Clinical Diagnostics Market

Market Overview

The global clinical diagnostics market size was valued at USD 67.29 billion in 2021. It is expected to reach USD 109.70 billion by 2030, growing at a CAGR of 6.3% during the forecast period (2022–2030).

Clinical diagnostic tests are increasingly popular because many companies offer a broad portfolio of genetic tests with well-known applications. These include non-invasive prenatal testing (NIPT), cardiovascular disease predisposition testing, the screening of hereditary cancers, rare disease diagnosis, and personalized medicine apps that can help patients select individualized treatment options. The primary factors contributing to the growth of the clinical diagnostics market are growing incidences of infectious and chronic diseases, increasing adoption of the automated platform, and better access to healthcare facilities by the general population.

Market Dynamics

Global Clinical Diagnostics Market Drivers

Growing Incidences of Infectious and Chronic Diseases

The global population is bearing an ever-increasing burden of infectious diseases and chronic conditions. Microorganisms cause infectious diseases, including diphtheria, ebola, flu, hepatitis, HIV/AIDS, HPV, tuberculosis, etc., and sudden outbreaks like dengue, Zika virus, COVID-19, and Swine flu drive demand for clinical diagnostic tests internationally. Additionally, chronic disorders like different types of cancers, diabetes, cardiovascular diseases, obesity, and many others, are increasing significantly, due to which the demand for clinical diagnostics is also expected to rise.

Clinical diagnostic tests represent one of the most accurate methods to identify and characterize microorganisms. A practical test must be precise, rapid, and capable of measuring the level of infection. Better testing, therefore, quickly determines the organism's strain and drug susceptibility, reducing the delay in finding the right antibiotic. According to tuberculosis (TB) report published by the World Health Organization (WHO) in 2018, the disease ranked among the leading ten causes of death across the globe. This will likely be a significant growth factor for the market. The high incidence of cancer cases in countries with higher living standards is primarily due to the availability and access to better diagnostic procedures. Clinical cancer diagnostics equipment is used extensively for these procedures, due to which their demand is expected to increase during the forecast period.

Increasing Adoption of Automated Platform

There has been an increase in the automated platform for diagnostic devices over the past few years. The increased elderly population, improved lab tests, and proactive healthcare and disease-state management will boost automated platform use. There is a massive lack of workforce in managing large laboratories involved in processing different tests. The United States Bureau of Labor Statistics in April 2018 predicted that 18,000 clinical laboratory science (CLS) program vacancies would be available by the end of the year. Still, only 5000 students graduate from accredited CLS programs each year. This indicates that there is a substantial lack of qualified workers, which is a problem that can be solved by automating the tasks of the laboratory.

Additionally, in February 2021, Thermo Fisher Scientific launched the TaqPath COVID–19 HT Kit for use on its automated amplitude platform. The highly automated amplitude platform is a molecular diagnostic system that allows labs to increase their COVID-19 testing capacity by combining Thermo Fisher's extraction and real-time PCR instruments with liquid handling products from Tecan Group. The above factors are expected to affect the market growth during the forecast period positively.

Global Clinical Diagnostics Market Restraint

Affordability for High-end Molecular Diagnostics

The cost of molecular diagnostics has fallen rapidly over the last few years. As the cost of advanced molecular diagnostics becomes progressively cheaper, there is expected to be a shift toward this diagnostic method. There are many reasons why molecular diagnostics are seeing a decrease in their costs. A significant factor is their relative convenience and ease of use. Molecular diagnostics are more sensitive methods that detect lower amounts of infectious agents in the sample. As a result, they make it possible to identify infections at an earlier stage than was previously possible. This capability is critical when it comes to screening blood.

Additionally, molecular diagnostics is also applied for treatment guidance and monitoring. Real-Time PCR tests provide an effective and convenient tool to establish the efficacy of therapy and modify the treatment when appropriate. Nucleic acid sequencing, another diagnostic test, is used extensively to identify and differentiate specific viral strains. The relative popularity of these methods of diagnostic tests means that companies can mass-produce them, thus lowering their prices. Therefore, the convenience of using molecular tests and their lower costs are expected to act as significant restraints to the market growth of clinical diagnostics.

Global Clinical Diagnostics Market Opportunities

Growing Demand for Advanced Diagnostic Solutions

The health of patients is managed through the use of clinical diagnostics. It makes it possible to detect diseases at an earlier stage and helps follow the progression of illnesses. Additionally, it may assist infected individuals in avoiding long-term consequences, likely increasing public awareness of the value of clinical diagnosis. Further, healthcare spending and increased health awareness promote market expansion. It is predicted that the demand for clinical diagnostic kits will increase during the projection period due to increased concerns about the danger of disease transmission from infected patients. Diagnostic testing can be carried out using either services or tools and supplies. This feature will probably increase patient convenience, which will help the market.

Regional Analysis

North America Dominates the Global Market

By region, the global clinical diagnostics market is segmented into North America, Europe, Asia-Pacific, the Middle East and Africa, and South America.

North America is the largest shareholder in the global clinical diagnostics market and is expected to grow at a CAGR of 5.5% over the forecast period. The rising elderly population, improving patient understanding of the significance of laboratory tests, and the increased prevalence of patients with infectious and chronic diseases are the main factors driving the clinical diagnostic market in the United States. Chronic diseases are the most common reason people die or become disabled in the United States. According to the Centers for Conditions Control and Prevention (CDC), 133 million people in the US, which accounts for 45 percent of the population, are predicted to have at least one chronic disease in 2018. Over 1.7 million Americans die from chronic diseases each year, which account for seven out of every ten fatalities in the country. This scenario leads to a higher demand for better treatment with efficient management that will further drive the market in the United States.

Europe is expected to grow at a CAGR of 6.6%, generating USD 109,700 million during the forecast period. The German healthcare system provides patients with access to technologically advanced products, and it is a high-focus market for most diagnostic manufacturers. Factors like the aging population, the rise in chronic and infectious diseases, and the growing patient awareness drive the global market. The increase in the incidence of HIV infection is also anticipated to boost the market during the forecast period. According to the study conducted and published under the title HIV outcomes: Beyond Viral Suppression in 2019, around 86,000 people are living with HIV in Germany, and approximately 20% of the infected population resides in Berlin. The prevalence of chronic obstructive pulmonary disease ranged from 1.3% to 13.2% in 2018, according to an article released in 2018. It is anticipated that this number will grow to 24% by 2030. Thus, the heavy burden of chronic diseases is expected to drive the German clinical diagnostics market studied over the forecast period

China represents one of the fastest-growing geographies in the clinical diagnostics market share in the Asia-Pacific region. The market's growth is due to China's aging population, which indicates that the country is expected to experience an explosion of chronic conditions, such as diabetes, heart disease, and cancer. These conditions require in vitro diagnostic tests as a part of their primary diagnosis. In October 2020, the Ministry of Civil Affairs in China predicted that the country's senior population would reach 300 million in five years, i.e., between 2021-2026, marking a demographic transition to a moderately aging society. By around 2040, there will be more than 400 million seniors and fewer babies. This has become a severe concern to the Chinese ministry as an upcoming surge in the aging population is expected to increase the burden of various chronic diseases in the country. According to prior healthcare expenditures, residents in this region are willing to spend more for diagnostic tests and assays due to increased disease knowledge. All these factors create development prospects in this region.

Segmental Analysis

The global clinical diagnostics market is segmented by test, product, and end-user.

By test, the global market is segmented into lipid panel, liver panel, renal panel, complete blood count, electrolyte testing, infectious disease testing, and other tests.

The lipid panel segment accounts for the largest market share and is expected to grow at a CAGR of 5.1% during the forecast period. A lipid panel is a blood test measuring lipid fats and fatty substances used as a body energy source. Stroke is globally the second highest cause of death after ischemic heart disease, and it is projected to remain so till 2030, as per a 2019 study by Abolfazl Avan et al., published in the BMC Medicine Journal. In conjunction with a cardiac risk assessment, the lipid panel is used to predict the possibility of developing heart disease and the optimal course of treatment for patients at low, moderate, or high risk. Therefore, the increasing prevalence of vascular diseases boosts segment growth.

By product, the global market is segmented into instruments, reagents, and other products.

The reagents segment accounts for the largest market share and is expected to grow at a CAGR of 6.5% during the forecast period. The segment covers assay reagents, sample preparation reagents, control solutions, and test kits utilized in clinical diagnostic tests. Reagents are an integral part of clinical diagnosis. In addition, the growing competitive pressures are encouraging, and they are available in a wide range to diagnose several different diseases. The use of complex reagent combinations in laboratory illness diagnosis from biological samples has expanded due to the complexity of conditions and the need for early diagnosis, quick results, and ongoing quality improvement in laboratories. Thus, owing to the abovementioned factors, the market is expected to witness a healthy CAGR over the forecast period.

By end user, the global market is segmented into hospital laboratories, diagnostic laboratories, point-of-care testing, and other end users.

The hospital laboratory segment accounts for the largest market share and is expected to grow at a CAGR of 5.7% during the forecast period. The hospital laboratory segment of the market studied includes hospital centers with an in-built diagnostic section, where molecular diagnostics tests are performed. They usually have the same equipment as diagnostic laboratories. The bulk purchase of reagents and kits benefits the hospitals in terms of cost. Hospitals establish trade contracts and agreements with manufacturers and distributors to achieve economies of scale. These factors contribute to the growth of the hospital segment in the market studied globally.

Recent Developments

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• June 2022 - Abbott (NYSE: ABT) today announced it's developing a new wearable that will continuously monitor glucose and ketone levels in one sensor. The system has secured breakthrough device designation from the US Food and Drug Administration, designed to expedite the review of innovative technologies that can improve people’s lives with life-threatening or irreversibly debilitating diseases or conditions.