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세계의 니어 페이션트 분자 솔루션 시장 보고서(2025년)
Near-Patient Molecular Solutions Global Market Report 2025
상품코드 : 1889517
리서치사 : The Business Research Company
발행일 : On Demand Report
페이지 정보 : 영문 250 Pages
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한글목차

최근 수년간 니어 페이션트 분자 솔루션 시장 규모는가 급속히 확대되고 있습니다. 2024년 41억 3,000만 달러에서 2025년에는 45억 4,000만 달러로, CAGR 10.0%로 성장하였습니다. 지금까지의 성장은 감염증의 신속 진단에 대한 수요 증가, 전염병의 확산, 분산형 의료 제공에 대한 주목의 고조, 공중 위생 시스템 내에서의 포인트 오브 케어 검사 프로그램의 급증, 저중소득국에서의 의료 접근성 확대, 조기 질환 발견에 대한 의식 향상 등이 요인이었습니다.

니어 페이션트 분자 솔루션 시장 규모는 향후 수년간 강력한 성장이 예상됩니다. 2029년에는 66억 5,600만 달러에 이르고 CAGR은 9.6%를 나타낼 전망입니다. 예측기간의 성장은 만성질환과 신흥감염증 증가, 정밀 의료 및 맞춤 의료의 보급 확대, 1차 의료 네트워크와 니어 페이션트 검사의 통합 진전, 진단 인프라 강화를 목적으로 한 정부 시책의 급증, 지역 및 가정 기반 검사 모델의 확대, 진단 접근성 확대를 지지하는 의료 지출 증가에 의해 견인될 전망입니다. 예측 기간의 주요 동향으로는 마이크로플루이딕스 카트리지 설계의 기술적 진보, 다중 분자 분석 플랫폼의 진전, 샘플에서 결과를 즉시 제공하는 휴대용 분석 장치의 혁신, 연결 기능을 갖춘 데이터 보고 시스템의 개발, 현장 사용을 위한 시약의 소형화에 관한 연구 개발, 완전 자동화된 니어 페이션트 분자 워크플로의 혁신 등을 들 수 있습니다.

향후 수년간, 가정용 포인트 오브 케어 기기에 대한 수요 증가가 니어 페이션트 분자 솔루션 시장의 성장을 견인할 것으로 예측됩니다. 이러한 가정용 포인트 오브 케어 기기는 환자나 비검사실 직원이 가정 또는 주변에서 조작하는 진단 검사 시스템이며, 기존 중앙 검사실 외부 및 진료 현장에 가까운 장소에서 검체 채취, 분석, 결과 해석을 가능하게 합니다. 가정용 포인트 오브 케어 기기의 보급 확대는 종래의 의료 환경을 넘어 편리하고 빠르며 접근하기 쉬운 건강 모니터링을 소비자가 요구하는 경향에 뒷받침되고 있습니다. 니어 페이션트 분자 솔루션은 표준 검사 환경 밖에서 사용하기에 적합한 정확하고 신속하며 휴대 가능한 분자 솔루션을 제공함으로써 이러한 장비를 보완합니다. 예를 들어, 2023년 2월 미국 식품의약국(FDA)이 발표한 최신 COVID-19 검사 정보에 따르면 분자 처방전 가정용 검사 키트에 대해 1건, 항원 처방전 가정용 검사 키트에 대해 2건, 항원 시판(OTC) 가정용 검사 키트에 대해 26건, 분자 OTC 가정용 검사 키트에 대해 4건의 긴급 승인을 허가했습니다. 따라서, 가정용 포인트 오브 케어 기기에 대한 수요 증가가 니어 페이션트 분자 솔루션 시장의 성장에 기여하고 있습니다.

니어 페이션트 분자 솔루션 시장의 주요 기업은 검사 효율, 휴대성 및 진단 정확도를 향상시키기 위해 등온 핵산 증폭 방법과 같은 첨단 기술의 통합에 주력하고 있습니다. 등온 핵산 증폭법은 표적 핵산 서열을 일정 온도에서 증폭시키는 분자 기술이며, 종래의 중합효소 연쇄반응(PCR)법에 사용되는 써멀 사이클링을 필요로 하지 않습니다. 이를 통해 빠르고 민감하며 컴팩트한 분자 검사가 가능합니다. 예를 들어, 2023년 6월에는 분자를 전문으로 하는 미국 의료 기술 기업 큐헬스사가 Cue COVID-19 분자 검사 키트에 대해 FDA로부터 판매 승인을 받았습니다. 등온 증폭 기술을 사용한 해당 진단 기기는 SARS-CoV-2 RNA의 가정 및 진료 현장에서의 검출을 목적으로 설계되어 있습니다. 시스템에는 일회용 카트리지, 블루투스 지원 리더, 검사 절차를 안내하고 약 20분 내에 결과를 제공하는 모바일 앱이 포함됩니다. Cue COVID-19 분자 검사는 정확한 분자 접근성 향상, 결과 보고 시간 단축, 전통적인 실험실 환경 밖에서의 실시간 건강 판단을 촉진합니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향과 전략

제4장 시장 : 금리, 인플레이션, 지정학, 무역전쟁과 관세, 코로나 및 회복이 시장에 미치는 영향을 포함한 거시경제 시나리오

제5장 세계의 성장 분석과 전략 분석 프레임워크

제6장 시장 세분화

제7장 지역별 및 국가별 분석

제8장 아시아태평양 시장

제9장 중국 시장

제10장 인도 시장

제11장 일본 시장

제12장 호주 시장

제13장 인도네시아 시장

제14장 한국 시장

제15장 서유럽 시장

제16장 영국 시장

제17장 독일 시장

제18장 프랑스 시장

제19장 이탈리아 시장

제20장 스페인 시장

제21장 동유럽 시장

제22장 러시아 시장

제23장 북미 시장

제24장 미국 시장

제25장 캐나다 시장

제26장 남미 시장

제27장 브라질 시장

제28장 중동 시장

제29장 아프리카 시장

제30장 경쟁 구도와 기업 프로파일

제31장 기타 주요 기업 및 혁신 기업

제32장 세계 시장의 경쟁 벤치마킹과 대시보드

제33장 주요 인수합병(M&A)

제34장 최근 시장 동향

제35장 시장 잠재력이 높은 국가, 전략

제36장 부록

CSM
영문 목차

영문목차

Near-patient molecular solutions are diagnostic tests that use molecular biology methods, such as deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) detection, and are performed at or near the point of care. These tests analyze small biological samples on-site rather than sending them to a central laboratory, enabling rapid and accurate identification of pathogens or biomarkers using portable or simplified instruments. By providing quick and reliable results in outpatient, emergency, or remote environments, they support timely treatment decisions and improved health outcomes.

The key product types of near-patient molecular solutions include infectious disease testing kits, urinalysis testing kits, tumor or cancer markers, pregnancy and fertility tests, hematology testing kits, glucose monitoring kits, drugs-of-abuse testing kits, coagulation monitoring kits, cardiometabolic monitoring kits, and others. Infectious disease testing kits are diagnostic tools designed to quickly detect and identify pathogens such as bacteria, viruses, or parasites in patient samples to support prompt diagnosis and treatment. The different technologies used include polymerase chain reaction (PCR)-based methods, genetic sequencing-based methods, and hybridization-based techniques, and they serve various end users such as hospitals and clinics, ambulatory care centers, research laboratories, home care settings, and others.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the healthcare sector, particularly in the supply of critical medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are facing higher costs for imported surgical instruments, imaging equipment, and consumables such as syringes and catheters, many of which have limited domestic alternatives. These increased costs are straining healthcare budgets, leading some providers to delay equipment upgrades or pass on expenses to patients. Additionally, tariffs on raw materials and components are disrupting the production of essential drugs and devices, causing supply chain bottlenecks. In response, the industry is diversifying sourcing strategies, boosting local manufacturing where possible, and advocating for tariff exemptions on life-saving medical products.

The near-patient molecular solutions market research report is one of a series of new reports from The Business Research Company that provides near-patient molecular solutions market statistics, including the near-patient molecular solutions industry global market size, regional shares, competitors with the near-patient molecular solutions market share, detailed near-patient molecular solutions market segments, market trends, and opportunities, and any further data you may need to thrive in the near-patient molecular solutions industry. This near-patient molecular solutions market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenarios of the industry.

The near-patient molecular solutions market size has grown rapidly in recent years. It will grow from $4.13 billion in 2024 to $4.54 billion in 2025 at a compound annual growth rate (CAGR) of 10.0%. The growth in the historic period resulted from increasing demand for rapid infectious disease diagnosis, rising prevalence of communicable diseases, growing focus on decentralized healthcare delivery, a surge in point-of-care testing programs within public health systems, expansion of healthcare access in low- and middle-income countries, and rising awareness of early disease detection.

The near-patient molecular solutions market size is expected to see strong growth in the next few years. It will grow to $6.656 billion in 2029 at a compound annual growth rate (CAGR) of 9.6%. The growth in the forecast period will be driven by the increasing burden of chronic and emerging infectious diseases, rising adoption of precision and personalized medicine approaches, growing integration of near-patient testing into primary care networks, a surge in government initiatives aimed at strengthening diagnostic infrastructure, expansion of community- and home-based testing models, and rising healthcare expenditure supporting broader diagnostic accessibility. Major trends in the forecast period include technological advancements in microfluidic cartridge design, progress in multiplex molecular assay platforms, innovations in sample-to-answer portable analyzers, developments in connectivity-enabled data reporting systems, research and development in reagent miniaturization for field use, and innovations in fully automated near-patient molecular workflows.

Growing demand for home-based point-of-care devices is anticipated to drive the expansion of the near-patient molecular solutions market in the coming years. These home-based point-of-care devices are diagnostic testing systems operated by patients or non-laboratory users at or near their homes, allowing sample collection, analysis, or result interpretation outside a conventional central laboratory and close to the site of care. The increasing popularity of home-based point-of-care devices is fueled by consumer preference for convenient, rapid, and accessible health monitoring beyond traditional healthcare settings. Near-patient molecular solutions complement these devices by delivering accurate, fast, and portable molecular diagnostics suitable for use outside standard laboratory environments. For example, in February 2023, the US Food & Drug Administration (FDA) reported in its COVID-19 testing update that it had issued one Emergency Use Authorization (EUA) for a molecular prescription at-home test, two EUAs for antigen prescription at-home tests, 26 EUAs for antigen over-the-counter (OTC) at-home tests, and four EUAs for molecular OTC at-home tests. As a result, the rising demand for home-based point-of-care devices is contributing to the growth of the near-patient molecular solutions market.

Key players in the near-patient molecular solutions market are focusing on integrating advanced technologies, such as isothermal nucleic acid amplification, to improve testing efficiency, portability, and diagnostic accuracy. Isothermal nucleic acid amplification is a molecular diagnostic technique that amplifies target nucleic acid sequences at a constant temperature, eliminating the need for thermal cycling used in conventional polymerase chain reaction (PCR) methods. This enables rapid, sensitive, and compact molecular testing. For instance, in June 2023, Cue Health Inc., a US-based healthcare technology company specializing in molecular diagnostics, received FDA marketing authorization for the Cue COVID-19 Molecular Test. This isothermal amplification-based diagnostic device is designed for at-home and point-of-care detection of SARS-CoV-2 RNA. The system includes a single-use cartridge, a Bluetooth-enabled reader, and a mobile app that guides users through testing and provides results in approximately 20 minutes. The Cue COVID-19 Molecular Test enhances access to accurate molecular diagnostics, shortens turnaround time, and facilitates real-time health decision-making outside traditional laboratory settings.

In July 2024, Roche Holding AG, a Switzerland-based provider of in-vitro diagnostics and pharmaceuticals, acquired LumiraDx's point-of-care (POC) technology business for $353.5 million. This acquisition gives Roche access to LumiraDx's portable, multi-assay diagnostic platform, strengthening its decentralized and near-patient testing capabilities, expanding its presence in primary care and community settings, and improving the delivery of rapid, reliable diagnostic results outside conventional laboratories. LumiraDx Group Limited, a UK-based provider of next-generation point-of-care diagnostics, is recognized for its compact instrument that integrates immunoassay, clinical chemistry, and emerging molecular testing capabilities for near-patient applications.

Major companies operating in the near-patient molecular solutions market are Bosch Healthcare Solutions GmbH, Roche Holding AG, Thermo Fisher Scientific Inc., Abbott Laboratories, Danaher Corporation, Siemens Healthineers AG, Hologic Inc., bioMerieux SA, Sysmex Corporation, QuidelOrtho Corporation, QIAGEN NV, DiaSorin SpA, OraSure Technologies Inc., Molbio Diagnostics Pvt Ltd, Cue Health Inc., Biocartis Group NV, Vela Diagnostics Pte Ltd, Co-Diagnostics Inc., Hyris Ltd, Genedrive plc.

North America was the largest region in the near-patient molecular solutions market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in near-patient molecular solutions report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the near-patient molecular solutions market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The near-patient molecular solutions market consists of sales of sample preparation devices, nucleic acid extraction kits, portable molecular analyzers, isothermal amplification kits, microfluidic cartridges, and multiplex detection panels. Values in this market are 'factory gate' values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

Near-Patient Molecular Solutions Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses on near-patient molecular solutions market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.

Reasons to Purchase

Where is the largest and fastest growing market for near-patient molecular solutions ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The near-patient molecular solutions market global report from the Business Research Company answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.

Scope

Table of Contents

1. Executive Summary

2. Near-Patient Molecular Solutions Market Characteristics

3. Near-Patient Molecular Solutions Market Trends And Strategies

4. Near-Patient Molecular Solutions Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Trade Wars and Tariffs, And Covid And Recovery On The Market

5. Global Near-Patient Molecular Solutions Growth Analysis And Strategic Analysis Framework

6. Near-Patient Molecular Solutions Market Segmentation

7. Near-Patient Molecular Solutions Market Regional And Country Analysis

8. Asia-Pacific Near-Patient Molecular Solutions Market

9. China Near-Patient Molecular Solutions Market

10. India Near-Patient Molecular Solutions Market

11. Japan Near-Patient Molecular Solutions Market

12. Australia Near-Patient Molecular Solutions Market

13. Indonesia Near-Patient Molecular Solutions Market

14. South Korea Near-Patient Molecular Solutions Market

15. Western Europe Near-Patient Molecular Solutions Market

16. UK Near-Patient Molecular Solutions Market

17. Germany Near-Patient Molecular Solutions Market

18. France Near-Patient Molecular Solutions Market

19. Italy Near-Patient Molecular Solutions Market

20. Spain Near-Patient Molecular Solutions Market

21. Eastern Europe Near-Patient Molecular Solutions Market

22. Russia Near-Patient Molecular Solutions Market

23. North America Near-Patient Molecular Solutions Market

24. USA Near-Patient Molecular Solutions Market

25. Canada Near-Patient Molecular Solutions Market

26. South America Near-Patient Molecular Solutions Market

27. Brazil Near-Patient Molecular Solutions Market

28. Middle East Near-Patient Molecular Solutions Market

29. Africa Near-Patient Molecular Solutions Market

30. Near-Patient Molecular Solutions Market Competitive Landscape And Company Profiles

31. Near-Patient Molecular Solutions Market Other Major And Innovative Companies

32. Global Near-Patient Molecular Solutions Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Near-Patient Molecular Solutions Market

34. Recent Developments In The Near-Patient Molecular Solutions Market

35. Near-Patient Molecular Solutions Market High Potential Countries, Segments and Strategies

36. Appendix

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