through market profile, market size, market value of branded biologics that face patent expiry, operating margin for biosimilar manufacturers, investor concerns regarding biosimilars and the commercial impact of the European biosimilars industry is looked at.
Key factors that determine success of the biosimilars industry are analyzed such as long term strategy of the market, development of competitive intelligence, proper financial structure, etc.
Impacts on the global biosimilars industry are analyzed, along with market drivers and challenges.
Regulatory framework governing the global biosimilars industry is analyzed in Europe, Japan, and the United States. We also analyze biosimilar approval pathways in the US and Europe.
Factors determining market entry in the global biosimilar industry are looked at including biosimilars manufacturing in emerging markets.
Competition in the industry is analyzed through key industry players, key industry suppliers, generic drug producers, major stakeholders in the industry, developed versus emerging biosimilar markets, biosimilar launches, etc.
Biosimilar markets analyzed in the report include Australia, BRIC countries, European Union nations (France, Germany, Italy, Spain and the UK), Japan and the US.
Analysis of some major biosimilars are carried out - Epoetin, Filgrastim and Somatropin.
Patent expiries of branded drugs and opportunities for biosimilars are analyzed including the strategies being employed by Big Pharma to combat biosimilars.
A country-wise analysis of the biosimilar market is carried out for France, Germany, India, Italy, Japan, Spain, the UK and the United States.
An analysis of the major industry players through a company overview, analysis of the business segments, their presence in the global biosimilars market and a SWOT analysis.
A total of 15 major biosimilar players are analyzed in the report.
Global biosimilars market outlook includes an overall market outlook, forecast for biosimilar sales, forecast for the US biosimilar market, forecast for the European biosimilar market, the Japanese biosimilars market, forecast for biosimilars for monoclonal antibodies against cancer, EPO biosimilar market forecast, hGH biosimilar market forecast, and other biosimilar market forecast is also included.