Cancer Diagnostics Global Market estimated to be worth $10,627.4 million by 2026

In modern medicine, diagnosis of disease is one of the biggest challenges faced by the healthcare sector and is very important in case of cancer, where there will be a dramatic improvement in the chances of patient survival due to early detection. A cancer diagnosis is a multistep process, where it entails a detailed examination of an individual, during an investigation, the patient will have to undergo different methods of laboratory testing and exposed to different imaging techniques. Due to the radiation side effects and morphological ambiguities associated with image based approach, alternative methods or non-imaging tests are being developed; these are based on detection of various tumor markers, antigen-antibody reaction, staining of cells/tissues for identification of morphological changes from the normal cells/tissues or by studying the expression of individual genes. Insights from such diagnostic tests will aid in the understanding of tumorigenesis, progression of cancer and this, in turn, will enable rapid and precise decision making on cancer staging as well as an individual response to therapy. Many genetic testing are being developed which have ability to detect susceptibility of an individual for development of cancer.

The cancer diagnostic technologies are used in the broad range of applications for the screening of different types of cancer, where, techniques like ELISA, RIA, CLIA, Ag-Ab based rapid tests, histology based, NGS, PCR, in-situ hybridization, micro-array, flow cytometry etc are being used. One of the key challenges faced by these new molecular and immunology-based invitro diagnostics is to demonstrate the clinical value with respect to reproducibility and accuracy in diagnosis and also optimization of the test for each type of cancer diagnosis.

As per the latest data, cancer burden has increased to 18.1 million new cases with 9.6 million deaths in 2018. And the number of people living with 5 years of survival is estimated to be 43.8 million. Asia with 60% of global population accounted for 57.3% of new cancer cases and America with 13.3% of the global population, reported 21.0% of new cancer cases with the mortality of 14.4% in 2018.

According to IQ4I analysis, the cancer diagnostics global market is expected to reach $10,627.4 million by 2026 growing at a high single digit CAGR from 2019 to 2026 due to the growing demand of non-image based tests which are rapid and precise with higher sensitivity. The factors driving the growth of the cancer diagnostics market are increasing prevalence of different types of cancers, increasing awareness of personalized medicine, national program for cancer control by individual countries, availability of companion diagnostics, growth in the point of care testing, increase in sequencing-based tests and other molecular and immunology based techniques. Cancer diagnostics play a pivotal role in the evaluation of the cancer and for the effective response for specific therapy. However, the complex regulations for the approval of newly developed tests, high cost of the tests, lack of reimbursement and also shortage of technical experts are some of the restrains for the growth of the cancer diagnostics market.

Cancer diagnostics global market is segmented based on technology, sample source, applications and end-users. The technology category is segmented into immunoassays molecular-based assays and others, among which, the immunoassays segment accounted for the largest revenue in 2019 and this segment is expected to grow at a high single digit CAGR from 2019 to 2026. Within the immunoassays, ELISA segment commanded the largest revenue in 2019, and IHC segment is expected to grow at a high single digit CAGR from 2019 to 2026. Among molecular based assay, PCR commanded the largest revenue in 2019, sequencing is expected to grow at a double digit CAGR from 2019 to 2026. Among sample sources, blood accounted for the largest revenue in 2019; this market is expected to grow at a strong double digit CAGR from 2019 to 2026.

The application segment is further classified into two categories by cancer type and by cancer care. By cancer type segment, the largest revenue was generated by colorectal cancer in 2019, and is expected to grow at a strong double digit CAGR from 2019 to 2026. By cancer care segment, diagnosis accounted for the largest revenue in 2019, whereas, companion diagnostics is expected to grow at a strong double digit CAGR from 2019 to 2026. The high growth rate is attributed to the increasing population based preventive screening to reduce the burden of patient at later stages. Diagnosis at right time will aid in the accurate detection of cancer stage thereby reducing the further economic burden of cancer as well as better treatment and cure.

With respect to end-user, Clinical/centralized laboratories accounted for the largest revenue in 2019 and the market is expected to grow at high single digit CAGR from 2019 to 2026, this is because clinics and centralized laboratories provide novel technologies with more advanced instruments and diagnostic tests when compared to hospitals and also tests in clinics and centralized laboratories are cost-effective than in hospitals. Hospitals segment is the fastest growing segment with a strong double digit CAGR from 2019 to 2026.

Among geographic market segments, North America commanded for the largest revenue in 2019 and is expected to grow at a high single digit CAGR from 2019 to 2026, this is due to the rise in early cancer screening, increased demand for personalized medicine, and increased innovation in technologies related to medical diagnostics. Asia-Pacific is expected to grow at a strong double digit CAGR from 2019 to 2026, due to the increased number of cancer cases, awareness on the importance of cancer early screening and prevention, precision health, rise in healthcare investments by public and private sectors and also availability of the high specificity, sensitivity of the tests.

Cancer diagnostics market is experiencing rapid growth because of approvals, collaborations and acquisitions, For instance, In November 2019, Exact Sciences Corporation completed its acquisition of Genomic Health thereby providing strong platform continued growth in early screening as well as in companion diagnostics (Oncotype Dx) and in March 2020, the company acquired Paradigm Diagnostics, Inc. and Viomics, Inc., two privately held companies based in Phoenix. Together, Paradigm and Viomics provide a differentiated late-stage therapy selection test and deep competencies in sequencing and biomarker discovery. The acquisition has further 

In 2019, Cytura Therapeutics and Enpicom collaborated to develop a diagnostic test for early detection of cancer. Similarly, in January 2020, Guardant health collaborated with Amgen for developing the blood-based companion diagnostics for Amgen’s AMG 510, an investigational oral therapy that inhibits KRAS G12C mutant protein (metastatic lung cancer), globally.

According to IQ4I analysis, during 2018 - 2019, the overall funding for the cancer research was found to be approximately ~$632.9 million. For instance, a cancer diagnostic firm Lucence (Singapore) has raised $20.0 million in funds for expansion of liquid biopsy tests, Cancer Research U.K. has announced to provide funding to support research on early cancer detection. According to the American Cancer Society, it had awarded funding to tune of $420 million for 749 research products on various types of cancer.

Due to the need for precise and reliable tests, there is a rapid advancement in technology, for instance, the latest innovation in early screening and prognosis of colorectal cancer by studying methylation profiles of circulating DNA, further, precision and pharmacodiagnostics tests that are emerging are ideally implemented in the patient-specific treatment and also monitoring the effectiveness of treatment. Baltimore-based BioMarker Strategies is developing a system called the SnapPath, which creates a functional signaling profile by using live tumor cells for the treatment selection for colon, pancreatic, breast, solid tumors and lung cancer.

Further, a team of Israel, American and British researchers have developed breath analyzer device (NaNose) for early detection and progression of lung cancer with 90% accuracy. The device is based on nano chip technology and also, Owlstone Medical, a U.K. based firm has designed "Breath biopsy" device called LuCID for early detection of volatile organic compound (VOC) secreted by lung tumors and is under clinical trial. A team researchers in John Hopkins University by collaborating with Australian scientist have developed a blood based early detection test called CancerSeek which can detect even a minute amount of DNA or protein in the blood released by cancer cells. The test has been found to detect eight common cancers such as stomach, ovarian, bowel esophageal, breast, pancreatic and lung cancer at the same time.

The other factors which are influencing the growth of the market include product launches, for instance, Myriad Genetics has submitted for the supplementary pre-market approvals for its mychoice CDx test to be used as companion diagnostics for ovarian cancer in January 2020. Also in December 2019, the company has received FDA approval for its BRAC analysis as companion diagnostics for prostate cancer.

According to IQ4I analysis, there were about 492 clinical trials on ctDNA, cfDNA, CTC and companion diagnostics of which 11.4% were in phase 3, 21.1% in phase2/phase3, 32.1% were in phase 2, 7.9% in phase1/phase 2, 19.9% in phase 1 and 7.5% of the trials are in early phase. Most of phase 3 clinical trials are focused on colorectal cancer, breast and lung cancer which could result in new early and companion diagnostic tests for these life-threatening cancers. There were 118 clinical trials on Immunoassays, of which 52.5% are in phase 2, 16.1% are in phase1/phase2, 24.6% are in phase 1 and 5.1% are in phase 3 for early diagnosis, companion diagnostics and prognosis.

Major players in the cancer diagnostics global market are F. Hoffmann-La Roche AG (Switzerland), Danaher Corporation (U.S.), Siemens Healthineers (Germany), Hologic, Inc. (U.S.), Guardant Health (U.S.), Abbott Laboratories (U.S.), Qiagen (Netherlands), Exact Sciences Corp. (U.S.), Myriad Genetics, Inc. (U.S.) and Agilent Technologies (U.S.).

Some of the other prominent players in the cancer diagnostics market are Thermo-fisher scientific. (U.S.), Biocartis (U.S.), Diasorin (Italy), BGI (China), Biocept Inc, (U.S.), Opko (U.S.), ViennaLab Diagnostics (Austria), Oncodiag (France), Concile (Germany) and Epigenomic (Germany).