PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1887103
PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1887103
The global lab-based in vitro diagnostics (IVD) market remains a foundational pillar of modern healthcare, driven by rising chronic disease prevalence, infectious disease outbreaks, and the global shift toward precision medicine. According to the latest industry assessment, the market was valued at USD 42.42 billion in 2024, supported by strong diagnostic demand across hospitals and clinical laboratories. The market is expected to increase to USD 44.85 billion in 2025, eventually reaching USD 66.41 billion by 2032, advancing at a CAGR of 5.8% throughout 2025-2032.
North America dominated the global market with 39.39% share in 2024, attributed to its advanced healthcare infrastructure, high diagnostic testing rates, and the presence of leading companies such as Roche, Abbott, Thermo Fisher Scientific, and BD. The rising need for rapid, reliable, and high-precision diagnostic results is accelerating investment in automated testing platforms, molecular diagnostics, and next-generation sequencing technologies.
Market Drivers
A key driver for the lab-based IVD market is the growing global burden of chronic and infectious diseases. According to WHO, 8.2 million people were diagnosed with tuberculosis (TB) in 2023, up from 7.5 million in 2022, indicating heightened screening needs worldwide. Additionally, WHO reported in 2024 that 254 million individuals were living with hepatitis B and 50 million with hepatitis C, further boosting demand for routine laboratory testing.
Growing awareness of early disease detection, increasing screening programs, and public health initiatives-such as the WHO's 2023 Essential Diagnostics List (EDL)-continue to improve access to lab-based diagnostic tools across emerging and developed markets. The expanding geriatric population further contributes to diagnostic demand, as elderly individuals are more susceptible to chronic and infectious diseases requiring regular monitoring.
Market Restraints
Despite strong growth potential, the market faces challenges from unfavorable reimbursement policies in several emerging markets. The high cost of genetic and molecular diagnostic tests limits adoption in regions such as Africa, Brazil, and parts of Asia. In China, reimbursement occurs at the provincial level with differing codes, creating delays and inconsistency in diagnostic uptake. These factors collectively restrict large-scale penetration of advanced IVD systems.
Market Opportunities
Major opportunities lie in the rising adoption of molecular diagnostics, including next-generation sequencing (NGS) and PCR-based technologies. Companies are increasingly pursuing FDA approvals and global regulatory certifications to strengthen their molecular testing portfolios. For example, DiaSorin S.p.A. received FDA approval for its Simplex COVID-19 & Flu A/B Direct assay in 2023, expanding its high-value molecular pipeline. The shift from traditional diagnostics to molecular precision tools opens pathways for improved cancer detection, viral load testing, and genetic screening.
Market Trends
A significant trend in the lab-based IVD market is the rising integration of automation and digitalization in laboratory workflows. Automated PCR systems, AI-enabled analyzers, and advanced hematology systems are improving test accuracy and turnaround time. In April 2025, Seegene Inc. announced development of its next-generation automation platform, CURECA, designed to streamline PCR testing processes globally.
Additionally, several companies are investing in personalized diagnostic solutions. In February 2024, Quest Diagnostics launched MelaNodal Predict, an AI-supported gene expression test for personalized melanoma treatment guidance.
Segmental Overview
By Product Type
Reagents & consumables dominated the market in 2024 due to increasing regulatory approvals and growing test volumes. The instruments segment is projected to grow steadily through 2032 with rising adoption of rapid testing devices and advanced PCR systems.
By Technique
Immunodiagnostics led the market in 2024, supported by new assay launches such as Roche's Elecsys HBeAg quant test. The molecular diagnostics segment held the second-largest share, fueled by the growing number of PCR-based solutions and next-generation sequencing applications.
By Sample Type
Blood-based tests dominated the market in 2024 and are expected to grow at the highest CAGR due to widespread usage in acute infections, oncology, and chronic disease assessments.
By Application
Infectious diseases remained the leading segment in 2024, supported by high global burdens of TB, HIV, and hepatitis. Oncology is expected to grow at the second-highest CAGR due to rising cancer cases and the launch of highly sensitive cancer assays.
By End-User
Clinical laboratories dominated the IVD market in 2024, driven by high patient volumes and advanced testing capabilities. Hospitals continued to support significant demand due to increasing hospitalization rates for chronic diseases.
North America
North America generated USD 16.71 billion in 2024, maintaining market leadership through advanced healthcare standards and continuous product approvals from the FDA.
Europe
Europe ranked second in 2024, supported by chronic disease prevalence and strong innovation momentum from Siemens Healthineers, Sysmex, and Roche.
Asia Pacific
Asia Pacific is expected to record the fastest CAGR through 2032 due to rising early-diagnosis awareness and increased product launches, including Abbott's Alinity i immunoassay module in 2024.
Latin America & Middle East & Africa
These regions show steady growth supported by rising TB cases and increasing adoption of automated chemistry and hematology analyzers.
Conclusion
With the market rising from USD 42.42 billion in 2024 to USD 66.41 billion in 2032, the global lab-based IVD industry is set for significant expansion. Growing infectious disease screening, rapid adoption of molecular diagnostics, automation improvements, and strategic partnerships across companies will continue shaping the future of clinical diagnostics worldwide.
Segmentation By Product Type
By Technique
By Sample Type
By Application
By End-user
By Region