市場調查報告書
商品編碼
1218865
全球數字 PCR 市場:到 2028 年的預測——按產品、技術、適應症、應用、最終用戶和地區分析Digital PCR Market Forecasts to 2028 - Global Analysis By Product, Technology, Indication, Application, End User and Geography |
根據 Stratistics MRC 的數據,2022 年全球數字 PCR 市場規模將達到 5.3973 億美元,預計到 2028 年將達到 21.4948 億美元,預測期內復合年增長率為 25.9%。
數字聚合□鏈反應 (dPCR) 是一種用於定量核酸的新技術,它提供了一種靈敏且可重複的方法來估計樣品中 DNA 或 RNA 的濃度。包括研究(基礎和應用)、臨床診斷和法醫學在內的所有領域都對 dPCR 寄予厚望。dPCR 系統的應用包括拷貝數變異、稀有序列檢測、突變檢測、miRNA 分析、基因表達分析、下一代測序的樣本量化等。
根據 GLOBOCAN 報告,2020 年全球約有 1929 萬人被診斷出患有癌症。根據國際糖尿病聯合會糖尿病地圖集第 10 版 2021 年,全球約有 5.37 億成年人被診斷患有糖尿病,到 2030 年和 2045 年這一數字將增加到 6.43 億。預計到 2018 年將增長到 7.83 億。
市場動態
促進者
越來越多地使用生物標誌物分析進行疾病診斷
在體液和組織中發現的核酸(DNA、microRNA、mRNA 等)是一類被稱為生物標誌物和基因組標誌物的特徵分子。通過表觀遺傳、遺傳和蛋白質水平的分子譜分析,生物標誌物可以成為確定疾病性質和治療效果的可靠和準確的信息來源。生物標誌物分析目前正用於診斷測試、療效監測和藥物開發。在生物標誌物分析中,使用 qPCR 和 dPCR 技術檢測和測量分離樣本中的遺傳物質。在過去十年中,隨著越來越多的公共機構和私營公司專注於監測疾病進展和開發個性化藥物和治療的新技術的研發,生物標誌物分析程序在臨床上與疾病相關。它在診斷和預後方面越來越重要。
阻礙因素
系統成本高
雖然數字小工具有許多有用的應用程序,但它們也有可能阻止它們在市場上被廣泛接受的缺點。與其他選擇相比,數字小工具價格昂貴。這些元素在市場上的存在導致了多種選擇。對於絕對定量,可以使用計數 PCR 代替數字聚合□鏈反應。基因表達、拷貝數變異和病毒載量均已量化。預計此類選項將抑制這些數字設備的市場擴張。
機會
dPCR 相對於實時聚合□的一些優勢
數字聚合□鏈反應有助於提供目標核酸分子的全局測量,而不是從實時儀器獲得的相對測量。這種絕對 DNA 量化帶來的可重複性、靈敏度和精確度使研究人員能夠更好地評估微小突變,甚至量化更小的差異。由於病毒中存在大量基因組類型,樣本中模板濃度極低,實時儀器鍊式反應儘管應用廣泛,但已成功測試了多種寄生病原體,如瘧疾和 COVID -19. 它不是檢測傳染病的首選技術。數字液滴技術可以克服這些問題並通過改進的組比較產生準確的結果。這些因素正在加速市場的擴張。
威脅
缺乏技術能力
常見的 dPCR 方法在 PCR 反應的指數階段存在信號測量、需要優化和驗證檢測程序、由於反應抑製劑導致目標檢測困難以及核甘酸模板質量差等問題。存在許多技術限制,例如無法檢測分子。此外,致癌化學品的使用、試劑對 dsDNA 的化學附著以及無法測量 DNA 質量 (AluQuant) 是直接影響其在基因組研究中使用的 qPCR 試劑的操作限制。
COVID-19 的影響
由於 COVID-19 的影響,該市場在 2020 年顯著增長。這是由於這種病毒的廣泛流行,增加了對有效診斷以防止其傳播的需求。在全球範圍內,數字 PCR 市場發展迅猛。重新分配 COVID-19 治療的醫療費用、增加對 COVID-19 診斷的需求,以及診斷中心和研究機構對該設備的使用增加,都推動了對該設備的需求。我是。全球高負擔國家 COVID-19 檢測的顯著增加也促成了積極的結果。
基於芯片的數字 PCR 部分預計在預測期內將是最大的
基於芯片的數字 PCR 部分將看到有利可圖的增長,因為基於芯片的數字 PCR 方法利用編織有數千個閥門和通道的矽芯片在納升中執行大規模 rtPCR。估計。在檢測次數相同的情況下,該芯片可以一次檢測多達 48 或 96 個樣本,讓您從一次反應中獲得更多洞察力。基於芯片的數字 PCR 因其降低交叉污染的風險和穩定的液滴流動而日益流行。未來,這種新技術很可能會診斷出更多的疾病。
預計診斷中心部分將在預測期內見證最高的複合年增長率
預計診斷中心部分將在預測期內呈現最快的複合年增長率。這些數字設備在各種類型的診斷中的廣泛使用和傳染病流行率的上升都是這一領域增長的原因。COVID-19 的爆發也促使許多市場進入者專注於創建和銷售 COVID-19 診斷試劑盒。
佔比最大的地區
由於其完善的醫療保健行業、投資新產品發布的頂級分子診斷公司的存在以及使用個性化藥物的患者比例上升,北美將在預測期內佔據最大的市場份額。預計將佔據。北美數字 PCR 市場由於老年人口的增加、傳染病的鑑定以及醫療設施的擴建而擴大。由於這些原因,該地區有望在預測期內實現盈利增長。
複合年增長率最高的地區
由於歐洲是製藥製造和研究的主要參與者,預計在預測期內歐洲的複合年增長率最高。通過融合需要基因分析的技術,正在創建靶向治療和個性化精準醫療等創新方法。由於歐洲為研究和開發提供了大量的機構資助,研究質量也在提高。由於該地區疾病的流行以及微陣列、PCR 和其他基因組學和蛋白質組學技術的使用,分子診斷學的使用正在增加。
重大發展
2022 年 4 月,Stira 和 Promega Corporation 宣布了一項聯合營銷協議,將樣品製備與最新的 Maxwell 系統相結合,數字聚合□鏈反應與 6 色 Naica 系統相結合。該合作夥伴關係加強了兩家公司的產品組合。
2022 年 3 月,Stilla 宣布與 EMEA 地區的 12 家分銷商建立合作夥伴關係。通過這種合作關係,該公司擴大了其在歐洲、中東和非洲地區的業務。
2021 年 9 月,Thermo Fisher Scientific Inc. 宣布推出 Applied Biosystems Quant Studio Absolute Q 數字系統。
2020年6月,Stilla宣布推出全球首款6色數字聚合□鏈反應裝置。
2020年5月,Stilla宣布推出數字聚合□鏈反應解決方案Naica System。該產品可以可靠地檢測 SARS-CoV-2 病毒,並在參與 COVID-19 應對的所有實驗室和醫院測量其病毒載量。
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According to Stratistics MRC, the Global Digital PCR Market is accounted for $539.73 million in 2022 and is expected to reach $2149.48 million by 2028 growing at a CAGR of 25.9% during the forecast period. The digital polymerase chain reaction (dPCR) is a new technique for quantifying nucleic acids that provides a sensitive and reproducible means to estimate the concentration of DNA or RNA in a sample. Research (basic and applied), clinical diagnostics, forensics, and other sectors all show great promise for dPCR. Applications for dPCR systems include copy number variation, uncommon sequence detection, mutation detection, miRNA analysis, gene expression analysis, and next-generation sequencing sample quantification.
According to the GLOBOCAN report, in 2020, around 19.29 million people in the world are affected by cancer. According to the International Diabetes Federation Diabetes Atlas Tenth edition 2021, in 2021, around 537 million adults all over the world were found to have diabetes; with the numbers projected to grow to 643 million by 2030 and 783 million by 2045.
Market Dynamics:
Driver:
Increasing use of biomarkers profiling for disease diagnostics
Nucleic acids (including DNA and micro RNA or mRNA), which may be found and measured in bodily fluids and tissues, are examples of distinctive molecules known as biomarkers or genomic markers. Through the process of molecular profiling at the epigenetic, genetic, and protein levels, a biomarker can be a dependable, precise source for determining the nature of a disease and therapeutic response. Currently, biomarker analysis is employed in diagnostic testing methods, therapeutic efficacy monitoring, and drug development. The isolated sample's genetic material is detected and measured using qPCR and dPCR technology in the biomarker analysis process. With more public and private organisations concentrating on R&D into novel techniques for monitoring disease progression and developing personalised medicines and treatment options, biomarker analysis procedures have grown in significance in the clinical diagnosis and prognosis of diseases over the past ten years.
Restraint:
High Cost of Systems
Digital gadgets have many useful applications, but they also have some drawbacks that may prevent widespread market acceptance. Its acceptance may be constrained by some issues, namely the higher price of these digital gadgets in comparison to alternative options. Multiple alternative possibilities are created as a result of this element in the market. For absolute quantification, counting PCR might be used instead of digital polymerase chain reaction. Gene expressions, copy number variation, and viral load are all quantified. This alternative is anticipated to restrain the market's expansion of these digital devices.
Opportunity:
Several Benefits of dPCR Over Real-time Polymerase
Digital polymerase chain reaction aids in delivering a comprehensive measure of the target nucleic acid molecules as opposed to the relative measure obtained from real-time instruments. Because of the reproducibility, sensitivity, and precision provided by this absolute DNA quantification, researchers are also able to properly assess minor mutations and quantify smaller differences. Due to the numerous types of genomes present in the virus and the extremely low template concentration present in the sample, real-time devices chain reaction is not a preferred technique for detecting various parasitic infectious diseases such as malaria and COVID-19, despite its widespread application. Digital droplet technologies get beyond these problems and produce precise results with improved group comparisons. These elements are therefore accelerating the market's expansion.
Threat:
Lack of technical skills
A typical dPCR method has a number of technical restrictions, including the measurement of the signal during the exponential phase of the PCR reaction, the requirement for assay procedure optimization and validation, difficulties in target detection caused by reaction inhibitors, and the inability to detect the target molecules due to the poor quality of the nucleotide template. Additionally, the usage of carcinogenic chemicals, chemical attachment of the reagent to dsDNA, and inability to measure DNA quality (AluQuant) are some of the operational constraints of qPCR reagents that have a direct impact on their use in genomic research.
COVID-19 Impact
The market grew significantly in 2020 as a result of COVID-19's effects. This is explained by the fact that the virus has spread widely, raising the need for efficient diagnostics to stop its transmission. The market for digital PCR in the world expanded tremendously. The demand for the devices was fuelled by the reallocation of healthcare funds for COVID-19 therapy, which led to an increase in the number of persons seeking a COVID-19 diagnosis and the use of the device in diagnostic centres and research facilities. The considerable growth of COVID-19 testing in high-burden nations worldwide also contributed to the favourable outcome.
The chip-based digital PCR segment is expected to be the largest during the forecast period
The chip-based digital PCR segment is estimated to have a lucrative growth, due to chip-based digital PCR method carries out rtPCR on a huge scale in nanoliter amounts by utilising silicon chips with thousands of interweaving valves and channels. With the same number of assays, the chip can test up to 48 or 96 samples at once, yielding numerous findings from a single response. Chip-based digital PCR is gaining popularity daily due to its decreased risk of cross-contamination and consistent droplet flow. In the future, additional diseases are probably going to be diagnosed with new technologies of this kind
The diagnostics centers segment is expected to have the highest CAGR during the forecast period
The diagnostics centers segment is anticipated to witness the fastest CAGR growth during the forecast period, due to the expanding use of these digital devices for the diagnosis of various sorts of these diseases and the rising prevalence of infectious diseases are both responsible for the segment's growth. Additionally, numerous market participants boosted their focus on creating and marketing COVID-19 diagnostics kits as a result of the COVID-19 outbreak.
Region with largest share:
North America is projected to hold the largest market share during the forecast period owing to its well-established healthcare sector, the presence of top molecular diagnostics firms that invest in the release of new products, and the rise in the proportion of patients utilising personalised medicines. Because there were more elderly individuals, more infectious diseases were being identified, and there were improved healthcare facilities, the digital PCR market in North America expanded. With all of this, the region is anticipated to grow profitably during the projection period.
Region with highest CAGR:
Europe is projected to have the highest CAGR over the forecast period; due to it is a major player in the creation and research of pharmaceuticals. Innovative approaches like targeted therapy and personalised precision medicine are being created by merging technology that requires genetic analysis. Because of the substantial institutional funding that Europe offers for R&D, the calibre of research has increased. Due to the high prevalence of diseases in the area and the use of microarray, PCR, and other genomic and proteomic techniques, there has been an increase in the use of molecular diagnostics.
Key players in the market
Some of the key players profiled in the Digital PCR Market include Thermo Fisher Scientific Inc., Bio-Rad Laboratories, Inc., JN Medsys, QIAGEN, Stilla, Sysmex Corporation, Standard BioTools Inc., Precigenome LLC., Fluidigm Corp., Formulatrix, Inc., Avance Bioscience, Merck KGAA, Agilent Technologies, Inc., BioMerieux, Takara Bio Inc., Beckman Coulter, Inc., General Electric, Roche Sequencing, PerkinElmer Inc. and Siemens
Key Developments:
In April 2022, Stilla and Promega Corporation announced their co-marketing agreement that combined sample preparation with the latest Maxwell systems and digital polymerase chain reaction on the six-color Naica system. This collaboration strengthened both companies' product portfolio.
In March 2022, Stilla announced its partnership with 12 distributors across the EMEA region. With this partnership, the company expanded its presence in the EMEA region.
In September 2021, Thermo Fisher Scientific Inc. announced the launch of Applied Biosystems Quant Studio Absolute Q a digital system.
In June 2020, Stilla announced the launch of the world's first six-color digital polymerase chain reaction instrument.
In May 2020, Stilla announced the availability of its digital polymerase chain reaction solution, the Naica system. The product can reliably detect the SARS-CoV-2 virus and measure its viral load in all research centers and hospitals involved in the fight against COVID-19.
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Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.