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市場調查報告書
商品編碼
1759875
核酸增幅檢查(NAAT)的世界市場規模,趨勢,預測(2025年~2033年)Global Nucleic Acid Amplification Testing (NAAT) Market Size, Trends & Forecast 2025-2033 |
核酸擴增檢測 (NAAT) 市場規模及預測
全球核酸擴增檢測 (NAAT) 市場規模預計將從 2024 年的 86.6 億美元增至 2033 年的 237.9 億美元,2025 年至 2033 年的複合年增長率為 11.88%。對癌症、傳染病和遺傳疾病快速且準確診斷的需求日益增長,推動著市場的發展。 PCR 檢測已被廣泛應用,尤其是在新冠疫情期間,這加速了 NAAT 技術的部署。
核酸擴增檢測 (NAAT) 市場的關鍵成長動力
向即時偵測 (POCT) 的轉變
向即時檢測 (POCT) 的轉變正在徹底改變診斷環境,因為它可以在診所、機場和偏遠地區等分散的地點進行快速的現場檢測。這一趨勢的驅動力在於,人們需要更快、更準確地獲得診斷結果,而無需承受中心實驗室處理的延遲。像 Cepheid 這樣的公司正在開發小巧易用的診斷系統。
例如,Cepheid 於 2024 年 9 月宣布了一款新的概念驗證系統,該系統可快速檢測包括呼吸道病毒在內的多種疾病,旨在簡化初級保健和急診環境中的分子診斷。
隨著科技的發展,POCT 在醫療保健領域的應用預計將變得越來越重要,有助於遏制傳染病的傳播並改善病患照護。
邁向高通量系統和自動化
隨著實驗室尋求提高生產力、減少人為錯誤並擴大營運規模以滿足高檢測量,NAAT 對自動化和高通量技術的需求日益增長。透過整合樣本製備、擴增和分析步驟,全自動系統可以優化工作流程,並提供快速的周轉時間和可靠的結果。
為了進一步提高通量,各公司正大力投資開發能夠同時處理多個樣本的先進機器人設備和軟體。
例如,漢密爾頓公司於 2023 年 2 月推出了 Microlab STAR 自動化液體處理系統。該系統旨在支援高通量工作流程,並提高分子診斷實驗室樣本處理的準確性和效率。
科技發展
由於技術進步,這些診斷設備的性能和可近性得到了顯著提高,這是全球市場成長的主要因素。擴增技術的進步,包括環介導等溫擴增 (LAMP) 和快速聚合酶鍊式反應 (PCR),顯著提高了檢測速度和效率,從而可以更快地做出診斷和治療決策。
例如,Bio-Rad Laboratories 於 2023 年 8 月推出了 ddPCR(數位液滴 PCR)技術,顯著提高了識別低豐度核酸的靈敏度和準確性,提升了分子診斷的潛力。該技術於 2024 年 7 月推出。
透過實現遠端監控和即時數據共享,與遠距醫療平台和數據分析等數位健康解決方案的整合將進一步增強這些檢測的實用性並推動市場擴張。
核酸擴增檢測 (NAAT) 市場的課題
設備和偵測成本高
核酸擴增檢測 (NAAT) 廣泛實施的一個主要障礙是其成本高昂,尤其是在中低收入地區。先進的核酸擴增檢測 (NAAT) 技術需要昂貴的設備和符合嚴格品質要求的特定試劑。此外,這些系統通常需要高技能的人員和設備齊全的實驗室才能運作。這些資金基礎設施需求對於規模較小的醫療機構和資源有限的地區來說可能是個負擔。因此,儘管 NAAT 具有很高的靈敏度和特異性,但在世界許多地方尚未普及。這些成本障礙不僅阻礙了快速診斷和治療,還影響了某些檢測的使用,導致醫療保健服務和結果的不公平。
本報告提供全球核酸增幅檢查(NAAT)市場相關調查,成長推動因素與課題,各市場區隔的分析,主要企業的分析等資訊。
Nucleic Acid Amplification Testing Market Size and Forecast
Nucleic Acid Amplification Testing Market is expected to reach US$ 23.79 billion by 2033 from US$ 8.66 billion in 2024, with a CAGR of 11.88% from 2025 to 2033. The growing need for quick and precise diagnostics in cancer, infectious illnesses, and genetic disorders is propelling the market. PCR-based tests have been widely used, particularly during the COVID-19 epidemic, which has accelerated the deployment of NAAT technology.
Nucleic Acid Amplification Testing Global Market Report by Type (Polymerase Chain Reaction (PCR) Tests, Isothermal Nucleic Acid Amplification Technology (INAAT) Tests, Ligase Chain Reaction (LCR) Tests), Application (Infectious Disease Testing, Oncology Testing, Others), End Use (Central & Reference Laboratories, Hospitals, Others), Countries and Company Analysis, 2025-2033.
Global Nucleic Acid Amplification Testing Industry Overview
The market is growing as a result of increased R&D expenditures for creating innovative biotechnology diagnostic methods and rising demand for sophisticated fast diagnostics. Additionally, the need for various nucleic acid amplification testing methods has been driven by the rising frequency of infectious illnesses worldwide and the requirement for highly effective testing options to effectively control disease outbreaks. The need for quick and precise diagnostic techniques, including nucleic acid amplification, to identify the SARS-CoV-2 virus has grown as a result of COVID-19. To satisfy the strong demand for quick and point-of-care testing, major market participants have created novel product offerings, such as tests based on isothermal nucleic acid amplification technology.
For example, Abbott Laboratories' Abbott ID NOW COVID-19 test, which can provide positive findings in five minutes and negative results in thirteen, was granted Emergency Use Authorization (EUA) in March 2020. It is anticipated that these pandemic-driven strategic efforts would accelerate market expansion in the near future.
New opportunities for market expansion are being created by emerging infectious illnesses like the monkeypox virus. The introduction and regulatory approval of nucleic acid amplification test items for certain illnesses is proof of this. For example, Quest Diagnostics was granted the Emergency Use Authorization (EUA) by the U.S. FDA in September 2022 for their Quest Monkeypox PCR test, which was introduced in July 2022. Likewise, Todos Medical Ltd. commercially introduced their Monkey Pox PCR-based diagnostic in the United States in August 2022. Therefore, it is anticipated that these new infections would accelerate market expansion.
Key Factors Driving the Nucleic Acid Amplification Testing Market Growth
Shift toward point-of-care testing
By facilitating quick, on-site testing at dispersed locations like clinics, airports, and distant places, the move toward point-of-care testing is revolutionizing the diagnostic environment. The need for faster, more precise findings without the delays of central lab processing is what is driving this trend. Businesses like as Cepheid are developing small, easy-to-use systems.
For example, Cepheid introduced a new proof of concept system in September 2024 that offers quick findings for a variety of diseases, including respiratory viruses, and aims to streamline molecular diagnostics in primary care and emergency situations.
The use of point-of-care NAAT in healthcare settings is expected to become increasingly important as technology develops, helping to reduce the spread of infectious illnesses and improve patient care.
Transition to high-throughput systems and automation
As labs look to increase productivity, reduce human error, and scale operations to meet high test numbers, there is a growing need for automation and high-throughput technologies in NAAT. By combining the procedures for sample preparation, amplification, and analysis, fully automated systems optimize workflows and provide quicker turnaround times and more reliable findings.
To further increase throughput, businesses are making large investments in creating sophisticated robotic equipment and software that can handle several samples at once.
For example, Hamilton unveiled the Microlab STAR automated liquid handling system in February 2023. This system is intended to support high-throughput workflows, enhancing the accuracy and efficiency of sample processing in molecular diagnostics labs.
Developments in technology
The performance and accessibility of these diagnostic instruments are greatly improved by technological improvements, which are a major factor in the worldwide market's growth. Faster diagnostic and treatment decisions are now possible thanks to advancements in amplification techniques including loop-mediated isothermal amplification (LAMP) and fast polymerase chain reaction (PCR), which have significantly increased test speed and efficiency.
As an illustration, Bio-Rad Laboratories introduced ddPCR (digital droplet PCR) technology in August 2023, which greatly increases sensitivity and precision in identifying low-abundance nucleic acids and advances the potential of molecular diagnostics. This technology was introduced in July 2024.
By enabling remote monitoring and real-time data sharing, this integration with digital health solutions-such as telehealth platforms and data analytics-further increases the usefulness of these tests and propels market expansion.
Challenges in the Nucleic Acid Amplification Testing Market
High Cost of Equipment and Tests
One major obstacle to wider implementation of nucleic acid amplification testing (NAAT) is its high cost, especially in low- and middle-income areas. Expensive equipment and specific reagents that must adhere to strict quality requirements are needed for advanced NAAT technologies. Furthermore, these systems frequently require highly skilled workers and a well-equipped laboratory setting to function. Smaller healthcare facilities and locations with limited resources may find these financial and infrastructure requirements onerous. Because of this, even though NAAT has a high sensitivity and specificity, it is still not widely available in many regions of the world. This expense barrier contributes to inequities in healthcare delivery and results by impeding prompt diagnosis and treatment in addition to affecting the use of certain tests.
Complex Regulatory Landscape
It takes a lot of effort and resources to navigate the regulatory environment for nucleic acid amplification testing (NAAT). Strict standards for clinical validation, quality assurance, and performance testing are enforced by regulatory agencies, such as the FDA in the United States and the EMA in Europe. To prove accuracy, sensitivity, specificity, and repeatability under many circumstances, developers must submit copious amounts of data. These procedures frequently entail drawn-out clinical studies and thorough paperwork, which postpones market entrance and raises development costs dramatically. These requirements can be especially taxing on startups and smaller businesses. Global commercialization is further hampered by disparate foreign regulatory regulations. Public health results may be impacted by this disjointed and drawn-out approval procedure, which can impede innovation and limit patients' access to state-of-the-art diagnostic tools.
Nucleic Acid Amplification Testing Market Overview by Regions
Regional differences in the NAAT market include North America's superior healthcare systems, Europe's emphasis on innovation and regulation, Asia-Pacific's explosive expansion, and emerging nations' access and infrastructure issues. The following provides a market overview by region:
United States Nucleic Acid Amplification Testing Market
The market for nucleic acid amplification testing in the US is a crucial part of the country's diagnostic environment, which is distinguished by its sophisticated healthcare system and strong R&D environment. The diagnosis of viral illnesses, genetic abnormalities, and some types of cancer depends on NAAT approaches, such as polymerase chain reaction and isothermal amplification techniques. The rising incidence of infectious and chronic illnesses, the increased need for quick and precise diagnostics, and large expenditures in biotechnology and diagnostics are some of the reasons driving the market. Additionally, the United States enjoys robust reimbursement laws and a favorable regulatory environment, which support the broad implementation of NAAT across a range of healthcare settings, including as hospitals, diagnostic labs, and point-of-care facilities. This all-encompassing strategy highlights America's dominance in the worldwide NAAT business.
United Kingdom Nucleic Acid Amplification Testing Market
The nucleic acid amplification testing (NAAT) market in the United Kingdom represents a sizeable portion of the larger European diagnostics business. Integrating NAAT for a range of uses, such as genetic screening and infectious illness detection, has been made possible in large part by the UK's sophisticated healthcare system, which is headed by the National Health Service (NHS). The COVID-19 pandemic significantly sped up the use of NAAT, demonstrating its effectiveness in quick and precise diagnosis. This change has led to further expenditures in molecular diagnostics, which has improved testing capacity and encouraged innovation. Additionally, the UK's dedication to biotechnology research and development guarantees that NAAT technologies will continue to advance. The UK continues to lead NAAT developments, striking a balance between innovation and regulatory supervision to uphold high diagnostic standards as the need for customized treatment and early illness identification increases.
India Nucleic Acid Amplification Testing Market
The market for nucleic acid amplification testing (NAAT) in India is developing quickly due to rising healthcare expenditures and the rising prevalence of infectious disorders. Particularly since the pandemic, the nation has seen a sharp increase in testing due to the broad use of technologies like PCR and isothermal amplification techniques. Particularly in underprivileged areas, government programs like the National Tuberculosis Elimination Program have made it easier to include quick molecular tests like Truenat and CBNAAT into standard diagnostic procedures. Enhancing early illness diagnosis and expanding access to healthcare are the goals of these initiatives. The industry is expected to continue growing despite obstacles including high costs and inadequate infrastructure, thanks to continuous improvements in diagnostic technology and an emphasis on increasing testing capacities nationwide.
United Arab Emirates Nucleic Acid Amplification Testing Market
The market for nucleic acid amplification testing (NAAT) in the United Arab Emirates (UAE) is expanding quickly due to improvements in molecular diagnostics and higher healthcare spending. The UAE's healthcare system relies heavily on NAAT technologies, such polymerase chain reaction (PCR) and isothermal amplification techniques, which make it easier to identify genetic and infectious illnesses. The introduction of these tools was further pushed by the COVID-19 pandemic, underscoring their significance in public health response and surveillance. The incorporation of NAAT into clinical practice has been strengthened by government programs and collaborations with foreign healthcare professionals. The UAE is a leader in the regional molecular diagnostics market because of its dedication to innovation and high-quality healthcare, even in the face of obstacles like exorbitant costs and the requirement for specialized training.
Recent Developments in Nucleic Acid Amplification Testing Industry
Market Segmentations
Type
Application
End Use
Regional Outlook
North America
Europe
Asia Pacific
Latin America
Middle East & Africa
All the Key players have been covered