[시장보고서]미국의 체외진단(IVD) 시장(제6판)

미국의 체외진단(IVD) 시장(제6판)

In Vitro Diagnostics (IVD) in the United States, 6th Edition

상품코드 : 1884189

리서치사 : Kalorama Information

발행일 : 2025년 12월

페이지 정보 : 영문 127 Pages

라이선스 & 가격 (부가세 별도)

한글목차

샘플 요청 목록에 추가

'미국의 체외진단(IVD) 시장(제6판)'은 세계에서 가장 크고 가장 영향력 있는 체외진단(IVD) 시장에 대한 종합적인 분석을 제공합니다. 이 보고서는 미국의 IVD 산업에 대한 실용적인 지식을 요구하는 기업, 제조업체, 경영진, 마케팅 담당자 및 기타 주요 이해 관계자에게 필수적인 출처입니다. 미국의 IVD 시장은 진단 기술 혁신의 세계 인큐베이터 역할을 하며 세계 의료 기술 기준을 정하는 시장입니다.

2025년부터 2030년까지의 기간을 대상으로 하여, 주요 검사 카테고리, 기술, 주요 분석 항목별로 분류한, 달러화의 신뢰성이 높은 시장 추계·예측을 제공합니다. 모든 데이터는 제조업체의 수익을 기반으로 전략적 계획 수립의 정확성과 관련성을 보장합니다. 분석은 현행기술, 신흥이노베이션, 표준치료의 예측되는 변화를 반영함과 동시에 가치에 근거한 가격설정, 상환동향, 규제동향, 의료이용패턴 등 중요한 요소에도 언급하고 있습니다.

주요 특징은 다음과 같습니다.

시장 세분화 및 예측 : 임상 화학, 미생물학 및 바이러스학(분자진단 포함), PoC(Point-of-Care) 검사, 면역 측정, 응고, 조직학, 혈액학, 혈액 스크리닝 등에 대한 자세한 수익 예측
경쟁 구도 : Abbott, Roche, Siemens Healthineers, Danaher 및 기타 업계 리더를 포함한 미국 체외진단(IVD) 시장의 주요 기업 순위 및 프로파일
규제 및 정책 분석 : PAMA, SALSA, CARES 법이 상환에 미치는 영향, FDA의 실험실 개발 검사(LDT)에 관한 노력, AI 구동 진단 및 액체 생검에 관한 진화하는 틀에 대해.
시장 성장 촉진요인과 동향 : 맞춤형 의료, 동반진단, 원격 의료의 통합, 관세, 재택 및 소매 검사 채널의 대두
혁신 파이프라인 : 미래 성장을 형성하는 AI 대응 진단, 디지털 연결성, 차세대 분자 및 면역 측정 플랫폼

이 보고서의 조사 방법은 공개 데이터, 기업 공개 정보, 전문가 인터뷰, 독자 분석을 조합하여 투명성과 엄밀성을 확보하고 있습니다. 시장 예측에는 고유한 불확실성이 수반되지만, 가라올라 정보는 가장 합리적이고 검증된 기법을 적용하여 전략적 의사결정을 위한 신뢰성 높은 예측을 제공합니다.

미국과 체외 진단
미국 환자 인구
메디케어의 임상시험 - 상환 삭감과 시장 가격 설정
맞춤형 의료
임상 실무에 있어서 AI
액체 생검의 AI
미국의 체외진단(IVD) 시장에 대한 관세의 영향
원격 의료
원격 의료 eMed가 재택 검사 치료 프로그램을 도입
주목할만한 인수
임상 검사(LDT)
미국의 의료 인프라와 검사 채널
결론

제3장 미국의 체외진단(IVD) 시장 분석

임상 화학
미생물학과 바이러스학 - ID/AST와 분자
분자감염증
- 분자 감염증 검사의 최신 동향
- 최근 시장 동향
PoC(Point-of-Care) 검사
- 최근 동향
면역 측정
- 비감염성 질환 면역 측정
- 감염증 면역 측정
- 성감염증 검사의 최근 동향
분자 비감염성 질환 진단
응고
조직학
혈액학
혈액 검사, 분류, 형별
미국의 체외진단(IVD) 시장 전체
Abbott Laboratories
Becton Dickinson and Co
bioMerieux
Danaher Corporation
Dexcom, Inc
Exact Sciences
Hologic
Natera
QuidelOrtho
Roche Diagnostics
Siemens Healthineers
Thermo Fisher Scientific

KTH

영문 목차

영문목차

"In Vitro Diagnostics (IVD) in the United States, 6th Edition" provides a comprehensive analysis of the largest and most influential IVD market in the world. This report is an essential resource for companies, manufacturers, executives, marketers, and other key stakeholders seeking actionable insights into the U.S. IVD industry-a market that serves as a global incubator for diagnostic innovation and sets the standard for healthcare technologies worldwide.

Covering the period 2025-2030, the report delivers authoritative market size estimates and forecasts in U.S. dollars, segmented by major test categories, technologies, and leading analytes. All data are based on manufacturer revenues, ensuring accuracy and relevance for strategic planning. The analysis reflects current technologies, emerging innovations, and anticipated shifts in the standard of care, while addressing critical factors such as value-based pricing, reimbursement trends, regulatory developments, and healthcare utilization patterns.

Key features include:

Market Segmentation and Forecasts: Detailed revenue projections for clinical chemistry, microbiology and virology (including molecular diagnostics), point-of-care testing, immunoassays, coagulation, histology, hematology, blood screening, and more.
Competitive Landscape: Rankings and profiles of the top U.S. IVD market participants, including Abbott, Roche, Siemens Healthineers, Danaher, and other industry leaders.
Regulatory and Policy Analysis: Impact of PAMA, SALSA, and the CARES Act on reimbursement; FDA initiatives for laboratory-developed tests (LDTs); and evolving frameworks for AI-driven diagnostics and liquid biopsy.
Market Drivers and Trends: Personalized medicine, companion diagnostics, telehealth integration, tariffs, and the rise of at-home and retail testing channels.
Innovation Pipeline: AI-enabled diagnostics, digital connectivity, and next-generation molecular and immunoassay platforms shaping future growth.

The report's methodology combines publicly available data, company disclosures, expert interviews, and proprietary analysis, ensuring transparency and rigor. While market estimates involve inherent uncertainty, Kalorama Information applies the most rational and validated approach to deliver reliable projections for strategic decision-making.

Chapter 1: Executive Summary

About Kalorama Information
U.S. IVD Market
- Table 1-1: U.S. IVD Market, by Segment, 2025-2030 ($ million) [Blood Typing, Clinical Chemistry, Coagulation, Hematology, Histology, Microbiology - ID/AST, Molecular (Molecular Infectious Disease (with NAT & mass spec), Molecular - non-Infectious Disease), POC Diabetes (all), Immunoassay (Immunoassay Infectious Disease, Immunoassay non-Infectious), POC - Other, Others]
- Figure 1-1: IVD Market Segments, by Share of Total U.S. Market, 2025 (%) [Blood Grouping, Clinical Chemistry, Coagulation, Hematology, Histology, Microbiology - ID/AST, Microbiology - Molecular, Molecular - non-Infectious Disease, POC Diabetes, Immunoassay - Infectious, Immunoassay - Other, POC - Other, Others]
Top 12 U.S. IVD Market Participants and Rankings
- Table 1-2: Top 12 Companies - S. IVD Market Rankings, by Estimated US Revenue, 2025
Scope and Methodology
Conclusions

Chapter 2: Introduction to U.S. Health Care

The United States and In Vitro Diagnostics
U.S. Patient Population
- Healthcare System Utilization
- Aging
  - Figure 2-1: U.S. Projections of Older Adult Population, 2016-2060
- Disease Prevalence and Incidence
  - Table 2-1: U.S. Cancer Cases, 2025 Estimates
  - Table 2-2: Reported Cases of Selected Notifiable Diseases in the U.S., 2022
- U.S. Clinical Lab Expenditure
  - Table 2-3: U.S. Clinical Lab Market, by Channel by Share of Market, 2024 (%)
- Preventive Health Care
- Product Innovation from Value-Based Pricing
Clinical Testing under Medicare - Reimbursement Cuts and Market-Based Pricing
- PAMA
  - Table 2-4: Implemented and Proposed Clinical Diagnostic Laboratory Test Rates, 2020-2027
- Impact of CARES Act on PAMA
- Saving Access to Laboratory Service Act (SALSA)
- RESULTS Act
- Advanced Laboratory Tests (ADLT)
  - Table 2-5: List of Approved ADLTs, March 2025
Personalized Medicine
- Companion Diagnostics
  - Table 2-6: FDA Approved Companion Cancer Diagnostics, 2025
AI in Clinical Practice
- Table 2-7: Selected AI Market Cleared Tests
- Regulatory Pathway
AI in Liquid Biopsy
- Role of AI in Liquid Biopsy Interpretation
- Industry Leaders and Initiatives
- New Liquid Biopsy / AI Products in Development or Recently Launched
  - Table 2-8: Selected AI/Liquid Biopsy Initiatives
Effect of Tariffs on U.S. IVD Market
- Table 2-9: Selected Company Reported 2025 Impact
Telehealth
Telehealth eMed to Implement Home Test to Treat Program
Notable Acquisitions
- Table 2-10: Notable Selected Second Half 2025 US Company Acquisitions
Laboratory-Developed Tests (LDTs)
- FDA
U.S. Healthcare Infrastructure and Testing Channels
- Hospitals
- Independent Labs
- Physician Office Laboratories
- At-Home Testing
- Home Collection Trend
  - Table 2-11: Worldwide Home Collection Test Kit Market*, by Category, 2025 (% Estimated Share) [Cholesterol, Drug of Abuse, Fertility Testing, Genetic, Infectious Disease (COVID-19, STDs, HIV, etc.), Tumor DNA Markers, Other (Hormone, Allergies, HbA1c, Heavy Metals, etc.)]
  - Table 2-12: Selected Molecular Tests EUAs for Home Collection SARS-CoV-2 Tests
- Retail Clinics
Conclusions

Chapter 3: U.S. IVD Market Analysis

Clinical Chemistry
- Table 3-1: U.S. Clinical Chemistry Market, 2025-2030 ($ million) [Blood Gases, General Chemistry, Urinalysis]
- Figure 3-1: U.S. Clinical Chemistry Market, 2025 and 2030 ($ million)
Microbiology and Virology - ID/AST and Molecular
- Table 3-2: U.S. ID/AST Microbiology Market, 2025-2030 ($ million) [Auto ID/AST Systems, Blood Culture, Chromogenic Media, Manual ID/AST Systems, Rapid Micro]
- Figure 3-2: U.S. ID/AST Microbiology Market, 2025 and 2030 ($ million)
Molecular Infectious Disease
- Table 3-3: U.S. Molecular Infectious Disease, Market Distribution Estimates, by Segment, 2025-2030 (%) [GC/Chlamydia, HAI (c. diff, sepsis, MRSA, VRE, others), Hepatitis, HIV, Mycobacteria/TB, Other Microbiology, Respiratory (including COVID-19)]
- Figure 3-3: U.S. Molecular Microbiology/Virology Market Distribution Estimates, by Segment, 2025 (%) [GC/Chlamydia, HAI (c. diff, sepsis, MRSA, VRE, others), Hepatitis, HIV, Mycobacteria/TB, Other Microbiology, Respiratory (including COVID-19)]
- Leading Trends in Molecular Infectious Disease Testing
- Recent Market Developments
Point-of-Care Testing
- Recent Developments
  - Table 3-4: U.S. Point-of-Care (POC) Diagnostics Markets, 2025 and 2030 ($ million) [Blood & Electrolytes, Cancer Tumor Marker, Cardiac Markers, Coagulation, Drugs of Abuse, FOB, Glucose incl. HbA1c, CGM, Infectious Disease, Lipid, Pregnancy & Fertility, Urine, Miscellaneous]
  - Figure 3-4: U.S. Point-of-Care (POC) Diabetes Market, 2025 and 2030 ($ million)
  - Figure 3-5: U.S. Point-of-Care (POC) Market without Diabetes, 2025 and 2030 ($ million)
Immunoassays
- Non-Infectious Disease Immunoassay
  - Table 3-5: S. Immunoassays Market - non-Infectious Disease, 2025-2030 ($ million) [Allergy, Anemia, Autoimmune, Cardiac Markers, Fertility, HbA1c, Proteins, Therapeutic Drugs, Thyroid, Tumor Markers, Vitamin D, Others]]
  - Figure 3-6: S. Immunoassays Market - non-Infectious Disease, 2025 and 2030 ($ million)
- Infectious Disease Immunoassay
  - Table 3-6: U.S. Immunoassays Market - Infectious Disease, 2025-2030 ($ million) [HAIs/Sepsis, Hepatitis, HIV, Respiratory (including COVID-19), STDs, ToRCH, Others]
  - Figure 3-7: U.S. Immunoassays Market - Infectious Disease, 2025 and 2030 ($ million)
- Recent Developments in STD Testing
Molecular Non-Infectious Disease Diagnostics
- Figure 3-8: U.S. Molecular - non-Infectious Disease Revenues, 2025 and 2030 ($ million)
Coagulation
- Table 3-7: U.S. Coagulation Diagnostics Market, by Segment, 2025-2030 ($ million) [Molecular-lab Thrombophilia SNPs, PT/INR, D-Dimer]
- Figure 3-9: U.S. Coagulation Diagnostics Market, 2025 and 2030 ($ million)
Histology
- Table 3-8: U.S. Histology/Cytology IVD Market, by Segment, 2025-2030 ($ million) [HPV Molecular, Immunohistochemistry, in situ Hybridization, Pap Tests, Traditional non-Pap Stains]
- Figure 3-10: U.S. Histology and Cytology Diagnostics Market, 2025 and 2030 ($ million)
Hematology
- Table 3-9: U.S. Lab-based Hematology Market, by Analyte, 2025-2030 ($ million) [CBC, Hemoglobin, Other]
- Figure 3-11: U.S. Hematology Diagnostics Market, 2025 and 2030 ($ million)
Blood Screening, Grouping and Typing
- Table 3-10: U.S. Blood Screening and Grouping/Typing, by Segment, 2025-2030 ($ million) [ABO Grouping/Typing, Screening]
- Figure 3-12: U.S. Blood Grouping and Typing Diagnostics Market, 2025 and 2030 ($ million)
- Figure 3-13: U.S. Blood Screening Diagnostics Market, 2025 and 2030 ($ million) [Immunoassay Blood Screening, Molecular (NAT) Blood Screening]
Total U.S. IVD Market
- Table 3-11: U.S. IVD Market including COVID-19, by Segment, 2025-2030 ($ million) [Blood Typing, Clinical Chemistry, Coagulation, Hematology, Histology, Microbiology - ID/AST, Molecular (Molecular Infectious Disease (with NAT & mass spec), Molecular - non-Infectious Disease), POC Diabetes (all), Immunoassay (Immunoassay Infectious Disease, Immunoassay non-Infectious), POC - Other, Others]
- Figure 3-14: IVD Market Segments, by Share of Total U.S. Market, 2025 (%) [Blood Grouping, Clinical Chemistry, Coagulation, Hematology, Histology, Microbiology - ID/AST, Microbiology - Molecular, Molecular - non-Infectious Disease, POC Diabetes, Immunoassay - Infectious, Immunoassay - Other, POC - Other, Others]
- Table 3-12: Top 12 U.S. IVD Competitor Revenues, 2025 ($ million) Estimated
Abbott Laboratories
Becton Dickinson and Co
bioMerieux
Danaher Corporation
Dexcom, Inc
Exact Sciences
Hologic
Natera
QuidelOrtho
Roche Diagnostics
Siemens Healthineers
Thermo Fisher Scientific