World Point of Care (PoC) Diagnostics Market Report 2023-2033: Rising Number of CLIA Waived POC Tests & Increasing Incidence of Target Conditions Bolsters Growth

Dublin, June 29, 2023 (GLOBE NEWSWIRE) -- The "Point of Care Diagnostics Market Report 2023-2033" report has been added to's offering.

The Point of Care Diagnostics Market will surpass US$43 billion in 2023

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?

Market Dynamics

Market Driving Factors

  • High Prevalence of Infectious Diseases Across the Globe
  • Increasing Incidence of Target Conditions
  • Growing Government Support
  • Rising Number of CLIA Waived POC Tests

Market Restraining Factors

  • Pricing Pressure Owing to Reimbursement Cuts and Budget Constraints
  • Stringent and Time-Consuming Regulatory Policies

Market Opportunities

  • POC Tests with Multiplexing Capabilities
  • Healthcare Decentralization - Converting Lab Tests to POC Tests

COVID-19 Impact Analysis

Porter's Five Forces Analysis

PEST Analysis

SWOT Analysis

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

Segments Covered in the Report


  • 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


  • Prescription-based
  • OTC


  • Blood
  • Nasal and Oropharyngeal Swabs
  • Urine
  • Other


  • Lateral Flow Assay
  • Dipstick
  • Microfluidics
  • Molecular diagnostics
  • Immunoassay

End User

  • Clinics
  • Hospitals
  • Home Care Setting
  • Others

North America

  • U.S.
  • Canada


  • 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


  • GCC
  • South Africa
  • Rest of MEA

For more information about this report visit

About is the world's leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.


Contact Data