Report Overview

United States In-Vitro Diagnostics (IVD) Market - Industry Trends & Forecast Report, 2030

United States In-Vitro Diagnostics (IVD) Market size was estimated to be worth USD 33.50 billion in 2023. During the forecast period between 2024 and 2030, United States In-Vitro Diagnostics (IVD) Market size is projected to grow at a CAGR of 5.70%, reaching a value of USD 49.10 billion by 2030. Major growth factors for United States In-Vitro Diagnostics (IVD) Market include the rising prevalence of various communicable and non-communicable diseases and the increasing geriatric population. As a result, the number of point-of-care tests is growing along with the increasing adoption of automation in laboratories and automated instruments, which is anticipated to present lucrative growth opportunities for United States In-Vitro Diagnostics (IVD) Market over the forecast period.

In-Vitro Diagnostics (IVD) – Overview

In Vitro Diagnostics (IVD) refers to tests conducted on samples such as blood or tissue that have been extracted from the human body. These diagnostics are used to detect diseases or other health conditions, monitor a person's overall health, and assist in treating illnesses. In precision medicine, IVDs are also used to identify patients likely to benefit from particular treatments or therapies. Next-generation sequencing tests are an example of an IVD that screens an individual's DNA to detect genomic variations. IVDs are critical tools for everyday medical practice and emergencies, and numerous treatment decisions are based on their results.

United States In-Vitro Diagnostics (IVD) Market

Growth Drivers

Rising Prevalence of Chronic and Infectious Diseases

The increasing geriatric population and rising rate of prevalence of chronic and infectious diseases in the United States have directly influenced the demand for in-vitro diagnostics (IVD) in the country. According to the United States Census Bureau, 55.8 million people, or 16.5% of the population, which is one in six people, are above the age of 65 years and over in the country. With the rapidly aging population, the prevalence of age-associated diseases, such as high blood cholesterol levels, stroke, and diabetes, is projected to rise in the coming years. For example, about 80% of the elderly population in the US has one or more chronic illnesses, and 78.7% have two or more. Hence, the growing elderly population and the rising prevalence of chronic and infectious diseases among Americans across demographic segments are driving United States In-Vitro Diagnostics (IVD) Market.

Challenges

Unfavorable Reimbursement Policies

Inadequate reimbursement is one of the major factors restraining the growth of United States In-Vitro (IVD) Diagnostics Market. Medicare revised its reimbursement policy for several IVD investigations, including molecular diagnostics, in the United States a few years ago. Certain molecular pathology diagnostics are invoiced using unlisted codes since they lack codes for their own Healthcare Standard Procedure Coding System (HCPCS). Medicare Administrative Contractors (MACs) establish a reimbursement amount for their local jurisdictions in such circumstances. As of January 2017, over 75% of studies indicated that reimbursement rates have decreased (CMS). Genetic testing, five to fifty gene-targeted NGS review tables, and cancer tests are a few of such research. The US market for genetic and molecular testing is predicted to suffer as a result of these developments, which would hinder the expansion of the IVD market.

Impact of Escalating Geopolitical Tensions on United States In-Vitro Diagnostics (IVD) Market

The escalating geopolitical tensions disrupt the growth of United States in-vitro diagnostics (IVD) market. For instance, China is one of the leading trading partners of the United States and a major exporter of medical diagnostic test instruments. However, the escalating rift between the two countries owing to the advancing military capabilities of China may pose a threat to the healthcare trade as well. Furthermore, geopolitical tensions causes supply chain disruption which hinders the accessibility to healthcare products as well as eventually lead to surge in prices, which may negatively impact the growth In-Vitro Diagnostics (IVD) Market in United States.

United States In-Vitro Diagnostics (IVD) Market

Segmental Coverage

United States In-Vitro Diagnostics (IVD) Market – By Product and Services

Based on products and services, United States In-Vitro Diagnostics (IVD) Market is segmented into reagents & kits, instruments, and software & services. The reagents & kits segment accounts for the highest market share. The extensive research & development activities for the development of novel biomarkers and the launch of new products on the market are propelling market growth. The instrument segment is anticipated to grow at a high rate during the period in analysis. Technological advancements and rising automation in the industry, along with an increasing demand for faster and more efficient diagnostic processes, are anticipated to drive the growth of the instrument segment during the forecast period.

United States In-Vitro Diagnostics (IVD) Market – By Technique

On the basis of technique, United States In-Vitro Diagnostics (IVD) Market is segmented into molecular diagnostics, tissue diagnostics, clinical chemistry, immunodiagnostics, hematology, and others. The molecular diagnostics segment holds the largest share in United States In-Vitro Diagnostics (IVD) Market by technique. The growth of the market is mainly attributed to the rising adoption of rapid testing and point-of-care. Molecular diagnosis is used for various purposes, including disease diagnosis and monitoring, risk detection, and determining the best-suited therapy for a patient. The rising demand for precision medication is anticipated to fuel the demand for molecular diagnosis as well over the forecast period.

United States In-Vitro Diagnostics (IVD) Market – By Application

Based on application, United States In-Vitro Diagnostics (IVD) Market is segmented into infectious diseases, cancer, cardiac diseases, immune system disorders, nephrological diseases, gastrointestinal diseases, and others. The infectious disease segment accounts for the highest market share owing to the rising prevalence of communicable diseases in the United States. This results in the launch of testing solutions specifically designed for testing infectious diseases, which drives market growth. In addition, the COVID-19 outbreak further proliferated market growth owing to the use of assays for the detection of SARS-CoV-2.

Competitive Landscape

United States In-Vitro Diagnostics (IVD) market is intensely competitive, as a number of companies are competing to gain a significant market share. Key players in the market include Roche Diagnostics, Abbott Laboratories, Siemens Healthineers, Danaher Corporation, Thermo Fisher Scientific, Johnson & Johnson, Ortho-Clinical Diagnostics, Sysmex Corporation, Bio-Rad Laboratories, bioMérieux, QIAGEN, and Becton, Dickinson and Company. To further enhance their market share, these companies employ various strategies, including mergers and acquisitions, partnerships, joint ventures, license agreements, and new product launches.

Recent Developments

• In November 2023 – Veracyte, a global diagnostics company based in the United States, announced a multi-year agreement with Illumina Inc., an American biotechnology company, to offer in-vitro diagnostic tests to patients globally.

Scope of the Report

By Product and Services

• Reagents & Kits

• Instruments

• Software & Services

By Technique

• Molecular Diagnostics

• Tissue Diagnostics

• Clinical Chemistry

• Immunodiagnostics

• Hematology

• Others

By Application

• Infectious Diseases

• Cancer

• Cardiac Diseases

• Immune System Disorders

• Nephrological Diseases

• Gastrointestinal Diseases

• Others

By End User

• Standalone Laboratories

• Hospitals

• Academic & Medical Schools

• Point of Care

• Others

1. Research Framework
   1. Research Objective
   2. Product Overview
   3. Market Segmentation
2. Executive Summary
3. United States In-Vitro Diagnostics (IVD) Market Insights
   1. Industry Value Chain Analysis
   2. DROC Analysis
      1. Growth Drivers
         1. Increasing Prevalence of Chronic Diseases
         2. Innovations in IVD Technology, such as Point-Of-Care Testing, Molecular Diagnostics, and Automation
         3. Rising Healthcare Expenditure
         4. Growing Awareness about Early Disease Detection
      2. Restraints
         1. Unfavorable Reimbursement Scenario
         2. High Cost of Development
         3. Stringent Regulatory Environment
      3. Opportunities
         1. Emerging Technologies such as Liquid Biopsy, Digital Pathology, and Microfluidics
         2. Increasing Adoption of Personalized Medicine
         3. Growing Demand for Rapid and Accessible Diagnostic Solutions
      4. Challenges
         1. Shortage of Skilled Professionals in the IVD Industry
         2. Increasing Concerns about Data Privacy and Security
   3. Technological Advancements/Recent Developments
   4. Regulatory Framework
   5. Porter’s Five Forces Analysis
      1. Bargaining Power of Suppliers
      2. Bargaining Power of Buyers
      3. Threat of New Entrants
      4. Threat of Substitutes
      5. Intensity of Rivalry
4. United States In-Vitro Diagnostics (IVD) Market: Marketing Strategies
5. United States In-Vitro Diagnostics (IVD) Market: Pricing Analysis
6. United States In-Vitro Diagnostics (IVD) Market Overview
   1. Market Size & Forecast, 2019–2030
      1. By Value (USD Billion)
   2. Market Share & Forecast
      1. By Product and Services
         1. Reagents & Kits
         2. Instruments
         3. Software & Services
      2. By Technique
         1. Molecular Diagnostics
         2. Tissue Diagnostics
         3. Clinical Chemistry
         4. Immunodiagnostics
         5. Hematology
         6. Others
      3. By Application
         1. Infectious Diseases
         2. Cancer
         3. Cardiac Diseases
         4. Immune System Disorders
         5. Nephrological Diseases
         6. Gastrointestinal Diseases
         7. Others
      4. By End User
         1. Standalone Laboratories
         2. Hospitals
         3. Academic and Medical Schools
         4. Point of Care
         5. Others
7. Competitive Landscape
   1. List of Key Players and Their Products
   2. United States In-Vitro Diagnostics (IVD) Company Market Share Analysis, 2023
   3. Competitive Benchmarking, By Operating Parameters
   4. Key Strategic Developments (Mergers, Acquisitions, Partnerships)
8. Impact of Escalating Geopolitical Tensions on United States In-Vitro Diagnostics (IVD) Market
9. Company Profiles (Company Overview, Financial Matrix, Competitive landscape, Key Personnel, Key Competitors, Contact Address, and Strategic Outlook, and SWOT Analysis)
   1. Roche Diagnostics
   2. Abbott Laboratories
   3. Siemens Healthineers
   4. Danaher Corporation
   5. Thermo Fisher Scientific
   6. Johnson & Johnson
   7. Ortho-Clinical Diagnostics
   8. Sysmex Corporation
   9. Bio-Rad Laboratories
   10. bioMérieux
   11. QIAGEN
   12. Becton, Dickinson and Company
   13. Other prominent players
10. Key Strategic Recommendations
11. Research Methodology
    1. Qualitative Research
       1.  Primary & Secondary Research
    2.    Quantitative Research
    3.    Market Breakdown & Data Triangulation
       1.  Secondary Research
       2.  Primary Research
    4.    Breakdown of Primary Research Respondents
    5.    Assumptions & Limitations

*Financial information of non-listed companies can be provided as per availability.

**The segmentation and the companies are subject to modifications based on in-depth secondary research for the final deliverable.

List of Figures

Figure 1       United States In-Vitro Diagnostics (IVD) Segmentation

Figure 2       United States In-Vitro Diagnostics (IVD) Market Value Chain Analysis

Figure 3       Company Market Share Analysis, 2023

Figure 4       United States In-Vitro Diagnostics (IVD) Market Size, By Value (USD Billion), 2019–2030

Figure 5       United States In-Vitro Diagnostics (IVD) Market Share, By Product and Services, By Value (USD Billion), 2019–2030

Figure 6       United States In-Vitro Diagnostics (IVD) Market Share, By Technique, By Value (USD Billion), 2019–2030

Figure 7       United States In-Vitro Diagnostics (IVD) Market Share, By Application, By Value (USD Billion), 2019–2030                                       

Figure 8       United States In-Vitro Diagnostics (IVD) Market Share, By End User, By Value (USD Billion), 2019–2030

List of Tables      

Table 1        United States In-Vitro Diagnostics (IVD) Market Size, By Value (USD Billion), 2019–2030

Table 2        United States In-Vitro Diagnostics (IVD) Market Share, By Product and Services, By Value (USD Billion), 2019–2030

Table 3        United States In-Vitro Diagnostics (IVD) Market Share, By Technique, By Value (USD Billion), 2019–2030

Table 4        United States In-Vitro Diagnostics (IVD) Market Share, By Application, By Value (USD Billion), 2019–2030

Table 5        United States In-Vitro Diagnostics (IVD) Market Share, By End User, By Value (USD Billion), 2019–2030

Table 6        Roche Diagnostics Company Overview

Table 7        Roche Diagnostics Financial Overview

Table 8        Abbott Laboratories Company Overview

Table 9        Abbott Laboratories Financial Overview

Table 10      Siemens Healthineers Company Overview

Table 11      Siemens Healthineers Financial Overview

Table 12      Danaher Corporation Company Overview

Table 13      Danaher Corporation Financial Overview

Table 14      Thermo Fisher Scientific Company Overview

Table 15      Thermo Fisher Scientific Financial Overview

Table 16      Johnson & Johnson Company Overview

Table 17      Johnson & Johnson Financial Overview

Table 18      Ortho-Clinical Diagnostics Company Overview

Table 19      Ortho-Clinical Diagnostics Financial Overview

Table 20      Sysmex Corporation Company Overview

Table 21      Sysmex Corporation Financial Overview

Table 22      Bio-Rad Laboratories Company Overview

Table 23      Bio-Rad Laboratories Financial Overview

Table 24      bioMérieux Company Overview

Table 25      bioMérieux Financial Overview

Table 26      QIAGEN Company Overview

Table 27      QIAGEN Financial Overview

Table 28      Becton, Dickinson and Company - Company Overview

Table 29      Becton, Dickinson and Company Financial Overview