Oncology Molecular Diagnostics Market Analysis North America, Europe, Asia, Rest of World (ROW) - US, China, Germany, Japan, France - Size and Forecast 2024-2028

Oncology Molecular Diagnostics Market Size 2024-2028 

The oncology molecular diagnostics market size is forecast to increase by USD 3.95 billion at a CAGR of 13.64% between 2023 and 2028. The market is experiencing significant growth due to the increasing prevalence of cancer globally. This sector is witnessing the integration of advanced technologies like next-generation sequencing (NGS), chips, and microarrays in clinical testing and clinical trials. The adoption of these technologies is enabling early and accurate diagnosis of diseases such as cervical and colorectal cancer. However, the unfavorable reimbursement scenario poses a challenge to market growth. Reagents and kits are indispensable in molecular diagnostic tests, facilitating the detection of genetic mutations, gene expression patterns, or protein markers. Dietary changes and lifestyle modifications are also contributing factors influencing the market dynamics. The market is expected to grow steadily due to the increasing focus on personalized medicine and the availability of government funding for cancer research.

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The market is witnessing significant growth due to the increasing prevalence of cancer and the need for early detection and personalized treatment. This market focuses on the identification of genetic sequences, DNA, RNA, and cell proteins in cancer cells to develop effective diagnostic tools and therapies. The evolving regulatory framework is playing a crucial role in shaping the adoption of point of care testing and advancing technology for diagnostic testing, ensuring both accuracy and accessibility in healthcare. The regulatory landscape for molecular diagnostics in oncology is well-established, with regulatory bodies such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) providing guidelines for the development and approval of these diagnostic tools.

Furthermore, the market is rapidly growing, driven by innovations like the BD Onclarity HPV test, which aids in early detection of cervical cancer and other infectious diseases through advanced molecular testing for cancer. With rising cancer deaths, especially from nonsmall cell lung cancer, kidney cancer, and liver cancer, the market is seeing increased demand for Polymerase Chain Reaction (PCR) technologies and point-of-care testing. The Cancer Tech Accelerator program is pushing forward diagnostic tools, despite challenges such as the lack of skilled workforce and the low intake of healthy food. Additionally, factors like obesity, tobacco and alcohol uptake, and regulatory frameworks continue to shape the landscape of cancer diagnostics, emphasizing the need for infectious disease molecular testing and improved healthcare access.

Market Segmentation

The market research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD billion" for the period 2024-2028, as well as historical data from 2018-2022 for the following segments.

• Product
  • Reagents and kits
  • Instruments
• Type
  • Breast cancer
  • Colorectal cancer
  • Prostate cancer
  • Others
• Geography
  • North America
    • US
  • Europe
    • Germany
    • France
  • Asia
    • China
    • Japan
  • Rest of World (ROW)

By Product Insights

The reagents and kits segment is estimated to witness significant growth during the forecast period. Molecular diagnostics play a crucial role in identifying specific genetic sequences linked to various cancers, including kidney and liver diseases. The global cancer prevalence is escalating, leading to an augmented demand for precise and dependable diagnostic tools. According to the World Health Organization (WHO), cancer accounted for approximately 10 million deaths worldwide in 2020, representing nearly one in six deaths. Infectious diseases, such as hepatitis B and C, can also be diagnosed using molecular diagnostics. Illumina, a leading company in this field, offers innovative solutions for early cancer detection and treatment decision-making.

Furthermore, laboratories rely on these advanced tools to monitor treatment response and ensure optimal patient care. Molecular diagnostics contribute significantly to the early detection and treatment of cancer, ultimately improving patient outcomes.

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The reagents and kits segment was valued at USD 1.98 billion in 2018 and showed a gradual increase during the forecast period.

Regional Insights

North America is estimated to contribute 41% to the growth of the global market during the forecast period. Technavio's analysts have elaborately explained the regional trends and drivers that shape the market during the forecast period.

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The North America market is experiencing significant growth within the healthcare sector. Technological innovations, including Next-Generation Sequencing (NGS) technologies, are driving this expansion. The increasing prevalence of cancer in North America is also fueling the demand for molecular diagnostics in this region. Key factors propelling the market growth include the adoption of personalized medicine, the requirement for early cancer detection, and the development of targeted therapies. North America's strong healthcare infrastructure, expertise in genomic research, and broad access to molecular diagnostics further contribute to market growth. The region's increasing cancer incidence will continue to boost the North American market during the forecast period.

Furthermore, synthetic biology and RNA sequencing are emerging technologies poised to revolutionize oncology molecular diagnostics. These advanced techniques will enable more precise diagnosis and treatment of various types of cancers. The North American market for oncology molecular diagnostics is expected to witness substantial growth due to these technological advancements and the rising cancer burden.

Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.

Market Driver

The increasing prevalence of cancer worldwide is the key driver of the market. Cancer incidence and mortality are significant health concerns in the United States and globally. Unhealthy lifestyle choices, such as poor diet, physical inactivity, and tobacco, and alcohol use, contribute to the development of various types of cancer, including those affecting the lungs, stomach, kidney, head, neck, and larynx. Exposure to ionizing radiation, chemical mutagens, infectious micro-organisms, and environmental pollutants also increase the risk of cancer. When examining demographic groups, African-American men have the highest cancer mortality rate (227 per 100,000).

Furthermore, advancements in biotechnology, particularly in automation and biomarker identification, have revolutionized oncology molecular diagnostics. These advancements enable early cancer detection and personalized treatment plans based on individual genetic profiles. Blood banks play a crucial role in providing essential resources for cancer research and diagnosis. The use of blood samples for cancer diagnostics, such as liquid biopsies, is becoming increasingly common.

Market Trends

Integration of next-generation sequencing in oncology molecular diagnostics is the upcoming trend in the market. Next-generation sequencing (NGS) technologies have significantly transformed molecular diagnostics by facilitating in-depth analysis of genetic material. NGS enables the examination of multiple genes or entire genomes concurrently, offering extensive genetic profiling for cancer detection, prognosis, and treatment decision-making. This technology's application in genomics research and pharmaceutical development has grown increasingly essential. In cancer research, NGS is utilized to explore the genetic foundations of various cancers, pinpoint prospective therapeutic targets, and identify new biomarkers. The integration of NGS in these domains has fueled the need for oncology molecular diagnostics.

Furthermore, researchers and pharmaceutical companies heavily rely on NGS-based tests to bolster their investigations and the creation of personalized medicine therapies, such as those for cervical and colorectal cancers. NGS plays a pivotal role in advancing clinical testing and clinical trials, contributing to the progression of precision medicine. Key technologies in this field include Chips & Microarrays, DNA analysis, and NGS platforms. These tools facilitate the identification of genetic variations and mutations associated with cancer, enabling accurate and timely diagnosis and treatment. In summary, NGS technologies have become indispensable in oncology molecular diagnostics, driving advancements in cancer research, drug development, and personalized medicine.

Market Challenge

An unfavorable reimbursement scenario is a key challenge affecting the market growth. The rising number of cancer cases and deaths globally has fueled the need for advanced diagnostic methods to identify and treat cancer at its earliest stages. One such area of research is oncology molecular diagnostics, which involves analyzing cancer cells and their genome sequencing to identify specific biomarkers and proteins. This information is crucial for personalized treatment plans and improving patient outcomes. However, the high cost of these tests and the uncertainty surrounding reimbursement and insurance coverage pose significant challenges. Reimbursement policies play a pivotal role in determining the accessibility and utilization of molecular diagnostic tests for cancer.

Furthermore, inadequate or insufficient reimbursement rates can create financial barriers for patients and healthcare providers, hindering market growth. In certain regions, patients or healthcare institutions may be required to cover the remaining costs of these tests, which can deter them from undergoing the tests, leading to delayed or missed diagnoses. The increasing focus on reducing healthcare expenditure by governments worldwide has intensified the need for cost-effective and efficient molecular diagnostic solutions. Stakeholders need to collaborate and find ways to address the financial challenges associated with these tests to ensure timely and accurate diagnoses for cancer patients.

Exclusive Customer Landscape

The market forecasting 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 market growth analysis strategies.

 Customer Landscape

Key Companies & Market Insights

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.

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

The market research and growth report includes detailed analyses of the competitive landscape of the market and information about key companies, including:

• 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.
• HTG Molecular Diagnostics Inc.
• Illumina Inc.
• MDXHEALTH SA
• Myriad Genetics Inc.
• QIAGEN NV
• QuidelOrtho Corp.
• Siemens Healthineers AG
• Sysmex Corp.
• TBG Diagnostics Ltd.
• Thermo Fisher Scientific Inc.
• 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.

Research Analyst Overview

Molecular diagnostics in oncology is a rapidly evolving field that leverages advanced technologies to identify and analyze cancer cells at a molecular level. Biotechnology advancements, including automation, have revolutionized the identification of biomarkers in cancer research. Behavioral changes, such as dietary modifications and preventive medicine, have led to an increase in early detection of various cancers, including breast, colorectal, cervical, liver, kidney, and lung. Molecular biology technology, including chips & microarrays, mass spectrometry, and cancer genome sequencing, plays a pivotal role in cancer research methods. These tools enable the identification of genetic sequences and cell proteins, facilitating personalized treatment plans.

Furthermore, the prevalence of cancer continues to rise, with cancer cases and deaths attributed to various forms of the disease, such as blood cancer, prostate cancer, and infectious diseases caused by pathogens. Regulatory frameworks are in place to ensure the safety and efficacy of molecular diagnostic tools, including point-of-care (POC) testing and clinical trials. Synthetic biology and RNA sequencing are emerging technologies that hold promise in the field of oncology molecular diagnostics. POC testing allows for quick and accurate diagnosis, enabling timely intervention and treatment. The integration of these technologies with clinical testing in laboratories will continue to transform the market.

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

• CAGR of the market during the forecast period
• Detailed information on factors that will drive the market growth and forecasting between 2024 and 2028
• Precise estimation of the size of the market  and its contribution of the market in focus to the parent market
• Accurate predictions about upcoming market growth and trends and changes in consumer behaviour
• Growth of the market across North America, Europe, Asia, and Rest of World (ROW)
• Thorough analysis of the market's competitive landscape and detailed information about companies
• Comprehensive analysis of factors that will challenge the growth of market companies

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