RECOMBINANT ERYTHROPOIETIN MARKET ANALYSIS

The global recombinant erythropoietin market size was valued at US$ 7.01 billion in 2023 and is expected to reach US$ 8.68 billion by 2030, grow at a compound annual growth rate (CAGR) of 3.1% from 2023 to 2030.

Recombinant erythropoietin (rEPO) is a synthetic version of the hormone erythropoietin, which is responsible for regulating red blood cell production in the body. The rEPO market is primarily driven by its use in treating anemia associated with chronic kidney disease, cancer chemotherapy, and other conditions that result in low red blood cell levels.

Global Recombinant Erythropoietin Market Regional Insights

• North America: North America has been a significant market for recombinant erythropoietin due to well established healthcare infrastructure and high prevalence of chronic kidney disease and cancer. The U.S., in particular, has a large patient population requiring rEPO therapy. Stringent regulatory frameworks and reimbursement systems also influence the market, and this region holds a substantial percentage of the market share, accounting for approximately 33.5%.
• Europe: Europe is another important market for recombinant erythropoietin. Countries like Germany, France, and the U.K. have a high demand for rEPO due to a significant patient population with anemia associated with chronic kidney disease and cancer. Robust healthcare systems, favorable reimbursement policies, and well-established pharmaceutical industries contribute to market growth and Europe holds around 26.1% of the market share.
• Asia Pacific: The Asia Pacific region presents significant opportunities for the recombinant erythropoietin market. Countries like China, Japan, and India have a large patient population and an increasing prevalence of chronic kidney disease and cancer. Rising healthcare expenditure, improving healthcare infrastructure, and increasing awareness about rEPO therapy contribute to market growth, and Asia Pacific accounts for approximately 20.3% of the market share.

Figure 1. Global Recombinant Erythropoietin Market Share (%), by Region, 2023

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Analyst View:

• The global recombinant erythropoietin market is expected to witness steady growth over the forecast period, driven by the rising prevalence of chronic kidney diseases and cancer globally. The growing number of patients suffering from anemia due to chemotherapy is increasing the demand for erythropoietin-stimulating agents. Additionally, the increasing approval of newer therapeutic indications for erythropoietin drugs will further aid the market expansion. North America currently dominates the market owing to high healthcare expenditures and growing awareness regarding the treatment of blood-related disorders in the region. However, the Asia Pacific region is poised to be the fastest-growing market in the coming years.
• The market is expected to face certain restraints, mainly due to the availability of biosimilars and clinical risks associated with recombinant erythropoietin. Biosimilars provide cost-effective treatment options and impose pricing pressure on innovator drugs. Furthermore, frequent product recalls over blood clotting risks may hamper physician confidence and adoption rates. Stringent regulations for drug approval also pose challenges. Nonetheless, market players have opportunities to tap the growth potential of developing nations through product innovations, branding, and strategic collaborations with local distributors. Moreover, the expansion of distribution channels in rural areas will further aid market penetration. In conclusion, though certain challenges persist, the global recombinant erythropoietin market.

Global Recombinant Erythropoietin Market Drivers:

• Rising Prevalence of Chronic Kidney Disease (CKD): CKD is a major driver of the global recombinant erythropoietin market. Patients with CKD often experience anemia due to decreased production of endogenous erythropoietin. rEPO therapy helps stimulate red blood cell production, improving anemia and reducing the need for blood transfusions in CKD patients. For instance, according to data published in April 2022, chronic kidney disease is a progressive condition that affects >10% of the general population worldwide, amounting to more than 800 million individuals in 2022.
• Increasing research and development activities: The demand for such life-saving drugs has been continually rising in recent years. Pharmaceutical companies have recognized the market potential and have been aggressively investing in research and development to develop more effective and affordable biosimilars. For instance, in October 2020, the Australian and New Zealand Intensive Care Research Center, initiated a clinical trial titled “A Randomized, Double-blind, Placebo-controlled Trial of Erythropoietin Alfa Versus Placebo in Mechanically Ventilated Critically Ill Patients Following Traumatic Injury”. The EPO-TRAUMA study is a prospective, multi-center, double-blind, phase III, randomized controlled trial evaluating the efficacy of epoetin alfa compared to placebo in reducing mortality and severe disability at six months in critically ill trauma patients. The study is currently in phase 3. The study is estimated txxxxo be completed on December 31, 2025.
• Rising demand for biosimilar erythropoietin: The demand for affordable treatment options across the globe is driving the growth of biosimilar erythropoietin in the global recombinant erythropoietin market. Biosimilar erythropoietin are identical versions of originator biologic drugs and offer a more cost-effective treatment for patients suffering from anemia. Major patent expiries of the few remaining blockbuster erythropoietin brands in the coming years will provide further impetus for biosimilar manufacturers to penetrate developing markets and expand their reach to a wider population. Although the ongoing pandemic situation poses short-term challenges, long-term demand for affordable biologic options is set to ensure sustainable growth opportunities for key players in this domain.
• Advancements in Biotechnology: Technological advancements in biotechnology have facilitated the production of recombinant erythropoietin through genetic engineering techniques. These advancements have improved the availability, efficacy, and safety profile of rEPO, driving its adoption in clinical practice.

Global Recombinant Erythropoietin Market Opportunities:

• Emerging Markets: There are significant opportunities for market expansion in emerging economies, particularly in Asia Pacific, Latin America, and parts of Africa. These regions have a growing patient population, improving healthcare infrastructure, and increasing healthcare investments, which create favorable conditions for the adoption of rEPO therapy.
• Untapped Therapeutic Areas: While rEPO is primarily used for anemia associated with chronic kidney disease and cancer, there are opportunities to explore its potential in other therapeutic areas. Research is being conducted to evaluate the efficacy of rEPO in conditions such as anemia related to inflammatory diseases, hematologic disorders, and neurodegenerative diseases. Expanding the application of rEPO to these untapped therapeutic areas can open new avenues for market growth.
• Biosimilars: The expiry of patents for original rEPO products has led to the development and commercialization of biosimilar versions. Biosimilars offer a more cost-effective alternative to the original rEPO products, increasing accessibility and affordability. The market for biosimilar rEPO is expected to grow as healthcare systems and regulators encourage their adoption.
• Collaborations and Partnerships: Collaboration between pharmaceutical companies, research institutions, and healthcare providers can drive innovation and market growth. Partnerships can help in conducting clinical trials, expanding product portfolios, and improving market access. Collaborative efforts can also support the development of advanced delivery systems and novel formulations of rEPO, enhancing patient experience and treatment outcomes.

Global Recombinant Erythropoietin Market Trends:

• Growing Focus on Biosimilars: The development and commercialization of biosimilar versions of rEPO products are gaining momentum. Biosimilars offer comparable efficacy and safety profiles to the original rEPO products at a lower cost. Increasing regulatory approvals and healthcare systems' emphasis on cost containment drive the adoption of biosimilars in the recombinant erythropoietin market.
• Shift towards Long-Acting Formulations: There is a trend towards the development of long-acting rEPO formulations that provide sustained effects and reduce the frequency of administration. These formulations offer convenience for patients and healthcare providers by reducing the number of injections required and improving treatment adherence.
• Focus on Patient-Centric Delivery Systems: Efforts are being made to develop patient-centric delivery systems for rEPO therapy. This includes the use of autoinjectors, wearable devices, and other advanced drug delivery technologies that enhance patient comfort, convenience, and self-administration capabilities. Patient-centric delivery systems aim to improve patient experience and overall treatment outcomes.
• Increasing Adoption of Subcutaneous Administration: Subcutaneous administration of recombinant erythropoietin is gaining popularity over traditional intravenous (IV) administration. Subcutaneous administration offers advantages such as ease of self-administration, reduced healthcare facility visits, and improved patient convenience. This trend is driven by the development of subcutaneous formulations and patients' preference for at-home treatment options.

Global Recombinant Erythropoietin Market Restraints:

• Stringent Regulatory Requirements: Regulatory agencies impose stringent requirements for the approval and use of rEPO products due to concerns related to safety, efficacy, and immunogenicity. Meeting these regulatory standards can be time-consuming and costly, posing challenges for market entry and product development.
• Safety Concerns and Side Effects: Although rEPO therapy is generally well-tolerated, there are safety concerns associated with its use. Excessive administration of rEPO can lead to adverse effects such as hypertension, thrombotic events, and pure red cell aplasia. These safety concerns may limit its use in certain patient populations and require careful monitoring and dose adjustments. For instance, according to data published on February 1, 2023, by the Mayo Foundation for Medical Education and Research (MFMER), the side effects of epoetin alfa include chest pain, bone or joint pain, red, irritated eyes, general feeling of tiredness or weakness, etc.
• Reimbursement Challenges: Reimbursement policies and limitations imposed by healthcare systems and insurance providers can pose challenges for the adoption of rEPO therapy. Limited reimbursement coverage, high out-of-pocket costs for patients, and stringent reimbursement criteria can impact market access and affordability.
• Counterbalance: Proper reimbursement policies should be there for recombinant erythropoietin drugs which can provide positive impact on the market.

Recent Developments

New product launches/ approval

• In July 2019, Kyowa Kirin Co., Ltd., a company involved in the discovery, development, production, and commercialization of pharmaceuticals and biotechnology products, announced the launch of the "Darbepoetin Alfa Injection Syringe [KKF]" in Japan.
• In September 2019, JCR Pharmaceuticals Co., Ltd., a pharmaceutical company, announced that they had received marketing approval in Japan for Darbepoetin Alfa BS Injection JCR, a long-acting erythropoiesis-stimulating agent.

Collaboration and partnerships

• In September 2020, Lotus Pharmaceutical Co., Ltd, which manufactures and distributes oral medicine, ointment, and injection medicine, announced a partnership with Chong Kun Dang Pharmaceutical Corp, a company engaged in the manufacture, distribution, research, and development of pharmaceuticals, for the biosimilar Darbepoetin alfa, a second-generation epoetin indicated for the treatment of anemia associated with chronic renal failure. This long-term partnership will provide Lotus Pharmaceutical Co., Ltd. the rights to market the Darbepoetin alfa exclusively in Taiwan and South East Asian markets.
• In October 2020, Astellas Pharma Inc., a pharmaceutical company, announced that, in collaboration with FibroGen, a biopharmaceutical company, and AstraZeneca, a global pharmaceutical company, 42 roxadustat abstracts will be presented at the American Society of Nephrology (ASN) Kidney Week 2020 Reimagined Congress. Six abstracts (one oral presentation and five ePosters) sponsored by Astellas focus on the use of roxadustat as a treatment in adult patients with anemia of chronic kidney disease (CKD). These abstracts include presentations of the Phase 3 DOLOMITES study (abstract #TH-OR02) and a Japanese Phase 3 CL-0310 study (#PO0269), with both studies evaluating roxadustat versus darbepoetin alfa as a treatment for patients with anemia of CKD not on dialysis. Other presentations include safety data from two Japanese Phase 3 studies assessing the ophthalmological effects of roxadustat treatment in patients with anemia of CKD on dialysis and not on dialysis, and a study of patients' treatment preferences for anemia of CKD.

Figure 2. Global Recombinant Erythropoietin Market Share (%), by Drug Type, 2023

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Top companies in Global Recombinant Erythropoietin Market

• Amgen Inc.
• Johnson & Johnson (Janssen Pharmaceuticals)
• Pfizer Inc.
• F. Hoffmann-La Roche AG
• Novartis AG
• Biocon Limited
• LG Chem Ltd.
• Intas Pharmaceuticals Ltd.
• Dr. Reddy's Laboratories Ltd.
• Celltrion Inc.
• 3SBio Inc.
• BioSidus SA
• Astellas Pharma Inc
• Lotus Pharmaceutical Co., Ltd

*Definition: Recombinant erythropoietin (rEPO) is a growth factor produced in the kidneys that stimulates the production of red blood cells. It works by promoting the division and differentiation of committed erythroid progenitors in the bone marrow.