qPCR Instruments Market- Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Test Type (7500, QuantStudio Dx, QuantStudio 5, ViiA 7 Dx, One Step/One, Step Plus, LightCycler 2.0, Cobas 4800, CFX96, SmartCycler, GeneXpert, Rotor-Gene Q 5Plex HRM System, Rotor-Gene Q, BIOFIRE FILMARRAY SYSTEMS, BMS Mic System), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 1.29 Billion
CAGR (2026-2031)	7.04%
Fastest Growing Segment	GeneXpert
Largest Market	North America
Market Size (2031)	USD 1.94 Billion

Market Overview

The Global qPCR Instruments Market will grow from USD 1.29 Billion in 2025 to USD 1.94 Billion by 2031 at a 7.04% CAGR. The Global qPCR Instruments Market encompasses advanced analytical platforms designed to amplify and quantify nucleic acids in real-time, integrating thermal cycling with fluorescence detection for critical applications in clinical diagnostics and life sciences research. The primary drivers supporting market growth include the escalating global prevalence of infectious diseases and genetic disorders, which necessitate the deployment of rapid, high-sensitivity molecular testing solutions. Furthermore, robust funding for genomic studies and the expanding implementation of personalized medicine protocols are pivotal factors that sustain the demand for these precise diagnostic tools, distinct from transient technological trends.

However, the market faces a significant impediment regarding the increasingly stringent regulatory landscape governing in vitro diagnostics, which creates substantial compliance burdens for device manufacturers. This complex environment can delay product launches and elevate operational costs, particularly for specialized applications. According to MedTech Europe, in 2024, 26.6% of in vitro diagnostic manufacturers reported plans to transition less than 5% of their orphan device portfolios to the new regulatory framework due to these resource-intensive requirements. Such regulatory hurdles present a considerable challenge that could restrict the availability of innovative testing solutions and dampen overall market expansion.

Key Market Drivers

The escalating global prevalence of infectious diseases and genetic disorders constitutes a primary force propelling the adoption of qPCR instruments, necessitating the deployment of rapid and precise molecular diagnostic platforms. As pathogens evolve and the incidence of chronic genetic conditions rises, clinical laboratories are increasingly reliant on real-time PCR for sensitive detection and quantification in patient management. According to the World Health Organization, November 2025, in the 'Tuberculosis Key Facts' update, in 2024, an estimated 10.7 million people fell ill with tuberculosis worldwide, underscoring the critical need for robust diagnostic infrastructure. This high burden of disease drives the sustained procurement of qPCR systems to ensure timely identification and effective outbreak control, solidifying the technology's role in modern healthcare.

Concurrently, robust growth in public and private funding for life sciences research is invigorating the development of next-generation genomic technologies. Industry leaders are channeling substantial capital into research and development to enhance instrument throughput, automation, and multiplexing capabilities, which directly addresses the market demand for efficiency. According to Thermo Fisher Scientific, October 2025, in the 'Third Quarter 2025 Earnings Release', research and development expenses for the twelve months ending September 30, 2025, totaled $1.41 billion, reflecting a continued financial commitment to innovation. This investment fuels market activity, evidenced by key players maintaining strong revenue streams despite economic fluctuations. According to QIAGEN, November 2025, in the 'Q3 2025 Results', revenue for the twelve months ending September 30, 2025, reached $2.07 billion, highlighting the enduring market demand for comprehensive molecular testing portfolios.

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Key Market Challenges

The growth of the Global qPCR Instruments Market is significantly impeded by the increasingly stringent regulatory landscape governing in vitro diagnostics. This complex compliance environment imposes substantial operational burdens on manufacturers, requiring extensive clinical evidence and rigorous technical documentation for device certification. As companies are forced to divert capital and personnel toward meeting these heightened standards, the resources available for research and development of next-generation qPCR platforms are inevitably reduced. Consequently, the introduction of advanced diagnostic instruments is delayed, and manufacturers become hesitant to enter markets with unpredictable approval timelines or excessive compliance costs.

The direct impact of these regulatory hurdles is evident in the strategic decisions of major industry players regarding market entry. According to MedTech Europe, in 2024, large in vitro diagnostic manufacturers reported a 40% decline in selecting the European Union as their primary geography for first product launches compared to previous regulatory frameworks. This trend demonstrates how compliance challenges actively discourage the commercialization of new technologies. By slowing the pace of product innovation and creating barriers to market access, these regulations directly restrict the availability of new solutions and dampen the overall expansion of the qPCR instruments sector.

Key Market Trends

Manufacturers are aggressively developing compact, portable, and battery-operated qPCR devices to enable decentralized testing in clinics, field settings, and emergency departments. This shift toward miniaturization allows healthcare providers to conduct sophisticated molecular diagnostics directly at the point of care, significantly reducing the turnaround time compared to traditional centralized laboratories. The rapid adoption of these streamlined systems is evident in the surging demand for platforms designed specifically for non-laboratory environments. According to bioMérieux, September 2025, in the 'First-Half 2025 Financial Results', sales for the SPOTFIRE point-of-care system increased by 143% organically compared to the previous year, highlighting the sector's robust transition toward accessible, near-patient testing solutions.

Concurrently, there is a distinct expansion in high-multiplicity multiplexing capabilities, driven by the critical need to detect multiple targets, such as complex pathogen panels, within a single reaction. Laboratories are prioritizing instruments that can simultaneously analyze numerous channels to improve diagnostic efficiency and conserve valuable patient samples, moving beyond simple single-target assays. This demand for comprehensive syndromic testing is reshaping product portfolios as companies integrate higher channel counts and broader detection menus. According to QIAGEN, November 2025, in the 'Q3 2025 Results', sales of the QIAstat-Dx syndromic testing platform grew by 11% at constant exchange rates, reflecting the market's strong preference for advanced multiplexing technologies that streamline workflow efficiency.

Segmental Insights

The GeneXpert segment currently represents the fastest growing category within the Global qPCR Instruments Market due to the rising preference for decentralized diagnostic solutions. This expansion is largely propelled by strong recommendations from the World Health Organization regarding the use of molecular assays to diagnose tuberculosis and drug resistant strains. Such regulatory support has significantly increased the global installation base of these systems. Furthermore, the ability of the platform to combine sample preparation and analysis into a single automated unit minimizes manual intervention, making it a preferred choice for facilities requiring immediate and accurate diagnostic results.

Regional Insights

North America maintains a dominant position in the global qPCR instruments market due to established healthcare infrastructure and substantial investment in life sciences research. The region benefits from the presence of major industry manufacturers and widespread adoption of genomic analysis in pharmaceutical development. Furthermore, the high prevalence of chronic and infectious diseases drives the continuous demand for accurate diagnostic capabilities. Supportive regulatory frameworks provided by agencies like the U.S. Food and Drug Administration (FDA) facilitate the approval and commercialization of new diagnostic technologies, reinforcing the region's market leadership.

Recent Developments

• In September 2024, QIAGEN N.V. launched the QIAcuityDx Digital PCR System, a platform designed to bring the absolute quantification benefits of digital PCR into clinical diagnostic settings. This new instrument received regulatory listing in the United States and certification in Europe, enabling its use for in vitro diagnostic applications. The system integrates the entire digital PCR workflow—including partitioning, thermocycling, and imaging—into a single automated unit. The launch addresses the growing demand for precise detection of rare targets in oncology and infectious diseases, offering clinical laboratories a streamlined and efficient solution for molecular testing.
• In July 2024, Seegene Inc. presented its comprehensive portfolio of molecular diagnostic solutions at the Association for Diagnostics & Laboratory Medicine Annual Scientific Meeting. The company highlighted the Seegene STARlet-AIOS, a fully automated system that integrates liquid handling and real-time PCR instruments to facilitate hands-free testing workflows. This modular solution is designed to perform everything from nucleic acid extraction to data analysis, addressing the need for efficiency and accuracy in high-volume laboratories. Additionally, the company introduced various high-multiplex assays capable of identifying multiple pathogen targets in a single reaction, reinforcing its focus on syndromic testing and automated diagnostics.
• In April 2024, Bio-Rad Laboratories, Inc. announced a strategic collaboration with Oncocyte Corporation to commercialize transplant monitoring assays on the QX600 Droplet Digital PCR System. This agreement granted Bio-Rad exclusive rights to market specific donor-derived cell-free DNA tests in regulated markets, positioning the platform as a decentralized alternative to sequencing-based methods. The partnership included a financial investment in Oncocyte, underscoring a shared commitment to advancing precision medicine. By leveraging the high sensitivity of digital PCR technology, the collaboration aims to provide laboratories with cost-effective, reproducible tools for non-invasive monitoring of solid organ transplant recipients.
• In February 2024, Standard BioTools Inc. entered into an exclusive partnership with Next Gen Diagnostics to manufacture the NGD-100, a specialized version of the Biomark X9 System. This collaboration aims to automate library preparation for pathogen whole-genome sequencing, addressing critical cost and throughput barriers in clinical microbiology. The customized instrument leverages proprietary microfluidics technology to streamline laboratory workflows, enabling rapid bacterial sequencing at a significantly reduced cost per sample. The partnership combines advanced liquid handling automation with bioinformatics capabilities, intending to facilitate the widespread adoption of genomic surveillance tools in hospitals and public health laboratories globally.

Key Market Players

• Thermo Fisher Scientific, Inc.
• F. Hoffmann-La Roche Ltd.
• AstraZeneca Inc.
• Bio-Rad Laboratories, Inc.
• Danaher Corporation
• QIAGEN N.V.
• Agilent Technologies, Inc.
• Abbott Laboratories Inc.
• Azure Biosystems Inc.
• Bio Molecular Systems Pty Ltd

By Test Type	By Region
7500 QuantStudio Dx QuantStudio 5 ViiA 7 Dx One Step/One Step Plus LightCycler 2.0 Cobas 4800 CFX96 SmartCycler GeneXpert Rotor-Gene Q 5Plex HRM System Rotor-Gene Q BIOFIRE FILMARRAY SYSTEMS BMS Mic System	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global qPCR Instruments Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• qPCR Instruments Market, By Test Type:

• 7500
• QuantStudio Dx
• QuantStudio 5
• ViiA 7 Dx
• One Step/One
• Step Plus
• LightCycler 2.0
• Cobas 4800
• CFX96
• SmartCycler
• GeneXpert
• Rotor-Gene Q 5Plex HRM System
• Rotor-Gene Q
• BIOFIRE FILMARRAY SYSTEMS
• BMS Mic System

• qPCR Instruments 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