Point-Of-Care Molecular Diagnostics Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, 2021-2031

The Global Point-Of-Care Molecular Diagnostics Market is projected to experience significant growth, rising from a valuation of USD 2.88 Billion in 2025 to USD 5.45 Billion by 2031, reflecting a CAGR of 11.21%. Point-of-care molecular diagnostics utilize automated testing platforms to identify pathogenic genetic material or mutations immediately at the site of patient care. These portable systems provide rapid and accurate results without the need for centralized laboratory processing, facilitating prompt clinical decision-making. The market is largely driven by the rising global prevalence of infectious diseases and a shift toward decentralized healthcare that demands accessible testing solutions. Additionally, ongoing advancements in microfluidics have improved the speed and usability of these devices, supporting their adoption across various medical settings.

However, the industry faces substantial challenges due to strict regulatory environments and high compliance costs. The move toward more rigorous frameworks has placed significant financial burdens on manufacturers, which threatens to stifle innovation and delay product launches. For example, MedTech Europe reported that in 2024, certification costs for manufacturers under the new In Vitro Diagnostic Regulation rose by up to 100 percent compared to previous directives. This increase in expenses establishes a high barrier to entry and may hinder the widespread expansion of cost-effective diagnostic solutions.

Market Drivers

The escalating global burden of infectious diseases and pandemics serves as a primary catalyst for the market, creating a critical need for robust diagnostic tools capable of rapidly identifying pathogens such as influenza, RSV, and COVID-19. As respiratory viruses continue to co-circulate, healthcare systems are prioritizing multiplex molecular assays that can differentiate between overlapping symptoms to improve patient management. This strong demand is reflected in the commercial success of major industry players offering comprehensive respiratory panels. According to Danaher Corporation’s Q4 2024 earnings results released in January 2025, Cepheid's respiratory testing revenue hit approximately $550 million in the fourth quarter alone, driven by high volumes of their four-in-one test, underscoring the market's reliance on molecular point-of-care solutions for managing seasonal outbreaks.

Simultaneously, the growing shift toward decentralized healthcare and near-patient testing is transforming the industry by relocating advanced diagnostics from central labs to clinics and urgent care centers. This transition is supported 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 demand for accessible testing closer to the patient. According to bioMérieux’s 2024 financial results from March 2025, sales of the SPOTFIRE point-of-care system reached nearly €95 million for the year, with an installed base of 3,000 units. despite this progress, significant gaps remain in global access; the World Health Organization noted in October 2024 that only 48 percent of newly diagnosed tuberculosis cases were tested using a WHO-recommended rapid molecular diagnostic as the initial test, highlighting the immense unmet need driving future market expansion.

Market Challenges

The sector encounters major obstacles regarding stringent regulatory environments and associated compliance costs, which act as a significant brake on market momentum. As regulatory bodies enforce more rigorous standards to ensure device safety and performance, manufacturers are forced 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.

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 in a December 2024 press release regarding the acquisition of Sherlock Biosciences, 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 a Ctech article from June 2025, Visby Medical raised approximately $55 million 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.

Key Players Profiled in the Point-Of-Care Molecular Diagnostics Market

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

Report Scope

In this report, the Global Point-Of-Care Molecular Diagnostics Market has been segmented into the following categories:

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
• Europe
• Asia-Pacific
• South America
• Middle East & Africa

Competitive Landscape

Company Profiles: Detailed analysis of the major companies present in the Global Point-Of-Care Molecular Diagnostics Market.

Available Customization

The analyst offers customization according to your specific needs. The following customization options are available for the report:

• Detailed analysis and profiling of additional market players (up to five).

This product will be delivered within 1-3 business days.