Global Clinical Diagnostics Market Analysis

Global Clinical Diagnostic Market Executive Summary

The Global Clinical Diagnostic market was valued at $68.92 Bn in 2022 and is estimated to expand at a CAGR of 6% from 2022-30 and will reach $109.85 Bn in 2030. The process of determining a disease, ailment, or damage based on a patient's signs and symptoms, as well as the patient's health history and physical exam. Following a clinical diagnosis, further testing such as blood tests, imaging studies, and biopsies may be performed.

Because of the COVID-19 pandemic, there has been a rise in lab testing, which has caused demand to expand even faster in order to keep up with the suspected cases of COVID-19. According to the Atlantic Monthly Group, COVID-19 tests have increased dramatically worldwide, rising from 760,441 in September 2020 to 964,792 by October 2020. Hence, the increasing number of tests due to the steady increase in patients and government financing were the elements responsible for driving the overall market growth tremendously. Furthermore, due to the advent of a mutant strain of the COVID-19 virus, the need for clinical diagnostics is predicted to stay steady during the post-pandemic period, leading to the growth of the market over 5 years.

Market Dynamics

Market Growth Drivers

The rising incidence of chronic and infectious diseases, such as cancer, diabetes, cardiovascular diseases, and infectious diseases, is a major driver of the clinical diagnostics market. Globally 3 in 1 suffer from Chronic disease. Chronic disease/ Noncommunicable diseases (NCDs) kill 41 Mn people per year, accounting for 74% of all deaths worldwide. Every year, 17 Mn people die from an NCD before the age of 70, with low- and middle-income nations accounting for 86% of these premature fatalities. 77% of NCD fatalities occur in low- and middle-income countries. Cardiovascular diseases kill the most individuals each year (17.9 Mn), followed by cancer (9.3 Mn), chronic respiratory disorders (4.1 Mn), and diabetes (2.0 Mn including kidney disease deaths caused by diabetes). The need for accurate and timely diagnosis of these diseases is increasing, leading to a higher demand for clinical diagnostic tests and equipment.

The development of advanced diagnostic technologies, such as next-generation sequencing, digital pathology, and point-of-care testing, is driving the growth of the clinical diagnostics market. These technologies enable faster and more accurate diagnoses, leading to better patient outcomes. Personalized medicine, which involves the use of diagnostic tests to tailor treatment to individual patients, is becoming increasingly important in the healthcare industry. This trend is driving the demand for clinical diagnostic products that can provide more precise and personalized diagnoses. Point-of-care testing, which involves conducting diagnostic tests at the patient's bedside or in the physician's office, is becoming more popular due to its convenience and efficiency. This trend is driving the demand for clinical diagnostic products that can be used in point-of-care settings. Governments around the world are implementing favorable policies and initiatives to improve healthcare infrastructure and increase access to healthcare services. This is driving the growth of the clinical diagnostics market by increasing the demand for diagnostic tests and equipment. The global aging population is increasing, leading to a higher incidence of age-related diseases, such as cancer and Alzheimer's disease. This is driving the demand for clinical diagnostic products that can diagnose and monitor these diseases.

Market Restraints

Diagnostic tests can be expensive, particularly advanced tests and imaging procedures. This can limit access to these tests for some patients, particularly those in low-income countries or those without adequate health insurance coverage. The interpretation of diagnostic test results requires specialized knowledge and skills, which can be in short supply in some regions. This can limit the availability and quality of diagnostic services. Clinical diagnostic products are subject to stringent regulatory requirements, particularly in developed countries. Meeting these requirements can be time-consuming and expensive, which can limit the ability of small and medium-sized companies to enter the market. The reimbursement for diagnostic tests can be limited in some countries, particularly for advanced tests and procedures. This can limit the demand for these tests and affect the financial viability of diagnostic companies. The lack of standardization in diagnostic tests can lead to variability in test results, making it difficult to compare results across laboratories or establish consistent treatment protocols. The clinical diagnostics market is subject to the threat of counterfeit products, which can pose a risk to patient safety and the reputation of legitimate diagnostic companies.

Competitive Landscape

Key Players

• Abbott
• BioMérieux
• Bio-Rad Laboratories
• Danaher Corporation
• Siemens
• Hologic
• Qiagen NV
• Quest Diagnostics
• F. Hoffmann-La Roche
• Thermo Fisher Scientific
• Sysmex
• Sonic Healthcare
• Exact Sciences Corporation
• NeoGenomics
• BioReference Laboratories
• Laboratory Corporation of America Holdings
• DiaSorin
• PerkinElmer
• FUJIFILM Corporation

Healthcare Policies and Regulatory Landscape

In the United States, the Food and Drug Administration (FDA) regulates diagnostic tests under the Clinical Laboratory Improvement Amendments (CLIA) program. The FDA also regulates in vitro diagnostic (IVD) tests under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA has established a classification system for IVD tests based on their level of risk to patients, with Class I tests being considered low risk and Class III tests being considered high risk.

In Europe, diagnostic tests are regulated under the European Union (EU) In Vitro Diagnostic Regulation (IVDR), which went into effect in May 2022. The IVDR establishes a new regulatory framework for IVD tests in the EU, with a focus on ensuring the safety and performance of tests and improving patient access to innovative tests. Under the IVDR, IVD tests are classified based on their level of risk, similar to the FDA's classification system.

Other countries and regions have their own regulatory frameworks for diagnostic tests. For example, in Japan, diagnostic tests are regulated by the Ministry of Health, Labour and Welfare (MHLW) under the Pharmaceutical Affairs Law (PAL). In China, diagnostic tests are regulated by the China Food and Drug Administration (CFDA) under the Medical Device Regulations.

Latest News and Updates

1. 17 Feb 2023, BioEcho has received two patents for their unique EchoLUTION technology, which transforms traditional nucleic acid extraction techniques
2. 6 Sep 2022, the Azerbaijan Thalassemia Center and BGI performed a virtual signing ceremony to conclude a Cooperation Agreement in September. With genetic technologies, the collaboration hopes to improve thalassemia screening in Azerbaijan
3. In March 2020, Thermo Fisher Scientific completed its acquisition of Qiagen, a leading provider of sample and assay technologies for molecular diagnostics. The acquisition was valued at $11.5 Bn and is expected to strengthen Thermo Fisher's position in the clinical diagnostics market

Reimbursement Scenario

The reimbursement scenario for clinical diagnostic tests varies by country and region. In general, government and private insurers determine the reimbursement rates for diagnostic tests. The rates may vary depending on factors such as the type of test, the complexity of the test, and the setting in which the test is performed.

In many countries, government-run healthcare systems, such as the National Health Service (NHS) in the UK, provide reimbursement for diagnostic tests. In these systems, diagnostic tests are typically provided free of charge to patients. Private insurers also provide reimbursement for diagnostic tests, often with some out-of-pocket cost to the patient.

In the United States, reimbursement for diagnostic tests is typically provided by private insurance companies or by Medicare, the government-run insurance program for people over 65 and certain people with disabilities. Reimbursement rates are determined through a complex process that considers factors such as the cost of the test, the clinical utility of the test, and the potential impact of the test on patient outcomes.

Reimbursement rates for diagnostic tests can vary widely depending on the country and the type of test. Some tests may be reimbursed at a higher rate than others, particularly if they are considered to be medically necessary or if they are used to diagnose a rare or serious condition.