The Point of Care Diagnostics Market Report 2023-2033: This report will prove invaluable to leading firms striving for new revenue pockets if they wish to better understand the industry and its underlying dynamics. It will be useful for companies that would like to expand into different industries or to expand their existing operations in a new region.
CLIA defines waived tests as straightforward laboratory investigations and procedures with a very low chance of producing an erroneous result. In addition to approving manufacturer petitions for test system waivers, the Food and Drug Administration (FDA) determines what standards testing must follow in terms of being simple and error prone. The Binx health io CT/NG test, a molecular platform used to detect STDs such as chlamydia and gonorrhea at the point of treatment, acquired a CLIA waiver from the US FDA in April 2021, according to a statement released at the time
Increasing Incidence of Target Conditions and Rising Number of CLIA Waived POC Tests Are Driving the Market Growth
Target conditions for POC testing are illnesses or disorders that require ongoing monitoring, such as diabetes, hemophilia, cancer, and cardiac problems. The adoption of POC testing equipment can therefore be attributed in large part to the rising incidence and prevalence of these illnesses. Diabetes is a serious, chronic disorder that can significantly affect people's lives, wellbeing, and families all around the world. According to IDF, in 2021, there were 537 million diabetics worldwide between the ages of 20 and 79.CLIA defines waived tests as straightforward laboratory investigations and procedures with a very low chance of producing an erroneous result. In addition to approving manufacturer petitions for test system waivers, the Food and Drug Administration (FDA) determines what standards testing must follow in terms of being simple and error prone. The Binx health io CT/NG test, a molecular platform used to detect STDs such as chlamydia and gonorrhea at the point of treatment, acquired a CLIA waiver from the US FDA in April 2021, according to a statement released at the time
Stringent and Time-Consuming Regulatory Policies Likely to Challenge Market Growth
The complicated FDA regulations and CLIA laboratory standards present manufacturers with some regulatory challenges despite the rising demand for POC equipment (for the premarket approval of POC testing kits). Manufacturers must provide performance data to the FDA for any new POC equipment to be approved in the United States. This should show that people and healthcare professionals can use these tools and get outcomes that are comparable to those of clinical laboratory tests. For in vitro diagnostic (IVD) equipment as opposed to non-IVD ones, the amount of examination is also rather exceptional. For instance, the FDA typically waits until the intended application, conditions for usage, target patient demographic, and test performance characteristics remain intact before re-examining approved prescription non-IVD devices for use in new situations. Though under this rule POC devices are not covered.What Questions Should You Ask before Buying a Market Research Report?
- How is the point of care diagnostics market evolving?
- What is driving and restraining the point of care diagnostics market?
- How will each point of care diagnostic submarket segment grow over the forecast period and how much revenue will these submarkets account for in 2033?
- How will the market shares for each point of care diagnostics submarket develop from 2023 to 2033?
- What will be the main driver for the overall market from 2023 to 2033?
- Will leading point of care diagnostics markets broadly follow the macroeconomic dynamics, or will individual national markets outperform others?
- How will the market shares of the national markets change by 2033 and which geographical region will lead the market in 2033?
- Who are the leading players and what are their prospects over the forecast period?
- What are the point of care diagnostics projects for these leading companies?
- How will the industry evolve during the period between 2023 and 2033? What are the implications of point of care diagnostics projects taking place now and over the next 10 years?
- Is there a greater need for product commercialisation to further scale the point of care diagnostics market?
- Where is the point of care diagnostics market heading and how can you ensure you are at the forefront of the market?
- What are the best investment options for new product and service lines?
- What are the key prospects for moving companies into a new growth path and C-suite?
You need to discover how this will impact the point of care diagnostics market today, and over the next 10 years:
- Our 352-page report provides 158 tables, 225 charts/graphs exclusively to you.
- The report highlights key lucrative areas in the industry so you can target them - NOW.
- It contains in-depth analysis of global, regional and national sales and growth.
- It highlights for you the key successful trends, changes and revenue projections made by your competitors.
Forecasts to 2033 and other analyses reveal commercial prospects
- In addition to revenue forecasting to 2033, the new study provides you with recent results, growth rates, and market shares.
- You will find original analyses, with business outlooks and developments.
- Discover qualitative analyses (including market dynamics, drivers, opportunities, restraints and challenges), cost structure, impact of rising point of care diagnostics prices and recent developments.
Segments Covered in the Report
Product
- Glucose Monitoring
- Cardiometabolic Monitoring
- Infectious Disease Testing
- Coagulation Monitoring
- Pregnancy & Fertility Testing
- Tumor/Cancer Marker Testing
- Urinalysis Testing
- Cholesterol Testing
- Hematology Testing
- Drugs-of-abuse Testing
- Fecal Occult Testing
- Other POC Products
Mode
- Prescription-based
- OTC
Sample
- Blood
- Nasal and Oropharyngeal Swabs
- Urine
- Other
Platform
- Lateral Flow Assay
- Dipstick
- Microfluidics
- Molecular diagnostics
- Immunoassay
End User
- Clinics
- Hospitals
- Home Care Setting
- Others
North America
- U.S.
- Canada
Europe
- Germany
- UK
- France
- Italy
- Spain
- Netherlands
- Rest of Europe
Asia Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of Asia Pacific
Latin America
- Brazil
- Mexico
- Rest of Latin America
MEA
- GCC
- South Africa
- Rest of MEA
Leading companies and the potential for market growth
- Abbott
- AccuBioTech Co., Ltd
- BD
- bioMerieux SA
- Chembio Diagnostics, Inc.
- Danaher
- EKF Diagnostics
- F. Hoffmann-La Roche Ltd
- Fluxergy
- LumiraDx
- Meridian Bioscience
- Nipro Europe Group Companies
- Nova Biomedical
- Orasure Technologies, Inc.
- PTS Diagnostics
- Qiagen
- Quidel Corporation
- Response Biomedical
- Sekisui Diagnostics
- Siemens Healthcare GmbH
- Spectral Medical Inc.
- Thermo Fisher Scientific Inc.
- Trinity Biotech Ireland
- Trividia Health, Inc.
- Werfen
How will the Point of care diagnostics Market, 2023 to 2033 report help you?
In summary, this 350+ page report provides you with the following knowledge:- Revenue forecasts to 2033 for Point of Care Diagnostics Market, 2023 to 2033 Market, with forecasts for product, mode, sample, platform, end user, each forecast at a global and regional level - discover the industry’s prospects, finding the most lucrative places for investments and revenues.
- Revenue forecasts to 2033 for five regional and 18 key national markets - See forecasts for the Point of Care Diagnostics Market, 2023 to 2033 market in North America, Europe, Asia-Pacific, Latin America, and MEA. Also forecasted is the market in the US, Canada, Mexico, Brazil, Germany, France, UK, Italy, Spain, Netherlands, China, India, Japan, Australia, South Korea, Brazil, GCC, and South Africa among other prominent economies.
- Prospects for established firms and those seeking to enter the market - including company profiles for 25 of the major companies involved in the Point of Care Diagnostics Market, 2023 to 2033.
Information found nowhere else
With this new report, you are less likely to fall behind in knowledge or miss out on opportunities. See how this work could benefit your research, analyses, and decisions. The study is for everybody needing commercial analyses for the Point of Care Diagnostics Market, 2023 to 2033, market-leading companies. You will find data, trends and predictions.Table of Contents
1 Report Overview
3 Market Overview
4 Point of Care Diagnostics Market, by Product, 2023-2033
5 Point of Care Diagnostics Market, by Mode, 2023-2033
6 Point of Care Diagnostics Market, by Sample, 2023-2033
7 Point of Care Diagnostics Market, by Platform, 2023-2033
8 Point of Care Diagnostics Market, by End User, 2023-2033
9 Point of Care Diagnostics Market Analysis by Region, 2023-2033
10 North America Point of Care Diagnostics Market, 2023-2033
11 Europe Point of Care Diagnostics Market, 2023-2033
12 Asia Pacific Point of Care Diagnostics Market Analysis
13 Latin America Point of Care Diagnostics Market Analysis
14 MEA Point of Care Diagnostics Market Analysis
15 Company Profiles
16 Conclusion and Recommendations
Companies Mentioned
- Abbott
- AccuBioTech Co., Ltd
- BD
- bioMerieux SA
- Chembio Diagnostics, Inc.
- Danaher
- EKF Diagnostics
- F. Hoffmann-La Roche Ltd
- Fluxergy
- LumiraDx
- Meridian Bioscience
- Nipro Europe Group Companies
- Nova Biomedical
- Orasure Technologies, Inc.
- PTS Diagnostics
- Qiagen
- Quidel Corporation
- Response Biomedical
- Sekisui Diagnostics
- Siemens Healthcare GmbH
- Spectral Medical Inc.
- Thermo Fisher Scientific Inc.
- Trinity Biotech Ireland
- Trividia Health, Inc.
- Werfen
- Abaxis, Inc.
- Accriva Diagnostics
- Acon Laboratories, Inc.
- Alere Inc.
- Applied Biomedical
- BHR Pharmaceuticals
- Binx Health
- Biomedomics
- Biomeme, Inc.
- Biomerieux
- Bioptix, Inc.
- BTNX
- C2N Diagnostics
- Church & Dwight Co. Inc.
- Credo Diagnostics Biomedical
- Curiosity Diagnostics
- DexCom, Inc.
- DiabetOmics
- DNAe
- DnaNudge
- Dragerwerk Ag & Co. Kgaa
- DRW Diagnostics for the Real World
- Eiken Chemical Co Ltd.
- Enigma Diagnostics, Ltd.
- Enterix, Inc.
- Exact Sciences
- Gene Capture
- Genedrive
- Hangzhou AllTest Biotech
- Helena Laboratories
- Kaya17
- Lifescan, Inc.
- Luminostics
- Lumos Diagnostics
- Magellan Diagnostics
- Mbio Diagnostics, Inc.
- MedMira, Inc.
- Menarini Diagnostics
- Mesa Biotech
- Micronics, Inc.
- Nexus DX
- Ortho Clinical Diagnostics
- Quantumdx Group Limited
- Radiometer Medical A/S
- Rapid Diagnostics
- Response Biomedical Corp
- Rheonix, Inc.
- Roswell Biotechnologies
- RPS Diagnostics
- Sandhill Crane Diagnostics
- Veredus Laboratories Pte Ltd
- Xagenic
- American Association of Medical Colleges (AAMC)
- Astar’s Genome Institute of Singapore (GIS)
- Biocertis group
- Biotechnology Industry Research Assistance Council (BIRAC)
- Clinical Laboratory Improvement Amendments (CLIA)
- Clinical Laboratory Improvement Amendments (CLIA)
- Diagnostic Related Group (DRG)
- Food and Drug Administration (FDA)
- Indian Department of Biotechnology (DBT)
- Indian institute of technology (IIT)
- Indian Medical Device Industry (AIMED)
- International Diabetes Federation (IDF)
- International Organisation for Standardisation (ISO)
- Joint United Nations Programme on HIV and AIDS (UNAIDS)
- Nichirei Bioscience
- The Bill & Melinda Gates Foundation
- The Clinton Health Access Initiative (CHAI)
- The Foundation for Innovative New Diagnostics (FIND)
- U.S. India Science and Technology Endowment Fund (U.S. ISTEF)
- World Health Organization (WHO)
