Clinical Biomarkers Markets, 2031 - ResearchAndMarkets.com

DUBLIN--(BUSINESS WIRE)--The "Clinical Biomarkers - A Global and Regional Analysis: Focus on Offering, Clinical Area, Technology, Application, End User, and Region - Analysis and Forecast, 2022-2032" report has been added to ResearchAndMarkets.com's offering.

In 2021, the global clinical biomarkers market was valued at $21,304.3 million, and it is expected to reach $54,294.0 million by 2032, growing at a CAGR of 8.73% during the forecast period 2022-2032.

The growth in the global clinical biomarkers market is expected to be driven by the increasing demand for clinical biomarker products, increasing key player initiatives, and increasing prevalence of infectious diseases and various types of cancer globally.

Market Lifecycle Stage

Clinical biomarkers have been extensively preferred in the field of clinical medicine to offer individualized treatment options to patients. Biomarkers are crucial to the rational development of medical therapeutics and are involved in their use in in-vitro diagnostics purposes, particularly in the fields of chronic disease and nutrition.

Companies such as Illumina, Inc., F. Hoffmann-La Roche Ltd Agilent Technologies, Inc., and Myriad Genetics, Inc., in the clinical biomarkers market are launching products, majorly focusing on indications for infectious diseases and cancer types such as breast cancer, ovarian cancer, lung cancer, and cervical cancer.

Several companies, such as Thermo Fisher Scientific Inc., QIAGEN N.V., NeoGenomics Laboratories, and CENTOGENE N.V., are collaborating and partnering with the stakeholders to develop and expand technological expertise to offer potential products in the global clinical biomarkers market. Breast cancer is the most frequent tumor growth in women, and its incidence experienced innovation in systematic screening. The increasing incidence of breast cancer has led to an increase in demand for its diagnosis and treatment.

Increasing demand for clinical biomarkers products is anticipated to support the growth of the global clinical biomarkers market during the forecast period 2022-2032. The market is expected to grow at a significant growth rate due to opportunities such as the expansion of biomarker discovery and increased research funding for executing research and development exercises.

Impact of COVID-19

The current global clinical biomarkers market comprises various applications such as translational research and clinical diagnostic. It has been noticed that there has been a reduction in the capacity or shutdowns of laboratories and other research institutions, which has led to reduced usage of various products and services related to research.

The government imposed various restrictions during COVID-19, such as travel bans, quarantines, curfews, business shutdowns, and closures. This led to an increased cost of COVID-19-related services. There have been many issues during the COVID-19 pandemic, such as operational failures, shipping issues, inaccurate demand forecasts, and other production issues.

Furthermore, the health and safety of employees were impacted as COVID-19 reduced the efficacy of employees' work potential. However, the market related to COVID-19 grew during the pandemic as customers were in need of testing services. The implementation of lockdown and travel restrictions amidst the pandemic shook the entire clinical biomarkers industry globally, leading to manufacturing difficulties and delays in clinical trials of biomarkers.

The following section represents how the COVID-19 crisis is dismantling drug manufacturing along with the other industry sectors that rely on drug discovery and development, disease risk assessment, and others. The pandemic has impacted the clinical biomarkers market, resulting in fewer sales of the services.

Furthermore, the sales of products and services would grow after COVID-19, resulting in better-operating outcomes. However, things have been better after the removal of various restrictions and lockdowns imposed by governments.

Market Segmentation

Based on offering, with respect to the overall market share, the service segment held the largest share, i.e., 55.41% of the global clinical biomarkers market in 2021.

This trend is expected to continue during the forecast period 2022-2032, with the segment anticipated to hold a 52.88% share in 2032. The high share of the service segment is majorly due to the rising demand for clinical biomarkers services in oncology, the rising number of product launches and approval in recent years, and increasing emphasis on the adoption of clinical biomarkers technologies.

Based on technology, in 2021, global clinical biomarkers market was dominated by next-generation sequencing, with a massive market share of 31.28%. This trend is expected to continue during the forecast period 2022-2032, with the segment anticipated to hold a 34.34% share in 2032. This is primarily due to the growing cancer genomics research.

Based on application, the translational research segment accounted for the largest share in 2021, holding a 53.03% market share. This trend is expected to continue during the forecast period 2022-2032, with the translational research segment expecting to have a 54.11% share of the market in 2032.

Based on clinical area, the cancer biomarkers segment accounted for the largest share in 2021, holding a 42.04% market share. This trend is expected to continue during the forecast period 2022-2032. Increasing cancer cases across the globe will contribute significantly to the growth of this market.

Based on end user, the contract research organizations (CROs) segment accounted for the largest share in 2021, holding a 35.69% market share. This trend is expected to continue during the forecast period 2022-2032.

The North America region is expected to dominate the global clinical biomarkers market during the forecast period 2022-2032. North America has a high adoption rate of cancer genomics research. Backed by several healthcare companies working in the marketplace, the U.S. has the highest implementation of PCR, NGS, and other technologies.

Recent Developments in the Global Clinical Biomarkers Market

• Acquisition in 2021: NeoGenomics Laboratories acquired Inivata. With this acquisition, the company strengthened its market position and expanded its footprint in the clinical biomarkers market.
• Collaboration: In 2022, F. Hoffmann-La Roche Ltd collaborated with Nordic Bioscience to strengthen the development of biomarkers for chronic diseases.
• Product Approval: In 2020, F. Hoffmann-La Roche Ltd received FDA approval for an assay to detect the HER2 biomarker in breast cancer.

Market Dynamics

Market Drivers

• Increasing Demand for Clinical Biomarker Products
• Rising Key Player Initiatives
• Increasing Prevalence of Infectious Diseases and Various Types of Cancer Globally

Market Challenges

• Higher Price of Product/Service Hampering the Expansion in Low-Income countries
• Complex Regulatory Frameworks Delaying the Approval of New Clinical Biomarkers Tests
• Lack of Qualified Professionals

Market Opportunities

• Technological Advancement in Biomarker Discovery
• Increased Research Funding for Executing Research and Development Exercise

Industry Insights

Regulatory Framework in the U.S.

• FDA Regulations
• Biomarker Qualification: Evidentiary Framework Guidance for Industry and FDA Staff
• Regulatory Framework in the U.S. for Medical Devices

Legal Requirements and Framework in Europe

• U.K.
• Germany

Legal Requirements and Framework in Asia-Pacific

• China
• Japan

Pharmaceuticals and Medical Devices Agency (PMDA)

Market Overview

• Clinical Biomarkers Approaches in Precision Medicine
• Market Size Potential for Clinical Biomarkers, 2021-2032
• COVID-19 Impact on Global Clinical Biomarkers Market
• Impact on Market Size

Some of the prominent names established in this market are:

• Abbott
• Agilent Technologies, Inc.
• Bio-Rad Laboratories, Inc.
• Illumina, Inc.
• PerkinElmer Inc.
• QIAGEN N.V.
• Thermo Fisher Scientific Inc.
• NeoGenomics Laboratories
• Charles River Laboratories
• F. Hoffmann-La Roche Ltd
• Quest Diagnostics Incorporated
• Enzo Biochem Inc.
• ALCEN
• Myriad Genetics, Inc.
• CENTOGENE N.V.
• bioMerieux S.A.
• Arsenal Capital Partners
• Novogene Co., Ltd.
• Q2 Solutions
• Caris Life Sciences
• Broad Institute
• Personalis Inc.
• Azenta Life Sciences
• Discovery Life Sciences(DLS)
• BGI
• Eurofins Scientific
• Becton, Dickinson and Company

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