“The global Carcinoembryonic antigen (CEA) market is expected to develop at a 6.8% CAGR from 2024 to 2031. The market size is estimated to reach XX in 2024 and YY in 2031.”
North America dominates the market, accounting for around YY% of total worldwide market share. Key metrics include rising cancer rates, increased use of tumor marker testing, and advances in diagnostic technology.
The CEA market is growing steadily, owing to the rising incidence of various malignancies, particularly colorectal and pancreatic cancers, where CEA testing is critical in monitoring treatment response and detecting recurrence. The growing use of CEA testing in cancer care, as well as an increased emphasis on early cancer identification, are driving market growth.
Market Trend: Integration of CEA Testing in Liquid Biopsy Platforms
The CEA market is undergoing a substantial change towards the incorporation of CEA diagnostics into full liquid biopsy platforms. The increased demand for minimally invasive diagnostic techniques, as well as the promise of liquid biopsies to provide a more comprehensive view of tumor biology, are driving this movement. Advanced liquid biopsy platforms that incorporate CEA, other biomarkers, and circulating tumor DNA (ctDNA) analysis are developing as potent cancer diagnostic and monitoring methods.
Recent clinical trials have yielded encouraging outcomes for integrated liquid biopsy techniques. A multicenter trial of 500 colorectal cancer patients found that a liquid biopsy panel that included CEA and ctDNA analysis increased recurrence detection sensitivity by 40% compared to CEA testing alone. Industry analysts expect that by 2026, more than 30% of CEA testing will be performed as part of larger liquid biopsy panels, possibly revolutionizing cancer diagnoses and surveillance.
Market Driver: Increasing Cancer Incidence and Emphasis on Early Detection
The rising global prevalence of cancer, combined with a growing emphasis on early identification and surveillance, is a major driver of the CEA market. CEA testing is critical in the therapy of numerous cancer types, particularly colorectal cancer, where it is commonly used for post-treatment surveillance.
According to the World Health Organisation, cancer is the greatest cause of death globally, accounting for approximately 10 million deaths in 2020. Colorectal cancer, one of the principal uses for CEA testing, is the third most frequent disease worldwide, with an estimated 1.9 million new cases diagnosed in 2020. The American Cancer Society recommends regular CEA testing for colorectal cancer survivors, which increases demand for these tests. According to market research, the number of CEA tests performed annually for cancer monitoring is expected to rise by 15-20% by 2025, reflecting an increasing patient population and greater acceptance of guideline-recommended testing techniques.
Market Restraint: Limited Specificity and Emerging Alternative Biomarkers
While CEA testing is widely utilized, its poor specificity and the advent of other biomarkers offer barriers to market expansion. CEA levels can rise in a variety of non-cancerous situations, resulting in false-positive results and needless follow-up operations.
A meta-analysis of CEA performance in colorectal cancer surveillance found a pooled specificity of 70–75%, indicating a high percentage of false-positive outcomes. This constraint has prompted studies on more specific biomarkers and multi-marker panels. Furthermore, emerging technologies such as circulating tumour DNA (ctDNA) analysis are showing promise in some applications that have previously relied on CEA testing. In a recent comparative investigation of post-surgical colorectal cancer patients, ctDNA analysis revealed recurrence an average of three months before CEA surveillance. These factors have the potential to impede the growth of the CEA market in certain categories, especially when other technologies receive clinical acceptability and regulatory approval.
The reagents & kits segment dominates the CEA market, accounting for over YY% of the market share.
Reagents and kits for CEA testing have emerged as the market leader due to their widespread use in clinical laboratories and the recurring nature of consumable purchases. This segment's dominance is due to the huge amount of CEA tests performed for cancer surveillance and the ongoing need for dependable, standardised testing materials.
Market statistics confirm the strength of the Reagents & Kits segment. A survey of 200 clinical laboratories found that 85% execute CEA testing in-house, with the majority citing reagent quality and consistency as important factors in their purchasing selections. The market is likely to maintain its dominance, with a 7.2% CAGR through 2031, owing to technological advances in assay design and the launch of high-sensitivity CEA kits.
While the Instruments category is modest, it is growing steadily, owing to increased clinical laboratory automation and the incorporation of CEA testing into multi-parameter analysers. According to recent industry studies, the demand for automated immunoassay systems capable of performing CEA tests alongside other tumour markers has increased by 10% over the last three years, indicating a trend towards centralised, efficient testing platforms.
North America leads the global Carcinoembryonic antigen (CEA) market, with a market share of approximately YY%.
High healthcare expenditure, superior diagnostic infrastructure, and well-established cancer screening and surveillance programs all contribute to North America's CEA market supremacy. The United States has been at the forefront of incorporating CEA testing into standard cancer care.
Colorectal cancer affects around 150,000 people in the United States each year, according to the American Cancer Society. The National Comprehensive Cancer Network (NCCN) recommendations advocate regular CEA testing for post-treatment surveillance in colorectal cancer patients, resulting in a large market demand. The region's strong emphasis on cancer research and personalised treatment fuels market growth, with numerous clinical trials looking into novel applications of CEA testing in conjunction with other biomarkers.
Europe follows closely after North America, accounting for approximately YY% of the market share. The market in the region places a high value on standardised cancer care regimens and the use of sophisticated diagnostic technology. The European Group on Tumour Markers (EGTM) publishes guidelines for the use of CEA in various malignancies, which influence clinical practice across the continent. Countries such as Germany, France, and the United Kingdom are pioneers in the deployment of comprehensive cancer surveillance systems that involve regular CEA testing.
The Asia-Pacific area is emerging as the fastest-growing market for CEA testing, with a CAGR of 8.5% expected until 2031. Countries such as China, Japan, and India are driving significant growth by raising cancer awareness, upgrading healthcare infrastructure, and boosting healthcare spending. For example, China's cancer screening programs have grown dramatically in recent years, driving up demand for tumour marker tests such as CEA. These countries' vast populations and increasing middle classes provide significant market expansion potential.
The CEA market is characterized by the presence of both large diagnostic businesses offering full test menus and specialized biomarker assay vendors. To increase their market positions, key firms are focussing on creating high-sensitivity CEA assays, improving test automation capabilities, and forming strategic collaborations.
Leading market players, such as Roche Diagnostics and Abbott Laboratories, have established strong positions through their extensive portfolios of tumor marker assays and innovative immunoassay platforms. Roche announced a 5% year-over-year rise in its tumor marker business in 2023, with CEA assays playing a prominent role.
Emerging players are making tremendous progress in creating new CEA testing methods. For example, Adaptive Biotechnologies has garnered popularity for its next-generation sequencing-based approach to minimal residual illness identification, which uses CEA as part of a multi-marker panel. The business reported a 30% rise in clinical test volume for their cancer monitoring assays in 2023, indicating a growing demand for advanced, molecular-based cancer surveillance techniques.
The market has also seen a surge in collaborations between diagnostic companies and pharmaceutical companies in the area of companion diagnostics development. In 2023, over 15 major agreements in the cancer biomarker area were announced, with CEA used in multi-biomarker panels for patient stratification and treatment response monitoring in clinical trials.
The Carcinoembryonic antigen (CEA) market is expected to continue growing and evolving, owing to the ongoing demand for better cancer monitoring tools and the incorporation of CEA testing into more comprehensive diagnostic procedures. We predict that advances in assay technology, notably better sensitivity and specificity, will increase the clinical relevance of CEA testing and potentially broaden its uses beyond established use cases.
The rise of personalised medicine and the development of multi-biomarker panels present both potential and problems for the CEA industry. While CEA may face competition from newer biomarkers in some applications, its long clinical track record and widespread awareness among oncologists indicate that it will remain an important component of cancer care for the foreseeable future.
Furthermore, we anticipate a greater emphasis on the standardisation of CEA testing and reporting across several platforms and laboratories. Global efforts to harmonise CEA readings could improve findings comparability and increase the biomarker's utility in clinical practice and research contexts.
Roche Diagnostics
Abbott Laboratories
Siemens Healthineers
Beckman Coulter, Inc. (Danaher Corporation)
Orthoclinical Diagnostics
Thermo Fisher Scientific Inc.
Fujirebio Diagnostics, Inc.
DiaSorin S.p.A.
Bio-Rad Laboratories, Inc.
Tosoh Bioscience
October 2023: Roche Diagnostics introduces a new high-sensitivity CEA assay for their Cobas immunoassay analysers, which improves detection of low CEA levels for better monitoring of patients with early-stage colorectal cancer.
Siemens Healthineers and a top pharmaceutical company announced a collaboration in May 2024 to develop a companion diagnostic tool integrating CEA and other indicators for patient selection in a phase III clinical trial of a revolutionary targeted therapy for gastrointestinal cancer.
1. INTRODUCTION
1.1. Market Definitions & Study Assumptions
1.2. Market Research Scope and 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. Roche Diagnostics
5.2. Abbott Laboratories
5.3. Siemens Healthineers
5.4. Beckman Coulter, Inc. (Danaher Corporation)
5.5. Orthoclinical Diagnostics
5.6. Thermo Fisher Scientific Inc.
5.7. Fujirebio Diagnostics, Inc.
5.8. DiaSorin S.p.A.
5.9. Bio-Rad Laboratories, Inc.
5.10. Tosoh Bioscience (LIST, NOT EXHAUSTIVE)
6. MARKET DYNAMICS
6.1. Market Trends
6.1.1. Integration of CEA Testing in Liquid Biopsy Platforms
6.1.2. Development of high-sensitivity CEA assays
6.1.3. Growing use of CEA in multi-biomarker panels
6.2. Market Drivers
6.2.1. Increasing cancer incidence and emphasis on early detection
6.2.2. Expanding applications of CEA testing in cancer management
6.2.3. Technological advancements in immunoassay platforms
6.3. Market Restraints
6.3.1. Limited Specificity and Emerging Alternative Biomarkers
6.3.2. Variability in CEA testing methods and result interpretation
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. Reagents and Kits
7.1.1. ELISA kits
7.1.2. Chemiluminescence immunoassay kits
7.2. Instruments
7.1.1. Automated immunoassay analysers
7.1.2. Point-of-care testing devices
8. BY APPLICATION (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH)--2020-2031)
8.1. Colorectal Cancer
8.1.1. Diagnosis and staging
8.1.2. Post-treatment monitoring
8.2. Pancreatic Cancer
8.2.1. Early detection
8.2.2. Treatment response assessment
8.3. Ovarian Cancer
8.3.1. Differential diagnosis
8.3.2. Recurrence monitoring
8.4. Breast Cancer
8.4.1. Metastasis detection
8.4.2. Prognosis evaluation
8.5. Others
8.5.1. Lung cancer
8.5.2. Gastric cancer
9. BY END USER (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
9.1. Hospitals
9.1.1. Hospital laboratories
9.1.2. Oncology departments
9.2. Diagnostic Laboratories
9.2.1. Reference laboratories
9.2.2. Speciality cancer diagnostic centers
9.3. Cancer Centres
9.3.1. Academic cancer centres
9.3.2. Community cancer centres
9.4. Research Institutes
9.4.1. Academic research institutions
9.4.2. Pharmaceutical R&D laboratories
10. REGION (MARKET SIZE/VALUE (US$ Mn), SHARE (%), MARKET FORECAST (%), YOY GROWTH (%)-- 2020-2031)
10.1. North America
10.1.1. United States
10.1.2. Canada
10.1.3. Mexico
10.2. South America
10.2.1. Brazil
10.2.2. Argentina
10.2.3. Rest of South America
10.3. Europe
10.3.1. Germany
10.3.2. United Kingdom
10.3.3. France
10.3.4. Italy
10.3.5. Spain
10.3.6. Russia
10.3.7. Rest of Europe
10.4. Asia-Pacific
10.4.1. China
10.4.2. Japan
10.4.3. India
10.4.4. Australia
10.4.5. South Korea
10.4.6. Rest of Asia-Pacific
10.5. Middle-East
10.5.1. UAE
10.5.2. Saudi Arabia
10.5.3. Turkey
10.5.4. Rest of Middle East
10.6. Africa
10.6.1. South Africa
10.6.2. Egypt
10.6.3. 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:
Reagents & kits
Instruments
By Application:
Colorectal Cancer
Pancreatic Cancer
Ovarian Cancer
Breast Cancer
Others
By End User:
Hospitals
Diagnostic laboratories
Cancer Centres
Research Institutes
By Region:
North America
Europe
Asia-Pacific
Latin America
Middle East & Africa
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