Rising demand for diagnostic tests for early detection of diseases augmenting the growth of in-vitro diagnostics

In-Vitro Diagnostics Market by Products & Services (Instruments, Kits & Reagents and Services), Technology (Immunoassay, Molecular Diagnostics, Hematology, Urinalysis and Microbiology), Application (Infectious Diseases, Oncology, Cardiology, Nephrology, Diabetes, Gastrointestinal Diseases) End User (Hospitals, Clinical Laboratories, Academics/Research Institutes, Point-of-care Testing) – Global Outlook & Forecast 2021-2031

According to the deep-dive market assessment study conducted by Growth+ Reports, the global in-vitro diagnostics market was pegged at ~US$ 85.81 billion in 2020. The market is expected to witness a CAGR of ~2.4% from 2021 to 2031. 

Rising geriatric population (who are more susceptible to infectious diseases), rising demand for diagnostic tests for early detection of diseases, and new product launches by manufacturers are some of the key factors driving the global in-vitro diagnostics market. However, inadequate reimbursement is a major factor restraining the growth of the IVD market.

During recent years the prevalence of infectious diseases, as well as genetic disorders, has increased significantly. In-vitro diagnostic products can be used for diagnosis of a disease or disorder, screening of diseases, determining the state of health, and guide treatment decisions. IVD products are generally classified into Class I, II, or III according to the level of regulatory control that is necessary to assure safety and effectiveness. The sudden outbreak of H1N1 & COVID-19 has led to increasing demand or IVD devices and kits as these can be used for diagnosis of SARS-CoV-2. To meet this demand, several in vitro diagnostic manufacturers have launched point-of-care test kits to increase patient access to coronavirus diagnostic testing. For instance, in Dec 2020, Abbott’s BinaxNOW Covid-19 rapid test received FDA emergency use authorization for first virtually guided, at-home rapid test.

The increasing incidence of infectious diseases globally has led to increasing demand for early detection of diseases. For instance, according to The National Diabetes Statistics Report, published by the Centers for Disease Control and Prevention (CDC), in 2018, around 34.2 million people of all or 10.5% of the US population had diabetes. Early detection of disease helps in the prevention of the disease and as in-vitro diagnostic tests are used for screening of such diseases, this factor, in turn, is expected to propel the market growth in the coming years. Rising geriatric population globally has also positively impacted the IVD market growth as various diseases are associated with age.

Rising adoption of diagnostic techniques such as reverse-transcription polymerase chain reaction and NGS have also played a pivotal role in boosting the global market. For instance, as the number of COVID-19 cases started rising rapidly, companies started to develop and launch test kits that can be used for the diagnosis of coronavirus. Eurofins Scientific’s GSD NovaPrime SARS-CoV-2 (COVID-19) RT-PCR, a Multiplex Real-Time PCR with CE-IVD marking is one of such PCR based testing kit that is used for direct qualitative pathogen detection of the novel Coronavirus (SARS-CoV-2). Similarly, there has been a surge in the volume of point-of-care testing during the pandemic. Multiple test kits were launched by companies that can be used by the population to confirm an active infection.

Unfavorable reimbursement scenario is expected to restrain the market growth to a certain extent. Novel diagnostic in-vitro test developers face challenges in securing reimbursement through national coverage systems. Genetic testing in particular faces challenges in getting reimbursement by third-party payers. Lack of transparency in reimbursement criteria across countries and the increasing number of digital diagnostic solutions that can be used as an alternative to IV diagnosis is also hampering the market growth to a certain extent.       

Regionally, Asia-Pacific is anticipated to witness the highest CAGR during the forecast period. The growth of the in-vitro diagnostic market in this region can be attributed to several factors such as the increasing prevalence of infectious diseases coupled with rapidly developing healthcare infrastructure. Moreover, during the Covid-19 pandemic, the testing volume for diagnosis of  SARS-CoV-2 has rapidly increased, and to meet the increasing testing demands several companies have launched multiple testing kits. For instance, in Jan 2020, Co-Diagnostics, Inc., a molecular diagnostics company launched IVD products in the Indian market.

Some of the prominent players operating in the in-vitro diagnostics market are F. Hoffmann-La Roche Ltd., Thermo Fisher Scientific Inc., Abbott, Siemens Healthcare Private Limited, Bio-Rad Laboratories, Inc., Danaher, BD, Johnson & Johnson Services, Inc., Agilent Technologies, Inc., Sysmex Corporation, among others.

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