The global point-of-care diagnostics market, valued at $49.7 billion in 2023, is projected to reach $77.8 billion by 2028, growing at a CAGR of 9.4%. Key drivers include the rising prevalence of infectious diseases like influenza, HIV, and tuberculosis, supportive government policies, and the shift towards healthcare decentralization. Challenges include pricing pressures due to reimbursement cuts and stringent regulatory approvals. Significant growth opportunities exist in emerging markets like China, India, Brazil, and Mexico. In 2022, glucose monitoring products held a significant market share, with lateral flow assays leading by platform. Major players include Abbott Laboratories, F. Hoffman-La Roche Ltd., BD, Danaher Corporation, and Siemens Healthineers. Recent developments feature FDA approvals for new diagnostic panels by bioMérieux and BD, and a partnership between Thermo Fisher Scientific and Project HOPE to expand HIV testing in Sub-Saharan Africa.
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The Lateral Flow Assays segment, by platform, is expected to register the largest market share of the global point of care diagnostics market in 2022.
Based on platform, the point-of-care diagnostics market is segmented into lateral flow assays, immunoassays, microfluidics, dipsticks, and molecular diagnostics. The lateral flow assays segment dominated this market with a share of in 2022.Lateral flow assays are simple in usage, relatively inexpensive, making it more accessible for patients and healthcare provider, LFA technology does not require trained person to operate, allowing them to be used in various healthcare settings, from clinics and pharmacies to remote arears, promoting healthcare decentralization. All these factors are contributing towards the dominance of lateral flow technology in point of care diagnostics market.
The OTC testing product segment, by mode of purchase, to dominate the global point of care diagnostics market in 2022.
On the basis of mode of purchase OTC testing products segment accounted the largest market share in 2022 attributed to the increasing adoption of OTC products owing to its ease of usage and convenience. The presence of diverse range of OTC point of care devices for diseases screening, personal health monitoring and various other conditions further contribute to the rising demand for OTC PoC testing devices among consumers.
North America to account for the largest share of point of care diagnostics industry during the forecast period.
North America is the expected to be the largest regional market for point of care diagnostics during the forecast period. The presence of a well-established healthcare system, rapid adoption of advanced point of care testing products, increase in the availability of medical reimbursement, favourable government support for the novel product development, and higher user awareness about the presence of point of care testing products are anticipated to support the market growth in the region
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Point of Care Diagnostics Market Dynamics:
Drivers:
1. Rising incidence of infectious diseases
2. Increasing prevalence of target conditions
3. Favorable government initiatives for POC testing
4. Rising number of CLIA-waived POC tests
Restraints:
1. Pricing pressure on POC manufacturers
2. Stringent regulatory approval process for product commercialization
Opportunities:
1. High growth potential of emerging markets
2. Decentralization of healthcare
3. Innovative product development
Challenge:
1. Inadequate standardization with centralized lab methods
2. Limited awareness in emerging markets
3. Premium pricing of novel platforms
Key Market Players of Point of Care Diagnostics Industry:
As of 2022, the point of care diagnostics market was dominated by Abbott Laboratories (US), F. Hoffmann-La Roche Ltd. (Switzerland), Siemens Healthineers (Germany), Danaher Corporation (US), and Becton, Dickinson and Company (US)
Recent Developments of Point of Care Diagnostics Industry:
· In May 2023, bioMérieux received the US FDA CLIA-waiver for the BIOFIRE SPOTFIRE Respiratory (R) Panel Mini,a second multiplex PCR-based test cleared for use on the BIOFIRE SPOTFIRE System
· In August 2023, BD received the US FDA approval for its BD Respiratory Viral Panel (RVP) for BD MAX System, a single molecular diagnostic combination test that identifies & distinguishes SARS-CoV-2, influenza A, influenza B, and Respiratory Syncytial Virus (RSV) in ~ 2 hours.
· In December 2023, Thermo Fisher Scientific Inc. and Project HOPE, a leading global health and humanitarian organization, partnered to expand the accessibility of HIV testing services offered by Thermo Fisher among HIV Positive Youth in Sub-Saharan Africa.
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