The global sales of cancer diagnostics are estimated to be worth USD 60.4 billion in 2024 and anticipated to reach a value of USD 136.7 billion by 2034. Sales are projected to rise at a CAGR of 8.5% over the forecast period between 2024 and 2034. The revenue generated by cancer diagnostics in 2023 was USD 55.7 billion.
This increasing emphasis on early cancer detection is an important of modern oncology, driven by the critical need to improve patient survival rates, reduce healthcare costs, and enhance the quality of life for individuals diagnosed with cancer. Early detection enables identification of cancer at its initial stages when it is most treatable and before it spreads to other parts of the human body.
According to World Health Organization in 2022, there were an estimated 20 billion new cancer cases and 9.7 billion deaths. The estimated number of people who were alive within 5 years following a cancer diagnosis was 53.5 billion. About 1 in 5 people develop cancer in their lifetime, approximately 1 in 9 men and 1 in 12 women die from the disease.
Global Cancer Diagnostics Industry Assessment
| Attributes | Key Insights |
|---|---|
| Historical Size, 2023 | USD 55.7 billion |
| Estimated Size, 2024 | USD 60.4 billion |
| Projected Size, 2034 | USD 136.7 billion |
| Value-based CAGR (2024 to 2034) | 8.5% |
Several innovative techniques are advancing early cancer detection. Technologies like mammography for breast cancer, low-dose computed tomography (CT) for lung cancer, and colonoscopy for colorectal cancer are still among the standard screening tools.
Liquid biopsies are revolutionizing detection through circulating tumor DNA (ctDNA) or circulating tumor cells (CTCs) in blood, offering a non-invasive, highly sensitive method for the detection of cancer before it becomes symptomatic. MCED tests, based on genomic and proteomic profiling, detect various types of cancer from single blood sample, hence making a significant shift towards preventive oncology.
Molecular diagnostics can include PCR and NGS as a method of identifying cancer risk-associated genetic mutations or biomarkers. Additionally, AI assists in improving the speed and precision of imaging analysis to note even slight changes that indicate early malignancies. On the other hand, wearable devices along with digital health platforms enable constant monitoring of physiological changes indicative of cancer.
Hence, the growing focus on early detection is not only a clinical imperative but also a social one - addressing the global cancer burden and saving lives while optimizing healthcare resources.
The below table presents the expected CAGR for the global cancer diagnostics market over several semi-annual periods spanning from 2024 to 2034. In the first half (H1) of the decade from 2023 to 2033, the business is predicted to surge at a CAGR of 9.2%, followed by a slightly lower growth rate of 8.9% in the second half (H2) of the same decade.
| Particular | Value CAGR |
|---|---|
| H1 | 9.2% (2023 to 2033) |
| H2 | 8.9% (2023 to 2033) |
| H1 | 8.5% (2024 to 2034) |
| H2 | 8.0% (2024 to 2034) |
Moving into the subsequent period, from H1 2024 to H2 2034, the CAGR is projected to decrease slightly to 8.5% in the first half and decrease moderately at 8.0% in the second half. In the first half (H1) the market witnessed a decrease of 70.00 BPS while in the second half (H2), the market witnessed a increase of 90.00 BPS.
Emergence of Multi-Cancer Early Detection (MCED) Tests is a Transformative Market Driver
Emergence of multi-cancer early detection tests is revolutionizing cancer diagnostics, meeting the much-needed early and accurate detection of multiple types of cancer. Unlike traditional methods that use single-cancer screening, MCED tests are based on a single blood sample to detect various types of cancers simultaneously. It is reshaping preventive health care by offering a non-invasive, all-round approach to early cancer detection, which is the basis for improving survival rates and reducing treatment costs.
Multi-cancer early detection tests use advanced technologies like next-generation sequencing (NGS) and proteomics to identify genetic mutations associated with cancer or epigenetic changes/protein biomarkers in circulating tumor DNA (ctDNA) or other blood-based components. Such tests are sensitive enough to detect cancers at pre-symptomatic stages including types not having routine screening options like pancreatic, ovarian, and liver cancers.
Governments and health care systems are beginning to realize their potential to reduce the economic and social burden of cancer. For example, large pilot studies and clinical trials are being conducted to assess whether these multi-cancer early detection technologies can be integrated into national cancer screening programs for mass implementation.
The continuing refinement and decreasing costs of multi-cancer early detection tests associated with technological advancement will boost the share of these technologies in the early detection landscape and accelerate growth and innovation in the global cancer diagnostics market.
Nanotechnology-Driven Diagnostic Tools is Propelling the Overall Market Growth
Nanotechnology is a potential revolution in cancer diagnostics by creating ultra-sensitive tools to measure biomarkers that signal the onset of cancer. These technologies greatly benefit from nanoparticles and nanostructured materials, significantly enhancing precision and speed while improving reliability of processes, thereby leading to detection at earlier stages for more favorable patient outcomes.
Specifically, nanotechnology finds applicability in diagnostics when applied for the identification of cancers when they are still in nascent stages, as traditional methods suffer from low sensitivity or specificity during such stages.
Nanoparticles are designed specifically to bind cancer-specific biomarkers in minute quantities, DNA, proteins, and metabolites. These have a huge surface area-to-volume ratio and can be tuned such that their optical and magnetic properties allow for greater signal amplification to detect trace cancer-related substances.
Examples of nanotechnology-based tools are Veridex's NanoVelcro Chips, used to capture circulating tumor cells (CTCs) from blood samples that help in early diagnosis and monitoring of treatment. Thermo Fisher Scientific's nanoparticle-enhanced flow cytometry systems improve cell sorting and detection capabilities.
Nanosensors and nanofluidic devices represent portable point-of-care tools for cancer diagnosis on emerging nanotechnology-based platforms, offering fast in-real-time analysis of biosamples, thus decreasing the need for centralized laboratory testing.
Liquid biopsies are poised to Play an Increasingly Vital Role in Cancer Diagnostics Market
Liquid biopsies are now being adopted even beyond their traditional role in the first-time diagnosis of cancer: they are being used real-time to monitor the success of treatment and the ongoing evolution of tumors, ensuring that this innovation is a fundamental driver of the cancer diagnostics market.
Liquid biopsies are generally non-invasive tests with circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), or any other cancer-derived components evaluated in bodily fluids such as blood, urine, and saliva. This expansion into dynamic monitoring offers a paradigm shift in patient management by enabling continuous assessment of cancer progression and treatment responses without the need for invasive procedures like tissue biopsies.
Addiitonally, liquid biopsies detect minimal residual disease (MRD) after surgery or chemotherapy and may offer some indication of recurrence even when the patient still feels healthy, and even when no abnormal imaging results have appeared. Early warning like this is potentially better able to intervene when the disease is still relatively tractable.
What makes liquid biopsies preferred is their non-invasive nature, speedy turnaround, and ability to capture the heterogeneity of tumors when traditional biopsies would reveal only a spot in one region of a tumor. Continued improvements in these technologies of liquid biopsy promise to raise sensitivity and specificity, where the application would be very much in the real-time monitoring of this technology; thus, innovative ideas shall drive improvement with better outcomes of patients and heavily reduce invasive diagnostics.
Challenges Related to Regulatory and Approval Pose a Significant Barrier for Market Expansion
The approval process for cancer diagnostics is a multi-step process that begins with preclinical testing to show feasibility and safety. This is followed by clinical trials, which must establish the diagnostic's sensitivity, specificity, and overall performance in accurately detecting or monitoring cancer. The requirement for comprehensive validation across diverse populations further extends the timeline, making the process time-consuming and resource-intensive.
Divergence in requirements by global markets further complicates the situation. While one region might demand that a diagnostic test demonstrates the ability to detect certain biomarkers, another region might demand completely different validation metrics. Such differences result in repeated testing and compliance, leading to higher costs and delay in entering global markets.
Added to this, regulations change with time. For instance, changing classification criteria for diagnostics or even establishing new routes may call for a company's strategy to be amended midcourse. These delay further approvals. Complexness will be highly associated with emerging diagnostics, which involve liquid biopsies and multi-omics platforms and have been requiring fully new pathways in regulatory approaches.
These challenges collectively restrain the cancer diagnostics market by protracting time-to-market, rising costs, and discouraging innovation. Smoother regulatory pathways, harmonization of international standards, and policies that strike a balance between innovation and patient safety will be essential toward addressing these issues.
The global cancer diagnostics industry recorded a CAGR of 7.5% during the historical period between 2019 and 2023. The growth of cancer diagnostics industry was positive as it reached a value of USD 55.7 billion in 2023 from USD 40.8 billion in 2019.
The cancer diagnostics market has evolved due to progress in medical imaging and integration with molecular biology and artificial intelligence. In the beginning, there was just basic X-rays and ultrasounds and their combinations, later supplemented with advancements in CT, MRI, PET scans for better precision as well as multi-dimensional views.
This has been accompanied simultaneously by the establishment of the gold standards for definitive diagnoses with biopsy-based techniques. There have also been an emergence of tumor marker testing for detecting tumors without any invasion.
This has been the transformative phase, with the advent of genomics and proteomics, enabling molecular diagnostics like PCR and next-generation sequencing (NGS) to detect genetic mutations and predict cancer susceptibility. Liquid biopsies, analyzing circulating tumor cells or DNA from blood samples, further enhanced early detection and monitoring capabilities.
Future trajectory will lead toward precision oncology, wherein diagnostics are converged into treatment to provide tailored therapies. Artificial intelligence and machine learning are transforming diagnostic imaging through increased precision and decreased turnaround times.
Point-of-care diagnostics continue to increase their presence in bringing results quickly at decentralized points. Increased cancer prevalence, awareness, and early screening programs promoted by governments also drive growth within this market. The focus will remain on minimally invasive and cost-effective diagnostic solutions, continuing to drive the dynamics of this market.
Tier 1 companies comprise market leaders with a significant market share of 26.1% in global market. These companies invest heavily in research and development to innovate new treatments, particularly in point of care diagnostics and test accuracy. These companies also engage in strategic partnerships and acquisitions to expand their product portfolios and access cutting-edge technologies.
Additionally, they emphasize extensive clinical trials to validate the efficacy and safety of their products. Prominent companies in tier 1 include F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific Inc., Abbott Laboratories, Siemens Healthineers, GE Healthcare and Becton, Dickinson and Company (BD)
Tier 2 companies include mid-size players having presence in specific regions and highly influencing the local market and holds around 33.5% market share. They typically pursue partnerships with academic institutions and research organizations to leverage emerging technologies and expedite product development.
These companies often emphasize agility and adaptability, allowing them to quickly bring new treatments to market, sometimes targeting specific types of cancer or rare conditions. Additionally, they focus on cost-effective production methods to offer competitive pricing. Prominent companies in tier 2 include Illumina Inc., bioMérieux SA, Hologic Inc. and Qiagen.
Finally, Tier 3 companies, such as Agilent Technologies Inc. and Myriad Genetics Inc. They specialize in specific products and cater to niche markets, adding diversity to the industry.
Overall, while Tier 1 companies are the primary drivers of the market, Tier 2 and 3 companies also make significant contributions, ensuring the cancer diagnostics sales remains dynamic and competitive.
The section below covers the industry analysis for the cancer diagnostics market for different countries. Market demand analysis on key countries in several regions of the globe, including North America, Latin America, East Asia, South Asia & Pacific, Western Europe, Eastern Europe and MEA, is provided. The United States is anticipated to remain at the forefront in North America, with higher market share through 2034. In Asia Pacific, India is projected to witness a CAGR of 6.3% by 2034.
| Countries | Value CAGR (2024 to 2034) |
|---|---|
| United States | 3.6% |
| Germany | 3.9% |
| China | 5.2% |
| France | 3.5% |
| India | 6.3% |
| Spain | 4.0% |
| Australia & New Zealand | 4.2% |
| South Korea | 5.4% |
United States cancer diagnostics market is expected to grow at a CAGR of 3.6% between 2024 and 2034. Currently, it holds the highest share in the North American market, and the trend is expected to continue during the forecast period.
Emphasis on patient safety and quality healthcare provided within the United States is a strong driver of growth in the cancer diagnostics market. In recent years, the United States healthcare system has increasingly worked toward better alignment and improvement in treatment outcomes with minimum patient risks, especially in cancer care. This focus has been at the forefront of spearheading advances within lung cancer therapies, emphasizing effectiveness, safety, and approach by the patient.
With the help of the FDA that is instrumental in assuring new therapies reach high standards, not only for safety but also for effectiveness. Specifically, breakthrough therapies and orphan drugs are considered for FDA accelerated approval, which has contributed to innovation in targeted therapies and immunotherapies against lung cancer. These therapies include immune checkpoint inhibitors and tyrosine kinase inhibitors, which have better safety profiles than cytotoxic chemotherapy by having fewer side effects and more personalized manners of approach.
China’s cancer diagnostics market is poised to exhibit a CAGR of 5.2% between 2024 and 2034. Currently, it holds the highest share in the East Asia market, and the trend is expected to continue during the forecast period.
The growth of the biotechnology industry in China, coupled with government policies, has favorably positioned the country as an attractive location for therapeutic manufacturing companies in the oncology segment. The companies in the country are regularly participating in developing and manufacturing cancer therapeutics for lung cancer with the support of advanced technologies and research capabilities. These low-cost productions by the domestic manufacturers make treatments relatively efficient and more accessible to a greater mass.
At the same time, strategic focusing on innovation by Chinese authorities encourages enhanced investment in research and development, often in collaboration with leading academic institutions and international partners. This has facilitated the introduction of new cancer therapies tailored to the specific needs of the local market.
Additionally, China as a significant exporter of cancer diagnostics to multiple other markets, adding to its influence within the global cancer treatment industry.
India’s cancer diagnostics market is poised to exhibit a CAGR of 6.3% between 2024 and 2034. Currently, it holds the highest share in the South Asia & Pacific market, and the trend is expected to continue during the forecast period.
India is emerging as a leader of the global cancer diagnostics market due to several key factors; these include the country's large population, rising levels of cancer prevalence, and enhanced awareness about early detection. The rising demand for diagnostic technologies related to molecular diagnostics, immunohistochemistry, and liquid biopsies is also stimulating the market.
Furthermore, small-scale Indian manufacturers also played a role in contributing to the rise of cancer diagnostics market. It offers more economical solutions for cancer testing with less cost because they help patients have access easily in more remote and needy places; the gaps are bridged between more premium diagnostic centers, which contribute to early treatment.
Such growth in the healthcare infrastructure of India coupled with better regulatory factors offers much scope to the expansion of cancer diagnostics market into a leader in this market.
The section contains information about the leading segments in the industry. By test type, the biopsy segment holds the highest market share of 34.2% in 2024.
| By Test Type | Biopsy |
|---|---|
| Value Share (2024) | 34.2% |
Biopsy dominates the cancer diagnostics market due to its highly accurate and definite results that form the basis of identifying the type, stage, and grade of cancer. The detailed examination of tissue samples allows pathologists to precisely identify malignancies and their characteristics, enabling informed treatment decisions.
In addition, biopsies are being increasingly utilized for the procurement of molecular information to support personalized medicine. Tissue samples collected can be analyzed for genetic mutations, biomarkers, and molecular profiles-all crucial in deciding on treatment options. This capability has become critical with the advent of targeted therapies where treatments are specifically selected based on a patient's unique tumor profile.
Also, the growth of minimally invasive biopsy techniques, such as fine-needle aspiration and liquid biopsies, further improves patient accessibility and comfort, thus driving the lead position of biopsy in the cancer diagnostics market. This combination of accuracy, personalization, and patient convenience continues to fuel biopsy's leading role in cancer detection.
| By End User | Hospital Associated Lab |
|---|---|
| Value Share (2024) | 44.2% |
The majority of cancer diagnostics market share is held by hospital-associated laboratories due to comprehensive infrastructure, availability of sophisticated diagnostic equipment, and multidisciplinary expertise. Such laboratories benefit from being integrated with hospitals so that collaboration among oncologists, pathologists, and radiologists is facilitated without any gaps, thereby increasing the chances of correct diagnoses and faster clinical decision-making.
Their ability to provide a wider range of diagnostic tests, be it through imaging, biopsy, molecular diagnostics, and blood-based testing, helps them become first choice for a cancer diagnostics patient. Typically, patients rely upon the hospital laboratories for complex diagnosis because of associated trust along with hospital standard and higher capacity to undertake a heavy volume of patient.
Hospital-associated labs continue to invest in the latest technologies, including next-generation sequencing and automated imaging systems, allowing for accurate diagnosis and profiling of advanced cancers. These factors further cement the position of hospital-associated laboratories as the market leaders in this emerging market space.
The market players are using strategies to stay competitive, such as product differentiation through innovative formulations, strategic partnerships with healthcare providers for distribution. Another key strategic focus of these companies is to actively look for strategic partners to bolster their product portfolios and expand their global market presence.
Recent Industry Developments in Cancer Diagnostics Market:
In terms of test type, the industry is divided into- tumor biomarkers tests - (PSA tests, CTC tests, AFP tests, CA tests HER2 tests, BRCA tests, ALK tests, CEA tests, EGFR mutation tests, KRAS mutation tests, others, ultrasound, mammography, MRI scan, PET scan, CT scan, SPECT & others). Biopsy- (needle biopsy, endoscopic biopsy, bone marrow biopsy, other), liquid biopsy, immunohistochemistry and in situ hybridization.
In terms of indication, the industry is segregated into breast cancer, lung cancer, colorectal cancer, melanoma, blood cancer, prostate cancer, ovarian cancer, stomach cancer, liver cancer and others
In terms of end user, the industry is segregated into- hospital associated labs, independent diagnostic laboratories, diagnostic imaging centers, cancer research institutes and others.
Key countries of North America, Latin America, Western Europe, Eastern Europe, South Asia and Pacific, East Asia and Middle East and Africa (MEA) have been covered in the report.
The global cancer diagnostics market is projected to witness CAGR of 8.5% between 2024 and 2034.
The global cancer diagnostics industry stood at USD 55.7 billion in 2023.
The global cancer diagnostics market is anticipated to reach USD 136.7 billion by 2034 end.
India is set to record the highest CAGR of 6.3% in the assessment period.
The key players operating in the global cancer diagnostics market include F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific Inc., Abbott Laboratories, Illumina Inc., bioMérieux SA, Siemens Healthineers, GE Healthcare, Hologic Inc., Agilent Technologies Inc., Becton, Dickinson and Company (BD), Myriad Genetics Inc. and Qiagen.
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Cancer Diagnostics Market
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