Bioengineering: sales growth forecast
The volume of the global biosimilar market may reach USD 55 billion by 2020
Weekly Pharmacy www.apteka.uaAccording to the report of the analytical company "GBI Research" (Global Biosimilars Market Value Could Hit $55 Billion by 2020, says GBI Research – VM), the total sales of biosimilars – medicines of biological origin containing an analogue of the active substance of a biological drug – in the global pharmaceutical market will increase from $20 billion.
Projected by the end of 2015, up to 55 billion US dollars by 2020. According to analysts, the growth of this market will primarily be due to promising drugs that are currently under development, as well as the desire of governments of various countries to reduce healthcare costs.
According to GBI Research, today biologics account for an average of 17-20% of the global pharmaceutical market with sales of about $ 200 billion. It is worth noting that these products can replace 70% of chemical medicines in the next 20 years.
According to Sumith Ladda, an analyst at GBI Research, a reduction in the price of biosimilars by 30-50% compared to original biological products can lead to significant savings in healthcare costs.
Currently, 642 biosimilars are being studied, bioequivalent to 146 original molecules. At the same time, the main therapeutic area of application of drug candidates is the therapy of oncological diseases. The share of such biosimilars is 36%. At the same time, medicines used in the field of immunology account for 21% of developments. Consequently, these 2 segments focus on themselves more than half of all research.
S. Ladda stressed that at first the main objects for the development of biosimilars were simple proteins, such as filgastrim and epoetin. But today, the focus of development has shifted to monoclonal antibodies, as numerous blockbusters based on them lose patent protection.
Among other things, the GBI Research report states that while the regulatory framework for the approval of biosimilars has been adopted in all major markets, some aspects, for example, interchangeability and issues related to extrapolation by indications, must still be agreed and harmonized.
As S. Ladda explained, the European Medicines Agency (EMA) has developed and implemented clear guidelines for this category of drugs. It is worth noting that countries such as Japan, China and South Korea have already developed similar recommendations.
The US Food and Drug Administration (FDA) completed work on recommendations for biosimilars in 2014. Already on March 6, 2015, marketing permission was granted to the first Zarxio/Zarsio biosimilar (filgrastim). According to analysts, this indicates the confident entry of biosimilars into the American pharmaceutical market. S. Ladda emphasizes that the market of biological drugs in the USA is 2 times larger in monetary terms compared to that in the EU countries. But the level of introduction of biosimilars in Europe is almost 4 times higher, which indicates a future increase in the share of these drugs in the US pharmaceutical market.
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08.07.2015