North America Diagnostic Labs Market Size, Share, By Lab Type, Testing Services, Diseases, Revenue Source, and Country - Trends, Analysis, and Forecast till 2035

• The target market is calculated to expand at USD 55.7 billion by 2035.
• In 2024, the North America diagnostic labs market size benefited at USD 36.0 billion.
• The market is growing at a CAGR of 4.0%.

Diagnostic laboratory is a facility that is equipped with reagents, apparatus for performing diagnostic test and for detecting human infection. Rise in healthcare industries, rapid test kits, and rising cases of chronic diseases, increasing rates of allergic diseases are key factors contributing to diagnostic labs market growth in North America. Furthermore, it is hoped that business partnerships and collaborations will also create opportunities for the market to flourish throughout the forecast period.

Key Takeaways:

• The U.S. region of North America dominates the market due to the increasing cases of chronic diseases.  
• For instance, according to the data published by Centers for Disease Control & Prevention in February 2024, an estimated 129 million people in the U.S. have at least 1 major chronic disease, such as heart disease, cancer, diabetes, obesity, and hypertension as defined by the U.S. Department of Health and Human Services. Five of the top 10 leading causes of death in the U.S. are, or are strongly associated with, preventable and treatable chronic diseases.

Key Drivers of Target Market:

Increasing Cases of Chronic Diseases can Drive the Market Expansion

Rising cases of chronic diseases in the region can drive the North America diagnostic labs market growth as diagnostic labs plays a significant role to manage chronic diseases. Diagnostic labs helps to detect chronic diseases by offering screening tests and health checkups, to monitor progression of disease, and they also help to evaluate treatment response.

• For instance, according to the data published by the Centers for Disease Control & Prevention in February 2024, an increasing proportion of people in America are dealing with multiple chronic conditions; 42% have 2 or more, and 12% have at least 5.

Restraints:

Challenges Associated with Diagnostic Labs May Hinder the Market Growth

Challenges associated with diagnostic labs, such as developing, implementing and monitoring risk procedures can be time consuming, and potentially costly, a failure in risk management procedures that leads to the failure of an independent laboratory audit, and others, are expected to limit the market expansion.

Counterbalance Statements: Clearly, greater laboratory automation is one way of reducing the dependence on staff while minimizing the risk of potentially audit-failing human errors. Additionally, prioritize compliance with the Clinical Laboratory Improvement Amendments (CLIA) regulations, establish a team or designate a compliance officer responsible for staying up-to-date with regulatory changes, regular training sessions for staff on regulatory compliance and quality control practices, and among others are some of the solutions over challenges faced by diagnostic labs.

Opportunities:

Integration of Advance Technologies with Diagnostic Labs Fuels Market Expansion

Integration of advanced technologies, such as 3D printing, AI, electronic health records, molecular diagnostic, Nano medicine, cloud computing, genetic sequencing techniques, and others with diagnostic labs for the purpose of medical imaging, improvement of data exchange, infectious disease testing, and to treat medical conditions will help to create future opportunities.

• For instance, in December 2024, ARUP LABORATORIES, a leading global medical technology company, and Babson Diagnostics, a science-first health care technology company announced an expansion of fingertip blood collection and testing technologies for use by the U.S. health systems and other large provider networks in settings, including urgent cares, doctor offices, and other ambulatory care settings.
• For instance, in July 2023, Roche introduces its latest advancements in lab automation, core lab systems, molecular and point-of-care solutions, and to learn more about the advancements in breakthrough high-medical-value diagnostic and digital solutions that are transforming patient care at science-driven and patient-centric exhibit at the 2023 American Association of Clinical Chemistry (AACC) Scientific Meeting and Clinical Lab Expo.

Lab type, testing services, diseases, revenue source, and country are classification of target market.

Lab Type

According to the lab type, the market is classified into single/independent laboratories, hospital-based labs, physician office labs, and others. Hospital-based labs dominates the diagnostic labs market share as a result of rising number of patients in North America.

• For instance, in August 2024, Quest Diagnostics, a leading provider of diagnostic information services, and University Hospitals, one of the nation's leading nonprofit health systems and academic medical centers, announced a definitive agreement for Quest to acquire selected assets of University Hospitals' outreach laboratory services business.

Testing Services

Physiological function testing, general & clinical testing, esoteric testing, specialized testing, non-invasive testing, COVID-19 testing, and others are testing services on which the market is segmented. The COVID-19 testing segment is leading the market due to the pandemic, which caused rapid growth in the infection cases.

• For instance, in November 2022, Roche announced a new name and brand for the COVID-19 At-Home Test – Pilot COVID-19 At-Home Test. The Pilot COVID-19 At-Home Test, the first over-the-counter test distributed in the U.S. by Roche Diagnostics, received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) on December 24, 2021, and is manufactured by SD Biosensor Inc. 

Diseases

Cardiology, oncology, neurology, orthopedics, gastroenterology, gynecology, odontology, and others are ailments that make up the targeted market. Nonetheless, the market’s highest share was held by the oncology division as a result of rise in cancer cases.

• For instance, according to the data published by the American Cancer Society in January 2024, in 2024, 2,001,140 new cancer cases and 611,720 cancer deaths are projected to occur in the U.S. There will be approximately 2,001,140 new cancer cases, the equivalent of about 5480 diagnoses each day. In addition, there will be about 56,500 new cases of ductal carcinoma in situ in women and 99,700 new cases of melanoma in situ of the skin in 2024. 
• For instance, in December 2024, Cizzle Biotechnology Holdings plc, the U.K. based diagnostics developer, announced that it has signed an extension to its exclusive licensing and partnership agreement for the U.S. and Canada, with Cizzle Bio Inc (BIO) for its proprietary CIZ1B biomarker test to help detect early-stage lung cancer, to include the 14 Sovereign States of the Caribbean and the Cayman Islands. 

Revenue Source

The market is distinguished into healthcare plan, out-of-pocket, public system, and others on the grounds of revenue source. Healthcare plan dominates the North America diagnostic labs market as it offers coverage for various types of ailments & surgeries.

North America Diagnostic Labs Market Report Scope:

Segmentation:

By Lab Type:

• Single/Independent Laboratories
• Hospital-Based Labs
• Physician Office Labs
• Others

By Testing Services:

• Physiological Function Testing
• General & Clinical Testing
• Esoteric Testing
• Specialized Testing
• Non-Invasive Testing
• COVID-19 Testing
• Others

By Diseases:

• Cardiology
• Oncology
• Neurology
• Orthopedics
• Gastroenterology
• Gynecology
• Odontology
• Others

By Revenue Source:

• Healthcare Plan
• Out-of-Pocket
• Public System

By Region:

• North America
  • U.S.
  • Canada

Quest Diagnostics Incorporated, Sonic Healthcare Limited, and Empire City Laboratories, Inc., among others are key companies, which operate in the target market. Integration of latest advancements, acquisitions, new testing services, agreement with other firms, advanced systems launches, and others are some of the key strategies executed by key players for market expansion.

List of Key Players in the Market:

• BioReference Health, LLC
• Quest Diagnostics Incorporated
• Sonic Healthcare Limited
• Empire City Laboratories, Inc.
• AGILENT TECHNOLOGIES, INC.
• UNILABS
• ARUP LABORATORIES
• EXACT SCIENCES CORPORATION
• LIFELABS
• Precision Bio Laboratories Inc.
• PathGroup.
• MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH

• In September 2024, MAYO FOUNDATION FOR MEDICAL EDUCATION AND RESEARCH N.V. announced the launch of the QIAcuityDx Digital PCR System, a pivotal addition to its digital PCR portfolio now expanding into clinical diagnostics. The instrument and accessories are 510(k) exempt in the U.S. and IVDR-certified for diagnostic use in Europe.
• In October 2024, the World Health Organization (WHO) has granted emergency use authorization for Abbott Laboratories’ Mpox diagnostic test, marking the first approval under the agency’s initiative to strengthen testing capabilities in regions experiencing Mpox outbreaks.

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