Cancer Diagnostics Market Size, Share & Industry Analysis, By Product (Instruments and Assay Kits & Reagents), By Technique (Immunohistochemistry (IHC), Immunoassays, Molecular Diagnostics [Next Generation Sequencing (NGS), Polymerase Chain Reaction (PCR), In-situ Hybridization (ISH), and Others], and Others), By Type (Tissue Biopsy and Liquid Biopsy), By Cancer Type (Lung Cancer, Breast Cancer, Colorectal Cancer, Prostate Cancer, and Others), By End-user (Hospitals & Clinics, Clinical Laboratories, and Others), and Regional Forecast, 2024-2032

The global cancer diagnostics market size was valued at USD 15.13 billion in 2023. The market is projected to grow from USD 16.12 billion in 2024 to USD 31.00 billion by 2032, exhibiting a CAGR of 8.5% during the forecast period. North America dominated the cancer diagnostics market with a market share of 35.89% in 2023.

Cancer diagnostics through techniques such as immunohistochemistry, in-situ hybridization, and others, helps distinguish various types of cancer and identify the subtypes of the disease. The increasing burden of cancer globally has been fueling the demand for effective diagnostics that help in the early diagnosis of the disease.

• For instance, as per data published by the World Health Organization (WHO), the new cancer cases globally are expected to reach 35 million in 2050, experiencing an increase of 77% from 20 million in 2022.

Moreover, the increasing focus of key players on R&D activities for the launch of advanced diagnostics has also been fueling the global market growth.

• In February 2023, F. Hoffmann-La Roche Ltd expanded its partnership with Janssen Biotech Inc. to continue its R&D for companion diagnostics such as next-generation sequencing, digital pathology, polymerase chain reaction, and immunoassay.

During the COVID-19 pandemic, in 2020, the market experienced a decline in its value. The decline was due to the lockdown restrictions and postponement of cancer screening programs to control the spread of the virus. The pandemic caused disruptions in routine cancer screenings, temporarily affecting market growth. However, the adoption of telemedicine offered some continuity in patient care.

Furthermore, the market experienced significant growth in 2021 and 2022 due to the re-initiation of cancer screening programs and an increasing number of patient visits to hospitals and doctor’s clinics for cancer diagnoses.

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MARKET DYNAMICS

Market Drivers

Increasing Burden of Cancer to Fuel the Demand for Effective Diagnostics Driving the Market Growth  

The incidence of cancer, such as prostate cancer, breast cancer, and colorectal cancer, among others, has been growing significantly across the globe.

• For instance, according to data published by the American Cancer Society, Inc., in 2022, 1,918,030 new cancer cases and 609,360 cancer deaths are projected to occur in the U.S.


• However, as per data published by the World Health Organization (WHO), in 2022, the number of new cancer cases that occurred in the U.S. increased to 2,380,189, and deaths due to cancer were estimated to be around 605,761.

Such an increasing burden of the disease has been boosting the need for early diagnosis of the disease for effective and on-time treatment, which helps in reducing the mortality rates due to cancer. Therefore, the increasing number of cancer cases, along with the high burden of mortality rates, has been fueling the demand for advanced and effective cancer diagnostics, thereby fueling the global cancer diagnostics market growth.

Increasing Initiatives for Early Cancer Diagnosis and the Growing Number of Cancer Awareness Programs to Fuel the Market Growth

The growing burden of cancer has increased the focus of cancer organizations and government regulatory bodies on creating awareness regarding cancer.

• For instance, in August 2020, the World Health Assembly adopted an initiative, Global Strategy for Cervical Cancer Elimination. This strategy aimed to create awareness regarding cancer, focusing on early screening and treatment of the disease.

Furthermore, government and regulatory bodies in many countries are also focusing on conducting cancer screening programs to help in the early diagnosis of the disease.

• For instance, Against Colorectal Cancer in Our Neighborhoods (ACCION) is a colorectal screening program that is conducted in the U.S. to promote colorectal cancer (CRC) screening among uninsured Hispanic adults in the country.


• Similarly, in the U.K., Bowel Cancer Screening (BCSP) Programme is conducted every two years to conduct colorectal cancer screening through the fecal immunochemical test (FIT).

Moreover, there are many programs, such as the Alliance of Glycologists for Cancer Research, Cancer Immunoprevention Network (CIP-Net), and Early Detection Research Network (EDRN), among others, that are involved in conducting research studies for controlling cancer.

Therefore, the increasing government initiatives in various countries on creating awareness regarding cancer and the benefits of early treatment has been increasing the demand for effective cancer diagnostics. Additional factor positively influencing market growth is the initiation of various cancer screening programs.

Market Restraints

High Cost and Side Effects Associated with the Medication May Restrict the Market Growth

The increasing prevalence of cancer and rising awareness regarding the benefits of early diagnosis have been fueling the demand for effective diagnostics. However, there are certain risk factors associated with the use of cancer diagnosis tools that have been limiting the market growth.

• For instance, colonoscopy is considered a gold standard in many countries, such as in the U.S., for colorectal cancer screening and diagnosis. However, risk factors such as bleeding, perforation, risk of device-associated infection, and others, limit its adoption for cancer diagnosis.

Furthermore, the high cost associated with the use of diagnostics for cancer screening and diagnosis is another factor that has been limiting their adoption.

For instance, the cost of a PCR machine can start from USD 3,000. However, it can go as high as up to USD 30,000. Moreover, these devices require regular maintenance. Due to all these factors, healthcare facilities, especially in emerging countries, limit themselves from expanding their diagnostics facility and undergoing regular maintenance. This can hinder the efficacy of these devices. 

Therefore, the high cost of cancer diagnostics and risk factors associated with its use may limit the market growth.

Market Opportunities

Expanding Diagnostic Capabilities in Emerging Markets

The development and commercialization of technologically advanced diagnostics has been increasing significantly. However, its adoption in the emerging market of the countries in the Asia Pacific region is limited due to finite healthcare infrastructure.

The emphasis of government bodies in the countries of Asia Pacific on increasing investment in the development of healthcare infrastructure will fuel the adoption of advanced diagnostics in the region in the coming years. 

Awareness about Telemedicine in Cancer Diagnosis

During the outbreak of COVID-19, many clinical studies were initially postponed due to lockdown restrictions. Furthermore, cancer screening programs were postponed to control the spread of the virus. However, the availability of screening test kits in online pharmacies helped the population with regular screening. Furthermore, the rise of telemedicine in cancer diagnostics offers the potential to reach underserved populations, especially for follow-ups and consultations.

Market Challenges

Limited Access to Advanced Technologies in the Emerging Markets

The development and adoption of advanced technology-based diagnostic equipment are increasing significantly across the globe. However, emerging markets such as Afghanistan and South Africa, face challenges in acquiring advanced diagnostics due to limited infrastructure, trained professionals, and economic constraints.

Other Challenging Factors

• Supply Chain Disruptions

Global trade restrictions and tariffs can hinder access to advanced diagnostic tools, particularly for developing markets.

• Regulatory Challenges

Differing regulatory environments between regions can delay the introduction of innovative diagnostic technologies in certain countries.

• Impact of Trade Wars

Trade tensions, particularly between major economies, could affect the availability of essential diagnostic equipment, slowing market growth.

CANCER DIAGNOSTICS MARKET TRENDS

Increasing Focus of Market Players on New Product Launches to Fulfill the Increasing Demand

The burden of cancer, such as colorectal, liver, and breast cancer, has been growing significantly. To control the growing burden of the disease, many awareness initiatives have been conducted by government regulatory bodies and healthcare providers. The increasing awareness regarding the severity of cancer and the benefits of early diagnosis of the disease has increased the demand for effective and early diagnosis of cancer among the population globally.

To fulfill this demand, market players have increased their focus on new product development and launches.

• In June 2022, F. Hoffmann-La Roche Ltd launched BenchMark ULTRA PLUS, for the diagnosis of cancer and timely patient care. With this launch, the company aimed at enhancing targeted patient care.

Moreover, artificial intelligence (AI) is becoming a pivotal tool in cancer diagnostics, especially in early-stage detection and image analysis. AI models are being used for risk profiling and improving diagnostic accuracy, such as reducing false positives in lung cancer screenings. The market players have increased their focus on partnerships to enhance the use of AI in their diagnostic tools.

• In October 2023, F. Hoffmann-La Roche Ltd partnered with Ibex Medical Analytics and Amazon Web Services to increase the accessibility of Ibex’s AI-powered decision support tool to pathology diagnostic laboratories. This partnership aimed to enhance the diagnosis results of prostrate and blood cancer.

Therefore, the increasing focus of market players on new advanced product launches is expected to increase the accessibility of effective cancer diagnostics.

Increasing Adoption of Technological Advancements in Diagnostics to Enhance the Diagnosis

The increasing prevalence of cancer has been fueling the adoption of liquid biopsies for invasive as well as non-invasive cancer detection, such as for lung and breast cancers. To increase the availability of advanced diagnostics, market players have increased their focus on partnerships for new advanced product development.

• For instance, in April 2021, Illumina, Inc. and Kartos Therapeutics partnered for the development of NGS-Based TP53 Companion Diagnostic for cancer diagnosis.

Moreover, the market players have also been focusing on the development of cost-effective diagnostics. For instance, as per data published by the World Economic Forum, in July 2024, a new blood protein test was developed in the U.S. by Novelna, a biotechnology company, that claims to identify 18 early-stage cancers with high accuracy. This breakthrough could lead to cost-effective population-wide screening for early cancer detection.

Increasing Development of Personalized Medicine

Market players have also been focusing on partnerships to increase the accessibility of diagnostic tests with genetic testing to tailor effective cancer treatments.

• For instance, in May 2023, Pfizer Inc. and Thermo Fisher Scientific Inc. collaborated to enhance accessibility to the next-generation sequencing (NGS) diagnosis of lung and breast cancer among patients in more than 30 countries across Africa, Latin America, the Middle East, and Asia.

Rising Trend of Medical Tourism

Diagnostics and treatment options are quite cheap in the countries of the Asia Pacific region. Due to this, the population in the neighborhood countries prefers visiting countries in the region for diagnosis and treatment of the disease, thereby fueling medical tourism.

Increasing Adoption of Biomarkers for Effective Diagnosis

Market players increased their focus on the development and launch of biomarker-based diagnostics to facilitate early and precise detection of cancers.

• For instance, in April 2024, Bio-Rad Laboratories, Inc. announced the launch of a multiplexed digital PCR assay, the ddPLEX ESR1 Mutation Detection Kit.

Therefore, the increasing commercial availability of biomarkers is creating lucrative growth opportunities.

SEGMENTATION ANALYSIS

By Product Analysis

Increasing Number of Diagnosis Tests and New Product Launches to  Propel the Assay Kits & Reagents Segment Growth

On the basis of product, the global market is segmented into instruments and assay kits & reagents.

The assay kits & reagents segment accounted for the largest share of the global cancer diagnostics market in 2023. The segment’s dominance is attributed to the growing burden of cancer, which has been fueling the number of cancer diagnoses which is being conducted globally. Furthermore, the increasing focus of market players on new advanced product launches has also been fueling the market growth.

• In May 2022, Illumina, Inc. announced the addition of a companion diagnostic (CDx) indication to its CE-marked in vitro diagnostic TruSight Oncology (TSO) comprehensive test. This single kit launched in Europe is available to assess multiple tumor genes and biomarkers that are helpful in the molecular profiling of the patient's cancer.

Moreover, the instruments segment is expected to grow at a considerable CAGR during the forecast period. The segment growth is attributed to the increasing healthcare spending by countries globally.

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By Technique Analysis

Increasing Demand for Immunosassays for Various Types of Cancer to Fuel the Segment Growth

Based on technique, the market is segmented into immunohistochemistry (IHC), immunoassays, molecular diagnostics, and others. The molecular diagnostics segment is further segmented into next-generation sequencing (NGS), polymerase chain reaction (PCR), in-situ hybridization (ISH), and others.

The immunoassays segment dominated the market in 2023. Immunoassays are very effective and accurate in diagnosing prostate cancer, breast cancer, and others. Therefore, the increasing incidence of these cancer types has been fueling the segment growth.

• For instance, as per data published by Breastcancer.org in July 2024, breast cancer is one of the most diagnosed cancers in the U.S. and around 30% of all newly diagnosed cancers are breast cancer.


• As per the same source, around 310,720 women and 2,800 men are estimated to be diagnosed with breast cancer in the U.S.

Furthermore, the immunohistochemistry (IHC) segment is anticipated to grow at the fastest growth rate during the forecast period. The high growth of the segment is attributed to the various advantages associated with the use of immunohistochemistry in cancer diagnoses, such as precise diagnosis and its efficacy in predicting treatment response.

By Type Analysis

Advantages Associated with Tissue Biopsy to Drive the Segmental Dominance

On the basis of type, the market is bifurcated into tissue biopsy and liquid biopsy.

The tissue biopsy segment dominated the market in 2023. The segment’s dominance is attributed to its high accuracy and detailed information provided which are crucial for initial diagnoses and molecular profiling.

The liquid biopsy segment is expected to grow at the fastest CAGR over the forecast period. The segment’s growth is attributed to the time-efficient output of results. For instance, as per a study published by the National Centers for Biotechnology Information (NCBI) in 2023, the liquid biopsy next-generation sequencing result output was 26.8 days faster than tissue biopsy.

By Cancer Type Analysis

Breast Cancer Segment Dominates to the Increasing Burden of Cancer such as Bladder and Kidney Cancer

On the basis of cancer type, the market is segmented into lung cancer, breast cancer, colorectal cancer, prostate cancer, and others.

The breast cancer segment held a dominant position in the global market in 2023. The growth of the segment is attributed to the increasing burden of breast cancer globally.

• For instance, as per data published by the World Health Organization (WHO), in 2020, 2.26 million new cases of cancer were observed globally. However, this number reached 2.31 million in 2022.

The lung cancer segment is expected to grow at the fastest CAGR during the forecast period. The segment growth is attributed to the increased addiction to smoking among youths, which is the major cause of lung cancer.

By End-user Analysis

Increasing Number of Clinical Laboratories with Technologically Advanced Products to Drive the Segment Growth

Based on the end-user, the market is segmented into hospitals & clinics, clinical laboratories, and others.

The clinical laboratories segment dominated the market in 2023. The  dominance is attributed to the increasing number of clinical laboratories globally with the availability of technologically advanced equipment. Furthermore, the high number of laboratory tests being conducted globally has also been fueling the segment’s growth.

• For instance, as per data published by the National Centers for Biotechnology Information (NCBI) in 2024, around 4 billion tests are annually conducted in the U.S.

Moreover, the hospital segment is attributed to grow at a significant CAGR during the forecast period. The segment growth is due to the increasing preference of patients for getting diagnosed and treated both at the same place.

CANCER DIAGNOSTICS MARKET REGIONAL OUTLOOK

Based on geography, the market has been studied across North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

North America

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North America dominated the market in 2023, accounting for a revenue of USD 5.43 billion. The robust regional growth is attributed to the strong presence of market players such as Thermo Fisher Scientific Inc., Abbott, Illumina, Inc., and GE Healthcare, among others.

Europe

The Europe market accounted for a significant global cancer diagnostics market share in 2023. The market growth in the region is attributed to the increasing focus of market players on partnerships to enhance cancer diagnoses in the region.

• For instance, in March 2024, Bayer AG and Thermo Fisher Scientific Inc. collaborated to develop next-generation sequencing (NGS)-based companion diagnostic assays. This collaboration aimed to identify the cancer patients who can benefit from Bayer AG's precision cancer therapies.

Furthermore, the increasing adoption of precision oncology in the research and development of personalized cancer diagnostics has also been fueling the market growth. For instance, as per  data published by the World Economic Forum in July 2024, the National Health Service conducted a 100,000 genomes project that studied over 13,000 tumor samples in the U.K. This would help in the development of effective personalized diagnostic and treatment for cancer patients.

Asia Pacific

The Asia Pacific market is expected to grow at a significant CAGR during the forecast period. The regional market growth is attributed to the growing burden of cancer.

• As per data published by the World Health Organization (WHO), around 4,824,703 total cancer cases were recorded in China in 2022.

Latin America and Middle East & Africa

The market in Latin America and the Middle East & Africa is expected to grow substantially during the forecast period. This is attributed to the growing burden of cancer and rising awareness about early diagnosis in both regions.

COMPETITIVE LANDSCAPE

Key Industry Players

Increasing Focus of Market Players on Partnerships and Acquisitions to Enhance their Product Offerings to Drive their Revenue Growth

Market players such as F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific Inc., and Abbott are among the major players, accounting for a significant share of the global cancer diagnostics market. The significant presence of these companies in the market is attributed to their focus on the launch of new diagnostic solutions.

• For instance, in December 2021, F. Hoffmann-La Roche Ltd launched three research use only (RUO) digital pathology algorithms, uPath Ki-67 (30-9), uPath ER (SP1), and uPath PR (1E2) for the image analysis of breast cancer.

Moreover, other players, such as Illumina, Inc., GE Healthcare, and BD, among others, have been focusing on new product approvals to enhance their presence in the market.

• For instance, in August 2024, Illumina, Inc. announced the Food and Drug Administration (FDA) approval of its in vitro diagnostic (IVD) TruSight Oncology (TSO) comprehensive test with the aim to enhance its offerings for cancer diagnostics. A single test screens over 500 genes and profiles the patient's solid tumor.

LIST OF KEY CANCER DIAGNOSTICS PLAYERS PROFILED IN THIS REPORT: 

• F. Hoffmann-La Roche Ltd (Switzerland)


• Thermo Fisher Scientific Inc. (U.S.)


• Abbott (U.S.)


• Illumina, Inc. (U.S.)


• GE Healthcare (U.S.)


• BD (U.S.)


• bioMérieux SA (France)


• Myriad Genetics, Inc (U.S.)


• Bio-Rad Laboratories, Inc. (U.S.)


• QIAGEN (Germany)

KEY INDUSTRY DEVELOPMENTS:

• August 2024 – Illumina, Inc. announced the expansion of the oncology menu in its NovaSeq X Series diagnostic equipment to enhance its offerings in the cancer diagnostics portfolio.


• April 2024 – F. Hoffmann-La Roche Ltd received a CE Mark for VENTANA HER2 (4B5) Rabbit Monoclonal Primary Antibody RxDx. This product helps to identify metastatic breast cancer patients with low HER2 expression.


• March 2024 – Myriad Genetics, Inc. enhanced its portfolio for precision oncology with the launch of Precise Solutions. Precise Solutions includes the Precise Tumor Molecular Profile Test.


• November 2023 – Abbott received the approval of the U.S. Food and Drug Administration (FDA) for Alinity m high-risk (HR) HPV assay indicated for HPV detection and routine screening for cervical cancer.


• November 2023 – Illumina, Inc. launched a liquid biopsy assay for genomic profiling, TruSight Oncology 500 ctDNA v2 (TSO 500 ctDNA v2), with an aim to enhance cancer research.

REPORT COVERAGE

The global cancer diagnostics market report provides a detailed competitive landscape and market insights. It also includes key insights, such as top industry developments covering partnerships, mergers, and acquisitions. Additionally, it focuses on key points, such as new solution launches in the market. Furthermore, the report covers regional analysis of different market segments, profiles of key market players, market trends, and the impact of COVID-19 on the market. The report consists of quantitative and qualitative insights that have contributed to the market growth.

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Report Scope & Segmentation