In Vitro Diagnostics Market in U.S. Overview With Detailed Analysis, Competitive Landscape, Forecast To 2028

Reagents occupied the highest share of the market in 2016 and is expected to maintain the lead during the forecast period owing to wide range of availability of cost effective and efficient reagents and recent approval of new reagents for IVD.


In vitro diagnostics (IVD) are laboratory-based analysis performed in in vitro conditions to determine general state of health and presence of diseases, and to assess disease progression and treatment. Infections, cancer, cardiovascular immunological, nephrological, and gastroenterological diseases are diagnosed in an in vitro environment. Evolution of information technology plays an important role in the development of automated techniques.

The U.S. IVD market was valued at $15,746 million in 2016, and is projected to reach at $20,707 million by 2023, growing at a CAGR of 3.9% from 2017 to 2023. The reagent segment accounted for more than three-fifths share of the total market in 2016.

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COVID-19 scenario-

  • The Covid-19 pandemic and followed by lockdown has affected several manufacturing industries.
  • The prolonged lockdown resulted in a disrupted supply chain and increased the prices of raw materials.
  • However, as the world has been recovering from the pandemic, the market is estimated to get back on track.

Increase in geriatric population, rise in disposable income, and high healthcare expenditure in the U.S. drive the market growth. However, unfavorable reimbursement policies and stringent government regulations related to the safety and efficacy of the IVD are expected to restrain the market growth during the forecast period. Ongoing R&D associated with the IVD and increase in awareness of preventive healthcare measures provides huge growth potential for IVD market.

Based on product type, the reagents segment held the highest market share in 2016, owing to the recent government approval of new novel reagents in the market and wide availability of cost effective and efficient reagents.

Based on technique, the immunodiagnostics segment contributed the highest market share in 2016, owing to the increase in prevalence of chronic and infectious diseases such as diabetes, cancer, & others and rise in awareness of personalized medicine among the population.

Based on application, the infectious diseases segment contributed the highest market share in 2016, owing to the increase in rise in awareness of preventive health measures and increase in adoption of home test kits.

Based on end users, the standalone laboratory segment captured the highest market share in 2016, mainly due to wide availability of skilled professional and complex tests & high-tech infrastructure enabling fast and reliable test results.

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The Major Key Players Are:

Thermo Fisher Scientific Inc., Alere Inc., Biomerieux, Danaher Corporation, F. Hoffmann-La Roche AG, Becton Dickinson and Company, Bio-Rad Laboratories, Bayer AG, Sysmex Corporation, and Johnson & Johnson among others.

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