North America in vitro diagnostics Market Share Analysis Report, 2023-2032
The North America in vitro diagnostics market size was exhibited at USD 50.19 billion in 2022 and is projected to hit around USD 66.86 billion by 2032, growing at a CAGR of 2.91% during the forecast period 2023 to 2032.
Key Pointers:
North America in vitro diagnostics Market Report Scope
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Report Coverage |
Details |
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Market Size in 2023 |
USD 51.65 Billion |
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Market Size by 2032 |
USD 66.86 Billion |
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Growth Rate from 2023 to 2032 |
CAGR of 2.91% |
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Base year |
2022 |
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Forecast period |
2023 to 2032 |
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Segments covered |
Product, Technology, Application, End-use, Test location, Region |
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Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
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Key companies profiled |
Abbott; bioMérieux SA; Bio-Rad Laboratories, Inc.; BD; Siemens Healthcare GmbH; QIAGEN; Quidel Corporation; F. Hoffmann-La Roche Ltd; Sysmex Corporation; Charles Rivers Laboratories International, Inc.; Quest Diagnostics; Danaher |
The market is also expected to cater to various growth opportunities in key segments. For example, the development of automated in vitro diagnostic solutions for hospitals and laboratories to provide accurate, efficient, and error-free diagnosis is anticipated to drive market growth in the coming years. In addition, rising efforts to develop POC solutions and the surge in adoption of POC tests across different medical diagnostic applications, including infectious diseases, pregnancy, cancer, and others, are fueling the market growth.
The market growth is likely to be fueled by rising efforts from leading participants to develop fast and accurate products that allow easy-to-use, advanced, and flexible testing options. For instance, in August 2022, DxGen Corp. and Precision Diabetes, Inc. announced an agreement to develop and launch a fully automatic POC analyzer in the U.S. market to measure a complete profile of diabetes tests. The analyzer is capable to test C-reactive protein, urine analysis, A1C levels, and other diabetes confirmatory tests at POC facilities.
Furthermore, in November 2021, Lumos Diagnostics, a key player in POC diagnostics, announced that its Lumos CoviDx SARS-CoV-2 Rapid Antigen Test received an interim order authorization from Health Canada. This test offers easy-to-interpret outcomes in just 15-20 minutes in serial testing of asymptomatic patients. The easy availability of point-of-care tests in home care settings, community pharmacies, retail health clinics, urgent care centers, intensive care units, and operating rooms is fueling the adoption of POC IVD products across the region.
The North America in vitro diagnostics industry is gaining traction as diagnostic laboratories frequently employ fully automated tools. Moreover, automated devices are highly scalable, meet a high level of performance expectations, eliminate batch testing, and provide quick results to medical professionals. Leading participants are continuously working on building automated devices because of these benefits. For instance, in May 2022, BD launched a new, fully automated high-throughput infectious disease molecular diagnostics platform in the U.S. market.
Furthermore, the increasing incidence of target diseases, favorable government initiatives, and the flourishing healthcare sector in the region are anticipated to offer lucrative growth opportunities.
For instance, in November 2022, Hologic, Inc. was awarded a USD 19 million contract from BARDA to support its research and development activities. In addition, in January 2022, Aline, Inc. & Nectar Product Development announced a strategic partnership to improve POC in vitro diagnostic products.
Product Insights
The reagents segment held the largest share of 65.9% in 2022 and is anticipated to advance at a steady CAGR during the projected period. Factors such as extensive R&D initiatives being undertaken by major market players for the development of novel tests for different applications and the commercialization of new reagents are likely to drive market growth.
For instance, in March 2021, Promega Corporation introduced XpressAmp direct amplification reagents, which facilitate automation-friendly RNA extraction-free sample preparation. Moreover, in November 2021, 28 Fungal Analyte Specific Reagents (ASRs) were launched by Applied BioCode to sell to clinical laboratories and IVD manufacturers.
The instruments segment held the second largest revenue share in 2022; the high revenue share of the segment can be attributed to the rising demand for PoC testing instruments, technological advancements, and the rising demand for advanced instruments by end-users. Furthermore, key manufacturers are focused on developing new technologies with higher efficiency & accuracy. For instance, the VIDAS and MINI VIDAS systems by bioMérieux are multiparametric immunoassay systems designed to offer highly accurate & precise laboratory results.
Technology Insights
The molecular diagnostics segment dominated the market for North America in vitro diagnostics owing to factors such as rapid evolution in technology, increasing burden of target diseases, the outbreak of COVID-19, and surge in product launches by leading participants. For instance, in November 2022, Roche planned to launch the cobas 5800 system, a compact and fully automated lab instrument that offers flexible PCR testing solutions, in the U.S.
Moreover, the presence of flexible regulations for manufacturers to combat the rising number of infectious diseases is anticipated to accelerate North America in vitro diagnostics industry growth. For instance, in March 2021, the U.S. FDA issued a EUA for Abbott’s molecular test to detect COVID-19. Moreover, the launch of initiatives & programs is further propelling the demand for molecular diagnostics to reduce disease burden. For instance, in March 2022, Molecular Characterization Initiative was launched by the National Cancer Institute to provide childhood cancer molecular characterization.
The rising demand for regular health checkups, the surge in the prevalence of hematological disorders, and the rising demand for POC & portable devices are some factors responsible for the growth of the hematology segment. The rising demand for benchtop and portable devices is pushing manufacturers to develop hematology instruments with new features and enhanced performance. For instance, in July 2022, HORIBA Medical launched Yumizen 550 and 500 in its hematology product portfolio. Similarly, in August 2020, IDEXX Laboratories, Inc. launched the ProCyte One Hematology Analyzer, which delivers accurate and consistent results with operability in PoC settings.
Application Insights
In 2022, the infectious disease segment held the largest market share of 60.8% owing to the rising burden of infectious diseases in the region and the increasing uptake of IVD products for the detection of infectious diseases. The COVID-19 pandemic has increased segment growth exponentially. In addition, leading participants are engaged in commercializing precise testing solutions for infectious diseases. For instance, in October 2021, QIAGEN launched the QuantiFERON-TB test for tuberculosis infection. The newly launched product aimed to reduce the rising tuberculosis burden in the region.
The diabetes segment held the second largest share due to the growing trend of a sedentary lifestyle in North America, the prevalence of obesity, and the rising demand for homecare diagnostic solutions. Several companies are introducing portable and home-use devices owing to their high demand. For instance, in May 2022, LabCorp launched the LabCorp OnDemand at-home collection kit, which can measure HbA1c from small blood samples.
The oncology segment is anticipated to exhibit a lucrative growth rate throughout the forecast period. The increasing burden of cancer in the U.S. & Canada, rising demand for advanced screening solutions, and increasing awareness for early disease diagnosis among people are all expected to support segment expansion.
Test Location Insights
Most tests are performed in central laboratory settings. However, the increased focus of the regulatory bodies on self-test or OTC molecular diagnostics to lower the burden on laboratories is boosting the OTC test market’s growth. For instance, in March 2021, Cue Health, Inc. announced the U.S. FDA approval of its OTC and at-home self-test for SARS-CoV-2, making it the first non-prescription diagnostic test in the U.S. Moreover, in May 2021, the retail chain Kroger Co. announced the availability of self-testing kits by Abbott across its store to increase overall access to test kits.
The point-of-care segment is projected to register a robust growth rate throughout the projected period. The rising developments of tests that provide faster detection are projected to boost the segment’s growth. These POC tests have revolutionized the market by decreasing the processing time and augmenting rapid decision-making. For instance, in April 2021, the U.S. FDA approved amended EUA requests for various tests, expanding POC and OTC testing options for COVID-19.
End-use Insights
The hospitals segment captured the largest revenue share in 2022. Factors such as the rising demand for affordable services, increasing hospitalization rates, the surging trend of personalized treatments, and the presence of favorable reimbursement policies are fueling the segment’s expansion. Moreover, the increasing incidence of hospital-acquired infections in hospitalized patients is expected to support market growth. According to the CDC, around 5% of hospitalized patients suffer from MRSA infections and carry the bacteria.
On the other hand, home care is likely to show a positive growth rate during the coming years. The rising demand for homecare in vitro diagnostic devices, the surge in the geriatric population, and the robust availability of portable home-use IVD products are facilitating segment expansion. Moreover, favorable government initiatives to promote home care diagnosis are fueling segment growth. For instance, the U.S. FDA has authorized a large number of over-the-counter COVID-19 diagnostic tests for home use.
Regional Insights
The U.S. led the North America in vitro diagnostics industry in 2022 due to the presence of many strong players coupled with various strategic initiatives undertaken by them. Moreover, the high burden of target diseases, rising demand for advanced diagnostic solutions at different healthcare facilities, and surge in demand for POC tests are also anticipated to support the growth.
Canada is projected to witness the fastest growth rate over the forecast period. The increasing geriatric population, large patient pool with the increasing prevalence of chronic diseases, and supportive reimbursement policies in the country are the factors bolstering the country’s market growth. Moreover, the introduction of technologically advanced products is likely to cater to the nation's market. For instance, in October 2021, Bio-Rad introduced the CFX Opus 384 Dx System and CFX Opus 96 Dx Systems, which are real-time PCR detection systems.
Some of the prominent players in the North America in vitro diagnostics Market include:
Segments Covered in the Report
This report forecasts revenue growth at regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2032. For this study, Nova one advisor, Inc. has segmented the global North America in vitro diagnostics market.
By Product
By Technology
By Application
By End-use
By Test Location
By Regional
Cross-segment Market Size and Analysis for Mentioned Segments
Additional Company Profiles
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Additional Countries (Apart
From Mentioned Countries)
Country/Region-specific Report
Go To Market Strategy
Region Specific Market DynamicsRegion Level Market Share Import Export AnalysisProduction AnalysisOthers