Clinical Diagnostics Market Size
| Study Period | 2021 - 2029 |
| Market Size (2024) | USD 84.18 Billion |
| Market Size (2029) | USD 109.92 Billion |
| CAGR (2024 - 2029) | 5.48 % |
| Fastest Growing Market | Asia-Pacific |
| Largest Market | North America |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Clinical Diagnostics Market Analysis
The Clinical Diagnostics Market size is estimated at USD 84.18 billion in 2024, and is expected to reach USD 109.92 billion by 2029, growing at a CAGR of 5.48% during the forecast period (2024-2029).
Continuous innovations in diagnostic technologies, such as next-generation sequencing (NGS), digital pathology, and advanced imaging techniques, are enhancing the accuracy, efficiency, and capabilities of diagnostic tests. The rising incidence of chronic diseases like cancer, diabetes, and cardiovascular diseases, as well as infectious diseases like COVID-19, drives the demand for diagnostic tests for early detection and monitoring.
The increasing incidence of various infectious diseases and chronic diseases, such as tuberculosis, cancer, and HIV/AIDS, to emerging pathogens poses a significant burden on global health. For instance, according to the World Health Organization report in November 2023, over 10.6 million people were affected by tuberculosis globally, including 5.8 million men and 3.5 million women. Similarly, according to a report published by the World Health Organization in December 2023, over 1.3 to 4.0 million cases of cholera are reported annually. Thus, the rising cases of infectious diseases are expected to propel the growth of the clinical diagnostics market.
The increasing adoption of evolving technology is also one of the major drivers propelling the growth of the clinical diagnostics market. For instance, in April 2023, Sapphiros, a platform company, announced that it had been selected by the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Tech program to develop a high-performance, over-the-counter (OTC) molecular multiplex respiratory diagnostic test that can rapidly detect the respiratory syncytial virus (RSV), influenza A, and influenza B in a single test.
Moreover, medical device manufacturers' rising adoption of primer technology to develop highly efficient polymerase chain reaction (PCR) tests has transformed the molecular diagnostics industry. For instance, in April 2023, Co-Diagnostics Inc. developed its unique co-primers technology. Co-primers are designed to dramatically reduce errors in amplification and increase the accuracy and specificity of PCR testing, making them a transformative technology for multiplexed assays. Hence, with the evolution of such advanced technologies, the development of novel clinical diagnostic tests is expected to increase.
In conclusion, factors such as the increase in chronic and infectious diseases and the demand for clinical diagnostics are propelling the growth of the clinical diagnostics market.
However, affordability for high-end molecular diagnostics and limitations associated with reimbursement scenarios may restrain the market’s growth during the forecast period.
Clinical Diagnostics Market Trends
The Reagents Segment is Expected to Register Considerable Growth During the Forecast Period
- Reagents are an integral part of clinical diagnostics. They are used for a wide range of different types of disease diagnosis. With the growing complexity of diseases and demand for early diagnosis, laboratories are increasingly using complex reagent combinations to diagnose diseases from biological samples. Laboratories face growing competition, necessitating ongoing quality enhancement and swift delivery of results. This requirement underscores the importance of reagents that can efficiently perform multiple tasks.
- Reagents are critical components in diagnostic tests and laboratory procedures, and several factors drive their market demand and development. Biotechnology and molecular biology innovations are leading to the development of more sophisticated and efficient reagents. These advancements enable more accurate, sensitive, and faster diagnostic tests. The increasing prevalence of chronic diseases, infectious diseases, and genetic disorders boosts the demand for diagnostic tests, thereby driving the need for high-quality reagents.
- For instance, according to a report published by the Molecular Medicine Reports in May 2023, the advancements in molecular diagnostic technologies such as PCR, isothermal amplification, gene chips, and high-throughput significantly enhance the capabilities and demand for specialized reagents in clinical diagnostics. These technologies rely on high-quality reagents to achieve precise, sensitive, and rapid detection of infectious disease pathogens and genetic variations, thereby propelling growth in the reagents segment of the clinical diagnostics market. The growing field of molecular diagnostics, which includes PCR, next-generation sequencing, and CRISPR-based technologies, relies heavily on specialized reagents, driving market growth. The rise in point-of-care testing, which allows for rapid diagnosis at the site of patient care, requires robust and reliable reagents to deliver accurate results quickly.
- Furthermore, growth strategies adopted by key players to cater to the rising demand for reagents are boosting the segment's growth. For instance, in January 2024, Fujirebio Holdings, Inc. and Agappe Diagnostia agreed to a Contract Development and Manufacturing Organization (CDMO) partnership for a cartridge-based CLIA system reagents manufacturing project for the immunology equipment Mispa i60 and Mispa i121.
- The factors mentioned above, such as increasing cases of chronic diseases and the growth strategies of the key players, are propelling the growth of the reagents segment.
North America is Expected to Dominate the Clinical Diagnostics Market During the Forecast Period
- The market for clinical diagnostics in North America is driven by the increasing geriatric population, rising patient awareness about clinical tests, and the rising prevalence of infectious and chronic disease patients.
- The increasing number of infectious diseases such as flu, HIV, and other diseases is the key factor driving the demand for molecular diagnostic tests and kits. For instance, as per the data published by the government of Canada in the Weekly Influenza Report, from May 12 to May 25, 2024, about 313 influenza B and 107 influenza A cases were recorded in week 21. Similarly, according to the annual report published by the government of Canada in October 2023, influenza tests rose from 0.75 million during 2021-2022 to 1.19 million during 2022-2023. Concurrently, influenza detections surged from 16,126 during 2021-2022 to 74,344 during 2022-2023. The rising incidence of influenza drives the need for molecular diagnostic methods to detect and identify influenza viruses through conserved gene targets. This surge in demand is fueling the market's growth in the region. With a significant portion of the population affected by influenza, the market is poised for a surge in demand for diagnostic tests, including rapid antigen testing, reverse transcription polymerase chain reaction (RT-PCR), and rapid molecular assays.
- Furthermore, due to the rising incidence of bacterial and viral infections and cancer in the area, there is an increasing need for point-of-care diagnostics. This demand is further driven by heightened research and development efforts in next-generation sequencing and the continuous evolution of technologies for treating chronic diseases. For instance, according to the report published by the American Cancer Society in January 2023, about 1.9 new cancer cases were diagnosed in the United States in 2023. Thus, the high number of cancer cases is anticipated to increase the adoption of clinical diagnostics for cancer diagnosis, propelling the market’s growth.
- Hence, the increasing geriatric population, rising patient awareness about laboratory tests, and the rising prevalence of infectious and chronic disease patients are expected to fuel the clinical diagnostics market’s growth in the region.
Clinical Diagnostics Industry Overview
The market is highly competitive and consists of global and local players. The competitive landscape includes an analysis of a few international as well as local companies that hold market shares and are well known. The major key players in the market include Abbott Laboratories, Bio-Rad Laboratories Inc., Danaher Corporation, Becton, Dickinson and Company, Qiagen, and Roche Diagnostics.
Clinical Diagnostics Market Leaders
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Bio-Rad Laboratories
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Danaher Corporation
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F. Hoffmann-La Roche AG
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Abbott Laboratories
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bioMérieux
*Disclaimer: Major Players sorted in no particular order
Clinical Diagnostics Market News
- April 2024 Bio-Rad Laboratories Inc. launched its ultrasensitive multiplexed digital PCR assay, the ddPLEX ESR1 Mutation Detection Kit. The assay helped expand the company’s Droplet Digital PCR offering for the oncology market, where highly sensitive and multiplexed mutation detection assays aid translational research, therapy selection, and disease monitoring.
- January 2024: ELITechGroup launched its CE-IVDR-certified GI Bacterial PLUS ELITe MGB Kit and expanded its in vitro diagnostic portfolio. The kit is tailored specifically for diagnosing gastrointestinal bacterial infections. The in vitro assay exclusively targets major bacterial pathogens.
Clinical Diagnostics Market Report - Table of Contents
1. INTRODUCTION
- 1.1 Study Assumption and Market Definition
- 1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
- 4.1 Market Overview
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4.2 Market Drivers
- 4.2.1 Growing Burden of Infectious and Chronic Diseases
- 4.2.2 Increasing Adoption of Automated Platforms
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4.3 Market Restraints
- 4.3.1 Affordability for High-end Molecular Diagnostics
- 4.3.2 Limitations Associated with Reimbursement Scenario
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4.4 Porter's Five Forces Analysis
- 4.4.1 Threat of New Entrants
- 4.4.2 Bargaining Power of Buyers/Consumers
- 4.4.3 Bargaining Power of Suppliers
- 4.4.4 Threat of Substitute Products
- 4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Value in USD)
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5.1 By Test
- 5.1.1 Lipid Panel
- 5.1.2 Liver Panel
- 5.1.3 Renal Panel
- 5.1.4 Complete Blood Count
- 5.1.5 Electrolyte Testing
- 5.1.6 Infectious Disease Testing
- 5.1.7 Other Tests
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5.2 By Product
- 5.2.1 Instruments
- 5.2.2 Reagents
- 5.2.3 Other Products
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5.3 By End User
- 5.3.1 Hospital Laboratory
- 5.3.2 Diagnostic Laboratory
- 5.3.3 Point-of-care Testing
- 5.3.4 Other End Users
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5.4 By Geography
- 5.4.1 North America
- 5.4.1.1 United States
- 5.4.1.2 Canada
- 5.4.1.3 Mexico
- 5.4.2 Europe
- 5.4.2.1 Germany
- 5.4.2.2 United Kingdom
- 5.4.2.3 France
- 5.4.2.4 Italy
- 5.4.2.5 Spain
- 5.4.2.6 Rest of Europe
- 5.4.3 Asia-Pacific
- 5.4.3.1 China
- 5.4.3.2 Japan
- 5.4.3.3 India
- 5.4.3.4 Australia
- 5.4.3.5 South Korea
- 5.4.3.6 Rest of Asia-Pacific
- 5.4.4 Middle East and Africa
- 5.4.4.1 GCC
- 5.4.4.2 South Africa
- 5.4.4.3 Rest of Middle East and Africa
- 5.4.5 South America
- 5.4.5.1 Brazil
- 5.4.5.2 Argentina
- 5.4.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
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6.1 Company Profiles
- 6.1.1 Abbott Laboratories
- 6.1.2 Becton, Dickinson and Company
- 6.1.3 BioMerieux
- 6.1.4 Bio-Rad Laboratories Inc.
- 6.1.5 Danaher Corporation
- 6.1.6 Siemens AG
- 6.1.7 Hologic Inc.
- 6.1.8 Qiagen NV
- 6.1.9 F. Hoffmann-La Roche AG
- 6.1.10 Thermo Fisher Scientific
- 6.1.11 Quest Diagnostics Inc.
- 6.1.12 Sysmex Corporation
- 6.1.13 Sonic Healthcare Ltd
- 6.1.14 Charles River Laboratories
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
** Subject To AvailablityClinical Diagnostics Industry Segmentation
As per the scope of the report, a clinical diagnostic test is a type of medical test performed to aid in the diagnosis or detection of any disease. These tests play a vital role in the prevention, control, and surveillance of any disease. Clinical diagnostics help improve patient care, contribute to consumer safety, and reduce healthcare spending. The clinical diagnostics market is segmented by test, product, end user, and geography. The test segment is further segmented into lipid panel, liver panel, renal panel, complete blood count, electrolyte testing, infectious disease testing, and other tests. The product segment is further divided into instruments, reagents, and other products. The end user is further bifurcated into hospital laboratory, diagnostic laboratory, point-of-care testing, and other end users. The geography is further segmented into North America, Europe, Asia-Pacific, Middle East and Africa, and South America. The market report also covers the estimated sizes and trends for 17 countries across major regions globally. The report offers values (in USD) for the above segments.
| 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 Geography | North America | United States |
| Canada | ||
| Mexico | ||
| By Geography | Europe | Germany |
| United Kingdom | ||
| France | ||
| Italy | ||
| Spain | ||
| Rest of Europe | ||
| By Geography | Asia-Pacific | China |
| Japan | ||
| India | ||
| Australia | ||
| South Korea | ||
| Rest of Asia-Pacific | ||
| By Geography | Middle East and Africa | GCC |
| South Africa | ||
| Rest of Middle East and Africa | ||
| By Geography | South America | Brazil |
| Argentina | ||
| Rest of South America |
Clinical Diagnostics Market Research FAQs
How big is the Clinical Diagnostics Market?
The Clinical Diagnostics Market size is expected to reach USD 84.18 billion in 2024 and grow at a CAGR of 5.48% to reach USD 109.92 billion by 2029.
What is the current Clinical Diagnostics Market size?
In 2024, the Clinical Diagnostics Market size is expected to reach USD 84.18 billion.
Who are the key players in Clinical Diagnostics Market?
Bio-Rad Laboratories, Danaher Corporation, F. Hoffmann-La Roche AG, Abbott Laboratories and bioMérieux are the major companies operating in the Clinical Diagnostics Market.
Which is the fastest growing region in Clinical Diagnostics Market?
Asia-Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Clinical Diagnostics Market?
In 2024, the North America accounts for the largest market share in Clinical Diagnostics Market.
What years does this Clinical Diagnostics Market cover, and what was the market size in 2023?
In 2023, the Clinical Diagnostics Market size was estimated at USD 79.57 billion. The report covers the Clinical Diagnostics Market historical market size for years: 2021, 2022 and 2023. The report also forecasts the Clinical Diagnostics Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
What are the emerging trends in Clinical Diagnostics Technology?
The emerging trends in Clinical Diagnostics Technology are a) Personalized medicine b) Point-of-care testing
Clinical Diagnostics Industry Report
The global clinical diagnostics market is flourishing, driven by the increasing need to diagnose and manage chronic and infectious diseases. With a focus on tests like lipid panels, liver panels, and complete blood counts, the market is witnessing significant growth in the diagnostics of cardiovascular diseases due to rising awareness and preventive healthcare. Product-wise, the diagnostics market includes advanced instruments, reagents, and other products. Instruments are set to dominate due to technological innovations enhancing diagnostic accuracy and efficiency. Key end-users such as hospital laboratories, diagnostic centers, and point-of-care settings are crucial in disease management, with hospitals holding a major market share.
Geographically, North America leads with its advanced healthcare infrastructure, while the Asia-Pacific region shows promising growth fueled by healthcare investments. As the diagnostics industry evolves, the demand for diverse and sophisticated diagnostics solutions from clinical diagnostics companies is surging, indicating a robust expansion in diagnostics market size.
Industry trends highlight the importance of market reports and market size in understanding the current landscape. Industry reports and industry research provide valuable insights into the global market, while industry statistics and industry analysis offer a deeper understanding of market dynamics. Market analysis and market data are essential for making informed decisions, and market forecast helps predict future trends. Market growth is driven by technological advancements and increasing healthcare needs, with market segmentation allowing for targeted strategies.
The market outlook remains positive, with significant market value projected in the coming years. Market leaders continue to innovate, driving market predictions and market review. The industry outlook suggests continued growth, supported by comprehensive industry information and industry sales data. The growth rate of the market is expected to remain strong, with research companies providing detailed report examples and report PDFs for further analysis.
