Visiongain has published a new report entitled In Vitro Diagnostics Market Report 2025-2035 (Including Impact of U.S. Trade Tariffs): Forecasts by Product (Instruments, Reagents & Kits), by Test (Clinical Chemistry, Immunoassay/Immunochemistry, Molecular Diagnostics, Haematology, Urinalysis, Others), by Application (Cardiology, Diabetes, Oncology, Infectious Diseases, Nephrology, Autoimmune Diseases, Drug Testing/Pharmacogenomics, Others), by End-users (Academic & Research Institutes, Diagnostic Laboratories, Hospitals, Others) AND Regional and Leading National Market Analysis PLUS Analysis of Leading Companies.

The global in vitro diagnostics market is estimated at US$99.05 billion in 2025 and is projected to grow at a CAGR of 5.1% during the forecast period 2025-2035.

Impact of US Trade Tariffs on the Global In Vitro Diagnostics Market   

The U.S. trade tariffs are substantially affecting the global In Vitro Diagnostics (IVD) market by elevating the expenses associated with imported reagents, instruments, and components, especially from China and the European Union.  This is exerting pressure on profit margins, compelling companies to reevaluate supply chains, transition to local manufacturing, and postpone R&D investments.  Smaller enterprises are particularly susceptible, whereas global rivals from non-tariff regions may acquire market share.  The tariffs are inducing cost inflation, necessitating operational realignment, and altering the competitive dynamics of the IVD industry.

Increasing Applications of Next-Generation Sequencing (NGS) Technology

Next-Generation Sequencing (NGS) has significantly transformed genetic diagnostics by offering a rapid, high-throughput, and cost-effective approach to analysing extensive genomic content. This advancement has deepened our understanding of genetic diversity, especially in rare diseases, and has been pivotal in exploring complex medical conditions and unknown biological structures. NGS is increasingly being adopted for diagnosing infectious diseases, hereditary disorders, and immunological conditions, thereby equipping healthcare providers with timely and precise diagnostic insights.

On April 24, 2025, when Element Biosciences unveiled the accelerated rollout of its Direct-in-Sample Sequencing (DISS) for the AVITI24™ intelligent multiomics system. This innovation eliminates the need for conventional library preparation, allowing researchers to analyse RNA, proteins, phosphoproteins, and cell morphology directly from a single sample in a fully automated workflow. The DISS technology facilitates high-resolution and multi-dimensional profiling in one run, unlocking new applications in lineage tracing, CRISPR screens, targeted RNA sequencing, and custom protein analysis. Pre-orders for the system commenced on May 21, 2025, reflecting strong market interest.

NGS also plays a critical role in non-invasive prenatal diagnostics and personalised cancer therapies, particularly in guiding treatment decisions for somatic cancers. As cancer prevalence continues to rise globally, the use of NGS in companion diagnostics is becoming increasingly vital, fuelling the shift toward precision medicine. Looking forward, the future of NGS is set for further growth, driven by innovations in bioinformatics, robotics, and system miniaturisation. These trends will not only expand the clinical utility of NGS but also extend its reach into fields such as agriculture, environmental monitoring, and evolutionary biology, underscoring its growing impact across the life sciences.

How will this Report Benefit you?

Visiongain’s 356-page report provides 125 tables, 212 charts/graphs. Our new study is suitable for anyone requiring commercial, in-depth analyses for the in vitro diagnostics market, along with detailed segment analysis in the market. Our new study will help you evaluate the overall global and regional market for In Vitro Diagnostics. Get financial analysis of the overall market and different segments including type, process, upstream, downstream, and company size and capture higher market share. We believe that there are strong opportunities in this fast-growing in vitro diagnostics market. See how to use the existing and upcoming opportunities in this market to gain revenue benefits in the near future. Moreover, the report will help you to improve your strategic decision-making, allowing you to frame growth strategies, reinforce the analysis of other market players, and maximise the productivity of the company.

What are the Current Market Drivers?

Rising Geriatric Population and Escalating Incidence of Chronic & Infectious Diseases

The rapid global increase in the elderly population is directly linked to a surge in age-related chronic and infectious diseases, driving substantial demand for advanced healthcare solutions such as in vitro diagnostics (IVD). As reported by the United Nations Population Fund (UNFPA), the proportion of individuals aged 65 and older nearly doubled—from 5.5% in 1974 to 10.3% in 2024. This demographic evolution reflects a significant shift in healthcare priorities worldwide, emphasizing the need for early detection and continuous monitoring technologies.

Advancing age is strongly correlated with a heightened susceptibility to chronic conditions. According to the Centers for Disease Control and Prevention (CDC), approximately 80% of older adults in the United States are affected by at least one chronic illness. Complementary data from the National Council on Aging (NCOA) indicates that 94.9% of individuals aged 60 and above live with one or more chronic diseases, while 78.7% are burdened with multiple conditions. Notably, ailments such as hyperlipidemia (elevated cholesterol levels) significantly raise the risk of cardiovascular diseases—currently the foremost cause of death globally—followed by stroke, which ranks as the fifth leading cause of mortality.

Equally pressing is the prevalence of diabetes and endocrine disorders in older adults, as the natural ageing process heightens susceptibility to metabolic and hormonal imbalances. The global diabetes burden among the elderly continues to climb, with complications ranging from renal dysfunction to impaired wound healing and immunosuppression—each requiring regular and accurate diagnostic support.

Given these trends, the IVD sector is poised for significant expansion, driven by the growing need for early disease detection, accurate diagnostics, and continuous monitoring of health conditions in ageing populations. Innovations in non-invasive sampling, point-of-care testing, and multiplex assays will be critical in managing age-related disease burdens. As healthcare systems worldwide pivot towards preventative and personalised care models, IVD technologies will play an indispensable role in addressing the complex and evolving needs of the global elderly demographic.

Favourable Government and Non-Government Initiatives to Drive Market Growth

Governmental and non-governmental organizations continue to play a pivotal role in advancing global healthcare services, thereby fostering an environment conducive to the growth of the in vitro diagnostics (IVD) market.

In March 2024, the World Health Organization (WHO) announced a call for submissions for the fifth edition of its Essential Diagnostics List (EDL). This initiative aims to provide evidence-based guidance for countries to develop or update their national lists of essential in vitro diagnostic tests, thereby improving access to critical diagnostics and strengthening health systems worldwide.

Africa has taken notable steps toward strengthening its diagnostic infrastructure. In April 2024, the Africa Centres for Disease Control and Prevention (Africa CDC) unveiled two landmark initiatives: the Integrated Genomic Surveillance and Data Sharing Platform (IGS) and the Integrated Genomic Surveillance for Outbreak Detection (DETECT). These programmes are designed to enhance the continent’s capabilities in molecular diagnostics, particularly for outbreak detection and genomic surveillance of antimicrobial resistance. By promoting timely data sharing across national and regional networks, these efforts mark a pivotal advancement in Africa’s public health preparedness and response systems.

Furthermore, in response to the mpox outbreak, Africa CDC and the African Union Development Agency-New Partnership for Africa’s Development (AUDA-NEPAD) have collaborated to streamline the evaluation and approval process for mpox diagnostic tests. This joint effort seeks to accelerate access to essential diagnostics during public health emergencies.

These initiatives reflect a coordinated push to improve diagnostic services, especially in areas where healthcare infrastructure remains underdeveloped. By prioritizing the enhancement of diagnostic capabilities, these efforts are poised to accelerate the adoption of in vitro diagnostic (IVD) technologies. This momentum is expected to drive substantial market growth across Africa and other emerging regions, as demand for accurate, rapid, and scalable testing solutions continues to rise.

Where are the Market Opportunities?

Expanding Growth Potential in Emerging Markets

Emerging economies such as India, China, Brazil, and Russia continue to present compelling growth opportunities for stakeholders in the in vitro diagnostics (IVD) market. These regions are characterised by high disease burden, expanding patient populations, and an increasing awareness of the importance of early and accurate diagnostics. Improved access to healthcare services, rising healthcare expenditure, and a growing middle class with higher disposable incomes are accelerating the demand for modern diagnostic technologies in these countries.

In 2024, several notable developments have underscored this momentum. For instance, India’s National Medical Devices Policy has started catalysing investment in local diagnostics manufacturing, aiming to reduce import dependency. Meanwhile, China has continued to boost its innovation pipeline, with its 2024 Five-Year Healthcare Plan placing significant emphasis on molecular diagnostics and digital health integration. Brazil’s health regulator ANVISA has further streamlined its product registration framework to fast-track the approval of critical IVD products, particularly those related to infectious diseases like dengue and Zika, which remain prevalent.

South American countries, particularly Brazil and neighbouring nations, continue to face high incidence rates of vector-borne diseases such as chikungunya, dengue, and malaria, increasing the urgency for robust IVD solutions. In parallel, Asia-Pacific nations—including Indonesia, Thailand, and Vietnam—are emerging as attractive markets due to relaxed regulatory environments, improved laboratory capacity, and government-led screening programmes.

Market players are capitalising on these favourable dynamics through a mix of strategic alliances, regulatory approvals, and market expansion efforts. Key companies have launched region-specific products, invested in training programmes for laboratory personnel, and entered into public-private partnerships to deploy diagnostic platforms in underserved areas. These initiatives not only facilitate access to advanced testing technologies but also support the broader healthcare transformation efforts across emerging economies.

Inclination Toward Personalised Medicine: Tailoring Diagnostics for Better Outcomes

The paradigm shift toward personalised medicine continues to reshape the global IVD landscape, creating new pathways for innovation and patient-centred care. As medical strategies increasingly aim to account for individual variability in genes, environment, and lifestyle, the role of precision diagnostics has become paramount. In vitro diagnostics are at the core of this transformation, enabling the identification of genetic markers, disease predispositions, and treatment-response profiles.

The demand for molecular diagnostics, companion diagnostics, and next-generation sequencing (NGS) assays is expected to surge, driven by their critical role in facilitating targeted therapies for conditions such as cancer, autoimmune disorders, and rare genetic diseases. This is reflected in the expanding number of IVD-based companion diagnostic approvals globally. In 2024, the U.S. FDA and European regulators approved several new companion diagnostics for oncology treatments, reinforcing the importance of IVDs in guiding therapy decisions.

Healthcare providers and payers are also increasingly acknowledging the clinical and economic benefits of personalised diagnostics, particularly in reducing treatment failure rates and enhancing outcomes. This has prompted substantial investments by diagnostic firms into R&D, particularly in bioinformatics, liquid biopsy platforms, and AI-based predictive modelling tools that support individualised treatment pathways.

With this trajectory, the IVD market is positioned for sustained growth, as it plays a foundational role in enabling personalised healthcare delivery. As genomic medicine and targeted therapy uptake expands, diagnostic firms that align their portfolios with precision health demands are expected to gain competitive advantage, improve patient outcomes, and drive long-term market value.

Competitive Landscape

The major players operating in the in vitro diagnostics market are QIAGEN, BD, BioMérieux, F. Hoffmann-La Roche, Ltd., Quidel, Ortho Corporation, Abbott, Agilent Technologies, Inc., Thermofisher Scientific, Inc., Siemens Healthineers AG, Bio-Rad Laboratories, Inc., Danaher, Sysmex Corporation, Charles River Laboratories, Quest Diagnostics Incorporated, Illumina, Inc., Hologic, Revvity, and Exact Sciences. These major players operating in this market have adopted various strategies comprising M&A, investment in R&D, collaborations, partnerships, regional business expansion, and new product launch.

Recent Developments

• On 15^th April 2025, QIAGEN announced plans to launch three new sample preparation instruments by 2026, aiming to enhance lab automation. The first, QIAsymphony Connect, is set for a phased launch in 2025, targeting oncology and genomics workflows. Subsequent releases, QIAsprint and QIAmini, are scheduled for 2026, catering to varying throughput demands.
• On 13^th January 2025, Revvity, Inc. and Element Biosciences entered a strategic agreement to commercialize an IVD workflow solution for neonatal sequencing. This collaboration aims to advance sequencing-based diagnostics in neonatal care.
• On 13^th January 2025, bioMérieux entered into an agreement to acquire SpinChip Diagnostics ASA (“SpinChip”), a privately held Norwegian diagnostics company that has developed a game-changing immunoassay diagnostics platform. The small benchtop analyzer is well adapted to near patient testing as it can deliver a result from a whole blood sample within 10 minutes with the same high-sensitivity performance as the laboratory instruments. bioMérieux has held a minority stake in SpinChip since March 2024.

Notes for Editors

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