Introduction of Clinical Biomarkers Market
The global clinical biomarkers market was valued at $24.80 billion in 2023 and is expected to reach $53.20 billion by 2033, growing at a CAGR of 7.93% between 2023 and 2033. The term clinical biomarkers refers to the quantifiable biological parameter that facilitates the understanding of the progression and early diagnosis of a disease. Clinical biomarkers specifically refer to molecular biomarkers that provide new targets for disease characterization, drug discovery, and development. The report focuses on the manufacturers of different types of tests based on biomarkers, namely prognostic, predictive, and diagnostic biomarkers, as well as services.

Market Introduction
The global clinical biomarkers market includes manufacturers and service providers offering proprietary biomarkers testing products and services for clinical diagnostics and research purposes. The study considers tests based on various technologies for different underlying applications in oncology and non-oncology diseases to detect biomarkers. However, the report does not cover instruments and software.

Industrial Impact
The global clinical biomarkers market is expected to witness high growth, attributed to the growing usage of products and services, the increasing key player initiatives, and the rising government initiatives in clinical biomarkers. The continued significant investments by healthcare companies to meet industry demand and the growing adoption of drug discovery and development, disease risk assessment, and others among major end users are the major factors propelling the growth of the global clinical biomarkers market. Drug discovery encompasses a rapidly evolving range of assays and systems that facilitate cancer biomarkers, cardiac biomarkers, infectious diseases, and others. Infectious diseases also offer prognostic assessments for a wide range of diseases, as well as assistance with treatment selection and monitoring of drug treatment efficacy.

Market Segmentation:

Segmentation 1: by Offering

  • Product
    • Efficacy Biomarker
    • Safety Biomarker
    • Validation Biomarker
  • Service
    • Genomic Biomarker Service
    • Tissue Biomarker Service
    • Cell Service
    • Proteomics Service


Product Segment to Dominate the Clinical Biomarkers Market (by Offering)
Based on product, the global clinical biomarkers market was led by the product segment, with a 76.59% share in 2022. The report focuses on the manufacturers of different types of biomarkers, namely, prognostic, predictive, and diagnostic biomarkers. Acknowledging the future potential for massive growth in demand for biomarker-based assays, several biotechnology and life science companies, such as Illumina, Inc., Bio-Rad Laboratories, Inc., Thermo Fisher Scientific Inc., and F. Hoffmann-La Roche Ltd, have invested substantially to aid further developments in clinical biomarkers market.

Segmentation 2: by Clinical Area

  • Cancer Biomarkers
  • Cardiac Biomarkers
  • Neurological Biomarkers
  • Infectious Disease
  • Immunological Biomarkers
  • Non-Invasive Prenatal Testing
  • Other Clinical Areas



Cancer Biomarkers to Witness the Highest Growth between 2023 and 2033
Cancer biomarkers are the biomolecules or the processes observed during the presence of the tumor. These biomolecules could be found in blood, serum, or any other body fluid, indicating the presence of any abnormal process. These biomarkers could be in the form of genetic biomarkers, protein biomarkers, and glycoproteins that are used for the diagnosis or prognosis of a tumor. A few of the biomarkers that have been diagnosed for the development of any diagnostic assay are BRCA1/BRCA2 and EGFR for breast cancer, SSC and TPA for lung cancer, and PSA for prostate cancer.

Segmentation 3: by Technology

  • Next-Generation Sequencing (NGS)
  • Polymerase Chain Reaction (PCR)
  • Immunohistochemistry (IHC)
  • Enzyme-Linked Immunosorbent Assay (ELISA)
  • Other Technologies



Next-Generation Sequencing (NGS) to Witness the Highest Growth between 2023 and 2033
Based on technology, the clinical biomarkers market was led by next-generation sequencing, with a 31.55% share in 2022. Next-generation sequencing (NGS) has been increasingly used in cancer genomics research over the last decade (from 2010 to the present) as new sequencing technology has been developed and improved. NGS is a modern and alternative technique that allows clinicians to evaluate several genes of malignancy at the same time. Material from a patient’s tumor that has been biopsied or surgically excised can be used for next-generation sequencing.

Segmentation 4: by End User

  • Contract Research Organizations (CROs)
  • Research and Academic Laboratories
  • Biopharmaceutical and Biotech Companies
  • Diagnostic Centers
  • Other End Users



Contract Research Organization (CRO) to Witness the Highest Growth between 2023 and 2033
Contract research organizations (CROs) primarily use biomarker testing services for purposes related to bioanalysis in support of the pharmaceutical and biotechnology industry as well as research and academic institutions. Also, research and academic institutions are outsourcing identification and sequencing projects to CROs in an attempt to cut down on research costs. As a result, CROs form a considerable part of the end users in the clinical biomarkers market.

Segmentation 5: by Region

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • U.K.
    • France
    • Italy
    • Spain
    • Rest-of-Europe
  • Asia-Pacific
    • Japan
    • India
    • China
    • South Korea
    • Australia
    • Rest-of-Asia-Pacific
  • Latin America
    • Brazil
    • Mexico
    • Rest-of-Latin America
  • Rest-of-the-World

Recent Developments in the Global Clinical Biomarkers Market
  • In August 2023, Quest Diagnostics launched the AD-Detect test for Alzheimer’s disease in the U.S., offering consumers the first opportunity to acquire and evaluate a blood-based biomarker test for assessing the potential risks of developing AD.
  • In September 2023, Becton, Dickinson and Company partnered with Navigate BioPharma Services, Inc. to develop and commercialize flow cytometry-based companion diagnostics and clinical decision tools. The collaboration combined Navigate BioPharma’s expertise in biomarker assay design for clinical trials with BD’s extensive portfolio of flow cytometry instruments, reagents, software, and in vitro diagnostics (IVD) development services.
  • In November 2023, Abbott Laboratories’s Alinity i Lab-Based Blood Test was cleared by the FDA. The product is used to assess mild traumatic brain injury (TBI) or concussion in individuals using two biomarkers.
  • In November 2023, Illumina Inc., a leader in DNA sequencing and array-based technologies, launched the updated TruSight Oncology 500 ctDNA v2 (TSO 500 ctDNA v2), a research assay designed for noninvasive comprehensive genomic profiling (CGP) of circulating tumor DNA (ctDNA) from blood. It is tailored for situations where tissue testing is unavailable or as a complement to tissue-based testing.
  • In May 2023, Thermo Fisher Scientific Inc. declared that its BRAHMS PlGF plus KRYPTOR and BRAHMS sFlt-1 KRYPTOR biomarker immunoassays had received FDA clearance for assessing and managing the risk of preeclampsia.



Demand – Drivers, Challenges, and Opportunities

Market Demand Drivers:
Growing Demand for Clinical Biomarker Products: Due to the ever-rising cancer cases, the need for better products is becoming more evident. Several key players are aligning their technologies as per the market requirements to provide technologically advanced products and services by adopting inorganic strategies such as product launches. Globally, there has been a significant increase in the number of people suffering from different types of cancer. Incidence rates of cancer continue to increase, primarily owing to high-fidelity diagnostic and screening measures. Cancer prevalence has also been a major factor of concern for the global healthcare industry.

Market Challenges:
High Price of Products/Services Limiting Adoption of Clinical Biomarkers in Low-Income Countries: Despite a high opportunity for expansion in different regions, the need for high investment and infrastructure is the only reason restraining the market players from making investments. Expensive instruments are the major contributing factor to the high capital requirement. Therefore, the scale of capital investment required varies depending on the scale and abilities of the laboratory established. Though the global clinical biomarkers market possesses immense potential, the high capital investment requirement is hampering the expansion of global reach and thereby challenging the growth of the market globally.

Market Opportunities:
Technological Advancement in Biomarker Testing: Significant advancements have been achieved in biomarker detection technologies, leading to the development of various methods based on highly specific recognition biomarkers. Biomarker detection techniques encompass a range of approaches, including enzyme-linked immunosorbent assay (ELISA), gel electrophoresis, surface plasmon resonance (SPR), Mass-sensing BioCD protein array, surface-enhanced Raman spectroscopy (SERS), colorimetric assay, electrochemical assay, and fluorescence methods.

How Can This Report Add Value to an Organization?
Product/Innovation Strategy: The global clinical biomarkers market has been segmented on the basis of various categories, such as offering, technology, clinical area, end user, and region. Segments such as by offering and by clinical area are then further subsegmented to ensure the comprehensiveness and thoroughness of the report.

Growth/Marketing Strategy: Product launches and upgradations accounted for the maximum number of key developments, at nearly 59% of the total developments in the clinical biomarkers market between January 2019 and December 2023. Numerous synergistic activities, fundings, and acquisitions of the market have also been tracked during the same time period.

Competitive Strategy: The global clinical biomarkers market is a highly fragmented market, with many smaller and private companies constantly entering the market. Key players in the clinical biomarkers market analyzed and profiled in the study involve established players that offer various kinds of products and services.

Methodology

Key Considerations and Assumptions in Market Engineering and Validation

  • The base year considered for the calculation of the market size is 2022. A historical year analysis has been done for the period FY2019-FY2021. The market size has been estimated for FY2022 and projected for the period FY2023-FY2033.
  • The scope of this report has been carefully derived based on interactions with experts in different companies across the world. This report provides a market study of clinical biomarkers.
  • The market contribution of clinical biomarkers anticipated to be launched in the future has been calculated based on the historical analysis of the solutions.
  • Revenues of the companies have been referenced from their annual reports for FY2022 and FY2023. For private companies, revenues have been estimated based on factors such as inputs obtained from primary research, funding history, market collaborations, and operational history.
  • The market has been mapped based on the available clinical biomarker solutions. All the key companies with significant offerings in this field have been considered and profiled in this report.



Primary Research:
The primary sources involve industry experts in clinical biomarkers, including the market players offering centrifugation products and services. Resources such as specialists, scientists, marketing heads, researchers, CXOs, and manufacturing managers have been interviewed to obtain and verify both qualitative and quantitative aspects of this research study.

The key data points taken from the primary sources include:

  • validation and triangulation of all the numbers and graphs
  • validation of the report’s segmentation and key qualitative findings
  • understanding the competitive landscape and business model
  • current and proposed production values of a product by market players
  • validation of the numbers of the different segments of the market in focus
  • percentage split of individual markets for regional analysis



Secondary Research

Open Sources

  • World Health Organization (WHO), National Institute of Health, National Medical Product Administration (NMPA), Food and Drug Administration (FDA), National Institute of Health (NIH) and PubMed, among others.
  • Annual reports, SEC filings, and investor presentations of the leading market players
  • Company websites and detailed study of their product portfolio
  • Gold standard magazines, journals, white papers, press releases, and news articles
  • Databases such as MarkerDB, Global Online Biomarker Platform (GOBIOM) and Cancer Biomarkers database
  • Paid databases

    The key data points taken from the secondary sources include:
  • segmentations and percentage shares
  • data for market value
  • key industry trends of the top players of the market
  • qualitative insights into various aspects of the market, key trends, and emerging areas of innovation
  • quantitative data for mathematical and statistical calculations



Key Market Players and Competition Synopsis
The companies that are profiled have been selected based on inputs gathered from primary experts and analyzing company coverage, product portfolio, and market penetration.

The product segment players leading the market captured around 76.59% of the market’s presence as of 2022. Services, on the other hand, accounted for approximately 23.41% of the market presence in 2022.

Some prominent names established in this market are

  • Abbott Laboratories
  • Agilent Technologies, Inc.
  • ALCEN
  • Arsenal Capital Partners
  • Azenta Life Sciences
  • Becton, Dickinson and Company
  • BGI
  • bioM?rieux S.A.
  • Bio-Rad Laboratories, Inc.
  • Broad Institute
  • Caris Life Sciences
  • CENTOGENE N.V.
  • Charles River Laboratories
  • Discovery Life Sciences (DLS)
  • Enzo Biochem Inc.
  • Eurofins Scientific
  • F. Hoffmann-La Roche Ltd
  • Illumina, Inc.
  • Myriad Genetics, Inc.
  • NeoGenomics Laboratories
  • Novogene Co., Ltd.
  • Personalis Inc.
  • Q? Solutions
  • QIAGEN N.V.
  • Quest Diagnostics Incorporated
  • Thermo Fisher Scientific Inc.