Point-Of-Care Molecular Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Technology (PCR-based, Genetic Sequencing-based, Hybridization-based, Microarray-based), By Application (Infectious Diseases, Oncology, Hematology, Prenatal Testing, Endocrinology, Other), By Test Location (OTC, POC), By End User (Decentralized Labs, Hospitals, Home-care, Assisted Living Healthcare Facilities, Others), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 2.88 Billion
CAGR (2026-2031)	11.21%
Fastest Growing Segment	Hybridization-Based Technology
Largest Market	North America
Market Size (2031)	USD 5.45 Billion

Market Overview

The Global Point-Of-Care Molecular Diagnostics Market will grow from USD 2.88 Billion in 2025 to USD 5.45 Billion by 2031 at a 11.21% CAGR. Point-of-care molecular diagnostics refer to automated testing platforms that detect pathogenic genetic material or mutations directly at the site of patient care. These portable systems enable rapid and accurate results without requiring centralized laboratory processing, thereby facilitating immediate clinical decisions. The market is primarily driven by the increasing global prevalence of infectious diseases and a paradigm shift toward decentralized healthcare necessitating accessible testing solutions. Furthermore, continuous advancements in microfluidics have enhanced the speed and usability of these devices, fostering their adoption in diverse medical environments.

However, the sector faces significant hurdles regarding stringent regulatory environments and associated compliance costs. The transition to more rigorous frameworks has imposed substantial financial burdens on manufacturers, potentially stifling innovation and delaying product launches. For instance, according to MedTech Europe, in 2024, certification costs for manufacturers under the new In Vitro Diagnostic Regulation increased by up to 100 percent compared to previous directives. This escalation in expenses creates a high barrier to entry and may impede the widespread expansion of cost-effective diagnostic solutions.

Key Market Drivers

The Escalating Global Burden of Infectious Diseases and Pandemics acts as a primary catalyst for the market, necessitating robust diagnostic tools that can rapidly identify pathogens like influenza, RSV, and COVID-19. As respiratory viruses continue to co-circulate, healthcare systems are prioritizing multiplex molecular assays that distinguish between overlapping symptoms to optimize patient management. This sustained demand is evident in the commercial performance of major industry players providing comprehensive respiratory panels. According to Danaher Corporation, January 2025, in the 'Q4 2024 Earnings Results', Cepheid's respiratory testing revenue reached approximately $550 million in the fourth quarter alone, driven by high volumes of their four-in-one test. Such figures underscore the market's heavy reliance on molecular point-of-care solutions to manage seasonal outbreaks effectively.

Simultaneously, the Rising Shift Toward Decentralized Healthcare and Near-Patient Testing is reshaping the industry by moving advanced diagnostics from central labs to clinics and urgent care centers. This transition is enabled by compact platforms that deliver lab-quality results in non-traditional settings, significantly accelerating time-to-treatment. Manufacturers are aggressively expanding their installed bases to meet this growing requirement for accessible testing closer to the patient. According to bioMérieux, March 2025, in the '2024 Financial Results', sales of the SPOTFIRE point-of-care system accelerated to nearly €95 million for the year, with the installed base reaching 3,000 units. Despite this progress, significant gaps remain in global access to these technologies. According to the World Health Organization, in October 2024, only 48 percent of people newly diagnosed with tuberculosis were tested using a WHO-recommended rapid molecular diagnostic as the initial test, highlighting the immense unmet need driving future market expansion.

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Key Market Challenges

The sector faces significant hurdles regarding stringent regulatory environments and associated compliance costs, which act as a substantial brake on market momentum. As regulatory bodies enforce more rigorous standards to ensure device safety and performance, manufacturers are compelled to reallocate critical resources from research and development toward navigating complex approval processes. This diversion of capital and technical expertise slows the pace of innovation, preventing potentially breakthrough diagnostic platforms from reaching the commercial stage efficiently. The sheer volume of documentation and clinical evidence required creates prolonged development cycles, delaying the availability of essential point-of-care solutions.

These regulatory pressures are actively reshaping global market strategies, causing manufacturers to hesitate or withdraw from markets with unpredictable certification timelines. The intense focus on compliance reduces the attractiveness of regions that were once hubs for medical technology innovation. According to MedTech Europe, in 2024, the percentage of large diagnostic manufacturers selecting the European Union as their priority region for first product launches declined by 40% due to the challenges associated with the new regulatory framework. This trend demonstrates how regulatory burdens are directly impeding the widespread expansion and accessibility of molecular diagnostic technologies.

Key Market Trends

The Emergence of CRISPR-Based Diagnostic Technologies is revolutionizing the market by enabling highly sensitive, instrument-free molecular detection that rivals traditional PCR without requiring complex thermal cycling. This technology utilizes Cas enzymes to identify specific genetic targets directly from samples, significantly reducing device complexity and manufacturing costs for point-of-care settings. The commercial scalability of this innovation is driving major strategic acquisitions aimed at deploying next-generation assays for decentralized screening. According to OraSure Technologies, December 2024, in the 'OraSure Technologies Acquires Sherlock Biosciences' press release, the company estimates that the total addressable market for Sherlock's CRISPR-based Chlamydia and Gonorrhea self-test alone represents more than $1.5 billion, underscoring the immense financial opportunity in these advanced gene-editing diagnostics.

Simultaneously, the Expansion of Direct-to-Consumer and Home-Use Molecular Testing Kits is fundamentally altering patient access by allowing individuals to perform lab-quality assays in their own homes. Manufacturers are increasingly securing regulatory authorizations for over-the-counter platforms that diagnose sexual health and respiratory conditions, thereby bypassing traditional clinical bottlenecks and physician referrals. This trend is attracting substantial investment capital aimed at scaling manufacturing and distribution networks for consumer-initiated diagnostics to meet rising public demand. According to Ctech, June 2025, in the 'Visby Medical raises $55M to bring lab-grade STI testing home' article, Visby Medical secured approximately $55 million in funding specifically to accelerate the commercial reach of its FDA-cleared at-home sexual health test, highlighting the sector's rapid pivot toward user-centric diagnostic models.

Segmental Insights

Hybridization-Based Technology is the fastest-growing segment in the Global Point-Of-Care Molecular Diagnostics Market, primarily driven by the expanding demand for precision medicine and rapid infectious disease identification. Technological strides in probe design, particularly in fluorescence in situ hybridization, have streamlined workflows to permit sensitive genetic analysis in decentralized environments. The capability of these assays to detect specific nucleic acid sequences directly supports the growing reliance on companion diagnostics, allowing clinicians to make immediate, evidence-based treatment decisions for oncology and pathogen-specific conditions without the latency of reference laboratory testing.

Regional Insights

North America maintains a leading position in the global point-of-care molecular diagnostics market, primarily driven by widely accessible healthcare infrastructure and the concentration of major industry manufacturers. This dominance is supported by favorable regulatory policies from the U.S. Food and Drug Administration, which streamline the approval process for new diagnostic platforms. Additionally, the increasing focus on decentralized testing for infectious diseases accelerates the adoption of rapid diagnostic solutions. High healthcare expenditure and strong government support for clinical research in the United States and Canada also contribute significantly to the sustained regional market expansion.

Recent Developments

• In June 2024, Roche announced that it had received Emergency Use Authorization from the U.S. FDA for a four-in-one molecular diagnostic test on its cobas liat system. This automated, multiplex real-time RT-PCR assay was designed to detect and differentiate SARS-CoV-2, influenza A, influenza B, and respiratory syncytial virus from a single nasopharyngeal or anterior nasal swab sample. The company highlighted that the test generates definitive results in 20 minutes, allowing healthcare professionals to make immediate clinical decisions during a single patient visit. This approval expanded the company’s portfolio of point-of-care solutions aimed at addressing the burden of respiratory illnesses in decentralized healthcare settings.
• In June 2024, Cepheid received FDA De Novo marketing authorization and a Clinical Laboratory Improvement Amendments (CLIA) waiver for its Xpert HCV test. This molecular diagnostic assay is the first of its kind to enable the detection of Hepatitis C Virus RNA directly from a capillary whole blood fingerstick sample. Designed for use on the GeneXpert Xpress System, the test delivers results in approximately one hour, facilitating a test-and-treat approach in point-of-care settings. The company emphasized that this authorization would help overcome barriers to diagnosis by allowing patients to be tested and linked to treatment within the same clinic visit.
• In June 2024, bioMérieux announced that the U.S. FDA granted Special 510(k) clearance and a CLIA waiver for its BIOFIRE SPOTFIRE Respiratory/Sore Throat Panel Mini. This multiplex PCR test was designed to detect and differentiate five common viral and bacterial causes of respiratory and sore throat infections, including Streptococcus pyogenes, from a single throat or nasopharyngeal swab. The test produces results in approximately 15 minutes on the BIOFIRE SPOTFIRE system. The company stated that this solution offers clinicians flexibility in testing and supports antimicrobial stewardship by delivering rapid, lab-quality results in outpatient and decentralized environments.
• In February 2024, Binx Health entered into a national distribution agreement with Cardinal Health to expand access to its point-of-care molecular diagnostics platform. The collaboration focused on the binx io system, which is FDA-cleared and CLIA-waived for the rapid detection of chlamydia and gonorrhea. This partnership aimed to increase the availability of the platform in acute care settings, such as urgent care clinics and primary care offices, across the United States. The company noted that the system delivers central laboratory-quality results in about 30 minutes, enabling a single-visit test-and-treat model for sexually transmitted infections.

Key Market Players

• Siemens Healthineers AG
• Quidel Corporation
• F. Hoffman-La Roche Ltd.
• Danaher Corporation
• Beckton & Dickinson Company
• Trinity Biotech plc
• Thermo Fisher Scientific Inc
• bioMérieux S.A.
• DiaSorin S.p.A
• AccuBioTech Co., Ltd.

By Technology	By Application	By Test Location	By End User	By Region
PCR-based Genetic Sequencing-based Hybridization-based Microarray-based	Infectious Diseases Oncology Hematology Prenatal Testing Endocrinology Other	OTC POC	Decentralized Labs Hospitals Home-care Assisted Living Healthcare Facilities Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Point-Of-Care Molecular Diagnostics Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Point-Of-Care Molecular Diagnostics Market, By Technology:

• PCR-based
• Genetic Sequencing-based
• Hybridization-based
• Microarray-based

• Point-Of-Care Molecular Diagnostics Market, By Application:

• Infectious Diseases
• Oncology
• Hematology
• Prenatal Testing
• Endocrinology
• Other

• Point-Of-Care Molecular Diagnostics Market, By Test Location:

• OTC
• POC

• Point-Of-Care Molecular Diagnostics Market, By End User:

• Decentralized Labs
• Hospitals
• Home-care
• Assisted Living Healthcare Facilities
• Others

• Point-Of-Care Molecular 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