Immunoassay Market Insights on Growth Drivers and Key Players

An immunoassay biological test is use to find the presence of a macromolecule or a small molecule in a solution. Infectious diseases are carry on by pathogens, which include bacteria, fungi, protozoa, worms, viruses, and prions. Immunoassays’ main purpose is to help the body fight off infections. For the effective diagnosis and treatment of infectious illnesses, quick pathogen detection from patient samples is necessary. Immunoassays can offer a quicker, easier, and more affordable detection than traditional techniques. The size of the global immunoassay market was $24.30 billion in 2021 and is estimated to grow by a CAGR of 7.3% from 2021 to 2030 to reach $45.82 billion. The industry is assume to be led by North America and Europe.

Immunoassays have different applications such as diagnosis of diseases, therapeutic drugs monitoring, clinical pharmacokinetics, bioequivalence studies in drug discovery, sports anti-doping analysis, pregnancy tests to detect the pregnancy maker, environmental monitoring, and food testing.

Growth Drivers Influencing the Immunoassay Industry

The Rise in Chronic Disease and Public Awareness is Anticipate to Boost the Market Growth.

Diabetes, cardiovascular disease, and cancer are all on the rise around the world. COVID-19, Dengue, Hepatitis, HIV, malaria, tuberculosis, and other infectious diseases are still on the rise.

Immunoassay treatment has become an important part of many diseases’ diagnostic processes. Immunoassay technology advancements provide faster results, higher sensitivity, and lower detection limits, all while lowering costs. Public awareness campaigns to identify symptoms of infectious diseases and ways to prevent them are an effective part of controlling epidemic diseases. As a result of increased patient awareness, immunoassays have been in high demand.

Public awareness campaigns aimed at identifying symptoms of infectious diseases and ways to prevent them are an effective part of controlling epidemic diseases. As a result of increased patient awareness, immunoassays have been in high demand.

For example, the International Society of Infectious Diseases’ advocacy program seeks to collaborate with public health practitioners, clinicians, and researchers worldwide to promote the exchange of scientific knowledge and evidence-based medical practices.

Furthermore, as part of its efforts to raise awareness about hepatitis and remove barriers in clinical diagnostic settings, the World Hepatitis Alliance launched the “Find the Missing Millions” campaign.

Impact of COVID-19 on the immunoassays market

The COVID-19 outbreak has harmed several economies worldwide. More than 100 countries have been harm by the pandemic. Although many dedicate healthcare workers are fighting this worldwide pandemic effectively, it is essential to stop virus transmission by developing kits for early diagnosis. Testing is most important for recognizing and controlling the coronavirus. There is a higher demand for immunological assays because molecular diagnostic procedures like PCR cannot be utilized to track the development of a disease.

The COVID-19 epidemic has also influenced the immunoassays market in three ways: pricing, demand, and supply chain.

Technological Advancements in Immunoassay Techniques are Propelling the Immunoassay Market Forward.

The most widely used immunoassay technique for diagnosing infectious diseases is ELISA. This technique is use to determine the concentrations of antibodies, antigens, proteins, and glycoproteins in biological samples. Examples include HIV infection diagnosis, pregnancy tests, and measuring cytokines or soluble receptors in cell supernatant or serum.

With the advancement of signal generation methods, the focus has shifted to the advancement of immunochemical methods and instruments to provide convenient, high-performance systems. Significant progress has been made in designing immunochemical approaches that allow small molecules, such as metabolites and toxins, to replace dynamic format assays with non-competitive formats, bringing benefits previously seen only with large molecular analytes. Furthermore, the continuous development of new biomarkers, cost-benefit analysis, and the growing adoption of automatic platforms for ELISA are anticipate to drive the adoption of this technology.

Types of Immunoassays

• Radioimmunoassay: Radioimmunoassay is among the oldest types of immunoassays. RIA is an immunoassay that labels the antibody/antigen with radioactive isotopes (I-235). It measures the antibody-antigen compound with high sensitivity by detecting radioactivity.
• Enzyme immunoassays: It is one of the most widely use immunoassays. Enzymes are use as probes in EIA instead of radioactive isotopes.
• Fluor immunoassay: It is similar to RIA, except that the label is a fluorophore (e.g., FITC, phycoerythrin) rather than a radioisotope. It is a device that can directly measure the fluorescence signal.
• Chemiluminescence immunoassay (CLIA)- A CLIA is a method for calculating sample concentrations on the basis of the amount of luminescence developed by a chemical reaction.
• Colloidal gold immunochromatographic assay:  The lateral flow immunoassay is the rapid test immunoassay that detects the presence of a target biomolecule in a sample (matrix) without the use of specialized and expensive equipment.

Restraints of the Immunoassay Market

Regulatory agencies have imposed stringent licensing and marketing requirements for immunoassay consumables and equipment in various countries. The immunoassay market’s growth is also slow by technological challenges such as antibody cross-reactivity, false negatives, and the limited detection limits of available antibodies.

Immunoassay technicians face numerous design issues, such as result misinterpretation. Furthermore, the clinical diagnostics industry has been plague for decades by a shortage of qualify experts, hamper the market.

Segmentation Analysis

• During the forecast period, the ELISA kits and reagents segment is anticipate to account for the largest share. The rising occurrence of infectious diseases such as HIV, growing awareness about cancer and autoimmune disease diagnosis, and the emergence of the coronavirus pandemic are the factors driving the segment’s growth.

• During the forecast period, the chemiluminescence immunoassays segment is anticipate to grow at the fastest CAGR. The rising adoption of chemiluminescence assays in clinical diagnostics, research applications, and pharmaceutical analysis due to their low cost per test drives this segment’s growth during the forecast period.

• The bone and mineral diseases segment is predict to grow at the fastest CAGR during the forecast period. The rising need for early osteoporosis detection and monitoring treatment effectiveness, as well as the rising demand for vitamin D testing, are driving the growth of this segment.

• North America was the dominant market and had the largest regional share of the immunoassays market in 2021. During the forecast period, Asia-Pacific is expected to grow at the fastest CAGR. The increasing incidence of infectious diseases and cancer, rising government spending on healthcare, and improved diagnosis and treatment access are all expected to drive growth in this market.

Key Players 

The major companies profiled in the global immunoassay market include, among others, F. Hoffman-La Roche AG (Switzerland), Abbott Laboratories (U.S.), Siemens Healthineers AG (Germany), Danaher Corporation (U.S.), Sysmex Corporation (Japan), bioMérieux SA (France), Thermo Fisher Scientific Inc. (U.S.), Becton, Dickinson, and Company (U.S.), Merck KG.