Global EGFR Testing Market

Global EGFR Testing Market Size Insights Forecasts to 2035

• The Global EGFR Testing Market Size Was Estimated at USD 2.15 Billion in 2024
• The Market Size is Expected to Grow at a CAGR of around 7.12 % from 2025 to 2035
• The Worldwide EGFR Testing Market Size is Expected to Reach USD 4.58 Billion by 2035
• North America is expected to grow the fastest during the forecast period.

According to a research report published by Decisions Advisors and Consulting, The Global EGFR Testing Market Size Was Worth Around USD 2.15 Billion In 2024 And Is Predicted To Grow To Around USD 4.58 Billion By 2035 With A Compound Annual Growth Rate (CAGR) Of 7.12 % From 2025 To 2035. Chronic kidney disease (CKD) has increased the population across the globe, with an increase in the rate of people who are aware of their kidney health. Also, as the technology for testing the estimated glomerular filtration rate (eGFR) has become easier to use, eGFR testing has also become increasingly accurate. The increased occurrence of kidney disease, including chronic kidney disease, supports the growth of the eGFR testing market.

 

Market Overview

The eGFR (estimated glomerular filtration rate) testing market comprises the overall global industry, providing means for diagnosing renal function through analysis of the way glomeruli filter blood. eGFR testing is an essential diagnostic tool that provides a means of identifying patients at risk of developing chronic kidney disease (CKD), diabetes, hypertension, and many other conditions affecting renal health. The eGFR testing market includes laboratory-based eGFR tests, point-of-care eGFR tests, and automated analysers used for eGFR testing in hospitals, clinics, and diagnostic centres. Major drivers of growth in this space include an increasing prevalence of CKD, a growing awareness of the importance of early detection, and continued advancements in technology available for testing. Additional factors contributing to growth in the eGFR testing market include supportive initiatives from governments and expanded healthcare delivery systems around the world. Major players involved in the eGFR testing market include diagnostic companies, eGFR testing providers, eGFR researchers, and others, all working to develop more accurate, accessible, and affordable methods for performing eGFR testing around the world.

 

Report Coverage

This research report categorises the EGFR testing market based on various segments and regions, forecasts revenue growth, and analyzes trends in each submarket. The report analyses the key growth drivers, opportunities, and challenges influencing the EGFR testing market. Recent market developments and competitive strategies, such as expansion, product launch, development, partnership, merger, and acquisition, have been included to draw the competitive landscape in the market. The report strategically identifies and profiles the key market players and analyzes their core competencies in each sub-segment of the EGFR testing market.     

 

Driving Factors  

The increase of chronic kidney disease (CKD) on a global scale due to diabetes, high blood pressure and ageing populations, there’s an increasing emphasis on early and accurate diagnostic methods that boost the market growth. Moreover, efforts from governmental, non-profit, and public health agencies have increased awareness about CKD, and as a result, routine testing of eGFR has increased in many types of healthcare settings. Another major factor contributing to the growth of the eGFR market is the growing use of eGFR testing outside of routine CKD diagnosis. In transplantation, eGFR testing is essential to monitoring the function of the graft and determining if there are any signs of early rejection. Increasingly, pharmaceutical companies and clinical researchers utilise eGFR values to calculate the optimal drug dosage in patients with impaired renal function to ensure medication safety and effectiveness. Patients are tested for eGFR, and as the tests are used for a growing number of reasons, growth in this market will likely continue through the forecast period, particularly with the growing acceptance of eGFR testing in developing countries.

 

QIAGEN announced the launch of its therascreen® EGFR Plus RGQ PCR Kit, now featuring detection of the EGFR C797S mutation, to support treatment decisions in non-small cell lung cancer (NSCLC).

 

Restraining Factors  

However, some factors might hinder the growth of the eGFR testing market. Factors such as factors include variations in assay methodology, calibration standards, and other factors may affect the overall accuracy of the eGFR test and affect clinical decision-making. Regulatory challenges regarding the validation, quality assurance, and international regulatory compliance and standards level of assays can also hinder market growth. Furthermore, the expense of developing advanced diagnostic instruments and reagents may constitute a significant barrier toward the adoption of these tests in middle- to low-income nations.

 

Market Segmentation    

The EGFR testing market share is classified into product type, test type, and application.     

 

• The kits segment accounted for the largest share in 2024 and is anticipated to grow at a significant CAGR during the forecast period.        

Based on the product type, the EGFR testing market is differentiated into kits, reagents, and instruments. Among these, the kits segment accounted for the largest share in 2024 and is anticipated to grow at a significant CAGR during the forecast period. Kits have become increasingly popular based on their ease of use, standardisation, and convenience; they are the most commonly used tools for eGFR in both clinical and research settings. The increased demand for rapid diagnostic tests and point-of-care testing has also accelerated the adoption of eGFR test kits in countries where laboratory infrastructure is limited.

 

• The creatinine-based segment accounted for the highest market revenue in 2024 and is anticipated to grow at a significant CAGR during the forecast period.     

Based on the test type, the EGFR testing market is segmented into creatinine-based, cystatin C-based, and combined. Among these, the creatinine-based segment accounted for the highest market revenue in 2024 and is anticipated to grow at a significant CAGR during the forecast period. In the past, creatinine-based testing has been the mainstay of testing because it is readily available, relatively inexpensive, and well-established in clinical practice. These tests measure serum creatinine to estimate glomerular filtration rate (GFR).

• The chronic kidney disease segment accounted for the highest market share in 2024 and is anticipated to grow at a significant CAGR during the forecast period.      

Based on the application, the EGFR testing market is divided into chronic kidney disease, kidney transplantation, drug dosing, and others. Among these, the chronic kidney disease segment accounted for the highest market share in 2024 and is anticipated to grow at a significant CAGR during the forecast period. Chronic kidney disease continues to be the primary use of the renal health application and is a major contributor to the overall market. The growing global incidence rate of CKD as a result of lifestyle-based risk factors such as obesity, diabetes, and high blood pressure, is leading to more need for accurate assessment of kidney function.

 

Regional Segment Analysis of the EGFR Testing Market

• North America (U.S., Canada, Mexico) 
• Europe (Germany, France, U.K., Italy, Spain, Rest of Europe)
• Asia-Pacific (China, Japan, India, Rest of APAC)
• South America (Brazil and the Rest of South America) 
• The Middle East and Africa (UAE, South Africa, Rest of MEA)

 

Asia Pacific is anticipated to hold the largest share of the EGFR testing market over the predicted timeframe.     

Asia Pacific is anticipated to hold the largest share of the EGFR testing market over the predicted timeframe. The area's fast-growing population, increased urbanisation, growing healthcare spending, and continued advancements in technology are all factors contributing to this growth. There has been a noticeable increase in the number of people living with chronic kidney diseases in China, India and Japan, adding to the demand for affordable and available methods of measuring patients' kidney function via estimated glomerular filtration rate (eGFR). Initiatives led by governments to improve access to quality health care services, and the continued growth of private diagnostic labs, should have a positive impact on the growth of eGFR testing markets in these regions.

 

North America is expected to grow at a rapid CAGR in the EGFR testing market during the forecast period. North America's dominance can be attributed to its well-developed health care system, a large number of people with chronic kidney disease (CKD), and the large number of major diagnostic companies located in North America. In the USA specifically, there is a large network of nephrology centres, transplant programs, and research facilities supporting demand for new and innovative eGFR Testing products. Furthermore, governments have taken steps to help create CKD awareness, promote early detection, and support preventive health care for people at risk to further grow the eGFR Testing Business. Furthermore, Canada has a large presence in the eGFR Testing market with an emphasis on health care quality and consumer access to new and advanced diagnostic tools.

 

Competitive Analysis:   

The report offers the appropriate analysis of the key organizations/companies involved within the EGFR testing market, along with a comparative evaluation primarily based on their product offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborative analysis focusing on the current news and developments of the companies, which includes product development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market.  

 

List of Key Companies

• Abbott Laboratories
• ARKRAY, Inc.
• Beckman Coulter, Inc.
• Bio-Rad Laboratories, Inc.
• Danaher Corporation
• DiaSys Diagnostic Systems GmbH
• F. Hoffmann-La Roche Ltd
• FUJIFILM Wako Pure Chemical Corporation
• Nova Biomedical
• Pointe Scientific, Inc.
• Randox Laboratories Ltd.
• Siemens Healthineers
• Sysmex Corporation
• Thermo Fisher Scientific Inc.
• Others  

 

Key Target Audience

• Market Players
• Investors
• End-users
• Government Authorities 
• Consulting and Research Firm
• Venture capitalists
• Value-Added Resellers (VARs) 

 

Recent Development

 

• In July 2025, the FDA granted accelerated approval to sunvozertinib (brand name ZEGFROVY) for adults with metastatic non-small cell lung cancer (NSCLC) harbouring EGFR exon 20 insertion mutations who have progressed after platinum-based chemotherapy. This marks the first targeted oral therapy specifically approved for this difficult-to-treat mutation.

 

• In June 2025, Datroway (datopotamab deruxtecan-dlnk, also known as Dato-DXd) received FDA accelerated approval for adults with previously treated advanced EGFR-mutated non-small cell lung cancer (NSCLC). It is the first TROP2-directed therapy approved in the U.S. for lung cancer, specifically for patients who have already received EGFR-targeted therapy and platinum-based chemotherapy.

 

Market Segment  

This study forecasts revenue at global, regional, and country levels from 2020 to 2035. Decisions Advisors has segmented the EGFR testing market based on the below-mentioned segments: 

  

Global EGFR Testing Market, By Product Type

• Kits
• Reagents
• Instruments

 

Global EGFR Testing Market, By Test Type

• Creatinine-based
• Cystatin C-based
• Combined

 

Global EGFR Testing Market, By Application

• Chronic Kidney Disease
• Kidney Transplantation
• Drug Dosing
• Others

 

Global EGFR Testing Market, By Regional Analysis

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Spain
  • Russia
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Rest of Asia Pacific
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Middle East & Africa
  • UAE
  • Saudi Arabia
  • Qatar
  • South Africa
  • Rest of the Middle East & Africa

 

Frequently Asked Questions (FAQ)

 

1. What is the current size of the global eGFR testing market?

The market was valued at USD 2.15 billion in 2024.

 

2. What is the projected market size by 2035?

It is expected to reach USD 4.58 billion by 2035.

 

3. What is the forecasted CAGR for the market?

The market is projected to grow at a CAGR of 7.12% from 2025 to 2035.

 

4. What are the main product types in the eGFR testing market?

The market is segmented into kits, reagents, and instruments, with kits holding the largest share in 2024.

 

5. Which test type leads the market?

Creatinine-based tests accounted for the highest revenue in 2024 and are expected to grow significantly.

 

6. What is the dominant application for eGFR testing?

Chronic kidney disease (CKD) held the highest market share in 2024 due to rising global prevalence.

 

7. Which region will grow the fastest?

North America is expected to grow at the fastest CAGR, driven by advanced healthcare systems and CKD awareness.

 

8. What drives growth in the Asia-Pacific region?

Rapid population growth, urbanisation, rising CKD cases in countries like China and India, and increasing healthcare investments position it to hold the largest market share.