Immuno-Oncology Assays Market

Global Immuno-Oncology Assays Market Size (2023 to 2028)

The global immuno-oncology assays market size is anticipated to be worth USD 8.44 billion by 2028 from USD 4.61 billion in 2023, growing at a CAGR of 12.88% from 2023 to 2028.

Global Immuno-Oncology Assays Market Share Insights:

• Based on product type, the consumables segment had the major share of the global market in 2022.
• Based on technology, the PCR segment led the market in 2022.
• Based on application, the research segment was the largest segment in the global market in 2022.
• Based on region, North America dominated the market in 2022.

Impact of COVID-19 on the global immuno-oncology assays market:

The COVID-19 pandemic has severely impacted the global healthcare supply chain and the market for immune-oncology assays. Healthcare organizations such as CDC, WHO and others have suggested to put the elective surgeries on hold and give priority to essential procedures and attending the needs of the COVID-19 patients. As a result, the treatment procedures of cancer patients were postponed or cancelled and significantly lowered the demand for immune-oncology assays. The COVID-19 pandemic caused an estimated 2.3 million cancer procedures to be postponed. Likewise, the COVID-19 pandemic had shown a negative impact on the growth of the immune-oncology assays market. However, the market is predicted to recover quickly and showcase a healthy growth rate in the coming years.

MARKET DRIVERS:

The growing prevalence of cancer worldwide is one of the major factors propelling the growth of the immune-oncology assays market. Cancer is one of the leading causes of deaths worldwide. WHO says an estimated 9.6 million people died of cancer in 2018. As per the projections of the International Agency for Research on Cancer (IARC), the number of new cancer cases are expected to increase to 29.5 million per year by 2040. The growing cancer patient population worldwide has fuelled the demand for more precise and personalized treatments, and these are further resulted in the increasing need for immune-oncology assays that can provide insights into the tumor microenvironment and immune response. Immuno-oncology assays are essential for detecting cancer and evaluating its response to treatment.

The growing investments to conduct R&D activities in the pharmaceutical industry for the treatment of cancer contributes to the growth of the immune-oncology assays market. These assays are employed in clinical trials as they save manual labour and research costs while improving the efficacy of research and treatments. Immuno-oncology assays are useful for ongoing analysis since they help keep cells healthy and in good condition. Assays for tumor-killing T lymphocytes, tumor cells, natural killer cells, macrophages, and dendritic cells are available in the immuno-oncology assays market. Adoption in clinical practices is encouraged by the availability of favorable reimbursement policies for immune-oncology assays.

The rapid adoption of immunotherapy for cancer treatment, advancements in understanding tumor-immune interactions, growing demand for personalized treatment strategies, increasing number of research collaborations and partnerships and rising focus on biomarker-driven therapy selection drive the growth of the immune-oncology assays market. The growing number of applications of immune-oncology assays in early cancer detection, regulatory support for immune-oncology innovations, growing investments in cancer research and development and the emergence of novel immuno-oncology targets supports the market growth. Technological advancements in assay platforms, the integration of artificial intelligence for data analysis, rising emphasis on precision medicine approaches and the potential for combination therapies with immunotherapies promotes the growth rate of the immune-oncology assays market.

MARKET RESTRAINTS:

Complex and evolving regulatory landscape for immune-oncology assays, variability in immune response across patients, lack of standardized assay protocols and high development and validation costs primarily hamper the market growth. Limited accessibility to advanced testing facilities, challenges in identifying reliable biomarkers, potential adverse effects of immunotherapy and limited reimbursement for innovative assays further impede the growth of the immune-oncology assays market. Resistance and relapse in immunotherapy and integration issues with existing diagnostic workflows hinder the market’s growth rate.

REPORT COVERAGE: 

This research report on global immune-oncology assays market has been segmented and sub-segmented based on the following categories.

Immuno-Oncology Assays Market - By Product Type:

• Consumables
• Instruments
• Software

Based on product type, the consumables segment is expected to dominate the immune-oncology assays market during the forecast period. Factors such as the growing adoption of immuno-oncology research for cancer therapy development, frequent usage of consumables in various stages of immuno-assay workflows and evolving biomarker discovery and validation efforts in oncology research majorly drive the growth of the consumables segment in the worldwide market.

The instruments segment is anticipated to account for a considerable share of the global market in the coming years owing to the growing demand for streamlined and reproducible immuno-assay workflows. The rising need for multiplexed assays to study complex interactions and the integration of advanced technologies like flow cytometry and mass spectrometry further contribute to the segmental growth.

Immuno-Oncology Assays Market - By Technology:

• PCR
• Immunoassay
• NGS
• ISH
• Flow Cytometry

Based on technology, the PCR segment is expected to hold the leading share of the global market during the forecast period. Factors such as the high sensitivity and specificity of PCR in detecting immune-related biomarkers, growing usage of PCR for quantifying gene expression and mutations relevant to cancer immunity and the integral for studying tumor microenvironment and immune cell interactions majorly drive the growth of the PCR segment in the global market. The rapid results and compatibility of PCR with various sample types further fuels the growth rate of the PCR segment.

The immunoassay segment is another promising segment among all and is predicted to account for a considerable share of the global market in the coming years. The growing adoption of immunoassay for assessing biomarkers such as PD-L1, CTLA-4 and others, the availability of various immunoassay formats catering to diverse research needs and rising focus on precision medicine and targeted therapies majorly drive the growth of the immunoassay segment in the worldwide market.

Immuno-Oncology Assays Market - By Application:

• Research Applications
• Clinical Diagnostics

Based on application, the research segment is expected to lead the market in the coming years. The growing demand for accurate and comprehensive characterization of the tumor microenvironment, the development of targeted immunotherapies necessitating robust research and increasing collaborative efforts between academia, industry, and research institutions primarily drive the segmental growth.

Immuno-Oncology Assays Market – By Region:

• North America
• Europe
• Asia Pacific
• Latin America
• Middle East and Africa

The North American region dominates the immuno-oncology assay market throughout the forecast period. The growing patient population suffering from cancer across North America is one of the major factors propelling the North American market growth. According to the National Library of Science, 1,918,030 new cancer cases and 609,360 cancer deaths occurred in 2022 in the United States, including approximately 350 deaths per day from lung cancer, the leading cause of cancer death.  The presence of several key market players in this region, the availability of high investments in research and development of novel cancer therapies, increasing collaborations between academic institutions and pharmaceutical companies, favorable regulatory environment supporting biomarker validation studies and the availability of specialized oncology centers and clinical trial networks propel the growth of the North American market. The U.S. accounts for the major share of the North American market during the forecast period owing to the growing adoption of personalized medicine approaches fuels immuno-oncology assay demand. Strong presence of immuno-oncology research institutes and rise in government funding for cancer research enhances immuno-oncology advancements further drive the U.S. market growth.

The Asia-Pacific immune-oncology assays market is expected to register the fastest CAGR during the forecast period. The rising prevalence of cancer across the Asia-Pacific region primarily drive the APAC market growth. According to the National Institute of Health, the cancer incidence in Asia was 169.1 per 1,00,000 in 2020, accounting for 49.3% of the global cancer incidence. According to the reports published by the National Cancer Registry Programme, the estimated number of incident cases of cancer in India was found to be 14,61,427 in 2022.  In India, one in nine people is likely to develop cancer in his/her lifetime. The growing number of research collaborations with global pharmaceutical companies, growing availability of targeted therapies and immunotherapies, rapid adoption of next-generation sequencing for immuno-oncology biomarker analysis and increasing number of initiatives from the governments of several APAC countries to promote precision medicine and cancer research further boost the regional market growth.

Europe is a promising regional market for immune-oncology assays and is expected to grow at a notable CAGR during the forecast period. Factors such as the presence of a well-established clinical trial networks for immuno-oncology research, collaborative initiatives between European countries for knowledge sharing and strong emphasis on translational research bridging the gap between research and clinical practice supports the European market growth. The rapid adoption of companion diagnostics in immuno-oncology therapies and growing focus on early cancer detection and screening programs further drive the European market growth.

KEY MARKET PLAYERS:

Novartis AG, Takeda Pharmaceuticals, Roche, Sanofi, Amgen Inc., Janssen Biotech, GlaxoSmithKline PLC., Thermo Fischer Scientific Inc., Merck Millipore, PerkinElmer Inc. and Agilent Technologies are some of the major companies operating in the global immune-oncology assays market.

RECENT HAPPENINGS IN THIS MARKET:

• In Sept 2022, Thermo Fisher Scientific Announces FDA Approval of Oncomine Dx Target Test as the First NGS-Based Companion Diagnostic to Aid in Therapy Selection for Patients with RET Mutations/Fusions in Thyroid Cancers.
• In June 2022, Agilent Technologies Inc., announced that the South Korea Ministry of Food and Drug Safety has approved the company’s PD-L1 IHC 22C3 pharmDx as a companion diagnostic to identify patients with non-small cell lung cancer who are suitable for first-line monotherapy with KEYTRUDA (pembrolizumab) on the Dako Omnis platform.