Next-Generation In-vitro Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type (Core Laboratory Diagnostics, PoC Testing, Molecular Diagnostics, Others), By Product (Consumables, Instruments, Software), By Application (Oncology/Cancer, Infectious Diseases, Diabetes, Cardiology, Others), By End User (Hospitals and Clinics, Diagnostic Laboratories, Academic and Research Institutions, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 92.79 Billion
CAGR (2026-2031)	8.92%
Fastest Growing Segment	Molecular Diagnostics
Largest Market	North America
Market Size (2031)	USD 154.93 Billion

Market Overview

The Global Next-Generation In-vitro Diagnostics Market will grow from USD 92.79 Billion in 2025 to USD 154.93 Billion by 2031 at a 8.92% CAGR. Next-Generation In-vitro Diagnostics (IVD) encompass advanced analytical tests performed on biological samples, utilizing molecular, genomic, and high-throughput technologies to detect diseases with elevated precision and speed. The market is primarily propelled by the increasing demand for personalized medicine and the necessity for early disease detection, which allows for targeted therapeutic interventions. Furthermore, the rising global prevalence of chronic conditions and infectious diseases serves as a critical catalyst for adoption, compelling healthcare systems to integrate these accurate diagnostic tools into routine clinical practice to improve patient outcomes.

However, market expansion is significantly challenged by the stringent and evolving regulatory environment which creates substantial compliance burdens for manufacturers. The high cost and complexity of obtaining approvals can delay the commercialization of new technologies and limit market access for innovators. This regulatory pressure requires companies to dedicate significant resources to ensure conformity with new standards. According to MedTech Europe, in 2024, a survey indicated that 79% of IVD manufacturers had transitioned at least part of their portfolios to compliance with the rigorous In Vitro Diagnostic Medical Devices Regulation.

Key Market Drivers

The rising incidence of chronic and infectious diseases acts as a primary catalyst for the Global Next-Generation In-vitro Diagnostics Market. Healthcare systems are increasingly reliant on advanced diagnostic modalities to manage the growing burden of conditions such as cancer, necessitating tools that offer higher sensitivity and faster turnaround times. This surge in disease prevalence compels the deployment of molecular and genomic testing to facilitate early intervention and improve patient survival rates. According to the American Cancer Society, January 2024, in the 'Cancer Facts & Figures 2024', it was projected that there would be approximately 2,001,140 new cancer cases diagnosed in the United States alone during the year. Such statistics underscore the critical need for precise diagnostic solutions capable of detecting malignancies at nascent stages.

The integration of artificial intelligence and machine learning into diagnostic workflows further accelerates market development by enhancing analytical precision and operational efficiency. These technologies enable the automation of complex data interpretation, particularly in genomics and digital pathology, thereby reducing human error and alleviating the workload on laboratory personnel. According to the U.S. Food and Drug Administration, August 2024, the agency had authorized 950 artificial intelligence and machine learning-enabled medical devices, reflecting the rapid integration of computational tools into diagnostic frameworks. This technological synergy not only refines diagnostic accuracy but also supports the financial stability of the sector through improved productivity. According to bioMérieux, April 2024, in the 'First-Quarter 2024 Business Review', the company reported organic sales growth of 9.8%, illustrating the robust economic activity driven by the continuous adoption of clinical diagnostic solutions.

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Key Market Challenges

The stringent and evolving regulatory environment functions as a significant restraint on the Global Next-Generation In-vitro Diagnostics Market. Manufacturers are compelled to navigate complex approval pathways that necessitate extensive clinical evidence and rigorous documentation, leading to substantial increases in operational costs and development timelines. This compliance burden forces organizations to reallocate vital resources from innovation and product development toward meeting administrative requirements. Consequently, the commercialization of advanced diagnostic technologies is often delayed, reducing the speed at which new solutions can reach the market and generating uncertainty that deters investment in potentially breakthrough innovations.

This regulatory pressure directly impacts strategic decision-making and market accessibility, effectively stalling the global diffusion of next-generation diagnostic tools. According to MedTech Europe, in 2024, the proportion of large IVD manufacturers choosing the European Union as their primary launch geography dropped by 40% relative to previous regulatory directives. Such a sharp decline demonstrates how heightened regulatory barriers discourage companies from prioritizing major markets, hampering the overall growth potential of the industry and limiting the availability of critical diagnostic tests.

Key Market Trends

The Global Next-Generation In-vitro Diagnostics Market is witnessing a significant shift towards decentralized and point-of-care molecular testing, driven by the necessity for rapid diagnostic turnaround times outside traditional hospital laboratories. This trend is characterized by the widespread deployment of compact, automated molecular systems in clinics, urgent care centers, and pharmacies, allowing for immediate treatment decisions for infectious diseases. This structural transition reduces the logistical delays associated with central laboratory processing and improves patient access to high-complexity testing in community settings. Underscoring the sustained demand for these accessible solutions, according to Danaher Corporation, October 2024, in the 'Third Quarter 2024 Earnings Results', the company reported that its Cepheid business generated $425 million in respiratory testing revenue alone during the quarter, reflecting the high volume of near-patient molecular tests.

Concurrently, there is a rapidly rising adoption of liquid biopsy technologies for non-invasive cancer monitoring and minimal residual disease (MRD) assessment. Clinicians are increasingly utilizing circulating tumor DNA (ctDNA) analysis to track treatment response and detect recurrence significantly earlier than radiological imaging, thereby facilitating more precise oncological management. This move towards blood-based genomic profiling minimizes the need for invasive tissue biopsies while providing dynamic insights into tumor evolution. According to Natera, Inc., November 2024, in the 'Third Quarter 2024 Financial Results', the company performed approximately 137,100 oncology tests during the quarter, representing a significant increase of 54.4% compared to the same period in the previous year, driven largely by the clinical uptake of its personalized liquid biopsy solutions.

Segmental Insights

Molecular Diagnostics represents the fastest-growing segment in the Global Next-Generation In-vitro Diagnostics Market. This rapid expansion is primarily driven by the escalating demand for precision medicine and the critical need for early, accurate detection of infectious diseases and cancer. Continuous improvements in genomic technologies, such as Next-Generation Sequencing, have enhanced test sensitivity, enabling clinicians to identify specific genetic markers and tailor treatments accordingly. Additionally, the growing prevalence of chronic conditions necessitates the granular biological insights that molecular testing provides, further accelerating its adoption over traditional diagnostic methods.

Regional Insights

North America holds the leading position in the Global Next-Generation In-vitro Diagnostics Market due to high healthcare expenditure and the rapid adoption of new testing technologies. The region is supported by a strong network of manufacturers and a well-defined legal framework. The U.S. Food and Drug Administration facilitates market growth through clear product approval guidelines, while the Centers for Medicare & Medicaid Services ensures accessibility through established reimbursement structures. These elements, combined with a focus on preventative care and early diagnosis, drive the continued expansion of the market across the region.

Recent Developments

• In May 2025, Danaher Corporation announced a strategic partnership with AstraZeneca to accelerate the development of AI-based precision diagnostics. The collaboration aims to create diagnostic tools that help clinicians identify patients best suited for next-generation treatments, such as antibody-drug conjugates. Danaher will utilize technology from its subsidiary, Leica Biosystems, to support all phases of diagnostic development, including digital pathology and computational algorithms. The companies established an R&D hub to facilitate the rapid creation of these companion diagnostics. This initiative focuses on improving patient selection for targeted therapies and streamlining the commercialization of precision medicines globally.
• In September 2024, Roche launched the cobas Respiratory flex test, a molecular diagnostic assay utilizing its proprietary Temperature-Activated Generation of Signal (TAGS) technology. This high-throughput test is designed to detect up to 12 common respiratory viruses, including influenza and respiratory syncytial virus, in a single polymerase chain reaction test. The new technology allows for the simultaneous identification of multiple pathogens by distinguishing up to three targets per fluorescence channel. The assay runs on Roche’s automated molecular systems, enabling clinical laboratories to perform scalable and flexible syndromic testing to diagnose respiratory infections more efficiently.
• In August 2024, Illumina received approval from the U.S. Food and Drug Administration for its TruSight Oncology Comprehensive test and two accompanying companion diagnostic indications. This in-vitro diagnostic kit is capable of profiling over 500 genes in solid tumors to identify variants associated with immuno-oncology biomarkers. The approval allows the test to be used as a companion diagnostic to identify patients eligible for specific targeted therapies for non-small cell lung cancer and other solid tumors. This development enables comprehensive genomic profiling to be conducted in local laboratories, thereby broadening patient access to precision oncology treatments.
• In March 2024, Thermo Fisher Scientific entered into a collaboration with Bayer to develop next-generation sequencing-based companion diagnostic assays. The partnership aims to identify patients who may benefit from Bayer's portfolio of precision cancer therapies. These diagnostics will be developed using Thermo Fisher’s Ion Torrent Genexus Dx System, which is designed to deliver results from tissue or liquid biopsy samples in as little as 24 hours. The collaboration focuses on offering decentralized genomic testing and rapid turnaround times to improve patient access to targeted treatments. The companies intend to support the clinical implementation of precision medicine through this agreement.

Key Market Players

• Thermo Fisher Scientific Inc.
• Becton, Dickinson, and Company
• Qiagen GmbH
• Illumina Inc.
• Beckman Coulter, Inc.
• Invivoscribe, Inc.
• Sysmex Corporation
• bioMérieux SA
• VWR International, LLC.
• Danaher Corporation

By Type	By Product	By Application	By End User	By Region
Core Laboratory Diagnostics PoC Testing Molecular Diagnostics Others	Consumables Instruments Software	Oncology/Cancer Infectious Diseases Diabetes Cardiology Others	Hospitals and Clinics Diagnostic Laboratories Academic and Research Institutions Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Next-Generation In-vitro Diagnostics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Next-Generation In-vitro Diagnostics Market, By Type:

• Core Laboratory Diagnostics
• PoC Testing
• Molecular Diagnostics
• Others

• Next-Generation In-vitro Diagnostics Market, By Product:

• Consumables
• Instruments
• Software

• Next-Generation In-vitro Diagnostics Market, By Application:

• Oncology/Cancer
• Infectious Diseases
• Diabetes
• Cardiology
• Others

• Next-Generation In-vitro Diagnostics Market, By End User:

• Hospitals and Clinics
• Diagnostic Laboratories
• Academic and Research Institutions
• Others

• Next-Generation In-vitro Diagnostics Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE