Elisa Tests Market

According to Stratistics MRC, the Global Elisa Tests Market is accounted for $2.78 billion in 2024 and is expected to reach $4.63 billion by 2030 growing at a CAGR of 8.9% during the forecast period. Enzyme-linked immunosorbent assays, or Elisa tests, are frequently used in medical diagnostics to find out whether biological samples contain antibodies, antigens, proteins, or hormones. The antigen-antibody interaction principle, which describes how an enzyme-linked antibody attaches to a target molecule in the sample, is the basis for this incredibly sensitive and specific assay. The presence and amount of the target substance are indicated by a measurable signal produced by the enzyme reaction, which is usually a color change. Moreover, Elisa tests are useful instruments for the diagnosis of autoimmune diseases, allergies, infectious diseases, and other health conditions.

According to the American Heart Association, Heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States.

Market Dynamics: 

Driver: 

Rising infectious disease prevalence

The rise in infectious diseases around the world, driven by causes like urbanization, international travel, and population growth, emphasizes how important it is to have timely and accurate diagnostics like Elisa tests. Additionally, continuous efforts to contain pandemics, like COVID-19, have sped up research and development in diagnostic technologies, encouraging the creation and use of cutting-edge Elisa assays for infectious disease surveillance, diagnosis, and monitoring.

Restraint:

Issues with compliance and regulatory difficulties

The market for Elisa tests is confronted with regulatory obstacles and compliance challenges, specifically pertaining to product registration, quality assurance, and compliance with strict regulations in various geographical areas. Product launches and market entry may be delayed if new assays or changes to existing ones require lengthy and resource-intensive regulatory approval processes. Furthermore, as standards and regulatory environments change, manufacturers and developers must continually monitor and adjust to ensure compliance, which increases their operational and financial burdens.

Opportunity:

Personalized health care and biomarker identification

Elisa tests have opportunities in biomarker discovery, validation, and clinical implementation due to the increasing focus on personalized medicine and biomarker-driven approaches to healthcare. In order to enable individualized treatment choices and patient stratification, Elisa assays are essential in locating and measuring biomarkers linked to disease diagnosis, prognosis, and treatment response. Moreover, the need for high-throughput Elisa assays that can validate and convert biomarker candidates into clinically useful tests is being driven by the development of omics technologies, including proteomics, metabolomics, and genomics, which offer a plethora of data for biomarker discovery.

Threat:

Price competition and market saturation

Due to the existence of multiple manufacturers offering comparable products, the Elisa test market is vulnerable to market saturation and intense price competition. In highly commoditized market segments, the multitude of competitors fighting for market share can result in pressure on margins and price erosion. Additionally, the situation is made worse by the availability of generic and less expensive alternatives, as well as by the surge in fake or inferior assays that damage the reputation and financial success of well-known brands.

Covid-19 Impact: 

The market for Elisa tests has been significantly impacted by the COVID-19 pandemic, which has resulted in an unparalleled need for diagnostic testing solutions to identify SARS-CoV-2 infection and track the progression of the disease. Elisa assay production, distribution, and the global supply chain were all initially disrupted by the pandemic. However, manufacturers quickly responded to the spike in demand by increasing production, building up their capacity, and speeding up the development of COVID-19-specific Elisa tests.

The Diagnostics segment is expected to be the largest during the forecast period

The diagnostics segment usually holds the largest share of the market for ELISA (enzyme-linked immunosorbent assay) tests. Many diseases, such as autoimmune disorders, allergies, hormone imbalances, and infectious diseases, can be diagnosed with ELISA tests. Moreover, these assays are preferred due to their high sensitivity, specificity, and precision in measuring target molecules. As ELISA assays are used in the diagnostics segment to screen, diagnose, and track diseases, they are a mainstay in clinical laboratories across the globe. 

The Pharmaceutical and Biotech Companies segment is expected to have the highest CAGR during the forecast period

In the ELISA test market, the pharmaceutical and biotech company segment usually shows the highest CAGR. These businesses mainly rely on ELISA assays for preclinical research, clinical trials, and drug development, among other uses. Early on in the drug discovery process, ELISA tests play a crucial role in identifying and validating potential targets and biomarkers. Additionally, ELISA assays are also used by biotech and pharmaceutical companies to monitor biomarker levels in patients participating in clinical trials and to assess the safety and efficacy of drug candidates.

Region with largest share:

When it comes to ELISA test sales, North America usually commands the largest market share. The aforementioned dominance can be attributed to multiple factors, such as the existence of a robust healthcare infrastructure, elevated adoption rates of sophisticated diagnostic technologies, substantial investments in research and development endeavors, and a substantial concentration of pharmaceutical and biotechnology enterprises. Furthermore, strong government support for healthcare initiatives, advantageous reimbursement practices, and a growing understanding of the significance of early disease detection and management also benefit the region. 

Region with highest CAGR:

In the market for ELISA tests, the Asia-Pacific region usually shows the highest CAGR. Numerous factors, such as the rising incidence of chronic illnesses and infectious diseases, rising healthcare costs, greater access to healthcare services, and rising investments in R&D, are driving this growth. Moreover, there is a huge need for diagnostic testing supplies, including ELISA assays, due to the region's expanding population, especially in nations like China and India. Moreover, the Asia-Pacific region's ELISA test market is growing quickly due to factors like the availability of a large pool of skilled labor, technological advancements, and improvements in healthcare infrastructure.

Key players in the market

Some of the key players in Elisa Tests market include F. Hoffmann-La Roche Ltd., BioLegend, Inc, Siemens Healthineers, Enzo Life Sciences, Inc, Bio-Rad Laboratories, Inc., Merck KGaA , Abbott Laboratories, Eurofins Scientific, General Electric, PerkinElmer, Inc., BioMerieux SA, Sysmex Corporation, Agilent Technologies, Inc., Ortho Clinical Diagnostics, Danaher Corporation, ZEUS Scientific, Inc., R&D Systems, Inc and Thermo Fisher Scientific.

Key Developments:

In June 2024, Siemens Healthineers and Hermes Medical Solutions, a molecular imaging software developer, have entered into an agreement to provide Siemens customers with access to Hermia dosimetry products. Hermia Organ Dosimetry will be integrated on syngo.via, the Siemens Healthineers vendor-neutral imaging software platform for 2D, 3D, and 4D reading and advanced visualization.

In May 2024, Merck KGaA has announced it has signed a definitive agreement to acquire Mirus Bio in a deal worth $600m, which will complement its current portfolio of novel modalities. Anticipated to close in the third quarter of 2024, the transaction will help to advance Merck’s viral vector manufacturing therapies from preclinical through to commercial production. 

In December 2023, Roche announced the entry into a definitive merger agreement to acquire Carmot Therapeutics, Inc. (“Carmot”), a privately owned US company based in Berkeley, California. Carmot’s R&D portfolio includes clinical stage subcutaneous and oral incretins with best-in-class potential to treat obesity in patients with and without diabetes, as well as a number of preclinical programs.

Methods Covered:
• Direct ELISA
• Indirect ELISA
• Sandwich ELISA
• Competitive ELISA
• Multiple and Portable ELISA
• Other Methods 
 
Technologies Covered:
• Chemiluminescent
• Colorimetric
• Fluorescent
• Other Technologies 

Applications Covered:
• Vaccine Development
• Immunology
• Diagnostics
• Toxicology
• Infectious Diseases
• Cancer
• Protein Quantitation
• Other Applications 

End Users Covered:
• Hospitals and Diagnostic Centers
• Research Laboratories
• Clinical Laboratories
• Academic Research Centers
• Pharmaceutical and Biotech Companies
• Other End Users

Regions Covered:
• North America
o US
o Canada
o Mexico
• Europe
o Germany
o UK
o Italy
o France
o Spain
o Rest of Europe
• Asia Pacific
o Japan        
o China        
o India        
o Australia  
o New Zealand
o South Korea
o Rest of Asia Pacific    
• South America
o Argentina
o Brazil
o Chile
o Rest of South America
• Middle East & Africa 
o Saudi Arabia
o UAE
o Qatar
o South Africa
o Rest of Middle East & Africa

What our report offers:
- Market share assessments for the regional and country-level segments
- Strategic recommendations for the new entrants
- Covers Market data for the years 2022, 2023, 2024, 2026, and 2030
- Market Trends (Drivers, Constraints, Opportunities, Threats, Challenges, Investment Opportunities, and recommendations)
- Strategic recommendations in key business segments based on the market estimations
- Competitive landscaping mapping the key common trends
- Company profiling with detailed strategies, financials, and recent developments
- Supply chain trends mapping the latest technological advancements

Free Customization Offerings: 
All the customers of this report will be entitled to receive one of the following free customization options:
• Company Profiling
o Comprehensive profiling of additional market players (up to 3)
o SWOT Analysis of key players (up to 3)
• Regional Segmentation
o Market estimations, Forecasts and CAGR of any prominent country as per the client's interest (Note: Depends on feasibility check)
• Competitive Benchmarking
Benchmarking of key players based on product portfolio, geographical presence, and strategic alliances