Immunodiagnostics Market Growth Report | Size & Share 2030

Immunodiagnostics Market Forecast to 2030 - Global Analysis by Product [Enzyme-Linked Immunosorbent Assays (ELISA), Chemiluminescence Immunoassays (CLIA), Radioimmunoassays (RIA), and Others], Clinical Indication (Infectious Diseases, Hepatitis+HIV, Endocrinology, Gastrointestinal, Metabolics, and Others), End User (Hospitals, Clinics, Diagnostic Laboratories, Academic & Research Institutes, and Others), and Geography

Publication Month : Jul 2023

  • Report Code : TIPRE00003722
  • Category : Biotechnology
  • Status : Published
  • No. of Pages : 270
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[Research Report] The immunodiagnostics market size is expected to grow to US$ 34,487.80 million by 2030 from US$ 19,218.89 million in 2022; the immunodiagnostics market is estimated to register a CAGR of 7.6% from 2022 to 2030.

 

Analyst Perspective:

The immunodiagnostics market is expected to flourish due to the significant rise in the developments in the diagnostic sector. The immunodiagnostics market growth was boosted during the COVID-19 pandemic. Various companies received emergency authorizations for their products that helped them commercialize into the market. In addition, the growth of the market was majorly attributed to the increased investments in research and development of faster diagnostics techniques. Companies made various strategic decisions to expand their product portfolio and geographic presence. In addition, the improved life expectancy has led to a significant rise in geriatric population, contributing to increased demand for immunodiagnostics. Moreover, the increasing awareness among people and changing health standards have increased the demand for early diagnosis, which has propelled the demand for various devices for diagnosis. Also, the awareness about the developments in immunodiagnostics and its benefits has increased the usage of immunodiagnostic techniques. 

Market Overview:

Immunodiagnostics is referred to as a diagnostic methodology that primarily uses antigen-antibody reaction as its primary means of detection. Antibodies specific to a 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 led to the development of rapid techniques for the diagnosis of diseases, microbes, and even illegal drugs in vivo. The key factors that are driving the rising prevalence of infectious diseases and the growing use of point-of-care propel immunodiagnostics market growth. However, inadequate reimbursements hinder market growth. Geographically, North America is the largest market and followed by Europe. In North America, the US holds the maximum market share of the immunodiagnostics market. Asia Pacific is the fastest-growing region in the global immunodiagnostics market. In Asia Pacific, China is the largest market for immunodiagnostics and is expected to retain its dominance during the forecast period.

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Immunodiagnostics Market: Strategic Insights

immunodiagnostics-market
Market Size Value inUS$ 19,218.89 million in 2022
Market Size Value byUS$ 34,487.80 million by 2030
Growth rateCAGR of 7.6% from 2022 to 2030
Forecast Period2022-2030
Base Year2022
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Market Driver:

 

Increasing Prevalence of Infectious Diseases

The diagnosis and management of several ever-growing infectious diseases caused by infectious agents such as viruses, fungi, bacteria, parasites, or their toxic products are surging number of prescriptions for immunodiagnostic tests, e.g., complement fixation, precipitation tests, agglutination tests, line blot assays, Western blot assays, enzyme immunoassays (EIA), and immunofluorescence tests.

Human immunodeficiency virus (HIV) continues to be a major public health issue worldwide. In 2021, there were ~38.4 million people worldwide with HIV, as per the Joint United Nations Programme on HIV/AIDS (UNAIDS). Besides, hepatitis is another major factor driving the immunodiagnostics market. According to the World Health Organization (WHO), nearly 58 million people worldwide suffer from chronic hepatitis C infection, with 1.5 million new conditions occurring yearly. Furthermore, about 3.2 million adolescents and children have hepatitis C infection. Approved by all member states, the global hepatitis WHO strategy aims to reduce new hepatitis infections by 90% and mortalities by 65% during 2016–2030. Such global initiatives are fueling the demand for immunodiagnostic products.

Further, tuberculosis (TB), COVID-19, and other hospital-acquired infections (HAIs) require immunodiagnostic tests.

  • TB has been the 13th leading cause of death and the second-leading infectious killer after COVID-19. In 2020, 1.5 million people died from TB and affected an estimated 10 million people, comprising 5.6 million males, 3.3 million females, and 1.1 million children globally.
  • In 2021, a total of 7,860 TB cases were reported to CDC's National Tuberculosis Surveillance System (NTSS) by the 50 states of America and the District of Columbia (DC).
  • According to Worldometer, millions of deaths were reported worldwide due to the COVID-19 pandemic. It strained healthcare systems and increased the need for immunodiagnostic tests.

Diagnostics play a vital role in determining suitable medical treatments. Immunodiagnostics help diagnose diseases that severely impact the immune system. Thus, the rising prevalence of infectious diseases leads to the surging demand for immunodiagnostic products.

Segment Analysis:

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The global immunodiagnostics market is segmented into product, clinical indication, and end user. Based on product, the 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 market share of the market by product. Infectious diseases are caused by harmful pathogens such as bacteria, viruses, parasites, and fungi entering the body. They are commonly spread through contaminated food or water and bug bites. Contagious diseases cover a significant section of the immunodiagnostics market. Immunodiagnostics tests are performed to complement the results of molecular assays in infectious disease studies. Several immunodiagnostic tests are employed to diagnose infectious diseases, detect endocrine and neoplastic disorders, and measure blood drug concentrations. Enzyme-based immunoassays use antibodies to detect antigens and quantify antibodies. A Western blot test involves detecting antibodies in patients’ samples such as serum or different body fluids based on reactions between antibodies and target antigens (viral components) immobilized into a membrane by blotting.

The chemiluminescence immunoassays (CLIA) segment is anticipated to register the highest CAGR during the forecast period. The CLIA segment is further segmented into vitamin D assay, HIV detection, HIV AG/AB combo assay, and others.

Based on clinical indication, the market is segmented into infectious diseases, hepatitis+hiv, endocrinology, gastrointestinal, metabolic, and others. Infectious diseases acquired the highest market value in 2022and is expected to register the highest CAGR during the forecast period. The infectious disease segment is further segmented into COVID-19, tuberculosis, Lyme, infection management, Zika, treponema, TORCH, measles and mumps, VZV, and EBV. Similarly, the endocrinology segment is further classified into hypertension, growth, diabetes, thyroid, and reproductive endocrinology.

Based on end user, the immunodiagnostics market is classified into hospitals, clinics, diagnostics laboratories, academic and research institutes, and others. The hospitals segment held the largest share of the market in 2022. The clinics segment is anticipated to register the highest CAGR during the forecast period.

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Regional Analysis:

North America held the largest market share of the global immunodiagnostics market, which was valued at US$ 9,772.80 million in 2022, with a CAGR of 7.5%. North America is the largest market for immunodiagnostics, with the US, Canada, and Mexico being the major contributors to this regional market. The growing government support for adopting advanced diagnostics, increasing R&D efforts, and initiatives such as strategic collaborations by market players contribute to significant immunodiagnostics market growth. In addition, technological advancements by the players operating in the diagnosis industry will likely be a major growth stimulator for the immunodiagnostics market in North America over the coming years. At the same time, Asia Pacific is the fastest-growing region in the global immunodiagnostics market. The US is the largest market, and the immunodiagnostics growth is driven by the increasing prevalence of cancer that demands diagnosis and growing developments in the field of immunodiagnostics.

The Asia Pacific immunodiagnostics market is segmented into China, India, Japan, South Korea, Australia, and the Rest of APAC. The increasing frequency of chronic illnesses in APAC resulted in high demand for diagnostic tests that provide essential details of medical care with detection, diagnostics, and therapy related to the diseases. In addition, the investment of domestic players to develop immunodiagnostics products and technologies is likely to propel the immunodiagnostics market growth during the forecast period.

Key Player Analysis:

The immunodiagnostics market majorly consists of players such as Abbott Laboratories, F. Hoffmann-La Roche Ltd, DiaSorin SpA, Danaher Corp, Thermo Fisher Scientific Inc, PerkinElmer Inc, Shenzhen Mindray Bio-Medical Electronics Co Ltd, bioMerieux SA, Svar Life Science AB, and Siemens Healthineers AG.

Abbott Laboratories and F. Hoffmann-La Roche Ltd are the top two players in the immunodiagnostics market. The companies have been implementing various strategies that have helped the growth of the company and in turn have brought about various changes in the market. The companies have utilized organic strategies such as launches, expansion, and product approvals. On the flip side, inorganic strategies, such as product launches, partnerships, and collaborations, were widely seen in the immunodiagnostics market.

Recent Developments:

Inorganic and organic strategies are highly adopted by companies in the immunodiagnostics market. A few recent key market developments are listed below: 

  • In April 2023, Thermo Fisher Scientific announced a partnership with ALPCO-GeneProof, a global leader in diagnostics. The partnership has helped in bringing TaqPath Menu | GeneProof PCR kits into the market.  
  • In July 2022, Abbott Diagnostics announced its participation in American Association for Clinical Chemistry (AACC) 2022. In the exhibition, the company demonstrated its diagnostics systems and analyzers.
  • In May 2023, Thermo Fisher Scientific announced that the US FDA had cleared its immunoassays, B·R·A·H·M·S PlGF plus KRYPTOR and B·R·A·H·M·S sFlt-1 KRYPTOR novel biomarkers. These immunoassays assess risks and clinical management of preeclampsia, a severe pregnancy complication.
Report Coverage
Report Coverage

Revenue forecast, Company Analysis, Industry landscape, Growth factors, and Trends

Segment Covered
Segment Covered

Product, Clinical Indication, End User, and Geography

Regional Scope
Regional Scope

North America, Europe, Asia Pacific, Middle East & Africa, South & Central America

Country Scope
Country Scope

Argentina, Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Saudi Arabia, South Africa, South Korea, Spain, United Arab Emirates, United Kingdom, United States

Frequently Asked Questions


What are Immunodiagnostics?

Immunodiagnostics is referred as a diagnostic methodology that primarily uses antigen-antibody reaction as its primary means of detection. Antibodies specific for a 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 has led to the development of rapid techniques for the diagnosis of disease, microbes and even illegal drugs in vivo.

What are the driving factors for the global immunodiagnostics market across the world?

The factors that are driving the growth of the immunodiagnostics market are the rising prevalence of infectious diseases and the growing use of point-of-care immunodiagnostics.

Who are the major players in the immunodiagnostics market across the globe?

The immunodiagnostics market majorly consists of the players, such as Abbott Laboratories, F. Hoffmann-La Roche Ltd, DiaSorin SpA, Danaher Corp, Thermo Fisher Scientific Inc, PerkinElmer Inc, Shenzhen Mindray Bio-Medical Electronics Co Ltd, bioMerieux SA, Svar Life Science AB, and Siemens Healthineers AG.

Which segment by type led the immunodiagnostics market?

The enzyme-linked immunosorbent assays (ELISA) segment held the largest share of the market in 2022. Whereas the chemiluminescence immunoassays (CLIA) segment is estimated to register the highest CAGR in the market during the forecast period.

Which region is projected to be the fastest-growing region in the global immunodiagnostics market?

The Asia Pacific is expected to be the fastest-growing region in the immunodiagnostics market over the forecast period due to the infectious diseases and the growing use of point-of-care immunodiagnostics, and developments by market players offering immunodiagnostics.

What is the market CAGR value of the immunodiagnostics market during the forecast period?

The CAGR value of the immunodiagnostics market during the forecasted period of 2022-2028 is 7.6%.

What are the growth estimates for the immunodiagnostics market till 2028?

The immunodiagnostics market is expected to be valued at US$ 34,487.80 million in 2030.

What is the estimated immunodiagnostics market size in 2022?

The immunodiagnostics market is estimated to be valued at US$ 19,218.89 million in 2022.

The List of Companies - Immunodiagnostics Market

  1. Abbott Laboratories
  2. F. Hoffmann-La Roche Ltd
  3. DiaSorin SpA
  4. Danaher Corporation
  5. Thermo Fisher Scientific Inc
  6. PerkinElmer Inc
  7. Shenzhen Mindray Bio-Medical Electronics Co Ltd
  8. bioMerieux SA
  9. Svar Life Science AB
  10. Siemens Healthineers AG.

The Insight Partners performs research in 4 major stages: Data Collection & Secondary Research, Primary Research, Data Analysis and Data Triangulation & Final Review.

  1. 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.

  1. 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:

Research Methodology

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.

  1. 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.

  1. 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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