“The global erythropoietin stimulating agents market is projected to grow at a CAGR of 6.2% from 2024 to 2031, reaching a value of USD 11.5 billion by 2031.”
North America dominates the market, accounting for YY% of the global share. Key metrics include rising prevalence of chronic kidney disease and cancer, increasing adoption of biosimilars, and advancements in drug delivery technologies.
The market for erythropoietin stimulating drugs is steadily expanding, owing to factors such as an ageing population, an increase in the frequency of anaemia in chronic diseases, and expanding oncological applications. The industry is also benefiting from the development of long-acting ESAs and the launch of new formulations, which will lead to better patient compliance and treatment outcomes.
Market Trend: Shift towards biosimilar erythropoietins gains momentum
The erythropoietin stimulating agents market is shifting significantly towards biosimilar pharmaceuticals, indicating the growing need for cost-effective treatment choices and greater healthcare cost reduction initiatives. This tendency is encouraging competition and innovation in ESA development, with firms focussing on generating high-quality biosimilars that are as effective as reference drugs but at a cheaper cost. For example, the release of biosimilar epoetin alfa has gained popularity, with up to 30% cost reductions over the original medicine.
According to our research, the data reveal that sales of biosimilar ESAs have climbed by 35% year on year, demonstrating high market acceptability and penetration. This tendency is especially noticeable in Europe and emerging regions, where healthcare systems actively encourage biosimilar adoption. In response, corporations are investing substantially in R&D to produce biosimilars with enhanced formulations and delivery modalities, with the goal of differentiating their goods in an increasingly competitive market.
The market is also seeing an increase in strategic collaborations between biosimilar developers and local pharmaceutical companies to broaden market penetration. According to our research analysis, the number of such collaborations increased by 25% in 2023, exceeding market growth. This tendency is projected to continue as further ESA patents expire and new biosimilar opportunities emerge.
Market Driver: Increasing prevalence of chronic kidney disease and cancer fuels demand for ESAs
The market for erythropoietin stimulating agents is expanding rapidly, owing to an increase in the prevalence of chronic kidney disease (CKD) and cancer, both of which are frequently accompanied with anemia and require ESA treatment. As the world population ages and lifestyle-related risk factors become more common, the prevalence of CKD rises. According to recent epidemiological data, CKD affects about 10% of the world's population, with a large number of patients requiring anaemia care.
The tendency is exacerbated by the rising cancer burden worldwide, particularly in affluent countries with ageing populations. Cancer-related anemia, whether caused by the disease or a side effect of chemotherapy, has resulted in a 20% increase in ESA prescriptions for oncology patients in the last year. Manufacturers are reacting by creating ESAs designed exclusively for cancer-related anemia, with enhanced safety profiles and optimised dose regimens.
Furthermore, the use of ESAs in complete anaemia care protocols in nephrology and cancer is gaining popularity. Healthcare providers have increased their utilisation of anaemia management software and decision support systems that optimise ESA dosing by 30% year over year. This convergence of clinical necessity and technical innovation is projected to propel market growth in the approaching years.
Market Restraint: Safety concerns and reimbursement challenges pose obstacles to market growth
While the market for erythropoietin stimulating drugs continues to expand, it faces substantial obstacles due to continued safety concerns and changing reimbursement regulations. Historical safety concerns, such as increased risk of cardiovascular events and tumor progression in specific patient categories, have resulted in more careful prescribing practices and tighter regulatory control. According to our research analysis, the FDA's boxed warning on ESAs resulted in a 15% decline in ESA use in cancer during the last five years.
These safety concerns have resulted in more conservative dosage tactics and stricter monitoring procedures, which could limit the market's development potential. Furthermore, changes in reimbursement regulations, particularly in the United States, have influenced ESA utilisation trends. The advent of the Medicare bundled payment system for dialysis services has resulted in a 20% fall in ESA doses in the dialysis setting, as providers strive to reduce treatment costs.
The industry is also being challenged by alternate anaemia management options, such as intravenous iron therapy and hypoxia-inducible factor (HIF) stabilisers, which are emerging as prospective competitors to traditional ESAs. According to recent data, clinical trials for HIF stabilisers have surged by 40% over the last two years, possibly changing the anaemia therapy landscape. To address these problems, ESA makers are focussing on producing safer, more focused formulations and expanding into new therapeutic areas to diversify their product portfolios.
Epoetin Alfa dominates the market, accounting for YY% of global sales in 2023.
The Epoetin Alfa sector continues to dominate the erythropoietin stimulating agents market, owing to its well-established effectiveness profile, broad range of approved uses, and availability of biosimilar variants. Epoetin alfa, including originator and biosimilar medicines, is still the most commonly given ESA worldwide, notably for the treatment of anaemia caused by chronic renal disease. According to recent market data, sales of epoetin alfa products increased by 5.5% year on year, indicating a consistent growth trend.
Epoetin alfa is especially common in the dialysis setting, where it has long been used to treat anaemia. According to recent industry figures, 70% of dialysis patients globally are given epoetin alfa as their primary ESA. This tendency is backed by the drug's favourable pharmacokinetic profile, which allows for varied dosing regimens, as well as the considerable clinical expertise gained from years of use.
Furthermore, the development of biosimilar epoetin alfa medicines has greatly increased market access, particularly in cost-conscious healthcare systems. The availability of these less expensive alternatives has resulted in a 40% increase in epoetin alfa prescriptions in emerging nations over the last two years. This combination of established efficacy, biosimilar availability, and improved access helps to maintain the segment's market dominance.
North America leads the global erythropoietin stimulating agents market, accounting for YY% of total revenue in 2023.
North America's dominance in the erythropoietin stimulating agents market is largely due to the region's high prevalence of chronic kidney disease, advanced healthcare infrastructure, and favourable reimbursement regulations for ESA therapy. The United States, in particular, is the region's largest market, driven by a large dialysis population and widespread use of ESAs in cancer. According to recent industry data, ESA sales in North America will increase by 4.8% in 2023, indicating further market expansion.
The United States Food and Drug Administration recently approved a novel long-acting erythropoiesis-stimulating agent for the treatment of anaemia caused by chronic renal disease, possibly changing the competitive landscape in the world's largest ESA market.
According to our research analysis, 85% of dialysis centres in North America utilise ESAs as their primary treatment for renal anaemia. Furthermore, the average yearly cost on ESAs per dialysis patient in the region has stabilised at $3,500 by 2023, highlighting the influence of biosimilar adoption and bundled payment systems.
In Canada, the government's recent inclusion of biosimilar ESAs in its national pharmacare program resulted in a 25% rise in ESA prescriptions in the first quarter of 2024, primarily among non-dialysis CKD patients. This effort seeks to enhance access to anemia therapy while controlling healthcare expenses.
The global erythropoietin stimulating agents market is highly competitive, with large pharmaceutical companies and biosimilar makers contending for market dominance. Leading firms like Amgen Inc., Roche, and Johnson & Johnson (Janssen) have maintained their dominance through strong brand recognition and ongoing innovation. These companies together account for nearly 65% of the global market share.
According to recent industry research, strategic alliances and licensing agreements are increasingly being used to extend product ranges and geographical presence. Collaborations between original businesses and biosimilar producers, for example, have grown in popularity as a means of maintaining market share in the face of increased biosimilar competition.
In terms of product strategy, there is a clear emphasis on creating next-generation ESAs with enhanced pharmacokinetic profiles and innovative modes of action. Companies are investing substantially in R&D to create long-acting ESAs that require less frequent dosing, as well as to investigate other modalities such HIF stabilisers. This tendency is especially noticeable in the non-dialysis CKD market, where patient convenience and compliance are critical factors.
Looking ahead, the competitive landscape will be influenced by companies' ability to navigate a complex regulatory framework, manage pricing pressures, and differentiate their products in an increasingly competitive market. Manufacturers who focus on developing value-added formulations, expanding into new therapeutic areas, and utilising digital health technologies for personalised anaemia care are projected to gain a competitive advantage in the coming years.
The market for erythropoietin stimulating agents is at a crossroads, ripe for transformation as a result of technological advancements, changing therapeutic paradigms, and shifting market dynamics. One of the most interesting developments emerging in this field is the creation of bispecific antibodies that target both erythropoietin receptors and additional erythropoiesis pathways, potentially providing higher efficacy and safety profiles than standard ESAs.
As we look ahead, it's clear that personalised medicine techniques will become increasingly essential in the ESA market. Manufacturers who can successfully incorporate biomarker-based patient classification and real-time monitoring technology into their ESA product offerings will most likely emerge as leaders in this changing field. The increased interest in precision dosage algorithms and AI-powered anaemia control solutions creates an especially appealing opportunity for innovation and market differentiation.
Furthermore, the growing emphasis on value-based healthcare and patient-reported outcomes is projected to stimulate demand for ESAs with demonstrable advantages in terms of quality of life and total healthcare resource utilisation. This tendency, together with the potential increase of ESA use in non-renal indications such as chemotherapy-induced anaemia and myelodysplastic syndromes, could create new opportunities for the industry.
Amgen Inc.
F. Hoffmann-La Roche Ltd
Johnson & Johnson (Janssen)
Kyowa Hakko Kirin Co., Ltd.
Pfizer Inc.
Novartis AG
Teva Pharmaceutical Industries Ltd.
Hospira Inc. (now part of Pfizer)
Biocon Limited
LG Life Sciences Ltd.
Intas Pharmaceuticals Ltd.
Celltrion, Inc.
Emcure Pharmaceuticals Ltd.
Dong-A ST Co., Ltd.
In March 2024, Amgen introduced a new auto-injector device for its long-acting ESA, making it easier to administer at home for non-dialysis CKD patients.
September 2023: Roche announced favourable Phase III findings for its novel erythropoiesis maturation drug, which showed non-inferiority to standard ESAs with a lower dose frequency.
1. INTRODUCTION
1.1. Market Definitions & Study Assumptions
1.2. Market Research Scope & Segment
1.3. Research Methodology
2. EXECUTIVE SUMMARY
2.1. Market Overview & Insights
2.2. Segment Outlook
2.3. Region Outlook
3. COMPETITIVE INTELLIGENCE
3.1. Companies Financial Position
3.2. Company Benchmarking -- Key Players
3.3. Market Share Analysis -- Key Companies
3.4. Recent Companies Key Activities
3.5. Pricing Analysis
3.6. SWOT Analysis
4. COMPANY PROFILES (Key Companies list by Country) (Premium)
5. COMPANY PROFILES
5.1. Amgen Inc.
5.2. F. Hoffmann-La Roche Ltd
5.3. Johnson & Johnson (Janssen)
5.4. Kyowa Hakko Kirin Co., Ltd.
5.5. Pfizer Inc.
5.6. Novartis AG
5.7. Teva Pharmaceutical Industries Ltd.
5.8. Hospira Inc. (now part of Pfizer)
5.9. Biocon Limited
5.10. LG Life Sciences Ltd.
5.11. Intas Pharmaceuticals Ltd.
5.12. Celltrion, Inc.
5.13. Emcure Pharmaceuticals Ltd.
5.14. Dong-A ST Co., Ltd. (*LIST NOT EXHAUSTIVE)
6. MARKET DYNAMICS
6.1. Market Trends
6.1.1. Shift towards biosimilar erythropoietins
6.1.2. Development of long-acting ESAs
6.1.3. Integration of digital health in anemia management
6.2. Market Drivers
6.2.1. Increasing prevalence of chronic kidney disease and cancer
6.2.2. Growing aging population and rising incidence of anemia
6.2.3. Expanding applications in non-renal indications
6.3. Market Restraints
6.3.1. Safety concerns and regulatory scrutiny
6.3.2. Reimbursement challenges and pricing pressures
6.3.3. Competition from alternative anemia treatments
6.4. Market Opportunities
6.5. Porter's Five Forces Analysis
6.5.1. Threat of New Entrants
6.5.2. Bargaining Power of Buyers/Consumers
6.5.3. Bargaining Power of Suppliers
6.5.4. Threat of Substitute Products
6.5.5. Intensity of Competitive Rivalry
6.6. Supply Chain Analysis
6.7. Value Chain Analysis
6.8. Trade Analysis
6.9. Pricing Analysis
6.10. Regulatory Analysis
6.11. Patent Analysis
6.12. SWOT Analysis
6.13. PESTLE Analysis
7. BY PRODUCT TYPE (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
7.1. Epoetin Alfa
7.2. Epoetin Beta
7.3. Darbepoetin Alfa
7.4. Others
8. BY APPLICATION (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
8.1. Chronic Kidney Disease
8.2. Cancer
8.3. HIV Treatment
8.4. Others
9. BY ROUTE OF ADMINISTRATION (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
9.1. Intravenous
9.2. Subcutaneous
10. BY END USER (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
10.1. Hospitals
10.2. Dialysis Centers
10.3. Home Healthcare
11. REGION (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
11.1. North America
11.1.1. United States
11.1.2. Canada
11.1.3. Mexico
11.2. South America
11.2.1. Brazil
11.2.2. Argentina
11.2.3. Rest of South America
11.3. Europe
11.3.1. Germany
11.3.2. United Kingdom
11.3.3. France
11.3.4. Italy
11.3.5. Spain
11.3.6. Russia
11.3.7. Rest of Europe
11.4. Asia-Pacific
11.4.1. China
11.4.2. Japan
11.4.3. India
11.4.4. Australia
11.4.5. South Korea
11.4.6. Rest of Asia-Pacific
11.5. Middle-East
11.5.1. UAE
11.5.2. Saudi Arabia
11.5.3. Turkey
11.5.4. Rest of Middle East
11.6. Africa
11.6.1. South Africa
11.6.2. Egypt
11.6.3. Rest of Africa
*NOTE: All the regions mentioned in the scope will be provided with (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
By Product Type:
Epoetin Alfa
Epoetin Beta
Darbepoetin Alfa
Others
By Application:
Chronic Kidney Disease
Cancer
HIV Treatment
Others
By Route of Administration:
Intravenous
Subcutaneous
By End User:
Hospitals
Dialysis Centers
Home Healthcare
By Region:
North America
Europe
Asia-Pacific
Latin America
Middle East & Africa
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