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  • Published In : May 2024
  • Code : CMI2632
  • Pages :165
  • Formats :
      Excel and PDF
  • Industry : Biotechnology

Market Size and Trends

Global immuno-oncology assays market is estimated to be valued at USD 4.98 Bn in 2024 and is expected to reach USD 10.47 Bn by 2031, exhibiting a compound annual growth rate (CAGR) of 11.2% from 2024 to 2031.

Immuno-Oncology Assays Market Key Factors

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The market trend for global immuno-oncology assays market is witnessing a high growth due to rising incidences of cancer globally and increasing adoption of targeted therapies for cancer treatment. Immuno-oncology is an evolving field in oncology that harnesses the power of the immune system to detect and destroy cancer cells. With promising clinical trial results, improved understanding of tumor microenvironment and biomarkers, new product approvals, and growing emphasis on precision medicine, the global immuno-oncology assays market is estimated to witness a healthy growth during the forecast period.

Rising Burden of Cancer Globally

Rise in burden of cancer across the globe is expected to augment growth of the global immuno-oncology assays market over the forecast period. Immuno-oncology (IO) is a class of treatment designed to boost the body's natural immune defense against cancer. For instance, in March 2023, according to the data published by the Centers for Disease Control and Prevention, it was estimated that a total of 32,320 new ovarian cancer cases will be diagnosed globally in the year 2023. Moreover, according to the World Health Organization (WHO), cancer was a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, or nearly one in six deaths. The most common cancers were breast, lung, prostate, and colon and rectum cancer. This in turn is expected to increase demand for immuno-oncology assays around the world.

Market Concentration and Competitive Landscape

Immuno-Oncology Assays Market Concentration By Players

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Increasing Awareness Programs

Increasing inorganic activities, such as awareness programs, is expected to drive the market growth over the forecast period. For instance, in June, 2022, the U.S. Department of Health and Human Services and the Centers for Medicare & Medicaid Services (CMS) announced a new model aimed at improving cancer care for Medicare patients and lowering health care costs.

Key Takeaways From Lead Analyst

The global immuno-oncology assays market is poised to grow substantially in the coming years. The market growth is driven by the rising prevalence of cancer worldwide and growing adoption of immuno-oncology drugs and therapies for treatment. Increased R&D investments by pharmaceutical companies to develop novel immuno-oncology biomarkers and companion diagnostics will further propel the demand. Advancements in immunoassay technologies for detection of circulatory tumor DNA and growing application of next-generation sequencing in liquid biopsy also create new opportunities.

However, complexity of immuno-oncology assays and challenges associated with developing robust and reproducible results could hinder the market growth to an extent. Strict regulatory framework around the development and commercialization of these assays also acts as a restraint.

Among regions, North America dominates the global immuno-oncology assays market currently due to presence of sophisticated healthcare infrastructure and rising healthcare expenditure. Asia Pacific is anticipated to be the fastest-growing regional market owing to expansion of healthcare facilities, increasing affordability, and rising cancer burden in developing nations.

Market Challenge – Dearth of Skilled Professionals

Dearth of skilled professionals is expected to hinder growth of the global immuno-oncology assays market. For instance, there is a shortage of lab technicians, technologists, and possessing advanced laboratory expertise, a major factor that restrains growth of the market. Currently, Canada is facing a nation-wide shortage of lab technologists.

Market Opportunity – Increasing Collaborations Among Key Market Players

Increasing adoption of inorganic growth strategies such collaborations by the key market players is expected to drive the market growth over the forecast period. For instance, in May, 2021, the University of California, San Francisco (UCSF) in collaboration with the San Francisco Veteran Affairs (VA) Health Care System, the Prostate Cancer Foundation, launched the Drew Foundation Precision Oncology Center of Excellence, providing precision medicine treatments to veterans facing prostate cancer.

Immuno-Oncology Assays Market By Product

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Insights, By Product: Versatility Drives Dominance of Consumables

Product segment is sub-segmented into consumables, software. The consumables segment is estimated to hold 65.9% of the market share in 2024, owing to the increasing incidences of colorectal cancer. According to International Agency for Research on Cancer, March 2022, in 2020, almost 2 million cases were diagnosed, for example, alcohol consumption was responsible for more than 160 000 new cases of colorectal cancer in 2020. It is the second most common cause of cancer death, leading to almost 1 million deaths per year. The burden of colorectal cancer is the highest in Asia, where more than half of all cases and deaths are recorded. China alone accounts for more than half a million new cases and more than 280 000 deaths per year. Japan records the second highest number of deaths from colorectal cancer, almost 60 000 per year.

Insights, By Indication: Increasing Incidences of Colorectal Cancer

Indication segment is sub-segmented into colorectal cancer, lung cancer, melanoma, bladder cancer, others. The colorectal cancer segment is estimated to hold 33.8% of the market share in 2024 owing to the increasing incidences of colorectal cancer. According to International Agency for Research on Cancer, March 2022, in 2020, almost 2 million cases were diagnosed, for example, alcohol consumption was responsible for more than 160 000 new cases of colorectal cancer in 2020. It is the second most common cause of cancer death, leading to almost 1 million deaths per year. The burden of colorectal cancer is the highest in Asia, where more than half of all cases and deaths are recorded. China alone accounts for more than half a million new cases and more than 280 000 deaths per year. Japan records the second highest number of deaths from colorectal cancer, almost 60 000 per year.

Insights, By Application: Focus on Translational Research Boosts Diagnostics in Research and Development

Application segment is sub-segmented into clinical diagnostics, and research and development. The research and development segment is estimated to hold 53.8% of the market share in 2024 due to the extensive translational research activities in this field. Pharmaceutical and biotech companies heavily rely on various immunoassay platforms to study immune mechanisms, discover and validate immune-related biomarkers, and conduct preclinical safety and efficacy testing of immunotherapies. National cancer institutes and academic medical centers too employ immuno-oncology assays while investigating tumor immunobiology, immunomonitoring, and novel treatment strategies. The need to deepen understanding of complex immune-tumor interactions, identify predictive and prognostic biomarkers along with responding patient subsets is driving the demand for customized research applications of these assays. Additionally, they aid evaluation of immune effects during nonclinical and early clinical phases of drug development. With ongoing efforts to harness immunity against cancer, the R&D application segment will likely maintain its lead position in the coming years backed by significant investments in immuno-oncology innovations.

Regional Insights

Immuno-Oncology Assays Market Regional Insights

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North America remains the dominant region in the global immune-oncology assays market and is estimated to hold 39.1% of the market share in 2024 owing to the increase in prevalence/incidence of cancer and rising elderly population in the region, especially in the U.S. By harnessing the immune system, immuno-oncology aims to activate or augment the body's natural response to fight cancer. For instance, according to the American Cancer Society (ACS), in 2022, there will be an estimated 1.9 million new cancer cases diagnosed and 609,360 cancer deaths in the U.S.

Asia Pacific is also expected to witness robust growth in the global immuno-oncology assays market due to the subsequent increase in the incidence of cancer and rise in geriatric population in the region. For instance, India’s cancer cases could increase by 12% in the next five years, with 1.5 million people projected to suffer from the non-communicable disease by 2025, up from 1.39 million in 2020, according to the report by the Indian Council of Medical Research (ICMR). This in turn is expected to increase the use of immuno-oncology assays.

Market Report Scope

Immuno-Oncology Assays Market Report Coverage

Report Coverage Details
Base Year: 2023 Market Size in 2024: US$ 4.98 Bn
Historical Data for: 2019 To 2023 Forecast Period: 2024 To 2031
Forecast Period 2024 to 2031 CAGR: 11.2% 2031 Value Projection: US$ 10.47 Bn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East: GCC Countries, Israel, and Rest of Middle East
  • Africa: South Africa, North Africa, and Central Africa
Segments covered:
  • By Product: Consumables and Software
  • By Technology: Immunoassay, PCR, NGS, Fow Cytometry, and Others
  • By Indication: Colorectal Cancer, Lung Cancer, Melanoma, Bladder Cancer, and Others
  • By Application: Clinical Diagnostics and Research and Development 
Companies covered:

Charles River Laboratories, F. Hoffmann-La Roche Ltd, llumina, Inc., Agilent Technologies, Inc., Thermo Fisher Scientific Inc., Merck KGaA, Invivoscribe, Inc., QIAGEN, PerkinElmer Inc., Sartorius AG, Bio-Rad Laboratories, Inc., Bruker Spatial Biology, Inc., Nexelis, Reaction Biology, Crown Bioscience, HTG Molecular Diagnostics, Inc., Axion BioSystems, Inc, and BioTherapeutics LLC

Growth Drivers:
  • Rising Burden of Cancer Globally
  • Increasing Awareness Programs
Restraints & Challenges:
  • Dearth of Skilled Professionals
  • High Costs Associated with Development of Immuno-oncology Assays

Key Developments

  • On January 30, 2024, Agilent Technologies Inc., a biotechnology company, announced that it had entered into an agreement with Incyte, a pharmaceutical company, to support the development and commercialization of Incyte’s hematology and oncology portfolio.
  • In November, 2023, Personalis, Inc., a leader in advanced genomics for precision oncology (Nasdaq: PSNL) and Tempus, a leader in artificial intelligence and precision medicine, announced a strategic collaboration to co-commercialize NeXT Personal Dx, Personalis’ whole genome-based liquid biopsy laboratory developed test (LDT) for detection of molecular residual disease (MRD) and recurrence in cancer.
  • In April 2023, TORL BioTherapeutics LLC, a biopharmaceutical company, announced a funding of USD 158 Mn to advance development of novel oncology biologics
  • In April, 2023, Ichor The Institute of Cancer Research, London announced a research collaboration with NeoPhore, an immuno-oncology company, to develop new potential cancer drugs. Under this collaboration The Institute of Cancer Research team will investigate the effect of NeoPhore’s inhibitors on tumours in the laboratory.

*Definition: Immuno-oncology is emerging as a novel approach to cancer treatment through the stimulation of the body's own immune system. It is a formidable weapon against cancer as it has the ability to harness the body's natural defenses against infection. It is one of the most promising areas of research in the world of anti-cancer therapeutics.

Market Segmentation

  • Product Insights (Revenue, USD Bn, 2019 - 2031)
    • Consumables
    • Software
  •  Technology Insights (Revenue, USD Bn, 2019 - 2031)
    • Immunoassay
    • PCR
    • NGS
    • Fow Cytometry
    • Others
  •  Indication Insights (Revenue, USD Bn, 2019 - 2031)
    • Colorectal Cancer
    • Lung Cancer
    • Melanoma
    • Bladder Cancer
    • Others
  •  Application Insights (Revenue, USD Bn, 2019 - 2031)
    • Clinical Diagnostics
    • Research and Development
  • Regional Insights (Revenue, USD Bn, 2019 - 2031)
    • North America
      • U.S.
      • Canada
    • Latin America
      • Brazil
      • Argentina
      • Mexico
      • Rest of Latin America
    • Europe
      • Germany
      • U.K.
      • Spain
      • France
      • Italy
      • Russia
      • Rest of Europe
    • Asia Pacific
      • China
      • India
      • Japan
      • Australia
      • South Korea
      • ASEAN
      • Rest of Asia Pacific
    • Middle East
      • GCC Countries
      • Israel
      • Rest of Middle East
    • Africa
      • South Africa
      • North Africa
      • Central Africa
  • Key Players Insights
    • Charles River Laboratories
    • F. Hoffmann-La Roche Ltd
    • llumina, Inc.
    • Agilent Technologies, Inc.
    • Thermo Fisher Scientific Inc.
    • Merck KGaA
    • Invivoscribe, Inc.
    • QIAGEN 
    • PerkinElmer Inc. 
    • Sartorius AG
    • Bio-Rad Laboratories, Inc.
    • Bruker Spatial Biology, Inc.
    • Nexelis
    • Reaction Biology
    • Crown Bioscience
    • HTG Molecular Diagnostics, Inc.
    • Axion BioSystems, Inc
    • BioTherapeutics LLC

Frequently Asked Questions

The CAGR of the immuno-oncology assays market is projected to be 11.2% from 2024 to 2031.

Rising burden of cancer globally and increasing awareness programs are the major factors driving the growth of the immuno-oncology assays market.

Dearth of skilled professionals and high costs associated with development of immuno-oncology assays are the major factors hampering the growth of the immuno-oncology assays market.

In terms of Product, Consumables is estimated to dominate the market revenue share in 2024.

Charles River Laboratories, F. Hoffmann-La Roche Ltd, llumina, Inc., Agilent Technologies, Inc., Thermo Fisher Scientific Inc., Merck KGaA, Invivoscribe, Inc., QIAGEN, PerkinElmer Inc., Sartorius AG, Bio-Rad Laboratories, Inc., Bruker Spatial Biology, Inc., Nexelis, Reaction Biology, Crown Bioscience, HTG Molecular Diagnostics, Inc., Axion BioSystems, Inc, and BioTherapeutics LLC are the major players.

North America is expected to lead the immuno-oncology assays market.

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