Summary

The clinical diagnostics market was valued at approximately USD 63,305 million in 2020, and it is expected to reach USD 93,851 million by 2026, registering a CAGR of 6.1% during the forecast period, 2021-2026. The market is expected to grow due to the increasing incidence of infectious and chronic diseases and the increasing adoption of the automated platform.

With the emergence of the SARS-CoV-2 virus, there has been an increase in lab testing, which saw demand grow even more in an attempt to keep pace with the suspected cases of COVID-19. The demand for clinical diagnosis has grown to 26-50 %, based on the article published by Brenda Silva 2020. According to the Atlantic Monthly Group, there was a tremendous increase in COVID-19 tests from 760,441 tests in September 2020 to 964,792 new tests by October 2020 worldwide. Thus, the rising number of tests owing to the constant upsurge in patients and the various funding by governments are the factors that are likely to escalate the demand for COVID-19 test kits and drive the overall market growth exponentially.

According to the World Health Organization (WHO), the prevalence of chronic disease is expected to rise by 57% by 2020, and 60% of this burden is expected to occur in emerging markets. Owing to the increase in chronic diseases, the demand for healthcare systems is also increasing. Clinical diagnostics have thus been proven to be beneficial in chronic disease conditions and are found to be valuable for disease prevention, detection, and management. Clinical diagnostics help in the detection of early warning signs and individual risk factors, creating new opportunities for prevention and early intervention. Thus, the rising chronic diseases are expected to further propel the overall market.

Key Market Trends

The Lipid Panel Tests Segment is Expected to Register Good Growth in the Forecast Period

The lipid panel is a blood test that measures lipids, fats, and fatty substances used as a source of energy by the body. The lipid panel includes tests for total cholesterol, HDL cholesterol, triglycerides, LDL cholesterol, cholesterol/HDL Ratio, and non-HDL cholesterol.

There are numerous studies that have observed a decrease in total cholesterol, LDL-C, and HDL-C levels in patients with COVID-19 infections. Based on various studies, the decrease in LDL-C and/or HDL-C was more profound with greater severity of the illness. Therefore, patients with low HDL-C levels at admission to the hospital were at an increased risk of developing a severe disease compared to patients with high HDL-C levels, which has boosted the test demand. With the recovery from COVID-19, the serum lipid levels return toward levels present prior to infection.

A lipid panel measures the level of specific lipids in blood to assess the risk of cardiovascular disease and is used in screening populations to identify the subjects with a high risk of developing a cardiac event. As per the American Heart Association Research Report 2018, cardiovascular diseases, listed as the underlying cause of death, account for nearly 836,546 deaths in the United States. This is nearly one out of every three deaths in the country. About 2,300 Americans die of cardiovascular diseases each day, which is an average of one death every 38 seconds. Hence, with the increase in the prevalence and mortality rate of cardiovascular diseases, there is an increase in the requirement of lipid profile testing at an early stage, thus driving the lipid panel segment.

Key companies are found to focus on novel product developments and launches to leverage potential opportunities. Hence, from the aforementioned factors, the segment is estimated to grow over the forecast period.

North America is Expected to Dominate the Clinical Diagnostics Market Over the Forecast Period

The market for clinical diagnostic in the United States is majorly driven by the increasing geriatric population, rising patient awareness about the value of laboratory tests, and the rising prevalence of infectious and chronic disease patients.

With the rising COVID-19 infections, there is increased funding and an increasing number of testing, which has boosted the overall market growth. For instance, in September 2020, the National Institutes of Health, United States, announced its plan to give funding of USD 129.3 million to nine companies, including MatMaCorp, Maxim Biomedical Inc., MicroGEM International, etc., to scale-up up the manufacturing support for a new set of COVID-19 testing technologies as part of its Rapid Acceleration of Diagnostics (RADx) initiative.

As per the Centers for Disease Control and Prevention (CDC), in 2018, 133 million Americans, i.e.,45% of the population, had at least one chronic disease. Chronic diseases are responsible for killing more than 1.7 million Americans every year. This has led to a higher demand for better treatment with efficient management, which will further drive the market in the United States. Hence, the increasing prevalence of infectious and chronic diseases and the rising awareness about the value of laboratory tests may fuel the market growth in the country.

Competitive Landscape

The market is found to be highly competitive and consists of global and local players. The major key players of the market include Abbott Laboratories, Bio-Rad Laboratories Inc., Danaher Corporation, Becton, Dickinson and Company, Qiagen, and Roche Diagnostics, among others. The rising patient awareness and rising demand for high-quality care have made it imperative for healthcare providers to develop targeted therapies through specific and sensitive diagnostic tests. With the rising advances in clinical diagnostics, more companies are expected to penetrate the market in the coming future.

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Table of Contents

1 INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Growing Burden of Infectious and Chronic Diseases​
4.2.2 Increasing Adoption of Automated Platform
4.3 Market Restraints
4.3.1 Affordability for High-end Molecular Diagnostics
4.3.2 Limitations Associated with Reimbursement Scenario
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 (Market Size in Value)
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
5.2 By Product
5.2.1 Instruments
5.2.2 Reagents
5.2.3 Other Products
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
5.4 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
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

7 MARKET OPPORTUNITIES AND FUTURE TRENDS