North America Immunodiagnostic Market

Historic Data: 2019-2020   |   Base Year: 2021   |    Forecast Period: 2022-2028

Analysis By Product [Enzyme-Linked Immunosorbent Assays, Chemiluminescence Immunoassays (Vitamin D Assay, HIV Detection, HIV Ag/Ab Combo Assay, and Others), Radioimmunoassays, and Others], Clinical Indication [Infectious Diseases (COVID-19, Lyme, Zika, Infection Management, TORCH, Tuberculosis, Treponema, Measles & Mumps, EBV, and VZV), Hepatitis+HIV, Gastrointestinal, Metabolics , Endocrinology (Hypertension, GROWTH, Diabetes, Thyroid, and Reproductive Endocrinology), and Others], and End User (Hospitals, Clinics, Diagnostic Laboratories, Academic & Research Institutes, and Others)


No. of Pages: 198  |  Report Code: BMIRE00026558  |  Category: Life Sciences

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North America Immunodiagnostic Market

The North America immunodiagnostics market is expected to reach US$ 15,040.40 million by 2028 from US$ 9,188.19 million in 2021; it is estimated to grow at a CAGR of 7.3% during 2022–2028.

 

Immunodiagnostics primarily uses antigen–antibody reactions as its primary means of detection. Antibodies specific to the desired antigen can be conjugated with a radiolabel, fluorescent label, or color-forming enzyme and are used as a probe to detect it. The speed, accuracy, and simplicity of such tests have promoted them as rapid techniques for the diagnosis of diseases and the detection of illegal drugs. The growth of the North America immunodiagnostics market is attributed to the increasing prevalence of infectious diseases and the rising use of point-of-care immunodiagnostics solutions. However, the inadequate reimbursement scenario is hampering the market growth. 

 

Market Insights

Increasing Prevalence of Infectious Diseases Fuels North America Immunodiagnostics Market Growth

The need for diagnosing & managing infections and other disease is contributing to the rising number of prescriptions for immunodiagnostics tests. There are several immunodiagnostic tests and technologies, such as agglutination tests, complement fixation, precipitation tests, line blot assays, Western blot assays, enzyme immunoassays (EIA), and immunofluorescence tests, developed for infectious diseases.

HIV is a major public health issue worldwide. According to the US Department of Health & Human Services, ~1.2 million people in the US have HIV. The Centers for Disease Control and Prevention (CDC) states that there were ~34,800 new HIV infections in the US in 2019. Similarly, the increasing prevalence of hepatitis, a viral infection that results in liver inflammation, is one of the major factors driving the North America immunodiagnostics market. In 2018, according to the US Department of Health & Human Services (HHS), 2.4 million people live with hepatitis C in the US; the actual upper limit reported is 4.7 million, while the lower limit reported is 2.5 million. Additionally, the WHO's global hepatitis strategy, endorsed by all WHO member states, aims to reduce new hepatitis infections by 90% and deaths by 65% during 2016–2030. The increasing prevalence of infectious diseases fuels North America immunodiagnostics market growth. 

The medical industry in North American countries witnessed a chaotic situation, with increased demand for clinical diagnostics and therapeutic systems in hospitals. With the growing infection rate and the rising demand for diagnosis, the immunodiagnostics market experienced a positive impact in the region. Healthcare facilities, clinical laboratories, and pharmaceutical and biotech companies preferred advanced diagnostic techniques and systems to handle the burden of COVID-19.

In March 2021, Eurofins' Clinical Enterprise, Inc. obtained an Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a direct-to-consumer (DTC) version of its EmpowerDX COVID-19 Home Collection Kit. The Eurofins at-home COVID-19 nasal PCR kit is one of the first over-the-counter SARS-CoV-2 at-home test kits. Similarly, in March 2020, the US FDA issued Emergency Use Authorization (EUA) to Abbott for its fastest available molecular point-of-care test to detect novel coronavirus (COVID-19), which delivers positive results in ~5 minutes and negative results in ~13 minutes. Thus, the rise in product launches during this global health crisis has supported the growth of the North America immunodiagnostics market.

Product-Based Insights

Based on product, the North America immunodiagnostics market is segmented into enzyme-linked immunosorbent assays (ELISA), chemiluminescence immunoassays (CLIA), radioimmunoassays (RIA), and others. The enzyme-linked immunosorbent assays (ELISA) segment held the largest share of the market in 2021. Moreover, the chemiluminescence immunoassays (CLIA) segment is expected to grow at the fastest CAGR during the forecast period.

 

Clinical Indication -Based Insights

Based on clinical indication, the North America immunodiagnostics market is segmented into infectious diseases, hepatitis+HIV, gastrointestinal endocrinology. The infectious diseases segment held the largest share of the market in 2021, and the same segment is expected to grow at the highest CAGR during the forecast period.

 

End User-Based Insights

Based on end user, the North America immunodiagnostics market is segmented into hospitals, clinics, diagnostics laboratories, academic & research institutes, and others. The hospitals segment held the largest share of the market in 2021. However, the clinics segment is expected to register the highest CAGR during the forecast period.

 

Strategic Insights

Product launches and approvals are the commonly adopted strategies by companies to expand their global footprints and product portfolios. Companies in the North America immunodiagnostics market focus on the collaboration strategy to enlarge their clientele, which, in turn, permits them to maintain their brand name across the world.

 

Immunodiagnostic Market: Competitive Landscape and Key Developments

 

  • In September 2022, Mindray launched the ToRCH Panel. With this panel, the company offers high-quality assays to meet different clinical needs. Mindray ToRCH kits can run tests on various sample types with less quality check controls and sample volumes, which ensures great ease and convenience during clinical detection.
  • In August 2022, Roche launched the Elecsys IGRA SARS-CoV-2 test in countries that accept the CE Mark. The Elecsys IGRA SARS-CoV-2 test supports a better understanding of immune response to SARS-CoV-2 infection and vaccination.
  • In July 2022, Roche received a Breakthrough Device Designation for the Elecsys ß-Amyloid (1-42) CSF and Elecsys Phospho-Tau (181P) CSF in vitro diagnostic immunoassays, which can measure ß-Amyloid (1-42) and Phospho-Tau concentrations in cerebrospinal fluid (CSF) in adult patients with cognitive impairment, who are being evaluated for Alzheimer’s disease (AD) or other causes of dementia.

 

A few of the companies included in our research scope are Abbott Laboratories; F. Hoffmann-La Roche Ltd; DiaSorin S.p.A.; Danaher Corp, Thermo Fisher Scientific Inc; Siemens Healthineers AG; PerkinElmer Inc.; Shenzhen Mindray Bio-Medical Electronics Co., Ltd.; and bioMerieux SA


North America Immunodiagnostic Strategic Insights

Strategic insights for the North America Immunodiagnostic provides data-driven analysis of the industry landscape, including current trends, key players, and regional nuances. These insights offer actionable recommendations, enabling readers to differentiate themselves from competitors by identifying untapped segments or developing unique value propositions. Leveraging data analytics, these insights help industry players anticipate the market shifts, whether investors, manufacturers, or other stakeholders. A future-oriented perspective is essential, helping stakeholders anticipate market shifts and position themselves for long-term success in this dynamic region. Ultimately, effective strategic insights empower readers to make informed decisions that drive profitability and achieve their business objectives within the market.

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North America Immunodiagnostic Report Scope

Report Attribute Details
Market size in 2021 US$ 9,188.19 Million
Market Size by 2028 US$ 15,040.40 Million
Global CAGR (2022 - 2028) 7.3%
Historical Data 2019-2020
Forecast period 2022-2028
Segments Covered By Product
  • Enzyme-Linked Immunosorbent Assays
  • Chemiluminescence Immunoassays
  • Radioimmunoassays
By Clinical Indication
  • Infectious Diseases
  • Hepatitis+HIV
  • Gastrointestinal
  • Metabolics
  • Endocrinology
By End User
  • Hospitals
  • Clinics
  • Diagnostic Laboratories
  • Academic & Research Institutes
Regions and Countries Covered North America
  • US
  • Canada
  • Mexico
Market leaders and key company profiles
  • Abbott Laboratories
  • F. Hoffmann-La Roche Ltd
  • DiaSorin S.p.A.
  • Danaher Corp
  • Thermo Fisher Scientific Inc
  • Siemens Healthineers AG
  • PerkinElmer Inc.
  • Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
  • bioMerieux SA
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North America Immunodiagnostic Regional Insights

The geographic scope of the North America Immunodiagnostic refers to the specific areas in which a business operates and competes. Understanding local distinctions, such as diverse consumer preferences (e.g., demand for specific plug types or battery backup durations), varying economic conditions, and regulatory environments, is crucial for tailoring strategies to specific markets. Businesses can expand their reach by identifying underserved areas or adapting their offerings to meet local demands. A clear market focus allows for more effective resource allocation, targeted marketing campaigns, and better positioning against local competitors, ultimately driving growth in those targeted areas.

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The List of Companies - North America Immunodiagnostic Market

  1. Abbott Laboratories          
  2. F. Hoffmann-La Roche Ltd               
  3. DiaSorin S.p.A.     
  4. Danaher Corp       
  5. Thermo Fisher Scientific Inc            
  6. Siemens Healthineers AG               
  7. PerkinElmer Inc.                  
  8. Shenzhen Mindray Bio-Medical Electronics Co., Ltd.   
  9. bioMerieux SA
Frequently Asked Questions
How big is the North America Immunodiagnostic Market?

The North America Immunodiagnostic Market is valued at US$ 9,188.19 Million in 2021, it is projected to reach US$ 15,040.40 Million by 2028.

What is the CAGR for North America Immunodiagnostic Market by (2022 - 2028)?

As per our report North America Immunodiagnostic Market, the market size is valued at US$ 9,188.19 Million in 2021, projecting it to reach US$ 15,040.40 Million by 2028. This translates to a CAGR of approximately 7.3% during the forecast period.

What segments are covered in this report?

The North America Immunodiagnostic Market report typically cover these key segments-

  • Product (Enzyme-Linked Immunosorbent Assays, Chemiluminescence Immunoassays, Radioimmunoassays)
  • Clinical Indication (Infectious Diseases, Hepatitis+HIV, Gastrointestinal, Metabolics, Endocrinology)
  • End User (Hospitals, Clinics, Diagnostic Laboratories, Academic & Research Institutes)
  • What is the historic period, base year, and forecast period taken for North America Immunodiagnostic Market?

    The historic period, base year, and forecast period can vary slightly depending on the specific market research report. However, for the North America Immunodiagnostic Market report:

  • Historic Period : 2019-2020
  • Base Year : 2021
  • Forecast Period : 2022-2028
  • Who are the major players in North America Immunodiagnostic Market?

    The North America Immunodiagnostic Market is populated by several key players, each contributing to its growth and innovation. Some of the major players include:

  • Abbott Laboratories
  • F. Hoffmann-La Roche Ltd
  • DiaSorin S.p.A.
  • Danaher Corp
  • Thermo Fisher Scientific Inc
  • Siemens Healthineers AG
  • PerkinElmer Inc.
  • Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
  • bioMerieux SA
  • Who should buy this report?

    The North America Immunodiagnostic Market report is valuable for diverse stakeholders, including:

    • Investors: Provides insights for investment decisions pertaining to market growth, companies, or industry insights. Helps assess market attractiveness and potential returns.
    • Industry Players: Offers competitive intelligence, market sizing, and trend analysis to inform strategic planning, product development, and sales strategies.
    • Suppliers and Manufacturers: Helps understand market demand for components, materials, and services related to concerned industry.
    • Researchers and Consultants: Provides data and analysis for academic research, consulting projects, and market studies.
    • Financial Institutions: Helps assess risks and opportunities associated with financing or investing in the concerned market.

    Essentially, anyone involved in or considering involvement in the North America Immunodiagnostic Market value chain can benefit from the information contained in a comprehensive market report.