Molecular diagnostics includes various techniques to analyze biological markers in the genome and proteome. These techniques are used to guide patient’s right from diagnosis to treatment, for diseases like cancer, infectious disease, cardiac disease and congenital abnormalities. These techniques help in identifying the genetic variants that have led to the disease. It includes the technologies such as PCR, NGS, INAAT, and ISH etc
Hoffmann-La Roche Ltd., and Abbott – Notable Market Players in Asia Pacific Molecular Diagnostics Market
Market leaders operating in the market have undertaken various organic growth strategies in the Molecular Diagnostics market. The Molecular Diagnostics market majorly consists of the players Abbott, Agilent Technologies, Inc., Thermo Fisher Scientific Inc., F. Hoffmann-La Roche Ltd., TBG Diagnostics Limited, QIAGEN, bioMérieux SA, Siemens Healthineers AG, Illumina, Inc., Danaher, Novartis AG. The companies have been implementing various strategies that have helped the growth of the company and in turn have brought about various changes in the market. The companies have utilized organic strategies such as launches, expansion, and product approvals. Moreover, the companies have utilized inorganic strategies including mergers & acquisitions, partnership, and collaboration.
Below is the list of the growth strategies done by the players operating in the Molecular Diagnostics market:
| Company | Month & Year | Category | Description |
| F. Hoffmann-La Roche Ltd | Feb-2021 | Product Approval | F. Hoffmann-La Roche Ltd, announced granting CE mark for its new “SARS-CoV-2 Rapid Antigen Test Nasal”. The test is available in countries accepting the CE mark since the mid-February 2021. When compared with the existing Roche’s SARS-CoV-2 Rapid Antigen Test, this new testing method help reduces the overall patient discomfort, specifically in sensitive individuals involving children, elder population, and people living with disabilities. |
| Bio-Rad Laboratories, Inc | July-2021 | Product Approval | Bio-Rad Laboratories, Inc., announced launching of new product “Reliance SARS-CoV-2/FluA/FluB RT-PCR Kit (IVD)”. The newly launched kit possesses standard and negative molecular controls as well as assay reagents. Additionally, the kit is validated to run on Bio-Rad’s CFX96 Dx Real-Time PCR System and real-time PCR system from other manufacturers. |
| Chembio Diagnostics, Inc. | April-2021 | Product Approval | Chembio Diagnostics, Inc. announced the commercial launch of FDA Emergency Use Authorization (EUA) for point-of-care COVID-19/Flu A&B test for utility in decentralized and traditional testing settings. The product inventory is on-hand and immediately available for shipment to customers and the product is approved in laboratories with a CLIA waiver licence, producing results within 15 minutes and requires no instrumentation. Also, the test simultaneously differentiates SARS-CoV-2 antigens and influenza Type A and Type B infections from a single swab. |
| Bio-Rad Laboratories, Inc. | June-2020 | Product Launch | Bio-Rad Laboratories, Inc. announced launching of new blood-based immunology assay kit intended to identify antibodies to the sARS-CoV-2 the virus associated with COVID-19. The newly launched product is specialized in detection of total immunoglobulin (IgG, IgA, and IgM). Further, the company plans to offer the immunoassay kit worldwide as it will offer high throughput processing and sample traceability. |
| Siemens Healthineers | Oct-2021 | Product Launch | Siemens Healthineers announced launching of new “CLINITEST Rapid COVID-19 Antigen Test” Rapid Antigen Test” for the Detection of SARS-CoV-2. The CLINITEST Rapid COVID-19 Antigen Test helps identifying infected individuals in 15 minutes so they can isolate sooner and avoid spreading COVID-19. |
| Nova Biomedical | Apr-2020 | Product Approval | Nova Biomedical announced the FDA has cleared its Stat Profile Prime Plus critical care blood gas analyser for point-of-care use. This clearance allows POC personnel to perform bedside critical care testing with results in one minute. |
| Nova Biomedical | Nov-2020 | Product Launch | Nova Biomedical announced the availability of Nova Primary, a rapid blood glucose laboratory analyser that aims to fill the need for a glucose reference analyser to replace the YSI Stat Plus 2300 Glucose and L-Lactate analyser. |
| Becton Dickinson and Company | July -2020 | Product Launch | Becton Dickinson and Company announced launching of new product for a rapid, point-of-care SARS-CoV-2 diagnostic test for use with its broadly available “BD Veritor Plus System”. The product is specialized such that it delivers results within 15 minutes in an easy-to-use, high portable instrument that is critical for improving access to COVID-19 diagnostics as it enables real-time results and decision making when the patient is onsite |
| Chembio Diagnostics, Inc. | September-2021 | Product Approval | Chembio Diagnostics, Inc. announced submission of EUA application to the Food and Drug Administration (FDA) for the company’s DPP Respiratory Antigen Panel Test System. The DPP Respiratory Antigen Panel Test System is designed to offer simultaneous, discrete, and differential detection of influenza A, influenza B, and SARS-CoV-2 antigens from a single patient sample using a simple nasal swab. |
| Bio-Rad Laboratories, Inc. | Feb-2019 | Product Launch | Bio-Rad Laboratories, Inc. announced launching of “QXDx AutoDG ddPCR System”, which uses Bio-Rad’s Droplet Digital PCR technology, and the QXDx BCR-ABL %IS Kit are the industry’s first digital PCR products. |
| F. Hoffmann-La Roche Ltd | Apr-2019 | Product Launch | F. Hoffmann-La Roche Ltd announced launching of new “VENTANA HER2 Dual ISH companion diagnostic test” intended for breast and gastric cancer patients. |
| Bio-Rad Laboratories, Inc. | Apr-2019 | Product Approval | Bio-Rad Laboratories, Inc. received U.S. Food and Drug Administration (FDA) approval for new product “BioPlex 2200 Lyme Total Assay”. This is an innovative multiplex test method for the diagnosis of Lyme disease. |
| Abbott Laboratories | May-2018 | Product Launch | Abbott Laboratories announced launching of new product “Afinion 2 analyser”. The newly launched product is the newest generation of the Affinion test system. |
| Siemens Healthineers | Apr-2021 | Acquisition | Siemens Healthineers announced acquisition of Varian Medical Systems, Inc. (“Varian”) creating a highly integrated product platform for imaging, laboratory diagnostics, artificial intelligence (AI), and treatment for the global fight against cancer with high potential. Through this acquisition both the companies will address the rising need for personalized, data-driven diagnosis, and precision care pinpointing to fight back against globally increasing cancer rate. |
| Quidel Corporation | April-2021 | Agreement | Quidel Corporation, announced distribution and fulfilment agreement with McKesson Corporation for expediting consumer access to “Quidel’s non-prescription QuickVue At-Home OTC COVID-19 Test” |
| F. Hoffmann-La Roche Ltd. | December, 2018 | Partnership | F. Hoffmann-La Roche Ltd and Merck entered into a collaboration to develop a companion diagnostic test to identify patients eligible for anti-PD-1 therapy based on the status of a biomarker in advanced solid tumours. |
