North America Laboratory Information Systems (LIS) Market Size, Share, and Trends Analysis Report – Industry Overview and Forecast to 2032

North America Laboratory Information Systems (LIS) Market Size

• The North America laboratory information systems (LIS) market size was valued at USD 660.41 million in 2024 and is expected to reach USD 1,335.36 million by 2032, at a CAGR of 9.20% during the forecast period
• The market growth is primarily driven by increasing demand for advanced diagnostic solutions, coupled with the growing volume of laboratory tests, which necessitate efficient data management and automation within clinical settings
• Moreover, rising adoption of cloud-based LIS platforms, regulatory pressure for accurate diagnostics, and integration with electronic health records (EHR) are encouraging healthcare providers to invest in robust laboratory informatics

North America Laboratory Information Systems (LIS) Market Analysis

• The North America laboratory information systems (LIS) market, offering digital platforms for managing laboratory data and optimizing diagnostic workflows, is becoming increasingly vital in healthcare settings across the United States, Canada, and Mexico, due to its ability to improve accuracy, streamline operations, and support regulatory compliance
• The growing demand for LIS is primarily fueled by the rising number of diagnostic tests, the push for healthcare digitalization, and the need for integrated systems that connect seamlessly with electronic health records (EHRs) and other clinical IT platforms
• U.S. dominated the North America laboratory information systems (LIS) market, with the largest revenue share of 42.7% in 2024, driven by early adoption of health IT solutions, strong government support, high test volumes, and a concentration of major LIS providers. The country continues to lead in LIS deployments, especially in large hospitals and diagnostic networks adopting automation and AI-powered analytics
• Canada is expected to be the fastest growing region in the North America laboratory information systems (LIS) market, supported by national digital health initiatives and increasing investments in laboratory infrastructure. Mexico is gradually advancing through modernization efforts in its public healthcare system, boosting LIS penetration in government labs and hospitals.
• The cloud-based LIS segment led the North America laboratory information systems (LIS) market with a share of 46.8% in 2024, owing to its scalability, cost efficiency, and suitability for small- to mid-sized laboratories

Report Scope and North America Laboratory Information Systems (LIS) Market Segmentation       

North America Laboratory Information Systems (LIS) Market Trends

“AI-Driven Automation and Cloud Integration Enhancing Lab Efficiency”

• A significant and accelerating trend in the North America LIS market is the growing integration of artificial intelligence (AI) and cloud-based infrastructure to modernize diagnostic workflows and improve laboratory efficiency across the United States, Canada, and Mexico. This technological advancement is transforming lab operations by offering enhanced accuracy, scalability, and real-time data access
  • For instance, LabWare and Orchard Software have introduced AI-enhanced modules within their LIS platforms that support predictive diagnostics, automate repetitive tasks, and detect workflow anomalies. These capabilities help laboratories reduce turnaround times and ensure compliance with clinical standards
• AI-enabled LIS solutions also analyze historical test data to improve decision-making and can issue proactive alerts regarding quality control issues or potential diagnostic errors. Meanwhile, cloud deployment models allow for centralized data access, multi-location connectivity, and streamlined software updates—especially vital in large healthcare systems across the U.S.
• The growing need for interoperability and remote diagnostics has made cloud-based LIS increasingly essential. In Canada, digital health strategies support cross-institutional data sharing, further driving cloud adoption
• The integration of AI and cloud capabilities into LIS platforms is redefining expectations for laboratory systems, offering labs a unified, intelligent environment that enables automation, real-time reporting, and centralized oversight
• As healthcare systems across the region continue to prioritize digital transformation, the demand for advanced LIS platforms with AI-powered automation and scalable cloud functionality is expected to grow rapidly in both public and private sectors

North America Laboratory Information Systems (LIS) Market Dynamics

Driver

“Increased Diagnostic Volume and Push for Digital Healthcare Transformation”

• The increasing diagnostic workload across healthcare systems, combined with regional efforts toward digital healthcare modernization, is a major driver for LIS market growth in North America. Laboratories require robust data management solutions to handle high volumes of patient samples while maintaining speed and accuracy
  • For instance, in March 2024, the U.S. Department of Health and Human Services introduced updated interoperability guidelines aimed at improving electronic data exchange, encouraging greater adoption of integrated LIS platforms across hospitals and diagnostic centers
• LIS solutions support automated sample tracking, result validation, and compliance monitoring, which are essential for labs operating under pressure. In Canada, national initiatives to enhance lab connectivity and reporting efficiency are also advancing LIS adoption
• As personalized medicine, molecular diagnostics, and genomics testing become more widespread, laboratories need intelligent systems capable of processing complex datasets. LIS platforms offering AI-powered tools and integration with EHR systems are increasingly favored in research centers and specialized labs across the region
• The widespread push for digital transformation, data-driven clinical decision-making, and quality assurance is expected to fuel the expansion of LIS adoption throughout North America in the coming years

Restraint/Challenge

“Data Security Concerns and Interoperability Barriers”

• Concerns over data privacy and cybersecurity vulnerabilities continue to challenge the broader deployment of LIS solutions in North America. Since LIS platforms handle highly sensitive patient and diagnostic data, they are frequently targeted by cyber threats and ransomware attacks
  • For instance, several healthcare data breaches reported in the U.S. in 2023 raised alarm over the security of cloud-based systems and third-party software integrations. Ensuring compliance with HIPAA and other data protection laws is crucial to gaining user trust and mitigating risk
• Another persistent challenge is interoperability, particularly when LIS platforms must integrate with outdated EHR systems or laboratory instruments lacking standardized protocols. This can result in delayed implementations and increased IT complexity.
• In addition, the high initial cost of LIS implementation, ongoing maintenance, and customization requirements can be a financial barrier, especially for small and mid-sized labs. In Mexico, slower digital infrastructure development and limited budgets in public institutions further constrain market penetration
• To overcome these challenges, LIS providers must prioritize secure system architecture, promote adoption of common data standards, and offer more affordable, scalable solutions tailored to diverse laboratory needs across the region

North America Laboratory Information Systems (LIS) Market Scope

The market is segmented on the basis of component, product, delivery mode, and end user.

• By Component

On the basis of component, the North America laboratory information systems (LIS) market is segmented into software and services. The software segment dominated the market with the largest revenue share in 2024, attributed to the rising need for automation in laboratory operations and the integration of LIS platforms with electronic health records (EHRs). Software solutions are critical in enabling data-driven workflows, automated result validation, and compliance tracking, making them indispensable for modern clinical and diagnostic laboratories.

The services segment is expected to witness the fastest growth rate from 2025 to 2032, driven by increasing demand for LIS customization, software upgrades, training, and technical support. As laboratories seek to optimize and maintain their LIS environments, service providers are playing a growing role in ensuring system uptime and long-term performance.

• By Product

On the basis of product, the North America laboratory information systems (LIS) market is segmented into integrated LIS and standalone LIS. The integrated LIS segment held the largest revenue share in 2024 due to its seamless compatibility with broader healthcare IT systems, including EHRs, billing software, and clinical decision support tools. Integrated LIS platforms are increasingly adopted in hospital laboratories and large diagnostic centers for their centralized control and multi-department coordination capabilities.

The standalone LIS segment is expected to witness the fastest CAGR from 2025 to 2032, particularly in small to mid-sized labs that require dedicated laboratory information management without the complexity of full hospital integration. These systems are valued for their cost-effectiveness and ease of deployment in niche testing environments and specialized research labs.

• By Delivery Mode

On the basis of delivery mode, the North America laboratory information systems (LIS) market is segmented into cloud-based, remotely-hosted, and on-premise models. The cloud-based segment led the market with the highest revenue share of 46.8% in 2024, driven by its scalability, reduced infrastructure costs, and ability to support remote access across multi-site laboratory networks. Cloud-based LIS platforms are increasingly favored in the U.S. and Canada due to regulatory compliance, real-time data availability, and streamlined updates.

The remotely-hosted segment is expected to witness significant growth during the forecast period as it offers a middle ground between on-premise control and cloud flexibility. It appeals to labs that seek external hosting without full cloud dependency, particularly those with moderate IT capacity.

• By End User

On the basis of end user, the North America laboratory information systems (LIS) market is segmented into hospital laboratories, independent laboratories, physician office laboratories, and others. The hospital laboratories segment held the largest market share in 2024, supported by high patient volumes, regulatory mandates, and the need for integrated diagnostics and centralized data management in clinical settings.

The independent laboratories segment is expected to witness the fastest CAGR from 2025 to 2032, fueled by rising demand for outsourced diagnostic services, growing test complexity, and investments in automation. These labs often prioritize flexible LIS systems that support high-throughput operations and diverse testing menus.

North America Laboratory Information Systems (LIS) Market Regional Analysis

• The U.S. dominated the North America laboratory information systems (LIS) market, with the largest revenue share of 42.7% in 2024, driven by early adoption of health IT solutions, strong government support, high test volumes, and a concentration of major LIS providers. The country continues to lead in LIS deployments, especially in large hospitals and diagnostic networks adopting automation and AI-powered analytics
• U.S. laboratories prioritize integrated, AI-enabled LIS platforms that enhance efficiency, ensure compliance with HIPAA regulations, and enable seamless data exchange with EHR systems—making LIS a core component of clinical operations
• The region's collective growth is underpinned by increasing awareness of data-driven diagnostics, a need for laboratory workflow automation, and rising emphasis on quality control and reporting accuracy across clinical and research setting

U.S. North America Laboratory Information Systems (LIS) Market Insight

The U.S. laboratory information systems (LIS) market captured the largest revenue share of 78% in 2024 within North America, driven by the country’s highly digitized healthcare infrastructure and the rising volume of diagnostic testing. Hospitals, clinics, and research laboratories are increasingly deploying advanced LIS platforms to streamline operations, meet regulatory requirements, and enhance diagnostic accuracy. The push for interoperability, integration with electronic health records (EHR), and adoption of AI-powered analytics tools are further fueling demand. In addition, government initiatives such as interoperability mandates and funding for health IT modernization are supporting widespread LIS implementation across public and private healthcare sectors.

Canada North America Laboratory Information Systems (LIS) Market Insight

The Canada laboratory information systems (LIS) market is projected to grow at a robust CAGR throughout the forecast period, fueled by national digital health strategies and investments aimed at modernizing laboratory systems. Public and private healthcare providers are increasingly adopting cloud-based LIS solutions to improve data accessibility and reporting efficiency across provinces. The focus on interoperability, data standardization, and quality control is driving the adoption of integrated LIS platforms. Canada’s emphasis on decentralized and community-based healthcare delivery is also promoting LIS expansion in outpatient and remote care settings.

Mexico North America Laboratory Information Systems (LIS) Market Insight

The Mexico laboratory information systems (LIS) market is anticipated to witness steady growth during the forecast period, supported by efforts to upgrade healthcare IT infrastructure and digitize public laboratories. While challenges such as budget constraints and limited interoperability persist, the demand for scalable and affordable LIS solutions is increasing, particularly in government-run hospitals and diagnostic centers. Cloud-based LIS platforms are gaining traction due to their cost-effectiveness and low IT maintenance requirements. Mexico’s growing awareness of diagnostic accuracy, coupled with an expanding healthcare network, is expected to continue driving LIS adoption.

North America Laboratory Information Systems (LIS) Market Share

The North America laboratory information systems (LIS) industry is primarily led by well-established companies, including:

• Thermo Fisher Scientific Inc. (U.S.)
• Illumina Inc. (U.S.)
• PerkinElmer (U.S.)
• Roper Technologies (U.S.)
• Agilent Technologies, Inc. (U.S.)
• Autoscribe Informatics (U.K.)
• Benchling (U.S.)
• Eusoft Ltd (Portugal)
• Infor AG (U.S.)
• Kritisoft (India)
• Labvantage Solutions Inc. (U.S.)
• Labware (U.S.)
• McKesson Corporation (U.S.)
• Orchard Software Corporation (U.S.)
• Novatek International (Canada)
• Lqms (U.S.)
• Starlims Corporation (U.S.)

What are the Recent Developments in North America Laboratory Information Systems (LIS) Market?

• In April 2024, LabWare launched LabWare 8, the latest iteration of its enterprise LIMS/LIS platform, with enhanced machine learning and AI analytics modules that enable predictive diagnostics and anomaly detection—emphasizing its commitment to next-gen lab informatics
• In March 2024, Orchard Software Corporation formed a strategic partnership with a major U.S. health system to deploy its cloud-based LIS platform across multiple facilities. The implementation enhances EHR integration and centralized access—highlighting the growing shift toward scalable, cloud-enabled LIS infrastructure
• In June 2024, CompuGroup Medical USA released CGM LABDAQ v24.4, which introduces strengthened audit-report search, microbiology and billing rules engines, and auto-verification—underscoring advancements in AI and rule-based lab workflows.Shortly after, CGM LABDAQ was named Best Laboratory Information System 2024 by Lighthouse Lab Services, validating its intuitive interface and reporting excellence
• In January 2024, Sunquest Information Systems (under Clinisys) integrated its LIS with genomic data platforms at a major U.S. academic medical center, enabling seamless management of high-complexity genetic testing workflows and reinforcing the trend toward precision medicine
• In December 2023, Cerner Corporation (Oracle Health) initiated a LIS modernization program across select U.S. hospital networks, focusing on interoperability enhancements, improved UX, and adherence to regulatory standards—demonstrating sustained investment in next-gen lab informatics

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