The North America in-vitro diagnostics market is expected to grow from US$ 56,890.44 million in 2022 to US$ 78,479.05 million by 2030; it is estimated to register a CAGR of 4.1% from 2022 to 2030.
Analyst Perspective:
In-vitro diagnostics (IVD) includes instruments, reagents, and software that are used to evaluate specimens such as blood, tissues, urine, stool, and other fluids obtained from the human body to diagnose infections, conditions, and diseases. Additionally, different IVD device types use various techniques, including tissue diagnostics, immunodiagnostics, hematological, and molecular diagnostics. Devices are used in specialized medical facilities since in-vitro diagnostics applications and management require technological competence and knowledge. Factors driving the North America in-vitro diagnostics market are the increasing prevalence of chronic diseases such as tuberculosis (TB), cancer, cardiovascular diseases, and diabetes and the rising incidence of infectious disorders such as gastrointestinal, respiratory, and STDs. Moreover, technological advancements by the players operating in this market will fuel the growth of the market. Combining in vitro diagnostics and artificial intelligence is the beginning of a new era of ‘Smart Diagnostics’. For instance, Hangzhou Zhiwei Information Technology Co. Ltd. has developed an AI bone marrow cell morphology analysis system, Morphogo. The Morphogo system can scan millions of cells in the bone marrow aspirate smears and detect metastatic carcinoma cells.
Market Overview:
In-vitro diagnostics can detect diseases or other conditions and can be used to monitor a person's overall health to help cure, treat, or prevent diseases. Devices can range from simple tests to sophisticated DNA technologies, including reagents, control materials, calibrators, kits, software, and related instruments. In-vitro diagnostics may also be used in precision medicine to identify patients who are likely to benefit from specific treatments or therapies.
The growth of the North America in-vitro diagnostics market is attributed to a few key driving factors such as increasing prevalence of chronic and infectious diseases and rising demand for in-vitro diagnostics during the COVID-19 pandemic. However, stringent regulatory policies and unclear reimbursement scenarios restrict the North America in-vitro diagnostics market growth. In addition, the integration of IVD technologies with digital health solutions is likely to provide opportunities for the market in the coming years.
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North America In-Vitro Diagnostics Market: Strategic Insights
Market Size Value in US$ 56,890.44 million in 2022 Market Size Value by US$ 78,479.05 million by 2030 Growth rate CAGR of 4.1% from 2022 to 2030 Forecast Period 2022-2030 Base Year 2022
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North America In-Vitro Diagnostics Market: Strategic Insights
| Market Size Value in | US$ 56,890.44 million in 2022 |
| Market Size Value by | US$ 78,479.05 million by 2030 |
| Growth rate | CAGR of 4.1% from 2022 to 2030 |
| Forecast Period | 2022-2030 |
| Base Year | 2022 |
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Market Driver:
Increasing Prevalence of Chronic and Infectious Diseases Drives North America In-Vitro Diagnostics Market Growth
North America is witnessing exponential increase in prevalence of infectious diseases. These diseases are prominently caused due to pathogenic microorganisms, such as viruses, bacteria, and parasites. Certain factors, such as poor sanitary conditions, lack of public hygiene, massive air pollution, and lack of safe drinking water, are playing a significant role in the increasing prevalence of infectious diseases. For instance, according to the Public Health Agency of Canada, in 2020, a total of 6,736 cases of hepatitis C (acute, chronic, and unspecified combined) were reported.
Moreover, chronic diseases prominently include cancers, chronic respiratory diseases, diabetes, and heart disease. These conditions are accelerating due to biological risk factors, increase in alcoholism, unhealthy diet, physical inactivity, tobacco consumption, and obesity. Chronic conditions are the leading cause of mortality in North America. According to CDC, six in ten Americans live with at least one chronic disease, like heart disease and stroke, cancer, or diabetes. These and other chronic diseases are the leading causes of death and disability in America, and they are also a leading driver of health care costs which was ~ US$4.1 trillion, in 2021. Along with cardiovascular conditions, a higher prevalence of other conditions, such as diabetes, cancer, and obesity, is equally anticipated to boost the growth of the North America in-vitro diagnostics market during the forecast period. According to CDC, heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States. Moreover, according to the same source, coronary artery disease (CAD) is the most common cause of mortality among adults in the United States, appro 375,476 people died in 2021. Additionally, The Centers for Disease Control and Prevention (CDC) has recently released the 2022 National Diabetes Statistics Report. This report estimated that more than 130 million adults were living with diabetes or prediabetes in the United States. According to a study by National Library of Medicine, in Mexico the prevalence of diabetes mellitus is continusly increasing. In addition, diabetes was the second highest cause of death in Mexico, in 2020 there were 148,437 diabetes-related deaths, and in 2021 there were 184,384 diabetes-related deaths. Certain factors, such as overweight conditions, genetic conditions, aging, and sedentary lifestyle, are further anticipated to boost the prevalence of diabetes in the region. Hence, rising incidence of infectious and chronic diseases, such as cardiovascular diseases, cancer, diabetes, and respiratory conditions, are projected to drive the North America in-vitro diagnostics market as in-vitro diagnostics (IVDs) are tests that can detect disease, conditions and infections.
Segmental Analysis:
The North America in-vitro diagnostics market is segmented on the basis of products and services, technology, application, and end user. Based on products and services, the market is segmented into kits, instruments, and software and services. In 2022, the reagents and kits segment accounted for the largest in-vitro diagnostics market share, and it is anticipated to register the highest CAGR during the forecast period. The increasing cases of viral and fungal infection with inadequate hygienic conditions are promoting the use of reagents. Thus, the players in the market are offering superior quality of molecular reagents and kits for better patient management and care, which is fueling the market growth for the segment.
Reagents and kits, in addition to other consumables, are frequently used in research processes. In-vitro diagnostics (IVDs) tests are performed on urine, blood, stool, and tissue samples to diagnose various conditions from mild infections to life-threatening diseases, such as cancer. Abbott; F. Hoffmann-La Roche Ltd; Bio-Rad Laboratories, Inc.; and other manufacturers offer kits and reagents. The governments implemented mass screening programs during the COVID-19 outbreak, which propelled the North America in-vitro diagnostics market growth. In 2020, Abbott Laboratories ramped up its production of COVID-19 test kits, including a new tool that could enable mass COVID-19 screening.
By technology, the North America in-vitro diagnostics market is segmented into immunoassay/immunochemistry, clinical chemistry, molecular diagnostics, microbiology, blood glucose self-monitoring, coagulation and hemostasis, hematology, urinalysis, and others. Based on application, the market is segmented into infectious disease, diabetes, oncology, cardiology, autoimmune disease, nephrology, and others. In terms of end user, the North America in-vitro diagnostics market is segmented into hospitals, laboratories, homecare, and others. This report offers insights and in-depth analysis of the market, emphasizing parameters such as market trends and market dynamics along with the competitive analysis of the leading market players.
Country Analysis:
The US held the largest share of the North America in-vitro diagnostics market. Chronic diseases such as cancer and cardiovascular diseases are the major causes of disability and death in the US. Per the National Center for Chronic Disease Prevention and Health Promotion, 6 in 10 people in the country have at least one chronic disease. According to the Centers for Disease Control and Prevention (CDC), in 2021, ~18.2 million adults aged 20 and above had coronary artery disease (CAD) in the US. Heart disease is the leading cause of death among people in the country. Additionally, the American Hospital Association estimates ~133 million people have at least one chronic disease, and that number is expected to reach 170 million by 2030. The high incidence of chronic diseases results in a huge demand for diagnostic procedures, which, in turn, drives the in-vitro diagnostics market in the US. Growing emphasis on preventive care coupled with enhanced access to healthcare facilities would further boost the market growth in the coming years.
Key Player Analysis:
The North America in-vitro diagnostics market majorly consists of players such as Abbott Laboratories, F. Hoffmann-La Roche Ltd, Danaher Corp, Siemens AG, Sysmex Corp, Thermo Fisher Scientific Inc, Becton Dickinson and Co, bioMerieux SA, Bio-Rad Laboratories Inc, and Qiagen NV. Among the players in the North America in-vitro diagnostics market, F. Hoffmann-La Roche Ltd and Abbott Laboratories are the top two players owing to the diversified product portfolio offered. F. Hoffmann-La Roche Ltd is a biotech company that provides in-vitro diagnostics and is a supplier of solutions for diseases area. The company specializes in medicines for oncology, virology, inflammation, metabolism, CNS, clinical chemistry, immunology, urinalysis, blood screening, genetics, infectious diseases, and microbiology. It also specializes in tissue-based cancer diagnostics, vitro diagnostics, and diabetes management. F. Hoffmann-La Roche Ltd provides its products and services to commercial laboratories, hospitals, researchers, healthcare professionals, and pharmacists. As of December 31, 2022, 29 billion tests were conducted with Roche Diagnostics products; 14.2 million patients were treated with Roche medicines; and had 20 manufacturing sites in pharmaceuticals and diagnostics worldwide. F. Hoffmann-La Roche Ltd conducts its business in two segments: diagnostics and pharmaceuticals. Diagnostics provides immunodiagnostics, cardiac tests, clinical chemistry, custom biotech, PCR tests, pathogen monitoring and detection, sexual health, donor screening, genomics, companion diagnostics, and tissue biopsies.
Recent Developments:
Inorganic strategies such as mergers and acquisitions, partnerships, collaborations, and joint ventures and organic strategies such as product launch, product approval, and expansion are highly adopted by companies in the North America in-vitro diagnostics market. A few recent key market developments are listed below:
- In April 2023, Thermo Fisher Scientific entered into a strategic partnership with ALPCO-GeneProof, a global leader in diagnostics, to broaden its CE-IVD molecular assay portfolio. The partnership combines the strengths of ALPCO-GeneProof’s expertise in molecular diagnostics with Thermo Fisher’s robust supply chain and support systems. The portfolio to be delivered by Thermo Fisher is comprised of 37 CE-IVD molecular diagnostic assays from ALPCO-GeneProof's portfolio, built on its innovative “one workflow” technology allowing for ease of use and compatibility with a wide range of qPCR instruments.
- In February 2023, Becton, Dickinson and Company received EUA from FDA for a new molecular diagnostic combination test for SARS-CoV-2, Influenza A + B, and Respiratory Syncytial Virus (RSV) to help combat illness in the current and future respiratory virus seasons. The test helps eliminate the need for multiple tests or doctor visits and assists clinicians in implementing the right treatment plan quickly.
- In January 2023, QIAGEN launched EZ2 Connect MDx for use in diagnostic laboratories, making the IVD platform for automated sample processing available for widescale use. The device carries the EU’s CE-IVD compliance marking for IVD for the European Union and other countries that accept this designation. It is also available in the US, Canada, and other countries.
Report Coverage
Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends
Segment Covered
Product and Services, Technology, Application, and End User
Regional Scope
North America, Europe, Asia Pacific, Middle East & Africa, South & Central America
Country Scope
Canada, Mexico, United States
Frequently Asked Questions
The North America in-vitro diagnostics market, based on technology, is segmented into immunoassay/immunochemistry, clinical chemistry, molecular diagnostics, microbiology, blood glucose self-monitoring, coagulation and hemostasis, hematology, urinalysis, and others. The immunoassay/immunochemistry segment held the largest market share in 2022. However, the molecular diagnostics segment is anticipated to register the highest CAGR during the forecast period.
The North America in-vitro diagnostics market was valued at US$ 56,890.44 million in 2022.
The North America in-vitro diagnostics market is expected to be valued at US$ 78,479.05 million in 2028.
The North America in-vitro diagnostics market majorly consists of the players such as Abbott Laboratories, F. Hoffmann-La Roche Ltd, Danaher Corp, Siemens AG, Sysmex Corp, Thermo Fisher Scientific Inc, Becton Dickinson and Co, bioMerieux SA, Bio-Rad Laboratories Inc, and Qiagen NV.
In-vitro diagnostics can detect diseases or other conditions and can be used to monitor a person's overall health to help cure, treat, or prevent diseases. Devices can range from simple tests to sophisticated DNA technology which include reagents, control materials, calibrators, kits, software, and related instruments. In-vitro diagnostics may also be used in precision medicine to identify patients who are likely to benefit from specific treatments or therapies.
The List of Companies - North America In-Vitro Diagnostics Market
- Abbott Laboratories
- F. Hoffmann-La Roche Ltd
- Danaher Corp
- Siemens AG
- Sysmex Corp
- Thermo Fisher Scientific Inc
- Becton Dickinson and Co
- bioMerieux SA
- Bio-Rad Laboratories Inc
- Qiagen NV
The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.
- Data Collection and Secondary Research:
As a market research and consulting firm operating from a decade, we have published many reports and advised several clients across the globe. First step for any study will start with an assessment of currently available data and insights from existing reports. Further, historical and current market information is collected from Investor Presentations, Annual Reports, SEC Filings, etc., and other information related to company’s performance and market positioning are gathered from Paid Databases (Factiva, Hoovers, and Reuters) and various other publications available in public domain.
Several associations trade associates, technical forums, institutes, societies and organizations are accessed to gain technical as well as market related insights through their publications such as research papers, blogs and press releases related to the studies are referred to get cues about the market. Further, white papers, journals, magazines, and other news articles published in the last 3 years are scrutinized and analyzed to understand the current market trends.
- Primary Research:
The primarily interview analysis comprise of data obtained from industry participants interview and answers to survey questions gathered by in-house primary team.
For primary research, interviews are conducted with industry experts/CEOs/Marketing Managers/Sales Managers/VPs/Subject Matter Experts from both demand and supply side to get a 360-degree view of the market. The primary team conducts several interviews based on the complexity of the markets to understand the various market trends and dynamics which makes research more credible and precise.
A typical research interview fulfils the following functions:
- Provides first-hand information on the market size, market trends, growth trends, competitive landscape, and outlook
- Validates and strengthens in-house secondary research findings
- Develops the analysis team’s expertise and market understanding
Primary research involves email interactions and telephone interviews for each market, category, segment, and sub-segment across geographies. The participants who typically take part in such a process include, but are not limited to:
- Industry participants: VPs, business development managers, market intelligence managers and national sales managers
- Outside experts: Valuation experts, research analysts and key opinion leaders specializing in the electronics and semiconductor industry.
Below is the breakup of our primary respondents by company, designation, and region:
Once we receive the confirmation from primary research sources or primary respondents, we finalize the base year market estimation and forecast the data as per the macroeconomic and microeconomic factors assessed during data collection.
- Data Analysis:
Once data is validated through both secondary as well as primary respondents, we finalize the market estimations by hypothesis formulation and factor analysis at regional and country level.
- 3.1 Macro-Economic Factor Analysis:
We analyse macroeconomic indicators such the gross domestic product (GDP), increase in the demand for goods and services across industries, technological advancement, regional economic growth, governmental policies, the influence of COVID-19, PEST analysis, and other aspects. This analysis aids in setting benchmarks for various nations/regions and approximating market splits. Additionally, the general trend of the aforementioned components aid in determining the market's development possibilities.
- 3.2 Country Level Data:
Various factors that are especially aligned to the country are taken into account to determine the market size for a certain area and country, including the presence of vendors, such as headquarters and offices, the country's GDP, demand patterns, and industry growth. To comprehend the market dynamics for the nation, a number of growth variables, inhibitors, application areas, and current market trends are researched. The aforementioned elements aid in determining the country's overall market's growth potential.
- 3.3 Company Profile:
The “Table of Contents” is formulated by listing and analyzing more than 25 - 30 companies operating in the market ecosystem across geographies. However, we profile only 10 companies as a standard practice in our syndicate reports. These 10 companies comprise leading, emerging, and regional players. Nonetheless, our analysis is not restricted to the 10 listed companies, we also analyze other companies present in the market to develop a holistic view and understand the prevailing trends. The “Company Profiles” section in the report covers key facts, business description, products & services, financial information, SWOT analysis, and key developments. The financial information presented is extracted from the annual reports and official documents of the publicly listed companies. Upon collecting the information for the sections of respective companies, we verify them via various primary sources and then compile the data in respective company profiles. The company level information helps us in deriving the base number as well as in forecasting the market size.
- 3.4 Developing Base Number:
Aggregation of sales statistics (2020-2022) and macro-economic factor, and other secondary and primary research insights are utilized to arrive at base number and related market shares for 2022. The data gaps are identified in this step and relevant market data is analyzed, collected from paid primary interviews or databases. On finalizing the base year market size, forecasts are developed on the basis of macro-economic, industry and market growth factors and company level analysis.
- Data Triangulation and Final Review:
The market findings and base year market size calculations are validated from supply as well as demand side. Demand side validations are based on macro-economic factor analysis and benchmarks for respective regions and countries. In case of supply side validations, revenues of major companies are estimated (in case not available) based on industry benchmark, approximate number of employees, product portfolio, and primary interviews revenues are gathered. Further revenue from target product/service segment is assessed to avoid overshooting of market statistics. In case of heavy deviations between supply and demand side values, all thes steps are repeated to achieve synchronization.
We follow an iterative model, wherein we share our research findings with Subject Matter Experts (SME’s) and Key Opinion Leaders (KOLs) until consensus view of the market is not formulated – this model negates any drastic deviation in the opinions of experts. Only validated and universally acceptable research findings are quoted in our reports.
We have important check points that we use to validate our research findings – which we call – data triangulation, where we validate the information, we generate from secondary sources with primary interviews and then we re-validate with our internal data bases and Subject matter experts. This comprehensive model enables us to deliver high quality, reliable data in shortest possible time.
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