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Clinical Biomarkers Market Key Players Analysis- Johnson & Johnson Services, Inc., QIAGEN, Bio-Rad Laboratories, Inc., Siemens Healthineers AG.
InsightAce Analytic Pvt. Ltd. announces the release of a market assessment report on the "Global Clinical Biomarkers Market - (By Offering (Product (Efficacy Biomarker (Diagnostic Biomarker, Predictive Biomarker, Prognostic Biomarker), Safety Biomarker, Validation Biomarker), Service (Genomic Biomarker Service, Tissue Biomarker Service, Cell Service, Proteomics Service), By Clinical Area (Cancer Biomarkers (Breast Cancer Biomarker, Lung Cancer Biomarker, Colorectal Cancer Biomarker, Prostate Cancer Biomarker, Other), Cardiac Biomarkers, Neurological Biomarkers, Infectious Disease, Immunological Biomarkers, Non-Invasive Prenatal Testing, Other Clinical Areas), By Technology (Next-Generation Sequencing (NGS), Polymerase Chain Reaction (PCR), Immunohistochemistry (IHC), Enzyme-Linked Immunosorbent Assay (ELISA), Other Technologies), By End User (Contract Research Organizations (CROs), Research and Academic Laboratories, Biopharmaceutical and Biotech Companies, Diagnostic Centers, Other End Users)), Trends, Industry Competition Analysis, Revenue and Forecast To 2031."According to the latest research by InsightAce Analytic, the Global Clinical Biomarkers Market is valued at US$ 25.02 Billion in 2023, and it is expected to reach US$ 47.25 Billion by 2031, with a CAGR of 8.54% during the forecast period of 2024-2031.
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Clinical biomarkers are measurable biological indicators that provide insights into disease progression and facilitate early diagnosis. Manufacturers and service providers in the global clinical biomarkers market offer proprietary testing products and services designed for both research and clinical diagnostics. These tests utilize a range of advanced technologies to identify biomarkers associated with various oncological and non-oncological disorders.
Healthcare providers are increasingly investing in clinical biomarker research and development to address growing industry demand. The expanding applications of clinical biomarkers in areas such as drug development and disease risk assessment are driving market growth. Various testing methods and analytical approaches are being employed to develop biomarkers for a broad spectrum of diseases. However, the lack of standardized reimbursement policies in both developing and developed countries remains a significant barrier to market growth. This challenge is further compounded by the rising global incidence of cancer, which is increasing the need for reliable diagnostic testing.
List of Prominent Players in the Clinical Biomarkers Market:
• F. Hoffmann-La Roche AG
• Epigenomics AG
• Abbott
• Thermo Fisher Scientific Inc
• General Electric
• Eurofins Scientific
• Johnson & Johnson Services, Inc.
• QIAGEN
• Bio-Rad Laboratories, Inc.
• Siemens Healthineers AG
• Merck KGaA
• PerkinElmer Inc.
• Agilent Technologies, Inc
• DiaMetra
• Others
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Market Dynamics
Drivers:
The increasing demand for clinical biomarkers is driven by the growing need for advanced products to address the rising global incidence of cancer. Leading companies are leveraging strategic initiatives such as product launches and technological upgrades to meet the market's evolving requirements for sophisticated diagnostic solutions. The rising prevalence of various types of cancer worldwide is largely attributed to the adoption of more precise diagnostic tools and enhanced screening programs, which are improving early detection rates and driving market growth.
Challenges:
Key challenges hindering market expansion include high costs, a shortage of skilled professionals, and the absence of standardized guidelines and protocols, particularly in developing regions where lockdowns and isolation measures have further disrupted healthcare operations. Demonstrating the clinical utility and cost-effectiveness of biomarker testing remains critical for securing reimbursement approvals. This requires comprehensive data on test accuracy, clinical outcomes, treatment impacts, and potential cost savings. Generating this evidence is often complex and time-consuming, particularly for novel biomarkers. Limited reimbursement coverage or delays in reimbursement approvals may further restrict the availability and adoption of innovative biomarker tests.
Regional Trends:
The North American clinical biomarkers market is expected to hold a significant share in terms of revenue and is projected to experience a high compound annual growth rate (CAGR) in the coming years. This growth is driven by the increasing adoption of advanced technologies such as next-generation sequencing (NGS) and a growing body of research supporting the efficacy of biomarkers in cancer diagnosis, drug development, and therapeutic efficiency. Similarly, Europe holds a substantial market share due to the increasing use of biomarker-based testing for cancer detection and the adoption of advanced diagnostic technologies in regional laboratories.
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Recent Developments:
• In Feb 2024, Johnson & Johnson released the primary findings from two important studies involving the use of nipocalimab: the VIVACITY research, which is currently underway in adults with gMG, and the DAHLIAS study, which is currently underway in people with Sjögren's disease (SjD).
• In Feb 2024, Abbott and Fujirebio teamed up to provide a research-use-only test for neurofilament-light chain (NfL). The neurology biomarker assay will be accessible on Abbott's Alinity I instrument and will be provided to researchers doing studies showcasing the usefulness of the NfL biomarker, as stated by the firms. The companies plan to release the test by 2025, making it the initial RUO assay for the Alinity I system. The businesses mentioned that NfL is being investigated as a biomarker for many neurological illnesses such as multiple sclerosis, Alzheimer's disease, and traumatic brain injury.
• In June 2023, Roche declared that its Elecsys® beta-Amyloid (1-42) CSF II (Abeta42) and Elecsys® Total-Tau CSF tests (tTau) had obtained clearance from the U.S. Food & Drug Administration (FDA) under the 510(k) process. The Elecsys AD CSF Abeta42 and tTau assays quantify beta-amyloid and tau proteins, two indicators of Alzheimer's pathology, in persons aged 55 and above undergoing evaluation for the illness.
Segmentation of Clinical Biomarkers Market-
By Offering
• Product
o Efficacy Biomarker
Diagnostic Biomarker
Predictive Biomarker
Prognostic Biomarker
o Safety Biomarker
o Validation Biomarker
• Service
o Genomic Biomarker Service
o Tissue Biomarker Service
o Cell Service
o Proteomics Service
By Clinical Area
• Cancer Biomarkers
o Breast Cancer Biomarker
o Lung Cancer Biomarker
o Colorectal Cancer Biomarker
o Prostate Cancer Biomarker
o Other
• Cardiac Biomarkers
• Neurological Biomarkers
• Infectious Disease
• Immunological Biomarkers
• Non-Invasive Prenatal Testing
• Other Clinical Areas
By Technology
• Next-Generation Sequencing (NGS)
• Polymerase Chain Reaction (PCR)
• Immunohistochemistry (IHC)
• Enzyme-Linked Immunosorbent Assay (ELISA)
• Other Technologies
By End User
• Contract Research Organizations (CROs)
• Research and Academic Laboratories
• Biopharmaceutical and Biotech Companies
• Diagnostic Centers
• Other End Users
By Region-
North America-
• The US
• Canada
• Mexico
Europe-
• Germany
• The UK
• France
• Italy
• Spain
• Rest of Europe
Asia-Pacific-
• China
• Japan
• India
• South Korea
• Southeast Asia
• Rest of Asia Pacific
Latin America-
• Brazil
• Argentina
• Rest of Latin America
Middle East & Africa-
• GCC Countries
• South Africa
• Rest of the Middle East and Africa
About Us:
InsightAce Analytic is a market research and consulting firm that enables clients to make strategic decisions. Our qualitative and quantitative market intelligence solutions inform the need for market and competitive intelligence to expand businesses. We help clients gain competitive advantage by identifying untapped markets, exploring new and competing technologies, segmenting potential markets and repositioning products. Our expertise is in providing syndicated and custom market intelligence reports with an in-depth analysis with key market insights in a timely and cost-effective manner.
Contact us:
InsightAce Analytic Pvt. Ltd.
Visit: www.insightaceanalytic.com
Tel : +1 551 226 6109
Asia: +91 79 72967118
info@insightaceanalytic.com
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