North America In Vitro Diagnostics Market size exceeded USD 38 billion in 2021 and is estimated to expand at 2.5% CAGR from 2022 to 2028.

Growing burden of chronic diseases such as diabetes, cancer, COPD, and other ailments has placed immense pressure on global healthcare systems, enhancing product uptake. Since many medical decisions are made with the support of IVD testing, their demand has been rising significantly. Over the past several years, advancements in the field of IVD has provided new tools to support chronic disease diagnosis and treatment. Companies are catering to the need for at-home tests that offer nearly instant results.

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Moreover, there has been significant rise in infectious disease such as SARS-CoV2 virus. As a result, the demand for in vitro diagnostic kits and reagents for the rapid diagnosis is on the rise. As in-vitro diagnostics involves testing of various biological samples, the outbreak of the COVID-19 pandemic is expected to influence the market outlook. Additionally, people in North American countries have high disposable income and affordability to undergo expensive treatment regimens.

North America Market, By Product

The reagents & kits segment accounted for USD 25 billion revenue in 2021, owing to the rising demand for point-of-care diagnostic products and increasing acceptance of self-testing kits. Leading industry participants are receiving regulatory approvals for their innovative products. Becton, Dickinson, and Company, for example, obtained CE-IVD mark for its new molecular diagnostic combination test, for flu, COVID-19, and respiratory syncytial virus in July 2022. Other diagnostic majors, including Abbott have also entered the home-based COVID-19 testing business.

North America Market, By Test Type

The immunoassay/immunochemistry segment will depict more than 3% CAGR through 2028, thanks to growing product use in drug testing and oncology. The incidence of cancer is on the rise in the region. To satisfy these growing patient demands, manufacturers are focusing on the development of innovative diagnostic assays and kits for early disease diagnosis. To illustrate, Agilent Technologies Inc. introduced its Enzyme-Linked Immunosorbent Assay (ELISA) kit to the market in February 2021. The novel product is used for the detection of SARS-CoV-2 and immunoglobulin G (IgG) antibodies in human plasma.

North America Market, By Application

The North America IVD market revenue from infectious disease application segment will reach USD 15 billion by 2028. Infectious diseases continue to exact a substantial toll on health and health-care resources in North America. Several communicable diseases, including HIV, chronic hepatitis, and other sexually transmitted infections affect millions of individuals in the region.

Governments are ensuring that scientific and technological advances in vitro diagnostics are well-integrated into the public health system. In this context, in July 2022, the Clinton Health Access Initiative (CHAI) partnered with Wondfo Biotech Company and Med Access to deliver HIV self-test kits for only $1 to the low- and middle-income communities. This renders the solution as the first lowest priced WHO-accredited HIV self-test.

North America Market, By End-Use

The diagnostic laboratories segment size will cross USD 20 billion by 2028. The presence of skilled healthcare professionals and consistent improvements in diagnostic-platform technologies are some of the crucial factors driving industry growth. Emergence of the COVID-19 pandemic has resulted in an unprecedent rise in patient volumes, that has led to increased testing demand in diagnostic laboratories.

North America Market, By Country

U.S. in vitro diagnostics market size was around USD 35 billion in 2021, attributed to the rising incidence of chronic illnesses in the region. As per the CDC, over six in ten Americans have at least one chronic ailment, such as cancer, heart disease and stroke, or diabetes. These chronic diseases are counted as major causes of disability and death in the nation, resulting in higher healthcare spending.

Competitive Industry Landscape

Major players involved in the market include Thermo Fisher Scientific Inc., Abbott, Becton Dickinson & company, BioRad Laboratories, and BioMerieux SA. These companies have adopted a host of marketing strategies such as new product launch, distribution agreements, business collaborations, and acquisitions that have helped them to sustain their market position in an increasingly competitive business sphere.