In Vitro Diagnostics Industry Overview

The global in vitro diagnostics (IVD) market size was estimated at USD 77.92 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 4.4% from 2024 to 2030. The growth can be attributed to increasing adoption of IVD owing to a rise in the incidence of infectious and chronic diseases. The development of automated IVD systems for laboratories and hospitals to provide efficient, accurate, and error-free diagnoses is expected to fuel market growth. The rising number of IVD products being launched by key players is also fueling market growth. For instance, in November 2023, ARUP Laboratories received a CE mark from EU-IVDR for AAV5 DetectCDx, a companion diagnostic to select the eligibility of severe hemophilia A-affected patients for BioMarin’s new gene therapy, Roctavian.

Gather more insights about the market drivers, restrains and growth of the In Vitro Diagnostics Market

Technological advancements in terms of accuracy, portability, and cost-effectiveness are expected to be one of the high-impact rendering drivers of this market. Introduction of novel and highly accurate clinical laboratory tests is boosting the adoption of novel IVD tests worldwide. In June 2023, Toray Industries, Inc. received marketing approval from Japan’s Ministry of Health, Labour and Welfare for its Toray APOA2-iTQ used to diagnose pancreatic cancer. Moreover, in March 2023, Abbott received U.S. FDA clearance for its novel laboratory Traumatic Brain Injury (TBI) blood test in the U.S. Increasing approvals of IVD tests for life-threatening diseases are expected to create new opportunities in the untapped market.

Key players in the market undertake various strategies to strengthen their position and offer their customers diverse, technologically advanced innovative products. New product launches and partnerships are the most prominently adopted by companies to attract more customers. For instance, in March 2023, BD received 510(k) clearance for BD Vaginal Panel on the BD COR System to detect infectious causes of vaginitis. In August 2023, the Precision Medicine Centre (PMC) formed a partnership with the Regional Molecular Diagnostic Service (RMDS) to implement genomic technology for the diagnosis of cancer in Northern Ireland.

Favorable initiatives undertaken by government and non-government bodies to improve overall healthcare services are anticipated to increase market growth. In October 2023, the WHO published the Essential Diagnostics List (EDL), a comprehensive list of IVD products that helps countries make decisions regarding diagnostic tools. It provides evidence-based recommendations and ensures the accessibility of essential products for target people. Moreover, in August 2023, the Africa CDC collaborated with the Africa Development Agency-New Partnership for Africa's Development (AUDA-NEPAD) to increase access to diagnostic tests across Africa. Such initiatives are expected to boost market growth.

A rise in the geriatric population and growth in knowledge regarding early testing have led to a surge in the number of regular check-ups, as a majority of deaths due to infections and chronic conditions occur in the population aged over 75 years. As per the Office for Budget Responsibility, UK, healthcare costs have risen exponentially, which can create economic pressure on nations with rapidly growing geriatric population. However, this expenditure is anticipated to translate positively for the IVD industry, driving market growth.

Browse through Grand View Research's Clinical Diagnostics Industry Research Reports.

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Key Companies Market Share Insights

Some of the key players operating in the in vitro diagnostics market include F. Hoffmann-La Roche Ltd.; Abbott; Quest Diagnostics Inc.; and Danaher. Market players are adopting various strategies, such as new product launches, mergers acquisitions, and partnerships, to strengthen their product portfolios and offer diverse technologically advanced innovative products.

Llusern Scientific, Biocartis Group NV, ARUP Laboratories, Veracyte, and Exact Sciences Corp are some of the emerging market participants in the market. Emerging companies are actively involved in developing novel and accurate IVD testing products to improve overall health services. Moreover, these companies are collaborating with research institutes, government bodies, and global leaders to increase the range of their products in potential markets.

Key In Vitro Diagnostics (IVD) Companies

• Abbott
• bioMérieux SA
• QuidelOrtho Corporation
• Siemens Healthineers AG
• Bio-Rad Laboratories, Inc.
• Qiagen
• Sysmex Corporation
• Charles River Laboratories
• Quest Diagnostics Incorporated
• Agilent Technologies, Inc.
• Danaher Corporation
• BD
• F. Hoffmann-La Roche Ltd

Recent Developments

In December 2023, ARUP Laboratories and Medicover collaborated to provide diagnostic and healthcare services in Europe. ARUP Laboratories has developed AAV5 DetectCDx in collaboration with BioMarin Pharmaceutical Inc. to select therapies for severe hemophilia A patients

In November 2023, Veracyte joined Illumina to develop molecular tests for decentralized IVD applications. Companies are focusing on the development of Prosigna breast cancer and Percepta nasal swab tests of Veracyte

In October 2023, Promega Corporation announced its plan to develop and commercialize companion diagnostics kits with GSK Plc to identify cancer patients with MSI-H solid tumors

In February 2023, Unilabs announced investing over USD 200 million in Siemens Healthineers' technology and acquiring more than 400 laboratory analyzers to strengthen its laboratory infrastructure

In February 2023, F. Hoffmann-La Roche Ltd. collaborated with Janssen Biotech Inc. to develop companion diagnostics for targeted therapies. Companion diagnostic technologies include digital pathology, NGS, PCR, immunoassays, and immunohistochemistry

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