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Immunochemistry merging as a reliable field in pharma industry

Suchita Gupta
Wednesday, November 16, 2022, 08:00 Hrs  [IST]

Immunohistochemistry (IHC) is referred as the study of a branch of chemistry including the study of various components and functions of the immune system with the application of antigen and antibodies as chemical reagents. The breakthrough for the establishment of modern immunochemistry happed when physician Paul Ehrlich established the side chain theory. After that, a number of theories of immunochemistry were adopted in order to explain the production of antibodies by lymphocyte cells in a body’s immune system.

Traditionally, immunochemistry based techniques have been used for the quantitation of proteins and peptides. Gradually, it has become an essential ancillary technique in clinical diagnostics. It is a technique that combines anatomy, physiology, immunology and biochemistry. It involves the use of simple, rapid, and robust automated techniques to do routine analyses in clinical laboratories. The relatively low cost of the instruments, tools, or the reagents made immunohistochemistry the popular choice in many areas of pharmaceutical analysis.

The selection of antibody panels is one of the most important aspects for finest applicability of immunohistochemistry. The antibodies are usually of two types - polyclonal or monoclonal, out of which, monoclonal antibodies are considered to be more beneficial than polyclonal ones. Although, so many successful immunoassays have been developed using polyclonal antibodies because of their higher degree of affinity and specificity towards the analyte. The polyclonal type is developed from animal immunization, whereas, the monoclonal group are obtained from hybrids enzymes are the most common labels for immunoassay methods in pharmaceutical compounds.

Immunohistochemistry or diagnostic reagents are widely used for testing the immune response of the body, for example allergic reactions. These are any organic or inorganic compounds that are added to an analyte to determine abnormalities or pathogenesis. An analyte or biological specimen can be urine, a blood sample, or biopsied human tissue. When reagents are added to the analyte, they either react directly with the sample being tested or perform as a catalyst for the chemical reaction. They are also used to detect cardiovascular disease makers and tumour makers.

Immunohistochemistry finds the usage of monoclonal as well as polyclonal antibodies. It can determine the tissue distribution of an antigen of interest in healthy and disease tissue, thereby, is majorly used for diagnosis of cancers and in surgical pathology. Other than that, immunohistochemistry is used to treat diseases such as heart disease, infectious disease, etc. as well as to identify muscular and neurodegenerative disorders.

Moreover, this biochemical field also finds its application in endocrinology, drug abuse testing, and drug development. In case of drug discovery and drug development, especially during the study of the action of drugs in the body for a new candidate, screening of huge data samples is necessary. By immunohistochemistry methods, analysis of complex biological matrices can be achieved. Immunohistochemistry, at the same time, can help in determining the function of specific gene products in fundamental biological processes.

There is no standard fixing solution for different kinds of antigen immobilization. Acetone is a primary fixing solution that is often used for frozen tissue and cytological smears, owing to its span penetrability and dehydration property. Similarly, alcohol is another primary fixing solution that maintains low molecular weight protein, polypeptide, and cytoplasmic proteins. Aldehyde, on the other hand, is a functional cross-linking agent which is widely used because it has a span penetrability, low background, and low contractibility. Also, non-aldehyde, mixed with glutaric dialdehyde or paraformaldehyde, is used in in tissue fixation of peptide hormones.

Immunohistochemistry is mainly used to identify therapeutic response in two types of tumors that are under the growth regulation of the hormones - estrogen and androgen. These tumors are named as carcinoma of breast and prostate. The special enzyme staining techniques that were used traditionally could only detect a limited number of enzymes, proteins, and tissue structures. Immunohistochemistry methods involve specific antigen and antibody reactions, thus, have brought about a revolution in approach to diagnosis of tumors.

According to a report published by Allied Market Research, the global immunochemistry reagents market size is projected to witness a considerable growth from 2021 to 2030. The growth of the market is mainly driven by certain factors such as rise in number of cases of various diseases, increase in R&D expenditure of biotechnology and pharmaceutical organizations, rise in specialization in drug monitoring, technological advancements, and surge in adoption of targeted immunotherapy. The alarming rise in the medical & healthcare spending and the shifting focus on value-based healthcare solutions are sequentially contributing to the growth of the market.

Currently, North America is holding the highest market share, owing to rapid commercialization, increasing uptake of immunohistochemistry products, and technological advancements in the pharmaceutical industry. The Asia-Pacific region, at the same time, is projected to witness the highest growth rate during the forecasted period. This is due to increase in prevalence of chronic diseases and rapid advancements in the field of biotechnology in emerging economies, such as India, China & others.

In addition, immunochemistry plays an important role within the development of biomarkers. Hence, surge in demand for biomarkers is sequentially contributing to the growth of the global immunochemistry reagents market. Favorable government regulations and investment of huge funds are presenting lucrative opportunities for the growth of the market.

On top of that, the outbreak of the Covid-19 pandemic led to have a positive impact on the growth of the global immunochemistry reagents market. This is attributed to rise in demand for vaccines and treatment drugs for Covid-19, which needs an immunohistochemically detection of SARS-CoV2 viral proteins for the appropriate interpretation of histologic findings. Hydroxychloroquine is a commonly used drug that has witnessed huge demand during the pandemic. The reagent used in testing for SARS-CoV2 infection are enzymes that can detect the genetic materials specific and unique to the virus. This trend is likely to continue in the post pandemic as well.

Furthermore, in the past couple of decades, there has been an exponential increase in publications as well as introduction of immunohistochemistry and immunocytochemistry techniques by researchers. For instance, mycophenolic acid (MPA) is an immunosuppressant drug that is widely used for prevention of rejection in organ transplantation and also for treating autoimmune diseases. A ready to use reagents kit i.e., Dosimyco has an essential role in enabling simultaneous quantification of MPA and its metabolite mycophenolate glucuronide (MPAG) in plasma by LC-MS/MS. Such factors are boosting the growth of the global immunochemistry reagents market even more.

Additionally, vendors across the world are constantly knocking at the front raw with new primary antibodies, detection systems with ultra-sensitivity, and FDA approved immunochemistry kits for multiple predictive biomarkers. Many exciting new firms have entered in the field of diagnostic pathologist with which immunochemistry will continue to evolve in more than one way. Here, it is worth mentioning that with improvements in knowledge and technology, the global immunochemistry reagents market has observed a noticeable rise and is expected to gather more growth prospects in the years to come.

(Author is a content writer)


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