Next-Generation in Vitro Diagnostics (IVD) Market Report 2025

The next-generation in vitro diagnostics (IVD) market size has grown rapidly in recent years. It will grow from $106.97 billion in 2024 to $117.97 billion in 2025 at a compound annual growth rate (CAGR) of 10.3%. The growth in the historic period can be attributed to the growing geriatric population, increased government funding, escalating investments in genomic research, expansion in clinical trials, and greater consumer health awareness.

The next-generation in vitro diagnostics (IVD) market size is expected to see strong growth in the next few years. It will grow to $172.02 billion in 2029 at a compound annual growth rate (CAGR) of 9.9%. The growth in the forecast period can be credited to the expanding advancement of personalized medicine, rising healthcare expenditures, increasing research and development activities, growing incidence of infectious diseases, and a surge in chronic disease cases. Key trends during the forecast period include technological innovations, the incorporation of artificial intelligence and machine learning in diagnostics, progress in advanced diagnostic technologies, personalized medicine, and the discovery of novel biomarkers.

The rising demand for personalized medicine is expected to drive the growth of the next-generation in vitro diagnostics (IVD) market moving forward. Precision medicine is a healthcare approach that tailors disease prevention and treatment based on an individual’s genetic profile, environment, and lifestyle. The growth of personalized medicine is fueled by the increasing availability of genomic data, enabling healthcare providers to develop targeted treatments based on a person’s unique genetic makeup, resulting in more effective care. Next-generation in vitro diagnostics (IVD) supports personalized medicine by delivering precise molecular and genetic insights that facilitate customized treatment and prevention strategies for individual patients. For example, in February 2024, the Personalized Medicine Coalition, a US-based hospital and healthcare organization, reported that the FDA approved 16 new personalized treatments for rare disease patients in 2023, up from six approvals in 2022. Therefore, the growing demand for personalized medicine is driving the expansion of the next-generation in vitro diagnostics (IVD) market.

Key players in the next-generation in vitro diagnostics (IVD) market are adopting strategic partnerships by collaborating with technology providers, research institutions, and healthcare organizations to accelerate innovation, improve diagnostic accuracy, and broaden access to advanced testing solutions for individuals, businesses, and governments. Strategic partnerships involve companies leveraging each other’s strengths and resources to achieve shared benefits and success. For instance, in October 2024, Yourgene Health, a UK-based biotechnology company, partnered with Genetix, a Colombia-based human genetic diagnosis company, to introduce Colombia’s first local non-invasive prenatal testing (NIPT) service. This initiative marks a significant advancement in prenatal care within the region, providing expectant parents with faster, more reliable, and cost-effective access to advanced genetic screening. The service employs Yourgene Health’s IONA Nx NIPT Workflow, a comprehensive, CE-marked in vitro diagnostic (IVD) solution. This workflow is highly flexible and scalable, accommodating varying sample volumes, and enables Genetix to offer a quality-assured prenatal screening service throughout Colombia.

In February 2023, SD Biosensor Inc., a South Korea-based in-vitro diagnostics company, along with SJL Partners LLC, a South Korea-based investment firm, acquired Meridian Bioscience Inc. for $1.53 billion. Through this acquisition, SD Biosensor aims to leverage Meridian’s expertise in diagnostic products and raw materials used in immunological and molecular tests across various applications. Meridian Bioscience Inc. is a US-based diagnostic company specializing in in vitro diagnostic enzymes.

Major players in the next-generation in vitro diagnostics (IVD) market are F Hoffmann-La Roche AG, Thermo Fisher Scientific Inc., Abbott Laboratories, Becton Dickinson and Company, Quest Diagnostics Incorporated, Grifols SA, Agilent Technologies Inc., Illumina Inc., Sysmex Corporation, Bio-Rad Laboratories Inc., Revvity Inc., Exact Sciences Corporation, QIAGEN NV, DiaSorin SpA, Singular Genomics Systems Inc., Guardant Health Inc., Pacific Biosciences of California Inc., Transasia Bio-Medicals Ltd., Athena Dx, and J Mitra and Co Pvt Ltd.

North America was the largest region in the next-generation in vitro diagnostics (IVD) market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in next-generation in vitro diagnostics (IVD) report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the next-generation in vitro diagnostics (IVD) market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The next-generation in vitro diagnostics (IVD) market consists of revenues earned by entities providing services such as genomic testing services, molecular diagnostics services, and companion diagnostics. The market value includes the value of related goods sold by the service provider or included within the service offering. The next-generation in vitro diagnostics (IVD) market also includes sales of molecular diagnostics kits, proteomics-based diagnostic kits, and NGS sample preparation kits. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The fast surge in U.S. tariffs and the trade tensions that followed in spring 2025 are heavily affecting the medical equipment sector, particularly for imported imaging machine components, surgical-grade stainless steel, and plastic disposables. Hospitals and clinics resist price hikes, pressuring manufacturers’ margins. Regulatory hurdles compound the problem, as tariff-related supplier changes often require re-certification of devices, delaying time-to-market. Companies are mitigating risks by dual-sourcing critical parts, expanding domestic production of commoditized items, and accelerating R&D in cost-efficient materials.

The next-generation in vitro diagnostics (IVD) market research report is one of a series of new reports that provides next-generation in vitro diagnostics (IVD) market statistics, including next-generation in vitro diagnostics (IVD) industry global market size, regional shares, competitors with a next-generation in vitro diagnostics (IVD) market share, detailed next-generation in vitro diagnostics (IVD) market segments, market trends and opportunities, and any further data you may need to thrive in the next-generation in vitro diagnostics (IVD) industry. This next-generation in vitro diagnostics (IVD) market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

Next-generation in vitro diagnostics (IVD) refers to advanced diagnostic tools and technologies that examine biological samples - such as blood, saliva, or tissue - outside the body to identify diseases, conditions, or infections with enhanced accuracy, speed, and personalization. These technologies often incorporate innovations like genomics, artificial intelligence, digital health platforms, and high-throughput sequencing. The main goal of next-generation IVD is to facilitate earlier, more precise, and patient-tailored diagnosis and monitoring of diseases, including cancer, infectious diseases, and genetic disorders.

The primary product categories in next-generation in vitro diagnostics (IVD) include consumables, instruments, software, and others. Core laboratory diagnostics involve centralized testing services that process a wide variety of biological samples using automated, high-throughput instruments and assays. This encompasses types such as core laboratory diagnostics, point-of-care testing, and molecular diagnostics. These tools are applied across various fields, including oncology, infectious diseases, diabetes, cardiology, and other diagnostic areas, serving a diverse range of end users like hospitals and clinics, diagnostic laboratories, academic and research institutions, and other healthcare providers.

The revenues for a specified geography are consumption values and are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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