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Biomarkers in Diagnostics: Global Strategic Insights and Forecasts to 2031
Publication Date: September 11, 2025
Tags: Cardiovascular Disease, Chronic Diseases, Clinical Chemistry, Diagnostics, Diagnostics Market Research, Drug Testing, Fertility, Genetic Diseases, Immunoassay, Infectious Diseases, Molecular Testing, Neurological Diseases, Oncology and Cancer, Respiratory Diseases
Pages: 260
SKU: 25-074KA
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.
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 3-1: Global Biomarker Sales, by Product Group, 2022-2031 ($ million) [Product Groups: 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
Digital Neuro Biomarkers and AI/ML Integration
Biomarkers for Other Neurological Disorders
Multi-Omics and Liquid Biopsy Approaches
Market Analysis
- Table 8-1: Global Neurological Biomarker Sales, by Product Group, 2022-2031 ($ million) [Alzheimer’s Disease, Epilepsy, Multiple Sclerosis, Neuropathy Disorders, Parkinson’s Disease, Other]
- Figure 8-1: Global Neurological Biomarker Sales, by Product Group, 2022-2031 ($ million) [Alzheimer’s Disease, Epilepsy, Multiple Sclerosis, Neuropathy Disorders, Parkinson’s Disease, Other]
- Figure 8-2: Global Neurological Biomarker Share, by Product Group, 2025 (%) [Alzheimer’s Disease, Epilepsy, Multiple Sclerosis, Neuropathy Disorders, Parkinson’s Disease, Other]
Biomarker Product Suppliers
Chapter 9: Autoimmune Biomarkers
Overview
Key Biomarkers for Autoimmune Diseases
Recent Developments
Expanding Beyond Traditional Autoantibodies
Biomarkers for Predicting Disease Progression and Treatment Response
Market Analysis
- Table 9-1: Global Autoimmune Biomarker Sales, by Product Group, 2022-2031 ($ million) [Celiac Disease, Crohn’s Disease, Hashimoto’s Thyroiditis, Rheumatoid Arthritis, Systemic Lupus Erythematosus (SLE), Type 1 Diabetes, Ulcerative Colitis, Other]
- Figure 9-1: Global Autoimmune Biomarker Sales, by Product Group, 2022-2031 ($ million) [Celiac Disease, Crohn’s Disease, Hashimoto’s Thyroiditis, Rheumatoid Arthritis, Systemic Lupus Erythematosus (SLE), Type 1 Diabetes, Ulcerative Colitis, Other]
- Figure 9-2: Global Autoimmune Biomarker Share, by Product Group, 2025 (%) [Celiac Disease, Crohn’s Disease, Hashimoto’s Thyroiditis, Rheumatoid Arthritis, Systemic Lupus Erythematosus (SLE), Type 1 Diabetes, Ulcerative Colitis, Other]
Biomarker Product Suppliers
Chapter 10: Other Biomarkers
Overview
Key Biomarkers for Other Conditions
Diabetes & Metabolic Biomarkers
Fertility & Pregnancy Biomarkers
Kidney Disorders
Inherited Diseases
Cystic Fibrosis
Down Syndrome
Sickle Cell Disease
Gaucher Disease
Familial Hypercholesterolemia
Muscular Dystrophy
Hemophilia
Von Willebrand Disease
Neurofibromatosis
Polycystic Kidney Disease
Spinal Muscular Atrophy
Klinefelter Syndrome
Canavan Disease
Cerebral Palsy
Angelman Syndrome (AS)
Other Inherited Diseases
Thyroid Conditions
All Other Biomarkers
Bone Disease Biomarkers
Gastrointestinal Biomarkers
Respiratory Biomarkers
Fecal Calprotectin
Market Analysis
- Table 10-1: Other Global Biomarker Sales, by Product Group, 2022-2031 ($ million) [Diabetes & Metabolic, Fertility & Pregnancy, Inherited Diseases, Kidney Disorders, Thyroid Conditions, All Other]
- Figure 10-1: Other Global Biomarker Sales, by Product Group, 2022-2031 ($ million) [Diabetes & Metabolic, Fertility & Pregnancy, Inherited Diseases, Kidney Disorders, Thyroid Conditions, All Other]
- Figure 10-2: Other Global Biomarker Share, by Product Group, 2025 (%) [Diabetes & Metabolic, Fertility & Pregnancy, Inherited Diseases, Kidney Disorders, Thyroid Conditions, All Other]
Chapter 11: Company Profiles
- Table 11-1: IVD Biomarker-Related Sales of Selected Industry Leaders, 2024 ($ million)
Abbott Diagnostics
Company Overview
Point-of-Care Tests
Core Laboratory
Molecular Assays
Companion Diagnostics
Liquid Biopsy
Financial
Asuragen (Bio-Techne)
Company Overview
Financial
Becton Dickinson, and Company
Company Overview
Financial
Bio-Rad Laboratories
Company Overview
Financial
Biocartis
Company Overview
Financial
Biodesix
Company Overview
Financial
bioMérieux
Company Overview
Financial
Biotheranostics, Inc. (Hologic)
Company Overview
Financial
Danaher Corporation
Company Overview
Cepheid
Radiometer
Beckman Coulter
Leica Biosystems
Financial
DiaSorin Group
Company Overview
Financial
Exact Sciences
Company Overview
Financial
Exosome Diagnostics (Bio-Techne)
Company Overview
Financial
Illumina
Company Overview
Financial
Myriad Genetics
Company Overview
Financial
QuidelOrtho
Company Overview
Financial
Qiagen
Company Overview
Precision Medicine / Companion Diagnostics
Liquid Biopsy
Financial
Roche Diagnostics
Company Overview
Molecular Testing
HPV and Cervical Cancer Screening
Immunohistochemistry – IHC
Companion Diagnostics
Circulating Tumor Cells
Financial
Siemens Healthineers
Company Overview
Financial
Sysmex Inostics
Company Overview
Financial
Thermo Fisher Scientific
Company Overview
Financial
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