Better information technology systems, noticeable progress on the use of sequencing in clinical medicine and smaller molecular instruments are among the trends noted by Kalorama Information in in vitro diagnostic (IVD) testing in 2015. The market research publisher specializes in vitro diagnostic testing markets. Recently the healthcare research marketer released the sixth edition of its report in Molecular Diagnostics.
1. Molecular POC Becomes Reality
Alere announced its Alere i Influenza A & B, that provides molecular flu results in less than 15 minutes. Cepheid launched its 9 inches tall GeneXpert Omni, the world’s most portable molecular diagnostics system enabling unprecedented access to accurate and fast diagnosis for patients suspected of TB, HIV and Ebola. Such products also push infectious disease testing into the point-of-care (POC) and near-patient testing arena, allowing providers to initiate care during the same visit or day. These announcements build on previous developments in near-patient molecular last year.
2. Cancer, Molecular and Infectious Disease Drive Sales
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.
3. Energetic Competitive Activity
The leader in IVD in 2015 remains the same as in 2014, according to Kalorama Information, but there was plenty of activity in the market. There were scores of acquisitions, partnership deals and distribution agreements in IVD. Roche Diagnostics remains the world’s largest supplier of clinical diagnostics products; Roche’s product sales are still almost twice its nearest competitor. The firm stayed active this year – Among several deals, in March 2015, Roche announced a global distribution agreement for kits and enzymes for cellular analysis, proteomics and conventional PCR applications with Sigma-Aldrich. In April 2015, Roche became the majority shareholder in Foundation Medicine. Foundation Medicine is a molecular information company dedicated to understanding the genomic changes that contribute to each patient’s unique cancer. April 2015, Roche acquired GeneWeave BioSciences (Los Gatos, CA) that will join Roche’s Molecular Diagnostics unit and will add to Roche’s infectious disease business that offers HIV, TB and hepatitis assays.
Kalorama noted that one competitor continued to grow, with close to 30% increase in IVD sales since 2010. Netherlands-based Qiagen pioneered DNA and RNA extraction for molecular test sample preparation. Now Qiagen’s clinical business is focusing on market and product expansion and is moving from a base in infectious diseases to cancer testing and personalized medicine. QIAGEN markets more than 500 products around the world, selling both consumable kits and automation systems to customers through four customer classes: Molecular Diagnostics (human healthcare), Applied Testing (forensics, veterinary testing and food safety), Pharma (pharmaceutical and biotechnology companies) and Academia (life sciences research).
4. Liquid Biopsy
Numerous liquid biopsy tests and enterprises progressed in 2015. Genomic DNA amplified or sequenced from circulating tumor cells (CTCs), circulating tumor cell DNA (ctDNA) and circulating cell-free DNA (cfDNA) harbor complementary information on mutations relevant for the treatment of individual cancer patients. Kalorama says the technology has had its ups and downs but is still in contention in the area of cancer diagnostics. It’s been known for many years that dying cells, including tumor cells, shed DNA into the bloodstream. These applications promise to impact clinical protocols and treatment regimens and will likely determine the future standard of care in oncology. Cell-free DNA (cfDNA) can be applied more broadly than ctDNA. cfDNA will determine the standard of care in oncology, transplant medicine and cardiovascular disease. This field is emerging as one of the most promising and exciting areas of medicine and has already made a huge impact on prenatal care. CTC technology is much more mature than that of cell free DNA. Veridex (Janssen Diagnostics, Warren, NJ) is the pioneer in CTC testing. The precursor company immunicon established the relevance of circulating tumor cells in 1999. The company was acquired by Johnson & Johnson, renamed Veridex and launched the first commercial CTC product in 2004.
5. Information Technology and Genomics
2015 saw progress in the use of information technology systems for genomic medicine. Hundreds of genome studies are underway, worldwide, involving sometimes hundreds of thousands of patient test results. IT helps researchers share data that is then aggregated to better understand the role of specific gene variants in disease processes. Data-sharing has become an essential requirement for the community, and through private and public consortia, users can connect and pool their knowledge on rare diseases and actionable findings. The Global Alliance, formed in 2013, is an international coalition of over 140 member organizations dedicated to improving human health by maximizing the potential of genomic medicine. The members are dedicated to producing work products and to undertaking data sharing projects that break down barriers and increase learning from data. The group’s diverse membership includes world-leading institutions in healthcare, research, patient and disease advocacy, life science, and information technology who are working together on open interfaces and catalytic projects to enable effective and responsible data sharing and guide this quickly evolving field. The Alliance is hosted by the Broad Institute of Harvard and MIT, the Ontario Institute of Cancer Research, and the UK Wellcome Trust Sanger Institute.
Kalorama published three reports recently that covered these topics in detail: 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.