Erythropoietin Drugs Market Analysis By Drug Class (Biologics, Biosimilars), By Product (Epoetin-alfa, Epoetin-beta, Darbepoetin-alfa, Others), By Application, And Segment Forecasts, 2018 - 2025

Report Overview

The global erythropoietin drugs market size was valued at USD 7.4 billion in 2016 and is expected to witness a CAGR of 11.5% during the forecast period. Increasing incidence of chronic diseases such as end-stage renal diseases, cancer, and HIV is expected to accelerate demand for EPO-stimulating agents as these diseases may cause anemia. To curb the rising incidence of anemia, the demand for Erythropoietin (EPO) drugs is expected to increase over the coming years.

One of the major reasons for anemia is Chronic Kidney Diseases (CKD). Rising incidence of CKD is the key contributing factor responsible for the growing demand. According to statistics published by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), approximately 661,000 people are affected by kidney failures in the U.S., and the number is projected to increase in the near future. This is anticipated to fuel the demand for the market further.

U.S. erythropoietin drugs market revenue by drug class, 2014 - 2025 (USD billion)

Patent expiration of major biologics during the coming years creates opportunities for the entry of erythropoietin biosimilars in the market. For instance, Amgen’s patent for Epogen expired in 2015, which offered tremendous opportunities for other companies to enter the industry. Hence, it is expected that there will be an increase in the number of new entrants investing in the market, leading to growth.

The prevalence rate of cancer, HIV, and CKD in developing countries is high, which serves as an important opportunity for drug manufacturers to expand their presence in this market. There is an increased demand for low-cost therapeutics in developing countries such as Asia Pacific and Middle East &Africa, which has triggered the production of biosimilars for EPOs in such regions. Growing utilization of biosimilar EPOs is anticipated to boost the growth of the overall EPO market in the coming years.

Erythropoietin Drugs Market Trends

Rising incidences of chronic diseases such as cancer, end-stage renal diseases, HIV, and neurological diseases are driving the erythropoietin drug market growth. Erythropoietin (EPO) drugs can be used for the treatment of severe anemia in patients suffering from kidney disorders, HIV, and cancer. As stated by the UNAIDS, in 2020, around 37.7 million people were suffering from HIV worldwide. According to the CDC, more than 37 million people in the U.S. suffered from chronic kidney diseases (CKD) in 2021. Thus, the demand for erythropoietin drugs is expected to be high during the forecast period.

Cancer patients undergo chemotherapy which affects the bone marrow, thus affecting the erythrocyte production. Additionally, if platinum drugs are used for chemotherapy, they affect the kidneys, affecting the erythropoietin hormone production. These factors lead to anemia in cancer patients. Across the Globocan, worldwide, around 19.3 million new cancer cases were diagnosed in 2020. This is attributed to the erythropoietin drugs market growth.

Moreover, the patent expiration of branded drugs has led to the use of recombinant DNA technology to develop biosimilars of erythropoietin drugs. Companies such as Biocon Ltd, Intas Pharmaceuticals Ltd., Ranbaxy Laboratories Ltd., and Dr. Reddy's Laboratories Ltd. developed biosimilars Erypro Safe, Epofit, Ceriton, and Cresp respectively, and entered the erythropoietin drug market. The expanding biosimilar availability across the globe is anticipated to propel market growth.

Increased therapeutic benefits associated with recombinant human erythropoietin (EPO) are expected to exhibit growth in the Erythropoietin Drug market. Apart from treating anemia, EPO is potentially advantageous in conditions such as brain disorders. EPO, when administered systematically, crosses the blood-brain barrier, thus improving neuroplasticity and enhancing cognitive functions in numerous brain disorders. Moreover, EPO treatment has been shown to stimulate neurogenesis, activate antioxidants, and anti-inflammatory signaling pathways, thus expanding the therapeutic benefits and supporting the market growth. For instance, in a study published in Alzheimer's Association, NeuroEPO showed positive clinical outcomes in patients with Alzheimer's disease.

Erythropoietin drugs are used as anti-anemic and performance-enhancing drugs. However, the high cost of erythropoietin drugs is one of the major factors impeding market growth, especially in developing and underdeveloped regions. Annually, the average cost per patient is around $12,319.41 and $919.47 for darbepoetin-alfa and epoetin-beta. Additionally, the growth and development of biosimilars could slow down the market growth, due to resulting in the loss of market share of companies selling branded erythropoietin drugs.

In addition, erythropoiesis-stimulating agents have different pharmacokinetic and pharmacodynamics properties, including half-lives and receptor affinity that directly affects the dosing and ease of administration of the drugs. However, there are adverse effects associated with erythropoietin treatment. The Japanese Registry of Dialysis study reported that there is about a 20% higher mortality risk from any cause in patients receiving long-acting ESA treatment as opposed to short-acting ESA ones. Auxiliary use of ESA can increase blood viscosity, which can increase the risk of myocardial infarction and ischemic stroke. These factors are expected to hinder the market growth.

Drug Class Insights

Of the various drug classes, the biologics erythropoietin class held a dominant share as of 2016, owing to patent protection. Presence of large patient population and higher uptake of biologics are other contributing factors towards its dominance. In addition, the availability of very few biologics in the market has led to increased adoption. Furthermore, owing to its wide applications in the treatment of CKD, the biologics segment accounted for the majority of the revenue share.

The biologics segment is anticipated to lose its market share due to recent patent expiration of major brands such as Epogen. This drug lost its patent exclusivity in May 2015, which resulted in reduced sales revenue for its manufacturer company, Amgen Inc.

Biosimilars are expected to gain popularity in the near future for the treatment of anemic conditions. Biosimilars are easy to develop, cost-effective, and require less time for approval as compared to biologics. These associated advantages are expected to propel the segment growth throughout the forecast period.

Increasing investments in R&D for biosimilars, strong product pipeline, and collaborations between hospitals &manufactures for the adoption of EPO biosimilars are key market drivers for the growth of the biosimilar segment. The recent launch of erythropoietin biosimilars in the U.S. is further expected to showcase a paradigm shift in global EPO drugs from biologics to biosimilars.

Product Insights

In the product segment, Epoetin-alfa held a dominant share due to its wide adoption amongst healthcare professionals. This product was the first biologic to be approved by the U.S.FDA for the treatment of anemia resulting from CKD, cancer chemotherapy, and HIV treatment. Epoetin-alfa was patent-protected, which restricted the production of any other recombinant human erythropoietin drug and helped this segment dominate in 2016.

Epoetin-beta is a recombinant form of epoetin-alfa. This segment held a considerable share in the products segment owing to its benefits such as improved efficacy and a longer half-life in comparison with epoetin-alfa. NeoRecormon, developed by F. Hoffman-La Roche, is the first drug containing epoetin-beta as the active ingredient.

Darbepoetin-alfa is yet another novel erythropoietin drug developed by Amgen, Inc., which is marketed under the brand name Aranesp. The patent for this drug expires in 2024 in the U.S. Until this period, this drug enjoys patent exclusivity rights in the U.S. In Europe, the patent for Aranesp expired in 2016, due to which the sales of this drug have decreased in this region.

Darbepoetin-alfa is anticipated to witness positive growth in the future due to its cost-effectiveness, improved efficacy, and longer half-life. This is a viable solution for the treatment of anemia rising from end-stage renal diseases. Research is being undertaken for the discovery of new therapeutic areas for the application of darbepoetin-alfa, which is expected to serve this industry with growth potential.

Other medications such as epoetin-zeta and epoetin-omega are expected to exhibit a lucrative growth rate in the coming years. These are biosimilar formulations of epoetin-alfa but are more effective in the treatment of anemic conditions. EporatiobyTeva Pharmaceutical Industries, Ltd. and Mircera by F. Hoffmann-La Roche Ltd. are major products in this segment.

Application Insights

Renal diseases held a dominant share as prevalence of anemia is increasing at a constant rate. The first erythropoietin drug, Epogen was approved by the U.S. FDA for the treatment of anemic indications arising from CKD. Owing to early introduction of this drug for the treatment of CKD and rising incidence of the same, this segment dominated as of 2016.

The cancer segment is expected to be the fastest-growing segment owing to the increasing number of cancer incidence worldwide. Cancer chemotherapy involves the use of medication that reduces the RBC count amongst patients. As a result, usage of these alongside chemotherapy has become common in recent years. This has resulted in increasing demand for EPO drugs for cancer treatment, which augments growth.

The hematology segment is anticipated to witness steady growth over the forecast period due to rising R&D initiatives to develop cost-effective and viable solutions for treating conditions such as hypoxia and anemia of prematurity. Proper dosage of recombinant human erythropoietin can cure anemia of prematurity and reduces the need of multiple blood transfusion in neonates. This is expected to serve this industry with growth potential.

The neurology segment is expected to showcase growth over the forecast period as many of the erythropoietin drugs are considered to be an effective solution for treating neurological disorders such as Parkinson’s disease. Companies are involved in discovering new therapeutic areas for application of erythropoietin-stimulating agents, apart from the treatment of anemia. Major therapeutic research is being carried out for the neurology segment.

Regional Insight

North America held a considerable share of erythropoietin drugs as of 2016 owing to the increasing incidence of chronic diseases such as cancer, CKD, and HIV. According to the Centers for Disease Control and Prevention (CDC), in 2019, around 1.2 million people were living with HIV in the U.S.  These statistics indicate the need for EPO drugs over the forecast period.

Global erythropoietin drugs market revenue, by application, 2016 (%)

The UK market for erythropoietin drugs is expected to grow steadily due to the well-established healthcare system, increasing incidence of end-stage renal diseases, HIV, and cancer. According to research, nearly 15% of UK people aged 35 years or above have chronic kidney disease that costs USD 1.75 billion annually to the NHS. Moreover, the high number of non-governmental organizations such as the Renal Association, which aims to provide and propagate the knowledge on the best treatment for CKD, fueling the market growth.

The Japan erythropoietin drugs market is expected to grow at a lucrative growth rate over the forecast period due to factors such as rising economic development in healthcare, favorable reimbursement policies, and the increasing prevalence of cancer and anemia. The country's healthcare policies provide around 70 % reimbursement for cancer treatment. Such a favorable reimbursement scenario raises the number of people opting for chemotherapy, thereby increasing the use of erythropoietin drugs. Higher healthcare awareness level and high demand for advanced therapies are the major factors boosting the regional market growth. 

Competitive Insights

The major companies in this industry are Johnson & Johnson; Celltrion, Inc.; Teva Pharmaceutical Industries Ltd.; Amgen, Inc.; F. Hoffmann-La Roche Ltd.; LG Life Sciences Ltd.; Biocon Limited; Intas Pharmaceuticals Ltd.; Sun Pharmaceutical Industries Ltd.; and Dr. Reddy’s Laboratories Ltd.

This industry is witnessing significant growth owing to the patent expiration of biologics. This has attracted several local and international players to invest in the production of erythropoietin drugs. The key factor responsible for the rising participation of various companies is to cater to the growing demand for anemia treatment.

The industry is competitive in nature with key players involved in continuous product development and partnership alliances to aid market penetration. Rising number of distributors and dealers are also expected to elevate industry rivalry in the near future.

Industry players are involved in extensive R&D activities. Many biosimilar products are under clinical trials in the U.S. & Europe, which are expected to gain approval over the coming years. Thus, owing to the aforementioned factors, competitive rivalry for this market is expected to be high throughout the forecast period.

Erythropoietin Drugs Market Report Scope

Segments Covered in the Report

This report forecasts revenue growth at global, regional, & country levels and provides an analysis of the industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the global erythropoietin drugs market on the basis of drug class, product, application, and region:

• Drug Class Outlook (Revenue, USD Million, 2014 - 2025)

  • Biologics

  • Biosimilars

• Product Outlook (Revenue, USD Million, 2014 - 2025)

  • Epoetin-alfa

  • Epoetin-beta

  • Darbepoetin-alfa

  • Others

• Application Outlook (Revenue, USD Million, 2014 - 2025)

  • Cancer

  • Hematology

  • Renal diseases

  • Neurology

• Regional Outlook (Revenue, USD Million, 2014 - 2025)

  • North America

    • The U.S.

    • Canada

  • Europe

    • Germany

    • The U.K.

  • Asia Pacific

    • Japan

    • China

    • India

  • Latin America

    • Brazil

    • Mexico

  • The Middle East and Africa

    • South Africa