Navigating Sustainable, Profitable Growth in a Rapidly Changing World

Healthcare and Pharmaceuticals

North America In-vitro Diagnostics ...

Historical and Forecast Market Trends

2018-34

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In-vitro diagnostics (IVD) refer to tests carried out on samples such as blood or tissue taken from the human body. In vitro diagnostics can detect diseases, infections, or other conditions, and may be used to monitor a person’s overall health to help treat, cure, or prevent illnesses. In-vitro diagnostics may also be employed in precision medicine to recognize patients likely to benefit from particular treatments or therapies. Such in-vitro diagnostics could include next generation sequencing tests, which scan an individual’s DNA to detect genomic variations. Some tests are carried out in laboratory or other health professional settings; others may be performed by consumers at home by themselves.

In-vitro diagnostic devices (IVDs) determine a significant percentage of clinical decision. Such devices aid in the identification, diagnosis and monitoring of illness or other conditions and assist in ascertaining states of health; in-vitro diagnostic devices seek to offer quicker, smaller, and more cost-effective tools that allow more accurate diagnosis and point-of-care testing or self-testing. Sequencing technologies and multi-omic analysis offer an extensive representation for personalised disease diagnosis. In-vitro diagnostic devices (IVDs) play a vital role in the selection of suitable therapeutic interventions in healthcare delivery, particularly with advancements in personalized medicine. In-vitro diagnostic products are seen as a subgroup of medical devices in the USA, regulated by the Food and Drug Administration (FDA).

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Artificial intelligence (AI) and cloud services also offer cost-effective solutions for limited-resource settings. Advanced technologies in laboratory medicine, including genetic sequencing, liquid biopsy, microfluidics and mass spectrometry technologies mirror such developments. Liquid biopsy allows a non-invasive, real-time tool to diagnose cancer early. Microfluidics and other micro/nano devices offer solutions to system integration and enable smaller instruments. Mass spectrometry aids in the achievement of quick, high-throughput and high-sensitivity testing. Such solutions are expected to stimulate the North America in-vitro diagnostics market.

Leading companies are looking to expand capabilities and develop advanced solution. For example, in 2019, QIAGEN and Illumina joined forces in the next-gen sequencing-based IVD testing and companion diagnostics market announcing a 15-year collaboration. For Illumina, the collaboration with Qiagen was set to add long-term expansion potential, specifically in the expanding market for companion diagnostics for targeted cancer therapies and immuno-oncology. Such developments are expected to drive the North America in-vitro diagnostics market.

In 2022, bioMérieux announced that it had finalized the acquisition of Specific Diagnostics, a privately held U.S. based company that had developed a rapid antimicrobial susceptibility test (AST) system that delivered phenotypic AST directly from positive blood cultures. With the acquisition, bioMérieux sought to further develop its global leadership in clinical microbiology, bringing major innovation to the market and strengthen its fight against antimicrobial resistance.

Key Findings of the Report:

  • The North America in-vitro diagnostics market is expected to be driven by the need for effective and efficient detection technologies.
  • Advanced solutions are expected to boost market growth.

Market Analysis by Product and Service, Technology, Application, and Country:

  • By product and service, the market is segmented into Reagents and Kits, Instruments, and Software and Services.
  • By technology, the market is divided into Immunoassay/Immunochemistry, Clinical Chemistry, Molecular Diagnostics, Microbiology, Haematology, Blood Glucose Self-Monitoring, Coagulation and Haemostasis, Urinalysis, and Others.
  • By application, the market is divided into Infectious Diseases, Diabetes, Oncology, Cardiology, Autoimmune Diseases, Nephrology, and Others.
  • By country, the market is classified into United States and Canada.

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