Erythropoietin (EPO) is a hormone that is produced in the bone marrow that controls and promotes the mechanism of erythropoiesis–production of red blood cells; the major part is produced in kidneys in the stage of adulthood. Biotechnology companies produced the first genetically engineered EPO in the 1980s for clinical use and since then the hormone has been used and is available as a therapeutic agent. EPO drugs have vast therapeutically applications in the treatment of anemia induced as a side-effect of chemotherapy or radiation in case of cancer treatment, HIV therapy, or heart failure. EPO is available the market for these medical treatments under trade names, such as Epogen, Procrit, and Aranesp. Recent clinical investigations are being made on using drugs for the treatment of sickle cell anemia. Recent advance in application of recombinant DNA technology in human cell culture has led to synthetic version of the drug– epoetin alfa, epoetin beta, darbepoetin alfa, epoetin omega, and epoetin delta, among others; among these synthetic forms, Epoetin alfa and its advance version, Darbepoetin alfa, are the most popular drugs. Epoetin alfa and Darbepoetin alfa segments combined accounted for about 80% of total revenue generated by EPO drug market.
These were first manufactured by Amgen Inc., patented and sold under the brand name as Epogen and Aranesp respectively, had garnered huge sales. However, the drug went off-patent that led many key drug manufacturers to make cheap biosimilars to consolidate their market positions. Hospira had obtained FDA approval of its Epogen biosimilar, but has been embroiled in a lawsuit with Amgen that has asked the court to delay it launch for 180 days. Market speculations are rife that Hospira would win the suit, leading Amgen to a colossus loss of revenue by original biologics Epogen in the U.S.
Recent developments & trends in EPO drugs market– The disqualification of athletes
Recent developments suggest to the trend of EPO drugs being used as performance-enhancers by athletes. Meldonium, a form of EPO, was in news when Maria Sharapova, a Russian tennis player, was disqualified for consuming the drug since it is banned performance-enhancer. However, as the athlete claims she took it for treating a heart condition. Having said that, World Anti-Doping Agency added the EPO drug to the banned list only last year and the criteria for its inclusion does not garner unanimous support from the sports fraternity; WADA has mentioned just one reason for meldonium to be banned: athletes can use it to boost performance. This implies that not sufficient evidence has been found for the substance to have a negative effect on the health of athletes. The instance of the substance being banned has a long history– an entire cycling team was banned from the 1998 Tour de France for its consumption since it was considered as a performance enhancer.
Market prospects and way forward
These developments have not marred the competitive landscape scenario in EPO drugs market as continuous advanced are being made for expanding the clinical applications of these drugs. Xenetic has developed ErepoXen™, a polysialylated form of erythropoietin (EPO), which is useful for the treating anemia in pre-dialysis patients suffering with chronic kidney disease. Recently, doctors prefer giving patients dose of EPO drugs before bloodless surgery that will induce the body to generate RBC and re-infuses the blood lost during surgery; the trend of bloodless surgery is fast gaining traction across regions. Meanwhile, market availability of other biosimilar has emerged as low-cost option to the patients going for EPO drugs that has led to increased adoption, particularly in developing regions. These developments will have a major impact on shaping the market dynamics.
As per a report by Allied Market Research titled “World Erythropoietin Drugs Market - Opportunities and Forecasts, 2013 – 2020”, the global EPO drugs market is estimated to reach $11.9 billion by 2020, registering CAGR of 9.7% from 2014 to 2020. Increasing count of patients suffering from various anemic condition induced due to cancer, HIV and ESRD treatment; favorable medical reimbursements and fast commercialization of biosimilars for EPO drug are key factors that would boost the growth of the market across regions.