Clinical Diagnostics Market Size & Share Analysis - Growth Trends & Forecasts (2024 - 2029)

Clinical Diagnostics Market Analysis

The clinical diagnostics market size is estimated at 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). Key drivers fuelling the expansion of the clinical diagnostics market include rising cases of infectious and chronic diseases, a surge in the adoption of automated platforms, and improved access to healthcare services for the general populace. Further, the rising popularity of clinical diagnostic tests can be attributed to numerous companies providing a diverse range of genetic tests. These tests have established applications, such as non-invasive prenatal testing (NIPT), assessments for predisposition to cardiovascular diseases, screenings for hereditary cancers, diagnoses of rare diseases, and personalized medicine applications that assist patients in choosing tailored treatment options.

Innovations in diagnostic technologies, including next-generation sequencing (NGS), digital pathology, and advanced imaging techniques, are bolstering the accuracy and efficiency of diagnostic tests. The growing prevalence of chronic diseases, such as cancer, diabetes, and cardiovascular conditions, alongside infectious diseases like COVID-19, underscores the heightened demand for early detection and monitoring through diagnostic tests.

Global healthcare industry faces a significant challenge from the rising incidence of infectious diseases and chronic conditions, ranging from tuberculosis and cancer to emerging pathogens. For example, a November 2023 report from the World Health Organization highlighted that tuberculosis affected over 10.6 million individuals worldwide, with 5.8 million men and 3.5 million women. Furthermore, a December 2023 World Health Organization (WHO) report noted annual cholera cases ranging between 1.3 to 4.0 million globally. Such escalating instances of infectious diseases are poised to drive the clinical diagnostics market's growth.

Technological advancements play a pivotal role in propelling the clinical diagnostics industry. For instance, in April 2023, Sapphiros, a platform company, revealed its selection by the National Institutes of Health (NIH) Rapid Acceleration of Diagnostics (RADx) Tech program. They are set to develop a cutting-edge, over-the-counter (OTC) molecular multiplex respiratory diagnostic test, capable of swiftly identifying respiratory syncytial virus (RSV), influenza A, and influenza B in one go.

Moreover, industry research shows government initiatives and recommendations to undergo clinical diagnostic procedures in a timely manner, are set to boost market growth during the forecast period. For instance, in October 2023, the World Health Organization (WHO) unveiled its Essential Diagnostics List (EDL), a curated evidence-based catalog of in vitro diagnostics (IVD) designed to guide nations in their diagnostic selections. This essential list presents key players with new opportunities to enhance their portfolios, particularly in the realm of emerging infectious diseases that require precise and prompt diagnostics in line with advanced trends.

In summary, the rising prevalence of chronic and infectious diseases, coupled with an increasing demand for clinical diagnostics, is driving the market's expansion. Yet, challenges remain. The high costs associated with advanced molecular diagnostics and certain reimbursement limitations could temper the market's growth trajectory during the forecast period.

Clinical Diagnostics Market Insights and Trends

The Reagents Segment is Expected to Register Considerable Growth During the Forecast Period

The reagent under the product segment is expected to have the fastest growth rate with a CAGR of 6.38% over the forecast period (2024-2029). Market research estimates that the reagent segment is expected to have a market value of USD 64.68 billion in 2024 and is likely to reach a market value of USD 88.12 billion by 2029.

A reagent is a substance or compound that facilitates a reaction, and it is commonly used in various tests. Reagents play a pivotal role in the clinical diagnosis of various diseases.

Various market reports have highlighted the importance of reagents for clinical diagnostics, which is likely to support the segment growth over the forecast period. For instance, a report published by Molecular Medicine Reports in May 2023 highlighted that, advancements in molecular diagnostic technologies, including PCR, isothermal amplification, gene chips, and high-throughput methods, significantly boost the demand for specialized reagents in clinical diagnostics.

These technologies depend on high-quality reagents to ensure precise, sensitive, and rapid detection of infectious disease pathogens and genetic variations. This dependency is driving growth in the reagents segment of the clinical diagnostics market. As the field of molecular diagnostics expands, encompassing technologies like polymerase chain reaction (PCR), next-generation sequencing, and clustered regularly interspaced short palindromic repeats (CRISPR), the reliance on specialized reagents becomes even more pronounced, fueling market growth. Additionally, the surge in point-of-care testing, which facilitates swift diagnoses at the patient's location, underscores the need for robust and reliable reagents to ensure quick and accurate results. Moreover, key players are adopting growth strategies to meet the rising demand for reagents, further propelling the segment's expansion. For example, in January 2024, Fujirebio Holdings, Inc. and Agappe Diagnostia entered into a Contract Development and Manufacturing Organization (CDMO) partnership. This collaboration focused on manufacturing reagents for a cartridge-based CLIA system, specifically for the immunology equipment Mispa i60 and Mispa. Thus, considering the strategic activities related to the manufacturing of reagents, their demand is likely to be increased, leading to segment growth over the forecast period.

The Infectious Disease Segment Expected to Hold the Highest Growth Rate in the Market

By test, the infectious disease segment held the highest growth rate, with an estimated market size of USD 10.42 billion in 2024, and expected to witness a CAGR of 8.84% over the forecast period (2024 - 2029). Industry analysis indicates it will grow to USD 13.28 billion by 2029. Factors such as an increase in the number of infectious diseases, a rise in demand for early diagnosis and detection coupled with the availability of innovative test kits and reagents for infectious disease diagnosis is expected to drive the segment growth over the forecast period.

The clinical diagnostics market is segmented by test, product, end user. 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 care testing, and other end users. Segmenting the market by test, product, and end-user enables stakeholders to grasp market dynamics and pinpoint key growth opportunities.

North America is Expected to Dominate the Global Market During the Forecast Period

By geography, the North America region is likely to hold a major clinical diagnostics market share with an estimated market size of USD 34.51 billion in 2024, expected to reach USD 44.80 billion by 2029. The North American clinical diagnostics market is fueled by a growing geriatric population, heightened patient awareness regarding clinical tests, and an uptick in both infectious and chronic disease prevalence across countries like the United States, Canada, and Mexico.

The rising incidence of infectious diseases, including flu and human immune deficiency virus (HIV), is significantly boosting the demand for molecular diagnostic tests and kits. For example, data from Canada's Weekly Influenza Report indicates that between August 2023, and August 2024 (covering weeks 35 to 34), a total of 1,224 laboratory-confirmed influenza outbreaks were documented in Canada.

Additionally, an annual report from the Canadian government in October 2023 highlighted a jump in influenza tests from 0.75 million in the 2021-2022 period to 1.19 million in 2022-2023. Correspondingly, detections of influenza cases increased from 16,126 to 74,344 in the same timeframe. Given this uptick, there's a heightened reliance on molecular diagnostic methods to pinpoint influenza viruses using conserved gene targets. This escalating demand is propelling market growth in the region. With a large segment of the population grappling with influenza, there's an anticipated surge in demand for various diagnostic tests, notably rapid antigen testing, reverse transcription polymerase chain reaction (RT-PCR), and rapid molecular assays.

Furthermore, growing government initiatives and increased regulatory approvals for rapid diagnostic tests in the region are expected to drive market growth. For instance, in July 2024, the United States Food and Drug Administration granted marketing authorization to Cepheid for its Xpert HCV test and the GeneXpert Xpress System. This marks the debut of the first hepatitis C virus (HCV) test, designed to facilitate timely diagnoses at certified point-of-care locations for those at risk of hepatitis C. Notably, the test can be conducted in various settings holding a CLIA (Clinical Laboratory Improvement Amendments) Certificate of Waiver. These include select substance use disorder treatment facilities, correctional institutions, syringe service programs, medical offices, emergency departments, and urgent care clinics.

Hence, regulations, product approvals, and an increase in infectious disease outbreaks are likely to boost the market growth over the forecast period in the region.

By geography, the global market is segmented into North America (United States, Canada, Mexico), Europe (Germany, United Kingdom, France, Italy, Spain, Rest of Europe), Asia-Pacific (China, Japan, India, Australia, South Korea, Rest of Asia-Pacific), Middle East and Africa (GCC, South Africa, Rest of Middle East and Africa), and South America (Brazil, Argentina, Rest of South America). Countries such as China, Japan, and India are at the forefront of rapidly advancing both the development of sophisticated diagnostic testing panels and the burgeoning market demand in the Asia-Pacific region. APAC region is prioritizing the establishment of response systems and advanced diagnostic panels to tackle emerging infectious diseases.

Clinical 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 Billion) 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

Geography
		North America United States Canada Mexico
		Europe Germany United Kingdom France Italy Spain Rest of Europe
		Asia-Pacific China Japan India Australia South Korea Rest of Asia-Pacific
		Middle East and Africa GCC South Africa Rest of Middle East and Africa
		South America Brazil Argentina Rest of South America