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.
Point of care Diagnostics Industry Dynamics
Driver: Increasing prevalence of infectious diseases globally
POC tests can primarily improve the management of infectious diseases, especially in emerging markets and resource limited settings. According to UNAIDS, approximately 39 million people were suffering from HIV-AIDS globally as of 2022, and an estimated 1.3 million individuals acquired HIV.
Restraint: Pricing pressure on PoC Manufacturers
Intense competition in the POC testing market can lead to pricing pressure, Moreover, decrease in reimbursement rates for POC tests from government payers, private insurers, or healthcare reimbursement programs are driving down profit margins for manufacturer significantly impacting the growth of point of care diagnostics market. Healthcare facilities, especially those in areas with limited resources or financial constraints, may have constrained budgets for investing in point-of-care testing equipment and materials, limiting the adoption of point of care testing.
Opportunity: High growth potential of emerging markets
Emerging markets such as China, India, Brazil, and Mexico are expected to offer significant growth opportunities for players operating in the POC diagnostics market. This is primarily due to the high and growing prevalence of infectious and lifestyle diseases in these countries. To meet the increasing demand for POC diagnostics in emerging markets, manufacturers focus on acquiring or entering into agreements and partnerships with regional/domestic players for product distribution and manufacturing. Regulatory policies in the Asia Pacific region are flexible and have less stringent regulations than established markets in North America and Europe. The saturation of mature markets will further compel manufacturers and leading POC testing companies to shift their focus to emerging markets
Challenge: Inadequate standardization with centralized lab methods
POC test results lack alignment with central lab methods due to many pre- and post-analytical errors. Pre-analytical errors for POC testing include unsuitable indications for the performance of the test, inappropriate sampling times and techniques, lack of information about patient conditions, and other factors such as fasting before functional tests or variations in posture/position during similar tests. On the other hand, post-analytical errors include inadequate technical validation, false assignment of results, and errors in data storage.
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
Prominent players in the point-of-care diagnostics market include:
- Abbott Laboratories (US)
- F. Hoffman-La Roche Ltd. (Switzerland)
- BD (US)
- Danaher Corporation (US)
- Siemens Healthineers (Germany)
- QuidelOrtho Corporation (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.
Conclusion:
The Point of Care (POC) Diagnostics market is poised for significant growth, driven by the increasing demand for rapid, accurate, and convenient diagnostic solutions. The shift towards decentralized healthcare, where patients can receive timely diagnostics outside traditional laboratory settings, underscores the importance of POC technologies. Advances in technology, including miniaturization, digital integration, and enhanced sensitivity of diagnostic tools, are further propelling market expansion.