According to the latest report the global clinical diagnostics market size was USD 82.19 billion in 2023, calculated at USD 86.72 billion in 2024, and is expected to reach around USD 140.53 billion by 2033, expanding at a CAGR of 5.51% from 2024 to 2033.
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Diagnostic tests play a critical role in clinical practice by accurately identifying diseases and guiding early, effective treatments. The responsibility for reporting high-quality diagnostic results lies squarely with the authors, whether using basic or advanced testing methods.
The clinical diagnostics market is experiencing rapid growth driven by advancements in diagnostic technologies and regulatory science initiatives such as the Clinical Diagnostics (CDx) program. This program focuses on improving diagnostic testing and product development through innovative regulatory approaches, facilitating quicker access to cost-effective advanced diagnostic technologies. Diagnostic products play a crucial role in the healthcare ecosystem by guiding clinical practices and enabling earlier detection of diseases, particularly in the era of personalized medicine.
The established regulatory framework for in vitro diagnostic (IVD) products, stakeholders acknowledge challenges including complexity, cost, and regulatory speed. The effectiveness of diagnostic tests, whether used for confirmation, triage, monitoring, prognosis, or screening, depends on factors such as reproducibility, accuracy, feasibility, and their impact on clinical decisions. Addressing these aspects is pivotal for sustaining market growth, enhancing patient care, and fostering innovation in clinical diagnostics.
Existing recommendations and standards for statistical content and format, variability in the quality of statistical reporting persists—from excellent to very poor—when evaluating diagnostic tests. This variability underscores the opportunity for growth in the clinical diagnostics market, driven by the increasing demand for improved standards and methodologies that ensure accurate and reliable diagnostic outcomes. Efforts to enhance reporting practices can lead to advancements in diagnostic technologies, increased confidence among healthcare providers, and ultimately contribute to market expansion through enhanced patient care and outcomes.
- In July 2023, LGC acquired Kova International, Inc., including Biochemical Diagnostics, Inc., strengthening its portfolio of quality measurement tools.
- In March 2024, Labcorp announced the acquisition of select assets of BioReference Health’s diagnostics business.
Key Takeaways
- By region, North America led the market in 2023.
- By therapy type, the liquid panel segment held a largest market share.
- By application, the instruments segment accounted largest market share.
- By end User, point-of-care testing segment held largest market share.
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Market Dynamics
Driver
Advancements in Consumer Health and Digital Transformation
Diagnostics are pivotal in screening, detecting, and stratifying patients, yet they typically comprise only 2–3% of healthcare spending. With the advent of wearable technology and direct-to-consumer testing, the landscape of consumer health is rapidly expanding. These innovations facilitate more accessible and continuous health monitoring, presenting opportunities for earlier disease detection and proactive health management. Health systems are transitioning from traditional analogue methods to digitally empowered infrastructures, further driving the expansion of the clinical diagnostics market. This shift enhances efficiency, accuracy, and accessibility of diagnostic services, aligning with evolving patient expectations and healthcare demands in the modern era.
Restraint
Cost Considerations
The total cost assessment of performing diagnostic tests in hospital laboratories highlights several significant factors. Salaries for technical staff represent the largest expenditure item, overshadowing costs associated with reagents, including radiopharmaceuticals, which are comparatively smaller. Critical role of diagnostic tests in healthcare, the overall costs involved are often underestimated by those requesting them. The utilization of commercially available assay kits, albeit efficient and cost-effective in terms of time and value, remains a substantial financial consideration. These cost dynamics necessitate careful planning in hospital budgeting processes to optimize resource allocation effectively. Addressing these financial constraints is essential to sustain and potentially enhance the growth of the clinical diagnostics market, ensuring continued access to high-quality diagnostic services while managing operational costs efficiently.
Opportunity
Role of Health Information Technology in Advancing Clinical Diagnostics
Health Information Technology (Health IT) encompasses a diverse array of tools and technologies integral to modern healthcare delivery. These include electronic health records (EHRs), clinical decision support systems, patient engagement tools, computerized provider order entry systems, laboratory information systems, medical imaging systems, health information exchanges, and various medical devices. Health IT plays a crucial role across multiple facets of the diagnostic process: from capturing comprehensive patient information that informs diagnostic decisions to shaping clinician workflows and facilitating seamless information exchange.
- In October 2022, Beckman Coulter Diagnostics announced the acquisition of StoCastic, LLC., a leading artificial intelligence company providing evidence-based decision support for hospital emergency departments (ED).
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Clinical Diagnostics Market Trends
What are the Market Drivers Fueling Growth for the Clinical
Diagnostics Market?
While the patient continues to play an ever-increasing role in the clinical diagnostics market, other macro trends fueling growth include:
- Liquid Biopsies. The global liquid biopsy market size reached USD 10.85 billion in 2023 and is projected to hit around USD 32.54 billion by 2033, expanding at a CAGR of 11.61% during the forecast period from 2024 to 2033. Unlike traditional biopsies which require access to tissue to conduct testing, liquid biopsies rely on organic biofluids such as blood, saliva, and cerebral spinal fluid (to name a few) for access to biomarkers that can inform doctors and patients on what underlying health/disease states look like within a patient. The research and discovery in liquid biopsies has made it possible to shift the care model from seeking to harvest tissue as a first step to shifting potentially to a last resort. Large implications for transplant monitoring, brain biopsies and painful prostate biopsies.
- Biomarkers. The global biomarkers market size was estimated at USD 81.19 billion in 2023 and is projected to hit around USD 284.76 billion by 2033, growing at a CAGR of 13.37% during the forecast period from 2024 to 2033. The discovery of new biomarkers (independent) of the advent of liquid biopsies is fuelling the clinical diagnostics marketplace. However, the combination of new biomarkers and the availability of liquid biopsies together is fuelling the pace of clinical diagnostics.
4. What are the Growth Areas within the Clinical Diagnostics Market?
- Companion Diagnostics. CDx or companion diagnostics allow doctors and patients to better understand if therapies will respond for specific patients. The growth in CDx is often closely linked to “precision medicine” or “personalized medicine”.
- Non-Invasive Pre-natal Testing (NIPT). A focus area for a long time is the need to understand the health of developing fetuses without engaging in invasive testing. The increasing focus on liquid biopsies and new biomarkers is fueling the demand for NIPT.
- Direct-to-Consumer Testing. As patients become more active in understanding genetic variations, progeny and legacy – the market for direct-to-consumer (DTC) testing continues to grow.
What are Clinical Lab Market Trends?
While there are several market trends within this industry, there is one macro trend that appears to be shaping the industry as a whole. And that is the fact that the Patient continues to play an increasing role in his/her own patient care. Understanding and knowing this fact is critical for all healthcare providers in adjusting their service delivery and care models to ensure that care is a bilateral conversation.
Consequently, the industry has responded to this shift in patient/consumer behavior by making the following adjustments to their business model:
- Increased Digital Engagement. Helps to improve the customer experience through innovative technologies that enable customers to be more engaged in patient care.
- Operational Cost-Cutting. Identifying ways to reduce waste and expand margins.
- Continued Focus on Value-Based Care. Continuing to transition to value-based care to improve outcomes, largely driven by the reimbursement landscape (and legistlation).
- Growth via Acquisitions. Expanding capabilities through acquisitions of labs that provide access to new patient care models as well as footprint expansions into new geographies (ie. Walmart & Safeway).
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Clinical Diagnostics Market Segments Covered
By Type Insights
The liquid panel test emerges as a leading segment in the clinical diagnostics market, notably through the lipid panel. This test measures specific lipid molecules in the blood, including various types of cholesterol, to assess cardiovascular health risks such as heart disease, heart attack, and stroke in both children and adults. By evaluating cholesterol levels, the lipid panel aids in identifying potential risks associated with the accumulation of cholesterol in blood vessels and arteries, which can lead to serious cardiovascular conditions. As a comprehensive panel test, it provides essential diagnostic information crucial for preventive healthcare strategies and early intervention, highlighting its significant role in managing and mitigating cardiovascular diseases through targeted clinical diagnostics.
Electrolyte testing is anticipated to be the fastest-growing segment in the clinical diagnostics market. This panel test measures essential minerals in the blood, known as electrolytes, which play crucial roles in various bodily functions. An electrolyte panel helps detect imbalances that can indicate underlying conditions affecting the heart, lungs, or kidneys. Electrolyte disturbances often result from dehydration. By identifying these imbalances early, healthcare providers can intervene promptly to prevent complications and tailor treatment plans effectively. The increasing demand for electrolyte testing underscores its critical role in diagnosing and managing conditions related to electrolyte abnormalities, driving its rapid growth within the clinical diagnostics sector.
By Application Insights
The instruments segment emerge as the foremost segment in the clinical diagnostics market, pivotal for healthcare professionals in early disease detection and management. These instruments play a critical role by facilitating accurate and timely diagnosis of medical conditions, crucially in their early stages. Early detection enables healthcare providers to initiate timely interventions and implement appropriate treatments, thereby preventing disease progression and significantly improving patient outcomes. Diagnostic instruments contribute to enhanced healthcare delivery in hospitals and clinics, optimizing workflow efficiency and ensuring precise diagnostic results. Their widespread application underscores their indispensable role in modern healthcare practices, benefiting both healthcare providers and patients through improved diagnostic accuracy and comprehensive care management.
The reagents segment is poised to be the fastest-growing segment in the clinical diagnostics market, driven by their crucial role in ensuring accurate disease diagnosis and management. High-quality reagents and diagnostic kits are essential for precise diagnostic outcomes across various diseases. With advancements in technology, the production of diagnostic kits and reagents has expanded significantly, offering a wide array of tools for detecting infectious diseases and other health conditions.
The widespread adoption of these diagnostic reagents and kits also places substantial demands on limited resources available to health laboratories, especially in developing countries. Balancing the need for quality diagnostics with resource constraints remains a critical challenge. The growing demand for reliable and effective diagnostic solutions underscores the pivotal role of reagents in enhancing healthcare outcomes globally, thereby driving their rapid growth in the clinical diagnostics market.
By End User Insights
The Point-of-Care Testing (POCT) segment stands out as the dominanting segment in the clinical diagnostics market, offering laboratory testing capabilities near patient care settings. This approach facilitates rapid turnaround of test results, enabling healthcare providers to promptly initiate appropriate treatments, thereby enhancing both clinical outcomes and economic efficiency compared to traditional laboratory testing methods. Technological advancements, particularly in electronics miniaturization and instrumentation, have played a pivotal role in revolutionizing POCT. These innovations have led to the development of compact and highly accurate testing devices, expanding the accessibility and usability of POCT across diverse healthcare settings. The growing adoption of POCT underscores its critical role in facilitating timely diagnostic decisions and improving overall patient care delivery, positioning it as a pivotal component of modern clinical diagnostics practices globally.
- In June 2023, Sysmex launched the world's first point-of-care testing system in Europe, enabling detection of antimicrobial susceptibility in just 30 minutes.
The diagnostic laboratory emerges as the fastest-growing segment in the clinical diagnostics market, playing a pivotal role in the comprehensive healthcare ecosystem. Medical laboratory testing is indispensable for early disease detection, accurate diagnosis, and effective treatment planning for patients. Routine lab testing enables healthcare providers to proactively identify health issues, allowing for timely interventions that can potentially mitigate future illness, reduce healthcare costs, and improve overall patient outcomes. Diagnostic laboratories serve as essential hubs where advanced diagnostic technologies and expert analysis converge to provide critical insights into patient health. As demand for precise and timely diagnostic services continues to rise, diagnostic laboratories are poised to expand their capabilities and infrastructure, leveraging innovation and technology to meet evolving healthcare needs effectively. Their pivotal role in healthcare delivery underscores their significant growth potential within the clinical diagnostics market.
Regional Insights
North America held the largest share of the clinical diagnostics market and is poised to dominate the clinical diagnostics market over the forecast period, driven by robust infrastructure and a skilled workforce. The region's clinical labs employ a diverse talent pool including pathologists, biochemists, medical laboratory scientists, and other highly skilled professionals, supporting hundreds of thousands of jobs. With approximately 80% of the nation's 322,488 clinical laboratories operating as small businesses, the sector significantly contributes to local economies and employment.
Clinical laboratory tests play a pivotal role in healthcare by facilitating early disease detection and prevention, saving time, costs, and lives. In the U.S. alone, over 7 billion clinical lab tests are conducted annually, providing crucial diagnostic insights at a relatively modest expenditure. Canada's publicly funded healthcare system is dynamic, continuously evolving through reforms to adapt to changes in medicine and society, further enhancing the region's healthcare capabilities and market potential in clinical diagnostics.
- In January 2023, Agilent announced the acquisition of Avida Biomed, developer of high-performance NGS target enrichment workflows for cancer research.
Recent Developments
- In November 2023, AstraZeneca introduced Evinova, a health-tech business aimed at accelerating innovation across the life sciences sector, improving clinical trial delivery, and enhancing health outcomes.
- In May 2024, Bruker completed the acquisition of molecular diagnostics innovator ELITech.
- In January 2023, Agilent and Akoya Biosciences announced a partnership to drive multiplex tissue assay development for biopharma applications.
Browse More Insights:
Diagnostic Testing Market: The global diagnostic testing market size was estimated at USD 211.27 billion in 2023 and is projected to hit around USD 449.78 billion by 2033, growing at a CAGR of 7.9% during the forecast period from 2024 to 2033.
Point Of Care Diagnostics Market: The global point-of-care diagnostics market size was exhibited at USD 44.25 billion in 2023 and is projected to hit around USD 80.75 billion by 2033, growing at a CAGR of 6.2% during the forecast period of 2024 to 2033.
Clinical Trials Market : The global clinical trials market size was estimated at USD 81.90 billion in 2023 and is projected to hit around USD 153.59 billion by 2033, growing at a CAGR of 6.49% during the forecast period from 2024 to 2033.
U.S. In Vitro Diagnostics Market : The U.S. In vitro diagnostics market size was valued at USD 37.19 billion in 2023 and is projected to surpass around USD 45.78 billion by 2033, registering a CAGR of 2.1% over the forecast period of 2024 to 2033.
U.S. Tissue Diagnostics Market: The U.S. tissue diagnostics market size was valued at USD 2.46 billion in 2023 and is projected to surpass around USD 3.61 billion by 2033, registering a CAGR of 3.92% over the forecast period of 2024 to 2033.
DNA Diagnostics Market : The global DNA diagnostics market size was estimated at USD 10.69 billion in 2023 and is projected to hit around USD 16.05 billion by 2033, growing at a CAGR of 4.15% during the forecast period from 2024 to 2033.
Molecular Diagnostics Market: The global molecular diagnostics market size was exhibited at USD 39.98 billion in 2022 and is projected to hit around USD 68.3 billion by 2032, growing at a CAGR of 5.5% during the forecast period 2023 to 2032.
Direct-to-Consumer Laboratory Testing Market: The global direct-to-consumer laboratory testing market size was valued at USD 3.95 billion in 2023 and is anticipated to reach around USD 9.27 billion by 2033, growing at a CAGR of 8.9% from 2024 to 2033.
Precision Diagnostics Market : The global precision diagnostics market size was valued at USD 76.19 billion in 2023 and is anticipated to reach around USD 270.31 billion by 2033, growing at a CAGR of 13.5% from 2024 to 2033.
Biomarkers Market : The global Biomarkers market size was estimated at USD 81.19 billion in 2023 and is projected to hit around USD 284.76 billion by 2033, growing at a CAGR of 13.37% during the forecast period from 2024 to 2033.
Biosimilars Market: The global biosimilars market size was valued at USD 29.45 billion in 2023 and is anticipated to reach around USD 150.26 billion by 2033, growing at a CAGR of 17.7% from 2024 to 2033.
Synthetic Biology Market : The global synthetic biology market size was exhibited at USD 14.09 billion in 2023 and is projected to hit around USD 80.17 billion by 2033, growing at a CAGR of 18.99% during the forecast period 2024 to 2033.
Clinical Diagnostics Market Top Key Companies:
- Abbott Laboratories
- Becton, Dickinson and Company
- BioMerieux
- Bio-Rad Laboratories Inc.
- Danaher Corporation
- Siemens AG
- Hologic Inc.
- Qiagen NV
- Hoffmann-La Roche AG
- Thermo Fisher Scientific
- Quest Diagnostics Inc.
- Sysmex Corporation
- Sonic Healthcare Ltd
- Charles River Laboratories
Clinical Diagnostics Market Report Segmentation
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the Clinical Diagnostics market.
By Test
- Lipid Panel
- Liver Panel
- Renal Panel
- Complete Blood Count
- Electrolyte Testing
- Infectious Disease Testing
- Other Tests
By Product
- Instruments
- Reagents
- Other Products
By End User
- Hospital Laboratory
- Diagnostic Laboratory
- Point-of-care Testing
- Other End Users
By Region
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East & Africa (MEA)
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Reasons to Purchase this Report
- Qualitative and quantitative analysis of the market based on segmentation involving both economic as well as non-economic factors
- Provision of market value (USD Billion) data for each segment and sub-segment
- Indicates the region and segment that is expected to witness the fastest growth as well as to dominate the market
- Analysis by geography highlighting the consumption of the product/service in the region as well as indicating the factors that are affecting the market within each region
- Competitive landscape which incorporates the market ranking of the major players, along with new service/product launches, partnerships, business expansions, and acquisitions in the past five years of companies profiled
- Extensive company profiles comprising of company overview, company insights, product benchmarking, and SWOT analysis for the major market players
- The current as well as the future market outlook of the industry with respect to recent developments which involve growth opportunities and drivers as well as challenges and restraints of both emerging as well as developed regions
- Includes in-depth analysis of the market from various perspectives through Porter’s five forces analysis
- Provides insight into the market through Value Chain
- Market dynamics scenario, along with growth opportunities of the market in the years to com
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