APAC Point Of Care (PoC) Molecular Diagnostic Market Analysis

The APAC Point Of Care (PoC) Molecular Diagnostic Market size stood at around xx Bn in 2023 and is projected to reach US $xx Bn by 2033, exhibiting a CAGR of xx% during the forecast period.

The APAC Point Of Care (PoC) Molecular Diagnostic Market Analysis Executive Summary

Point of Care (PoC) molecular diagnostics refers to medical testing performed at or near the site of patient care, rather than in a centralized laboratory. This in itself makes it possible to arrive at a quick and accurate diagnosis that helps the physician in a timely manner come to a conclusive decision concerning the patient’s management and treatment.

PoC molecular diagnostics are comparatively fast, yielding results in a few minutes or so, which is a big advantage for critical surgeries and conditions where timely clinical decisions greatly affect the patient. Altogether, these tests can be conducted in different facilities such as clinics, hospitals, pharmacies, or even at patients’ homes increasing the accessibility for people with rural background or inadequate healthcare. These are rapid diagnosed based on PCR, isothermal amplification, and Next Generation Sequencing to ensure enhanced sensitivity and specificity in identifying specific genetic material or pathogens. Such portable instruments find employment in multiple areas: infectious agents (COVID-19, HIV, TB), genetics, and certain forms of carcinoma, which is of significance in various healthcare strategies. The PoC molecular diagnostics market is crucial in identifying diseases in good time and efficiently managing the identified diseases especially the infectious types and chronic ailments.

Current statistics reveal that the WHO’s global prevalence of infectious diseases stands at 1:10, which confirms the need to undertake diagnostic tests as efficiently and effectively as possible. Third, the globally escalating burden of antimicrobial resistance (AMR) is evident, of which 700,000 population succumb to AMR related diseases, according to the WHO estimate, if no measures are taken, the figure would reach 10 million by 2050.

This industry segment, specifically the APAC Point of Care molecular diagnostics market, plays a crucial role in the improvement of the health care system and patients’ outcomes. Based on the factors such as increasing incidence of infections diseases and the chronic diseases, technological development, and the trend of point-of-care (PoC) diagnosis, the PoC molecular diagnostics market is set to expand in the future.

Market Dynamics for Point Of Care (PoC) Molecular Diagnostic Market in APAC

Market Growth Drivers Analysis

The Point of Care (PoC) molecular diagnostics market in APAC is set for significant growth due to the increasing prevalence of infectious diseases and chronic illnesses. The urgent need for prompt diagnostic tools is underscored by the high rates of diseases such as tuberculosis and HIV. Additionally, the rising incidence of chronic diseases like cancer further drives the demand for PoC diagnostics. Innovations in technologies such as polymerase chain reaction (PCR), genetic sequencing, and microfluidics have improved the accuracy and speed of these tests, enabling healthcare providers to obtain rapid results critical for timely clinical decisions. The growing elderly population is likely to increase the demand for routine diagnostics, while investments from government and private organizations are enhancing access to testing. The rapid results provided by PoC diagnostics are also promoting the trend of personalized medicine, which improves treatment outcomes and overall healthcare quality in APAC.

• Rising Incidence of Infectious Diseases: The global prevalence of infectious diseases, including 5 million new TB cases and 39 million HIV cases, drives demand for rapid diagnostic tools.

• Increasing Chronic Disease Prevalence: With 38% of women and 43% of men predicted to develop cancer, the need for effective diagnostics is growing.

• Advancements in Diagnostic Technologies: Innovations such as PCR, genetic sequencing, and microfluidics enhance the accuracy and speed of PoC tests, enabling results in minutes.

• Growing Elderly Population: The aging population, projected to double by 2050, is likely to increase the demand for routine diagnostics for chronic diseases.

• Increased Investment in Testing: Government and private sector investments, like Unitaid's $30 million contribution, are improving access to diagnostic technologies.

• Trend Towards Personalized Medicine: Rapid results from PoC diagnostics support the shift towards personalized medicine, improving treatment outcomes and healthcare quality.

• These drivers collectively position the PoC molecular diagnostics market in APAC for substantial growth and enhanced healthcare delivery.

Market Restraints

The APAC PoC Molecular Diagnostic Market also has several considerable barriers to point of care molecular diagnostics which is as follows. 

• Lower Reliability of Rapid Tests: Sensitivity issues in some rapid COVID-19 tests can lead to false negatives and misdiagnosis, reducing clinician trust. A study in The Lancet highlighted concerns regarding the reliability of certain rapid tests compared to standard laboratory procedures.

• High Capital Costs:  Initial investments for PoC diagnostic equipment, such as portable PCR machines, can exceed $10,000, making them costly for smaller healthcare facilities and low-resource settings.

• Underdeveloped Healthcare Systems: Many emerging markets, including APAC, suffer from poor healthcare infrastructure, making it difficult to effectively integrate PoC diagnostics. According to the WHO, over 5 billion people globally lack access to proper healthcare and diagnostic testing, hindering the potential for PoC solutions.

• Poor Training of Healthcare Personnel: Inadequate training can significantly impact the successful implementation and utilization of PoC diagnostics, as stated in a study published in BMC Health Services Research.

Competitive Landscape for Point Of Care (PoC) Molecular Diagnostic Market in APAC

Key Players

• Abbott Laboratories
• Roche Diagnostics
• Cepheid
• Thermo Fisher Scientific
• bioMérieux
• Quidel Corporation
• Danaher Corporation
• Siemens Healthineers
• Hologic
• Grifols 

Recent Developments

In November 2023, F. Hoffmann-La Roche Ltd. launched the Elecsys HBeAg quant, an immunoassay for detecting hepatitis Be antigen, showcasing the trend towards the development of advanced diagnostic solutions.

Mergers and Acquisitions

In June 2021, the Alzheimer's Drug Discovery Foundation (ADDF) Diagnostics Accelerator released four new research investments to develop digital biomarkers for Alzheimer's disease diagnosis.

In June 2023, Sysmex Corporation introduced a novel point-of-care testing system for rapid detection of antimicrobial susceptibility in Europe, utilizing proprietary microfluidic technology. This reflects the industry's focus on enhancing diagnostic capabilities to address urgent healthcare needs.

Healthcare Policies and Regulatory Landscape for Point Of Care (PoC) Molecular Diagnostic Market in APAC

Policy changes and Reimbursement scenario

PoC molecular diagnostics are often considered medical devices and are subject to regulatory oversight by agencies such as the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and other national regulatory bodies. These agencies establish guidelines for the safety, efficacy, and quality of PoC tests.

The FDA of the United States has its guidelines concerning IVDs, including PoC tests as defined below. The FDA has the responsibility of pre-market review and post-marketing surveillance as well as implementing necessary actions to enforce compliance.

When PoC molecular diagnostics include the use of patient health information, the issue of data protection becomes an issue. HIPAA in US and the GDPR in EU are examples of legal frameworks that regulate protection of PHE. To protect the patients’ information, organizations that are involved in the development or use of PoC diagnostics must follow these regulations on the confidentiality, integrity, and availability of patient data. Noncompliance is punishable, and this therefore attracts penalties as well as other legal implications.

It is noteworthy that the reimbursement of the cost of PoC molecular diagnostics can differ from one country’s healthcare system as well as between insurance services. Often, there are no definite regulatory policies concerning reimbursement issues or inadequate reimbursement policies restrict the implementation of PoC tests.