The global immuno-oncology assays market size was valued at USD 4114.12 million in 2022. It is estimated to reach USD 10,023.02 million by 2031, growing at a CAGR of 10.4% during the forecast period (2023–2031).
Immuno-oncology assays are widely used for the diagnosis of different types of cancer. Immune-oncological approaches are exciting tools to treat and possibly eradicate cancer curatively. Also, this assay increases the assay dynamic range. It is applied to amplify many targets in a polymerase chain reaction (PCR) and obtain more data from small amounts of proteins or other analytes in less time. Immune oncology aims to monitor the interactions between the body's immune system and cancer-causing cells.
Blood, DNA/RNA, and tumor samples are just a few sample types that can be used in immuno-oncology studies. The various methods can involve measuring the proteins circulating in the blood using immunoassays or examining the cellular component in the blood. Flow cytometry is a different method to evaluate the tumor cells. Many types of immuno-oncology testing include immuno-oncology tests involving tumor cells, T cells, natural killer cells, macrophages, dendritic cells, and neutrophils. Immuno-oncology assays find their application in pathogen identification, mutation analysis, linkage analysis, RNA detection, gene detection analysis, and others.
Personalized medicines are accurate and limited to individual patients for better treatment, depending on the response of the body and disease risk. According to the Personalized Medicine Coalition (PMC), personalized medicines accounted for 20% of the new molecular entities approved by the FDA in 2016. Furthermore, the personalized approach for developing cancer therapeutics is anticipated to lead to the advent of generic chemotherapies and may even eradicate most types of cancers.
Multiple assays are highly useful for the comprehensive production of personalized medicines. For instance, administering warfarin (used to prevent blood clots) is extremely difficult due to genetic variations in different patients and drug metabolism enzymes. Hence, immuno-oncology assays are used for panel-based tests expected to detect gene variations in one assay cycle. Thus, the adoption of personalized medicines is anticipated to continue to increase during the analysis period, and the impact of this factor is expected to drive the immuno-oncology assay market during the forecast period.
Traditional methods for assays are time-consuming and have the limitation of being able to analyze only one assay per cycle. This has led to high adoption and use of multiplex immuno-oncology assays; for example, MILLIPLEX MAP human immuno-oncology checkpoint protein panel magnetic bead panel offered by Merck and immuno-oncology checkpoint 14-Plex Human ProcartaPlex Panel offered by Thermo Fisher. Immuno-oncology assay reduces operational costs by increasing efficiency and providing greater output volume. Moreover, these immunoassays provide a global view in one assay cycle. Hence, low cost, minimal sample volume, and less manual labor are required for performing the immuno-oncology assays compared to traditional single-plex assays. Such factors drive market growth.
The demand for immuno-oncology assay has increased to reduce the man-hours required for many tests with single-plex assays. However, a dearth of skilled professionals, such as technologists and lab technicians, possessing advanced laboratory expertise, experience, and knowledge, has been witnessed specifically in remote healthcare organizations, which is the major factor that restrains the market growth. The U.S. Department of Labor's Bureau of Labor Statistics found that lab technicians have historically lacked the necessary skills. By 2026, the demand for lab technicians is projected to increase alarmingly, which is anticipated to impact market growth negatively.
The emerging economies of Asia-Pacific and LAMEA regions offer tremendous growth opportunities for expanding the market owing to improvements in healthcare infrastructure in these regions and an increase in demand for developed healthcare software from most of the patient population. In addition, a surge in the incidence of various chronic & infectious diseases and the increase in the research required to develop drugs to cure diseases have boosted the demand for immuno-oncology assays. Moreover, the surge in healthcare reforms in developing nations for the poor or disadvantaged groups that usually face financial barriers to accessing healthcare software is anticipated to offer remunerative opportunities for market expansion.
In addition, an increase in investments in healthcare and R&D in developing countries such as India, China, and Brazil supports the growth of the immuno-oncology assay market. In 2015, the Indian Government revealed that it plans to increase the percentage of GDP from 1.04% to 2.5% for healthcare expenditure by 2020. In addition, collaboration and acquisition are expected to further lead to the growth in new product launches, technological innovations, and continuous developments in the immuno-oncology assay market in emerging countries and are expected to create opportunities for market growth throughout the forecast period.
The global immuno-oncology assay market is bifurcated into product, indication, technology, and application.
Based on product, the global immuno-oncology assays market is bifurcated into consumables and software. The consumables segment owns the market and is predicted to boost at a CAGR of 10.0% over the forecast period. Immuno-oncology assay uses reagents & consumables while performing experiments in R&D labs and for disease diagnosis in clinical diagnostics labs and hospitals. For instance, TaqMan Multiplex Master Mix offered by Thermo Fisher Scientific is a reagent that provides four targets in a single reaction and decreases the reaction time. In addition, reagents offered by Luminex include LX200-CAL-K25, LX200-CON-K25, xMAP Sheath Fluid, and others.
Several companies offer various software for immuno-oncology assays to develop innovative, novel drugs to treat cancer. The software-providing companies offer a broad range of assays and platforms for in vitro testing of immuno-oncology agents, including core immunophenotyping, functional assays, and technologies for regulating the tumor microenvironment, enabling drug development to the next phase.
Based on technology, the global immuno-oncology assay market is divided into immunoassays into PCR, NGS, and flow cytometry. The PCR segment is the most significant contributor to the market and is estimated to expand at a CAGR of 9.8% throughout the forecast period. Polymerase chain reaction-amplified immunoassay (immuno-PCR, PCR) is a technique that conjoins the specificity of an immunological detection method and the sensitivity of a nucleic acid amplification method. The method is primarily based on chimeric conjugates of specific antibodies and nucleic acid molecules; the latter molecules are used as markers and amplified by PCR for signal generation. Furthermore, the efficiency of nucleic acid amplification leads to a 10–100,000-fold increase in the sensitivity of immuno-PCR compared to ELISA.
Immunoassay is a bioanalytical method designed to quantify an analyte depending on its reaction to an antibody. Immunoassays are widely used in several areas of pharmaceutical analysis, such as disease diagnosis, therapeutic drug monitoring, clinical pharmacokinetic, and bioequivalence studies in drug discovery and pharmaceutical industries. For example, ProQuantum high-sensitivity immunoassays are used for immuno-oncology research, and Thermo Fisher offers Immuno-Oncology ELISA kits for various types of cancer diagnosis.
Based on indication, the global immuno-oncology assays market is bifurcated into colorectal cancer, lung cancer, melanoma, bladder cancer, and others. The lung cancer segment dominates the market and is predicted to develop at a CAGR of 10.3% during the forecast period. Lung cancer is characterized by uncontrolled cellular growth in lung tissues. It is the most prevalent common cancer globally, which is caused due to cigarette smoking. Moreover, passive exposure to tobacco smoke causes lung cancer. Three major types of lung cancers are prevalent globally: small cell lung cancer, non-small cell lung cancer (NSCLC), and lung carcinoid tumor. Nearly more than 80% of lung cancers are NSCLCs.
Colorectal cancer is associated with tumorous growths in the large intestine or rectum and colon, the final section of the digestive tract. Additionally, it is the third most common type of cancer in the U.S. For instance, the American Cancer Society estimated 97,220 new cases of colon cancer in 2018 in the U.S.
Based on application, the global immuno-oncology assay market is segmented into research and clinical diagnostics. The research segment is the largest contributor to the market and is projected to increase at a CAGR of 12.48% throughout the forecast period. Immuno-oncology assays are crucial in drug discovery and the detection of novel biomarkers. They are used to determine the benefits & the mechanism of a new drug molecule under research. Moreover, they determine the suitable dosage of a new drug, its effectiveness, and the existing drug in the market. In addition, immuno-oncology assays are used to find new biomarkers for various diseases.
Traditionally, clinical diagnosis of diseases, such as gastrointestinal infection, cardiovascular diseases, and cancer, was performed using the conventional single-plex assays method. In addition, these assays have high throughput and enhanced ability to detect abnormalities. Furthermore, they are witnessing increased penetration for detecting multiple analytes in a single test and hence are extensively used for diagnosing cancer. Moreover, in December 2017, Quanterix Corporation launched a Single Molecule Array (Simoa) technology platform that offers the detection and measurement of biomarkers with unprecedented sensitivity.
Based on region, the global immuno-oncology assays market is bifurcated into North America, Europe, Asia-Pacific, and LAMEA.
During the forecast period, North America is estimated to grow at a CAGR of 9.9%, with the region holding the most significant market share. The growth of the North American immuno-oncology assay market is driven by a surge in government funding for the detection of new biomarkers, a rise in research and development activities for new drugs and diagnosis & treatment options, and an increase in the prevalence of chronic illnesses like cancer and strokes. Furthermore, the rise in cancer incidence promotes the demand for immuno-oncology assays and fuels the need to develop novel personalized drugs against cancer. North America is studied across the U.S., Canada, and Mexico. The U.S. dominates the regional market due to increased demand for assays in the pharmaceutical industry. However, due to increased investment in R&D and a spike in the development of the biotechnology sector in Mexico, the country is anticipated to grow at the quickest pace over the projected period. The leading players in this market have continuously focused on product approvals and novel product launches to maintain their dominance in the immuno-oncology assay market.
Europe is anticipated to boost at a CAGR of 9.7%. Due to the European Government's increased focus on technological developments in medical devices, well-established healthcare systems, and rising healthcare spending, Europe is predicted to grow steadily during the projection period. Furthermore, the growth of the European immuno-oncology assay market is driven by the penetrance of key players such as Luminous and Thermo Fisher. Significant increases in R&D activities for drug development and continuous product launches are expected to create new opportunities for market expansion during the forecast period. In Europe, key players are adopting partnerships as their key developmental strategy to introduce new immuno-oncology assays. Such partnerships are expected to give an edge to the companies over others. For instance, in July 2015, Seegene and Qiagen collaborated to co-develop multiplex disease testing panels. Moreover, the factors that promote the growth of the immuno-oncology assay market in Europe include a rise in demand for immuno-oncology assay in the pharmaceutical sector and an increase in investment by the European Union for R&D in the healthcare sector.
The most prominent factors affecting the growth of the immuno-oncology assay market in the Asia-Pacific region are an increase in per capita income in developing economies, a rise in government initiatives to improve the healthcare sector, and a rise in the focus of leading manufacturers on extending their geographic presence in emerging Asia-Pacific countries to seize high-growth market opportunities. Asia-Pacific is densely populated, with India and China being the most populated countries. Its growth is bolstered by an increase in demand for healthcare infrastructure, an increase in the number of hospitals in emerging countries, the development of the R&D sector, an increase in healthcare reforms, and technological developments in the healthcare industry. Moreover, leading manufacturers of immuno-oncology assays are gradually focusing on this region for product launch, propelling the market's growth.
LAMEA region includes Brazil, South Africa, Saudi Arabia, and the rest of LAMEA. The region is expected to show high potential growth during the forecast period, attributed to an increase in focus on biotech research in this region. Furthermore, the surge in the prevalence of cancer and the increase in R&D activities for the enhancement of new drugs & detection of biomarkers significantly contribute toward the market growth. The geriatric population in Latin America is increasing rapidly and is expected to reach 100.5 million by 2025. This population is highly prone to chronic diseases due to a weak immune system, which increases the prevalence of chronic disorders, thereby propelling the demand for rapid diagnostic techniques. Furthermore, increased demand for quick & advanced diagnostic methodologies in the healthcare industry is anticipated to offer remunerative opportunities for the immuno-oncology assay market in LAMEA during the forecast period.
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