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United States Clinical Laboratory Services Industry Future Outlook and Market Forecast | Impact of COVID-19,Key Player Strategies and M&A Activity 2025.
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Recent Product Launches In United States:
❇️August 2025: Abbott announced a $500 million investment to expand its transfusion diagnostics business, enhancing capacity for blood and plasma screening instruments.
❇️April 2025: QIAGEN revealed plans to launch three new sample preparation instruments by 2026, strengthening automated workflows in oncology and genomics labs.
❇️April 2025: Danaher opened two Centers of Innovation in Diagnostics for advanced lab instrument development integrating PCR, immunoassay, and immunohistochemistry technologies
Recent Product Launches In Japan-
❇️September 2025: Otsuka Pharmaceutical opened a new research laboratory in Tokyo focused on next-generation diagnostic devices, digital biomarkers, and AI-driven remote testing.
❇️May 2025: Nara Medical University began the world's first clinical trials for lab-made artificial blood aiming to solve blood shortages with universal compatibility and long shelf life.
❇️September 2025: Medical Biological Laboratories Co., Ltd. launched high-quality clinical diagnostic reagents for autoimmune and genetic testing targeting hospitals and labs.
Recent Mergers & Acquisitions (2025)
🌐Roche's acquisition of a Japanese molecular diagnostics firm in mid-2025 bolsters its position in precision medicine, allowing it to expand its offerings in cancer and infectious disease testing.
🌐Beckman Coulter completed the acquisition of a US-based digital pathology and AI imaging start-up, enhancing Beckman Coulter's diagnostic offerings with advanced image analysis and workflow automation.
🌐Qiagen announced that it would begin talks to acquire a US liquid biopsy company to enhance its non-invasive cancer diagnostics.
Recent Investments-
⚡US diagnostics firms raised over USD 110 million in 2025 for AI-driven predictive diagnostics and lab automation.
⚡Japan's Medical Innovation Fund granted USD 55 million for advancing clinical diagnostics in chronic and infectious diseases.
⚡Japanese venture capital invests heavily in startups creating portable diagnostics and telehealth-compatible lab solutions for elderly and rural healthcare.
⚡Additional US investment includes USD 40 million in genomics startups focusing on rapid disease detection and personalized medicine.
⚡Japan allocated USD 30 million for digital pathology and cloud-based diagnostic data platforms in 2025.
⚡Cross-border funding flows increased by 15% in 2025, reflecting global collaboration in diagnostic innovation.
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DataM Intelligence has published a new research report on "Clinical Laboratory Services Market Size 2025". The report explores comprehensive and insightful Information.The Clinical Laboratory Services Market report would provide approximately 24 tables, 53 figures and 210 pages.
Key Players-
Abbott Laboratories, Bio Reference Laboratories, Exact Sciences Corporation, Myriad Genetics, Inc, Neogenomics Inc, Quest Diagnostics Inc, Siemens Healthineer, Sonic Healthcare Limited, Laboratory Corporation of America and Synlab International GmbH.
Research Process:
Both primary and secondary data sources have been used in the Clinical Laboratory Services Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.
Key Segments:
♀️By Test Type- Microbiology, Serology, Clinical chemistry, Cytogenetics, Pathology, Others
♀️By End-users- Hospital-based, Clinic-based, Stand-alone laboratories, Others
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FDA Approvals
In May 2025, Roche's high-throughput PCR system secured FDA 510(k) approval for the scalable testing of infectious disease, COVID-19 variants, and influenza.
Also approved in 2025, Roche added AI diagnostic algorithms for hematology in its blood diagnostics product line, reinforcing laboratory automation for clinical use.
Latest News-
⏭️A new AI-powered remote diagnostic software platform by Otsuka Pharmaceutical launched in Japan nationwide in September 2025. The platform is expected to reduce diagnostic turnaround times by 30% and improve rural access to healthcare as it rolls out in Japan.
⏭️Roche's partnership with Broad Clinical Research Institute to expedite the development of multiplex diagnostic panels for cancer and infectious disease, announced May 2025. The goal is to produce panels that yield faster results for patient diagnostics and allow for real time up-to-date sensing.
⏭️The US Food and Drug Administration has initiated movement on regulatory pathways for artificial intelligence and digital pathology devices, outlining their encouragement for the innovation of devices in digital pathology and being able to enter the market quickly.
Impact of COVID-19
The advent of the pandemic sped up the adoption of lab automation in the United States and Japan by 25-30%, as labs tackled high testing volume and operational efficiency in the lab environment.
The demand for COVID-19 testing created supply chain issues in reagents and instruments, but it also helped spur local production and diversification.
After the pandemic, there is greater investment of public and private funding in laboratory capacity for infectious diseases diagnostics, including efforts that emphasize timely detection and outbreak readiness.
FAQ's
Q1: What is the current size of the Clinical Laboratory Services Market?
A: The Clinical Laboratory Services Market stood at US$ 22.56 billion in 2023 and is set to experience remarkable growth, reaching US$ 414.18 billion by 2031
Q2: How fast is the Clinical Laboratory Services Market growing?
A: The Market is on an impressive growth trajectory, expected to expand at a CAGR of 6.5% from 2024 to 2031
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