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市場調查報告書
商品編碼
1470759
恒溫核酸增幅技術市場:按產品類型、應用和最終用戶分類 - 2024-2030 年全球預測Isothermal Nucleic Acid Amplification Technology Market by Product, Type, Application, End-User - Global Forecast 2024-2030 |
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恒溫核酸增幅技術市場規模預估2023年為37.7億美元,2024年達42.5億美元,預計2030年將達到92.2億美元,複合年成長率為13.64%。
恒溫核酸增幅技術在醫院、學術和研究機構中的使用越來越多,在這些機構中,可以在目標分子存在的情況下在恆溫下產生 DNA 或 RNA。等溫擴增過程比聚合酵素鏈鎖反應(PCR) 更有效率,具有更高的擴增產量和更少的樣本製備步驟。這種恒溫核酸增幅技術因其準確性和檢測多種分子的能力而被廣泛用作血液篩檢和感染疾病診斷中的分子檢測技術。此外,隨著抗菌藥物和感染疾病的傳播,檢測抗菌藥物抗藥性基因和包括細菌和病毒在內的各種病原體的需求也越來越大。然而,缺乏對恒溫核酸增幅的認知和嚴格的法律規範可能會限制其在最終用途領域的使用。恒溫核酸增幅技術的進步以及醫療保健監管機構對創新技術的核准預計將在市場上創造巨大的機會。
主要市場統計 | |
---|---|
基準年[2023] | 37.7億美元 |
預測年份 [2024] | 42.5億美元 |
預測年份 [2030] | 92.2億美元 |
複合年成長率(%) | 13.64% |
透過產品恒溫核酸增幅技術系統的進步擴展業務和工作流程自動化
測定、套件和試劑對於恒溫核酸增幅過程至關重要,為反應提供必要的生化物質。這些產品通常包括在恆溫下發揮作用的 DNA 和 RNA聚合酵素等酶、用於擴增的核苷酸、緩衝液以及確保擴增過程的特異性和保真度的其他試劑。在恒溫核酸增幅中,系統是指促進和監控擴增過程所需的儀器和設備。這些系統旨在維持等溫擴增所需的恆溫,通常包括即時監控擴增過程、自動資料分析和使用者友善介面等功能。相較之下,檢測、套件和試劑直接應用於技術的最終用途,對於日常業務和測試至關重要,並且通常是經常性支出。另一方面,該系統是執行這些測定的資本設備,提供等溫擴增過程的自動化和進階監控。
對於類型臨床診斷,轉錄介導的擴增由於其快速和高擴增潛力而越來越受到青睞。
解旋酶依賴性擴增可以輕鬆整合到簡單、節能的微系統中。幫助開發用於引子雜合反應和隨後透過 DNA聚合酵素進行引子延伸的單鏈模板。恒溫環型核酸擴增(LAMP)和核酸增幅檢查(NAAT)在恆溫和短反應時間下進行,用於篩檢和鑑定病原體以診斷基於病原體的感染疾病。轉錄介導的擴增也會從目標核酸產生 DNA 或 RNA放大器,這可用於檢測各種疾病,例如 HIV-1 和茲卡病毒。鏈置換擴增 (SDA) 用於擴增 DNA 和 RNA 等核酸。相較之下,LAMP 方法通常是首選,因為它簡單且適合照護現場診斷。同時,HDA、SDA等其他方法也因其獨特的優勢而被選擇。特定應用的選擇受到所需的靈敏度和特異性、檢測開發所需的專業知識以及設備和試劑資源的影響。
應用廣泛利用恒溫核酸增幅技術進行疾病診斷,改善患者預後
在血液篩檢中,恒溫核酸增幅技術(INAAT)對於檢測致病核酸以確保輸血安全至關重要。 INAAT 具有高靈敏度和特異性,可快速識別捐贈血液製品中的血源性病原體。在疾病診斷中,INAAT用於快速、準確地檢測各種病原體。該技術可用於整體感染疾病,以促進早期療育,從而改善患者的治療結果。 INAAT 可同時快速檢測披衣菌感染和淋病等性行為感染傳染病。 INAAT 可以直接從臨床檢體中檢測出來,無需複雜的處理步驟,大大增加了其在 STI篩檢中的效用。病毒性肝炎感染(特別是B型和C型肝炎)的識別對於慢性肝病的管理和感染預防至關重要。 INAAT 可檢測低水平的病毒遺傳物質,促進早期診斷並實現病毒量監測,這對於確定治療策略和評估治療反應至關重要。 INAAT 有利於早期 HIV 檢測,並且可以在血清轉換之前識別病毒。這在嬰兒檢測等情況下尤其重要,因為母源抗體可能會干擾傳統的愛滋病毒免疫測量。對於流感病毒引起的呼吸道疾病,INAAT 提供有效病例管理和感染控制所需的快速檢測,特別是在流感季節和爆發期間。相較之下,恒溫核酸增幅技術廣泛應用於疾病診斷,透過早期療育改善患者預後。
最終用戶:恒溫核酸增幅技術在醫院透過快速且準確的診斷改善患者照護發揮著重要作用。
學術研究機構利用INAAT進行基礎科學研究、研發以及分子層面上的各種疾病的研究。由於學術研究的獨特性,INAAT 需要高靈敏度、特異性和適應性,才能對研究檢體中的核酸進行詳細、準確的檢測。在醫院領域,INAAT有多種用途,包括感染疾病檢測、癌症診斷、遺傳疾病篩檢等。參考文獻實驗室是專門的診斷設施,可以執行各種複雜的測試,通常作為高通量 INAAT 應用的中心。我們為其他實驗室、醫院和診所提供服務,提供在較小環境下無法實現的先進測試。相較之下,學術和研究機構注重彈性和成本效率進行深入研究,而醫院則優先考慮快速診斷以快速治療患者。同時,參考實驗室依靠 INAAT 的高通量和可靠性來有效地服務各種外部客戶。
區域洞察
美洲是一個高度開拓的地區,其市場格局的特點是診斷程序的增加以及醫院和學術研究機構引入創新等溫核酸解決方案的增加。印度、泰國、新加坡、馬來西亞和韓國等亞太地區醫療基礎設施的發展和醫療旅遊的增加,正在擴大使用恒溫核酸增幅技術檢測病毒性疾病的需求。 2023年1月,北京大學報告稱,中國已有9億人感染冠狀病毒,實驗室和診斷中心擴大使用恒溫核酸增幅方法檢測SARS-CoV-2 RNA的情況將進一步增加。此外,感染疾病的日益普及以及政府改進診斷程序的努力正在擴大恒溫核酸增幅技術在歐洲、中東和非洲地區的使用。此外,醫療保健監管機構對創新診斷技術的核准不斷增加,預計將推動恒溫核酸增幅技術的全球成長。
FPNV定位矩陣
FPNV定位矩陣對於評估恒溫核酸增幅技術市場至關重要。我們檢視與業務策略和產品滿意度相關的關鍵指標,以對供應商進行全面評估。這種深入的分析使用戶能夠根據自己的要求做出明智的決策。根據評估,供應商被分為四個成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市場佔有率分析
市場佔有率分析是一種綜合工具,可以對恒溫核酸增幅技術市場供應商的現狀進行深入而詳細的研究。全面比較和分析供應商在整體收益、基本客群和其他關鍵指標方面的貢獻,以便更好地了解公司的績效及其在爭奪市場佔有率時面臨的挑戰。此外,該分析還提供了對該行業競爭特徵的寶貴見解,包括在研究基準年觀察到的累積、分散主導地位和合併特徵等因素。這種詳細程度的提高使供應商能夠做出更明智的決策並制定有效的策略,從而在市場上獲得競爭優勢。
1. 市場滲透率:提供有關主要企業所服務的市場的全面資訊。
2. 市場開拓:我們深入研究利潤豐厚的新興市場,並分析其在成熟細分市場的滲透率。
3. 市場多元化:提供有關新產品發布、開拓地區、最新發展和投資的詳細資訊。
4.競爭評估與資訊:對主要企業的市場佔有率、策略、產品、認證、監管狀況、專利狀況、製造能力等進行全面評估。
5. 產品開發與創新:提供對未來技術、研發活動和突破性產品開發的見解。
1.恒溫核酸增幅技術市場規模及預測是多少?
2.在恒溫核酸增幅技術市場的預測期間內,有哪些產品、細分市場、應用和領域需要考慮投資?
3.恒溫核酸增幅技術市場的技術趨勢和法規結構是什麼?
4.恒溫核酸增幅技術市場主要廠商的市場佔有率為何?
5.進入恒溫核酸增幅技術市場的合適型態和策略手段是什麼?
[196 Pages Report] The Isothermal Nucleic Acid Amplification Technology Market size was estimated at USD 3.77 billion in 2023 and expected to reach USD 4.25 billion in 2024, at a CAGR 13.64% to reach USD 9.22 billion by 2030.
The usage of isothermal nucleic acid amplification technology is increasing across hospitals and academic & research institutes, which enables the creation of DNA and RNA in the presence of a target molecule at constant temperatures. The isothermal amplification processes have greater efficiency, produce higher amplification yields, and need fewer sample preparation steps than polymerase chain reaction (PCR). This isothermal nucleic acid amplification technology is widely used as a molecular detection technique in blood screening and infectious disease diagnosis owing to its accuracy and ability to detect various molecules. Furthermore, the growing prevalence of antimicrobial and infectious diseases has increased the need to detect antimicrobial resistance genes and various pathogens, including bacteria and viruses. However, a lack of awareness and a stringent regulatory framework for isothermal nucleic acid amplification may limit their use in end-use sectors. The advancement in isothermal nucleic acid amplification techniques and approvals from healthcare regulatory authorities for innovative technologies are expected to create immense opportunities for the market.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 3.77 billion |
Estimated Year [2024] | USD 4.25 billion |
Forecast Year [2030] | USD 9.22 billion |
CAGR (%) | 13.64% |
Product: Advancements in isothermal nucleic acid amplification technology systems to scale up their operations and automate their workflows
Assays, kits, and reagents are vital in the isothermal nucleic acid amplification process, providing the necessary biochemical substances for reactions. These products typically include enzymes such as DNA and RNA polymerases that function at a constant temperature, nucleotides for amplification, buffers, and other reagents that ensure the specificity and fidelity of the amplification process. Systems in the context of isothermal nucleic acid amplification refer to the instruments and devices needed to facilitate and monitor the amplification process. These systems are engineered to maintain the constant temperature required for isothermal amplification and often come with features such as real-time monitoring of the amplification process, automated data analysis, and user-friendly interfaces. In comparison, assays, kits, & reagents are often seen as recurring spend with direct application to the technology's end-use, making them integral for routine operations and testing. On the other hand, systems are capital equipment that enables these assays to be performed, offering automation and sophisticated monitoring of the isothermal amplification processes.
Type: Growing preference for transcription-mediated amplification in clinical diagnostics for its rapid and high amplification capacity
Helicase-dependent amplification is easily integrated into simple and low-energy consumption microsystems. It helps to develop single-stranded templates for primer hybridization and subsequent primer extension by a DNA polymerase. Loop-mediated isothermal amplification (LAMP) and nucleic acid amplification testing (NAAT) methods are carried out at a constant temperature with a short reaction time and used to screen and identify a pathogen for diagnosing pathogen-based infections. Moreover, transcription-mediated amplification produces DNA and RNA amplicon from a target nucleic acid and helps detect various diseases, such as HIV-1 and Zika virus. Strand displacement amplification (SDA) is used to amplify nucleic acids, such as DNA and RNA. In comparison, LAMP is often favored for its simplicity and suitability for point-of-care diagnostics. At the same time, other methods, such as HDA and SDA, are selected for their unique advantages. Selection for a specific application is influenced by required sensitivity and specificity, the expertise needed for assay development, and equipment and reagent resources.
Application: Extensive utilization of isothermal nucleic acid amplification technology for disease diagnoses for promoting better patient outcomes
In blood screening, isothermal nucleic acid amplification technology (INAAT) is crucial in detecting pathogenic nucleic acids to ensure the safety of blood transfusions. INAAT provides high sensitivity and specificity, allowing for the rapid identification of bloodborne pathogens in donated blood products. In the context of disease diagnosis, INAAT is leveraged to detect various pathogens promptly and accurately. This technology is utilized across infectious diseases, promoting better patient outcomes through early intervention. INAAT offers rapid and simultaneous detection of sexually transmitted infections such as chlamydia and gonorrhea. INAAT's ability to work directly from clinical samples without complex processing steps significantly enhances its utility in STI screening. Identifying viral hepatitis infections (notably Hepatitis B and C) is essential for managing chronic liver diseases and preventing transmission. INAAT detects low levels of viral genetic material, facilitating early diagnosis and monitoring of viral load, which is integral to treatment decisions, and assessing response to therapy. INAAT is beneficial in early-stage HIV detection, where it may identify the virus before seroconversion. This is particularly important in scenarios such as infant testing, where maternal antibodies can interfere with traditional HIV immunoassays. For respiratory illnesses, such as those caused by influenza viruses, INAAT offers the rapid detection necessary for effective patient management and infection control measures, especially during flu seasons or outbreaks. In comparison, the isothermal nucleic acid amplification technology is widely utilized in disease diagnosis for promoting better patient outcomes through early intervention.
End-User: Significant role of isothermal nucleic acid amplification technology in hospitals for rapid and accurate diagnostics to improve patient care
Academic and research institutes utilize INAAT for basic scientific research, method development, and the study of various diseases at the molecular level. The inherent nature of academic research demands high sensitivity, specificity, and adaptability of the technology, enabling detailed and accurate detection of nucleic acids in research specimens. In the hospital sector, INAAT is utilized for various applications such as infectious disease detection, cancer diagnostics, and genetic disorder screening. Reference laboratories are specialized diagnostic facilities that conduct a wide range of complex tests, often serving as the hubs for high-throughput INAAT applications. They serve other laboratories, hospitals, and clinics, providing sophisticated testing that may not be feasible in smaller settings. In comparison, academic and research institutes focus on flexibility and cost-efficiency for in-depth research, whereas hospitals prioritize rapid diagnostics for immediate patient care. On the other hand, reference laboratories rely on the high throughput and reliability of INAAT to serve various external clients efficiently.
Regional Insights
Americas represents a highly developing landscape for the isothermal nucleic acid amplification technology market characterized by an increasing number of diagnostic procedures across hospitals and academic & research institutes and an increasing introduction of innovative isothermal nucleic acid solutions. The development in healthcare infrastructure and increasing medical tourism in various Asia-Pacific regions, such as India, Thailand, Singapore, Malaysia, and South Korea, are expanding the need for isothermal nucleic acid amplification technology to detect viral diseases. In January 2023, Peking University reported that 900 million individuals had been infected with the coronavirus in China, and has further expected to expand the usage of isothermal nucleic acid amplification for the detection of SARS-CoV-2 RNA in research laboratories and diagnostic centers. Moreover, increasing the prevalence of infectious diseases and government initiatives for improving diagnostic procedures are subsequently expanding the use of isothermal nucleic acid amplification technology in the EMEA region. Additionally, rising approvals from healthcare regulatory authorities for innovative diagnostic technologies are expected to encourage the growth of isothermal nucleic acid amplification technology worldwide.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Isothermal Nucleic Acid Amplification Technology Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Isothermal Nucleic Acid Amplification Technology Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Key Company Profiles
The report delves into recent significant developments in the Isothermal Nucleic Acid Amplification Technology Market, highlighting leading vendors and their innovative profiles. These include Abbott Laboratories, AtilaBiosystems, Beijing SBS Genetech Co., Ltd., bioMerieux SA, Biosearch Technologies by LGC Limited, DiaSorin S.p.A., Eiken Chemical Co., Ltd., Fortis Life Sciences, LLC, GENOMTEC S.A., GenoSensor Corporation, Grifols S.A., highQu GmbH, Hologic, Inc., Illumina, Inc., Jena Bioscience GmbH, Life Sciences Advanced Technologies, Inc., Mast Group Ltd., Meridian Bioscience Inc. by SD Biosensor, Inc., New England Biolabs, Inc., OptiGene Limited, PCR Biosystems Ltd., QIAGEN GmbH, Quidel Corporation, Tecan Trading AG, Thermo Fisher Scientific Inc., Ustar Biotechnologies (Hangzhou) Ltd, Xiamen Jiqing Biomedical Technology Co., Ltd., Zhengzhou Laboao Instrument Equipment CO., LTD, and Zhuhai Biori Biotechnology Co., Ltd..
Market Segmentation & Coverage
1. Market Penetration: It presents comprehensive information on the market provided by key players.
2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
1. What is the market size and forecast of the Isothermal Nucleic Acid Amplification Technology Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Isothermal Nucleic Acid Amplification Technology Market?
3. What are the technology trends and regulatory frameworks in the Isothermal Nucleic Acid Amplification Technology Market?
4. What is the market share of the leading vendors in the Isothermal Nucleic Acid Amplification Technology Market?
5. Which modes and strategic moves are suitable for entering the Isothermal Nucleic Acid Amplification Technology Market?
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