ERYTHROPOIETIN DRUGS MARKET ANALYSIS

Market Overview

Erythropoietin alfa is widely used to treat anemia and increase the red blood cells count in the body. Erythropoietin drugs are developed in vitro by extracting the erythropoietin from the human body and developing it through the use of recombinant DNA technology. Erythropoietin drugs are also used to treat anemia induced from cancer, multiple myloma and HIV associated anemia. Recombinant DNA technology has allowed researchers to develop synthetic forms of erythropoietin such as epoetin alfa, epoetin beta, epoetin delta and epoetin omega. The erythropoietin drugs market has witnessed strong adoption in the cancer and HIV associated anemia treatment. The erythropoietin alfa biosimilars have gained significant traction in the past two years and the market will witness the introduction of new biosimilars as the existing erythropoietin drugs undergo patent expiration.

Growing prevalence of Anemia and introduction of Biosimilar will drive market growth

As per the WHO report published in 2011, an estimated 800 million people are affected by Anemia globally with large prevalence observed in Asia Pacific and African region. In U.S., the prevalence rate for Anemia is 5.6% which is estimated to increase in the near future as the rate of cancer witnesses a growing trend. According to the study conducted by India Spend, India has the highest prevalence of Anemia worldwide with 10.6% of YLD’s caused due to disability. Factors such as poor sanitation facilities, lack of healthy diet and poverty are responsible for high prevalence of Anemia in the country.

The erythropoietin drugs market has seen a dramatic shift from reference drugs to biosimilar with major pharmaceutical companies such as Amgen, Novartis and Pfizer developing erythropoietin biosimilar. The growth is accounted to the fact that biosimilar are relatively easier to develop and less cost intensive which has increased the adoption rate.

Europe leads the market and Asia Pacific will witness significant growth

Europe is the largest market for erythropoietin drugs market with large patient pool, developed healthcare infrastructure and better reimbursement scenario. The pharmaceutical companies continue to introduce biosimilar in the region to compete against the reference drugs. The drug approval process is less stringent as compared to North America which leads to fast approval of drugs. The mortality rate is 1.2 per 100,000 population for Anemia across Europe. North America is going to be an important market for the erythropoietin drugs industry as the drugs under clinical trials get approval from FDA and key drugs such as Epogen and Aranesp face patent expiration

Asia Pacific region is fastest growing erythropoietin drugs market, with countries such as India and China showing lucrative growth. India has the highest prevalence of anemia in the world followed by China. According to study conducted by Stanford University, an estimated180 million people suffer from Anemia in central and eastern China with the old age population more prone to it. The market of erythropoietin drugs will grow significantly as major pharmaceutical companies continue to expand the drug manufacturing process in countries such as India, China and Japan. Factors such as less stringent regulatory scenario and commercialization of erythropoietin biosimilars in the region will drive the market forward.

Introduction of new erythropoietin biosimilar will intensify the market competition

The key players in the erythropoietin drugs market are Amgen, GlaxoSmithKline, Pfizer, Johnson & Johnson, Novartis, Biocon, Ranbaxy Laboratories and Teva Pharmaceutical ltd. Due to the high cost associated with the development of innovator drugs and the patent expiration of the first erythropoietin drug launched by Amgen, the major players in the market are introducing erythropoietin biosimilar in the market with major focus on darbepoietin alfa drug. Key biosimilar such as NuPIAO, KRN321, ErepoXen and JR-131 are present at various stages of clinical development. The market is consolidated in nature and the key pharmaceutical companies will aim to introduce erythropoietin drugs in under-penetrated markets such as India, China, Japan and U.S. to stay competitive in the market.

Key Developments

1. Major market players in the market are involved in various growth strategies such as applying for regulatory approval from concerning authorities, in order to gain competitive edge in the global market. For instance, in August 2019, GlaxoSmithKline plc (GSK) filed submission for market approval of Japanese New Drug Application (JNDA) to the Ministry of Health, Labour, and Welfare for its dapordustat. It is an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) for the treatment renal anemia caused in chronic key disease. Anemia in CKD is caused by deficiency of erythropoietin
2. Key companies in the market are involved in various business strategies such as gaining product approval from regulatory authorities, in order to expand their product portfolio. For instance, in May 2018, Pfizer, Inc., a U.S.-based pharmaceutical company, received the U.S. Food and Drug Administration (FDA) approval for RETACRIT, which is a biosimilar to Epogen and Procrit. It is the first and only FDA approved biosimilar erythropoiesis-stimulating agent.