Critical Insights into IVD Market-Driving Segments - Kalorama’s Latest Reports in Cancer, Molecular and Infectious Disease Diagnostics

Critical Insights into IVD Market-Driving Segments - Kalorama’s Latest Reports in Cancer, Molecular and Infectious Disease Diagnostics

Kalorama Information’s latest in vitro diagnostics (IVD) titles delve into some of the fastest-growing and most critical areas of clinical diagnostics: cancer diagnostics, molecular assays and systems, and infectious disease tests. Together, these three IVD areas represent approximately 40% of the overall IVD market . The rate of growth for the combined segments is outpacing the growth of the overall IVD market by roughly two extra percentage points each year (+2% CAGR). Several subsegments of the cancer and molecular diagnostics markets are also growing at rates of over 8% each year. Kalorama Information has highlighted the superior market prospects of these IVD segments with three reports published in the past few months: The World Market for Molecular Diagnostics, 6th Edition, The World Market for Cancer Diagnostics, 6th Edition, and The World Market for Infectious Disease Diagnostic Tests.

Infectious disease diagnostics has been present in clinical pathology for over 100 years beginning with use of microbiology cultures and later expanding through the introduction of immunoassay and molecular assays. Cancer diagnostics and molecular diagnostics more recently claimed significant heft in the IVD market as a consequence of rapidly improving standards of living and healthcare worldwide as well as major advances in nucleic acid technologies over the past 25 years. Outside of infectious disease tests, cancer diagnostics and molecular assays, the IVD market is held by ‘core lab’ testing disciplines - clinical chemistry, non-infectious biomarkers, hematology, coagulation - and point-of-care tests (POCTs) diversely performed in hospitals, outpatient settings and even by patients. Most of the tests in the core lab and at points of care (POC) represent mature product markets with marginal growth everywhere except emerging regional markets.

In large part, the three IVD areas of infectious diseases, oncology and molecular diagnostics have sourced market growth from the translation of genomics to clinical care and the introduction and improvement of molecular diagnostic technologies including multiplex panel assays, next-generation sequencing (NGS), and PCR-alternative amplification technologies such as isothermal methods. While molecular diagnostics has introduced new capabilities to laboratory medicine, it has also been able to displace traditional microbiology and immunoassays in applications such as rapid testing, histology or pathology, and biomarker detection. Molecular assays have succeeded by offering analytical specificity and sensitivity without equal among diagnostics technologies available to the majority of clinical labs. Even routine, high-volume test markets served by relatively simple products, such as rapid influenza tests (RIDTs), are now threatened by molecular platforms that now require little space, user experience, lab certification, or testing time. Molecular diagnostics already represents over 25% of the infectious disease diagnostics market.

The treatment and diagnosis of cancer and other non-infectious diseases also stand to be revolutionized through molecular diagnostic technologies. Genetic risk factors for cancer can be detected and assessed using molecular assays with target sequences also more deeply interrogated using NGS. The characterization of tumors had long been exclusively accomplished from tissue or tumor samples, but cancer diagnostics is now amenable to blood sampling that reduces costs for collection and sample and facilitates screening and routine monitoring. Utilization of blood-based cell-free DNA (cfDNA), circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs) for cancer diagnostics has unlocked new therapies and made possible new preventive and interventional clinical actions in oncology. With greater understanding of systems biology, a bounty of cancer markers has been unveiled from blood samples including methylation patterns and gene mutations. The genetic etiology of cancer revealed by such tests can inform and personalize cancer therapy; assays used to identify specific mutations that determine the efficacy of a certain therapy are referred to as companion diagnostics (CDx). A subset of CDx, pharmacogenetics (PGx), uses genetic markers to determine individual patient drug metabolism and other traits and informs drug prescription and therapy choice.

The Kalorama Information reports on cancer and molecular diagnostics additionally detail markets for inherited disease tests, histology, and flow cytometry. Estimates of laboratory testing service markets associated with cancer testing and prenatal testing - booming areas of demand through sophisticated, proprietary laboratory-developed tests (LDTs) - are also available in The World Market for Molecular Diagnostics, 6th Edition and The World Market for Cancer Diagnostics, 6th Edition. Pathogen-specific IVD markets are also broken out in The World Market for Infectious Disease Diagnostic Tests; the report also specifies market sizes and growth trends by technology segment including blood screening nucleic acid tests (NATs), immunoassays, and traditional microbiology (ID/AST). Geographical market segmentation is also provided in the Kalorama reports.