市場調查報告書
商品編碼
1383390
至 2030 年 ELISA 測試市場預測:按類型、技術、應用、最終用戶和地區分類的全球分析Elisa Tests Market Forecasts to 2030 - Global Analysis By Type (Indirect ELISA, Sandwich ELISA, Competitive ELISA and Multiple and Portable ELISA), Technology (Chemiluminescent, Colorimetric and Fluorescent), Application, End User and By Geography |
根據 Stratistics MRC 的數據,2023 年全球 ELISA 檢測市場規模為 25.5 億美元,預計在預測期內將以 8.9% 的年複合成長率成長,並在 2030 年達到 46.4 億美元。
酵素結合免疫吸附測定法是一種標準測定技術,用於識別和定量血液中的抗體、荷爾蒙、胜肽和蛋白質。 ELISA 測試常用於藥物品管測試,例如內毒素測定和蛋白質定量,對於許多病毒性疾病的診斷至關重要。 ELISA是植物病理學和醫學中的診斷技術,也是許多不同領域的品管測試。酵素結合免疫吸附檢測法(ELISA) 測試經常在醫學和植物病理學等各個領域用作品質保證測試和篩選儀器。
根據世界衛生組織 (WHO) 統計,2020 年約有 3,770 萬人感染愛滋病毒。
有效的疾病管理和治療依賴早期和準確的診斷。 ELISA 測試的高靈敏度和特異性使醫療保健專業人員能夠識別和檢測患者樣本中的特定生物標記。早期診斷可以立即開始治療並顯著改善患者的治療效果。此外,對這些生物標記的快速識別使醫護人員能夠進行干涉並快速實施有效的治療技術。由於對早期準確診斷的需求,ELISA 檢測市場正在擴大。
診斷藥物的行銷很困難,因為有些產品被歸類為醫療設備,儘管它們的目的是供醫生用於診斷。如果沒有成功的臨床試驗,這類設備就無法推出,這是一個耗時、昂貴且不確定的過程。不同國家對這些設備的認證有不同的規則,這對國際公司來說是一個重大挑戰。此外,如果各種法規機構(例如 FDA)在產品開發過程中改變法規,則可能會出現潛在的產品推出延遲。這些嚴格的政府法規是市場成長的主要障礙。
ELISA 測試市場受益於技術發展,例如自動化系統的創建、多重功能以及檢測靈敏度和特異性的改進。技術進步創造了自動化 ELISA 系統,消除了體力勞動並提高了效率。自動化平台可以同時處理多個樣品,從而簡化測試程序並提高吞吐量。此外,透過減少週轉時間並提高實驗室效率,該技術使醫護人員能夠有效地進行大量測試。由於這些新興市場的開拓提高了功效、準確性和生產力,從而推動了市場需求,ELISA 測試在許多醫療保健環境中已廣泛應用。
即時檢測 (POCT) 設備、次世代定序(NGS) 和分子診斷技術(例如 PCR)等替代診斷技術與市場上的 ELISA 檢測競爭。這些創新具有快速週轉時間、更高的靈敏度以及同時檢測多種分析物的能力等優點。隨著這些技術的發展和變得更加廣泛應用,它們可能會取代 ELISA 測試或與 ELISA 測試競爭,特別是在分子診斷具有明顯優勢的領域。 ELISA 檢測市場可能會受到這些替代技術的可用性和普及的威脅。
最初,在 COVID-19 爆發期間,沒有特定的診斷測試來識別患者的疾病。最初嘗試了替代診斷方法,但成效有限。此外,某些 COVID-19 診斷測試的無法提供為診斷試劑盒製造商提供了銷售 COVID-19 診斷產品的有利可圖的機會。利用這個機會,許多老字型大小企業以及來自各國的新興企業不僅向當地市場而且還向全球市場提供了COVID-19診斷試劑盒。
夾心 ELISA 部分估計佔據最大佔有率。使用由兩層抗體(捕獲抗體和檢測抗體)組成的夾心 ELISA檢測抗原。標靶抗原上的兩個抗原位點已準備好與抗體結合。在夾心ELISA方法中,使用單株或多株抗體來捕捉和辨識抗體。夾心 ELISA 最適合檢測免疫反應,這一事實正在推動市場的擴張。夾心ELISA利用多種抗體來辨識和檢測相同抗原,也是最靈敏的檢測方法。它也非常彈性和具體。
預計感染疾病領域在預測期內將出現良好成長。由於慢性病和傳染病的盛行率不斷增加,感染疾病目前主導著ELISA市場的應用領域。酵素結合免疫吸附和觀察ELISA 測試占主導地位,因為它們是自動化的、易於執行,並且不需要放射性材料或昂貴的輻射設備。
由於其高度發達的醫療保健系統和不斷成長的醫療設備可用性,北美在預測期內佔據了最大的市場佔有率。製藥公司和政府機構針對糖尿病和慢性病等疾病的研發支出的增加也有助於預測期內該地區 ELISA 檢測市場的成長。
由於新興經濟體可支配所得和醫療保健支出的增加,預計歐洲在預測期內將出現盈利成長。由於已開發國家醫療設備的使用不斷增加,ELISA 檢測市場預計在未來年度將成長。此外,由於老年人口眾多以及研發投入龐大,預計在預測期內歐洲大陸非傳染性疾病的發生率也會增加,從而增加對 ELISA 檢測的需求。
According to Stratistics MRC, the Global Elisa Tests Market is accounted for $2.55 billion in 2023 and is expected to reach $4.64 billion by 2030 growing at a CAGR of 8.9% during the forecast period. The enzyme-linked immune sorbent assay is the standard assay technique used to identify and quantify antibodies, hormones, peptides, and proteins in the blood. The ELISA test is often used in pharmaceutical quality control tests like endotoxin assays and protein quantification and is crucial in the diagnosis of a number of viral diseases. ELISA is a diagnostic technique in plant pathology and medicine as well as a quality control checks in many different sectors. Enzyme-linked immune sorbent assay (ELISA) testing is frequently used as a quality assurance check and screening instrument in a variety of fields, including medicine and plant pathology.
According to the World Health Organization (WHO), around 37.7 million people had HIV in 2020.
Effective illness management and therapy rely on early and precise diagnosis. The high sensitivity and specificity of Elisa testing enable medical personnel to identify and measure particular biomarkers in patient samples. Early diagnosis enables quick treatment beginning, which can greatly enhance patient results. Additionally, healthcare practitioners can intervene and swiftly implement effective treatment techniques by quickly recognizing these biomarkers. The market for Elisa testing is expanding due to the demand for early and accurate diagnosis.
The marketing of diagnostic products is difficult because some products are categorized as medical devices even though they are intended for use in diagnostic procedures by doctors. Without successfully completing clinical trials, which are a time-consuming, expensive, and uncertain process, such devices cannot be launched. The reality that different countries have different rules for these devices' certification is a significant challenge for international corporations. Additionally, any modifications to rules made by various regulatory agencies, like the FDA, during the product development process may cause a delay in the introduction of potential products. These stringent government regulations are the major barriers to market growth.
The market for Elisa testing has benefited from technological developments such as the creation of automated systems, the ability to multiplex and enhanced sensitivity and specificity of assays. Technological improvements have led to the creation of automated Elisa systems, excluding manual labor and enhancing efficiency. Multiple samples can be handled simultaneously by automated platforms, streamlining the testing procedure and boosting throughput. Furthermore, by speeding up turnaround times and increasing laboratory efficiency, this technology enables healthcare practitioners to efficiently perform a higher volume of tests. Elisa tests are becoming more widely used in many healthcare settings as a result of these developments, which improve their effectiveness, accuracy, and productivity, which drives market demand.
Alternative diagnostic technologies, such as point-of-care testing (POCT) devices, next-generation sequencing (NGS), and molecular diagnostic techniques (e.g., PCR), compete with Elisa tests on the market. These innovations have benefits like quicker turnaround times, greater sensitivity, and the capacity to detect multiple analytes at once. Elisa tests may be replaced or competed with as these technologies develop and become more widely available, especially in areas where molecular diagnostics have clear advantages. The market for Elisa tests may be threatened by the availability and uptake of these substitute technologies.
Initially, in the COVID-19 epidemic, there were no particular diagnostic tests available to identify the illness in patients. Initially, alternative diagnostic procedures were attempted, but they were not very successful. Additionally, due to the unavailability of certain COVID-19 diagnostic tests, diagnostic kit manufacturers had profitable chances to market their COVID-19 diagnostic products. Utilizing this chance, many established companies as well as a few start-ups from different nations offered COVID-19 diagnostic kits to local as well as global markets.
The sandwich ELISA segment is estimated to hold the largest share. Antigen is measured using a sandwich ELISA, which consists of two layers of antibodies (the capture antibody and the detection antibody). Two antigenic sites on the target antigens are ready to bind to the antibodies. In sandwich ELISA techniques, monoclonal or polyclonal antibodies are employed to capture and recognize antibodies. Sandwich ELISA works the best for detecting immunological responses, and this fact is promoting market expansion. Sandwich ELISA, which uses a variety of antibodies to bind to the same antigen for recognition or detection, is also the most sensitive test available. It also has a high degree of flexibility and higher specificity.
The infectious diseases segment is anticipated to have lucrative growth during the forecast period, due to an increase in the prevalence of chronic illnesses and infectious disorders, infectious diseases are now leading the ELISA market's application sector. HIV, HBV, HCV, HTLV, Diphtheria, Giardiasis, and several other infectious blood-borne illnesses The application sector of the enzyme-linked immune sorbent assay (ELISA) testing market is dominated by ELISA tests because they provide quick and accurate findings, have high sensitivity, are automated and simple to perform, and do not require radioactive materials or expensive radiation gear.
North America commanded the largest market share during the extrapolated period due to the highly developed healthcare system and the growing use of medical gadgets. Rising R&D expenditures by pharmaceutical firms and government organizations for disorders and diseases, including diabetes and chronic illnesses, would also contribute to the market growth for ELISA tests in this region during the projected period.
Europe is expected to witness profitable growth over the projection period due to the rising disposable income and healthcare expenditure in emerging nations. The market for ELISA tests is anticipated to grow in the coming years as a result of the rising use of medical equipment in developed nations. Additionally, due to the large geriatric population and significant investment in research and development, in the projected time frame, it is also anticipated that the rising frequency of non-communicable diseases on the European continent will increase demand for ELISA testing.
Some of the key players in the Elisa Tests Market include: Abbott Laboratories, Danaher Corporation, BioMerieux SA, Quidel Corporation, Siemens Healthineers, Sysmex Corporation, Bio-Rad Laboratories, Ortho Clinical Diagnostics, Thermo Fisher Scientific, Inc., ZEUS Scientific, Inc., Hoffmann-La Roche AG, PerkinElmer, Inc., Enzo Life Sciences, Inc., Agilent Technologies, Inc., R&D Systems, Inc., Bruker, Eurofins Scientific, ELISA Technologies, Inc and BioLegend, Inc.
In May 2023, Abbott, a global leader in health care and nutrition, has partnered with Real Madrid, one of the most successful and popular football clubs in the world, to inaugurate the Abbott-Real Madrid Innovation Lab, a space for collaboration and research on the future of sports physiology and nutrition.
In March 2023, Thermo Fisher Scientific, the world leader in serving science, and Arsenal Biosciences, Inc. (ArsenalBio), a clinical-stage cell therapy company engineering advanced chimeric antigen receptor (CAR)-T cell therapies for solid tumors, announced an update to their strategic collaboration to further the development of manufacturing processes for new cancer treatments.
In November 2020, Siemens Healthineers announced that its SARS-CoV-2 IgG Antibody Test has proven to evaluate neutralizing antibodies and has gained CE Marking. This test is the better version of its previously launched COVID-19 antibody test.