Biomarkers are biological or biochemical molecules, genetic changes, or other characteristics that can be measured; they indicate or predict a condition, risk, or likely biological response. Biomarkers can be used for a range of diagnostic applications including diagnosis, predicting prognosis, identifying appropriate therapy for an individual, monitoring disease or for return of a disease, and other applications.
In 2020, growth in the total global market for clinical diagnostic markers has been strong, with strong expansion expected to continue. The report discusses how this growth will be fueled by an aging population that is more susceptible to disease, the increasing number of targeted therapies being developed and introduced, and the large and growing clinical diagnostic test market. Further, analysis in the report of key segments, such as the infectious disease and cancer segments, shows that growth will occur at different rates.
Cancer immunoassays (tumor markers) detect proteins in the blood, urine, or other body fluids such as sputum, breast nipple aspirate, and semen. The presence of these proteins, or their relative levels, may indicate an abnormal process in the body, such as cancer, and can provide further information if cancer is diagnosed. Doctors use tumor marker tests at various stages inpatient care: for diagnosis, treatment monitoring and disease recurrence.
The largest disease segment at this time is infectious diseases. This market includes tests to detect antigens or nucleic acid (DNA or RNA) sequences from microbes, and also markers of the body’s response to the infection, such as antibodies produced against a specific pathogen that has infected a person. These are important biomarkers to determine if a person is, or has been, infected. These biomarkers can also sometimes be used to demonstrate the efficacy of treatment. For bacterial infections, antibiotic resistance genes are also important biomarkers to predict which antibiotics are not likely to be effective for the treatment of a bacterial infection.
Cardiac biomarkers are substances that are released into the bloodstream when the heart is damaged or stressed. As discussed in the report, cardiovascular disease includes all diseases or disorder of the heart and the vascular system of the body. Many different biomarkers have been identified to help physicians diagnose disease, identify individuals at increased risk of disease, and to monitor certain conditions.
There are many different diseases that involve an abnormal immune response, as discussed in the report. Two immunological disease categories for which diagnostic testing is commonly performed are autoimmune disease and allergy. More than 80 different autoimmune-related diseases have been identified. In addition, individuals can develop an allergic response to a wide array of allergens. As a result, these diagnostic markets include a wide range of different biomarkers that can be tested.
Neurological diseases are those that affect the central nervous system (brain and spinal cord) and the peripheral nervous system. This group encompasses many age-related diseases such as dementia, neurodegenerative diseases, inherited neurodevelopmental disorders, as well as autoimmune diseases such as multiple sclerosis, diabetic neuropathy, stroke, and many others. Because they are systemic, distinct, complex and generally not as widespread as the illnesses discussed elsewhere in this report, biomarker development in this area has been slower. However, the aging of the population and the rapid increase of severe and costly diseases such as Alzheimer’s disease has made this area a priority for a rising number of research groups.
The “other” segment includes many different types of biomarkers used in diagnostic applications such as bone diseases, renal disease, transplantation, other endocrine diseases, and other varied disease indications. As discussed in the report, a broad definition of biomarkers is used has been used in this report. Biomarkers in this report include molecules or other characteristics that can be measured, and are indicators of health, risk of disease, disease or other condition, prognosis, response to therapy, or other biological effect. This definition includes biomarkers that are used in drug development as surrogates, markers of drug safety, or other applications. Traditionally, biomarkers have been discussed and evaluated as single molecules or characteristics, and many tests are available for individual biomarkers.
C-Reactive Protein (CRP)
C-Reactive Protein (CRP) is an important biomarker for several diseases.
For this report, the market for biomarkers focuses on applications of biomarkers. This includes both research and diagnostic applications of biomarkers. The potential market for biomarkers being evaluated as potential drug targets is not included in this market analysis, as that therapeutic market would be determined by the potential market for new therapies targeting the biomarker drug target.
The report examines biomarker market drivers and restraints. As in other markets, a variety of drivers and restraints exert influences to varying degrees. Some of these drivers and restraints operate at a macro level, affecting the entire industry, while others mainly affect certain segments, companies, geographies, or other select situations. The market for a biomarker that is developed and commercialized for diagnostic applications is driven by the market and need for diagnostic assays that detect that biomarker.
Many different technologies have been developed and are used in biomarker discovery, and also for detection and analysis of known biomarkers. These include traditional technologies, some of which have been used for decades. In addition, many new technologies developed for other applications are now being applied in this field. These include mass spectrometry and next generation DNA sequencing. Many tests performed using newer technologies are currently being done primarily as laboratory developed tests (LDTs) or by organizations performing clinical tests for pharmaceutical companies developing new drugs; however, some companies plan to eventually develop IVD test kits based on their laboratory assays.
The World Market for Biomarkers includes profiles of companies active in the discovery and/or commercialization of biomarkers. This includes companies commercializing in vitro diagnostic tests for detection and analysis of biomarkers, selected diagnostic companies commercializing diagnostic tests in their own CLIA certified laboratories for detection and analysis of biomarkers, and selected other players. The report’s focus is on companies with commercialized products and/or very advanced development programs. The diagnostics market is a highly competitive market, and there are many additional diagnostic companies that offer tests based on biomarkers discussed in this report. Companies profiled in the report range from large, multinational companies to smaller companies in or entering this market.
This report focuses on diagnostics. The World Market for Biomarkers estimates the world markets for biomarkers and biomarker tests from 2015 to 2024, with 2020 as the base year, providing global biomarker market forecasts for the total biomarker market
Clinical Diagnostic Biomarker Market by Disease
In 2020, growth in the total global market for clinical diagnostic markers has been strong, with strong expansion expected to continue. The report discusses how this growth will be fueled by an aging population that is more susceptible to disease, the increasing number of targeted therapies being developed and introduced, and the large and growing clinical diagnostic test market. Further, analysis in the report of key segments, such as the infectious disease and cancer segments, shows that growth will occur at different rates.
The report provides the following data on segments of the clinical diagnostic biomarker market by disease:
- Total Global Clinical Diagnostic Biomarker Market, 2015-2025, in $Millions (Cancer, Cardiovascular Disease, Immunological Disease, Infectious Disease, Neurological Disease, Other, Total)
- Clinical Diagnostic Biomarker Market Segments, 2015, 2020, 2025, by Share (Cancer, Cardiovascular Disease, Immunological Disease, Infectious Disease, Neurological Disease, Other)
Cancer Biomarker Market
Cancer immunoassays (tumor markers) detect proteins in the blood, urine, or other body fluids such as sputum, breast nipple aspirate, and semen. The presence of these proteins, or their relative levels, may indicate an abnormal process in the body, such as cancer, and can provide further information if cancer is diagnosed. Doctors use tumor marker tests at various stages inpatient care: for diagnosis, treatment monitoring and disease recurrence.
The report provides the following cancer biomarker market data:
- Total Global Clinical Diagnostic Cancer Biomarker Market, 2015-2025, in $Millions (Histology/Cytology, Immunoassays, Flow Cytometry, Rapid Tests, Molecular Assays, Total)
- Clinical Diagnostic Cancer Biomarker Market Segments, 2015, 2020, 2025, by Share (%) (Cancer, Cardiovascular Disease, Immunological Disease, Infectious Disease, Neurological Disease)
- Total Global Clinical Diagnostic Cancer Biomarker Market by Segment, 2015, 2020, 2025, in $Millions (Histology/Cytology: Immunohistochemistry, In Situ Hybridization; Immunoassays – Tumor Markers: PSA, CEA, CA 125, AFP, Others, Flow Cytometry; Rapid Tests: Fecal Occult Blood, PSA, NMP22, Others; Molecular Assays; Total)
Infectious Disease Biomarker Market
The largest disease segment at this time is infectious diseases. This market includes tests to detect antigens or nucleic acid (DNA or RNA) sequences from microbes, and also markers of the body’s response to the infection, such as antibodies produced against a specific pathogen that has infected a person. These are important biomarkers to determine if a person is, or has been, infected. These biomarkers can also sometimes be used to demonstrate the efficacy of treatment. For bacterial infections, antibiotic resistance genes are also important biomarkers to predict which antibiotics are not likely to be effective for the treatment of a bacterial infection.
The report provides the following infectious disease biomarker market data:
- Total Global Clinical Diagnostic Infectious Disease Biomarker Market, 2015-2025, in $Millions (Cardiac Markers, Cholesterol/Lipids, Coagulation, Total)
- Growth of Global Clinical Diagnostic Infectious Disease Biomarker Market, 2015-2025, in $Millions (Laboratory Immunoassays, Rapid Immunoassays, Molecular Assays)
- Clinical Diagnostic Infectious Disease Biomarker Market Segments, 2015, 2020 , 2025, by Share (%) (Laboratory Immunoassays, Rapid Immunoassays, Molecular Assays)
- Total Global Clinical Diagnostic Infectious Disease Biomarker Market by Segment, 2015, 2020 , 2025, in $Millions (Laboratory Immunoassays [Hepatitis; HIV; STDs including chlamydia, gonorrhea and syphilis; TORCH; Respiratory; Sepsis including sepsis markers, C. difficile, MRSA, other AMR/HAI tests; Parasitology; Mycology; Others including EBV, Chagas, dengue, malaria, Lyme disease, others], Rapid Immunoassays [Influenza; HIV; Malaria; Hepatitis; STDs including chlamydia and syphilis; C. difficile; E. coli; Strep A; H. pylori; Others including rapid tests for TB, Dengue, Chagas, vaginitis, Group B Strep and others], Molecular Assays [HAIs; HIV; Hepatitis; Chlamydia/Gonorrhea (CT/NG); HPV; Respiratory; Mycobacteria/TB; Others], Total)
Cardiovascular Disease Biomarker Market
Cardiac biomarkers are substances that are released into the bloodstream when the heart is damaged or stressed. As discussed in the report, cardiovascular disease includes all diseases or disorder of the heart and the vascular system of the body. Many different biomarkers have been identified to help physicians diagnose disease, identify individuals at increased risk of disease, and to monitor certain conditions.
The World Market for Biomarkers provides the following information on the global diagnostic market for cardiovascular disease biomarkers:
- Total Global Clinical Diagnostic Cardiovascular Disease Biomarker Market, 2015-2025, in $Millions (Cardiac Markers, Cholesterol/Lipids, Coagulation, Total)
- Clinical Diagnostic Cardiovascular Disease Biomarker Market Segments, 2015, 2020 , 2025, by Share (%) (Cardiac Markers, Cholesterol/Lipids, Coagulation)
- Total Global Clinical Diagnostic Cardiovascular Disease Biomarker Market by Segment, 2015, 2020 , 2025, in $Millions (Cardiac Markers [Acute Condition Cardiac Markers: CK-MB, myoglobin, brain natriuretic peptide (BNP); cTn; HscTn; Other cardiac markers: proBNP, hsCRP, homocysteine, others], Cholesterol/Lipids, Coagulation [PT/INR-lab, D-dimer, Molecular (Thrombophilia SNPs), POC], Total)
Immunological Disease Biomarker Market
There are many different diseases that involve an abnormal immune response, as discussed in the report. Two immunological disease categories for which diagnostic testing is commonly performed are autoimmune disease and allergy. More than 80 different autoimmune-related diseases have been identified. In addition, individuals can develop an allergic response to a wide array of allergens. As a result, these diagnostic markets include a wide range of different biomarkers that can be tested.
The report provides the following information on the sales of biomarkers related to the immunological disease:
- Total Global Clinical Diagnostic Immunological Disease Biomarker Market, 2015-2025, in $Millions (Autoimmune Disease, Allergy, Total)
- Clinical Diagnostic Immunological Disease Biomarker Market Segments, 2015, 2020 , 2025, by Share (%) (Autoimmune Disease, Allergy)
Neurological Disease Biomarker Market
Neurological diseases are those that affect the central nervous system (brain and spinal cord) and the peripheral nervous system. This group encompasses many age-related diseases such as dementia, neurodegenerative diseases, inherited neurodevelopmental disorders, as well as autoimmune diseases such as multiple sclerosis, diabetic neuropathy, stroke, and many others. Because they are systemic, distinct, complex and generally not as widespread as the illnesses discussed elsewhere in this report, biomarker development in this area has been slower. However, the aging of the population and the rapid increase of severe and costly diseases such as Alzheimer’s disease has made this area a priority for a rising number of research groups.
As such, it is a fast growing biomarker segment of which the report notes total global sales:
- Total Global Clinical Diagnostic Neurological Disease Biomarker Market, 2015-2025, in $Millions (Autoimmune Disease, Allergy, Total)
- Clinical Diagnostic Neurological Disease Biomarker Market Segments, 2015, 2020 , 2025, by Share (%) (Alzheimer’s Disease, Other Neurological Disorders)
Other Diseases
The “other” segment includes many different types of biomarkers used in diagnostic applications such as bone diseases, renal disease, transplantation, other endocrine diseases, and other varied disease indications. As discussed in the report, a broad definition of biomarkers is used has been used in this report. Biomarkers in this report include molecules or other characteristics that can be measured, and are indicators of health, risk of disease, disease or other condition, prognosis, response to therapy, or other biological effect. This definition includes biomarkers that are used in drug development as surrogates, markers of drug safety, or other applications. Traditionally, biomarkers have been discussed and evaluated as single molecules or characteristics, and many tests are available for individual biomarkers.
The World Market for Biomarkers provides the following information on the sales of biomarkers related to the following segments: general clinical chemistry, fertility/pregnancy, thyroid, diabetes/Hb1Ac, chromosome analysis & inherited disease, and other:
- Total Global Clinical Diagnostic Other Biomarker Market, 2015-2025, in $Millions (General Clinical Chemistry, Fertility/Pregnancy, Thyroid, Diabetes/Hb1Ac, Chromosome Analysis & Inherited Disease, Other, Total)
- Clinical Diagnostic Other Biomarker Market Segments, 2015, 2020, 2025, by Share (%)(General Clinical Chemistry, Fertility/Pregnancy, Thyroid, Diabetes/Hb1Ac, Chromosome Analysis & Inherited Disease, Other)
C-Reactive Protein (CRP)
C-Reactive Protein (CRP) is an important biomarker for several diseases.
Due to the high and rising interest in CRP tests, a breakout of estimated sales is provided:
- Total Global CRP Biomarker Market, 2015-2025, in $Millions
Biomarker Market Drivers and Restraints
For this report, the market for biomarkers focuses on applications of biomarkers. This includes both research and diagnostic applications of biomarkers. The potential market for biomarkers being evaluated as potential drug targets is not included in this market analysis, as that therapeutic market would be determined by the potential market for new therapies targeting the biomarker drug target.
The report examines biomarker market drivers and restraints. As in other markets, a variety of drivers and restraints exert influences to varying degrees. Some of these drivers and restraints operate at a macro level, affecting the entire industry, while others mainly affect certain segments, companies, geographies, or other select situations. The market for a biomarker that is developed and commercialized for diagnostic applications is driven by the market and need for diagnostic assays that detect that biomarker.
Key Technologies Used to Identify & Analyze Biomarkers
Many different technologies have been developed and are used in biomarker discovery, and also for detection and analysis of known biomarkers. These include traditional technologies, some of which have been used for decades. In addition, many new technologies developed for other applications are now being applied in this field. These include mass spectrometry and next generation DNA sequencing. Many tests performed using newer technologies are currently being done primarily as laboratory developed tests (LDTs) or by organizations performing clinical tests for pharmaceutical companies developing new drugs; however, some companies plan to eventually develop IVD test kits based on their laboratory assays.
Selected examples of companies using these various technologies are discussed in this report, including key players in the market:
- Selected Companies Using Immunoassays for Detection and Analysis of Biomarkers, 2020
- Selected Companies with Immunohistochemistry Tests for Detection of Biomarkers, 2020
- Selected Companies Using In Situ Hybridization for Detection and Analysis of Biomarkers, 2020
- Selected Companies Using PCR or Other Nucleic Acid Amplification-Based Technologies for Biomarker Assays, 2020
- Selected Companies Analyzing Gene Signatures, 2020
- Selected Companies Using Microarrays to Detect and Analyze Biomarkers, 2020
- Selected Diagnostics Companies and Clinical Laboratories with Sequencing-Based Biomarkers, 2020
- Selected Companies Using Mass Spectrometry, 2020
Competition in the Market
The World Market for Biomarkers includes profiles of companies active in the discovery and/or commercialization of biomarkers. This includes companies commercializing in vitro diagnostic tests for detection and analysis of biomarkers, selected diagnostic companies commercializing diagnostic tests in their own CLIA certified laboratories for detection and analysis of biomarkers, and selected other players. The report’s focus is on companies with commercialized products and/or very advanced development programs. The diagnostics market is a highly competitive market, and there are many additional diagnostic companies that offer tests based on biomarkers discussed in this report. Companies profiled in the report range from large, multinational companies to smaller companies in or entering this market.
Table of Contents
Chapter 1: Introduction
Chapter 2: Executive Summary
Chapter 3: Market Environment & Analysis
Chapter 4: Infectious Disease Biomarkers
Chapter 5: Cancer Biomarkers
Chapter 6: Cardiovascular Biomarkers
Chapter 7: Clinical Chemistry Biomarkers
Chapter 8: Neurological Biomarkers
Chapter 9: Autoimmune Biomarkers
Chapter 10: Other Biomarkers
Chapter 11: Company Profiles
Companies Mentioned
- 20/20 GeneSystems, Inc.
- Abacus Diagnostica Oy
- Abbott Laboratories
- Act Genomics Co., Ltd.
- Adaptive Biotechnologies Corp.
- Admera Health
- Agena Bioscience Inc.
- Agendia NV
- Agilent Technologies, Inc.
- ALPCO
- Ambry Genetics Corp.
- Athena Diagnostics, Inc. /Quest
- Banyan Biomarkers, Inc.
- BD
- Beckman Coulter, Inc.
- Becton, Dickinson and Company
- Bio-Rad Laboratories, Inc.
- BioFire Diagnostics, LLC/BioMerieux
- Biohit Oyj
- bioMérieux SA
- Cancer Genetics, Inc.
- Caris Life Sciences
- Cepheid/Danaher Corp.
- Curetis AG
- Danaher Corporation
- DiaSorin Group
- Exact Sciences Corp.
- Foundation Medicine, Inc.
- Fujirebio, Inc.
- Genomic Health, Inc.
- Hologic, Inc.
- Illumina, Inc.
- Leica Biosystems
- Liquid Biopsy
- Luminex Corporation
- Myriad Genetics
- NeoGenomics
- Ortho-Clinical Diagnostics
- Qiagen N.V.
- Quidel Corporation
- Roche Diagnostics
- Siemens Healthineers
- Sysmex Corp.
- Thermo Fisher Scientific, Inc.
- Ventana Medical Systems, Inc./Roche
- Zeus Scientific, Inc.
