The global molecular diagnostics devices and equipment market is expected to grow from $24.19 billion in 2021 to $27.91 billion in 2022 at a compound annual growth rate (CAGR) of 15.3%. The market is expected to grow to $46.87 billion in 2026 at a compound annual growth rate (CAGR) of 13.8%.
The molecular diagnostics devices (or) equipment market consists of sales of molecular diagnostics devices and related services. Molecular diagnostics devices are used to diagnose infectious diseases and perform screening by detecting specific sequences in DNA or RNA at the molecular level. It helps doctors to prescribe more accurate therapeutic interventions in the early stages of a disease.
The main products of molecular diagnostics devices (or) equipment are instruments, reagents, and consumables. A reagent is a substance that is used for causing a chemical reaction. Reagents are used to indicate the presence of another substance. The technologies involved are DNA (deoxyribonucleic acid) sequencing, polymerase chain reaction, isothermal nucleic acid amplification technology, transcription-mediated amplification (TMA), in situ hybridization, microarrays, mass spectrometry, and others (southern blotting, northern blotting, and electrophoresis). The various applications are cancer, pharmacogenomics, genetic testing, infectious disease, prenatal, neurological disease, and cardiovascular disease that are used by various end-users such as diagnostic laboratories, hospitals, and others (nursing homes, blood banks, point of care).
Asia Pacific was the largest region in the molecular diagnostics devices (or) equipment market in 2021. Western Europe was the second largest market in molecular diagnostics devices (or) equipment market. The regions covered in this report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa.
The growth in the molecular diagnostic devices and equipment market is attributed to factors such as the rapid rise in various bacterial and viral epidemics. The increase in the spread of diseases increases the demand for early and improved diagnostic methods. To improve the technology to enable the early diagnosis of such diseases, the Government and different organizations extend their financial support towards the major key players of the industry. For example, according to the reports from Centres for Disease Control and Prevention (CDC) US, as of March 2019, 72 Zika virus disease cases were reported in U.S state and 148 Zika virus disease cases reported in US Territories. Thus, the rise of such chronic diseases serves as a prime driver for the players in the industry to develop more accurate and sophisticated diagnostic devices and equipment. Following the increase in demand for early diagnosis of Zika virus, Co-Diagnostics, Inc. in February 2019 launched its first multi-disease molecular diagnostic test for dengue, chikungunya, and Zika.
The regulatory process involving the approval of molecular diagnostic tests is often slow. The lack of clear definition coupled with constant changes in the regulations is a challenge for companies developing these kits. In developing nations such as India and China lack of a well-defined regulatory framework negatively impacts the market, irrespective of the presence of a large population.
In the US market, because of the changes in the rules and regulations, the products already in the market may also be required to go through Food and Drug Administration (FDA)’s pre-marketing approval process. For example, CLIA (Clinical Laboratory Improvement Amendments Act) in the US certifies the validity of laboratory-based tests but it does not regulate the clinical validity of molecular diagnostic tests. This means that it does not control whether these results are clinically correct. This argument puts a restraint on the industry and opens an argument that FDA should play a greater role in overseeing laboratories.
The major players in the molecular diagnostic industry are focusing on developing automated solutions for devices and equipment used for molecular diagnostic processes. Automation of the process will help to enhance the productivity and consistency of the whole diagnostic process. Computerization of the diagnostic process gives reliable and efficient test results that manual testing by various experts does not. The major players of the industry are using nanotechnology-based Oral Fluid Nano Sensor Test (OFNASET). The test uses a microfluidic-based nanosensor for the detection of oral cancer biomarkers in saliva. To keep up with the trend of automation and accuracy, Roche, created cobas connection modules (CCM) to improve scalability and sample-flow efficiency by allowing samples to automatically move between different systems and instruments. Thus, creating a fully automated workflow.
The molecular diagnostic devices in the US are approved by Food and Drug Administration's (FDA) Center for Devices and Radiological Health (CDRH). These diagnostics devices are generally approved with an accompanying assay, to evaluate their safety and effectiveness or substantial equivalence regarding the assays they run and the assay's defined performance parameters. However, the same instruments do not require FDA approval or clearance when used for basic scientific research purposes. The European regulatory landscape has become more stringent and technically challenging for medical device companies. The introduction of four different risk classes of diagnostic devices i.e. classes A-D. Class A refers to the lowest risk tests and class D refers to the highest risk test such as HIV testing, blood grouping, and prenatal testing. Most of the genetic testing is classed into class C. The products bearing a CE mark, European approved tests, are safe to use, and are in full compliance.
In March 2019, Abbott received a CE mark for its Alinity m molecular diagnostic testing machine. This would allow it to sell the product across Europe.
The countries covered in the molecular diagnostics devices (or) equipment market are Brazil, China, France, Germany, India, Indonesia, Japan, South Korea, Russia, UK, USA, and Australia.
Major players in the molecular diagnostics devices (or) equipment market are Roche Ltd, Hologic, QIAGEN, Abbott, Danaher Corporation, Bio-Rad Laboratories, Siemens Healthcare, Becton Dickinson and Company, Cepheid Inc, and bioMerieux S.A.
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Report Attribute | Details |
---|---|
No. of Pages | 175 |
Published | May 2022 |
Forecast Period | 2022 - 2026 |
Estimated Market Value ( USD | $ 27.91 billion |
Forecasted Market Value ( USD | $ 46.87 billion |
Compound Annual Growth Rate | 13.8% |
Regions Covered | Global |
Table of Contents
Executive Summary
The Molecular Diagnostics Devices And Equipment Global Market Report 2022 covers this critical market and the impact on it from the COVID-19 virus. It provides strategists, marketers and senior management with the critical information they need to assess the increasing demand for molecular diagnostics devices and equipment due to COVID-19.
Reasons to Purchase
- Gain a truly global perspective with the most comprehensive report available on this market covering 12+ geographies
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- Benchmark performance against key competitors
- Utilize the relationships between key data sets for superior strategizing
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Description:
Where is the largest and fastest growing market for the molecular diagnostics devices and equipment? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward? The Molecular Diagnostics Devices And Equipment Market Global report answers all these questions and many more.
The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market’s historic and forecast market growth by geography.
- The Market Characteristics section of the report defines and explains the market
- The market size section gives the market size ($b) covering both the historic growth of the market, the influence of the COVID-19 virus and forecasting its growth
- Market segmentations break down market into sub markets
- The regional and country breakdowns section gives an analysis of the market in each geography and the size of the market by geography and compares their historic and forecast growth. It covers the growth trajectory of COVID-19 for all regions, key developed countries and major emerging markets
- Competitive landscape gives a description of the competitive nature of the market, market shares, and a description of the leading companies. Key financial deals which have shaped the market in recent years are identified
- The trends and strategies section analyses the shape of the market as it emerges from the crisis and suggests how companies can grow as the market recovers
Scope
Markets Covered:
1) By Product: Instruments; Reagents; Consumables
2) By End User: Diagnostic laboratories; Hospitals; Others( nursing home; blood banks; point of care)
3) By Technology: DNA(Deoxyribonucleic acid) sequencing; Polymerase chain reaction; Isothermal Nucleic Acid Amplification Technology; Transcription Mediated Amplification (TMA); In situ hybridization; Microarrays; Mass spectrometry; Others (southern blotting; northern blotting; electrophoresis)
4) By Application: Cancer; Pharmacogenomics; Genetic testing; Infectious disease; Prenatal; Neurological disease; Cardiovascular disease
Companies Mentioned: Roche ltd.; Hologic; QIAGEN; Abbott; Danaher Corporation
Countries: Australia; Brazil; China; France; Germany; India; Indonesia; Japan; Russia; South Korea; UK; USA
Regions: Asia-Pacific; Western Europe; Eastern Europe; North America; South America; Middle East; Africa
Time series: Five years historic and ten years forecast.
Data segmentations: country and regional historic and forecast data, market share of competitors, market segments.
Sourcing and Referencing: Data and analysis throughout the report is sourced using end notes.
Companies Mentioned
A selection of companies mentioned in this report includes:
- Roche ltd.
- Hologic
- QIAGEN
- Abbott
- Danaher Corporation
- Bio-Rad Laboratories
- Siemens Healthcare
- Becton Dickinson and Company
- Cepheid Inc.
- bioMerieux S.A.
- Agilent Technology
- Novartis
- Johnson and Johnson
- Tecan Group
- Bayer AG
- Danaher Corporation
- Grifols
- Thermo Fisher Scientific
- Sysmex Corporation
- Myriad Genetics
- Alere
- Dako
- Eppendorf
- PerkinElmer
Methodology
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