United States In Vitro Diagnostics Market Demonstrates Steady Growth Amid Technological Advancements and Rising Chronic Disease Burden

The in vitro diagnostics (IVD) market is undergoing a significant transformation, shaped by rapid technological innovations, rising global healthcare demands, and the growing prevalence of chronic diseases. Valued at US$101,058.9 million in 2024, the global market expanded to US$109,065.5 million in 2025 and is projected to advance at a resilient CAGR of 7.6% between 2025 and 2030, culminating in a forecasted valuation of US$157,632.5 million by the end of the period.

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This expansion is propelled by a combination of factors, including the rising incidence of diabetes, cardiovascular diseases, and cancer, all of which are creating heightened demand for accurate, timely, and accessible diagnostic solutions. Advancements in molecular diagnostics, liquid biopsy, and next-generation sequencing (NGS) are significantly enhancing testing precision, thereby fueling the broader movement toward personalized and targeted medical treatments. Additionally, the increasing popularity of portable and point-of-care testing solutions reflects the healthcare system’s shift toward efficiency, accessibility, and real-time monitoring.

Market Drivers: Growing Awareness and Shifting Patient Needs

One of the most important drivers of growth is the increasing awareness of early disease diagnosis, particularly across developing economies. As urbanization accelerates, healthcare access becomes a central issue. This has prompted governments and healthcare organizations to emphasize early detection, especially for conditions such as diabetes, cancer, and cardiovascular disease.

According to the IDF Diabetes Atlas 2025, an estimated 11.1% of global adults aged 20–79 years live with diabetes, with more than 40% of cases undiagnosed. This concerning statistic underscores the urgent need for improved screening and diagnostic tools. National health programs and infrastructure investments are intensifying efforts to increase awareness and availability of diagnostic services in regions such as Asia Pacific, Latin America, and Africa.

The aging global population further drives this demand. Older adults, particularly in regions like Japan, Europe, and North America, require regular diagnostic testing to monitor age-related health risks. This demographic trend is creating long-term demand for IVD solutions that can ensure timely disease management.

Market Restraints: Regulatory Complexity

Despite this positive outlook, the industry faces considerable challenges. Stringent regulatory requirements remain one of the most significant restraints. In major markets such as the United States, European Union, and Japan, manufacturers must comply with extensive frameworks established by agencies including the Food and Drug Administration (FDA), Conformité Européenne (CE), and Pharmaceuticals and Medical Devices Agency (PMDA).

The regulatory landscape often demands extensive clinical trials, strict quality assurance adherence, and detailed compliance documentation. This not only prolongs time-to-market but also increases operational costs for manufacturers. Additionally, evolving regulations such as the EU’s In Vitro Diagnostic Regulation (IVDR) continue to add uncertainty and complexity, requiring companies to remain highly adaptable.

Market Opportunities: Innovations in Immunoassay

Advances in immunoassay technologies present a substantial opportunity for growth. Techniques such as chemiluminescence and fluorescence immunoassays are improving both the accuracy and speed of diagnostic processes. These developments enable the detection of biomarkers at extremely low levels, facilitating early diagnosis of diseases like cancer and cardiovascular disorders.

Point-of-care (POC) immunoassays are especially promising. By delivering rapid results in hospitals, clinics, and even at-home care settings, these innovations reduce dependence on centralized laboratories while improving patient outcomes. As healthcare providers and patients alike push for more convenient solutions, POC technologies are emerging as a defining trend in the future of diagnostics.

Market Challenges: Data Privacy and Cybersecurity

The digitization of healthcare also introduces new challenges. With the rise of cloud-based storage, mobile health applications, and connected diagnostic devices, the risk of cyberattacks and data breaches has grown significantly. In 2024 alone, the United States healthcare sector reported 720 data breaches, impacting more than 186 million patient records, according to Scrut Automation.

Given the sensitivity of patient information, including genetic profiles and diagnostic results, safeguarding data has become an urgent priority. Healthcare providers and manufacturers are being forced to invest heavily in cybersecurity infrastructure to ensure compliance with privacy regulations and maintain public trust.

Segment Analysis: Point-of-Care and Hospitals Lead

By site of testing, point-of-care diagnostics emerged as the fastest-growing segment in 2024. POC solutions not only reduce diagnostic turnaround times but also lower costs by eliminating the need for centralized sample processing. This makes them particularly valuable in emergency care, remote settings, and personalized treatment plans for chronic conditions.

From an end-user perspective, hospitals and clinics remain the dominant segment, supported by strong adoption of molecular diagnostics, immunoassays, and NGS technologies. Government investments in healthcare infrastructure and reimbursement reforms further strengthen this position, ensuring patients benefit from faster and more affordable access to diagnostic services.

Regional Insights: Asia Pacific Gains Momentum

While established markets in North America and Europe continue to grow steadily, Asia Pacific is emerging as the fastest-growing region. Key players such as Sysmex Corporation (Japan), J. Mitra & Co. Pvt. Ltd. (India), and Luye Life Sciences Group (China) are accelerating product innovation and expanding global reach.

The region’s rapidly aging population, coupled with increased investments in healthcare infrastructure, is contributing to the expansion of IVD adoption. With countries such as China, India, and Japan prioritizing healthcare modernization, Asia Pacific is expected to remain a key growth engine for the global IVD industry.

Recent Developments

Product Launch: In February 2025, F. Hoffmann-La Roche Ltd (Switzerland) introduced a next-generation sequencing platform powered by Sequencing by Expansion (SBX), aimed at delivering faster and more scalable results.

Product Approval: In March 2025, Beckman Coulter Diagnostics (US) received FDA approval for its DxC 500i Clinical Analyzer, which integrates clinical chemistry and immunoassay testing.

Partnership: In May 2024, MeMed Ltd. (Israel) partnered with Beckman Coulter to distribute its BV test and MeMed Key analyzer across the United States and Europe.

Acquisition: In November 2024, Roche acquired Poseida Therapeutics, Inc. (US), bolstering its portfolio in advanced cell and gene therapies.

Key Players

Leading companies shaping the in vitro diagnostics market include:

Danaher (US)

F. Hoffmann-La Roche Ltd (Switzerland)

Abbott (US)

Siemens Healthineers AG (Germany)

Thermo Fisher Scientific Inc. (US)

Illumina, Inc. (US)

Hologic, Inc. (US)

Bio-Rad Laboratories, Inc. (US)

bioMérieux (France)

Sysmex Corporation (Japan)

Revvity (US)

Becton, Dickinson and Company (US)

Agilent Technologies, Inc. (US)

Qiagen (Netherlands)

DiaSorin S.p.A. (Italy)

Grifols, S.A. (Spain)

Werfen (Spain)

QuidelOrtho Corporation (US)

Outlook

The in vitro diagnostics market is on a trajectory of steady expansion, supported by rising healthcare demands, demographic shifts, and cutting-edge technologies. While regulatory complexities and cybersecurity risks pose challenges, opportunities in immunoassay innovations, point-of-care diagnostics, and growing awareness of early disease detection are expected to drive long-term growth.

With both established and emerging players heavily investing in research and development, the market is poised to transform the global healthcare landscape, enabling faster, more accurate, and more accessible diagnostic solutions for millions of patients worldwide.