Molecular Diagnostics Market Analysis and Forecast 2021-2025 | Revenue, Sales and Growth Rate by Regions, Future Demand and Key Players Analysis
Industry Trends
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
Competitive Landscape
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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