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POC(Point of Care) 분자진단 시장 : 시장 동향, 경쟁 구도 및 시장 예측(2034년)

Point-of-Care Molecular Diagnostics - Market Insights, Competitive Landscape, and Market Forecast - 2034

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 150 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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POC 분자진단 시장 요약

개요:

  • POC(Point-of-Care) 분자진단 시장은 2025년에 62억 달러로 평가되었으며, 2034년까지 148억 달러에 달할 것으로 예측됩니다. 이러한 성장은 세계 감염병 부담 증가, 분산형 및 환자 근접 검사로의 전환, 그리고 CLIA 면제 대상인 증후군별 검사 및 재택 분자 검사의 확대에 힘입은 것입니다.
  • 세계의 POC 분자진단 시장은 2026-2034년 예측 기간 동안 연평균 성장률(CAGR) 10.2%로 성장할 전망입니다.
  • 제품별로는 2025년에 분석법 및 소모품 부문이 58%의 점유율을 차지하며 POC 분자진단 시장을 주도했습니다.
  • 기술별로는 2025년에 실시간 PCR 부문이 45%의 점유율을 차지하며 POC 분자진단 시장을 주도했습니다.
  • 용도별로는 2025년에 감염병 부문이 62%의 점유율을 차지하며 POC 분자진단 시장을 주도했습니다.
  • 최종 사용자별로는 2025년에 병원 및 중환자 치료 시설 부문이 41%의 점유율로 POC 분자진단 시장을 독점했습니다.
  • 북미는 2025년에 46%의 점유율로 세계 POC 분자진단 시장의 매출을 주도하며, 세계적으로 가장 높은 지역별 시장 점유율을 기록했습니다.

POC 분자진단이란 중앙 집중식 검사실 밖에서 환자의 진료 현장 또는 그 인근에서 수행되는 핵산 증폭 검사를 의미하며, 병원체의 DNA나 RNA, 또는 유전자 마커를 검사실 수준의 정확도로 검출하는 것을 목적으로 합니다. 이 범주에는 소형 기기 및 분석 장치, 일회용 어세이, 카트리지, 시약, 그리고 연결용 소프트웨어가 포함되며, 카트리지형, 핸드헬드형 또는 기기 불필요한 형태로 제공됩니다. 핵심 기술로는 실시간 중합효소 연쇄반응(PCR), 루프 매개 증폭 및 니킹 효소 증폭과 같은 등온 핵산 증폭, CRISPR 기반 검출, 그리고 마이크로어레이법이 포함되며, 이들은 분산형 검사에 요구되는 '신속(Rapid)', '고감도(Sensitive)', '특이성(Specific)'이라는 REASSURED 기준을 충족하도록 설계되었습니다. 주요 용도 분야는 호흡기 감염증, 성병, 병원 내 감염, 간염, HIV, 결핵 등의 감염증 검사에 더해 종양학 및 유전자 검사까지 이릅니다. 검사는 병원, 응급실, 응급진료소, 진료소, 약국은 물론 가정에서도 점차 도입되고 있습니다. 코로나19 팬데믹을 계기로 가속화되어, 현재는 CLIA 면제, 증후군별 다중 검사 패널, 시판되는 자가 검사 키트를 통해 확대되고 있는 POC 분자진단은 신속한 결과를 제공함으로써 조기 치료를 가능하게 하고, 항생제의 적정 사용을 지원하며, 실험실 수준의 품질을 갖춘 검사를 환자 치료의 최전선으로 가져옵니다.

POC 분자진단 시장의 주요 시장 성장 촉진요인

  • 감염병으로 인한 세계적 부담이 증가함에 따라 수요가 확대되고 있으며, 세계보건기구(WHO)의 추산에 따르면 치료 가능한 4가지 성병의 신규 감염자는 매년 3억 7,400만 명에 달하고, 2023년에는 1,080만 명이 결핵에 걸릴 것으로 예측됩니다.
  • 신속하고 환자 곁에서 결과를 얻을 수 있다는 점에 대한 수요가 높아짐에 따라, 검사는 중앙 집중형 검사실에서 분산형 환경으로 전환되고 있으며, 한 번의 내원만으로 진단과 치료가 가능해졌습니다.
  • BIOFIRE사의 SPOTFIRE 호흡기 검사 시리즈 등, CLIA 면제 증후군별 다항목 검사 패널의 확대로 인해, 실험실 수준의 PCR 검사가 응급 진료, 진료소, 약국에 도입되고 있습니다.
  • 2025년 FDA가 최초로 승인한 성 건강을 위한 가정용 PCR 검사를 포함한 시판용 가정용 분자 검사의 등장으로 새로운 소비자 채널이 열리고 있습니다.
  • 등온 증폭, CRISPR 기반 검출, 그리고 기기가 필요 없는 일회용 PCR 분야의 기술 혁신을 통해 검사의 신속성, 휴대성 및 경제성이 향상되고 있습니다.
  • 신속한 분자 검사 결과로 인해 부적절한 항생제 사용이 줄어들고 표적 치료가 지원됨에 따라, 항생제 적정 사용이라는 우선순위가 이 기술의 도입을 뒷받침하고 있습니다.
  • 감염병의 부담, 의료의 분산화, 규제 측면의 지원, 그리고 기술 혁신이 맞물려 2034년까지 이 시장은 두 자릿수 성장을 유지할 것으로 예측됩니다.

POC(Point-of-Care) 분자진단 시장의 성장에 기여하는 요인

시장 성장 촉진요인

세계 감염병 및 항생제 내성 부담 증가

POC 분자진단 시장의 가장 강력한 시장 성장 촉진요인은 세계적으로 지속되고 계속 증가하는 감염병 부담입니다. 세계보건기구(WHO)의 추정에 따르면, 치료 가능한 4가지 성병으로 인한 신규 감염자는 매년 3억 7,400만 명에 달하며, 2023년에는 1,080만 명이 결핵에 걸렸습니다. 미국에서는 질병통제예방센터(CDC) 보고에 따르면 매년 160만 건의 클라미디아 신규 사례와 70만 건 이상의 임질 신규 사례가 확인되고 있으며, 더불어 인플루엔자, 호흡기 세포융합 바이러스 및 코로나19로 인한 계절적인 큰 부담도 발생하고 있습니다. 병원체를 신속하게 특정하지 못하면 경험적 항생제 투여로 이어지기 때문에 항생제 내성이 문제를 더욱 심각하게 만들고 있습니다. 현장 분자 검사는 병원체를 직접적이고 신속하게 검출하므로, 더 조기적이고 표적화된 치료를 가능하게 하고 감염 관리를 지원합니다. 감염병 발생률과 내성이 계속 증가하는 가운데, 2034년까지 임상 현장과 지역사회에서 신속하고 분산형 분자 검사에 대한 수요가 확대될 전망입니다.

환자 현장에서의 신속한 결과 및 분산형 의료에 대한 수요

의료 시스템에서는 검사가 중앙 집중식 검사실에서 환자 곁이나 분산형 환경으로 전환되고 있습니다. 이러한 환경에서는 신속한 검사 결과가 임상적 판단을 실시간으로 변화시킵니다. POC 분자진단 시스템은 15분에서 30분 내에 검사실 수준의 정확도를 갖춘 결과를 제공하므로, 임상의는 한 번의 진료 내에서 검사, 상담, 치료를 수행할 수 있게 되어 치료 성과 향상과 후속 관리 단절 감소로 이어집니다. 코로나19 팬데믹은 환자 병상 옆에서 실시하는 검사의 가치를 입증했으며, 이에 대한 기대는 응급실, 응급 진료소, 진료소, 약국 등에서 계속되고 있습니다. 미국 질병통제예방센터(CDC) 및 미국감염증학회(IDSA)는 외래 환자의 인플루엔자 검사에 대해 항원 검사보다 신속한 분자 검사를 권장하고 있으며, 이는 분산형 분자 검사의 임상적 타당성을 뒷받침합니다. 즉각적이고 실용적인 진단을 향한 이러한 구조적 변화는 시장 성장의 지속적인 원동력이 되고 있습니다.

시장 제약 요인

강한 성장세를 보이고 있음에도 불구하고, POC 분자진단 시장은 중대한 제약에 직면해 있습니다. POC 분자진단 시스템의 검사 1회당 비용은 중앙 검사실 검사나 신속 항원 검사의 대안에 비해 여전히 높으며, 카트리지 및 소모품 비용이 지속적인 비용으로 추가되기 때문에 가격에 민감한 환경이나 자원이 제한된 환경에서의 도입을 저해할 가능성이 있습니다. 보험 환급은 지역이나 적응증에 따라 불균일하며, 분산형 및 재택 분자 검사의 보험 적용 범위는 임상적 이용 가능성보다 뒤처지는 경우가 많아 이용을 제한하고 있습니다. 규제 측면의 복잡성도 두드러지며, 제조업체는 미국 내 FDA 승인 및 CLIA 면제 취득 절차에 더해, 더욱 엄격한 유럽 체외진단 의료기기 규정(IVDR)을 준수해야 하므로, 새로운 검사법이나 플랫폼 시장 출시까지 소요되는 기간이 길어지고 있습니다. 임상적 및 분석적 우려도 여전히 남아 있는데, 특정 음성 결과에 대해서는 중앙 검사실에서의 확인이 필요하거나, 통제된 환경 이외에서는 성능에 편차가 발생할 위험이 있다는 점 등이 있습니다. 소비자 부담형 자가 검사 시장은 아직 상업적 실적이 확립되지 않았으며, 규제 승인을 받았음에도 불구하고 초기 자가용 호흡기 복합 검사 키트가 시장에서 철수한 사례가 이를 보여주고 있어, 팬데믹 이외의 상황에서 수요 불확실성을 여실히 드러내고 있습니다. 공급망은 장비, 카트리지, 시약공급처가 소수의 업체에 집중되어 있어 공급 안정성 및 비용 측면의 위험이 발생하고 있습니다. 분산된 거점에서의 인력 교육, 연결성 통합, 품질 관리는 운영상의 부담을 가중시키고 있습니다. 감염병의 부담과 분산화라는 근본적인 촉진요인이 여전히 확고하게 존재함에도 불구하고, 이러한 비용, 보험 급여, 규제, 임상 및 운영상의 장벽이 복합적으로 작용하여 성장 속도를 둔화시키고 있습니다.

경쟁 현황

  • 시장 집중도 : 시장은 통합이 진행 중이며, 주요 기업 5곳이 매출의 대부분을 차지하고 있습니다. 또한, 독자적인 화학 분석법 및 폐쇄형 카트리지 생태계로 인해 진입 장벽이 높습니다.
  • 주요 기업 : Danaher(Cepheid), bioMerieux, F. Hoffmann-La Roche, Abbott, QIAGEN이 상위권을 형성하고 있습니다.
  • 지리적 확장 : 주요 기업들은 세계적인 판매 및 지원 네트워크를 운영하고 있으며, 아시아태평양, 중동 및 아프리카, 라틴아메리카를 대상으로 한 사업 확장 프로그램을 추진하고 있습니다.
  • 제품 포트폴리오의 강점 : 주요 기업들은 장비, 일회용 카트리지, 증후군 진단 패널, 연결용 소프트웨어에 걸친 통합적인 포트폴리오를 제공합니다.
  • 파이프라인의 강점 : CLIA 면제 증후군 진단 패널, 자가 검사 및 시판 검사 키트, 호흡기, 성 건강 및 기타 적응증을 아우르는 검사 메뉴 확충 등 활발한 파이프라인이 전개되고 있습니다.
  • 전략적 제휴 : 원격의료, 클라우드, 공중보건 분야의 파트너와의 협력을 통해 사업 영역을 확대되고 있습니다. 대표적인 사례로 주요 클라우드 제공업체와 통합된 자가 검사 플랫폼을 들 수 있습니다.
  • 인수합병(M&A) 활동 : 바이오메륨(BioMerieux)의 스핀칩 다이아그노스틱스(SpinChip Diagnostics) 인수나 로슈(Roche)의 루미라 Dx(Lumira Dx)사의 포인트 오브 케어(Point-of-Care) 기술 인수 등, 업계 재편이 계속되고 있습니다.
  • 생산 능력 : 카트리지 및 시약의 대량 생산 능력은 중요한 경쟁 우위인 동시에 공급망 측면에서 고려해야 할 사항이기도 합니다.
  • 혁신의 초점 : 기기가 필요 없는 일회용 PCR, 등온 증폭, CRISPR 기반 검출, 다중 질환 패널, 그리고 AI를 활용한 연결성.

POC(Point-of-Care) 분자진단 시장 보고서 조사에서 도출된 주요 포인트

  • 현재 POC(Point-of-Care) 분자진단 시장 규모(2025년)에 대한 분석 및 9년간(2026-2034년) 시장 전망
  • 지난 3년간 발생한 주요 제품 및 기술 개발, 합병, 인수, 제휴 및 합작 투자.
  • 세계 POC 분자진단 시장을 주도하는 주요 기업.
  • POC 분자진단 시장에서 경쟁사들에게 열려 있는 다양한 기회.
  • 2025년에 가장 호조를 보일 부문은 무엇일까요? 이러한 부문은 2034년에 어떤 추이를 보일까요?
  • 현재 POC(Point-of-Care) 분자진단 시장에서 가장 호조를 보이는 지역 및 국가는 어디인가?
  • 기업이 향후 POC(Point-of-Care) 분자진단 시장의 성장 기회에 집중해야 할 지역이나 국가는 어디인가?

본 ‘POC(Point-of-Care) 분자진단 시장’ 보고서 조사를 통해 혜택을 받을 수 있는 대상 독자

  • POC(Point-of-Care) 분자진단 제품을 제공하는 기업
  • 조사 기관 및 컨설팅 회사
  • POC(Point-of-Care) 분자진단과 관련된 조직, 협회, 포럼 및 기타 협력 단체
  • 정부 기관 및 기업
  • 스타트업, 벤처 캐피탈, 사모펀드
  • POC(Point-of-Care) 분자진단을 취급하는 유통업체 및 무역 회사
  • POC(Point-of-Care) 분자진단 시장 및 해당 시장의 최신 기술 동향에 대해 더 자세히 알고자 하는 다양한 최종 사용자.

자주 묻는 질문:

Q1. POC(Point-of-Care) 분자진단 시장의 성장률은 어느 정도입니까?

POC(Point-of-Care) 분자진단 시장은 2026-2034년 예측 기간 동안 연평균 성장률(CAGR) 10.2%로 확대될 것으로 전망됩니다.

Q2. POC(Point-of-Care) 분자진단 시장 규모는 어느 정도입니까?

POC(Point-of-Care) 분자진단 시장 규모는 2025년에 62억 달러로 추정되며, 2034년까지 148억 달러에 달할 것으로 예측됩니다.

Q3. POC(Point-of-Care) 분자진단 시장을 주도하는 지역은 어디인가?

북미는 제조업체가 밀집된 기반, 선진적인 분산형 검사 인프라, 확립된 FDA 승인 및 CLIA 면제 절차, 넉넉한 보험 환급 제도, 그리고 호흡기 감염증 및 성병의 높은 유병률 등의 요인에 힘입어 2025년에는 세계 매출의 46%를 차지하며 POC(Point-of-Care) 분자진단 시장을 주도했습니다. 아시아태평양은 예측 기간 동안 가장 빠르게 성장할 지역입니다.

Q4. POC 분자진단 시장의 주요 촉진요인은 무엇인가?

주요 촉진요인은 세계 감염병 부담 증가입니다. 세계보건기구(WHO)의 추정에 따르면, 2023년에는 매년 3억 7,400만 건의 치료 가능한 성병 신규 사례와 1,080만 건의 결핵 사례가 발생하고 있습니다. 신속하고 환자 곁에서 수행할 수 있는 분산형 검사로의 전환, CLIA 면제 증후군별 멀티플렉스 검사 패널 및 시판용 가정용 분자 검사의 확대, 그리고 등온 증폭, CRISPR 기반 검출, 기기 불필요 PCR 분야의 기술 혁신을 들 수 있습니다. 이러한 요인들은 항생제 적정 사용에 대한 우선순위에 의해 더욱 촉진되고 있습니다.

Q5. POC(Point-of-Care) 분자진단 시장의 주요 기업은?

주요 기업으로는 Danaher Corporation, F. Hoffmann-La Roche Ltd, Abbott Laboratories, bioMerieux SA, QIAGEN N.V., Becton, Dickinson and Company, Hologic, Inc., QuidelOrtho Corporation, Thermo Fisher Scientific Inc., SD Biosensor, Inc. 등이 분산형 카트리지식 검사 분야에서 선도적인 위치를 차지하고 있는 반면, 바이오메리유는 현장진단(PoC) 분야의 증후군별 검사 패널 분야에서 선도적인 위치를 차지하고 있습니다.

목차

제1장 POC(Point of Care) 분자진단 시장 보고서 서론

제2장 POC(Point of Care) 분자진단 시장 주요 요약

제3장 POC(Point of Care) 분자진단 시장의 주요 요인 분석

제4장 영향 분석 : AI, 지정학, 무역 및 경제 동향

제5장 규제 분석

제6장 POC(Point of Care) 분자진단 시장 : Porter's Five Forces 분석

제7장 POC(Point of Care) 분자진단 시장 평가

제8장 POC(Point of Care) 분자진단 시장 경쟁 구도

제9장 POC(Point of Care) 분자진단 시장 스타트업의 자금조달 및 투자 동향

제10장 POC(Point of Care) 분자진단 시장 : 기업 개요 및 제품 개요

제11장 KOL(Key Opinion Leader)의 견해

제12장 프로젝트 및 접근

제13장 DelveInsight에 대해

제14장 면책사항 및 문의

AJY

Point-of-Care Molecular Diagnostics Market Summary

Overview:

  • The Point-of-Care Molecular Diagnostics market is estimated at USD 6.20 billion in 2025 and is projected to reach USD 14.80 billion by 2034. Growth is anchored in the rising global burden of infectious disease, the shift toward decentralized and near-patient testing, and the expansion of CLIA-waived syndromic and home molecular tests.
  • The global Point-of-Care Molecular Diagnostics market is growing at a CAGR of 10.2% during the forecast period from 2026 to 2034.
  • By product, the assays and consumables segment dominated the Point-of-Care Molecular Diagnostics market with a 58% share in 2025.
  • By technology, the real-time PCR segment dominated the Point-of-Care Molecular Diagnostics market with a 45% share in 2025.
  • By application, the infectious diseases segment dominated the Point-of-Care Molecular Diagnostics market with a 62% share in 2025.
  • By end user, the hospitals and critical care settings segment dominated the Point-of-Care Molecular Diagnostics market with a 41% share in 2025.
  • North America dominated the global Point-of-Care Molecular Diagnostics market revenue with a 46% share in 2025, representing the highest regional market share globally.

Point-of-care molecular diagnostics refers to nucleic acid amplification testing performed at or near the site of patient care, outside centralized laboratories, to detect the DNA or RNA of pathogens or genetic markers with laboratory-grade accuracy. The category combines compact instruments and analyzers, single-use assays, cartridges, and reagents, and connectivity software, delivered through cartridge-based, handheld, or instrument-free formats. Core technologies include real-time polymerase chain reaction, isothermal nucleic acid amplification such as loop-mediated and nicking-enzyme amplification, CRISPR-based detection, and microarray methods, designed to meet the rapid, sensitive, and specific REASSURED criteria for decentralized testing. Major applications span infectious diseases, including respiratory, sexually transmitted, hospital-acquired, hepatitis, HIV, and tuberculosis testing, as well as oncology and genetic testing. Tests are deployed across hospitals and emergency departments, urgent care, physician offices, pharmacies, and increasingly the home. Accelerated by the COVID-19 pandemic and now expanding through CLIA-waiver, syndromic multiplex panels, and over-the-counter home tests, point-of-care molecular diagnostics deliver rapid results that enable earlier treatment, support antimicrobial stewardship, and bring laboratory-quality testing to the frontline of patient care.

Point-of-Care Molecular Diagnostics Market Key Growth Drivers

  • The rising global burden of infectious disease is expanding demand, with the World Health Organization estimating 374 million new infections each year from four curable sexually transmitted infections and 10.8 million people falling ill with tuberculosis in 2023.
  • Growing demand for rapid, near-patient results is shifting testing from centralized laboratories to decentralized settings, enabling diagnosis and treatment within a single visit.
  • The expansion of CLIA-waived syndromic multiplex panels, such as the BIOFIRE SPOTFIRE respiratory range, is bringing laboratory-grade PCR into urgent care, physician offices, and pharmacies.
  • The emergence of over-the-counter home molecular testing, including the first FDA-authorized at-home PCR test for sexual health in 2025, is opening new consumer channels.
  • Technological innovation in isothermal amplification, CRISPR-based detection, and instrument-free single-use PCR is improving speed, portability, and affordability.
  • Antimicrobial stewardship priorities are driving adoption, as rapid molecular results reduce inappropriate antibiotic use and support targeted therapy.
  • The convergence of infectious disease burden, decentralization, regulatory support, and technological innovation is expected to sustain double-digit growth in the market through 2034.

Key Companies in Point-of-Care Molecular Diagnostics Market

The competitive landscape is led by the following active manufacturers and developers:

  • Danaher Corporation
  • F. Hoffmann-La Roche Ltd
  • Abbott Laboratories
  • bioMerieux SA
  • QIAGEN N.V.
  • Becton, Dickinson and Company
  • Hologic, Inc.
  • QuidelOrtho Corporation
  • Thermo Fisher Scientific Inc.
  • SD Biosensor, Inc.

Factors Contributing to the Growth of the Point-of-Care Molecular Diagnostics Market

Market Drivers

Rising Global Burden of Infectious Disease and Antimicrobial Resistance

The most powerful driver of the Point-of-Care Molecular Diagnostics market is the persistent and rising global burden of infectious disease. The World Health Organization estimates that 374 million new infections occur each year from four curable sexually transmitted infections, and that 10.8 million people fell ill with tuberculosis in 2023. In the United States, the Centers for Disease Control and Prevention reports 1.6 million new chlamydia cases and over 700,000 gonorrhea cases annually, alongside a large seasonal burden of influenza, respiratory syncytial virus, and COVID-19. Antimicrobial resistance compounds the challenge, as the inability to identify pathogens rapidly drives empirical antibiotic use. Point-of-care molecular tests detect pathogens directly and quickly, enabling earlier, targeted treatment and supporting infection control. As infectious disease incidence and resistance continue to rise, demand for rapid decentralized molecular testing expands across clinical and community settings through 2034.

Demand for Rapid, Near-Patient Results and Decentralized Care

Healthcare systems are shifting testing away from centralized laboratories toward near-patient and decentralized settings, where rapid results change clinical decisions in real time. Point-of-care molecular systems deliver laboratory-grade results in 15 to 30 minutes, allowing clinicians to test, counsel, and treat within a single visit, which improves outcomes and reduces loss to follow-up. The COVID-19 pandemic demonstrated the value of testing at the patient bedside, and that expectation has persisted across emergency departments, urgent care, physician offices, and pharmacies. The Centers for Disease Control and Prevention and the Infectious Diseases Society of America recommend rapid molecular assays over antigen tests for influenza in outpatients, reinforcing the clinical case for decentralized molecular testing. This structural shift toward immediate, actionable diagnosis is a sustained driver of market growth.

Market Restraints

Despite strong momentum, the Point-of-Care Molecular Diagnostics market faces material constraints. The cost per test for molecular point-of-care systems remains higher than for central-laboratory testing and rapid antigen alternatives, with cartridge and consumable expenditure adding recurring cost that can limit adoption in price-sensitive and lower-resource settings. Reimbursement is uneven across geographies and indications, and coverage for decentralized and home molecular testing often lags clinical availability, constraining utilization. Regulatory complexity is significant, as manufacturers must navigate FDA clearance and CLIA-waiver pathways in the United States and the more demanding European In Vitro Diagnostic Regulation, lengthening time to market for new assays and platforms. Clinical and analytical concerns persist, including the need to confirm certain negative results in centralized laboratories and the risk of variable performance outside controlled settings. The consumer-pay home market remains commercially unproven, illustrated by the withdrawal of an early at-home combination respiratory test despite regulatory success, underscoring uncertain demand outside pandemic conditions. Supply chains are exposed through reliance on a concentrated set of instrument, cartridge, and reagent suppliers, creating availability and cost risk. Workforce training, connectivity integration, and quality oversight across distributed sites add operational burden. Together, these cost, reimbursement, regulatory, clinical, and operational barriers temper the pace of growth, even as the underlying drivers of infectious disease burden and decentralization remain firmly intact.

Point-of-Care Molecular Diagnostics Market Segment Analysis

The Point-of-Care Molecular Diagnostics Market by Product (Assays and Consumables, Instruments and Analyzers, Software and Services), Technology (Real-Time PCR, Isothermal Nucleic Acid Amplification, CRISPR-Based Detection, Microarray, Sequencing-Based, Others), Application (Infectious Diseases, Oncology, Genetic Testing, Others), End User (Hospitals and Critical Care Settings, Physician Offices and Clinics, Urgent Care and Ambulatory Centers, Home Care and Self-Testing, Others), and Geography (North America, Europe, Asia-Pacific, Rest of World).

By Product

Dominant Subsegment: Assays and Consumables. The assays and consumables category is expected to dominate the market.

Dominant: Assays and Consumables ~ 58%

The assays and consumables segment accounted for 58% of the Point-of-Care Molecular Diagnostics market in 2025. Assays and consumables are the leading product segment because point-of-care molecular testing operates on a razor-and-blade model in which single-use cartridges, reagents, and test kits are consumed on every run, producing recurring revenue that scales directly with testing volume. As decentralized testing expands across respiratory, sexual health, and other indications, consumable demand deepens with each new installed instrument. Manufacturers reinforce this dynamic by pairing proprietary platforms with closed-system cartridges, locking testing sites into ongoing purchases, as seen with Cepheid GeneXpert cartridges and BIOFIRE SPOTFIRE panels. A steady cadence of new assay launches, including CLIA-waived syndromic respiratory and sore-throat panels and the first over-the-counter PCR sexual health test, continuously expands the consumable menu. The combination of recurring economics, growing test volumes, and menu expansion secures the segment's leadership across the forecast period, while the instruments and analyzers tier underpins the installed base and the software and services tier captures connectivity, data, and support revenue.

By Technology

Dominant Subsegment: Real-Time PCR. The real-time PCR category is expected to dominate the market.

Dominant: Real-Time PCR ~ 45%

The real-time PCR segment accounted for 45% of the Point-of-Care Molecular Diagnostics market in 2025. Real-time polymerase chain reaction is the most widely deployed point-of-care molecular technology, valued as the diagnostic gold standard for its high sensitivity, specificity, and broad validated assay menu. Its dominance is reinforced by large installed bases of cartridge-based PCR platforms such as Cepheid GeneXpert, Roche cobas liat, and bioMerieux BIOFIRE SPOTFIRE, and by professional guidelines that recommend nucleic acid amplification testing over rapid antigen tests for conditions such as influenza. Continued innovation sustains the segment, including instrument-free single-use PCR devices that deliver laboratory-grade results in the palm of the hand and multiplex panels that detect many pathogens simultaneously. Adjacent technologies are advancing rapidly: isothermal nucleic acid amplification enables low-power, instrument-light testing, and CRISPR-based detection is expected to be among the fastest-growing approaches. While these alternatives expand the technology landscape and grow quickly from smaller bases, real-time PCR retains leadership through its accuracy, versatility, and entrenched clinical validation across the forecast period.

By End User

Dominant Subsegment: Hospitals and Critical Care Settings. The hospitals and critical care settings category is expected to dominate the market.

Dominant: Hospitals and Critical Care Settings ~ 41%

The hospitals and critical care settings segment accounted for 41% of the Point-of-Care Molecular Diagnostics market in 2025. Hospitals and critical care settings are the largest end user because emergency departments, intensive care units, and hospital-based near-patient testing sites combine high testing volumes with the greatest clinical urgency. Rapid molecular results in these settings guide isolation, admission, and treatment decisions for respiratory, bloodstream, and hospital-acquired infections, where delays carry serious consequences. Hospitals have the infrastructure, accreditation, and throughput to deploy multiple molecular platforms and syndromic panels, and they anchor the installed base for cartridge-based systems. The clinical case is reinforced by antimicrobial stewardship programs that depend on rapid pathogen identification. At the same time, the expansion of CLIA-waived testing is driving rapid growth in physician offices, urgent care and ambulatory centers, and the emerging home-care and self-testing channel, as molecular testing moves closer to the patient. While these decentralized settings are the fastest-expanding cohort, hospitals and critical care settings retain leadership in 2025 on the strength of volume, acuity, and infrastructure.

Point-of-Care Molecular Diagnostics Market Region Analysis

Dominant Region: North America

North America accounted for 46% of the global Point-of-Care Molecular Diagnostics market revenue in 2025, representing the highest regional market share globally. The region's dominance reflects the concentration of leading molecular diagnostics manufacturers, an advanced healthcare infrastructure, and the most active decentralized testing environment, particularly in the United States. Market-size influence is amplified by high per-capita testing volumes, strong reimbursement for molecular diagnostics, and rapid uptake of CLIA-waived syndromic panels in urgent care, physician offices, and pharmacies. The regulatory environment is supportive, with established FDA clearance and CLIA-waiver pathways and a series of landmark authorizations, including the first over-the-counter PCR sexual health test in 2025 and CLIA-waived BIOFIRE SPOTFIRE respiratory panels in 2024. Disease burden is substantial, with the Centers for Disease Control and Prevention reporting 1.6 million new chlamydia cases and over 700,000 gonorrhea cases annually alongside heavy seasonal respiratory demand. A deep manufacturer base and strong private and public investment anchor the region's continued leadership.

Dominant: North America ~ 46% (Largest)

Fastest Growing Region: Asia-Pacific

Asia-Pacific is the fastest-growing region in the Point-of-Care Molecular Diagnostics market. The region's elevated CAGR is driven by a large population, a high burden of infectious disease including tuberculosis and respiratory and sexually transmitted infections, and expanding access to decentralized testing across China, India, Japan, South Korea, and Australia. Rising healthcare investment, government infectious-disease surveillance programs, and the growth of affordable domestic platforms such as chip-based real-time micro-PCR systems are broadening access in both urban and remote settings. Manufacturing expansion and local innovation are lowering costs and accelerating adoption, while increasing awareness, urbanization, and insurance coverage support demand. The combination of high disease burden, decentralization, and cost-effective regional platforms positions Asia-Pacific as the principal source of incremental growth over the forecast period.

Regional Commentary

North America

North America accounted for 46% of the global Point-of-Care Molecular Diagnostics market revenue in 2025. The United States dominates on the strength of its manufacturer base, decentralized testing infrastructure, CLIA-waiver and FDA pathways, and strong reimbursement, while Canada contributes through public-health testing programs and expanding near-patient diagnostics in primary and remote care.

Europe

Europe is a large and advanced regional market, led by Germany, the United Kingdom, France, Italy, and Spain. Growth is supported by strong public health systems, antimicrobial stewardship initiatives, and rising syndromic testing, while the transition to the European In Vitro Diagnostic Regulation is raising the evidence bar for new point-of-care molecular assays and shaping market entry across the region.

Asia-Pacific

Asia-Pacific is the fastest-growing region, propelled by a large population, a high infectious-disease burden, and expanding access to decentralized testing across China, India, Japan, South Korea, and Australia. Affordable domestic platforms, government surveillance programs, and rising healthcare investment are accelerating adoption in both clinical and community settings.

Rest of World

The Rest of World region, spanning Latin America, the Middle East, and Africa, is an emerging growth frontier. A high burden of tuberculosis, HIV, and other infectious diseases, combined with limited centralized laboratory capacity, makes rapid decentralized molecular testing especially valuable, and international health programs and donor funding are expanding access to point-of-care platforms across these markets.

Point-of-Care Molecular Diagnostics Market Competitive Landscape

The Point-of-Care Molecular Diagnostics market is classified as Consolidated. A small group of global diagnostics companies controls the majority of platform and consumable revenue, with Danaher leading through its Cepheid GeneXpert systems, followed by bioMerieux in syndromic testing, Roche and Abbott in cartridge-based and rapid molecular platforms, and QIAGEN in portable systems. A broad and active field of specialized challengers, including Visby Medical, Co-Diagnostics, Molbio Diagnostics, and SD Biosensor, competes in instrument-free, home, and emerging-market segments.

The competitive landscape can be evaluated across the following dimensions:

  • Market concentration: Consolidated, with the top five players holding the majority of revenue and high barriers to entry from proprietary chemistry and closed-cartridge ecosystems.
  • Leading players: Danaher (Cepheid), bioMerieux, F. Hoffmann-La Roche, Abbott, and QIAGEN anchor the top tier.
  • Geographic reach: Leaders operate global commercial and support networks, with expansion programs targeting Asia-Pacific, the Middle East, Africa, and Latin America.
  • Product portfolio strength: Top players offer integrated portfolios spanning instruments, single-use cartridges, syndromic panels, and connectivity software.
  • Pipeline strength: Active pipelines in CLIA-waived syndromic panels, home and over-the-counter assays, and expanded menus across respiratory, sexual health, and other indications.
  • Strategic partnerships: Collaborations with telehealth, cloud, and public-health partners extend reach, exemplified by home testing platforms integrated with major cloud providers.
  • M&A activity: Consolidation continues, including bioMerieux's acquisition of SpinChip Diagnostics and Roche's acquisition of LumiraDx point-of-care technology.
  • Manufacturing capabilities: Scale manufacturing of cartridges and reagents is a key competitive moat and a supply-chain consideration.
  • Innovation focus: Instrument-free single-use PCR, isothermal amplification, CRISPR-based detection, multiplex syndromic panels, and AI-enabled connectivity.

Point-of-Care Molecular Diagnostics Market Recent Developmental Activities

In June 2025, Danaher Corporation (Cepheid), received a Health Canada medical device license for the Xpert HIV-1 Viral Load XC, a next-generation extended-coverage test used to monitor the effectiveness of antiretroviral therapy. Strategic significance: Extends decentralized molecular monitoring into HIV care and strengthens Cepheid's GeneXpert menu for global health programs.

In March 2025, Visby Medical, Inc., received FDA De Novo authorization for the Visby Medical Women's Sexual Health Test, the first over-the-counter PCR diagnostic authorized for home use for any indication, detecting chlamydia, gonorrhea, and trichomoniasis in 30 minutes. Strategic significance: Opens the at-home PCR market and establishes instrument-free molecular testing as a consumer category.

Point-of-Care Molecular Diagnostics Market Segmentation

Point-of-Care Molecular Diagnostics Market by Product

  • Assays and Consumables
  • Instruments and Analyzers
  • Software and Services

Point-of-Care Molecular Diagnostics Market by Technology

  • Real-Time PCR
  • Isothermal Nucleic Acid Amplification
  • CRISPR-Based Detection
  • Microarray
  • Sequencing-Based
  • Others

Point-of-Care Molecular Diagnostics Market by Application

  • Infectious Diseases
  • Respiratory Infections
  • Sexually Transmitted Infections
  • Hospital-Acquired Infections
  • Hepatitis and HIV
  • Tuberculosis
  • Oncology
  • Genetic Testing
  • Others

Point-of-Care Molecular Diagnostics Market by End User

  • Hospitals and Critical Care Settings
  • Physician Offices and Clinics
  • Urgent Care and Ambulatory Centers
  • Home Care and Self-Testing
  • Others

Point-of-Care Molecular Diagnostics Market by Geography

  • North America Point-of-Care Molecular Diagnostics Market
  • United States Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
  • Canada Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
  • Mexico Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
  • Europe Point-of-Care Molecular Diagnostics Market
  • Germany Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
  • United Kingdom Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
  • France Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
  • Italy Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
  • Spain Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
  • Rest of Europe Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
  • Asia-Pacific Point-of-Care Molecular Diagnostics Market
  • China Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
  • Japan Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
  • India Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
  • Australia Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
  • South Korea Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
  • Rest of Asia-Pacific Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
  • Rest of the World (RoW) Point-of-Care Molecular Diagnostics Market
  • Middle East Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
  • Africa Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
  • South America Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)

Key Takeaways from the Point-of-Care Molecular Diagnostics Market Report Study

  • Market size analysis for the current Point-of-Care molecular diagnostics market size (2025), and market forecast for 9 years (2026 to 2034).
  • Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures that happened over the last 3 years.
  • Key companies dominating the global Point-of-Care molecular diagnostics market.
  • Various opportunities available for competitors in the Point-of-Care molecular diagnostics market space.
  • What are the top-performing segments in 2025? How will these segments perform in 2034?
  • Which are the top-performing regions and countries in the current Point-of-Care molecular diagnostics market scenario?
  • Which are the regions and countries where companies should concentrate their opportunities for Point-of-Care molecular diagnostics market growth in the future?

Target audience who can benefit from this Point-of-Care molecular diagnostics market report study

  • Point-of-Care Molecular Diagnostics product providers
  • Research organizations and consulting companies
  • Point-of-Care Molecular Diagnostics-related organizations, associations, forums, and other alliances
  • Government and corporate offices
  • Start-up companies, venture capitalists, and private equity firms
  • Distributors and traders dealing in Point-of-Care molecular diagnostics
  • Various end-users who want to know more about the Point-of-Care molecular diagnostics market and the latest technological developments in the Point-of-Care molecular diagnostics market.

Frequently Asked Questions:

Q1. What is the growth rate of the Point-of-Care Molecular Diagnostics market?

The Point-of-Care Molecular Diagnostics market is projected to expand at a CAGR of 10.2% during the forecast period from 2026-2034.

Q2. What is the market size of the Point-of-Care Molecular Diagnostics market?

The Point-of-Care Molecular Diagnostics market is estimated at USD 6.20 billion in 2025 and is projected to reach USD 14.80 billion by 2034.

Q3. Which region dominates the Point-of-Care Molecular Diagnostics market?

North America dominated the Point-of-Care Molecular Diagnostics market with a 46% share of global revenue in 2025, supported by a dense base of manufacturers, advanced decentralized testing infrastructure, established FDA clearance and CLIA-waiver pathways, strong reimbursement, and a high burden of respiratory and sexually transmitted infections. Asia-Pacific is the fastest-growing region over the forecast period.

Q4. What are the key drivers of the Point-of-Care Molecular Diagnostics market?

The principal drivers are the rising global burden of infectious disease, with the World Health Organization estimating 374 million new curable sexually transmitted infections each year and 10.8 million tuberculosis cases in 2023; the shift toward rapid, near-patient, decentralized testing; the expansion of CLIA-waived syndromic multiplex panels and over-the-counter home molecular tests; and technological innovation in isothermal amplification, CRISPR-based detection, and instrument-free PCR, reinforced by antimicrobial stewardship priorities.

Q5. Who are the major players in the Point-of-Care Molecular Diagnostics market?

The major players include Danaher Corporation, F. Hoffmann-La Roche Ltd, Abbott Laboratories, bioMerieux SA, QIAGEN N.V., Becton, Dickinson and Company, Hologic, Inc., QuidelOrtho Corporation, Thermo Fisher Scientific Inc., and SD Biosensor, Inc., among other active manufacturers profiled in the Competitive Landscape section, along with specialized developers such as Visby Medical, Co-Diagnostics, and Molbio Diagnostics. Danaher's Cepheid leads in decentralized cartridge-based testing, while bioMerieux leads in point-of-care syndromic panels.

Table of Contents

1. Point-of-Care Molecular Diagnostics Market Report Introduction

  • 1.1 Scope of the Study
  • 1.2 Market Segmentation
  • 1.3 Market Assumptions

2. Point-of-Care Molecular Diagnostics Market Executive Summary

  • 2.1 Market at a Glance

3. Point-of-Care Molecular Diagnostics Market Key Factors Analysis

  • 3.1 Point-of-Care Molecular Diagnostics Market Drivers
    • 3.1.1 Rising Burden of Infectious Disease and Antimicrobial Resistance
    • 3.1.2 Demand for Rapid, Near-Patient, Decentralized Testing
    • 3.1.3 Expansion of CLIA-Waiver and Syndromic Multiplex Testing
    • 3.1.4 Emergence of Home and Over-the-Counter Molecular Testing
  • 3.2 Point-of-Care Molecular Diagnostics Market Restraints and Challenges
    • 3.2.1 High Cost per Test and Reimbursement Variability
    • 3.2.2 Regulatory Complexity and IVDR Transition
    • 3.2.3 Consumer-Pay and Operational Barriers
  • 3.3 Point-of-Care Molecular Diagnostics Market Opportunities
    • 3.3.1 CRISPR-Based and Instrument-Free Platforms
    • 3.3.2 Emerging-Market and Home Testing Expansion

4. Impact Analysis: AI, Geopolitical, Trade, and Economic Developments

5. Regulatory Analysis

  • 5.1 United States
  • 5.2 Europe
  • 5.3 Japan
  • 5.4 China

6. Point-of-Care Molecular Diagnostics Market Porter's Five Forces Analysis

  • 6.1 Bargaining Power of Suppliers
  • 6.2 Bargaining Power of Buyers
  • 6.3 Threat of New Entrants
  • 6.4 Threat of Substitutes
  • 6.5 Competitive Rivalry

7. Point-of-Care Molecular Diagnostics Market Assessment

  • 7.1 By Product
    • 7.1.1 Assays and Consumables
    • 7.1.2 Instruments and Analyzers
    • 7.1.3 Software and Services
  • 7.2 By Technology
    • 7.2.1 Real-Time PCR
    • 7.2.2 Isothermal Nucleic Acid Amplification
    • 7.2.3 CRISPR-Based Detection
    • 7.2.4 Microarray
    • 7.2.5 Sequencing-Based
    • 7.2.6 Others
  • 7.3 By Application
    • 7.3.1 Infectious Diseases
      • 7.3.1.1 Respiratory Infections
      • 7.3.1.2 Sexually Transmitted Infections
      • 7.3.1.3 Hospital-Acquired Infections
      • 7.3.1.4 Hepatitis and HIV
      • 7.3.1.5 Tuberculosis
    • 7.3.2 Oncology
    • 7.3.3 Genetic Testing
    • 7.3.4 Others
  • 7.4 By End User
    • 7.4.1 Hospitals and Critical Care Settings
    • 7.4.2 Physician Offices and Clinics
    • 7.4.3 Urgent Care and Ambulatory Centers
    • 7.4.4 Home Care and Self-Testing
    • 7.4.5 Others
  • 7.5 By Geography
    • 7.5.1 North America
      • 7.5.1.1 United States Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
      • 7.5.1.2 Canada Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
      • 7.5.1.3 Mexico Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
    • 7.5.2 Europe
      • 7.5.2.1 Germany Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
      • 7.5.2.2 United Kingdom Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
      • 7.5.2.3 France Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
      • 7.5.2.4 Italy Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
      • 7.5.2.5 Spain Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
      • 7.5.2.6 Rest of Europe Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
    • 7.5.3 Asia-Pacific
      • 7.5.3.1 China Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
      • 7.5.3.2 Japan Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
      • 7.5.3.3 India Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
      • 7.5.3.4 Australia Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
      • 7.5.3.5 South Korea Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
      • 7.5.3.6 Rest of Asia-Pacific Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
    • 7.5.4 Rest of World
      • 7.5.4.1 Middle East Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
      • 7.5.4.2 Africa Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)
      • 7.5.4.3 South America Point-of-Care Molecular Diagnostics Market Size in USD million (2023-2034)

8. Point-of-Care Molecular Diagnostics Market Competitive Landscape

  • 8.1 Market Concentration and Structure

9. Point-of-Care Molecular Diagnostics Market Startup Funding and Investment Trends

10. Point-of-Care Molecular Diagnostics Market Company and Product Profiles

  • 10.1 Danaher Corporation
    • 10.1.1 Company Overview
    • 10.1.2 Company Snapshot
    • 10.1.3 Financial Overview
    • 10.1.4 Product Portfolio
    • 10.1.5 Strategic Initiatives / Entropy
  • 10.2 F. Hoffmann-La Roche Ltd
    • 10.2.1 Company Overview
    • 10.2.2 Company Snapshot
    • 10.2.3 Financial Overview
    • 10.2.4 Product Portfolio
    • 10.2.5 Strategic Initiatives / Entropy
  • 10.3 Abbott Laboratories
    • 10.3.1 Company Overview
    • 10.3.2 Company Snapshot
    • 10.3.3 Financial Overview
    • 10.3.4 Product Portfolio
    • 10.3.5 Strategic Initiatives / Entropy
  • 10.4 bioMerieux SA
    • 10.4.1 Company Overview
    • 10.4.2 Company Snapshot
    • 10.4.3 Financial Overview
    • 10.4.4 Product Portfolio
    • 10.4.5 Strategic Initiatives / Entropy
  • 10.5 QIAGEN N.V.
    • 10.5.1 Company Overview
    • 10.5.2 Company Snapshot
    • 10.5.3 Financial Overview
    • 10.5.4 Product Portfolio
    • 10.5.5 Strategic Initiatives / Entropy
  • 10.6 Becton, Dickinson and Company
    • 10.6.1 Company Overview
    • 10.6.2 Company Snapshot
    • 10.6.3 Financial Overview
    • 10.6.4 Product Portfolio
    • 10.6.5 Strategic Initiatives / Entropy
  • 10.7 Hologic, Inc.
    • 10.7.1 Company Overview
    • 10.7.2 Company Snapshot
    • 10.7.3 Financial Overview
    • 10.7.4 Product Portfolio
    • 10.7.5 Strategic Initiatives / Entropy
  • 10.8 QuidelOrtho Corporation
    • 10.8.1 Company Overview
    • 10.8.2 Company Snapshot
    • 10.8.3 Financial Overview
    • 10.8.4 Product Portfolio
    • 10.8.5 Strategic Initiatives / Entropy
  • 10.9 Thermo Fisher Scientific Inc.
    • 10.9.1 Company Overview
    • 10.9.2 Company Snapshot
    • 10.9.3 Financial Overview
    • 10.9.4 Product Portfolio
    • 10.9.5 Strategic Initiatives / Entropy
  • 10.10 SD Biosensor, Inc.
    • 10.10.1 Company Overview
    • 10.10.2 Company Snapshot
    • 10.10.3 Financial Overview
    • 10.10.4 Product Portfolio
    • 10.10.5 Strategic Initiatives / Entropy

For illustrative purposes, only the top 10 companies are listed in the Table of Contents. The report may include analysis and references to additional companies where relevant to the market assessment.

11. KOL Views

12. Project Approach

13. About DelveInsight

14. Disclaimer and Contact Us

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