Kalorama Information's "Biomarkers in Diagnostics: Global Strategic Insights and Forecasts to 2031" provides a comprehensive analysis of the worldwide clinical diagnostic biomarker market, with forecasts from 2022 through 2031. The report examines diagnostic substances and tests used for disease detection, therapy selection, disease monitoring, and evaluation of treatment effectiveness across seven major product categories: infectious diseases, cancer, cardiovascular diseases, general clinical chemistry analytes, neurological conditions, autoimmune conditions, and other conditions such as diabetes, metabolic disorders, fertility, pregnancy, kidney disorders, inherited diseases, and thyroid conditions.
Global and regional sales data-along with projections for the U.S., Europe, China, India, and Japan-are provided for each category and major subgroup. All market values reflect end-user spending on biomarker-related reagents, test kits, and consumables, excluding the value of diagnostic instruments. Data are compiled from extensive primary interviews with manufacturers, laboratory professionals, and industry experts, as well as secondary sources including government statistics, trade associations, company filings, and Kalorama publications.
The report explores key industry drivers such as aging populations, targeted therapy adoption, diagnostic test market expansion, and advances in technologies including mass spectrometry, next-generation sequencing, and bioinformatics. Coverage includes the role of biomarkers in personalized and precision medicine, trends in pharmacogenomics, automation, reimbursement, and innovation pipelines. Detailed competitive analysis profiles leading IVD companies and specialized biomarker firms, highlighting commercialized products, emerging technologies, and market positioning.
With in-depth segmentation, market trends, and strategic insights, "Biomarkers in Diagnostics: Global Strategic Insights and Forecasts to 2031 (Tumor Markers, Kidney Disorder Markers, Inherited Disease Markers, Cardiac Markers, Neurological Markers, Autoimmune Disorders, Infectious Disease, and Other Markers)" serves as an essential resource for companies competing in the biomarker space or seeking to enter this high-growth market.
Table of Contents
Chapter 1: Introduction
About Kalorama Information
Report Coverage
Methodology
Sources of Information
Chapter 2: Executive Summary
Table 2-1: Global Biomarker Sales, by Product Group & Region, 2022-2031 ($ million) (Product Groups: Autoimmune, Cancer, Cardiovascular, Clinical Chemistry, Infectious Diseases, Neurological, Other) & (Africa/Middle East, Asia/Pacific, Central & South America, Eastern & Western Europe, North America)
Chapter 3: Market Environment & Analysis
Overview
Demographic Patterns
Total Population
Population Aged 65 Years & Older
World Healthcare Trends
Health Expenditures
Hospitals
Physicians
Patient Activity
Hospital Admissions
Surgical Procedures
Outpatient Consultations
Table 3-1: Global Demographic & Healthcare Indicators, 2022-2031 (World Population, Healthcare Expenditures, Healthcare Resources, and Healthcare Activity)
Global Economic Climate
Biomarker Technologies
The Rising Role of AI and Machine Learning in Biomarker Analysis
Biomarker Market Analysis
Key Market Trends
Biomarker Product Markets
Table 3-2: Global Biomarker Sales, by Product Group, 2022-2031 ($ million) (Autoimmune, Cancer, Cardiovascular, Clinical Chemistry, Infectious Diseases, Neurological, Other)
Figure 3-2: Global Biomarker Share, by Product Group, 2025 vs. 2031 (%) (Autoimmune, Cancer, Cardiovascular, Clinical Chemistry, Infectious Diseases, Neurological, Other)
Geographical Markets
Table 3-3: Global Biomarker Sales, by Region, 2022-2031 ($ million) (Africa/Middle East, Asia/Pacific (China, Japan, Other), Central & South America, Eastern & Western Europe, North America (U.S., Canada, Mexico))
Figure 3-3: Global Biomarker Sales, by Region, 2022-2031 ($ million) (Africa/Middle East, Asia/Pacific, Central & South America, Eastern & Western Europe, North America)
Figure 3-4: Global Biomarker Share, by Region, 2025 vs. 2031 (%) (Africa/Middle East, Asia/Pacific, Central & South America, Eastern & Western Europe, North America)
Chapter 4: Infectious Disease Biomarkers
Overview
Infectious Disease Biomarker Technologies
Key Biomarkers for Infectious Disease
Respiratory Diseases
Table 4-1: Global Respiratory Disease Biomarker Sales, by Condition, 2022-2031 ($ million) (Group A Strep, Influenza, Pneumonia, Tuberculosis, Other)
Figure 4-1: Global Respiratory Disease Biomarker Sales, by Condition, 2022-2031 ($ million) (Group A Strep, Influenza, Pneumonia, Tuberculosis, Other)
Figure 4-2: Global Respiratory Disease Biomarker Share, by Condition, 2025 (%)
Table 4-2: Global Respiratory Disease Biomarker Sales, by Technology, 2022-2031 ($ million) (Laboratory Immunoassay, Molecular, POC)
Figure 4-3: Global Respiratory Disease Biomarker Sales, by Technology, 2022-2031 ($ million) (Laboratory Immunoassay, Molecular, POC)
Figure 4-4: Global Respiratory Disease Biomarker Share, by Technology, 2025 (%) (Laboratory Immunoassay, Molecular, POC)
COVID-19
Pneumonia
Influenza
Group A Streptococcus Infections
Tuberculosis
Other Respiratory Infections
Healthcare-Associated Infections (HAIs)
Clostridioides difficile (c. diff)
Sepsis
Staphylococcus aureus
Enterococcus
Other Healthcare-Associated Infections
Table 4-3: Global Healthcare-Associated Infections (HAIs) Biomarker Sales, by Type, 2022-2031 ($ million) (C. diff, Enterococci, Sepsis, Staph, Other)
Figure 4-5: Global Healthcare-Associated Infections (HAIs) Biomarker Sales, by Type, 2022-2031 ($ million) (C. diff, Enterococci, Sepsis, Staph, Other)
Figure 4-6: Global Healthcare-Associated Infections (HAIs) Biomarker Share, by Type, 2025 (%) (C. diff, Enterococci, Sepsis, Staph, Other)
Hepatitis
Table 4-4: Global Hepatitis Biomarker Sales, by Type, 2022-2031 ($ million) (Hepatitis B, Hepatitis C, Other Types)
Figure 4-7: Global Hepatitis Biomarker Sales, by Type, 2022-2031 ($ million) (Hepatitis B, Hepatitis C, Other Types)
Figure 4-8: Global Hepatitis Biomarker Share, by Type, 2025 (%) (Hepatitis B, Hepatitis C, Other Types)
HIV
Table 4-5: Global HIV Biomarker Sales, by Technology, 2022-2031 ($ million) (Immunoassay, Molecular, Rapid POC)
Figure 4-9: Global HIV Biomarker Sales, by Technology, 2022-2031 ($ million) (Immunoassay, Molecular, Rapid POC)
Figure 4-10: Global HIV Biomarker Share, by Technology, 2025 (%) (Immunoassay, Molecular, Rapid POC)
Sexually Transmitted Diseases (STDs)
Human Papillomavirus (HPV)
Chlamydia/Gonorrhea (CT/NG)
Trichomoniasis
Herpes Simplex Virus (HSV-1 & HSV-2)
Other Sexually Transmitted Diseases
Syphilis
Balanitis
Chancroid
Molluscum Contagiosum
Pelvic Inflammatory Disease (PID)
Pubic Lice
Scabies
Vaginitis
Table 4-6: Global STD Biomarker Sales, by Type, 2022-2031 ($ million) (CT/NG, HPV, HSV 1&2, Trichomoniasis, Other)
Figure 4-11: Global STD Biomarker Sales, by Type, 2022-2031 ($ million) (CT/NG, HPV, HSV 1&2, Trichomoniasis, Other)
Figure 4-12: Global STD Biomarker Share, by Type, 2025 (%) (CT/NG, HPV, HSV 1&2, Trichomoniasis, Other)
TORCH
Table 4-7: Global TORCH Biomarker Sales, 2022-2031 ($ million)
Figure 4-13: Global TORCH Biomarker Sales, 2022-2031 ($ million)
Other Infectious Diseases
Malaria
Lyme Disease
H. pylori
Dengue
All Other Disease Biomarkers
Chagas Disease
Cyclosporiasis
Cysticercosis
Ebola
Hantavirus
Ringworm
West Nile Virus (WNV)
Zika Virus
Sales of Other Infectious Disease Biomarkers
Table 4-8: Global Other Infectious Disease Biomarker Sales, by Type, 2022-2031 ($ million) (Malaria, Lyme Disease, E. Coli, H. pylori, Dengue, All Other)
Figure 4-14: Global Other Infectious Disease Biomarker Sales, by Type, 2022-2031 ($ million) (Malaria, Lyme Disease, E. Coli, H. pylori, Dengue, All Other)
Figure 4-15: Global Other Infectious Disease Biomarker Share, by Type, 2025 (%) (Malaria, Lyme Disease, E. Coli, H. pylori, Dengue, All Other)
Market Analysis
Table 4-9: Global Infectious Disease Biomarker Sales, by Major Product Group, 2022-2031 ($ million) (HAIs, Hepatitis, HIV, Respiratory, STDs, TORCH, Other)
Figure 4-16: Global Infectious Disease Biomarker Sales, by Major Product Group, 2022-2031 ($ million) (HAIs, Hepatitis, HIV, Respiratory, STDs, TORCH, Other)
Figure 4-17: Global Infectious Disease Biomarker Share, by Major Product Group, 2025 (%) (HAIs, Hepatitis, HIV, Respiratory, STDs, TORCH, Other)
Table 4-10: Global Infectious Disease Biomarker Sales, by Technology, 2022-2031 ($ million) (Lab Immunoassay Tests, Molecular Tests, Rapid Immunoassay Tests)
Figure 4-18: Global Infectious Disease Biomarker Sales, by Technology, 2022-2031 ($ million) (Lab Immunoassay Tests, Molecular Tests, Rapid Immunoassay Tests)
Figure 4-19: Global Infectious Disease Biomarker Share, by Technology, 2025 (%) (Lab Immunoassay Tests, Molecular Tests, Rapid Immunoassay Tests)
Biomarker Product Suppliers
Chapter 5: Cancer Biomarkers
Overview
Key Biomarkers for Cancer
Table 5-1: Global Cancer Biomarker Sales, by Type, 2022-2031 ($ million) (Circulating Tumor Markers (CTMs), Tissue Tumor Markers (TTMs))
Figure 5-1: Global Cancer Biomarker Sales, by Type, 2022-2031 ($ million) (Circulating Tumor Markers (CTMs), Tissue Tumor Markers (TTMs))
Figure 5-2: Global Cancer Biomarker Share, by Type, 2025 (%) (Circulating Tumor Markers (CTMs), Tissue Tumor Markers (TTMs))
Recent Developments
Predictive Biomarker Tests for Drug-Gene Match
Pharmacodiagnostic Tests
Precision Cancer Therapy
Liquid Biopsy-based Non-Invasive Cancer Molecular Diagnostics
Circulating Tumor Cell (CTC) Tests
Exosome Sequencing
Next-Generation Sequencing Tests
Market Analysis
Table 5-2: Global Cancer Biomarker Sales, by Condition, 2022-2031 ($ million) (Bladder, Breast, Colorectal, Esophageal, Kidney, Leukemias, Liver, Lung, Melanoma, Multiple Myeloma, Non-Hodgkin Lymphoma, Ovarian, Pancreatic, Prostate, Stomach, Thyroid, Uterine, All Other)
Figure 5-3: Global Cancer Biomarker Sales, by Condition, 2025-2031 ($ million) (Bladder, Breast, Colorectal, Esophageal, Kidney, Leukemias, Liver, Lung, Melanoma, Multiple Myeloma, Non-Hodgkin Lymphoma, Ovarian, Pancreatic, Prostate, Stomach, Thyroid, Uterine, All Other)
Figure 5-4: Global Cancer Biomarker Share, by Condition, 2025 (%) (Bladder, Breast, Colorectal, Esophageal, Kidney, Leukemias, Liver, Lung, Melanoma, Multiple Myeloma, Non-Hodgkin Lymphoma, Ovarian, Pancreatic, Prostate, Stomach, Thyroid, Uterine, All Other)
Biomarker Product Suppliers
Chapter 6: Cardiovascular Biomarkers
Overview
Key Biomarkers for Cardiovascular Conditions
Recent Developments
High-Sensitivity Troponins (hs-cTn)
Natriuretic Peptides (BNP/NT-proBNP)
Inflammatory Biomarkers
Metabolic and Lipid-Related Biomarkers
Emerging Biomarkers and Multi-Omics Approaches
Integration of AI and Machine Learning
Market Analysis
Table 6-1: Global Cardiovascular Biomarker Sales, by Product Group, 2022-2031 ($ million) (Atherosclerosis, CAD (Coronary Artery Disease), Cerebrovascular, CHF (Congestive Heart Failure), Cholesterol/Lipid, Coagulation, MI (Myocardial Infarction), Other)
Figure 6-1: Global Cardiovascular Biomarker Sales, by Product Group, 2022-2031 ($ million) (Atherosclerosis, CAD (Coronary Artery Disease), Cerebrovascular, CHF (Congestive Heart Failure), Cholesterol/Lipid, Coagulation, MI (Myocardial Infarction), Other)
Figure 6-2: Global Cardiovascular Biomarker Share, by Product Group, 2025 (%) (Atherosclerosis, CAD (Coronary Artery Disease), Cerebrovascular, CHF (Congestive Heart Failure), Cholesterol/Lipid, Coagulation, MI (Myocardial Infarction), Other)
Biomarker Product Suppliers
Chapter 7: Clinical Chemistry Biomarkers
Overview
Key Biomarkers for Clinical Chemistry
Electrolytes and Blood Gases
Urinalysis
Workstation Immunoassay Tests
Thyroid Testing
Fertility and Other Biomarkers
Recent Developments
Market Analysis
Table 7-1: Global Clinical Chemistry Biomarker Sales, by Product Group, 2022-2031 ($ million) (Cardiac Biomarkers, Drugs of Abuse, Electrolytes, Enzymes, Glucose, HbA1c, Proteins, Therapeutic Drugs, Other)
Figure 7-1: Global Clinical Chemistry Biomarker Sales, by Product Group, 2022-2031 ($ million) (Cardiac Biomarkers, Drugs of Abuse, Electrolytes, Enzymes, Glucose, HbA1c, Proteins, Therapeutic Drugs, Other)
Figure 7-2: Global Clinical Chemistry Biomarker Share, by Product Group, 2025 (%) (Cardiac Biomarkers, Drugs of Abuse, Electrolytes, Enzymes, Glucose, HbA1c, Proteins, Therapeutic Drugs, Other)
Biomarker Product Suppliers
Chapter 8: Neurological Biomarkers
Overview
Key Biomarkers for Neurological Conditions
Recent Developments
Revolution in Alzheimer's Disease Blood Tests
Advances in Traumatic Brain Injury (TBI) Biomarkers