Market Overview
Cancer molecular diagnostics include the detection, diagnosis, sub-classification, prognosis, and monitoring response to therapy. These techniques identify the alterations in DNA or RNA sequences, associated with cancer. Molecular diagnostics are effective for analyzing the biological markers involved in inducing cancer and analyzing how cancer cells are expressing their genes. These techniques differentiate cancer from benign tumors, the type of tissue involved in cancer, and cancer subtypes.
Molecular diagnostics are useful for designing, implementing accurate diagnostic methods, and personalizing the treatment modalities for cancer. Molecular diagnostics are useful for monitoring the outcomes among patients with cancer. These techniques determine the risk for cancer occurrence. Molecular diagnostics are useful for physicians to decide the requirement for the more intensive screening or preventive measures. The market is dominated by the availability of several molecular diagnostics techniques such as polymerase chain reaction (PCR), in situ hybridization, isothermal nucleic acid amplification technology (INAAT), chips & microarrays, mass spectrometry, sequencing, transcription-mediated amplification, and others.
the global Cancer Molecular Diagnostics market was valued at USD 32,052.90 million in 2021. It is forecasted to reach USD YY million by 2029, growing at a CAGR of 6.30% during the forecast period (2023-2030).
Market Dynamics
Increasing Incidence of Cancer is Driving the Growth of the Market
The market is driven by the increasing demand for cancer molecular diagnostics with the increasing incidence of cancer. According to the World Health Organization (WHO), Cancer is a leading cause of death worldwide in 2020. Around, 10 million people died due to cancer in 2020. Globally, approximately 4 million children develop cancer in each year. Lung cancer, colorectal cancer, prostate cancer, breast cancer, oesophagus cancer, and stomach cancer are the most common cancer worldwide. A large number of people are suffering from lung cancer followed by breast cancer, colorectal cancer, prostate cancer, and stomach cancer. Lung cancer accounts for 11.6% of all cancer incidence cases i.e., 2.09 million incidence cases, breast cancer accounts for 11.6% of all cancer incidence cases i.e., 2.08 million incidence cases, colorectal cancer accounts for 10.2% of all cancer incidence cases i.e., 1.84 million incidence cases, prostate cancer accounts for 7.1% of all cancer incidence cases i.e., 1.27 million incidence cases, stomach cancer accounts for 5.7% of all cancer incidence cases i.e., 1.03 million incidence cases.
Increasing initiatives by several organizations and institutes for Cancer Molecular Diagnostics is boosting the market growth
Several institutes and organizations are raising their initiatives for the development of tests for Cancer Molecular Diagnostics. For instance, National Cancer Institute is supporting the research through the clinical proteomic tumour analysis Consortium (CPTAC) and another initiative to advance the identification and use of protein molecular markers and proteogenomic information for the treatment of cancer. Clinical Proteomic Tumor Analysis Consortium (CPTAC) is the collaborative effort initiated by various academic institutions, industries, and several federal agencies for measuring the entire complement of proteins in tumours in a rapid and large-scale manner. It also combines this information with genomic, imaging, and clinical data from patients.
Technological Advancement for Cancer Molecular Diagnostics is Fueling the Market Growth
The market is witnessing technological advancement for cancer molecular diagnostics for the diagnosis, prevention, treatment and management of cancer. Several companies, institutes, and organizations are focusing on developing novel molecular diagnostics including image analysis, sample preparation, shotgun sequencing, and microsatellite technology. Promega’s MSI Analysis System detects the microsatellite instability associated with the Lynch Syndrome. The PCR-based MSI Analysis System involves the use of the fluorescently labelled primers for microsatellite markers in multiplexed PCR reactions. Enzo’s PCR-based AMPIPROBE platform involves the use of PCR primers labelled with fluorescent reporters and quenchers. It detects the amount of the DNA or RNA of interest present in the sample.
There is ongoing research regarding the genomic biomarkers in testicular germ-cell tumours. According to the American Society of Clinical Oncology (ASCO), in 2019, the researchers identified the potential of the serum levels of the genomic biomarker microRNA371 (M371) as a strategy to stage testicular germ-cell tumours and assess response to treatment. The studies have demonstrated that the M371 test was very accurate for predicting the clinical stage, tumour size, and response to treatment of testicular germ-cell tumours. M371 test can be an effective tool for the diagnosis and management of cancer. Germ-cell BRCA testing is performed to identify patients with breast or ovarian cancer likely to benefit from olaparib.
COVID-19 Impact Analysis
The global cancer molecular diagnostics market is impacted due to the COVID-19 pandemic as the increasing number of people affected by COVID-19 has resulted in a reduction in testing and diagnosis rate of various cancers such as lung cancer, colorectal, ovarian, breast cancers, and others. Lung cancer has been worse affected due to COVID-19 as the COVID-19 is a respiratory disease and patients would normally consult their doctor for the signs and symptoms that are potentially being mistaken for the novel coronavirus. There is a decrease in the number of samples being received in the laboratories. Fewer number biopsies are being performed in the hospitals due to the COVID-19 pandemic. Regular screening of cancer patients has witnessed a decrease in the number of regular screenings with the decrease in the number of people having medical appointments, and repurposing of lab resources toward providing COVID-19 testing. Therefore, there is a decrease in the number of diagnostic tests and specific biomarker tests for cancer.
According to one of the community hospitals, molecular oncology testing had slumped by 25% due to a rapid increase in the COVID-19 cases. According to the commercial and public payors, less than 4,000 fewer EGFR tests were performed in March 2020. There was a decrease of 14% in the number of new patients diagnosed with colorectal cancer. There were decreases in the number of the RAF test by 9%, MSI/MMR test by 8%, and RAS test by 6%. The number of new patients diagnosed with breast cancer has witnessed a decrease of 8.4%. The new diagnosis of ovarian cancer has witnessed a decrease of 8.6%. There was a decrease of 14% in the number of new patients diagnosed with acute myeloid leukaemia. There were decreases in the number of the FLT3 test by 12%, IDH1 test by 11%, and IDH2 test by 12%.
Epidemiology
According to the World Health Organization, cancer is most predominant among males in comparison to females. The total number of incidence cases of males was 9.45 million and females were 8.622 million worldwide in 2018. Europe accounts for 23.4% of all cancer incidence cases i.e., 4.22 million incidence cases, North America accounts for 13.2% of all cancer incidence cases i.e, 2.37 million incidence cases, Asia accounts for 48.4% of all cancer incidence cases i.e., 8.75 million incidence cases. Europe accounts for 20.3% of all cancer mortality cases i.e., 1.94 million mortality cases, North America accounts for 7.3% of all cancer mortality cases i.e, 0.69 million mortality cases, Asia accounts for 57.3% of all cancer mortality cases i.e., 5.477 million mortality cases.
Globally, a large number of people died due to lung cancer followed by colorectal cancer, stomach cancer, liver cancer, and breast cancer. Lung cancer accounts for 18.4% of all cancer mortality cases i.e., 1.76 million mortality cases, colorectal cancer accounts for 9.2% of all cancer mortality cases i.e., 0.88 million mortality cases, stomach cancer accounts for 8.2% of all cancer mortality cases i.e., 0.78 million mortality cases, liver cancer accounts for 8.2% of all cancer mortality cases i.e., 0.78 million mortality cases, breast cancer accounts for 6.6% of all cancer mortality cases i.e., 0.62 million mortality cases.
Segment Analysis
Reagents and kits segment is expected to hold the largest share in the Cancer Molecular Diagnostics market
By-Products, the market is classified as the instruments, reagents and kits, and others. The reagents and kits segment is anticipated to hold the largest share in the cancer molecular diagnostics market due to the high availability of the reagents and kits for conducting molecular diagnostic testing for diagnosis, management, and treatment of cancer. There is increasing usage of the reagents and kits for conducting research and development activities. Several companies are developing the reagents and kits. For instance, Abbott Molecular Inc.’s Vysis EGR1 FISH Probe Kit detects the LSI EGR1 probe target on chromosome 5q in bone marrow specimens. Assay of Vysis EGR1 FISH Probe Kit is effective to characterize bone marrow specimens from patients with acute myeloid leukaemia or myelodysplastic syndrome. Qiagen’s therascreen PIK3CA RGQ PCR Kit is a real-time qualitative in vitro diagnostic PCR test useful for the detection of 11 mutations in the phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) gene by using a sample of DNA extracted from either formalin-fixed, paraffin-embedded (FFPE) breast tumour tissue or K2EDTA anticoagulated blood plasma.
By Technology, Polymerase Chain Reaction (PCR) Segment is Expected to Witness a High Growth Over the Forecast Period
The market is classified based on the technology as the Polymerase Chain Reaction (PCR), Transcription Mediated Amplification (TMA), In Situ Hybridization, Sequencing, Isothermal Nucleic Acid Amplification Technology (INAAT), Chips and Microarrays, Mass Spectrometry, and Others. The polymerase Chain Reaction (PCR) segment is expected to witness the highest market growth due to the high adoption of the polymerase chain reaction for identifying the target genetic sequence of DNA or RNA. Polymerase Chain Reaction amplifies the genetic material through a series of heating and cooling cycles. There is growing advancement for the development of the polymerase chain reaction. Real-time PCR monitors the amplification process in real-time. Real-Time Quantitative Reverse Transcription PCR (qRT-PCR) allows the reliable detection and measurement of the target genetic sequence of DNA or RNA generated during each cycle of the PCR process. There is rising automation of the automation of PCR instruments.
Geographical Analysis
North America region holds the largest market share global Cancer Molecular Diagnostics market
North America region is dominating the global cancer molecular diagnostics market accounted for the largest market share in 2021 owing to the increasing number of incident cases of cancer. According to the American Cancer Society, the total number of incident cases of cancer was 1.9 million in North America in 2022. Around, 0.609 million people expected died due to cancer in 2022. Breast cancer accounts for the highest incidence with 0.28 million cases followed by lung cancer with 0.236 million cases by prostate cancer with 0.268 million cases, and colorectal cancer with 0.104 million cases in North America in 2022.
The United States accounts for the highest market share due to the high technological advancement for cancer molecular diagnostics. For instance, NCI-funded researchers at Fred Hutchinson Cancer Research Center had used the cutting-edge proteomics technology to guide the selection of a PD biomarker to be used in patients. NCI-funded researchers from Baylor College of Medicine had created the patient tumour‒specific proteogenomic atlases that highlighted many new potential targets for personalized colon cancer treatment. New methods of comprehensive proteomic analysis that require a smaller amount of tissue in comparison to the previous methods were developed by NCI-funded researchers at the Broad Institute, Baylor College of Medicine, and their collaborators in 2020. There is increasing awareness regarding molecular diagnostics for cancer. The presence of the well-established diagnostic infrastructure & facilities shall stimulate market growth.
Asia-Pacific region is expected to grow at the fastest CAGR during the forecast period
Asia-Pacific region is estimated to be the fastest-growing region in the global cancer molecular diagnostics market owing due to the presence of several lucrative opportunities for the cancer molecular diagnostics market with unaddressed clinical needs in the market. There is increasing demand for improved cancer molecular diagnostics with the increasing number of people suffering from cancer. According to the World Health Organization (WHO), the total number of new incident cases of cancer was 9.50 million in Asia in 2020. Around, 5.80 million people died due to cancer in 2020. Lung Cancer accounts for the highest incidence with 1.31 million cases followed by colorectal cancer with 1 million cases by breast cancer with 1.02 million cases, and stomach cancer with 0.81 million cases in Asia in 2020.
There is an increase in the number of companies developing cancer molecular diagnostics. There is rising research and development activities for the development of technological advanced molecular diagnostics for cancer. Several public and private players are raising the funding & investment for the development of molecular diagnostics for diagnosis, management, and treatment of cancer. For instance, in May 2020, Endofotonics had secured an investment of USD 8.5 million led by Singapore Medical Group (SMG), and Parkway Holdings. This funding would be used to drive the commercialization of its early gastric cancer detection system, SPECTRA IMDx, in the Asia Pacific and to expand the coverage of its cancer detection technology to other organs.
Competitive Landscape:
The cancer molecular diagnostics market studied is a fragmented market with the presence of a large number of market players. Abbott Laboratories, Bayer Healthcare, Becton Dickinson, Danaher Corporation, Qiagen N.V., Roche Diagnostics, Siemens Healthcare, Beckman Coulter, and Nuvera Biosciences are the major market players with the significant market share. Companies are adopting several growth strategies such as product launches, acquisitions, mergers, collaborations, and licensing for increasing their market presence. For instance,
Mergers & Collaborations:
In March 2020, NuProbe, a global molecular diagnostics company had entered into the collaboration agreement with QIAGEN to develop next-generation sequencing (NGS)-based cancer diagnostic tests for non-invasive liquid biopsy. Under the terms of the agreement, both companies would explore NuProbe's proprietary Blocker Displacement Amplification (BDA) technology and QIAGEN's Single Primer Extension (SPE) technology, for accurate and affordable analysis of DNA mutations with very low variant allele fractions and advanced non-invasive cancer genomic profiling.
In January 2020, Amgen had entered into the collaboration with Guardant Health, Inc. and QIAGEN N.V. to develop blood- and tissue-based companion diagnostics (CDx), respectively, for investigational cancer treatment AMG 510. Under the terms of the agreement, both companies would initially focus on companion diagnostics tests for non-small cell lung cancer (NSCLC) but allow for further development of the diagnostic tests for Amgen's other oncology clinical development programs.
In July 2019, Exact Sciences Corp. had merged with Genomic Health, Inc. to create the global cancer diagnostics company. The company would provide the Cologuard and Oncotype DX, the strongest and fastest-growing brands in cancer diagnostics. This merger of the companies would bring new innovative cancer diagnostics to patients across the globe.
Product Launch & Approvals:
On 25th August 2021, BD launched a fully automated high-quality molecular diagnostic platform in the United States laboratories. The launch will make the BD Onclarity HPV Assay with extended genotyping for the BD COR System available to the high-quality labs that process the majority of cervical cancer screening specimens in the United States.
Acquisition:
In June 2019, Blue Earth Diagnostics had agreed to acquire all outstanding shares of privately-held Blue Earth Diagnostics from leading healthcare company Syncona for USD 450 million-plus closing adjustment estimated at USD 25 million. Under the terms of the agreement, Blue Earth Diagnostics would be the subsidiary of Bracco Imaging.
Partnerships
In June 2020, Genetron Holdings Limited had entered into a partnership with Thermo Fisher Scientific to build on the sequencer Genetron S5. This partnership would enhance innovation, commercialization and promotion of next-generation sequencing (NGS) platforms in the field of molecular cancer diagnosis in China’s public hospitals.