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Clinical Biomarkers Market Analysis and Forecast, 2023-2033 - Cancer Biomarkers to Witness the Highest Growth between 2023 and 2033
By: PR Newswire Association LLC. - 13 Feb 2024Back to overview list

DUBLIN, Feb. 12, 2024 /PRNewswire/ -- The "Clinical Biomarkers Market - A Global and Regional Analysis: Focus on Offering, Clinical Area, Technology, End User, and Region - Analysis and Forecast, 2023-2033" report has been added to's offering.

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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.

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.

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.

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.

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.

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.

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.

Key Market Players and Competition Synopsis

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.
  • Arsenal Capital Partners
  • Azenta Life Sciences
  • Becton, Dickinson and Company
  • BGI
  • bioMerieux S.A.
  • Bio-Rad Laboratories, Inc.
  • Broad Institute
  • Caris Life Sciences
  • 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
  • Quest Diagnostics Incorporated
  • Thermo Fisher Scientific Inc.

Key Topics Covered:

Executive Summary

1 Market

2 Market Scope

3 Research Methodology

4 Market Overview

4.1 Introduction

4.2 Clinical Biomarkers Approaches in Precision Medicine

4.3 Market Size Potential for Clinical Biomarkers, 2022-2033

4.4 COVID-19 Impact on Global Clinical Biomarkers Market

4.5 Market Trends

4.5.1 Integration of Artificial Intelligence in Biomarker Discovery

4.5.2 Increasing Biomarkers Usage in Precision Medicine

4.5.3 Technologies Being Used in Clinical Biomarker Testing

4.5.4 Clinical Biomarker Discovery Making Early Disease Diagnosis Possible

5 Industry Insights

5.1 Regulatory Framework

5.1.1 Regulatory Framework in the U.S.

5.1.2 FDA Regulations

5.1.3 Biomarker Qualification: Evidentiary Framework Guidance for Industry and FDA Staff

5.1.4 Regulatory Framework in the U.S. for Medical Devices

5.1.5 Legal Requirements and Framework in Europe

5.1.6 Legal Requirements and Framework in Asia-Pacific

5.2 Patent Analysis

5.3 Competitive Index (Unmet Needs and Innovations)

5.4 Pain Points of Manufacturers

6 Competitive Insights

6.1 Corporate Strategies

6.2 Business Strategies

6.3 Supply Chain Analysis

6.4 Pricing Analysis

6.5 Market Share Analysis (by Product Manufacturer)

6.6 Market Share Analysis (by Service Provider)

7 Market Dynamics

7.1 Overview

7.2 Impact Analysis

7.3 Market Drivers

7.3.1 Growing Demand for Clinical Biomarker Products

7.3.2 Increase in Industrial Activity in Clinical Biomarker Landscape

7.3.3 Environment Changes Provoking Swift Care and Diagnosis

7.4 Market Challenges

7.4.1 High Price of Products/Services Limiting Adoption of Clinical Biomarkers in Low-Income Countries

7.4.2 Complex Regulatory Frameworks Delaying Approval of New Clinical Biomarkers Tests

7.4.3 Difficulty in Identifying New Biomarkers

7.5 Market Opportunities

7.5.1 Technological Advancement in Biomarker Testing

7.5.2 Increased Research Funding for Executing Research and Development Exercise

7.5.3 Discovery of Novel Biomarkers Expanding Precision Medicine Horizons

8 Global Clinical Biomarkers Market, by Offering, $Billion, 2022-2033

8.1 Overview

8.2 Product

8.3 Service

9 Global Clinical Biomarkers Market, by Technology, $Billion, 2022-2033

9.1 Overview

9.2 Next-Generation Sequencing (NGS)

9.3 Polymerase Chain Reaction (PCR)

9.4 Immunohistochemistry (IHC)

9.5 Enzyme-Linked Immunosorbent Assay (ELISA)

9.6 Other Technologies

10 Global Clinical Biomarkers Market, by Clinical Area, $Billion, 2022-2033

10.1 Overview

10.2 Cancer Biomarker

10.2.1 Breast Cancer Biomarker

10.2.2 Lung Cancer Biomarker

10.2.3 Colorectal Cancer Biomarker

10.2.4 Prostate Cancer Biomarker

10.2.5 Other

10.3 Cardiac Biomarker

10.4 Neurological Biomarker

10.5 Infectious Disease Biomarker

10.6 Non-Invasive Prenatal Testing

10.7 Immunological Biomarker

10.8 Other Clinical Areas

11 Global Clinical Biomarkers Market, by End User, $Billion, 2022-2033

11.1 Overview

11.1.1 Contract Research Organizations (CROs)

11.1.2 Research and Academic Laboratories

11.1.3 Diagnostic Centers

11.1.4 Biopharmaceutical and Biotech Companies

11.1.5 Other End Users

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