Diagnostic Testing Market (By Type: Clinical Diagnostic, Home Diagnostic; By Application: Cardiology, Oncology, Neurology, Orthopedics, Gastroenterology, Gynecology, Odontology, Others; By Approach; By Solution; By Technology; By Mode of Testing; By Sample Type; By Testing Type; By Age; By Distribution Channel; By End User))- Global Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2024-2033

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.

Diagnostic Testing Market Overview

The diagnostic testing market is a crucial sector within the healthcare industry, encompassing a wide range of tests and procedures aimed at identifying diseases, conditions, or abnormalities in patients. This market includes various types of diagnostic tests, such as molecular diagnostics, immunoassays, clinical chemistry, microbiology, hematology, and others. one of the key drivers of the diagnostic testing market is the increasing prevalence of diseases worldwide, including infectious diseases, chronic conditions, and cancer. As the global population grows and ages, the demand for diagnostic tests continues to rise, driving market growth.

Advancements in technology have also played a significant role in shaping the diagnostic testing market. Innovations such as next-generation sequencing, digital pathology, and point-of-care testing have enhanced the accuracy, speed, and efficiency of diagnostic procedures, leading to better patient outcomes. Moreover, the growing focus on personalized medicine and targeted therapies has increased the demand for companion diagnostics, which are tests used to identify patients who are most likely to benefit from specific treatments. This trend has further fueled the expansion of the diagnostic testing market.

In addition to technological advancements, factors such as increasing healthcare expenditure, rising awareness about preventive healthcare, and government initiatives to improve healthcare infrastructure have contributed to the growth of the diagnostic testing market.

However, the market also faces challenges, including regulatory hurdles, reimbursement issues, and the high cost of certain diagnostic tests. Furthermore, the COVID-19 pandemic has had a significant impact on the diagnostic testing market, with an unprecedented demand for tests such as PCR assays and antigen tests to detect the SARS-CoV-2 virus.Overall, the diagnostic testing market is expected to continue growing as healthcare systems worldwide prioritize early detection and accurate diagnosis to improve patient outcomes and reduce healthcare costs.

Diagnostic Testing Market Report Scope

Diagnostic Testing Market Growth Factors

The growth of the diagnostic testing market. Firstly, the increasing prevalence of diseases globally, including infectious diseases, chronic conditions, and cancer, drives demand for diagnostic tests. Secondly, advancements in technology, such as next-generation sequencing and point-of-care testing, enhance the accuracy and efficiency of diagnostic procedures. Thirdly, the rising focus on personalized medicine and targeted therapies boosts demand for companion diagnostics. Additionally, factors like growing healthcare expenditure, awareness about preventive healthcare, and government initiatives to improve healthcare infrastructure also fuel market growth. Despite challenges like regulatory hurdles and reimbursement issues, the market is expected to expand as healthcare systems prioritize early detection and accurate diagnosis for improved patient outcomes.

Diagnostic Testing Market Size in the U.S. 2024 To 2033

The U.S. diagnostic testing market size was valued at USD 84.85 billion in 2023 and is anticipated to reach around USD 158.77 billion by 2033, growing at a CAGR of 6.5%% from 2024 to 2033.

The market for diagnostic tests is dominated by North America due to the region's growing elderly population. According to the Centers for Condition Control and Prevention (CDC), six out of ten individuals in the United States have at least one chronic disease, and four out of ten persons have two or more. The top causes of mortality and disability in the United States are chronic illnesses like cancer, heart disease, and diabetes, which also account for the majority of the USD 3.8 trillion in yearly health care expenses. As a result, there is now a greater need in the United States for better care that is managed effectively. Therefore, it is anticipated that the rising incidence of infectious and chronic illnesses as well as increased recognition of the importance of laboratory testing will drive market expansion in the nation.

Due to the availability of affordable diagnostic tests for chronic illnesses in the area, Asia-Pacific (APAC) is anticipated to have considerable growth during the forecast period of 2024 to 2033.

Diagnostic Testing Market Top Trends

• Advancements in Technology: The diagnostic testing market is witnessing rapid advancements in technology, such as the development of point-of-care testing devices, molecular diagnostics, and advanced imaging techniques. These technological innovations are enhancing the accuracy, speed, and efficiency of diagnostic tests.
• Personalized Medicine: There's a growing trend towards personalized medicine, which involves tailoring medical treatment to the individual characteristics of each patient. Diagnostic tests play a crucial role in this approach by providing insights into a patient's genetic makeup, biomarkers, and specific disease characteristics, enabling healthcare providers to deliver more targeted and effective therapies.
• Rise of Molecular Diagnostics: Molecular diagnostics, including techniques like polymerase chain reaction (PCR) and next-generation sequencing (NGS), are gaining prominence in the diagnostic testing market. These techniques allow for the detection of genetic mutations, infectious agents, and other molecular markers with high sensitivity and specificity, leading to improved disease diagnosis and monitoring.
• Point-of-Care Testing (POCT): Point-of-care testing, which involves conducting diagnostic tests at or near the site of patient care, is becoming increasingly popular due to its convenience, speed, and accessibility. POCT devices enable rapid diagnosis and decision-making, particularly in emergency and resource-limited settings, thereby improving patient outcomes.
• Digital Health Solutions: The integration of digital health technologies, such as mobile health apps, remote monitoring devices, and electronic health records, is transforming the diagnostic testing landscape. These solutions facilitate seamless data exchange, remote consultations, and real-time monitoring of patient health metrics, enhancing the efficiency and effectiveness of diagnostic testing processes.
• Increasing Demand for Non-Invasive Tests: There's a growing preference for non-invasive diagnostic tests that minimize patient discomfort and risk. Non-invasive techniques, such as imaging modalities (e.g., MRI, CT scan) and liquid biopsy tests, are gaining traction as alternatives to traditional invasive procedures, driving market growth.
• Focus on Early Disease Detection and Prevention: There's a shift towards proactive healthcare strategies aimed at early disease detection and prevention. Diagnostic tests that enable the early identification of diseases, such as cancer, cardiovascular conditions, and infectious diseases, are in high demand as they facilitate timely intervention and improved patient outcomes.
• Growing Awareness and Accessibility: Increasing awareness about the importance of regular health screenings and early diagnosis, coupled with efforts to improve healthcare infrastructure and access to diagnostic services, is expanding the market for diagnostic testing globally. This trend is particularly evident in emerging economies where healthcare systems are undergoing rapid development.

Segments Insights:

Type Insights

At order to diagnose or identify any illness or other medical disorders, clinical diagnostics encompasses all medical tests carried out in a pathology lab, diagnostic centre, hospital, or any other type of medical institution. These tests aid in the early identification of diseases and the identification of risk factors linked to such diseases, providing chances for both prevention and therapy. The rise in sedentary-related illnesses including diabetes, cardiovascular disease, high blood pressure, and lipid disorders, among others, is what motivates the development of clinical diagnostic tests. Additionally, it is anticipated that the number of patients with cancer and chronic renal disease would rise in the next years, propelling the market for clinical diagnostics. Additionally, advantages related to clinical diagnostics are predicted to drive the market through 2026, including rapid test results, simple testing procedures, simplicity of obtaining samples, and reduced discomfort.

Home diagnostics, often known as at-home diagnostics, allows patients or users to do various tests on-site at their homes. These test kits are often used to monitor an existing medical condition, identify a medical disease that has gone undetected, or provide information about a person's specific health characteristics. The continuous efforts to increase people's involvement in their healthcare benefit greatly from these testing. It is crucial that the findings are precise and simple for people to acquire. The global market for home diagnostic tests is largely driven by the expanding need for diagnostics brought on by the global geriatric population as well as the rising prevalence of different chronic illnesses. The popularity of diagnostic kits for at-home usage has expanded as a result of technical developments. The market for home diagnostics is fuelled by a number of factors, including the increasing use of telemedicine, the decline in healthcare costs, and the convenience of at-home use.

Approach Insights

The diagnostic tests market is divided into molecular diagnostic tools, in-vitro diagnostic tools, and point-of-care testing tools based on technique. Since in-vitro diagnostics are increasingly used to test samples like blood and saliva to diagnose illnesses or other disorders, the in-vitro diagnostic instrument sector is predicted to dominate the market. Additionally, the frequency of infectious and chronic illnesses is anticipated to rise during the projection period along with the ongoing expansion in the senior population.

The global response to the pandemic has been greatly aided by molecular diagnostic testing for COVID-19. Government agencies from all around the world are assisting laboratories in expediting COVID-19 testing procedures since testing is still an essential step in slowing the disease's fast spread. Accordingly, regulatory agencies used techniques to hasten the licencing of molecular diagnostic tools. As diagnostic testing continues to be the foundation of the COVID-19 response, supporting containment efforts to reduce the outbreak, significant corporations have also made strategic innovations to deploy COVID-19 quick tests and neutralise the influence of COVID-19 on their operating capabilities. Additionally, due to the severity of the crisis and growing capacity problems with PCR-based testing, diagnostic solutions were developed more quickly to fulfil the need for mass testing.

Tests for in-vitro diagnostics are conducted using human blood or tissue samples. This kind of diagnostic testing is mostly used to find infections, illnesses, and disorders. In-vitro diagnostics are used in precision medicine today to identify individuals who need certain medications or treatments. With the availability of trained experts and infrastructure development, in-vitro diagnostics tests are often performed in laboratories and healthcare institutions. In the upcoming years, a growing number of pathology laboratories and services outfitted with cutting-edge diagnostic equipment are anticipated to fuel market expansion.

The research (diagnosis & monitoring) of a variety of diseases, such as cancer, diabetes, heart disorders, and others, uses point-of-care (POC) diagnostics, which are medical tools used to obtain an instantaneous response. Due to the frequency of chronic and infectious illnesses in developing nations, the point-of-care diagnostics market is expanding. Globally, the prevalence of chronic illnesses including diabetes, rheumatism, and cancer is rising for a number of reasons, including an ageing population, sedentary lifestyles, poor dietary habits, and environmental factors.

Application Insights

The diagnostic tests market is divided into categories based on application, including cardiology, oncology, neurology, orthopaedics, gastrointestinal, gynaecology, odontology, and others. Due to the global rise in heart patients and other cardiovascular disorders, the cardiology segment is predicted to dominate the market. The majority of cardiovascular disorders require diagnostic testing in order to be identified and treated. Cardiovascular diagnostic testing can reveal details about the electrical activity of the heart, the rhythm of the heartbeat, the efficiency with which blood pumps through the heart's chambers and valves, the ease with which blood flows through the coronary arteries to the heart muscle, and the presence of tumours or structural abnormalities in the cardiovascular system. The risk factors for heart disease are found via laboratory testing. These include the measurement of blood lipids such as LDL, HDL, and triglycerides as well as fats, cholesterol, and lipid components. For the diagnosis of diabetes, blood sugar and glycosylated haemoglobin levels are tested.

End User Insights

The diagnostic tests market is divided into hospitals, diagnostic centres, research laboratories and institutes, research institutions, homecare, blood banks, specialised clinics, ambulatory surgery centres, and others based on the end user. As hospitals perform a variety of diagnostic tests, including glucose tests, infectious diseases tests, cytology tests, CBC tests, blood culture tests, syphilis tests, urea tests, C-reactive protein tests, antigen tests, and HBA1C tests, causing for the detection and treatment of serious diseases or other major conditions, the hospitals segment is anticipated to dominate the market.

Key Market Developments

• In January 2021, Roche introduced its Cobas Pulse System in a few nations that accepted the CE Mark. The item is a networked point-of-care solution from Roche Diagnostics' most recent generation. The most recent release provides expert blood glucose management.
• In September 2021, Ortho Clinical Diagnostics announced that Immediate Spin Crossmatch (ISXM), a tool for identifying recipient and donor incompatibility in blood transfusions, will be made available on the company's Ortho Vision and Ortho Vision Max Analyzers.

Diagnostic Testing Market Players

• F-Hoffman La-Rcohe Ltd. (Switzerland)
• Danaher (US)
• BD (US)
• Thermo Fisher Scientific Inc. (US)
• ACON Laboratories Inc. (US)
• Hemosure, Inc. (US)
• MicroGen Diagnostics (US)
• Grifols, S.A (Spain)
• BODITECH MED INC. (South Korea)
• Chembio Diagnostic Systems, Inc. (US)
• Nanoentek (South Korea)
• DiaSorin S.p.A. (Italy)
• Bio-Rad Laboratories, Inc. (US)
• BIOMEDOMICS INC (US)
• EKF Diagnostics Holdings plc (UK)
• Siemens Healthcare GmbH (Germany)
• PerkinElmer Inc. (US)
• bioMérieux SA (France)
• ARKRAY USA, Inc. (US)
• Biohit Oyj (Finland)
• Quidel Corporation (US)
• Illumina, Inc. (US)
• Lamdagen Corporation (US)
• LifeSign LLC. (US)
• Medixbiochemica (Finaland)
• Nova Biomedical (US)
• Ortho Clinical Diagnostics (US)
• Sannuo Biosensing Co., Ltd. (US)
• STRECK (US)
• Sysmex Corporation (Japan)

Segments Covered in the Report

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 Diagnostic Testing market.

By Type

• Clinical Diagnostic
• Home Diagnostic

By Application

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

By Approach

• Molecular Diagnostic Instrument
• In-Vitro Diagnostic Instrument
• Point Of Care Testing Instrument

By Solution

• Services
• Products

By Technology

• Immunoassay-Based
• PCR-Based
• Next-generation Sequencing
• Spectroscopy-Based
• Chromatography-Based
• Microfluidics
• Substrate Technology
• Others

By Mode of Testing

• Prescription Based Testing
• OTC Testing

By Sample Type

• Urine
• Saliva
• Blood
• Hair
• Sweat
• Others

By Testing Type

• Biochemistry
• Hematology
• Microbiology
• Histopathology
• Others

By Age

• Pediatric
• Adult & Geriatric

By Distribution Channel

• Direct Tenders
• Retail Sales
• Online Sales

By End User

• Hospitals, Diagnostic Center
• Research Labs and Institutes
• Research Institute
• Homecare
• Blood Banks
• Specialty Clinics
• Ambulatory Surgical Centers
• Others

By Region

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa (MEA)