Advancements in molecular diagnostics have facilitated the detection of numerous diseases and are particularly effective when faced with challenging differential diagnosis. Technological advancements in molecular diagnostics are anticipated to substantially drive the market growth as they facilitate cost-effectiveness, accuracy, and portability. The commercialization of MinION, an affordable and portable sequencer by Nanopore Technologies, is suitable for use in small laboratories and point-of-care facilities, which is projected to boost the market for molecular diagnostics.
According to the WHO, the average prevalence rate of hospital-acquired infections in 2019 was 4.5% and 7.1% in U.S. and Europe, respectively. Molecular diagnostics play an essential role in the testing of infectious diseases as they offer quick and effective results. Thus, the growing prevalence of hospital-acquired infections and infectious diseases are further estimated to drive the demand for molecular diagnostics over the forecast period. Growing funding by governments and numerous organizations for R&D in molecular diagnostics is anticipated to drive the demand for molecular testing. Funding plays a significant role in product development process. For instance, Accelerate Diagnostics received USD 19.5 million from various entities, such as Oracle Partners, Oracle Institutional Partners, and the Schuler Family Foundation, to enhance the development and sales of infectious disease in vitro diagnostics tests and tools.
The regulatory framework for approvals has always posed major restrictive factors on pharmaceutical, biotechnology, and medical technology industries. Faulty diagnostic kits could provide inaccurate results. Hence, the possibility of causing harm to the patients has driven the FDA to ensure compliance with premarketing regulations. The regulatory environment is already complicated, and the FDA is becoming increasingly careful owing to the growing dependency on molecular diagnostics for making critical medical decisions.
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The U.S. FDA also conducts post-market investigation of in vitro diagnostic device (IVD) products to ensure parity between performance and claims. For instance, a heavy penalty was imposed on Nichols Institute, a subsidiary of Quest Diagnostics, as its test kits produced results that were inaccurate and unreliable. Hence, the stringency of regulations associated with the approval process for molecular diagnostics is limiting market growth.
Molecular Diagnostics in Healthcare Market Revenue & Forecast, (US$ Million), 2015 – 2027
Key players in the global market include: Roche Diagnostics; Abbott; Bio-Rad Laboratories, Inc.; Siemens Healthcare GmbH; Alere, Inc.; Bayer AG; Dako; Hologic, Inc. (Gen probe); Sysmex Corporation; Danaher; Johnson & Johnson; Novartis AG; Qiagen N.V.; Becton, Dickinson and Company; Cepheid; and bioMerieux SA.
Key players are adopting various strategies such as mergers and acquisitions to increase their market share. For instance, Qiagen acquired STAT-Dx, a Spanish firm developing next-generation multiplex diagnostics using a novel system based on real-time PCR and Qiagen chemistries. Players are also focusing on expanding their product portfolio. For instance, in 2019, Roche launched the first IVD ROS1 IHC assay-VENTANA ROS1 (SP384) Rabbit Monoclonal Primary Antibody-for the detection of ROS1 protein in cancers.
Molecular Diagnostics Healthcare Market:
Products and Services: Reagents and Kits, Instruments, Software and Services
By Application: Genetic Tests, Infectious Diseases, Oncology, Others
By Technology: PCR, INAAT, DNA Sequencing & NGS, In Situ Hybridization, DNA Microarrays, Others
By End-user: Diagnostic Laboratories, Hospitals, Others
By Geography:North America: (U.S, Canada, Mexico, Rest of North America)Europe: (France, The UK, Spain, Germany, Italy)
Nordic Countries: (Denmark, Finland, Iceland, Sweden, Norway)
Benelux Union: (Belgium, The Netherlands, Luxembourg, Rest of Europe)
Asia Pacific:(China, Japan, India, New Zealand, Australia, South Korea)
Southeast Asia: (Indonesia, Thailand, Singapore)
Rest of Southeast Asia
Middle East and Africa: (Saudi Arabia, UAE, Egypt, South Africa, Rest of Middle East and Africa)
Latin America: (Brazil, Argentina, Rest of Latina America)
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