The World Market for Cancer Diagnostics, 5th Edition: Precision and Personalized Testing Arrives
Cancer testing is maturing from personalized medicine to precision medicine, where protein and molecular biomarkers are essential for precise diagnosis, therapy selection, therapy monitoring and early detection of cancer recurrence. The market for cancer testing are comprehensively covered in Kalorama Information’s Worldwide Market for Cancer Diagnostics, 5th. Edition. This report, authored by Kalorama Diagnostic Analyst Shara Rosen, contains detailed market data on the following IVD segments for their use in cancer diagnostics:
- Flow Cytometry
- Rapid Tests
- Molecular Assays
- Tissue Arrays
- Circulating Tumor Cells
- Pharmacodiagnostics, Molecular
Cancer Testing: Constant Innovation
Given the unfortunate statistics of cancer in the developed world, innovation is a must. Growth rates in cancer testing tends to be higher than in other IVD fields. Diagnostic tests for effective cancer screening are obviously needed more than ever. As this report goes to print a number of significant developments are taking place in cancer follow up.
- New imaging modalities and digital analysis of x-ray mammograms are looking to improve the accuracy of breast cancer screening. These same imaging techniques are being used to screen patients for the metastasis of cancer from the primary site.
- Lab testing for new cancer biomarkers – hormone, receptor and protein assays – improve the detection of cancer in patients that present with symptoms. These are now available in multiplexed tests that make better use of tissue samples.
- With developments in the analysis of circulating cancer cells and cell free DNA in peripheral blood they are poised to help in the screening of high risk individuals.
- Improved immunohistochemical stains and in situ hybridization make detection of cancer cells in biopsied tissue more effective. The use next generation analysis of individual tumor cells including sequencing, mass spectrometry and PCR further enhance cancer testing in tissues.
- Bioinformatic analysis of gene and protein patterns detected in tumor cells and peripheral blood is proving to be a big breakthrough in cancer diagnosis. The technology has pinpointed gene and protein targets that will make up the next generation of cancer tumor marker panels.
- The next big advances are related to tests based on the detection of circulating nucleic acid molecules and RNA and DNA methylation patterns.
Complete Market and Trend Analysis
Kalorama Information reports are always based on primary research of the market with particular attention to important market trends that are more important to understand than today’s numbers. Shara Rosen not only defines the marketplace and provides market numbers, but her report also examines trends that are driving cancer testing now and determining where it will go in the future. Some of the trends examined in this report include:
- Commercializing Next Generation Cancer Tests
- Clinical Molecular Test Reimbursement Coding In The U.S.
- Regulatory Requirements of Cancer Tests
- Gene Patents and Test Commercialization
- The Physician’s Role in Test Acceptance
- Biomarkers: Issues in Research to Clinic
- Miniaturization and Multiplexed Assays
- The Emergence Of Non-Invasive Tools
- Bioinformatics – Data To Information
- Digital PCR, Mass Spectrometry, Next-Generation Sequencing
- Sample Preparation and System Automation
- The Role of In Vivo Cellular and Molecular Imaging
and Analyst Conclusions, Strategy Implications and Unmet Market Needs
Based on an analysis of these trends, the report includes a ‘Technology Forecast’ to 2025 that takes each particular technology used now in solid tumor testing and predicts its future role.
Personalized Cancer Testing and Advances In Precision
The phenomenon of test personalization comes under many guises – pharmacogenomic, pharmacogenetic, companion tests, and represents one of the fastest growing segments of the market for cancer tests. It has emerged fully from research into clinical practice. Instrumentation now automates many of the sample preparation and assay steps that were formerly labor intensive. New tests are being launched all the time. Some personalized cancer tests are CE Marked and FDA-cleared and many more are in development.
More and more laboratories offer complex panels of tests that help physicians evaluate disease risk and make therapeutic decisions. Government and private healthcare payers have recognized the value of new molecular tools and are agreeing to pay for them.
This report covers those trends and has tables describing the following:
- Most Common Cancer Drug/Gene Mutation Combinations
- Selected Pharmacodiagnostic Histology Tests
- Chemotherapy Resistance Tests
- Innovations in Personalized Molecular Tests for Cancer
- Therapeutic Drug Monitoring Immunoassays
- Major Protein And Molecular Markers Used In Tissue Staining
Unparalleled Review of Cancer Testing Competitors: Top Tier IVD Companies And Specialist Companies
This report is written from the point of view of diagnostic modalities for the detection and management of cancer and in particular solid tumors. The technology to detect cancers of the blood – lymphomas, myelomas and leukemias – is mature and well established. The routine complete blood count screens for blood cell abnormalities and is followed by bone marrow analysis and flow cytometric studies of the blood cell surface markers. These to arrive at a more specific diagnosis. As such this report does not discuss area of hematological cancer diagnosis in great detail.
Market analysis in this report covers world markets for in vitro cancer diagnostics, however the reader will find a bias toward the developed areas of the globe — N. America, Japan and Western Europe. However cancer is a growing global problem and where possible the report covers cancer testing in the more industrialized developing countries of Latin America and Asia Pacific.
The emphasis is on in vitro diagnostic tests, however a discussion of the role of diagnostics in cancer management, must include in vitro and in vivo tests. The two are inextricably linked. The same cell markers used in flow cytometry and antibodies used for immunoassays to detect elements of the immunity process are used as vectors for imaging agents to detect tumors and to monitor the extent of cancer metastasis.
In addition to extensive reviews of products on the market and in development in each segment, the report provides detailed company profiles in several sections. Companies profiled include the following:
Beckman Coulter Inc./Danaher
Becton, Dickinson and Company
Bio-Rad Laboratories Inc.
IRIS International, Inc.
Ortho Clinical Diagnostics
Siemens Healthcare Diagnostics
Cynvenio Biosystems, Inc.
Epic Sciences Inc.
Fluxion Biosciences, Inc.
Sony DADC Biosciences
Advanced Cell Diagnostics
Amoy Diagnostics Co. Ltd.
Applied Spectral Imaging
Biocare Medical, LLC
CCC Diagnostics, Inc.
Caliper Life Sciences
Circadian Technologies Limited
Cymogen Dx, LLC
Diagnostic Biosystems (DBS)
DVS Sciences Inc.
DxTerity Diagnostics Inc.
Halo Healthcare Inc. (formerly NeoMatrix, LLC)
Horizon Discovery Ltd
Metamark Genetics, Inc.
Oxford Cancer Biomarkers
Philips Handheld Diagnostics
Theranostics Health Inc.
Ventana Medical Systems Inc.
Arbor Vita Corporation
Axela Biosensors, Inc.
Binding Site (The)
Fujirebio Diagnostics, Inc.
Gold Standard Diagnostics:
Nano Discovery Inc.
Oncimmune USA LLC
OPKO Health, Inc.
Polymedco Cancer Diagnostic Products, LLC
Radient Pharmaceuticals Corporation
Saladax Biomedical, Inc.
Adaptive Biotechnologies Corporation
Agilent Technologies Inc.
Arrayit Diagnostics Inc.
Enzo Biochem Inc.
Falcon Genomics, Inc.
GeneCentric Diagnostics, Inc.
Genetic Technologies Limited
Inform Genomics, Inc.
And Many More Companies..