Cancer Diagnostics Market

The global Cancer Diagnostics Market is valued at USD 109.61 Billion in 2024 and is projected to reach a value of USD 215 Billion by 2035 at a CAGR (Compound Annual Growth Rate) of 6.35% between 2025 and 2035.

Key Highlights of Cancer Diagnostics Market

• The market was mainly led by North America in 2023, accounting for 41.6% of the total market share
• The Asia Pacific is expected to be the fastest region in the coming years
• The Instruments segment significantly contributed to the market’s expansion, constituting over 53.2% of the overall revenue share in 2023
• The IVD Testing segment took the lead in the market, contributing 52.5% of revenue share in 2023
• The Breast Cancer segment took the lead in the market in 2023, constituting over 16.5% of the market share
• In 2023, the Hospitals and Clinics segment played a crucial role in the market’s growth, representing the majority of the revenue share, i.e., 62.6%
• ISO standards, including ISO 13485 for quality management systems and ISO 15189 for medical laboratories, provide diagnostic manufacturers and laboratories globally with quality assurance and regulatory compliance guidance. In Canada, cancer diagnostic products are regulated by Health Canada by the Medical Devices Regulations (SOR/98 282)
• An emerging development in the worldwide market for Cancer Diagnostics is the growing integration of artificial intelligence (AI) technologies. The accuracy and efficacy with which AI algorithms can analyze complex medical data, including imaging scans, pathology slides, and genetic profiles, have been demonstrated
• An emerging phenomenon in the worldwide market for Cancer Diagnostics is the incorporation of multi-omics methodologies. Multi-omics encompasses the exhaustive examination of diverse molecular data types—genomics, transcriptomics, proteomics, metabolomics, and epigenomics—to acquire a holistic comprehension of the biology of cancer

Cancer Diagnostics Market: Regional Overview

The North America Cancer Diagnostics market showed significant dominance in 2023, with 41.6% of the revenue share. The North American Cancer Diagnostics market is undergoing substantial expansion in 2023, predominantly propelled by several factors that contribute to the development and expansion of diagnostic technologies and services. An essential determinant driving market expansion is the rising incidence of cancer throughout the area. The increasing prevalence of diverse forms of cancer has generated a surge in the need for precise and effective diagnostic instruments and services that aid in the timely identification and commencement of treatment.

Proactive screening programs and a focus on preventive healthcare measures have propelled market expansion. Due to the active promotion of cancer screening initiatives by governments, healthcare organizations, and advocacy groups, a favorable environment for the adoption of cancer diagnostic tests and services has been established in North America. In addition to high healthcare expenditures and insurance coverage, the presence of a well-established healthcare infrastructure has contributed to the expansion of the Cancer Diagnostics market in North America.

U.S. Cancer Diagnostics Market Overview

The Cancer Diagnostics market in the United States, with a valuation of USD 6.9 Billion in 2023, is projected to reach around USD 17.01 Billion by 2032. This forecast indicates a substantial Compound Annual Growth Rate (CAGR) of 10.4% from 2024 to 2032. The Cancer Diagnostics market in the United States is the leading country in 2023. The escalating prevalence of cancer among diverse demographic groups is an initial and substantial catalyst. As lifestyle factors and an aging population contribute to the increased risk of cancer, there is a growing need for efficient diagnostic instruments and services that can identify the disease during its early stages when treatment outcomes are more favorable. Furthermore, the increased focus on preventive healthcare and cancer screening initiatives in the United States has significantly amplified consciousness regarding the critical nature of timely identification. Implementing government initiatives, public health campaigns, and insurance coverage for screening tests has contributed to a surge in the demand for cancer diagnostic services by encouraging individuals to undertake routine screenings.

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The global Cancer Diagnostics market can be categorized as Product, Technology, End User, and Region.

Cancer Diagnostics Market: Product Overview

In 2023, there was substantial expansion in the global Cancer Diagnostics market within the Instruments category, i.e., 53.2%. The Product segment is segmented into Consumables, Instruments, and Biopsy Instruments. Within the worldwide Cancer Diagnostics market, the term “instruments” denotes the machinery, apparatus, and equipment utilized in various diagnostic processes to identify and assess malignant cells or tissues. Laboratory equipment, including PCR machines and flow cytometers, as well as imaging techniques like MRI and CT scans, require these instruments to perform an extensive array of diagnostic tests. Technological progress significantly influences the expansion of the market. Cancer Diagnostics have been significantly transformed by advancements including molecular diagnostics, digital pathology, and high-throughput screening technologies, which provide detection methods that are both more rapid and precise.

Cancer Diagnostics Market: Technology Overview

There was remarkable growth in the IVD Testing segment, with 52.5% of the market share in 2023. Based on the Technology, the Cancer Diagnostics market is categorized into IVD Testing, Imaging, and Biopsy Technique. IVD (In-Vitro Diagnostic) testing is paramount in the worldwide Cancer Diagnostics industry, substantially contributing to its expansion and development. IVD testing pertains to examining human specimens obtained externally, including blood, tissue, or urine, to identify diseases or conditions, including cancer, via various laboratory methodologies. In the worldwide market for Cancer Diagnostics, IVD testing comprises an extensive array of diagnostic techniques, such as clinical chemistry, immunoassays, and molecular diagnostics. As a result of technological advances in IVD testing, diagnostic assays that are more precise, efficient, and sensitive have been created. An example of this is the significant impact that next-generation sequencing (NGS) technologies have had on molecular diagnostics. These technologies have facilitated the identification of genetic mutations and alterations associated with cancer with unparalleled precision and velocity.

Cancer Diagnostics Market: End User Overview

In 2023, the global Cancer Diagnostics market experienced significant growth, with a 62.6% share in the Hospitals and Clinics segment. The End User segment is divided into Hospitals and Clinics, Diagnostic Laboratories, Diagnostic Imaging Centers, and Research Institutes. As critical stakeholders in the diagnosis and treatment of cancer, hospitals and clinics hold a significant position within the global Cancer Diagnostics market. Medical facilities are establishments where individuals seek healthcare services, such as consultations, diagnostic procedures, and treatment approaches for cancer and other ailments. Progress in diagnostic technologies has brought about a paradigm shift in cancer detection and monitoring. To improve their capacity for precise and timely cancer detection, hospitals and clinics are increasingly implementing advanced diagnostic technologies, including imaging techniques (e.g., MRI, CT scans, PET scans), molecular diagnostics (PCR, next-generation sequencing), and liquid biopsies.

Key Trends

1. Advancements in Precision Medicine: A minimally invasive alternative to conventional tissue biopsies, liquid biopsies are utilized for cancer diagnosis and monitoring. These assays identify exosomes, cell-free DNA (cfDNA), and circulating tumor cells (CTCs) in blood samples, thereby furnishing significant genetic data about malignancies. Liquid biopsies are favored by healthcare providers and patients due to their convenience and accessibility. They allow healthcare providers to monitor the treatment, follow up on recurrences, and detect them earlier. As the sensitivity and specificity of liquid biopsy technology continues to improve, their integration into clinical practice is becoming more common leading to an increase in market growth. Moreover, efforts are currently underway to expand the applicability of tube biopsy for a broad range of cancer types, which will increase its use on the market.
2. Rising Adoption of Liquid Biopsies: Due to significant improvements in accuracy, efficiency, and automation, the integration of AI and machine learning algorithms into cancer detection is on the rise. In order to assist in the diagnosis, prognosis, and treatment planning processes, these technologies analyze large data sets arising from imaging studies, genetic profiles, or healthcare records. Subtle patterns and anomalies that are impossible for humans to detect can be identified by diagnostic tools powered by AI, resulting in earlier detection and individualized treatment recommendations. As AI continues to develop its capabilities underpinning market growth, integrating AI in Cancer Diagnostics will be increasingly common. Developing and adopting AI diagnostic solutions is also aided by partnerships with technology companies, healthcare establishments and research organisations that contribute to market growth.
3. Integration of Artificial Intelligence (AI) in Diagnostics: The use of AI and machine learning algorithms to diagnose cancer is on the rise, with significant improvements in accuracy, effectiveness or automation. In order to assist the diagnosis, prognosis and planning of treatment, these technologies analyze complex data obtained from scans, genetic profiles or medical records. Subtle patterns and anomalies that humans cannot detect can be identified by diagnostic tools powered by AI, resulting in earlier detection and individualized treatment recommendations. As AI advances its capabilities, which are driving the growth of the market, it is increasingly being integrated into Cancer Diagnostics. Moreover, the development and adoption of AI-based diagnostic solutions are driven by established partnerships between technology companies, healthcare institutions, and research organizations, contributing to market growth.

Premium Insights

The regulatory environment governing the worldwide market for Cancer Diagnostics is intricate and diverse, comprising a range of standards and regulations established by various international organizations and governmental entities. Ensuring the quality, safety, and efficacy of cancer diagnostic products and services, these regulations also promote access to new technologies and innovation. In the United States, the regulation of cancer diagnostic tests and devices is the responsibility of the U.S. Food and Drug Administration (FDA). Laboratory-developed tests (LDTs) and in vitro diagnostic (IVD) tests are the two categories of diagnostic tests, and distinct regulatory pathways govern each classification. FDA sanction or clearance is customarily necessary before commercializing a cancer diagnostic test or device within the United States. The degree of regulatory surveillance is contingent upon the test’s risk classification. The regulation governing cancer diagnostic products in the European Union (EU) is known as the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746.

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Market Dynamics

The increasing incidence of cancer represents a major driving force for the global diagnostics market in this area. Several factors, including the need to detect and develop technologies earlier and a shift toward personalized medicine, are driving the markets growth. The impact of this market growth driver is further strengthened by the continuing developments, e.g., implementation of screening programs that include AI and expanding point of sale terminals. In addition, a significant factor affecting the global market for Cancer Diagnostics is an increase in R&D spending. The catalyst encourages advances in the identification of biomarkers, the development of advanced diagnostic tools, and the application of research findings to medicine. The market growth has been significantly influenced by ongoing trends, e.g., increased focus on precision medicine, the emergence of Digital Health and Big Data Analytics, as well as collaboration and funding initiatives worldwide.

The growing recognition and priority of preventive healthcare measures is another significant factor boosting the global market for Cancer Diagnostics. Healthcare organizations, governments and the general public are driving this catalyst intending to improve cancer prevention, early detection and screening efforts. Increased engagement in cancer screening initiatives has been driven by the importance of early detection and increased awareness about risk factors for cancer. Screening programs aim to identify precancerous lesions or detect cancer in its early stages, thus enabling rapid intervention and improving the results of therapy. As a result, the market for diagnostic testing and technologies to aid cancer screening initiatives is growing.

Competitive Landscape

The competitive landscape in the Cancer Diagnostics market is marked by strategic collaborations aimed at expanding global accessibility to advanced technologies. For instance, Pfizer and Thermo Fisher Scientific Inc. announced in May 2023 that they had entered into a collaboration agreement to facilitate in increasing local access to next-generation sequencing (NGS)-based testing for lung & breast cancer patients in more than 30 countries across Asia, Latin America, Africa, the Middle East, where advanced genomic testing has previously been limited or unavailable.

Recent Market Developments

• In Jan 2024, Agilent Technologies Inc. announced an agreement with Incyte that will bring together Agilent’s expertise and proven track record in developing companion diagnostics (CDx) to support the development and commercialization of Incyte’s hematology and oncology portfolio.
• In Jan 2024, QIAGEN Digital Insights announced their enhanced QIAGEN CLC Genomics Workbench Premium with LightSpeed technology, which now supports next-generation sequencing (NGS) for somatic cancer secondary analysis. The software accelerator converts raw sequencing data in FASTQ files to interpretable lists of genetic variants in VCF files at unprecedented low cost and high speed.
• In Nov 2023, GE HealthCare launched a new AI suite designed to simplify radiologists’ workflows when reading mammograms and help them detect breast cancer in patients sooner. The latest offering includes three AI tools made by iCAD.