U.S. IVD Market to Record an Exponential CAGR by 2032 – Exclusive Report by Allied Market Research

Technological advancements in IVD

The healthcare industry is developing at a significant rate due to demand for better healthcare services, significant investments by governments to improve healthcare infrastructure, rise in focus on the improvement of effectiveness, and safety of the medical devices. Earlier, molecular testing was time consuming and costly, but these days with automated technology one can get accurate, cost effective and quick results.

IVD market growth:

US In Vitro Diagnostic is a medical procedure that involves the examination, diagnosis, and monitoring of a sample taken from the human body, such as a blood sample, urine sample, or tissue sample, in a laboratory environment. The term “in vitro” is derived from the Greek word “in vitro”, which translates to “in glass”. IVD covers a broad range of medical tests, from clinical chemistry and immunoassay to molecular diagnostics and microbiology, as well as genetic testing. IVD plays an essential role in the decision-making process of healthcare, as it allows for the early identification of diseases, the monitoring of treatment efficacy, and the improvement of patient outcomes.

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Drivers:

• Increase in prevalence of chronic and infectious diseases
• Surge in awareness about early disease diagnosis and personalized medicine
• Rise in the number of diagnostic laboratories

Opportunities:

• Technological advancements in IVD

Restraints:

• Stringent regulatory policies

Economic Downturn Analysis: Impact of Recession in 2023 on the US IVD Market: 

• During a recession, individuals and governments tightened their budgets, leading to reduced healthcare spending. This has affected patients’ ability to access and afford in vitro diagnostics products, potentially leading to decreased demand for these products. In addition, economic uncertainty during a recession might cause individuals to delay or avoid non-essential medical visits, including routine check-ups. 
  
• However, the rise in research and development activities for in vitro diagnostics and the increase in the prevalence of chronic diseases is experiencing a moderate positive impact from the global recession.

Who are the leaders in the US IVD market?

• Roche Diagnostics
• Abbott Laboratories
• Siemens Healthineers
• Danaher Corporation (Beckman Coulter)
• Johnson & Johnson
• Sysmex Corporation
• BioMérieux
• QIAGEN
• Agilent Technologies
• Hologic, Inc.

Market Segmentation:

By Test Type:

• Immunoassays: Largest segment, used for detecting and measuring proteins, hormones, and other biomarkers.
• Molecular Diagnostics: Rapidly growing segment, used for genetic testing, pathogen identification, and personalized medicine.
• Clinical Chemistry: Analyzes blood and other fluids for indicators of various diseases and metabolic functions.
• Hematology: Focuses on blood cell analysis and coagulation testing.
• Microbiology: Identifies and analyzes microorganisms for diagnosis and treatment of infectious diseases.

By Application:

• Hospital Laboratories: Largest user segment, performing a wide range of tests for diagnosis, monitoring, and treatment of patients.
• Reference Laboratories: Specialized laboratories offering advanced testing not readily available in hospitals.
• Physician Offices and Clinics: Increasingly adopting point-of-care IVD tests for rapid results and improved patient management.
• Home Diagnostics: Growing segment with tests for pregnancy, glucose monitoring, and other conditions.

By Technology:

• Enzyme-linked Immunosorbent Assay (ELISA): Well-established and widely used for immunoassays.
• Polymerase Chain Reaction (PCR): Core technology for molecular diagnostics.
• Next-generation Sequencing (NGS): Advanced technology for genetic analysis and personalized medicine.
• Microfluidic and Lab-on-a-Chip Technologies: Miniaturized platforms for rapid and automated testing.
• Point-of-Care (POC) Testing: Portable devices for immediate results at the patient’s bedside.

By Regulatory Landscape: 

• FDA Regulation: US Food and Drug Administration (FDA) approval is required for most IVD tests before marketing.
• Clinical Laboratory Improvement Amendments (CLIA) Regulations: Govern the quality and accuracy of testing in clinical laboratories.
• Centers for Medicare & Medicaid Services (CMS) Reimbursement: Influences the adoption and utilization of IVD tests by healthcare providers.

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The report provides a detailed analysis of these key players in the US in vitro diagnostics market. These players have adopted strategies such as product launch, acquisition, partnership, product approval, and expansion to increase their market share and maintain dominant shares in different regions. The report is valuable in highlighting business performance, operating segments, product portfolio, and strategic moves of market players to showcase the competitive scenario.

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