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市場調査レポート
商品コード
1759875
核酸増幅検査(NAAT)の世界市場の規模、動向、予測(2025年~2033年)Global Nucleic Acid Amplification Testing (NAAT) Market Size, Trends & Forecast 2025-2033 |
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核酸増幅検査(NAAT)の世界市場の規模、動向、予測(2025年~2033年) |
出版日: 2025年06月01日
発行: Renub Research
ページ情報: 英文 200 Pages
納期: 即日から翌営業日
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核酸増幅検査(NAAT)の市場規模と予測
世界の核酸増幅検査(NAAT)の市場規模は、2024年の86億6,000万米ドルから2033年までに237億9,000万米ドルに達すると予測され、2025年~2033年にCAGRで11.88%の成長が見込まれます。がん、感染症、遺伝性疾患における迅速かつ正確な診断に対するニーズの高まりが、市場を後押ししています。PCRベースの検査は、特にCOVID-19パンデミック中に広く使用されており、NAAT技術の展開を加速させています。
核酸増幅検査(NAAT)市場の主な成長促進要因
ポイントオブケア検査へのシフト
診療所、空港、遠方などの分散した場所での迅速なオンサイト検査を円滑化することで、ポイントオブケア検査への移行は診断環境に革命をもたらしています。中央検査室での処理に遅れることなく、より迅速で正確な所見を得たいというニーズが、この動向を後押ししています。Cepheidのような企業は、小型で使いやすいシステムを開発しています。
例えば、Cepheidは2024年9月に、呼吸器系ウイルスを含むさまざまな疾患に対して迅速な所見を提供する新しい概念実証システムを発表し、プライマリーケアや緊急事態における分子診断の合理化を目指しています。
医療現場におけるポイントオブケアNAATの使用は、技術の発展とともにますます重要になると予測され、感染症の蔓延を抑え、患者ケアの向上に寄与します。
ハイスループットシステムと自動化への移行
検査室が生産性の向上、ヒューマンエラーの削減、高い検査数を満たすための業務規模の拡大を目指す中、NAATにおける自動化とハイスループット技術へのニーズが高まっています。サンプル調製、増幅、分析の手順を組み合わせることで、全自動システムはワークフローを最適化し、迅速な納期と信頼性の高い所見を提供します。
スループットをさらに向上させるため、企業は複数のサンプルを一度に処理できる精巧なロボット装置やソフトウェアの開発に大規模な投資を行っています。
例えば、Hamiltonは2023年2月にMicrolab STAR自動リキッドハンドリングシステムを発表しました。このシステムは、ハイスループットワークフローをサポートし、分子診断検査室におけるサンプル処理の精度と効率を高めることを目的としています。
技術の発展
これらの診断装置の性能とアクセシビリティは、技術的な向上により大幅に改良されており、これが世界市場の成長の大きな要因となっています。ループ媒介等温増幅法(LAMP)や高速ポリメラーゼ連鎖反応(PCR)を含む増幅技術の進歩により、検査速度と効率が大幅に向上したため、より迅速な診断と治療の決定が可能になっています。
その一例として、Bio-Rad Laboratoriesは2023年8月にddPCR(デジタルドロップレットPCR)技術を導入し、低存在核酸の同定における感度と精度を大幅に向上させ、分子診断の可能性を前進させました。この技術は2024年7月に導入されました。
遠隔モニタリングとリアルタイムのデータ共有を可能にすることで、遠隔医療プラットフォームやデータアナリティクスなどのデジタルヘルスソリューションとの統合は、これらの検査の有用性をさらに高め、市場の拡大を促進します。
核酸増幅検査(NAAT)市場の課題
装置と検査の高いコスト
核酸増幅検査(NAAT)を広く実施する上で大きな障害となっているのが、特に低中所得地域におけるその高いコストです。先進のNAAT技術には、高価な装置と厳格な品質要件に従わなければならない特定の試薬が必要です。さらに、これらのシステムを機能させるためには、高度な技術を持った作業員と装置の整った検査室が必要になることが多いです。小規模な医療施設や資源が限られている場所では、こうした財政的インフラ要件が負担となる可能性があります。このため、NAATは感度と特異度が高いにもかかわらず、世界の多くの地域ではまだ広く普及していません。このような費用の障壁は、迅速な診断と治療を妨げるだけでなく、特定の検査の使用にも影響を与えるため、医療の提供や結果に不公平をもたらす一因となっています。
当レポートでは、世界の核酸増幅検査(NAAT)市場について調査し、成長促進要因と課題、各セグメントの分析、主要企業の分析などを提供しています。
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