A quick peek into the report
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
As per BIS Research, 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
o Efficacy Biomarker
o Safety Biomarker
o Validation Biomarker
• Service
o Genomic Biomarker Service
o Tissue Biomarker Service
o Cell Service
o 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
o U.S.
o Canada
• Europe
o Germany
o U.K.
o France
o Italy
o Spain
o Rest-of-Europe
• Asia-Pacific
o Japan
o India
o China
o South Korea
o Australia
o Rest-of-Asia-Pacific
• Latin America
o Brazil
o Mexico
o 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.
Analyst’s Thoughts
According to Swati Sood, Principal Analyst – BIS Research, “Growing demand for precision medicine and targeted therapies is in turn growing the demand for the clinical biomarkers market. This trend is expected to continue in the coming years due to its increasing awareness all over the world, including emerging countries.”
Clinical Biomarkers Market - A Global and Regional Analysis
Focus on Offering, Clinical Area, Technology, End User, and Region - Analysis and Forecast, 2023-2033
Frequently Asked Questions
Clinical biomarkers are measurable and quantifiable biological indicators or substances that are used to assess various physiological or pathological processes within the body. These biomarkers play a crucial role in healthcare and medical research by providing valuable information about a person's health status, disease progression, response to treatments, or overall well-being. Clinical biomarkers can encompass a wide range of molecules, including proteins, nucleic acids (DNA and RNA), metabolites, hormones, and various cellular or tissue characteristics.
Existing clinical biomarkers players are continually exploring various strategies to enhance their market position in the industry. Some of the key strategies include the expansion of their integration of artificial intelligence into biomarker discovery, increasing biomarker usage in precision medicine, and advancements of technologies in clinical biomarkers diagnosis, among others.
The following are the USPs of this report:
• Market regulations and a list of key trends in the clinical biomarkers market
• Market share of top clinical biomarkers manufacturers and service providers
• A competitive index of the market specific to the unmet needs and innovations of the key players
• Key challenges faced by manufacturers
• Market dynamic analysis of the opportunities, trends, and challenges in the market
• Competitive benchmarking of key players for each product type
The global clinical biomarkers report gives a detailed analysis of all aspects of the market. This can be useful to manufacturers, service providers, and any of the end users to make informed decisions and enable targeted marketing, strategic planning, product benchmarking, and better resource allocation, among other things.