Immuno Oncology Assays Market Size
Study Period | 2019 - 2029 |
Base Year For Estimation | 2023 |
Forecast Data Period | 2024 - 2029 |
CAGR | 12.30 % |
Fastest Growing Market | Asia Pacific |
Largest Market | North America |
Major Players*Disclaimer: Major Players sorted in no particular order |
Need a report that reflects how COVID-19 has impacted this market and its growth?
Immuno Oncology Assays Market Analysis
The Immuno Oncology Assays Market is expected to register a CAGR of 12.3% over the forecast period.
Cancer patients have faced significant complications due to the 2019 coronavirus disease (COVID-19). The COVID-19 pandemic's breakout has severely impacted the global healthcare supply chain. Also, the Centers for Disease Control and Prevention (CDC) and many medical professional organizations recommended that cancer screening and other health prevention services, along with elective surgeries, be postponed. The only exception is if the risks have outweighed the benefits and secure the hospital infrastructure to treat COVID-19 patients. Thus, the COVID-19 pandemic has impacted the market. However, the situation has improved over the post-pandemic era gradually.
Immuno-oncology studies and develops treatments that utilize the body's immune system to fight cancer. The primary factor contributing to the market's growth is the increase in cancer incidence. According to the ECIS, the European cancer burden is expected to reach 3.36 million new cases by 2040, compared to 2.94 million patients in 2025. Furthermore, the increasing adoption of targeted therapy is boosting market growth. Immuno-oncology assays measure the concentration of the therapeutic antibody, anti-drug antibodies, and soluble protein biomarkers. As targeted therapy popularity increases, the assays' market growth increases.
Additionally, some primary factors driving the regional market are high expenditure on R&D by government organizations and pharmaceutical companies for disorders and diseases, such as chronic ailments like cancers. For instance, as per PhRMA, the biopharmaceutical industry invested an estimated USD 102,288 million in research and development (R&D) in 2021. Thus the significant funding for R&D helps the market to grow through new developments in immune-oncology assays.
Moreover, the new developments and advancements in assay methods and products, along with the approvals and launches, help the market to grow. For instance, in April 2022, Agilent Technologies Inc. received a CE-IVD marking in the European Union for its PD-L1 IHC 28-8 pharmDx immunohistochemical assay. It tests patients diagnosed with muscle-invasive urothelial carcinoma (MIUC) and tumor cell PD-L1 expression 1% for adjuvant treatment with OPDIVO (nivolumab). Similarly, in October 2021, the same company, Agilent, received CE-IVD mark approval for the PD-L1 IHC 28-8 pharmDx to guide options for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction, or esophageal cancers. Hence, with the new approvals and launches, the increase in cancer incidence and R&D expenditure is expected to drive the market over the forecast period.
However, stringent and unfavorable refund policies are hindering market growth factors.
Immuno Oncology Assays Market Trends
This section covers the major market trends shaping the Immuno Oncology Assays Market according to our research experts:
Immunoassay Segment is Expected to Have Significant Share in the Market Over the Forecast Period
Immunoassay is a test that relies on biochemistry to measure the presence and concentration of large proteins and antibodies produced by a person due to cancer. The immunoassay segment will hold a significant market share during the forecast period due to its advantages and easy usage. The factors driving the segment's growth include the rising burden of cancers and new product approvals and launches by the major players.
According to the LCRF, Lung Cancer Facts 2022, an estimated 236,740 people in the US will be diagnosed with lung cancer by the end of 2022. It also states that 1 in 16 people is expected to be diagnosed with lung cancer in their lifetime. Thus, the significant burden of cancer cases during the study period will positively impact the market as immunoassays will correctly identify cancer for better management.
Furthermore, new product approvals and launches help the market to grow. For instance, in June 2022, Nonagen Bioscience, a cancer diagnostics company, received CE marking for its Oncuria immunoassay for bladder cancer. Oncuria is the multiplex urine test for the quantitative detection of 10 biomarkers in urine that are associated with the presence of bladder cancer. Thus, the studied segment will witness significant growth over the forecast period due to the abovementioned factors.
North America is Expected to Have a Significant Share in the Market Over the Forecast Period
North America will witness healthy growth throughout the forecast period. The market growth is due to factors such as the presence of key players, the high prevalence of cancer in the region, and established healthcare infrastructure are some of the critical factors accountable for its significant share in the market. Furthermore, beneficial government initiatives and increased research partnerships are some drivers expected to increase market growth.
According to the report published by NIH, Cancer Stat Facts, 2022, the estimated number of new cancer cases in the US is expected to be 1,918,030 by the end of 2022. Similarly, as per the report published by Health Canada, in June 2022, an estimated 233,900 people in Canada were diagnosed with cancer, and 85,100 cancer-related deaths occurred. It also stated that the number of cancer diagnoses and deaths continues to climb because of population growth and aging. The statistics prove that the prevalence of cancer is high in the country, and this boosts the market growth.
Furthermore, new product developments help the market to grow. For instance, in October 2021, Agilent Technologies Inc. received approval for its Ki-67 IHC MIB-1 pharmDx (Dako Omnis) from the FDA. It aids in identifying patients with early breast cancer (EBC) at high risk of disease recurrence. It will be perfect for patients considered for adjuvant treatment with Verzenio (abemaciclib) in combination with endocrine therapy. Thus the new immune-oncology assay techniques in the market increase the scope of the usage, which helps the need to drive over the market's growth in North America during the forecast period.
Immuno Oncology Assays Industry Overview
The Immuno Oncology Assays market is moderately competitive and consists of several major players. Some companies currently dominating the market are Agilent Technologies, Inc, Thermo Fisher Scientific, Illumina, Inc., PerkinElmer, Inc., Crown Bioscience, InSphero., Merck KGaA, F. Hoffmann-La Roche Ltd., HTG Molecular Diagnostics, Inc.
Immuno Oncology Assays Market Leaders
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Agilent Technologies, Inc
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Thermo Fisher Scientific
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Illumina, Inc.
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PerkinElmer, Inc.
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Crown Bioscience
*Disclaimer: Major Players sorted in no particular order
Immuno Oncology Assays Market News
- September 2022: The US FDA approved Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic (CDx) aid in selecting patients. They do it with the help of RET-fusion positive locally advanced or metastatic non-small cell lung cancer (NSCLC), RET-fusion positive advanced or metastatic thyroid cancer, and RET-mutation positive advanced or metastatic medullary thyroid cancer (MTC) who may be eligible for treatment with Lilly's Retevmo (selpercatinib).
- June 2022: Agilent Technologies Inc. received approval from the South Korea Ministry of Food and Drug Safety (MFDS) for the company's PD-L1 IHC 22C3 pharmDx as a companion diagnostic (CDx) to identify patients with non-small cell lung cancer (NSCLC). It is suitable for first-line monotherapy with KEYTRUDA (pembrolizumab) on the Dako Omnis platform.
Immuno Oncology Assays Market Report - Table of Contents
1. INTRODUCTION
- 1.1 Study Assumptions and Market Definition
- 1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
- 4.1 Market Overview
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4.2 Market Drivers
- 4.2.1 Rising Incidence of Cancer Globally
- 4.2.2 Increasing Adoption of Targeted Therapy
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4.3 Market Restraints
- 4.3.1 Unfavorable Regulatory and Reimbursement Scenario
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4.4 Porter's Five Force Analysis
- 4.4.1 Bargaining Power of Suppliers
- 4.4.2 Bargaining Power of Buyers/Consumers
- 4.4.3 Threat of New Entrants
- 4.4.4 Threat of Substitute Products
- 4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size by Value - USD million)
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5.1 By Product
- 5.1.1 Reagents and Antibodies
- 5.1.2 Instruments
- 5.1.3 Software
- 5.1.4 Consumables and Accessories
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5.2 By Technology
- 5.2.1 Immunoassay
- 5.2.2 PCR
- 5.2.3 NGS
- 5.2.4 Flow Cytometry
- 5.2.5 Other Technologies
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5.3 By Indication
- 5.3.1 Lung Cancer
- 5.3.2 Colorectal Cancer
- 5.3.3 Melanoma
- 5.3.4 Other Cancers
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5.4 Geography
- 5.4.1 North America
- 5.4.1.1 United States
- 5.4.1.2 Canada
- 5.4.1.3 Mexico
- 5.4.2 Europe
- 5.4.2.1 Germany
- 5.4.2.2 United Kingdom
- 5.4.2.3 France
- 5.4.2.4 Italy
- 5.4.2.5 Spain
- 5.4.2.6 Rest of Europe
- 5.4.3 Asia-Pacific
- 5.4.3.1 China
- 5.4.3.2 Japan
- 5.4.3.3 India
- 5.4.3.4 Australia
- 5.4.3.5 South Korea
- 5.4.3.6 Rest of Asia-Pacific
- 5.4.4 Middle East and Africa
- 5.4.4.1 GCC
- 5.4.4.2 South Africa
- 5.4.4.3 Rest of Middle East and Africa
- 5.4.5 South America
- 5.4.5.1 Brazil
- 5.4.5.2 Argentina
- 5.4.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
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6.1 Company Profiles
- 6.1.1 Agilent Technologies, Inc
- 6.1.2 Thermo Fisher Scientific
- 6.1.3 Illumina, Inc.
- 6.1.4 PerkinElmer, Inc.
- 6.1.5 Crown Bioscience
- 6.1.6 InSphero
- 6.1.7 Merck KGaA
- 6.1.8 F. Hoffmann-La Roche Ltd.
- 6.1.9 HTG Molecular Diagnostics, Inc.
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
Immuno Oncology Assays Industry Segmentation
As per the scope of the report, Immuno oncology assays is a next-generation sequencing application that delivers real-time automated measurements of immune and tumor cell dynamics. With the help of this assay, people can analyze biological processes driving the immune response against cancer. It helps continuously examine and analyze key events from proliferation and activation to migration and immune cell killing without disturbing the existing body cells. The Immuno Oncology Assays Market is segmented by product (reagents and antibodies, instruments, software and consumables, and accessories), technology (immunoassay, PCR, NGS, Flow Cytometry, and other technologies), indication (lung cancer, colorectal cancer, Melanoma, and other cancers) and Geography (North America, Europe, Asia-Pacific, Middle East, and Africa, and South America). The report also covers the estimated market sizes and trends for 17 countries across major global regions. The report offers the value in (USD million) for the above segments.
By Product | Reagents and Antibodies | |
Instruments | ||
Software | ||
Consumables and Accessories | ||
By Technology | Immunoassay | |
PCR | ||
NGS | ||
Flow Cytometry | ||
Other Technologies | ||
By Indication | Lung Cancer | |
Colorectal Cancer | ||
Melanoma | ||
Other Cancers | ||
Geography | North America | United States |
Canada | ||
Mexico | ||
Geography | Europe | Germany |
United Kingdom | ||
France | ||
Italy | ||
Spain | ||
Rest of Europe | ||
Geography | Asia-Pacific | China |
Japan | ||
India | ||
Australia | ||
South Korea | ||
Rest of Asia-Pacific | ||
Geography | Middle East and Africa | GCC |
South Africa | ||
Rest of Middle East and Africa | ||
Geography | South America | Brazil |
Argentina | ||
Rest of South America |
Immuno Oncology Assays Market Research FAQs
What is the current Immuno Oncology Assays Market size?
The Immuno Oncology Assays Market is projected to register a CAGR of 12.30% during the forecast period (2024-2029)
Who are the key players in Immuno Oncology Assays Market?
Agilent Technologies, Inc, Thermo Fisher Scientific, Illumina, Inc., PerkinElmer, Inc. and Crown Bioscience are the major companies operating in the Immuno Oncology Assays Market.
Which is the fastest growing region in Immuno Oncology Assays Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Immuno Oncology Assays Market?
In 2024, the North America accounts for the largest market share in Immuno Oncology Assays Market.
What years does this Immuno Oncology Assays Market cover?
The report covers the Immuno Oncology Assays Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Immuno Oncology Assays Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
Immuno Oncology Assays Industry Report
Statistics for the 2024 Immuno Oncology Assays market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Immuno Oncology Assays analysis includes a market forecast outlook 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.