Immunoassay Market Size, Share and Global Analysis by 2027

Immunoassay Market to 2027 - Global Analysis and Forecasts By Product (Reagents & Kits, Analyzers & Instruments, and Software & Services), Technology [Enzyme-Linked Immunosorbent Assays (ELISA), Fluorescence, Chemiluminescence, Rapid Test, Western Blot, Enzyme-Linked Immune Absorbent Spot (ELISPOT), and Polymerase Chain Reaction (PCR)], Application (Therapeutic Drug Monitoring, Oncology, Cardiology, Endocrinology, Infectious Disease Testing, Autoimmune Diseases, and Others), and End User (Hospitals, Blood Banks, Clinical Laboratories, Pharmaceutical and Biotech Companies, Academic Research Centers, and Others)

Publication Month : Aug 2019

  • Report Code : TIPRE00005380
  • Category : Biotechnology
  • Status : Published
  • No. of Pages : 157
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[Research Report] The immunoassay market size was estimated to reach US$ 37,987.76 million by 2027 from US$ 21,800.00 million in 2018; it is estimated to grow at a CAGR of 6.5% during 2019-2027.

Market Insights and Analyst View:

Immunoassays are a group of laboratory techniques used to detect and quantify specific protein or other substances in biological samples. They are widely used in clinical diagnostics, pharmaceuticals research, and various other applications. The rising incidence of chronic diseases, cancer, diabetes, and infectious diseases, has driven the demand for accurate and efficient diagnostic methods, including immunoassays. Continuous advancements in immunoassay technology have improved sensitivity, specificity, and automation, making the tests more reliable, user-friendly, and capable of handling a large number of samples. Such factors are expected to propel the immunoassay market growth during the forecast period.

Growth Drivers and Challenges:

The emerging markets in the countries of Asia Pacific are creating significant opportunities for the key market players to expand their business. It is likely to be a prime factor contributing to the market growth during the coming years. Majority of the players concentrate on developing markets such as India and China, owing to the large population suffering from chronic diseases in these countries.

With rising costs of production against their practices, the medical device companies are striving to produce sufficient revenue to entertain their investors. The markets in some growing economies are expected to be an essential part of offering more reliable and profitable growth opportunities for the major players to expand their industry and geographic scope.

There has been an increase in the healthcare expenditure of the countries during the previous years. As per World Bank in the United States, 17.1% of its GDP is committed to the industry, whereas in Latin America, healthcare expenditures account for only 7.24%, with Mexico at 6.3% and Brazil at 8.3%. Moreover, the healthcare expenditure per capita for Germany, UK, China, and India was 11.3%, 9.1%, 5.6%, and 4.7% respectively for 2017. The factors mentioned above are expected to offer broad growth opportunities in the healthcare industry at the global level, and this is expected to cause the demand for global immunoassay market.

Various players in the industry have been investing a significant amount of their revenue in research and development activities for the development of better and advanced products and technologies to be used in the healthcare industry. The Asia Pacific market is anticipated to have the fastest growth in the forecast period. Presence of significant biopharmaceutical companies in countries, such as Japan, and the growing number of local companies in developing nations like China, Brazil, and India are the factors contributing to the market growth in the Asia Pacific. These activities in the region are increasing the demand for immunoassays.

Thus, the rising number of infectious disease incidences and advancements in emerging countries are likely to boost the immunoassay market size and are anticipated to provide significant growth opportunities to the players operating in the immunoassay market during the forecast period.

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Immunoassay Market: Strategic Insights

immunoassay-market
Market Size Value inUS$ 21,800.00 Million in 2018
Market Size Value byUS$ 37,987.76 Million by 2027
Growth rateCAGR of 6.5% from 2019 to 2027
Forecast Period2019-2027
Base Year2019
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Report Segmentation and Scope:

The “Global Immunoassay Market” is segmented based on product, technology, application, end-user, and geography. Based on product was segmented into reagents & kits, analyzers and instruments, and software and services. Based on technology was segmented into enzyme-linked immunosorbent assays (ELISA), fluorescence, chemiluminescence, rapid test, western blot, enzyme-linked immune absorbent spot (ELISPOT), and polymerase chain reaction (PCR). Based on application the global immunoassay market is segmented into therapeutic drug monitoring, oncology, cardiology, endocrinology, infectious disease testing, autoimmune diseases, and others. The immunoassay market based on geography is segmented into North America (US, Canada, and Mexico), Europe (Germany, France, Italy, UK, Russia, and Rest of Europe), Asia Pacific (Australia, China, Japan, India, South Korea, and Rest of Asia Pacific), Middle East & Africa (South Africa, Saudi Arabia, UAE, and Rest of Middle East & Africa), and South & Central America (Brazil, Argentina, and Rest of South & Central America)

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Segmental Analysis:

Based on product, the immunoassay market is segmented into reagents & kits, analyzers and instruments, and software and services. Reagents & kits product segment held the largest share of the market. However, software & services segment is expected to grow at the fastest rate over the forecast period, due to rising involvement of healthcare IT and increasing need to manage and enable instant access to all related data. The kits and reagents market is categorized by the presence of a large number of manufacturers like Abbott, F. Hoffmann-La Roche Ltd, Bio-Rad Laboratories, Inc., and others. Additionally, these products are frequently used in various research processes, which further is expected to propel growth. The various kits are used for the detection of multiple proteins and molecules that include growth factors, cytokines, and markers for infectious diseases, tumor, diabetes, drugs, small molecules, and more. The reagents used in the immunoassay include antibodies, sample diluents, conjugate stabilizer diluents, coating and wash buffers, and substrates for immunoassays. Furthermore, the developments and frequent product launches and increasing availability are one of the significant factors contributing to this growth rate. For instance, in February 2021, Agilent Technologies Inc. launched the Agilent Dako SARS-CoV-2 IgG Enzyme-Linked Immunosorbent Assay (ELISA) kit intended for the qualitative detection of immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human serum or plasma. Moreover, the major factors that are driving the market growth include the rising prevalence and incidence of chronic as well as infectious diseases along with the technological advancements in immunoassay instruments and the high sensitivity and specificity of the immunoassays, thereby driving the immunoassay instruments market growth during the forecasted period. Therefore, owing to the presence of the various market players that are offering multiple reagents & kits and rise in the technological advancements are likely to propel the growth of the immunoassay kits market during the forecast period.

Immunoassay Market, by Product – 2018 and 2027

 

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Based on end-user, the immunoassay market is segmented into hospitals and clinics, pharma, clients, and government agencies. In 2021, the hospitals and clinics segment held the largest share of the market. However, the client’s segment is expected to register the highest CAGR of 6.2% in the market during the forecast period. Nowadays, hospitals give better services to their patients. Usually, such hospitals offer diagnostic and treatment services for multiple indications. The team of doctors, nurses, and trained pathologist provide better treatments through proper diagnosis. Enormous patients are admitted for the procedure while several patient’s walk-in for the diagnostics treatment. Among the admitted patients, most of them are already suffering from some disorders. Therefore, to monitor and control their health in real-time, most of the hospitals are attached with clinical diagnostic laboratories. Thus, hospitals are contributing a significant market share to the immunoassay market and are expected to continue the trend during the forecast period.

Regional Analysis:

Based on geography, the immunoassay market is divided into five key regions: North America, Europe, Asia Pacific, South & Central America, and Middle East & Africa. North America immunoassay market has been analysed based on three major countries — the US, Canada, and Mexico.  The US immunoassay market is estimated to hold the largest immunoassay market share during the forecast period. The immunoassay market growth in the US is attributed to the to the rapidly increasing incidence of chronic diseases like cancer in the country and the growing demand for diagnostics. Immunoassay identifies and measures certain substances using the binding property of antigen and antibody. For instance, immunoassays measure the estrogen receptors in breast cancer). For example, as per the American Cancer Society, 1.9 million new cases of cancer were diagnosed in the country in 2021. The common types of cancer include breast cancer, lung and bronchus cancer, prostate cancer, colon and rectum cancer, melanoma cancer, and liver cancer. The incidences of cancer are increasing in the country at an alarming rate, which leads to increased demand for diagnosis for the cancer treatment.

Asia-Pacific is the second leading region in the global cell development market. China is holding the largest share in the Asia-Pacific immunoassay market during the forecast period due to the factors such as prevalence of chronic diseases in the countries, advanced healthcare infrastructure and growing government initiatives for the implementation of medical professional recruitment policies are likely to be the significant factors driving the growth of immunoassay market in this region.

Industry Developments and Future Opportunities:

Various initiatives taken by key players operating in the global immunoassay market are listed below:

  • In Feb 2021, Agilent Technologies Inc. launched the Agilent Dako SARS-CoV-2 IgG Enzyme-Linked Immunosorbent Assay (ELISA) kit intended for the qualitative detection of immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human serum or plasma.
  • In July 2023, Fapon Launched the Most Efficient Chemiluminescence Immunoassay Analyzer to Date with Throughput of 900 T/h. The Shine i8000/9000 Chemiluminescence Immunoassay Analyzer boasts an extraordinary testing performance and tackles the increasing needs of laboratories.
  • In July 2023, Siemens Healthineers launched the new Atellica CI Analyser for clinical chemistry and immunoassay testing. The Atellica CI Analyser enables standalone labs and satellite labs within larger health networks to access the same reagents, consumables, and intelligent software in the company’s Atellica Solution.

Covid-19 Impact: 

The exponential rise in globally occurring Coronavirus cases is increasing the demand for diagnostic kits for immunoassays. The reasons responsible for the growth in diagnostic demand include a rising market appetite for serology-based rapid-test products, a favorable regulatory climate for drug creation and marketing, and a substantial rise in the target patient population. Due to the rising demand for immunoassay kits, it has been observed that falsified medical products are flourishing in the market. These fake testing kits render the life of a patient at stake. WHO has received several reports concerning falsified immunoassay kits and laboratory reagents for SARS-CoV-2 detection. Thus, COVID-19 pandemic resulted in increasing demand of immunoassay kits and make appropriate use of those products in healthcare settings boosting the global immunoassay market in the forecasted period.

Competitive Landscape and Key Companies:

Some of the prominent players operating in the global immunoassay market F. Hoffmann-La Roche Ltd., Abbott, and Siemens, bioMérieux SA, BD, Danaher Corporation, Ortho Clinical Diagnostics, Sysmex Corporation, Thermo Fisher Scientific Inc., and Quidel Corporation among others among others are the leading companies operating in the immunoassay market. These companies focus on various growth strategies such as collaboration, product launches, business expansions, agreements among others to retain its position in the global market. They have a widespread global presence, which provides them to serve a large set of customers and subsequently increases their immunoassay market share.

Report Coverage
Report Coverage

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

Segment Covered
Segment Covered

Product, Technology, Application, End User and Geography

Regional Scope
Regional Scope

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

Country Scope
Country Scope

US, Canada, Mexico, UK, Germany, Spain, Italy, France, India, China, Japan, South Korea, Australia, UAE, Saudi Arabia, South Africa, Brazil, Argentina

Frequently Asked Questions


What are immunoassays

Immunoassays (IAs) are bio analytical technique in which the quantitation of the analyte relies on the reaction of an antigen and an antibody. Immunoassays play a vital role in many bio analytical settings, such as biopharmaceutical analysis, clinical diagnostics, security, environmental monitoring, and food testing.

What are the drivers for the immunoassay market?

The growth of the global immunoassay market is attributed to the rising incidences of chronic and infectious diseases, technological advancements in immunoassay devices, and growing biotechnology & biopharmaceutical industries.

Which are the top companies hold the market share in immunoassay market??

Major companies dealing in immunoassay market are F. Hoffmann-La Roche Ltd., bioMérieux SA, Abbott, Danaher Corporation, Thermo Fisher Scientific Inc, Ortho Clinical Diagnostics, Siemens, Quidel Corporation, Sysmex Corporation, BD.

What are the restraining factors for the immunoassay market across the globe?

Stringent regulatory requirements for immunoassay devices is the major factor hindering the market growth.

The List of Companies

  1. F. Hoffmann-La Roche Ltd.
  2. Abbott
  3. Siemens
  4. bioMérieux SA
  5. BD
  6. Danaher Corporation
  7. Ortho Clinical Diagnostics
  8. Sysmex Corporation
  9. Thermo Fisher Scientific Inc
  10. Quidel Corporation

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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