CLINICAL DIAGNOSTIC MARKET ANALYSIS

The global clinical diagnostic market was valued at US$ 74.03 Bn in 2021 and is forecast to reach a value of US$ 105.91 Bn by 2028 at a CAGR of 6.1% between 2022 and 2028. The global clinical diagnostic market is experiencing strong growth owing to the growing burden of infectious and chronic diseases and rise in usage of clinical diagnostic around the world. Moreover, outbreak of COVID-19 and growing geriatric population across the globe is expected to boost growth of the market. However, factors such as affordability for high-end molecular diagnostics and limitations associated with reimbursement scenario are expected to hamper the market growth.

Global Clinical Diagnostic Market: Regional Insights

Based on geography, the global clinical diagnostic market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa.

Among regions, North America is expected to gain highest share in the market over the forecast period due to the growing burden of infectious and chronic diseases, growing geriatric population, and rise in demand for personalized medicine in the region. Chronic diseases such as heart disease, cancer, and diabetes are the leading causes of death and disability in the U.S. According to Centers for Disease Control and Prevention (CDC), six in ten adults in the U.S. have a chronic disease and four in ten adults have two or more chronic diseases. Clinical diagnostic is a process of identifying a disease, condition, or injury based on the patient's signs/symptoms.

Europe and Asia Pacific are also expected to witness robust growth in the global clinical diagnostic market owing to the growing geriatric population, increasing prevalence of infectious and chronic diseases, and growing patient awareness towards disease diagnosis. For instance, according to the Longitudinal Ageing Study (LASI) released by the Union Ministry of Family and Health Welfare in January 2020, two in every three adults in India suffer from some chronic disease. Moreover, according to the World Health Organization (WHO/Europe), chronic diseases are the leading cause of mortality and morbidity in Europe.

Figure 1. Global Clinical Diagnostic Market Share (%), by Region, 2022

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Global Clinical Diagnostic Market Drivers:

Growing burden of infectious and chronic diseases to underpin market growth

One of the key factors expected to propel the growth of the global clinical diagnostic market over the forecast period is the growing burden of infectious and chronic diseases across the world. For instance, according to the World Health Organization (WHO), noncommunicable diseases (NCDs) (such as heart disease, cancer, and diabetes) kill 41 million people each year, equivalent to 74% of all deaths worldwide. Each year, over 15 million people die from a NCD between the ages of 30 and 69 years; 85% of these deaths occur in low- and middle-income countries.

Rise in use of clinical diagnostic worldwide to augment market growth

Another factor which is driving the growth of the global clinical diagnostic market is the increase in use of clinical diagnostic around the world. This is attributed to surge in awareness toward point-of-care (POC) diagnostics. In July 2021, QuantuMDx Group Limited announced the launch of Q-POC, a rapid, PCR point-of-care (POC) diagnostic system. Q-POC is a portable PCR system that compresses an entire molecular diagnostic laboratory into simple to use, accessible, and affordable single device offering rapid, molecular diagnostic testing at the point of care, with results in around 30 minutes. This in turn is driving the growth of the market.

Global Clinical Diagnostic Market Opportunities:

The outbreak of COVID-19 is expected to provide significant growth opportunities for players in the global clinical diagnostic market. For instance, due to the pandemic, there has been an increase in laboratory testing, causing demand to grow even faster to keep pace with the suspected cases of COVID-19. In September 2020, the National Institutes of Health (NIH) announced its plan to give funding of US$ 129.3 million to scale-up manufacturing support for a new set of COVID-19 testing technologies as part of its Rapid Acceleration of Diagnostics (RADx) initiative. Diagnostic testing is a critical component of the strategy to meet the challenge of the pandemic.

Growing geriatric population across the globe is expected to offer significant growth opportunities for players in the global clinical diagnostic market. For instance, aging increases the risk of chronic diseases, and with the rise in geriatric population, the burden of infectious and chronic diseases is also increasing with a rapid pace worldwide. According to the WHO, by 2030, one in six people in the world will be aged 60 years or over, and by 2050, the world’s population of people aged 60 years and older will double (2.1 billion). This in turn has increased the use of clinical diagnostic or is expected to increase the use of clinical diagnostic.

Global Clinical Diagnostic Market Trends:

Increase in use of clinical diagnostic tests is a recent trend

The use of clinical diagnostic tests, such as lipid panel blood test, has increased worldwide owing to the increase in burden of cardiovascular diseases (CVDs). A lipid panel or lipid profile, a blood test, measures the amount of cholesterol and triglycerides in the blood. The lipid panel includes tests for total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, cholesterol/HDL ratio, and non-HDL cholesterol. This in turn is expected to continue over the forecast period, driving the growth of the global clinical diagnostic market.

Technological advancements is another market trend

The latest cutting-edge diagnostics technology is poised to change the industry’s testing paradigm through speed, efficiency, and scalability to help guide care for patients. There are also a variety of automated equipment found in clinical laboratories that are designed to improve the quality, throughput, and efficiency of laboratory testing. Moreover, players in the market also focusing on launching technologically advanced diagnostic products in the market. This in turn is also expected to continue over the forecast period, driving the market growth.

Global Clinical Diagnostic Market Restraints:

High cost of high-end molecular diagnostics to hamper the market growth

Another factor which is hindering growth of the global clinical diagnostics market is affordability for high-end molecular diagnostics. The cost of high-end molecular diagnostic tests is significantly high and not all insurance companies’ cover them. However, the cost of molecular diagnostics has fallen rapidly over the years. As the cost of advanced molecular diagnostics becomes progressively affordable, a shift towards this type of diagnostic approach is expected.

Reimbursement scenario to hinder growth of the market

The current limitations for clinical diagnostics regarding the inadequate reimbursement are one of the major factors hindering growth of the clinical diagnostics market. The current reimbursement system is designed to support relatively simple diagnostic tests, it is not designed to support novel complex diagnostic tests, and research suggests that its shortcomings are hindering the progress of personalized medicine today. Limitations are more profound for novel diagnostics developers.

Figure 2. Global Clinical Diagnostic Market Share (%), by Test, 2022

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Global Clinical Diagnostic Market Segmentation:

The global clinical diagnostic market report is segmented into Test, Product, End User, and Geography.

Based on Test, the clinical diagnostic market is segmented into Lipid Panel, Liver Panel, Renal Panel, Complete Blood Count, Electrolyte Testing, Infectious Disease Testing, and Other Tests. Out of which, Other Tests Segment is expected to dominate the clinical diagnostic market over the forecast period and this is attributed to the increase in usage.

Infectious Disease Testing Segment is also expected to witness robust growth in the near future and this is owing to the increase in burden of infectious disease across the world.

Based on Product, the market is segmented into Instruments, Reagents, and Other Products. Out of which, Instruments Segment is expected to dominate the market over the forecast period and this is attributed to the increase demand for clinical diagnostics instruments. These instruments are used to detect health and disease state markers.

Reagents Segment is also expected to witness significant growth in the near future and this is owing to the increase in use of reagents in disease diagnosis. Reagents are integral part of clinical diagnostic. They are of a wide varied range for different types of disease diagnosis.

Based on End User, the market is segmented into Hospital Laboratory, Diagnostic Laboratory, Point-of-Care Testing, and Other End Users. Out of which, Hospital Laboratory Segment is expected to dominate the market during the forecast period and this is attributed to the increasing burden of infectious and chronic disease worldwide.

Point-of-Care Testing Segment is also expected to witness significant growth in the near future and this is owing to the surge in awareness toward point-of-care (POC) diagnostics.

Global Clinical Diagnostic Market: Key Developments

In October 2020, U-Diagnostics and CENTOGENE collaborated to provide increased COVID-19 testing services throughout the Netherlands.

In September 2020, KeyOptions announced the launch of the Virolens COVID-19 screening test, based on a nano-cellular microscope, after securing its commercial rights from Virolens to market the product in Australia and Southeast Asia.

In June 2020, Ortho Clinical Diagnostics launched two COVID-19 tests, Ortho’sVITROS Anti-SARS-CoV-2 Total and IgG tests, that can help identify people who have developed antibodies to SARS-CoV-2 (COVID-19).

In October 2019, Helena Biosciences, Belgium, launched Glyco Liver Profile at the world’s first Liver Glycomics Congress to monitor and predict liver disease.

Global Clinical Diagnostic Market: Key Companies Insights

The global clinical diagnostic market is highly competitive. This is attributed to the rise in burden of infectious and chronic disease around the world, as a result, players in the market are focusing on launching novel diagnostic products in the market.

Some of the key players in the global clinical diagnostic market are Thermo Fisher Scientific, F. Hoffmann-La Roche AG, Qiagen N.V, Hologic Inc., Siemens Healthineers AG, BioMerieux SA, Abbott Laboratories, Bio-Rad Laboratories Inc., Becton, Dickinson and Company, and Danaher Corporation (Beckman Coulter, Inc.), among others.

*Definition: Clinical diagnostic is the process of identifying a disease, condition, or injury based on the signs and symptoms a patient is having and the patient's health history and physical exam. These tests help detect and monitor many medical conditions, such as chronic diseases, infectious diseases, and autoimmune diseases that are being used to analyze drug therapies.