Biosensors for Point-of-Care Diagnostics 2022-2032: Technology, Opportunities, Players and Forecasts
用於即時檢測 (POCT) 和快速診斷的側流免疫分析 (LFA)、試劑盒、連續血糖監測儀 (CGM) 和電化學試紙。分析市場格局、COVID-19 影響和關鍵機遇。
醫療診斷市場正在從基於實驗室的傳統測試轉向直接在護理點進行測試。在 COVID-19 大流行期間，這種轉變從未像現在這樣重要。在本報告中，IDTechEx 討論了即時生物傳感器的發展、行業內的新興趨勢以及新技術將帶來的機遇。我們預測了這些將引領行業發展的軌跡。
即時檢測 (POCT) 是指在床邊或患者附近進行的診斷。這可以在醫院病房、醫生辦公室、零售診所和家裡。通過提供快速結果，POCT 可以更快地採取臨床行動。通過消除將樣品送到傳統實驗室進行測試的需要，POCT 解決了圍繞後續跟蹤和資源/時間承諾的臨床問題。此外，在家檢測允許患者直接檢測疾病/健康狀況，而無需去看醫生，這對於監測糖尿病等慢性疾病至關重要。
我們不斷變化的人口結構正在增加醫療保健系統的壓力。今天，醫療保健支出約佔世界 GDP 的 14%。在發達經濟體，由於人口老齡化和久坐不動的生活方式，慢性病病例不斷增加。隨著人口規模的擴大，新興經濟體對醫療保健的需求也在增長。對資源有限的環境進行診斷的需求推動了這些地區的 POCT。總體而言，在城市密度增加和氣候變暖的推動下，傳染病病例和新發流行病的頻率也在增加。這些因素共同推動床旁生物傳感器行業到 2032 年增長到 295 億美元。
隨著 COVID-19 的出現，診斷行業提高了 COVID-19 測試產品的製造能力。測試對於追蹤對大多數人來說是無症狀的感染至關重要，使人們能夠控制病毒的傳播。雖然在實驗室內使用 PCR 進行的傳統測試仍然是測試準確性的黃金標準，但家庭 COVID-19 測試的出現增加了測試的可及性，並允許個人以更高的頻率使用它。 2021 年，美國政府投資 10 億美元增加家庭測試的供應，使產量提高到每月約 2 億次測試。這個機會一直是該行業多個方面的關鍵助推器。開發了一種分子 COVID-19 在家測試的 Cue Health 於 2021 年從美國國防部獲得了 4 億美元的合同；而前一年的總收入為 2300 萬美元。對於 POCT 墨盒產品，安裝基數大幅增長：BD 的 Veritor 設備在六個月內幾乎將其美國安裝基數增加了兩倍，達到 70,000 台，而 Quidel 的 Sofia 在 2021 年同樣安裝了超過 75,000 台。這個已建立的用戶群有助於未來的市場擴張。該病毒還允許初創企業通過將他們正在開發的平台轉向 COVID-19 測試應用程序來播種市場，例如 Visby Medical 已為此開發了一種一次性、小型化 PCR -護理。
在本報告中，IDTechEx 將 POC 生物傳感器分為生物受體和傳感器組件，以探索這些細分市場中的關鍵技術和新技術。我們分析了旨在使核酸擴增小型化並將其用於醫療點的技術，例如 PCR、LAMP 和 NEAR。該報告還探討了轉換生物信號的新興方法，包括在電化學轉換中使用石墨烯和碳納米管，以及在光學傳感器中使用螢光有機染料和量子點。
儘管許多新興的生物傳感技術令人興奮，但仍有幾個問題需要解決。雖然 CRIPSR/Cas 的特性使其非常適合診斷，並具有出色的準確性潛力，但現實情況是該技術仍然不成熟。該技術在即時診斷應用中的參與者並不多，更多的是專注於其他應用，例如治療。同樣，我們詢問，儘管碳基納米材料適用，但哪些限制因素限制了碳基納米材料在當今傳感器中的商業化。
報告按應用細分和討論市場，著眼於每個細分市場的驅動因素和製約因素，以及行業參與者所針對的關鍵疾病和疾病生物標誌物。我們還按生物傳感器的格式進行細分，並評估格式的重要性，以將不同的生物傳感器帶到醫療點。這些細分是在我們的 10 年預測中推斷出來的，以探索應用程序和格式的構成以及它們可能會如何及時變化。
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Biosensors for Point-of-Care Diagnostics 2022-2032:
Technology, Opportunities, Players and Forecasts
Lateral flow immunoassays (LFAs), cartridges, continuous glucose monitors (CGMs), and electrochemical test strips for point-of-care testing (POCT) and rapid diagnostics. Analysis of market landscape, COVID-19 impact and key opportunities.
The market for medical diagnostics is shifting from conventional, laboratory-based testing towards testing directly at the point of care. No time has this shift been so vital as now, during the COVID-19 pandemic. In this report, IDTechEx discusses the growth of point-of-care biosensors, the emerging trends within the industry and what opportunities new technologies will present. We forecast the trajectory that these will take the industry.
Point-of-care testing (POCT) refers to diagnostics at the bedside or near the patient. This can be in hospital wards, physician's offices, retail clinics, and at home. By providing rapid results, POCT allows faster clinical action to be taken. By eliminating the need to send samples to conventional laboratories for testing, POCT solves the clinical issues around follow-ups and resources/time commitment. Furthermore, at-home testing allows patients to directly test for disease/health conditions without the need to visit a physician, which is critical for monitoring chronic diseases such as diabetes.
Our changing population demographics are increasing the pressure on healthcare systems. Today, healthcare spending makes up about 14% of the world GDP. In developed economies, there are rising cases of chronic diseases, driven by the aging population, and by more sedentary lifestyles. The demand for healthcare in emerging economies grows too, accelerated by an expanding population size. The need to bring diagnostics to resource limited settings drives POCT in these regions. Overall, cases of infectious disease and the frequency of emerging epidemics are growing too, driven by increasing urban density and a warming climate. Together, these factors are driving the point-of-care biosensor industry to grow towards $29.5 billion by 2032.
With the onset of COVID-19, the diagnostics industry ramped up manufacturing capacity for COVID-19 test products. Testing has been critical to tracking an infection which is asymptomatic for most of the population, allowing people to manage the spread of the virus. While conventional testing using PCR within the laboratory remains the gold-standard of testing accuracy, the emergence of at-home COVID-19 tests has increased testing accessibility and allowed individuals to use it at a higher frequency. In 2021, the US government invested $1 billion in increasing the supply of at-home tests, enabling the rise of production volume to approximately 200 million tests per month. This opportunity has been a key booster on several fronts for the industry. Cue Health, who developed a molecular COVID-19 at-home test, received a $400m contract from the US Department of Defense in 2021; versus a total revenue of $23m the year before. For POCT cartridge products, install-base has grown massively: BD's Veritor device almost tripled its USA install base, to 70,000, in six months, while Quidel's Sofia similarly installed over 75,000 units in 2021. This established user base facilitates future market expansion. The virus has also allowed start-ups to seed the market by pivoting the platforms they were developing into COVID-19 testing applications, such as Visby Medical who have developed a single-use, miniaturized PCR for the point-of-care.
In this report, IDTechEx divides the POC biosensor into its components of bioreceptors and transducers to explore the key and novel technologies within these segments. We analyse the techniques designed to miniaturize nucleic acid amplification and bring it towards point-of-care, such as PCR, LAMP, and NEAR. The report also explores emerging approaches to transducing biological signals, including the use of graphene and carbon nanotubes in electrochemical transduction, and the use of fluorescent organic dyes and quantum dots in optical transducers.
However, many of the biosensor technologies at point-of-care are mature with limited innovation. Lateral flow tests have been commercialised for half a century, yet they remain limited by the accuracy of their readings. Part of this problem is being resolved by a growing trend of using readers and smartphone-camera readers to digitalize and connect the results of these tests, eliminating inaccuracy such as misinterpreting faint lines by eye. Yet, the technology is fundamentally limited by the sensitivity and the specificity of their bioreceptors, which are usually antibodies.
Despite the excitement around many emerging technologies for biosensing, there are still several problems to solve. While the properties of CRIPSR/Cas make it good for diagnostics, with potential for excellent accuracy, the reality is that the technology is still immature. The technology does not see many players for a point-of-care diagnostics application, with many more focused on other applications such as therapeutics. Similarly, we ask what constraints are limiting carbon-based nanomaterials from their commercialization in transducers today, despite their suitability.
The report segments and discusses the market by applications, looking at the drivers and constraints of each segment, as well as the key diseases and disease biomarkers that industry players target. We also segment by the format of the biosensor and evaluate the importance of formats to bring different biosensors to the point-of-care. These segments are extrapolated in our 10-year forecast, to explore the make-up of applications and formats and how they might change in time.
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