Erythropoietin (EPO) Biomarkers Market
Erythropoietin (EPO) Biomarkers Market by Type (Erythropoietin Alfa, Erythropoietin Zeta), Application (Anemic disorder, Cancer, End-stage renal disorder), End User (Hospitals, Diagnostic Centers) - Global Forecast to 2030
OVERVIEW
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
The Erythropoietin (EPO) biomarkers market is projected to reach USD 1.06 billion by 2030 from USD 0.69 billion in 2025, at a CAGR of 9.0% from 2025 to 2030. Erythropoietin (EPO) biomarkers are the biological markers of erythropoietic function, oxygen sensing, and anemia status, and are employed for the support of diagnosis, disease monitoring, and treatment decision-making in conditions such as chronic kidney disease, cancer-related anemia, and other hematologic disorders.
KEY TAKEAWAYS
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BY REGIONThe APAC Erythropoietin (EPO) biomarkers market was the fastest growing at a CAGR of 12.5%.
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BY APPLICATIONThe cancer segment is expected to grow the fastest.
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BY TYPEErythropoietin alfa dominates the Erythropoietin (EPO) biomarkers market.
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COMPETITIVE LANDSCAPE - KEY PLAYERSAmgen Inc., Johnson & Johnson, and Roche were identified as some of the star players in the market, given their strong market share and product footprint.
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COMPETITIVE LANDSCAPE - STARTUPS/SMEsPerkinElmer and Eve Technology, among others, have distinguished themselves among startups and SMEs by securing strong footholds in specialized niche areas, underscoring their potential as emerging market leaders
The Erythropoietin (EPO) biomarkers market is expanding rapidly, propelled by the mainstreaming of precision medicine, broader reimbursement for diagnostic assays, and accelerating adoption of high-throughput immunoassays, multiplex platforms, and advanced analytics across oncology and chronic disease management.
TRENDS & DISRUPTIONS IMPACTING CUSTOMERS' CUSTOMERS
The EPO biomarkers market is expanding at a faster rate because of the availability of AI-assisted diagnostic solutions and remote anemia monitoring systems. The inclusion of hematocrit, reticulocyte count, and ferritin values in clinical trials, CKD management, and precision medicine increases the demand for validated endpoints. Pharma companies use big data analytics for uniform EPO characterization, which accelerates the development of biosimilars, improves patient selection in cancer, and maximizes treatment outcomes due to the rising incidence of chronic diseases.
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
MARKET DYNAMICS
Level
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Increasing prevalence of CKD and anemia-related conditions
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Advancement in biomarker diagnostics and precision medicine
Level
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High cost and limited accessibility of advanced testing
Level
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Point-of-care and home diagnostic innovations
Level
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Reimbursement and clinical adoption barriers
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
Driver: Increasing prevalence of CKD and anemia-related conditions
The rising global burden of chronic kidney disease and anemia associated with cancer and inflammatory disorders is driving demand for EPO biomarkers to support early diagnosis, disease stratification, and therapy monitoring.
Restraint: Regulatory uncertainty high cost and limited accessibility of advanced testing
Advanced EPO biomarker assays and associated analytical technologies remain costly and are often confined to specialized laboratories, limiting widespread adoption, particularly in resource-constrained healthcare settings.
Opportunity: Point-of-care and home diagnostic innovations
Advances in portable diagnostics and decentralized testing platforms create opportunities to expand EPO biomarker use beyond centralized labs, enabling faster clinical decision-making and improved patient monitoring.
Opportunity: Reimbursement and clinical adoption barriers
Limited reimbursement coverage and the absence of standardized clinical guidelines for EPO biomarker use pose challenges to routine adoption by healthcare providers and payers.
ERYTHROPOIETIN (EPO) BIOMARKERS MARKET: COMMERCIAL USE CASES ACROSS INDUSTRIES
| COMPANY | USE CASE DESCRIPTION | BENEFITS |
|---|---|---|
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Develops immunoassay-based EPO biomarker tests integrated into automated clinical laboratory platforms to measure endogenous erythropoietin levels and related hematologic parameters for anemia diagnosis and treatment monitoring in CKD and oncology settings. | Supports accurate diagnosis of anemia etiology, enables monitoring of erythropoiesis-stimulating agent (ESA) therapy response, improves treatment optimization, and enhances clinical decision-making in hospital and reference laboratory environments. |
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Provides quality control materials, assay systems, and laboratory workflows supporting standardized EPO biomarker testing and associated hematology markers across research and clinical laboratories. | Improves test reliability and reproducibility, supports regulatory compliance, enhances biomarker data quality, and enables consistent longitudinal monitoring of EPO-related disease states and therapeutic outcomes. |
Logos and trademarks shown above are the property of their respective owners. Their use here is for informational and illustrative purposes only.
MARKET ECOSYSTEM
The EPO biomarker market is where the manufacturers of diagnostic assays, suppliers of laboratory instruments, vendors of analytics solutions, pharmaceutical companies, CROs, healthcare providers, and reference laboratories come together. The suppliers provide validated immunoassays, hematology tests, and analytical solutions for the measurement of erythropoietin levels and erythropoietic response in a regulated clinical environment. The healthcare providers and dialysis centers require EPO biomarkers for anemia diagnosis and treatment monitoring, whereas pharmaceutical and CRO companies require them for clinical trials of patient stratification, efficacy evaluation, dose regimen optimization, and biosimilar development in the areas of nephrology and oncology.
Logos and trademarks shown above are the property of their respective owners. Their use here is for informational and illustrative purposes only.
MARKET SEGMENTS
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
Erythropoietin (EPO) Biomarkers Market, By Type
In 2024, erythropoietin-alpha leads as the primary recombinant form in biomarker assays for precise serum level measurement. It effectively tracks kidney function response and therapeutic effectiveness across various anemia treatment protocols in clinical diagnostics
Erythropoietin (EPO) Biomarkers Market, By Application
Anemic disorders drive primary demand for EPO biomarkers, supporting detection in chronic kidney disease and chemotherapy-induced cases. They enable personalized dosing decisions through detailed reticulocyte and ferritin trend analysis in patient care
Erythropoietin (EPO) Biomarkers Market, By End User
In 2024, hospitals accounted for the largest share of the Erythropoietin (EPO) biomarkers market, for rapid diagnosis and monitoring. These facilities support optimized inpatient treatment decisions and comprehensive anemia management workflows
REGION
Asia Pacific to be fastest-growing region in market during forecast period
During the forecast period, Asia Pacific surges as the fastest-growing region for Erythropoietin (EPO) biomarkers, propelled by Japan's aging population adopting advanced diagnostics for anemia care, China's AI push in multiplex assay platforms, and India's telehealth expansion via point-of-care analyzers. Government initiatives like Australia's Digital Health Strategy boost use in clinical trials and chronic kidney disease management, outpacing other regions.
ERYTHROPOIETIN (EPO) BIOMARKERS MARKET: COMPANY EVALUATION MATRIX
The EPO biomarkers market matrix positions Amgen as a star player, supported by its FDA-cleared, AI-driven proteomic platforms for anemia monitoring, strong penetration in remote CKD patient management, and a dominant global presence across nephrology and oncology, supported by extensive clinical data and regulatory approvals. Biocon is an emerging leader, driven by its strong biosimilar portfolio, expanding global footprint, and cost-competitive EPO offerings. Its growth is particularly notable in emerging markets and regulated regions through partnerships and increasing biosimilar adoption.
Source: Secondary Research, Interviews with Experts, MarketsandMarkets Analysis
KEY MARKET PLAYERS
- AMGEN INC. (US)
- BIOCON (India)
- JOHNSON & JOHNSON (US)
- F. HOFFMANN-LA ROCHE LTD (Switzerland)
- MERCK KGaA (Germany)
- PFIZER INC. (US)
- SIEMENS HEALTHINEERS (Germany)
- 3Sbio Group (China)
MARKET SCOPE
| REPORT METRIC | DETAILS |
|---|---|
| Market Size in 2024 (Value) | USD 0.64 Billion |
| Market Forecast in 2030 (Value) | USD 1.06 Billion |
| Growth Rate | CAGR of 9.0% during 2025-2030 |
| Years Considered | 2023-2030 |
| Base Year | 2024 |
| Forecast Period | 2025-2030 |
| Units Considered | Value (USD billion) |
| Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
| Segments Covered |
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| Regions Covered | North America, Europe, Asia Pacific, Latin America, Middle East, and Africa |
WHAT IS IN IT FOR YOU: ERYTHROPOIETIN (EPO) BIOMARKERS MARKET REPORT CONTENT GUIDE
DELIVERED CUSTOMIZATIONS
We have successfully delivered the following deep-dive customizations:
| CLIENT REQUEST | CUSTOMIZATION DELIVERED | VALUE ADDS |
|---|---|---|
| EPO biomarker strategy for personalized anemia management | Evaluated payer evidence requirements, clinical utility expectations, and health economic endpoints relevant to EPO biomarker testing. Developed a value narrative and evidence roadmap aligned with reimbursement pathways in key geographies. | Improves reimbursement success, strengthens payer negotiations, and enables sustainable commercial adoption of EPO biomarker testing solutions. |
| Real-world evidence (RWE) generation for EPO biomarker performance | Designed real-world studies leveraging hospital and dialysis network data to assess EPO biomarker utilization patterns, longitudinal outcomes, and treatment impact outside controlled trial settings. | Provides real-world validation of clinical utility, supports post-market commitments, and informs guideline inclusion and broader clinical uptake. |
RECENT DEVELOPMENTS
- May 2025 : Roche recently introduced the Elecsys PRO-C3 test, a biomarker-based diagnostic to evaluate liver fibrosis severity, which expands its biomarker portfolio with AI-enabled companion diagnostics.
- January 2025 : Merck expanded partnerships with companies like Diatech Pharmacogenetics to enhance biomarker testing access in the Middle East and Africa, specifically improving RAS biomarker testing and personalized treatment options.
Table of Contents
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Methodology
This research study extensively used secondary sources, directories, and databases to identify and collect valuable information to analyze the global Erythropoietin (EPO) Biomarkers Market. In-depth interviews were conducted with various primary respondents, including key industry participants, subject-matter experts (SMEs), C-level executives of key market players, and industry consultants, to obtain and verify critical qualitative and quantitative information and assess the growth prospects of the market. The global market size estimated through secondary research was then triangulated with inputs from primary research to arrive at the final market size.
Secondary Research
Secondary research was used mainly to identify and collect information for the extensive, technical, market-oriented, and commercial study of the Erythropoietin (EPO) Biomarkers Market. The secondary sources used for this study include American Society of Clinical Oncology (ASCO), Canadian Alliance for Healthy Hearts and Minds (CAHHM), Canadian Institute for Health Information (CIHI), Central Drugs Standard Control Organization (CDSCO), Center for Disease Evaluation and Research (CDER), Centers for Disease Control and Prevention (CDC), Chinese Medical Journal, Clinicaltrials.gov.in, European Medicines Agency (EMA), Food and Drug Administration (FDA), GLOBOCAN, International Agency for Research on Cancer (IARC), National Cancer Institute (NCI), National Center for Biotechnology Information (NCBI), National Institutes of Health (NIH), National Comprehensive Cancer Network (NCCN), Organization for Economic Co-operation and Development (OECD), Population Health Research Institute (PHRI), PubMed, World Bank, World Health Organization (WHO), Corporate and Regulatory Filings, Annual Reports, Sec Filings, Investor Presentations, and Financial Statements; Business Magazines & Research Journals; Press Releases, MarketsandMarkets Analysis. These sources were also used to obtain key information about major players, market classification, and segmentation according to industry trends, regional/country-level markets, market developments, and technology perspectives.
Primary Research
Extensive primary research was conducted after acquiring basic knowledge about the global Erythropoietin (EPO) Biomarkers Market scenario through secondary research. Several primary interviews were conducted with market experts from both the demand side (personnel from pharmaceutical & and biotechnology companies, hospitals & diagnostic laboratories, academic & research institutes, and other end users) and supply side (C-level and D-level executives, product managers, and marketing and sales managers of key manufacturers, distributors, and channel partners, among others, across six major regions—North America, Europe, the Asia Pacific, Latin America, Middle East, and Africa. Approximately 70% of primary interviews were conducted with supply-side representatives, while demand-side participants accounted for the remaining share. This preliminary data was collected through questionnaires, e-mails, online surveys, personal interviews, and telephonic interviews.
Market Size Estimation
Both top-down and bottom-up approaches were used to estimate and validate the total size of the Erythropoietin (EPO) Biomarkers Market. These methods were also used extensively to estimate the size of various subsegments in the market. The research methodology used to estimate the market size includes the following:
Bottom-up Approach
- The key players in the industry and market have been identified through extensive secondary research.
- The revenues generated from the Erythropoietin (EPO) Biomarkers Market business of leading players have been determined through primary and secondary research.
- All percentage shares, splits, and breakdowns have been determined using secondary sources and verified through primary sources.
Data Triangulation
After arriving at the market size from the market size estimation process explained above, the total market was divided into several segments and subsegments. To complete the overall market engineering process and arrive at the exact statistics for all segments and subsegments, data triangulation and market breakdown procedures were employed, wherever applicable.
Market Definition
A biomarker is a measurable indicator of a biological condition or process, often used to diagnose diseases, predict disease progression, and evaluate treatment response. Biomarkers can be molecular, histologic, radiographic, or physiological characteristics that provide valuable insights into normal and pathological processes. The Erythropoietin (EPO) Biomarkers Market encompasses a broad range of products and services that support biomarker discovery, validation, and application in clinical and research settings. This includes offerings such as consumables (assay kits, reagents, and instruments), software tools, and related services that facilitate biomarker analysis. The market report analyzes biomarker usage across multiple applications, including clinical diagnostics, drug discovery and development, personalized medicine, and clinical research. It also studies the adoption of biomarkers across key research areas, such as oncology, neurology, cardiology, infectious diseases, and metabolic disorders. Furthermore, the report segments the market by type of biomarkers, including safety, efficacy, and validation biomarkers. The study also considers regional trends, end-user adoption, and technological advancements shaping the global biomarker landscape.
Stakeholders
- Academic & Research Institutes
- Biomarkers Assays and Reagents Manufacturers, Vendors, and Distributors
- Contract Research Organizations (CROs)
- Biomarkers Service & Software Providers
- Diagnostics Companies
- Market Research and Consulting Firms
- Pharmaceutical and Biotechnology Companies
- Regulatory Agencies
- Venture Capitalists
- Forensics Labs
- Government organizations
- Private research firms
- Contract development and manufacturing organizations (CDMOs)
- Hospitals and Diagnostic Laboratories
Report Objectives
- To define, describe, and forecast the global Erythropoietin (EPO) Biomarkers Market based on offering, type, research area, technology, disease indication, application, end user, and region
- To provide detailed information regarding the major factors influencing market growth (such as drivers, restraints, opportunities, and challenges)
- To strategically analyze micro-markets with respect to individual growth trends, prospects, and contributions to the overall market
- To analyze the opportunities in the market for stakeholders and provide details of the competitive landscape for market leaders
- To forecast the size of the market segments in six regions: North America, Europe, the Asia Pacific, Latin America, the Middle East, and Africa
- To profile the key players in the global Erythropoietin (EPO) Biomarkers Market and comprehensively analyze their core competencies and market shares
- To track and analyze competitive developments such as acquisitions, product launches, expansions, agreements, partnerships, and collaborations in the Erythropoietin (EPO) Biomarkers Market
- To benchmark players in the Erythropoietin (EPO) Biomarkers Market using the “Company Evaluation Matrix” framework, which analyzes market players based on various parameters, including product portfolio, geographic reach, and market share.
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