Clinical diagnostics are medical devices used to perform diagnostic tests on biological specimens such as blood, urine, and tissues. It is a process of identifying a disease, condition, or injury based on the patient’s signs and symptoms. Clinical diagnostic help detect and monitor chronic diseases, infectious diseases, autoimmune diseases, and several medical conditions which are being used to analyze drug therapies. Moreover, clinical diagnostics help improve patient care, reduce healthcare spending, and contribute to the consumer (patient) safety.
Market Statistics:
The global Clinical Diagnostic Market is estimated to account for US$ 74.03 Bn in terms of value by the end of 2021.
Drivers:
Increase in use of clinical diagnostics due to growing patient awareness towards disease diagnosis is expected to propel the growth of the global clinical diagnostics market over the forecast period. With the growing burden of chronic and infectious diseases and rising patient awareness, the use of clinical diagnostic instruments/reagents is also increasing with a rapid pace worldwide. In May 2021, Neuberg Diagnostics announced the start of its clinical laboratory operations in the U.S. The North Carolina laboratory, NCGM Inc., will focus on genomic and molecular testing based on new generation sequencing techniques. NCGM has also introduced COVID-19 molecular test to detect active SARS CoV-2 (COVID-19) virus infection.
Opportunities:
Increase in incidence or prevalence of chronic and infectious diseases across the globe is expected to offer significant growth opportunities for players in the global clinical diagnostics market. For Instance, the burden of chronic and infectious disorders continues to increase, and the demand for clinical diagnostics has increased. Individuals suffering from both chronic and infectious diseases require immediate intervention of clinical diagnosis. In March 2020, Abbott announced that the United States Food and Drug Administration (USFDA) issued the Emergency Use Authorization (EUA) for ID NOW platform. It is a rapid, instrument- based, isothermal system for the qualitative detection of infectious diseases.
Restraints:
High cost of high-end molecular diagnostics and limitations associated with the reimbursement are major factors expected to hinder growth of the global clinical diagnostics market. The cost of high-end molecular diagnostic tests is significantly high and not all insurance companies’ cover them. Moreover, current reimbursement system is designed to support relatively simple diagnostic tests, it is not designed to support complex diagnostic tests. However, the cost of molecular diagnostics has fallen rapidly over the past few years. As the cost of high-end molecular diagnostics becomes progressively affordable, a shift towards this type of diagnostic approach is expected.
Global Clinical Diagnostic Market - Impact of Coronavirus (Covid-19) Pandemic:
The outbreak of COVID-19 has had a positive impact on the clinical diagnostic market. Due to the pandemic, there has been an increase in laboratory testing, resulting in an increase in the demand for lab testing to keep pace with suspected cases of COVID-19. In March 2022, Everything Genetic received approval from the U.K. regulatory bodies to sell COVID-19 Antigen Tests in the U.K. The company sells lateral flow devices at GBP 2 for single kits, this in turn is expected to surge the POC diagnostics, especially in developing economies. The pandemic has increased the demand for COVID-19 test kits, which in turn is driving the growth of the market.
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Key Takeaways:
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.
Among test segment Other Tests segment held dominant position in the global clinical diagnostic market in 2021, accounting for 58.0% share in terms of value, increasing approval and launch of new products is expected to propel growth of the segment during the forecast period.
Market Trends:
One of the key trends expected to propel the growth of the global clinical diagnostic market is the technological advancements in clinical diagnostics. The latest cutting-edge diagnostics technology is set to change the industry’s testing paradigm through speed, efficiency, and scalability. A variety of automated equipment is also found in clinical laboratories that are designed to improve 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.
Competitive Landscape:
Major players operating in the global clinical diagnostic market include Thermo Fisher Scientific, F. Hoffmann-La Roche AG, Qiagen N.V, Hologic Inc., Siemens Healthineers AG, BioMerieux, Abbott Laboratories, Bio-Rad Laboratories Inc., Becton, Dickinson and Company, and Danaher Corporation (Beckman Coulter, Inc.), among others.
Recent Developments:
In November 2020, Apollo Hospitals, in collaboration with Tata Medical & Diagnostics, launched 'TataMD CHECK' diagnostic test for COVID-19 in India.
In February 2019, Quest Diagnostics and Houston Healthcare collaborated to enhance the quality and value of diagnostic services to patients. As a part of the partnership, Quest will provide full laboratory management services for Houston Medical Center and Perry Hospital.
In April 2019, Quantabio announced the launch of Qscript to 1-step, a lyophilized single-reaction reagent optimized for highly sensitive and reproducible RT-qPCR RNA applications.
In March 2019, the U.S. Food and Drug Administration (FDA) approved Foundation Medicine’s FoundationOne CDx as a complementary diagnostic for all solid tumors.
