Oncology Molecular Diagnostics Market by Product, Type and Geography - Forecast and Analysis 2023-2027

Global Oncology Molecular Diagnostics Market Forecast 2023-2027

The global oncology molecular diagnostics market size is estimated to grow by USD 2.98 billion at a CAGR of 11.82% between 2022 and 2027. Rise in the adoption of microarrays which involve miniaturization, are emerging in the fields of genomics and proteomics, thereby enabling high-throughput processing. These techniques are used for genotyping, mutation screening, protein interaction studies, and gene expression analysis. Microarray technology helps to make analyses with small sample volumes and relatively low protein concentrations. For this reason, microarray technology is now becoming a trend in proteomics. Furthermore, protein microarrays can display multiple proteins simultaneously, and these properties increase the ability to process thousands of samples in parallel. This feature of protein microarrays is important for whole proteome analysis. Microarray technology has significant potential and is not limited to peptides and nucleotides. It is also used to diagnose cancer, which aids in deciding better treatment strategies. Hence, owing to such advancements, the market will grow during the forecast period. This report also includes an in-depth analysis of drivers, trends, and challenges. 

What will be the size of the Oncology Molecular Diagnostics Market During the Forecast Period?

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The market is a significant segment in the healthcare industry, focusing on the detection and diagnosis of cancer using molecular techniques. Prognostic and diagnostic kits, laboratories, and preventive measures are key components of this market. Early detection is crucial in cancer treatment, and molecular diagnostics plays a pivotal role in achieving this goal. The market for molecular diagnostics in oncology is driven by the rising incidence of cancer worldwide, technological advancements, and growing awareness about early detection. Preventive measures, such as cancer screenings, are also contributing to the growth of this market. The market for molecular diagnostics in oncology is expected to continue its growth trajectory in the coming years, with a focus on personalized medicine and precision oncology. The use of next-generation sequencing technologies and artificial intelligence in molecular diagnostics is also expected to revolutionize the field. The market for molecular diagnostics in oncology is a complex and dynamic one, with a diverse range of players, including diagnostic laboratories, biotech companies, and pharmaceutical firms.

Market Segmentation

The global market is experiencing significant growth due to the increasing prevalence of cancer, which accounted for nearly 10 million deaths worldwide in 2020, according to the World Health Organization. This demand is driven by the need for accurate and reliable diagnostic tests for early detection, treatment decision-making, and monitoring of treatment response. Key components of these diagnostic tests include reagents and kits, which are essential for conducting molecular diagnostic assays such as Transcription Mediated Amplification, RNA sequencing, and Synthetic biology. Product approvals and launches in this field are subject to stringent regulatory frameworks, including trade regulations. Technological innovations, such as the development of tumor models and preventive medications, are also driving market growth. For instance, prostate cancer diagnostic tests using RNA-based biomarkers have shown promising results. However, the regulatory approval process for these new technologies can be lengthy and complex. In summary, the Oncology Molecular Diagnostics market is growing due to the increasing prevalence of cancer and the need for accurate diagnostic tests. Reagents and kits are crucial components of these tests, and their development and approval are subject to a stringent regulatory framework and technological innovations.

Product Analysis

The market share growth by the reagents and kits segment will be significant during the forecast period. Reagents are the main elements used in molecular diagnostic tests to detect genetic mutations, gene expression patterns, or protein markers with various cancers. Cancer prevalence is increasing worldwide, resulting in a growing need for accurate and reliable diagnostic tests. Reagents are needed to perform molecular diagnostic tests that aid in early detection, treatment decision-making, and monitoring of treatment response.

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The reagents and kits segment was valued at USD 1.94 billion in 2017. The rapid advancement of technology has resulted in the development of new testing methods and techniques. As personalized medicine grows in importance, expected to increase demand for reagents and kits specifically designed for genetic testing, such as those designed to detect specific mutations and gene expression levels. Key market players in the reagents and kits segment include Thermo Fisher, Abbott, bioMerieux, and QIAGEN. Continued investment in R&D and collaborations with diagnostic laboratories and healthcare providers are expected to fuel the growth of the reagents and kits segment of the global market during the forecast period..

Regional Analysis

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North America is estimated to contribute 41% to the growth of the global market during the forecast period. The North American oncology molecular diagnostics market experiences significant growth due to automation in biotechnology advancements, early cancer detection through behavioral changes and molecular diagnostic tools, and the identification of biomarkers in various cancers, including breast, colorectal, kidney, liver, and lung. Factors driving this market include increasing cancer cases and deaths, FDA approval of personalized treatment methods, and clinical testing using Chips & Microarrays and Mass Spectrometry. Cancer research methods, such as cancer genome sequencing, focus on DNA analysis for patient epidemiology and targeted therapies. POC testing plays a crucial role in early detection, especially for blood cancers like leukemia. The market expansion includes clinical trials for infectious diseases and dietary changes impacting cancer risk. Key players include Illumina and various laboratories.

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Market Dynamics and Customer Landscape

The market is driven by cutting-edge technology for diagnostic testing and personalized treatment. With a focus on patient epidemiology and regulatory frameworks, this market aims to combat cancer cells by analyzing genetic sequences, DNA, RNA, and cell proteins. Early detection through biomarker identification and point-of-care testing is crucial, particularly for breast, colorectal, lung, and prostate cancers. Molecular diagnostic tools empower clinical testing and facilitate preventive medication, reducing cancer deaths and cases worldwide. Continuous advancements in cancer genome sequencing, tumor models, and research methods enhance the efficacy of clinical trials, revolutionizing oncology molecular diagnostics. There are multiple factors influencing market growth. Our researchers analyzed the data with 2022 as the base year, along with the key drivers, trends, and challenges. 

Key Market Drivers

The rise in cancer prevalence globally is a driving force for the expansion of the international market. Unhealthy lifestyle habits, including poor dietary choices, sedentary behavior, and tobacco and alcohol use, contribute to various cancers, such as breast cancer, colorectal cancer, and Non-Small Cell Lung Cancer (NSCLC). Moreover, exposure to factors like ionizing radiation, chemical mutagens, and environmental pollutants further escalates cancer risk. As the number of new cancer cases and related deaths continues to increase, there's a growing demand for effective diagnostic tools, including molecular diagnostics and companion diagnostics, for early detection and intervention.

These diagnostic methods rely on biomarker identification and technological advancements, including point-of-care testing, to enable early detection, preventive medication, and informed treatment decisions. Additionally, enhancing patient and healthcare professional awareness is crucial, alongside leveraging computational analysis and tumor models to understand genetic anomalies and inform behavioral and dietary changes. In this landscape, the U.S. oncology-based molecular diagnostics market, alongside global initiatives, plays a vital role in addressing the challenges, contributing to the advancement of diagnostic technologies and overall market growth.

Significant Market Trends

Integration of next-generation sequencing is the key trend driving the growth of the global market. NGS technology has revolutionized molecular diagnostics by enabling comprehensive analysis of genetic information. NGS enables simultaneous analysis of multiple genes or the entire genome, providing a comprehensive genetic profile for diagnosis, prognosis, and treatment selection. The consolidation of NGS in these fields will raise the demand for molecular oncology diagnostics as researchers and pharmaceutical companies depend on NGS-based tests to support the (R&D) of precision medicine treatments.

Moreover, NGS technology has expanded test menus, improved diagnostic accuracy, facilitated personalized medicine, supported research and drug development, and reduced costs. These factors have collectively contributed to the rising demand in clinical and research settings, which is expected to drive the growth of the market during the forecast period.

Major Market Challenges

The lack of skilled medical professionals performing oncology tests is the key challenge to the growth of the market. Several advanced diagnostic methods are inherently complex and require a thorough understanding of the device's mechanism for effective application. Additionally, without proper training, it can be difficult to obtain data from the systems. The lack of technical expertise of medical professionals using these devices poses operational and technical problems. A shortage of professionals, such as laboratory technicians and pathologists, can limit testing capacity. This can lead to longer test results, delayed diagnosis, and reduced patient access to molecular diagnostic testing.

Moreover, a shortage of skilled professionals may also affect the adoption of advanced molecular diagnostic techniques. Additional training and expertise may be required to effectively use these new technologies in clinical practices. The introduction and integration of advanced molecular diagnostics can be slowed without a sufficient number of skilled professionals. Hence, the lack of skilled medical professionals will impede the growth of the global market during the forecast period.

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Customer Landscape

The market report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their growth strategies.

Global Oncology Molecular Diagnostics Market Customer Landscape

Key Market Players 

Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market. The report also includes detailed analyses of the competitive landscape of the market and information about 20 market companies, including:

Abbott Laboratories: The company offers oncology molecular diagnostics such as the UroVysion bladder cancer kit.

Agilent Technologies Inc., Becton Dickinson and Co., Biocartis NV, bioMerieux SA, Danaher Corp., DiaSorin SpA, Exact Sciences Corp., F. Hoffmann La Roche Ltd., Grifols SA, Hologic Inc., Illumina Inc., MDXHEALTH SA, Myriad Genetics Inc., QIAGEN NV, QuidelOrtho Corp., Siemens Healthineers AG, Sysmex Corp., TBG Diagnostics Ltd., Thermo Fisher Scientific Inc., and Veracyte Inc.

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

Market Analyst Overview

The market is a significant segment in the healthcare industry, characterized by the use of advanced technologies for identifying and understanding various types of cancer at the molecular level. This market involves the development, approval, and commercialization of diagnostic tests that detect genetic mutations, biomarkers, and other molecular alterations associated with cancer. Key players in this market include F.DA. (Food and Drug Administration), Genetic Testing & Molecular Diagnostics Companies, Biotechnology Companies, and Research Organizations. They invest in research and development to bring innovative diagnostic solutions to the market. The Oncology Molecular Diagnostics market is driven by factors such as the increasing prevalence of cancer, growing awareness about early detection, and the availability of reimbursement policies for molecular diagnostic tests. Additionally, advancements in technology, such as Next-Generation Sequencing (NGS), are enabling the development of more accurate and comprehensive diagnostic tests. The market is segmented based on technology, application, and end-users. The major technologies used include Polymerase Chain Reaction (PCR), NGS, and In Situ Hybridization (ISH). The major applications include solid tumors and hematological malignancies. The major end-users include hospitals, diagnostic laboratories, and research organizations. 

The Market is witnessing significant growth due to technological advancements in diagnostic testing, particularly in the area of molecular testing for cancer. This includes the analysis of genetic sequences and cell proteins to aid in the detection and monitoring of various cancers, such as cervical cancer, blood cancer, kidney cancer, and liver cancer. Point of care testing and the development of innovative technologies, like the BD Onclarity HPV test, are expanding application niches and dominance within the market. However, challenges persist, including the high cost of molecular diagnostic tests, changes in market regulations, and the lack of a skilled workforce. Despite these obstacles, geographic expansions and initiatives such as the Cancer Tech Accelerator program are driving progress in combating cancer deaths worldwide. Additionally, efforts to address lifestyle factors such as low intake of healthy food are crucial in the fight against cancer.

Segment Overview

This market research and growth report forecasts market growth by revenue at global, regional & country levels and provides an analysis of the latest trends and growth opportunities from 2017 to 2027. 

• Product Outlook 
  • Reagents and kits
  • Instruments

• Type Outlook 
  • Breast-cancer
  • Colorectal-cancer
  • Prostate-cancer
  • Liver-cancer
  • Others

• Region Outlook 
  • North America
    • The U.S.
    • Canada
  • Europe
    • The U.K.
    • Germany
    • France
    • Rest of Europe
  • Asia
    • China
    • India
  • ROW 
    • Australia 
    • Brazil
    • Argentina

Market Scope
Report Coverage	Details
Page number	174
Base year	2022
Historic period	2017-2021
Forecast period	2023-2027
Growth momentum & CAGR	Accelerate at a CAGR of 11.82%
Market growth 2023-2027	USD 2.98 billion
Market structure	Fragmented
YoY growth 2022-2023(%)	10.87
Regional analysis	North America, Europe, Asia, and Rest of World (ROW)
Performing market contribution	North America at 41%
Key countries	US, Germany, France, China, and Japan
Competitive landscape	Leading Vendors, Market Positioning of Vendors, Competitive Strategies, and Industry Risks
Key companies profiled	Abbott Laboratories, Agilent Technologies Inc., Becton Dickinson and Co., Biocartis NV, bioMerieux SA, Danaher Corp., DiaSorin SpA, Exact Sciences Corp., F. Hoffmann La Roche Ltd., Grifols SA, Hologic Inc., Illumina Inc., MDXHEALTH SA, Myriad Genetics Inc., QIAGEN NV, QuidelOrtho Corp., Siemens Healthineers AG, Sysmex Corp., TBG Diagnostics Ltd., Thermo Fisher Scientific Inc., and Veracyte Inc.
Market dynamics	Market growth and trends, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, and Market condition analysis for the forecast period.
Customization purview	If our market report has not included the data that you are looking for, you can reach out to our analysts and get segments customized.

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What are the Key Data Covered in this Market Research Report?

• CAGR of the market during the forecast period
• Detailed information on factors that will drive the market growth and forecasting between 2023 and 2027
• Precise estimation of the market size and its contribution of the market in focus to the parent market
• Detailed analysis of customer landscape covering Diver of price sensitivity, Adoption of the lifecycle, and key purchase criteria 
• Companies landscape comparing criticality of inputs and factors of differentiation
• Exclusive Matrix on companies' position and classification
• Accurate predictions about upcoming trends and changes in consumer behavior
• Market growth analysis across North America, Europe, Asia, and Rest of World (ROW)
• Thorough analysis of the market’s competitive landscape and detailed information about companies
• Market forecasting of factors that will challenge the growth of the key market companies

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