바이오마커 시장 보고서 : 제품별, 유형별, 질환별, 용도별, 최종사용자별, 지역별(2025-2033년)

The global biomarkers market size reached USD 89.4 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 249.4 Billion by 2033, exhibiting a growth rate (CAGR) of 10.8% during 2025-2033. The rising prevalence of chronic diseases, ongoing developments in biotechnology and genomics, the shift toward personalized medicine, continuous advancements in analytical technologies, and increasing awareness among both healthcare professionals and patients about the benefits of biomarkers are some of the major factors propelling the market.

Biomarkers are measurable indicators within the human body that provide essential information about various biological processes and conditions. These markers can encompass a wide range of substances, including proteins, genes, hormones, or even physical characteristics. Biomarkers play a crucial role in medical research, diagnosis, and treatment planning. They enable healthcare professionals and researchers to assess the presence or progression of diseases, monitor the effectiveness of therapies, and predict an individual's susceptibility to certain health issues. In the realm of market research and consulting services, understanding biomarkers is pivotal, as they guide decision-making processes in healthcare and pharmaceutical industries, aiding in the development of innovative solutions and strategies.

The rise in chronic diseases, including cancer, cardiovascular disorders, and diabetes, represents one of the key factors driving the growth of the market across the globe. They are indispensable for early detection, disease monitoring, and the development of personalized treatment strategies. The continuous progress in biotechnology and genomics is leading to the discovery of novel biomarkers, expanding their applications across diagnostics, drug development, and precision medicine. Biomarkers are integral to pharmaceutical research, assisting in target identification, drug candidate efficacy evaluation, and safety profiling. This accelerates drug development, reduces costs, and enhances success rates. The shift towards personalized medicine relies heavily on biomarkers to tailor treatment plans to individual patient profiles, improving treatment outcomes and minimizing side effects. The globally aging population is a key driver, as elderly individuals are more prone to chronic diseases, necessitating early detection and effective management using biomarkers. Continuous improvements in analytical technologies, such as genomics, proteomics, and imaging enhance the sensitivity and specificity of biomarker detection, which is broadening their applications, thus facilitating the market growth across the globe.

Biomarkers Market Trends/Drivers:

Rising disease burden and healthcare costs

One of the primary drivers of the biomarkers market is the escalating global burden of diseases, particularly chronic conditions like cancer, cardiovascular diseases, and diabetes. Biomarkers play a pivotal role in the early detection, diagnosis, and monitoring of these diseases. They enable healthcare professionals to identify disease risks, formulate treatment strategies, and track treatment responses more effectively. As healthcare systems face the challenge of managing these increasing disease burdens, biomarkers provide a valuable tool for improving patient outcomes and reducing healthcare costs through early intervention and targeted therapies.

Significant advancements in biotechnology and personalized medicine

The continuous advancement of biotechnological tools and techniques, including genomics, proteomics, and high-throughput screening, has revolutionized biomarker discovery and validation. This has led to the identification of novel biomarkers with high specificity and sensitivity, enhancing their diagnostic and prognostic capabilities. Moreover, the paradigm shift towards personalized medicine relies heavily on biomarkers to tailor treatments to individual patient profiles. Biomarker-driven approaches enable healthcare providers to select the most suitable therapies, thereby increasing treatment efficacy and minimizing adverse effects. This has not only improved patient care but has also intensified the demand for biomarker-based tests and therapies.

Rise in drug development and clinical trials

Biomarkers are becoming indispensable in the pharmaceutical industry, which is driving drug discovery and development, thus acting as a major growth-inducing factor. They facilitate target identification, patient stratification for clinical trials, and assessment of drug efficacy and safety. This results in streamlined drug development processes, reduced costs, and increased success rates in bringing new drugs to market. Regulatory agencies, such as the FDA and EMA, increasingly recognize the significance of biomarkers in drug approvals, which is further accelerating their integration into clinical trials and drug development pipelines.

Biomarkers Industry Segmentation:

Breakup by Product:

• Consumables
• Services
• Software

Consumables dominate the market

The demand for consumables in the biomarkers market is driven by several influential factors. Primarily, the continuous expansion of biomarker research in various fields, including oncology, cardiology, and neuroscience, necessitates a steady supply of consumables. Researchers rely on consumables such as assay kits, reagents, and laboratory supplies to conduct experiments and validate biomarkers for clinical applications. The growing adoption of biomarkers for clinical diagnostics fuels demand for consumables used in diagnostic tests. Consumables like test kits, sample collection devices, and assay reagents are essential for accurate biomarker-based diagnosis, enabling early disease detection and monitoring. Biomarkers are integral to drug discovery and development, where consumables like cell culture media, plates, and assay components are essential. The pharmaceutical industry's robust pipeline of biomarker-driven therapies and the need for large-scale screening drive demand for consumables. The trend towards personalized medicine, which relies on biomarkers for treatment tailoring, has increased the need for consumables. Customized therapies based on individual biomarker profiles require specific consumables for their development and administration.

Breakup by Type:

• Efficacy Biomarkers
• Safety Biomarkers
• Validation Biomarkers

Safety biomarkers hold the largest share in the market

The demand for safety biomarkers in the biomarkers industry is influenced by several critical factors. Regulatory agencies, such as the FDA and EMA, mandate the evaluation of safety biomarkers in drug development to assess potential adverse effects and toxicity. Compliance with these regulations drives the demand for safety biomarker assays and testing services. The high costs associated with drug development, including the expenses incurred due to adverse events and late-stage failures, underscore the importance of safety biomarkers. Early detection of safety concerns can significantly reduce development expenses, prompting the pharmaceutical industry to invest in safety biomarker research and implementation. Ensuring patient safety is paramount in clinical trials. The utilization of safety biomarkers helps identify and mitigate potential risks to participants, aligning with ethical and safety considerations. Technological advancements, such as omics technologies (genomics, proteomics, metabolomics), enable the discovery of novel safety biomarkers with enhanced sensitivity and specificity. The availability of cutting-edge tools and assays drives the adoption of safety biomarkers in drug safety assessment.

Breakup by Disease:

• Cancer
• Cardiovascular Disorders
• Neurological Disorders
• Immunological Disorders
• Renal Disorders
• Others

Cancer dominates the market

Biomarkers play a pivotal role in cancer research, diagnosis, treatment, and patient management. Their applications in cancer are multifaceted and essential. Primarily, biomarkers enable the early detection of cancer, often before symptoms manifest. Blood-based biomarkers, such as circulating tumor DNA (ctDNA) and specific proteins like PSA (Prostate-Specific Antigen), aid in screening and early diagnosis. Biomarkers help confirm cancer diagnoses and classify tumors into specific subtypes. For instance, hormone receptor status (estrogen and progesterone receptors) in breast cancer guides treatment decisions. Biomarkers provide prognostic information, helping predict the course of the disease. Genetic markers and gene expression profiles assist in estimating a patient's likely outcome and risk of recurrence. Biomarkers guide treatment decisions by identifying targeted therapies. For instance, the presence of HER2/neu in breast cancer indicates eligibility for HER2-targeted therapies like trastuzumab. Biomarkers are used to monitor treatment efficacy and disease progression. Imaging biomarkers, like PET scans, assess tumor response to therapy, aiding treatment adjustments.

Breakup by Application:

• Diagnostics
• Drug Discovery and Development
• Personalized Medicine
• Others

Drug discovery and development hold the largest share in the market

Biomarkers are indispensable tools in drug discovery and development, offering several critical applications that streamline the process and increase its efficiency. Biomarkers help identify and validate potential drug targets by providing insights into their role in disease pathways. This ensures that drug development efforts are focused on biologically relevant targets. Biomarkers aid in assessing the effectiveness of drug candidates during preclinical and clinical trials. They provide quantifiable measurements of the drug's impact on the target and its downstream effects, helping to select the most promising candidates. Safety biomarkers are crucial for evaluating the potential adverse effects of drug candidates. They help identify safety concerns early in the development process, reducing the risk of late-stage failures. Biomarkers enable the stratification of patient populations, identifying subgroups that are more likely to respond to a specific treatment. This supports the development of targeted therapies, optimizing treatment outcomes.

Breakup by End User:

• Pharmaceutical and Biotechnology Companies
• Diagnostic and Research Laboratories
• Hospitals and Specialty Clinics
• Others

Diagnostic and research laboratories dominates the market

Biomarkers have a significant impact on the operations of diagnostic and research laboratories, serving a wide range of crucial purposes. Biomarkers are fundamental in clinical diagnostics, aiding in the accurate and early diagnosis of various diseases. They provide measurable indicators of disease presence or progression, enhancing diagnostic precision. Biomarkers enable the categorization of patients into different risk groups or disease subtypes, helping healthcare providers tailor treatment plans to individual profiles. In research and clinical settings, biomarkers are used to monitor disease progression and assess the effectiveness of treatments. This helps in disease management and optimization of therapeutic interventions. Laboratories use biomarkers to evaluate drug responses, assess drug metabolism, and understand the relationship between drug dose and effect. Biomarkers play a role in assessing the safety of drugs and therapies and identifying potential side effects and toxicities. Biomarkers serve as key tools in laboratory research, aiding in the discovery of new disease mechanisms, drug targets, and potential therapeutic interventions.

Breakup by Region:

• North America
• United States
• Canada
• Europe
• Germany
• France
• United Kingdom
• Italy
• Russia
• Spain
• Others
• Asia Pacific
• China
• Japan
• India
• South Korea
• Australia
• Indonesia
• Others
• Latin America
• Brazil
• Mexico
• Others
• Middle East and Africa

North America exhibits a clear dominance, accounting for the largest market share

The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Russia, Spain, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America accounted for the largest market share.

The biomarkers industry in North America is driven by several influential factors that contribute to its growth and development. The high prevalence of chronic diseases, including cancer, cardiovascular disorders, and diabetes, in North America has fueled the demand for biomarkers. Biomarkers are crucial for early detection, monitoring, and treatment selection in these conditions. North America boasts a well-developed healthcare infrastructure, including state-of-the-art laboratories and research facilities. This infrastructure supports biomarker research, development, and implementation. The region is home to a robust biotechnology and pharmaceutical industry. Biomarkers play a central role in drug discovery, development, and clinical trials, driving their demand. Regulatory agencies like the FDA in the United States have recognized the importance of biomarkers in drug development and diagnostics. Clear regulatory pathways for biomarker-based products encourage their use. Significant investments in research and development (R&D), both public and private, support biomarker discovery and validation, enhancing their role in healthcare. Ongoing technological advancements in genomics, proteomics, and diagnostic technologies are improving the accuracy and efficiency of biomarker assays.

Competitive Landscape:

Key players in the market are actively engaged in various strategic initiatives to advance research, development, and commercialization in this dynamic field. Leading companies invest heavily in R&D to discover and validate novel biomarkers. They collaborate with academic institutions and research organizations to expand their biomarker portfolios. Many biomarker companies form strategic partnerships with pharmaceutical and biotechnology firms to integrate biomarkers into drug development pipelines. These collaborations aim to identify biomarkers for patient stratification and treatment response prediction. Companies continuously expand their biomarker product portfolios, offering a wide range of assays, kits, and services for diverse applications, from diagnostics to drug development. Leading players invest in cutting-edge technologies, such as next-generation sequencing and mass spectrometry, to enhance the sensitivity and specificity of biomarker detection methods. Some key players focus on developing companion diagnostics, and aligning biomarker tests with specific therapies to ensure precise treatment selection and improve patient outcomes.

The market research report has provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the key players in the market include:

• Agilent Technologies Inc.
• Bio-Rad Laboratories Inc.
• Charles River Laboratories International Inc.
• Epigenomics AG
• Eurofins Scientific SE
• Merck KGaA
• Perkinelmer Inc.
• Qiagen N.V
• Quanterix Corporation
• SphingoTec GmbH
• Thermo Fisher Scientific Inc.

Key Questions Answered in This Report

• 1.What was the size of the global biomarkers market in 2024?
• 2.What is the expected growth rate of the global biomarkers market during 2025-2033?
• 3.What are the key factors driving the global biomarkers market?
• 4.What has been the impact of COVID-19 on the global biomarkers market?
• 5.What is the breakup of the global biomarkers market based on the product?
• 6.What is the breakup of the global biomarkers market based on the type?
• 7.What is the breakup of the global biomarkers market based on disease?
• 8.What is the breakup of the global biomarkers market based on the application?
• 9.What is the breakup of the global biomarkers market based on the end user?
• 10.What are the key regions in the global biomarkers market?
• 11.Who are the key players/companies in the global biomarkers market?

Table of Contents

1 Preface

2 Scope and Methodology

• 2.1 Objectives of the Study
• 2.2 Stakeholders
• 2.3 Data Sources
  • 2.3.1 Primary Sources
  • 2.3.2 Secondary Sources
• 2.4 Market Estimation
  • 2.4.1 Bottom-Up Approach
  • 2.4.2 Top-Down Approach
• 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

• 4.1 Overview
• 4.2 Key Industry Trends

5 Global Biomarkers Market

• 5.1 Market Overview
• 5.2 Market Performance
• 5.3 Impact of COVID-19
• 5.4 Market Forecast

6 Market Breakup by Product

• 6.1 Consumables
  • 6.1.1 Market Trends
  • 6.1.2 Market Forecast
• 6.2 Services
  • 6.2.1 Market Trends
  • 6.2.2 Market Forecast
• 6.3 Software
  • 6.3.1 Market Trends
  • 6.3.2 Market Forecast

7 Market Breakup by Type

• 7.1 Efficacy Biomarkers
  • 7.1.1 Market Trends
  • 7.1.2 Market Forecast
• 7.2 Safety Biomarkers
  • 7.2.1 Market Trends
  • 7.2.2 Market Forecast
• 7.3 Validation Biomarkers
  • 7.3.1 Market Trends
  • 7.3.2 Market Forecast

8 Market Breakup by Disease

• 8.1 Cancer
  • 8.1.1 Market Trends
  • 8.1.2 Market Forecast
• 8.2 Cardiovascular Disorders
  • 8.2.1 Market Trends
  • 8.2.2 Market Forecast
• 8.3 Neurological Disorders
  • 8.3.1 Market Trends
  • 8.3.2 Market Forecast
• 8.4 Immunological Disorders
  • 8.4.1 Market Trends
  • 8.4.2 Market Forecast
• 8.5 Renal Disorders
  • 8.5.1 Market Trends
  • 8.5.2 Market Forecast
• 8.6 Others
  • 8.6.1 Market Trends
  • 8.6.2 Market Forecast

9 Market Breakup by Application

• 9.1 Diagnostics
  • 9.1.1 Market Trends
  • 9.1.2 Market Forecast
• 9.2 Drug Discovery and Development
  • 9.2.1 Market Trends
  • 9.2.2 Market Forecast
• 9.3 Personalized Medicine
  • 9.3.1 Market Trends
  • 9.3.2 Market Forecast
• 9.4 Others
  • 9.4.1 Market Trends
  • 9.4.2 Market Forecast

10 Market Breakup by End User

• 10.1 Pharmaceutical and Biotechnology Companies
  • 10.1.1 Market Trends
  • 10.1.2 Market Forecast
• 10.2 Diagnostic and Research Laboratories
  • 10.2.1 Market Trends
  • 10.2.2 Market Forecast
• 10.3 Hospitals and Specialty Clinics
  • 10.3.1 Market Trends
  • 10.3.2 Market Forecast
• 10.4 Others
  • 10.4.1 Market Trends
  • 10.4.2 Market Forecast

11 Market Breakup by Region

• 11.1 North America
  • 11.1.1 United States
    • 11.1.1.1 Market Trends
    • 11.1.1.2 Market Forecast
  • 11.1.2 Canada
    • 11.1.2.1 Market Trends
    • 11.1.2.2 Market Forecast
• 11.2 Asia-Pacific
  • 11.2.1 China
    • 11.2.1.1 Market Trends
    • 11.2.1.2 Market Forecast
  • 11.2.2 Japan
    • 11.2.2.1 Market Trends
    • 11.2.2.2 Market Forecast
  • 11.2.3 India
    • 11.2.3.1 Market Trends
    • 11.2.3.2 Market Forecast
  • 11.2.4 South Korea
    • 11.2.4.1 Market Trends
    • 11.2.4.2 Market Forecast
  • 11.2.5 Australia
    • 11.2.5.1 Market Trends
    • 11.2.5.2 Market Forecast
  • 11.2.6 Indonesia
    • 11.2.6.1 Market Trends
    • 11.2.6.2 Market Forecast
  • 11.2.7 Others
    • 11.2.7.1 Market Trends
    • 11.2.7.2 Market Forecast
• 11.3 Europe
  • 11.3.1 Germany
    • 11.3.1.1 Market Trends
    • 11.3.1.2 Market Forecast
  • 11.3.2 France
    • 11.3.2.1 Market Trends
    • 11.3.2.2 Market Forecast
  • 11.3.3 United Kingdom
    • 11.3.3.1 Market Trends
    • 11.3.3.2 Market Forecast
  • 11.3.4 Italy
    • 11.3.4.1 Market Trends
    • 11.3.4.2 Market Forecast
  • 11.3.5 Spain
    • 11.3.5.1 Market Trends
    • 11.3.5.2 Market Forecast
  • 11.3.6 Russia
    • 11.3.6.1 Market Trends
    • 11.3.6.2 Market Forecast
  • 11.3.7 Others
    • 11.3.7.1 Market Trends
    • 11.3.7.2 Market Forecast
• 11.4 Latin America
  • 11.4.1 Brazil
    • 11.4.1.1 Market Trends
    • 11.4.1.2 Market Forecast
  • 11.4.2 Mexico
    • 11.4.2.1 Market Trends
    • 11.4.2.2 Market Forecast
  • 11.4.3 Others
    • 11.4.3.1 Market Trends
    • 11.4.3.2 Market Forecast
• 11.5 Middle East and Africa
  • 11.5.1 Market Trends
  • 11.5.2 Market Breakup by Country
  • 11.5.3 Market Forecast

12 SWOT Analysis

• 12.1 Overview
• 12.2 Strengths
• 12.3 Weaknesses
• 12.4 Opportunities
• 12.5 Threats

13 Value Chain Analysis

14 Porters Five Forces Analysis

• 14.1 Overview
• 14.2 Bargaining Power of Buyers
• 14.3 Bargaining Power of Suppliers
• 14.4 Degree of Competition
• 14.5 Threat of New Entrants
• 14.6 Threat of Substitutes

15 Price Analysis

16 Competitive Landscape

• 16.1 Market Structure
• 16.2 Key Players
• 16.3 Profiles of Key Players
  • 16.3.1 Agilent Technologies Inc.
    • 16.3.1.1 Company Overview
    • 16.3.1.2 Product Portfolio
    • 16.3.1.3 Financials
    • 16.3.1.4 SWOT Analysis
  • 16.3.2 Bio-Rad Laboratories Inc.
    • 16.3.2.1 Company Overview
    • 16.3.2.2 Product Portfolio
    • 16.3.2.3 Financials
    • 16.3.2.4 SWOT Analysis
  • 16.3.3 Charles River Laboratories International Inc.
    • 16.3.3.1 Company Overview
    • 16.3.3.2 Product Portfolio
    • 16.3.3.3 Financials
    • 16.3.3.4 SWOT Analysis
  • 16.3.4 Epigenomics AG
    • 16.3.4.1 Company Overview
    • 16.3.4.2 Product Portfolio
    • 16.3.4.3 Financials
    • 16.3.4.4 SWOT Analysis
  • 16.3.5 Eurofins Scientific SE
    • 16.3.5.1 Company Overview
    • 16.3.5.2 Product Portfolio
    • 16.3.5.3 Financials
    • 16.3.5.4 SWOT Analysis
  • 16.3.6 Merck KGaA
    • 16.3.6.1 Company Overview
    • 16.3.6.2 Product Portfolio
    • 16.3.6.3 Financials
    • 16.3.6.4 SWOT Analysis
  • 16.3.7 Perkinelmer Inc.
    • 16.3.7.1 Company Overview
    • 16.3.7.2 Product Portfolio
    • 16.3.7.3 Financials
    • 16.3.7.4 SWOT Analysis
  • 16.3.8 Qiagen N.V
    • 16.3.8.1 Company Overview
    • 16.3.8.2 Product Portfolio
    • 16.3.8.3 Financials
    • 16.3.8.4 SWOT Analysis
  • 16.3.9 Quanterix Corporation
    • 16.3.9.1 Company Overview
    • 16.3.9.2 Product Portfolio
    • 16.3.9.3 Financials
  • 16.3.10 SphingoTec GmbH
    • 16.3.10.1 Company Overview
    • 16.3.10.2 Product Portfolio
  • 16.3.11 Thermo Fisher Scientific Inc.
    • 16.3.11.1 Company Overview
    • 16.3.11.2 Product Portfolio
    • 16.3.11.3 Financials
    • 16.3.11.4 SWOT Analysis