PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1916507
PUBLISHER: Fortune Business Insights Pvt. Ltd. | PRODUCT CODE: 1916507
The global in-vitro diagnostics (IVD) market size was valued at USD 77.73 billion in 2025 and is expected to grow to USD 81.83 billion in 2026, reaching USD 135.65 billion by 2034, exhibiting a CAGR of 6.50% during the forecast period (2026-2034). North America dominated the global IVD market with a 37.70% market share in 2025, supported by advanced healthcare infrastructure, favorable reimbursement policies, and strong presence of major diagnostic manufacturers.
IVD devices are medical diagnostic tools used to analyze biological samples such as blood, urine, saliva, and tissues for disease detection, therapy monitoring, and health screening. According to the British In-Vitro Diagnostic Association, IVD tests influence nearly 70% of clinical decision-making, highlighting their essential role in modern healthcare systems.
Market Drivers
The increasing prevalence of chronic and infectious diseases is a major growth driver. According to the U.S. CDC, tuberculosis cases in the U.S. increased by 5% to 8,300 cases in 2022. Additionally, global prevalence of chronic Hepatitis B virus infection was estimated at 3.2% or 257 million cases in 2023, according to NCBI data.
Aging populations further increase testing volumes. China had approximately 297 million people aged 60 and above in 2023, increasing demand for diagnostic monitoring of cardiovascular, renal, and metabolic disorders. Rising government support also boosts adoption. In October 2023, the World Health Organization released the 2023 Essential Diagnostics List, encouraging countries to strengthen diagnostic access at primary and secondary healthcare levels.
Market Restraints
High equipment and maintenance costs restrict adoption in emerging economies. RT-PCR systems range from USD 15,000 to over USD 90,000, limiting affordability for small hospitals and laboratories. Additionally, skilled personnel requirements raise operational expenses, restricting penetration in low-resource settings.
Market Opportunities
Molecular diagnostics represents a major opportunity due to higher sensitivity and faster detection capabilities. Techniques such as PCR and next-generation sequencing enable early diagnosis from minimal samples. In March 2023, DiaSorin received FDA approval for Simplexa COVID-19 & Flu A/B Direct assay, expanding molecular testing portfolios.
Growing oncology biomarker testing and personalized medicine initiatives further support adoption of advanced diagnostic platforms. Expanding cancer screening programs and genomic testing are increasing molecular diagnostic volumes across developed and emerging regions.
Market Challenges
Unfavorable reimbursement policies limit test adoption in several countries. In Brazil and Mexico, coverage for advanced molecular tests remains insufficient. According to NCBI, Rare Disease Reference Centers provide only USD 142 per patient every three months, insufficient for advanced genomic testing. Regulatory complexity, supply chain disruptions, and intense market competition further increase operational challenges.
Market Trends
Point-of-care (POC) testing is gaining strong traction due to faster turnaround times and lower infrastructure requirements. In January 2023, Cipla launched Cippoint POC device, strengthening decentralized diagnostics. BD received CE approval in June 2022 for combined COVID, Flu, and RSV panels, supporting multiplex testing adoption.
Technological integration of automation and artificial intelligence is improving workflow efficiency, diagnostic accuracy, and sample throughput in clinical laboratories.
By Product Type
Reagents and consumables dominated in 2024 due to high testing volumes from chronic disease monitoring and POC kits. In February 2021, Thermo Fisher launched TaqPath COVID-19 HT kit for high-throughput testing. Instruments are expected to grow steadily due to automation upgrades, such as BD's FACSDuet Premium Sample Preparation System launched in June 2023.
By Technique
Molecular diagnostics dominated in 2024 due to increasing infectious disease and oncology testing. Seegene received ISO45001 certification in December 2023 for PCR diagnostics. Clinical chemistry also grows steadily due to rising metabolic disease screening.
By Sample
Blood samples dominated in 2024, supported by approximately 2 billion blood tests performed annually in the U.S. Urine and saliva testing volumes are increasing due to non-invasive diagnostic innovations.
By Setting
Laboratories dominated due to complex testing requirements and automation investments. POC settings are growing rapidly due to rapid infectious disease screening and emergency testing.
By Application
Infectious disease diagnostics dominated in 2024. WHO estimated 10.8 million global TB cases in 2023. Oncology diagnostics also show strong growth due to biomarker-based cancer screening expansion.
By End-User
Clinical laboratories dominated in 2024, supported by approximately 322,488 labs operating in the U.S. Hospitals show rising adoption for diabetes, pregnancy, and emergency testing.
North America generated USD 29.33 billion in 2025 and USD 30.92 billion in 2026, led by the U.S. reaching USD 27.98 billion in 2026. Europe remains second-largest, with Germany reaching USD 5.50 billion in 2026 and the U.K. at USD 3.83 billion in 2026. Asia Pacific reached USD 18.94 billion in 2026, with China at USD 6.61 billion, Japan at USD 4.32 billion, and India at USD 3.37 billion. Latin America reached USD 6.22 billion in 2026, while GCC markets reached USD 4.25 billion in 2026.
Competitive Landscape
The market is semi-consolidated, led by Roche, Abbott, Siemens Healthineers, Thermo Fisher Scientific, BD, Sysmex, DiaSorin, and Seegene. Companies focus on product innovation, regulatory approvals, and geographic expansion. In November 2023, Roche launched Elecsys HBeAg quant immunoassay, while Abbott partnered with LifeLabs in September 2023 to expand diagnostic service reach.
Conclusion
The global in-vitro diagnostics (IVD) market demonstrates steady and sustainable growth, expanding from USD 77.73 billion in 2025 to USD 81.83 billion in 2026, and projected to reach USD 135.65 billion by 2034, supported by a 6.50% CAGR during 2026-2034. Market expansion is primarily driven by rising prevalence of chronic and infectious diseases, increasing geriatric populations, and strong dependence of clinical decision-making on laboratory diagnostics, which influences nearly 70% of treatment decisions. North America maintains leadership with a 37.70% share in 2025, supported by strong reimbursement systems and advanced diagnostic infrastructure, while Asia Pacific shows rapid growth due to expanding healthcare access and rising disease burden. Segment-wise, reagents and consumables, molecular diagnostics, blood-based testing, and laboratory settings remain dominant due to high testing volumes and increasing automation. Although high instrument costs, reimbursement limitations, and regulatory complexities continue to challenge market penetration in emerging economies, growing adoption of molecular testing, point-of-care diagnostics, AI-enabled systems, and personalized medicine is strengthening long-term demand. Overall, IVD remains a foundational pillar of modern healthcare delivery, enabling early detection, treatment monitoring, and improved population health outcomes across global healthcare systems.
Segmentation By Product Type
By Technique
By Sample
By Setting
By Application
By End-user
By Region