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)
Description
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.
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
260 Pages
- 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
- BIOMERIEUX
- 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
Search Inside Report
Pricing
Currency Rates
Questions or Comments?
Our team has the ability to search within reports to verify it suits your needs. We can also help maximize your budget by finding sections of reports you can purchase.
