U.S. In-vitro Diagnostics Market Size, Share & COVID-19 Impact Analysis, By Product Type (Instruments and Reagents & Consumables), By Technique (Immunodiagnostics, Clinical Chemistry, Molecular Diagnostics, Hematology, and Others), By Setting (Laboratories and Point of Care), By Application (Infectious Diseases, Cardiology, Oncology, Gastroenterology, and Others), By End-user (Clinical Laboratories, Hospitals, Physician’s Offices, and Others), and Forecasts, 2023-2030

The U.S. in-vitro diagnostics market size was USD 32.94 billion in 2022. The market is anticipated to grow from USD 33.78 billion in 2023 to USD 56.81 billion by 2030, exhibiting a CAGR of 7.7% during the forecast period.

This market is anticipated to grow owing to the notable presence of several giant market players, growing demand for rapid diagnostic testing & point of care devices, increasing prevalence of chronic disorders, and rising awareness regarding early disease diagnosis.

• For instance, the Pan American Health Organization (PAHO), Childhood Cancer International, and St. Jude Children’s Hospital launched a campaign to create awareness regarding early cancer detection in children and adolescents. According to the PAHO, timely diagnosis and treatment of pediatric cancer can improve the chances of survival.

Moreover, the increasing geriatric population is also a major reason for the growing product demand. For instance, in July 2021, a demographic research projection published by the University of Washington assumed that every other person born since the beginning of the 21st century in the U.S. will live up to 100 years. This factor is expected to increase the use of diagnostic devices, thereby contributing to the U.S. in-vitro diagnostics market growth.

• According to the U.S. Census Bureau report, by 2060, the number of patients who have diabetes is projected to increase by 25.1% to 162 million.

Such initiatives by government organizations to increase awareness for early disease diagnosis are anticipated to surge the demand for diagnostics products and contribute to the market growth during the forecast period.

COVID-19 IMPACT 

Surged Usage of Molecular and Point of Care Diagnostic Devices Boosted Market Growth during COVID-19 Pandemic

The COVID-19 pandemic created a favorable environment for this industry to grow. During the pandemic, millions of tests were conducted in the U.S. to detect COVID-19 infections, which increased manufacturers' revenues by many folds.

• For instance, according to the data published by the U.S. CDC in 2022, from March 2020 to July 2022, around 921.4 million COVID-19-related Nucleic Acid Amplification Tests (NAATs) were performed in the U.S.


• Such a high number of tests led to increased revenue for manufacturers. For example, in 2020, the diagnostic division of Abbott registered a revenue growth of 65.4% in the U.S.

In 2021, the growth of the U.S. in-vitro diagnostics market continued at a similar rate. The increased number of product launches and rising demand for home healthcare devices propelled the market growth during this year. For instance, in March 2021, BATM Advanced Communications Ltd. announced the launch of its molecular diagnostics self-test kit to detect COVID-19.

In 2022, due to the reduced number of tests, the U.S. in-vitro diagnostic market growth slowed and reached to pre-pandemic level. Thus, the COVID-19 outbreak positively impacted the market and gained huge interest of investors toward this industry, which is expected to propel the market growth in the coming years.

LATEST TRENDS

Strategic Alliances Leading to Industry Consolidation Anticipated to Propel the Industry Growth

Investors of the in-vitro diagnostics market in the U.S. spotted various opportunities to utilize the revenue generated during the COVID-19 pandemic profitably. Some of the leading in-vitro diagnostics manufacturers have large reserves of cash owing to the high sales of COVID-19 tests and instruments. This is prompting speculation among investors about future mergers and acquisitions that might expand the U.S. in-vitro diagnostics market share. According to an article published in July 2022, many large manufacturers experienced investor pressure to develop strategic plans for investment of these cash reserves.

• For instance, in May 2022, Quidel Corporation announced the acquisition of Ortho Clinical Diagnostics Holdings plc. The acquisition aimed to diversify product pipeline and broader geographic footprint by uniting the platforms and technologies of both the companies. 

Moreover, Bruce Carlson, Senior Vice President at Kalorama Information, predicted that there were high chances of industry consolidation over the next two to five years. Such strategic alliances and acquisitions to maintain the investor’s interest in this industry will likely offer big players a chance to strengthen their presence and portfolios.

DRIVING FACTORS

Increasing Demand for Point of Care Diagnostics and Introduction of Advanced Products to Propel Market Growth

Point-of-care diagnostics enables decentralized testing for diabetes, infectious diseases, cardiovascular parameters, and others. It produces reliable and rapid results that help identify and monitor chronic diseases. Owing to the increasing applications, innovators in the point of care diagnostics field are constantly exploring bio-sensing technologies to measure a variety of proteins, biomarkers, and DNA. In-vitro diagnostics manufacturers are working to build technologies that can identify more than one type of disease on the same device.

• For instance, in March 2022, Visby Medical received funding of USD 25.5 million to develop a rapid flu-COVID-19 PCR test that can detect COVID-19, influenza A, and B from a single sample. The company received funding from the U.S. Biomedical Advanced Research and Development Authority.

Moreover, the rising prevalence of diabetes in the U.S. requires regular blood sugar monitoring, thereby increasing the demand for glucose monitoring products.

• For instance, according to the National Diabetes Statistics report published in June 2022, 37.3 million people in the U.S. had diabetes, which constituted around 11.3% of the country’s population.


• 96 million adults are reported to have prediabetes, which constitutes around 38% of the adult population in the U.S. Thus, the increasing diabetic patient pool is anticipated to boost the demand for glucose monitoring devices, driving this market.

RESTRAINING FACTORS

Compliance Challenges Faced by Manufacturers Due to Rule Changes to Limit Market Growth

The confusion about whether in-vitro diagnostics should be considered medical devices or biological products led to several updates in the regulatory system. However, these frequent changes can create operational barriers for IVD manufacturers, leading to unnecessary time and resource consumption.

• For instance, according to the U.S. Food and Drug Administration (USFDA), IVDs are currently considered medical devices. However, they might also be considered biological products subject to section 351 of the Public Health Service Act.

Moreover, advancements in laboratory tests led to increased scrutiny of these diagnostic tests that aren’t technically considered IVDs. The FDA has issued draft guidance and a discussion paper describing the enforcement discretion for certain regulatory requirements and types of LDTs. Such changes create a grey area for IVD manufacturers regarding compliance with IVD regulations, which hampers the market growth.

SEGMENTATION

By Product Type Analysis

Growing Demand for Testing COVID-19 Virus will Boost Usage of Reagents & Consumables 

Based on product type, the market is segmented into instruments and reagents & consumables. The reagents & consumables segment held a dominating in-vitro diagnostics market share. During the COVID-19 pandemic, the high demand for testing the SARS-CoV-2 virus established a sturdy base for the growth of the reagents & consumables segment. Additionally, a sudden surge in the diagnosis of cancer and other diseases boosted the demand for these products.

• For instance, the Illumina NovaSeq 6000Dx S2 Reagent Kit is a set of reagents & consumables intended for sequencing sample libraries when used with validated assays.

The instruments segment is anticipated to record a significant CAGR during the forecast period. The introduction of technologically advanced instruments is expected to contribute to the segment’s growth. For instance, in 2020 and 2021, Abbott developed and launched various lab-based serology blood tests on its ARCHITECT i1000SR and ARCHITECT i2000SR laboratory instruments and its Alinity system to detect an antibody to confirm if someone was previously infected by COVID-19. The tests were launched under EUAs in the U.S. and CE marks.

By Technique Analysis

Advanced Product Launches by Key Market Players to Fuel Demand for Molecular Diagnostics

Based on technique, the market is segmented into immunodiagnostics, clinical chemistry, molecular diagnostics, hematology, and others. In 2022, the molecular diagnostics segment dominated the market due to the increasing demand for medicines and introduction of technologically advanced molecular diagnostic tests by key players.

• For instance, in April 2021, BIO-TECHNE announced the launch of NOVEL DNASCOPE, a chromogenic DNA In-Situ Hybridization (ISH) technology. It enables visualization of single-molecule gene expression with single-cell resolution directly in intact cells and tissues.

Moreover, the other segments are projected to register a substantial CAGR during the forecast period. This growth is attributed to factors, such as increasing need for blood transfusion, rapidly growing incidence of chronic diseases, and developments in analytical methods. For instance, according to the Community Blood Center, 4.5 million Americans need blood transfusion annually, and only 37% of the U.S. population is eligible to donate blood. Thus, blood transfusions and donations in the U.S. will contribute to the growth of the hematology segment during the forecast period.

By Setting Analysis

Increasing Product Approvals to Boost the Point of Care Segment’s Growth

Based on setting, the market is segmented into laboratories and point-of-care. The laboratories segment dominated the market in 2022. The laboratories segment regained its pace after the COVID-19 pandemic, as during the lockdown, many laboratory tests were put on hold, and the adoption of point of care devices grew. After the pandemic, laboratory tests resumed and introduction of new products to handle large sample volumes contributed to the segment's robust growth in the market.

The point-of-care segment is projected to record a significant CAGR during the forecast period. During the COVID-19 pandemic, the point of care segment grew tremendously, and its increased adoption is anticipated to contribute to the market growth in the coming years. Moreover, increasing number of product approvals will also aid the market growth. For instance, in June 2021, Abbott received a CE mark for its Panbio rapid antigen self-test to detect the SARS-CoV-2 virus in adults and children with or without symptoms. Therefore, such product approvals will significantly augment POC diagnostics' business growth.

By Application Analysis

Increasing Incidence of Infectious Diseases to Surge the Demand for In-vitro Diagnostics

Based on application, the market is segmented into infectious diseases, cardiology, oncology, gastroenterology, and others. The infectious diseases segment dominated the market in 2022 due to the rising incidence of infectious diseases in the U.S.

• For instance, according to the data published in October 2022 by the U.S. Department of Health & Human Services, approximately 1.2 million people in the U.S. have HIV. About 13% of them remain undiagnosed and need testing.

The oncology application segment is expected to register a significant CAGR during the forecast period. The growth of this segment is attributed to new product launches and the rising prevalence of cancer.

• For instance, in August 2022, Thermo Fisher Scientific Inc. announced the launch of the CE-IVD (IVDD) Oncomine Dx Express Test and Oncomine Reporter Dx for use in clinical laboratories. The qualitative test claims to detect deletions, insertions, and substitutions, and deliver clinically approved tumor mutation profiling in less than 24 hours to help healthcare professionals offer better patient care.

By End-user Analysis

High Testing Capacity at Clinical Laboratories to Boost Product Demand

By end-user, the market is divided into clinical laboratories, hospitals, physician's offices, and others. The clinical laboratories segment dominated the market in 2022 due to the greater accuracy of lab tests, higher number of diagnostics procedures, and presence of advanced equipment that can handle large sample sizes. Moreover, the physician's offices segment is expected to record a higher CAGR due to the growing inclination of patients toward point-of-care tests under their physician’s guidance.

KEY INDUSTRY PLAYERS

Mergers and Acquisitions by Key Players to Propel Market Progress

The market is fragmented with leading players, such as Abbott, F. Hoffmann-La Roche AG, Quest Diagnostics Incorporated, and Bio-Rad Laboratories, Inc. The focus of these market players is to adopt strategies, such as joint ventures, business expansions, collaborations, and acquisitions to develop novel devices for patients suffering from chronic diseases.

• In February 2023, F. Hoffmann-La Roche AG announced that it had expanded its collaboration with Janssen Biotech Inc. (Janssen) to create companion diagnostics for targeted therapies. The collaboration aimed to strengthen research and innovation activities.

Other prominent market players are BD, Thermo Fisher Scientific Inc., Agilent Technologies, Inc., Siemens Healthineers AG, and Quidel Corporation. A significant rise in the prevalence of chronic diseases, adoption of point of care tests, and awareness about early disease diagnosis are encouraging the key players to introduce innovative products in the market.

LIST OF KEY COMPANIES PROFILED:

• Abbott (U.S.)


• F. Hoffmann-La Roche AG (Switzerland)


• Thermo Fisher Scientific Inc. (U.S.)


• Quest Diagnostics Incorporated (U.S.)


• Bio Rad Laboratories, Inc. (U.S.)


• BD (Becton, Dickinson, and Company) (U.S.)


• Agilent Technologies, Inc. (U.S.)


• Quidel Corporation (U.S.)


• Siemens Healthcare GmbH (Germany)

KEY INDUSTRY DEVELOPMENTS:

• February 2023 – BD received the Emergency Use Authorization (EUA) from the USFDA for its molecular diagnostic combination test for SARS-CoV-2, Influenza A + B, and Respiratory Syncytial Virus (RSV).


• October 2022 – Thermo Fisher Scientific Inc. agreed to acquire the Binding Site Group, which provides specialty diagnostic assays and instruments. The acquisition will enhance Thermo Fisher’s specialty diagnostics portfolio.


• March 2022 - Thermo Fisher Scientific Inc. launched Ion Torrent Genexus Dx Integrated Sequencer. The device was designed to be used in laboratories to perform clinical research and diagnostic testing on a single instrument.

REPORT COVERAGE

The research report provides a detailed market analysis and focuses on crucial aspects such as medical device manufacturers, products, and end-users. Additionally, it offers insights into the latest market trends, key industry developments such as collaborations, partnerships & acquisitions, and the impact of COVID-19 on the market. In addition to the above-mentioned factors, the report includes various other factors that have contributed to the market's growth in recent years with a regional analysis of different segments.

Report Scope & Segmentation

ATTRIBUTE	DETAILS
Study Period	2019-2030
Base Year	2022
Estimated Year	2023
Forecast Period	2023-2030
Historical Period	2019-2021
Growth Rate	CAGR of 7.7% from 2023-2030
Unit	Value (USD billion)
Segmentation	By Product Type, Technique, Setting, Application, End-user
By Product Type	Instruments Reagents & Consumables
By Technique	Immunodiagnostics Clinical Chemistry Molecular Diagnostics Hematology Others
By Setting	Laboratories Point-of-Care
By Application	Infectious Diseases Cardiology Oncology Gastroenterology Others
By End-user	Clinical Laboratories Hospitals Physician’s Offices Others