POC(Point of Care) 검사 시장은 2024년에 328억 7,000만 달러로 평가되었습니다. 2025년에는 371억 3,000만 달러에 이르고, CAGR 13.19%로 성장하여 2030년에는 691억 7,000만 달러에 달할 전망입니다.
| 주요 시장 통계 | |
|---|---|
| 기준 연도 : 2024년 | 328억 7,000만 달러 |
| 추정 연도 : 2025년 | 371억 3,000만 달러 |
| 예측 연도 : 2030년 | 691억 7,000만 달러 |
| CAGR(%) | 13.19% |
현장진단검사는 적시에 임상적 의사결정을 환자에게 더 가까이 가져다줌으로써 진단학의 형태를 계속 변화시키고 있습니다. 이 소개에서는 분산형 진단, 디지털 연결, 치료 의사결정 지원의 융합에 중점을 두고 POC 검사 생태계의 현대적 윤곽을 개괄적으로 설명합니다. 의료 시스템이 신속한 진료, 가치 기반 진료, 외래 환자 관리를 우선시하는 가운데, 진료 시점(point-of-care) 방식은 임상적 대기 시간을 줄이고 환자 경험을 개선하는 능력에 대해 점점 더 높은 평가를 받고 있습니다.
기술, 의료 서비스 제공 모델, 환자의 기대에 힘입어 현장 검사 환경은 변화의 시기를 맞이하고 있습니다. 첫째, 기술적 궤적은 단일 분석의 신속한 검사에서 다중화된 플랫폼과 통합된 분자 워크플로우로 이동하고 있으며, 필요한 시점에 보다 광범위한 진단을 가능하게 하고 있습니다. 동시에 센서의 소형화 및 미세 유체 집적화로 인해 시료의 양과 소요 시간이 단축되어 재택 및 외래 환경에서의 실현 가능성이 높아졌습니다.
미국의 2025년 관세 및 무역 조치 발동은 POC 검사 분야의 제조업체, 공급업체 및 최종 사용자에게 복잡한 영향을 미칠 것입니다. 부품, 소모품, 완제품에 대한 관세는 세계 공급망에 의존하는 제품들의 상륙 비용을 상승시키고, 조달 전략과 재주문 시점에 영향을 미칠 수 있습니다. 많은 장비와 시약에는 여러 지역에서 조달된 전자 부품, 플라스틱, 정밀 가공 부품이 포함되어 있기 때문에 관세로 인한 비용 상승은 특정 하위 부품의 원산지에 따라 불균일하게 발생하기 쉽습니다.
세분화 통찰력을 통해 제품 카테고리, 검사 유형, 샘플 매트릭스, 기술, 휴대성 옵션, 구매 모드, 용도, 최종 사용자, 유통 채널이 어떻게 수요 패턴과 개발 우선순위를 형성하는지 알 수 있습니다. 제품 세분화에서 소모품, 서비스 및 소프트웨어, 기기 및 분석기, 시약 및 분석은 각각 개별적인 의미를 가지고 있습니다. 소모품, 액세서리, 유지보수 및 교정 서비스, 소프트웨어 및 연결성은 지속적인 수익원 및 업무 연속성을 지원하고, 벤치탑 분석기, 분자 플랫폼, 휴대용 분석기, 판독기 및 스캐너는 도입 시나리오 및 임상 워크플로우를 결정하고, 포도당 검사 스트립, 혈액학 시약, 면역 측정 시약, 측면 흐름 분석 시약, 분자 분석 키트는 분석에 특화된 공급망 및 품질 보증 요구 사항을 촉진합니다.
지역적 뉘앙스는 POC 검사가 설계, 배포 및 상환되는 방식에 큰 영향을 미치며, 미국, 유럽, 중동 및 아프리카, 아시아태평양은 각기 다른 시장 성장 촉진요인과 운영 고려 사항을 나타냅니다. 북미와 남미에서는 의료 시스템이 외래 환자 치료의 최적화와 만성 질환 관리에 중점을 두면서 진료소와 가정 모두에서 원격 모니터링과 신속한 심혈관 및 대사 검사를 지원하는 장비와 측정법에 대한 수요가 발생하고 있습니다. 이 지역의 유통 네트워크는 통합된 공급망과 지역 밀착형 서비스 지원을 우선시하며, 강력한 애프터서비스와 주요 전자 의료 기록과의 데이터 상호 운용성을 입증할 수 있는 제조업체가 유리합니다.
POC 검사 경쟁 환경은 전략적 파트너십, 플랫폼 차별화, 장비, 소모품, 소프트웨어를 결합한 통합 솔루션에 집중하는 것이 특징입니다. 주요 기업들은 여러 분석 형식을 지원하는 모듈형 플랫폼 아키텍처를 우선시하여 보다 빠른 분석 배포와 소모품에 대한 지속적인 수요를 통해 평생 가치를 향상시킬 수 있는 모듈형 플랫폼 아키텍처를 선호하고 있습니다. 동시에, 연결성 공급업체 및 의료 IT 통합업체와의 파트너십은 임상 워크플로우 및 포퓰레이션 헬스 이니셔티브에 플러그인할 수 있는 데이터가 풍부한 진단 결과를 제공하는 데 필수적인 요소가 되고 있습니다.
경쟁력을 유지하고 임상적 관련성을 유지하기 위해 업계 리더들은 제품 개발을 업무 현실과 진화하는 치료 모델과 일치시키는 일련의 실행 가능한 이니셔티브를 추구해야 합니다. 첫째, 상호운용성과 사용자 중심의 소프트웨어 설계를 우선시하고, 임상의의 워크플로우와 전자의무기록에 원활하게 통합될 수 있도록 함으로써 도입 시 마찰을 줄입니다. 둘째, 신속한 분석 확장을 가능하게 하고 여러 샘플 유형을 지원하는 모듈식 플랫폼 전략에 투자하여 조달 팀의 유연성을 높이고 여러 기기 설치 공간을 줄일 수 있습니다.
본 분석을 뒷받침하는 조사방법은 엄격성, 타당성, 재현성을 보장하기 위해 설계된 정성적 접근과 정량적 접근을 통합한 것입니다. 1차 조사는 실제 이용 사례, 조달 제약, 미충족 수요를 파악하기 위해 임상의, 검사실 책임자, 조달 담당자, 장비 제조업체 및 유통업체 고위 경영진과의 심층 인터뷰를 통해 이루어졌습니다. 이러한 인터뷰는 임상적 우선순위를 제품 요구사항으로 전환하기 위해 시설 수준의 관찰과 워크플로우 통합 지점의 검증을 통해 보완되었습니다.
결론적으로, 현장 진료 검사는 기술적 성숙도, 진료 제공 모델의 변화, 정책적 변화가 진단 경로를 공동으로 재정의하는 변곡점에 있습니다. 분산형 진단으로의 전환은 분석 화학, 소형화, 기기 소형화, 소프트웨어 연결성의 발전으로 뒷받침되고 있지만, 이러한 전환은 운영, 규제, 공급망에 대한 과제를 제기하고 있으며, 의도적인 완화가 필요합니다. 관세 조치, 조달 선호도 변화, 지역적 규제 불균일성은 이해관계자들이 탄력적 조달, 적응형 제품 아키텍처, 견고한 증거 생성을 통해 해결해야 하는 복잡성의 층을 추가합니다.
The Point of Care Testing Market was valued at USD 32.87 billion in 2024 and is projected to grow to USD 37.13 billion in 2025, with a CAGR of 13.19%, reaching USD 69.17 billion by 2030.
| KEY MARKET STATISTICS | |
|---|---|
| Base Year [2024] | USD 32.87 billion |
| Estimated Year [2025] | USD 37.13 billion |
| Forecast Year [2030] | USD 69.17 billion |
| CAGR (%) | 13.19% |
Point of care testing continues to reshape diagnostics by bringing timely clinical decision-making closer to the patient. This introduction outlines the contemporary contours of the point of care testing ecosystem, emphasizing the convergence of decentralized diagnostics, digital connectivity, and therapeutic decision support. As health systems prioritize faster triage, value-based care, and outpatient management, point of care modalities are increasingly evaluated for their capacity to reduce clinical latency and improve patient experience.
Advances in miniaturized instrumentation, assay chemistry, and molecular methods now permit a broader range of analytes to be tested outside central laboratories. At the same time, software and connectivity tools are maturing to facilitate result integration with electronic health records and telehealth workflows. These developments are encouraging new use cases within emergency care, chronic disease monitoring, and community screening programs. Consequently, stakeholders across the value chain are recalibrating product development, reimbursement strategies, and distribution models to support rapid adoption while ensuring quality and regulatory compliance.
The landscape of point of care testing is undergoing transformative shifts driven by technology, care delivery models, and patient expectations. First, the technological trajectory is moving from single-analyte rapid tests toward multiplexed platforms and integrated molecular workflows, enabling broader diagnostic breadth at the point of need. Concurrently, sensor miniaturization and microfluidic integration are reducing sample volume and turnaround time, which enhances feasibility for home and ambulatory environments.
Second, care delivery models are evolving: outpatient and community settings are absorbing responsibilities historically held by centralized laboratories, and telemedicine interfaces increasingly rely on near-real-time diagnostics to inform remote consultations. Third, the role of software and connectivity has intensified, with interoperability and cybersecurity becoming prerequisites for clinical adoption. Regulatory pathways are also adapting to accommodate decentralized diagnostics, creating opportunities as well as expectations for robust quality management systems. Finally, patient-centric trends-such as convenience, rapid reassurance, and longitudinal monitoring-are reshaping product design priorities, emphasizing user experience, simplified workflows, and clear result interpretation. Together, these shifts are not incremental but collectively redefine procurement decisions, clinical pathways, and competitive positioning across the ecosystem.
The imposition of tariffs and trade measures by the United States in 2025 introduces a complex set of effects for manufacturers, suppliers, and end users in the point of care testing space. Tariffs on components, consumables, and finished devices can elevate landed costs for products that rely on global supply chains, thereby influencing procurement strategies and reorder cadence. Since many instruments and reagents incorporate electronic components, plastics, and precision machined parts sourced from multiple geographies, tariff-driven cost escalation tends to be uneven and dependent on the origin of specific subcomponents.
In response to tariff pressures, manufacturers may accelerate regional sourcing strategies, increase vertical integration of critical elements, or relocate certain production activities to tariff-favored jurisdictions. These operational adjustments can mitigate exposure but often require near-term capital and redesign efforts. For healthcare providers and distributors, the cumulative effect of tariffs can shift purchasing towards products with more stable supply chain footprints, local assembly, or alternative suppliers offering comparable clinical performance. Pricing adjustments may also influence inventory policies, with stakeholders maintaining higher safety stocks to buffer against potential re-pricing or delays. Importantly, the regulatory and quality assurance implications of sourcing changes necessitate careful validation to ensure clinical equivalence, so organizations must balance cost-containment with the need to preserve test accuracy and continuity of care.
Segmentation insights reveal how distinct product categories, test types, sample matrices, technologies, portability options, purchase modes, applications, end users, and distribution channels shape demand patterns and development priorities. Within product segmentation, consumables, services and software, instruments and analyzers, and reagents and assays each carry discrete implications: consumables, accessories and service maintenance and calibration, and software and connectivity underpin ongoing revenue streams and operational continuity; benchtop analyzers, molecular platforms, portable analyzers, and readers and scanners determine deployment scenarios and clinical workflows; while glucose test strips, hematology reagents, immunoassay reagents, lateral flow assay reagents, and molecular assay kits drive assay-specific supply chain and quality assurance requirements.
When viewed through test-type segmentation, the breadth from blood gases to infectious disease and molecular diagnostics affects instrument selection and clinician training, with cardiac markers and hematology requiring specialized assay robustness and coagulation testing demanding precise calibration and control across activated partial thromboplastin time, fibrinogen level, and prothrombin time and international normalized ratio assays. Infectious disease testing spans gastrointestinal, respiratory, and sexually transmitted infection panels, each influencing throughput needs and biosafety considerations. Sample-type segmentation, including blood, nasal and swab samples, saliva, and urine, informs collection device design, patient acceptability, and pre-analytical stability requirements. Technology segmentation differentiates biosensor electrochemical approaches, colorimetric platforms, immunoassays, lateral flow assays-spanning antibody, antigen, and multiplex formats-microfluidics, and PCR and molecular technologies, with each imparting trade-offs between sensitivity, specificity, cost, and operational complexity.
Portability options distinguish benchtop fixed analyzers from portable handheld devices, aligning device footprint with intended point of care settings. Mode of purchase segmentation separates over-the-counter accessibility from prescription-based dispensing, shaping labeling, user instructions, and post-market surveillance obligations. Application-driven segmentation-from chronic disease management to emergency and critical care, infectious disease diagnosis, occupational testing, oncology monitoring, and women's health-dictates performance thresholds and integration requirements with clinical care pathways. End-user segmentation that includes ambulatory care centers, diagnostic laboratories, free-standing emergency departments, home care, hospitals and clinics, and urgent care centers emphasizes differences in staffing, regulatory oversight, and capital acquisition processes. Finally, distribution channel segmentation across offline and online pathways, with offline methods such as direct sales, distributor and wholesale, and retail and pharmacy, impacts go-to-market strategies, margin structures, and customer support models. Taken together, these segmentation lenses provide a multifaceted view that guides product roadmaps, commercialization priorities, and lifecycle planning.
Regional nuances significantly influence how point of care testing is designed, deployed, and reimbursed, with the Americas, Europe, Middle East and Africa, and Asia-Pacific each presenting distinct market drivers and operational considerations. In the Americas, health systems emphasize outpatient care optimization and chronic disease management, creating demand for devices and assays that support remote monitoring and rapid cardiovascular and metabolic testing in both clinic and home settings. Distribution networks in this region prioritize integrated supply chains and localized service support, which favors manufacturers that can demonstrate robust after-sales service and data interoperability with dominant electronic health records.
Europe, Middle East and Africa exhibit heterogeneity in regulatory regimes and healthcare infrastructure, with pockets of high regulatory rigor coexisting with areas where access barriers remain. This diversity requires adaptable product configurations and flexible pricing models. Interoperability standards and data privacy frameworks are especially influential in regulatory decision-making and clinical adoption in Europe, while capacity building and decentralized solutions are prioritized in many parts of the Middle East and Africa. In Asia-Pacific, rapid urbanization, expanding primary care networks, and high-volume public health screening initiatives drive demand for scalable, cost-effective point of care solutions. Regional manufacturing capabilities and supplier ecosystems in Asia-Pacific often accelerate product iteration cycles, and partnerships with local distributors are critical to achieve penetration across varied healthcare settings. Across all regions, reimbursement pathways, regulatory timelines, and customer training imperatives shape adoption velocity and product design choices.
Competitive dynamics within the point of care testing landscape are characterized by strategic partnerships, platform differentiation, and a focus on integrated solutions that combine instruments, consumables, and software. Leading companies are prioritizing modular platform architectures that support multiple assay formats, enabling faster assay rollouts and improved lifetime value through recurring consumable demand. Concurrently, alliances with connectivity vendors and health IT integrators are becoming essential to deliver data-rich diagnostic results that plug into clinical workflows and population health initiatives.
Innovation strategies vary by firm, with some investing heavily in molecular and microfluidic technologies to expand the diagnostic menu, while others concentrate on low-cost lateral flow and biosensor technologies optimized for point-of-care ease of use. Service offerings, including field maintenance, calibration, and software updates, are being redefined as a competitive differentiator, and companies that can demonstrate rapid support turnaround and robust quality systems tend to secure larger institutional contracts. Supply chain resilience and localized manufacturing capabilities have also risen in strategic importance, prompting acquisitions and joint ventures to reduce exposure to global logistics disruptions. Finally, commercial models are shifting toward subscription and outcomes-based arrangements in select accounts, aligning vendor incentives with clinical performance and operational uptime.
To remain competitive and clinically relevant, industry leaders should pursue a set of actionable initiatives that align product development with operational realities and evolving care models. First, prioritize interoperability and user-centered software design so that devices integrate seamlessly into clinician workflows and electronic health records, thereby reducing friction at the point of adoption. Second, invest in modular platform strategies that allow rapid assay expansion and support multiple sample types, which increases flexibility for procurement teams and reduces the need for multiple device footprints.
Third, strengthen supply chain resilience through strategic regional sourcing, dual sourcing of critical components, and validated local assembly where feasible, which mitigates exposure to trade disruptions and tariff-driven cost pressures. Fourth, enhance post-market service offerings-particularly field maintenance and remote diagnostics-to preserve instrument uptime and protect clinical continuity. Fifth, adopt evidence-generation strategies that emphasize real-world performance, workflow impact, and patient-centric outcomes, thereby supporting payer discussions and clinical adoption. Finally, explore alternative commercial models, such as managed service agreements or outcome-linked contracts, to better align with healthcare purchasers' objectives and to create predictable revenue streams. Executing these actions with clear accountability and staged milestones will help firms convert technical capabilities into durable market advantage.
The research methodology underpinning this analysis integrates qualitative and quantitative approaches designed to ensure rigor, relevance, and reproducibility. Primary research consisted of in-depth interviews with clinicians, laboratory directors, procurement officers, and senior executives across device manufacturers and distributors to capture real-world use cases, procurement constraints, and unmet needs. These interviews were complemented by facility-level observations and validation of workflow integration points to translate clinical priorities into product requirements.
Secondary research included a systematic review of peer-reviewed clinical literature, regulatory guidance documents, industry standards for quality management and interoperability, and technical white papers describing assay and platform performance. Data triangulation techniques were employed to reconcile insights from diverse sources and to validate assumptions about operational behaviors and adoption barriers. The research also applied scenario analysis to assess supply chain risk and regulatory sensitivity, and key findings were stress-tested through expert panels to refine recommendations. Throughout, the methodology emphasized transparency, with audit trails linking conclusions to source materials and interview excerpts, ensuring that stakeholders can trace analytic judgments back to empirical evidence.
In conclusion, point of care testing is at an inflection point where technological maturity, changing care delivery models, and policy shifts are jointly redefining diagnostic pathways. The move toward decentralized diagnostics is supported by advances in assay chemistry, miniaturized instrumentation, and software connectivity, yet this transition also raises operational, regulatory, and supply chain challenges that require deliberate mitigation. Tariff actions, shifting procurement preferences, and regional regulatory heterogeneity add layers of complexity that stakeholders must address through resilient sourcing, adaptable product architectures, and robust evidence generation.
For manufacturers, the imperative is to deliver clinically rigorous, easy-to-use platforms that integrate seamlessly into workflows while offering sustainable service and supply models. For providers and payers, the focus should be on harnessing point of care capabilities to improve decision latency and patient experience without sacrificing quality controls. By aligning technology investments, commercial models, and implementation frameworks, stakeholders can realize the promise of point of care testing to deliver meaningful improvements in clinical care and operational efficiency.