Global Erythropoietin Stimulating Agents Market - 2020-2027
內因性促血紅細胞生長素 (EPO) ，是用尿細管合成的糖蛋白質造血荷爾蒙。控制及調節骨髓的紅血球生成的機制。紅血球造血刺激因素製劑 (ESA) ，有助於紅血球的刺激成長。推薦於慢性腎衰竭，化療，HIV造成的貧血的治療。
本報告提供全球紅血球造血刺激因素製劑 (ESA) 市場相關調查分析，產業分析，各市場區隔的市場分析，競爭情形，主要企業等相關的系統性資訊。
Endogenous erythropoietin (EPO) is a glycoprotein hematopoietic hormone synthesized, in the renal tubules. It controls and regulates the mechanism of erythropoiesis in the bone marrow. Erythropoietin stimulating agents (ESAs) are useful for stimulating the growth of the red blood cells. Erythropoietin stimulating agents are recommended for the treatment of the anemia due to chronic kidney failure, chemotherapy, and HIV. These stimulating agents are also useful for the treatment of reduced red blood cells during critical surgical procedures. The market is dominated by the availability of the several erythropoietin stimulating agents such as epoetin-alfa, epoetin-beta, epoetin omega, epoetin delta and darbepoetin-alpha. The global erythropoietin stimulating agents market valued USD XX million in 2019 and it is expected to grow at a CAGR of XX% to reach USD XX million by 2020-2027.
The market is driven by the growing demand for the erythropoietin stimulating agents (ESAs) with the increasing prevalence of the anemia. According to the World Vision Organization, more than 2 billion people are suffering from anemia worldwide. Males and females of all ages are affected with anemia. It is most common among the pregnant women and young children. Iron deficiency is the major cause of the anemia and insufficient red blood cell production. Several parasite infections, such as ascaris, schistosomiasis, and hookworms, lower the hemoglobin (Hb) concentration in blood. There is growing usage of the erythropoietin stimulating agents among the patients with HIV infections, cancer, and end-stage renal disorder. The increase in the number of the people undergoing the surgeries shall stimulate the market growth. The people undergoing the surgeries are at high risk of developing the thrombosis.
There is increase in the approval of the erythropoietin stimulating agents. For instance, in September 2019, JCR Pharmaceuticals Co., Ltd. and Kissei Pharmaceutical Co., Ltd. had received the approval for the Darbepoetin Alfa BS Injection JCR, a long-acting erythropoiesis-stimulating agent in Japan. The Phase III study demonstrated the equivalence in efficacy and safety compared with Darbepoetin alpha (innovator product), along with the similarity in the safety profile.
In June 2018, Vifor Pharma Inc. had received the approval for Mircera (methoxy polyethylene glycol-epoetin beta) from the United States Food and Drug Administration (FDA) for the pediatric patients 5 to 17 years of age on hemodialysis who are converting from another ESA after their hemoglobin level was stabilized with an ESA.
The global erythropoietin stimulating agents market is segmented based on product type as the epoetin alfa, epoetin beta, darbepoetin alfa, and others. Epoetin alfa is the human erythropoietin produced in cell culture with the help of the recombinant DNA technology. Epoetin alfa is used for the treatment of the anemia among the people with the kidney disease. It is effective for treating the anemia occurred due to the chemotherapy treatments. It is not recommended for patients with cancers that originate in the bone marrow, such as acute myelogenous leukemia. It is also used among the anemic patients with the high risk of blood loss to reduce the need for blood transfusions before the planned surgeries. It is not preferred for the treatment of anemia from other causes such as iron or folate deficiency or gastrointestinal bleeding. It acts by signaling the bone marrow to make more red blood cells. The growing incidence of the cancer shall stimulate the market growth.
Further, the market is also classified based on the application as the cancer, renal disorders, anti-retroviral treatment, neural diseases, and others. The cancer segment accounts for the highest market share due to the growing usage of the erythropoietin stimulating agents for the treatment of the anemic patients being treated with the chemotherapy. Around, 75% of anemia cases occurred due to the cancer chemotherapy. The studies have demonstrated that the use of the erythropoietin stimulating agents are effective in improving the quality of life among the patients. Erythropoietin stimulating agents work by targeting the major cause of the anemia in cancer patients undergoing chemotherapy against the myelosuppression and endogenous erythropoietin deficiency. Epoetin alfa and epoetin beta are most recommended erythropoietin stimulating agents among the cancer-related anemia. Procrit, Epogen, and NeoRecormon are the widely used erythropoietin stimulating agents.
By region, the global erythropoietin stimulating agents market is segmented into North America, South America, Europe, Asia-Pacific, Middle-East, and Africa. Among all of the regions, North America dominated the global erythropoietin stimulating agents market and expected to grow at the highest CAGR during the forecasted period due to the high prevalence of the chronic diseases such as cancer, renal disorders, neural diseases, chronic kidney disease, and others. According to the Centres for Disease Control and Prevention (CDC), around 37 million people are suffering from the Chronic Kidney Disease. Chronic Kidney Disease is most common among the people with aged 65 years or older. There is presence of the large number of the companies developing the erythropoietin stimulating agents. There is increasing launch of the biosimilars with the enhanced efficacy, enhanced therapeutic effect, and cost-effectiveness. There is increasing research and development activities for the innovative molecules. Several companies are focusing on discovering new therapeutic areas for the existing drugs.
The global erythropoietin stimulating agents market is highly competitive with the presence of several international and local markets. Product diversification, revenue generation, and opportunities intensify the market competition. Amgen Inc., Biocon Limited, Celltrion Inc., F. Hoffmann-La Roche Ltd, Intas Pharmaceuticals Ltd, Johnson and Johnson, Pfizer Inc., Teva Pharmaceutical Industries Ltd, and Thermo Fisher Scientific are the leading market players with significant market share.
The major players are using product development, product launch, product approval, market expansion, and capacity utilization strategies for holding their market position. For instance, in May 2018, Pfizer Inc. had received the approval for Retacrit (epoetin alfa-epbx), a biosimilar to Epogen and Procrit (epoetin alfa) from the United States Food and Drug Administration (FDA) for all indications of the reference product. Retacrit is the biosimilar erythropoiesis-stimulating agent (ESA). Retacrit may provide patients and their physicians with increased access to a high-quality, lower-cost alternative treatment option for anemia and the reduction of allogeneic red blood cell (RBC) transfusions in certain patients. Retacrit is indicated for the treatment of the Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis, Zidovudine in HIV-infected patients, the effects of concomitant myelosuppressive chemotherapy, and reduction of allogeneic red blood cell (RBC) transfusions in patients undergoing elective, noncardiac, nonvascular surgery.
In March 2018, Chugai Pharmaceutical Co., Ltd. had received the approval for Mircera Injection Syringe 12.5弮g from the Ministry of Health, Labour and Welfare for the treatment of renal anemia in Japan. Mircera is a long-acting erythropoiesis stimulating agent that raises the stability of epoetin beta in the bloodstream through pegylation. It stimulates erythropoiesis by a different interaction with the erythropoietin receptor on progenitor cells in the bone marrow, and enables stable and sustained control of anemia.
Several companies are entering into the collaborations, acquisitions, mergers, and licensing activities. For instance, in January 2017, Amgen had entered into the six-year sourcing and supply agreement with DaVita Inc. Under the terms of the new agreement, Amgen would supply DaVita with Epogen (epoetin alfa) and Aranesp (darbepoetin alfa) in amounts necessary to meet a specified annual percentage of DaVita's and its affiliates' requirements for erythropoiesis-stimulating agents used in providing dialysis services in the United States and Puerto Rico.
In May 2016, Vifor Pharma, a company of the Galenica group, had expanded its erythropoiesis stimulating agent (ESA) portfolio with the licensing of commercialization rights in the United States dialysis market to Pfizer's Retacrit, a proposed biosimilar epoetin, in the field of nephrology.
In May 2015, Roche had entered into an exclusive license agreement for the commercialization of Roche's drug Mircera in the United States and Puerto Rico. Under the terms of agreement, Galenica has the exclusive right to commercialize Mircera in the United States and Puerto Rico. Roche would manufacture and supply Mircera to Galenica. Roche would receive upfront and milestone payments, supply reimbursements, and tiered royalties on Mircera sales in the United States and Puerto Rico.