市場調查報告書
商品編碼
1402490
北美免疫診斷市場預測至 2030 年 - 區域分析 - 按產品(酶聯免疫吸附測定、化學發光免疫測定、放射免疫測定等)、臨床適應症和最終用戶North America Immunodiagnostics Market Forecast to 2030 - Regional Analysis - by Product (Enzyme-Linked Immunosorbent Assays, Chemiluminescence Immunoassays, Radioimmunoassays, and Others), By Clinical Indication, and End User |
北美免疫診斷市場預計將從2023年的104.6348億美元成長到2030年的173.991億美元。預計2023年至2030年CAGR為7.5%。
床邊免疫診斷的使用不斷成長推動北美工業機器人市場
由於需要快速診斷結果來確定準確、更快的治療方法,床邊檢測 (POCT) 已成為以患者為中心的醫療保健的關鍵。從集中式現場護理測試到分散式測試的轉變使得可以輕鬆存取這些診斷。免疫測定測試有助於監測慢性病並檢測病原體,例如細菌和病毒。先進的照護端設備能夠從單一樣本中快速篩選多達三種成分。此外,傾向於行動醫療 (mH) 智慧型裝置的照護端診斷 (POCD) 可能會徹底改變個人化醫療監控和管理,為下一代 POCT 鋪平道路。 POCT 可以顯著改善傳染病的管理,特別是在難以獲得及時醫療服務且醫療基礎設施陳舊且稀少的發展中國家。此外,技術開發的診斷試劑盒減少了手動錯誤,推動了免疫診斷市場的發展。一些市場參與者正在開發創新的免疫診斷產品。例如,賽默飛世爾科技(Thermo Fisher Scientific) 開發了酵素連結免疫(ELISA) 試劑和緩衝液、抗體和檢測探針、連接機制、封閉緩衝液和去污劑、檢測底物和捕獲表面等免疫診斷產品,以及生物共軛等服務和檢測。此外,2020年9月,羅氏推出了SARS-CoV-2快速抗原檢測,該檢測用於POC環境中,幫助醫療保健專業人員在15分鐘內識別疑似病毒攜帶者的感染情況。
2021 年 4 月,DiaSorin 推出了 LIAISON IQ(一種新型免疫診斷即時護理 (POC) 閱讀器)以及 LIAISON QuickDetect COVID TrimericS Ab 測試,該測試與 Lumos Diagnostics 為接受 CE 標誌的國家開發。 LIAISON IQ 的這項測試使用人體毛細血管血的指尖血,在 10 分鐘內識別出針對 SARS-CoV-2 刺突蛋白的特異性 IgG 抗體。
2021 年 4 月,Chembio Diagnostics, Inc. 推出了 FDA 緊急使用授權批准的、獲得許可的快速照護端 COVID-19/Flu A&B 測試,用於傳統和分散的測試環境。快速免疫檢測無需儀器,15 分鐘內即可得出結果。
世衛組織讚揚檢測試劑盒開發商在 COVID-19 危機期間為創新和滿足群眾需求所做的努力。據美國臨床病理學會稱,2020 年 3 月,Cepheid Xpert Xpress SARS-CoV-2 檢測成為第一個獲得美國食品和藥物管理局 (FDA) 緊急使用授權 (EUA) 的 POC COVID-19 檢測方法。
同樣,免疫診斷在癌症治療的應用也在增加。在腫瘤學中,免疫診斷測試可以透過檢測已知的腫瘤相關抗原或抗體來確認實體腫瘤的存在。這些優勢和適應症正在推動免疫診斷市場的發展。
北美免疫診斷市場概況
該國的癌症盛行率正在以驚人的速度增加,導致對癌症診斷的需求增加。根據美國癌症協會 (ASC) 對 2023 年癌症事實和數字的估計,美國登記了近 190 萬個新癌症病例。進一步預測,到 2023 年,該國將有 609,360 人死於癌症,即每天約 1,670 人死亡。然而,診斷的增加減少了與癌症相關的死亡人數。根據 ASC 的數據,在過去 28 年裡,男性和女性癌症死亡率從 1991 年的高峰到 2019 年下降了 32%。死亡率下降的原因是早期和晚期癌症診斷。人們對診斷技術進步的認知不斷增強。因此,它導致了美國免疫分析市場的顯著成長。同樣,糖尿病在美國老年族群的盛行率也很高。許多公司正在提供糖尿病免疫測定試劑盒。例如,Bio-Rad Laboratories, Inc. 提供 Bio-Plex Pro 人類糖尿病免疫測定法,該方法對於研究人類糖尿病和肥胖標記物可靠且方便。它們有助於管理和治療糖尿病患者的糖尿病。由於美國公民糖尿病盛行率的上升,預計該市場將顯著成長。根據美國疾病管制與預防中心(CDC)在2023年全國糖尿病統計報告中公佈的資料,美國有3,730萬人患有糖尿病,占美國總人口的11.3%。此外,報告也指出,18歲或以上的人有9,600萬處於糖尿病前期,占美國人口的38%。因此,考慮到該國糖尿病的盛行率,預計免疫診斷的需求將會增加,從而導致市場成長。近年來,創新和改進的醫療技術出現了前所未有的成長。結果,先進診斷和整個醫療保健行業取得了發展。此外,美國擁有多家公司開發用於現場診斷的尖端產品,為免疫診斷市場的成長鋪平了道路。 2020 年 4 月,Bio-Rad 實驗室推出了一種基於血液的免疫測定試劑盒,用於識別 SARS-CoV-2 抗體。
北美免疫診斷市場收入及 2030 年預測(百萬美元)
北美免疫診斷市場細分
北美免疫診斷市場分為產品、臨床適應症、最終用戶和國家。
根據產品,北美免疫診斷市場分為酵素連結免疫吸附測定(ELISA)、化學發光免疫測定(CLIA)、放射免疫測定(RIA)等。 2023年,酵素連結免疫吸附測定(ELISA)領域在北美免疫診斷市場中佔據最大佔有率。化學發光免疫分析 (CLIA) 領域進一步細分為維生素 D 分析市場、HIV 檢測市場、HIV ag/ab 組合分析市場和其他測試。
根據臨床適應症,北美免疫診斷市場分為傳染病、肝炎+HIV、內分泌、胃腸道、代謝等。 2023年,傳染病領域在北美免疫診斷市場中佔據最大佔有率。傳染病部分進一步細分為 COVID-19、結核病、萊姆病、感染管理、寨卡病毒、密螺旋體、火炬、麻疹和腮腺炎、水痘帶狀皰疹病毒和 EB 病毒。內分泌科進一步細分為高血壓、生長、糖尿病、甲狀腺和生殖內分泌。
根據最終用戶,北美免疫診斷市場分為醫院、診所、診斷實驗室、學術和研究機構等。 2023年,醫院細分市場在北美免疫診斷市場中佔據最大佔有率。
根據國家/地區,北美免疫診斷市場分為美國、加拿大、墨西哥。 2023年,美國在北美免疫診斷市場中佔據最大佔有率。
雅培實驗室;生物梅里埃公司;丹納赫公司; DiaSorin SpA; F.霍夫曼-拉羅氏有限公司;珀金埃爾默公司;深圳邁瑞生物醫療電子有限公司;西門子醫療保健有限公司;斯瓦爾生命科學公司;和 Thermo Fisher Scientific Inc 是北美免疫診斷市場上的一些領先公司。
The North America immunodiagnostics market is expected to grow from US$ 10,463.48 million in 2023 to US$ 17,399.10 million by 2030. It is estimated to grow at a CAGR of 7.5% from 2023 to 2030.
Growing Use of Point-of-Care Immunodiagnostics Drive North America Industrial Robotics Market
Point-of-care testing (POCT) has become critical to patient-centric healthcare due to the need for rapid diagnostic results to determine accurate and faster treatments. A shift from centralized point-of-care testing to decentralized testing has resulted in easy access to these diagnostics. Immunoassay testing helps monitor chronic conditions and detect pathogens, such as bacteria and viruses. Advanced point-of-care devices enable rapid screening of up to three components from a single sample. Also, the point-of-care diagnostics (POCD) inclined toward mobile healthcare (mH) smart devices could revolutionize personalized healthcare monitoring and management, paving the way for next-generation POCTs. The management of infectious diseases can be significantly improved by POCTs, particularly in developing countries where access to timely medical care is challenging and healthcare infrastructure is outdated and sparse. Additionally, the technologically developed diagnostic kits leading to fewer manual errors propel the immunodiagnostics market. Several market players are developing innovative immunodiagnostics products. For instance, Thermo Fisher Scientific has developed immunodiagnostics products such as enzyme-linked immunoassay (ELISA) reagents and buffers, antibodies and detection probes, linking mechanisms, blocking buffers and detergents, detection substrates, and capture surfaces, as well as services such as bioconjugation and detection. Further, in September 2020, Roche launched the SARS-CoV-2 Rapid Antigen Test, which is used in POC settings to help healthcare professionals identify the infection within 15 minutes in people suspected of carrying the virus.
In April 2021, DiaSorin introduced the LIAISON IQ, a new immunodiagnostics Point-of-Care (POC) reader, and the LIAISON QuickDetect COVID TrimericS Ab test, developed with Lumos Diagnostics for countries accepting the CE Mark. Using a fingerstick of human capillary blood, this test for the LIAISON IQ identifies specific IgG antibodies against SARS-CoV-2 Spike Protein in 10 minutes.
In April 2021, Chembio Diagnostics, Inc. launched an FDA Emergency Use Authorization-approved, in-licensed rapid point-of-care COVID-19/Flu A&B test for use in traditional and decentralized testing settings. The rapid immunoassay test requires no instrumentation and produces results in 15 minutes.
WHO applauded the test kit developers for efforts taken to innovate and respond to the masses' requirements during the COVID-19 crisis. According to the American Society for Clinical Pathology, in March 2020, the Cepheid Xpert Xpress SARS-CoV-2 test became the first POC COVID-19 detection assay to receive Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA).
Likewise, the use of immunodiagnostics in cancer treatment is increasing. In oncology, an immunodiagnostics test can confirm the presence of a solid tumor by detecting known tumor-associated antigens or antibodies. These advantages and indications are driving the immunodiagnostics market.
North America Immunodiagnostics Market Overview
The prevalence of cancer is increasing in the country at an alarming rate, leading to the rising demand for cancer diagnoses. According to the American Cancer Society's (ASC) cancer facts & figures estimates for 2023, nearly 1.9 million new cancer cases were registered in the US. It is further projected that in 2023, the country will register 609,360 deaths from cancer, which is ~1,670 deaths a day. However, the increased diagnostics have reduced the number of cancer-linked deaths. As per the ASC, in the past 28 years, the death rate from cancer in men and women has fallen 32% from its peak in 1991 to 2019. The fall in death rates was found to be because of early and advanced cancer diagnoses. The awareness of the advancements in diagnostic technology has grown among people. Therefore, it has resulted in the significant growth of the immunoassay market in the US. Similarly, diabetes is prevailing at a high rate in the geriatric population in the US. Many companies are providing immunoassay kits for diabetes. For instance, Bio-Rad Laboratories, Inc. offers Bio-Plex Pro human diabetes immunoassays, which are reliable and convenient for studying human diabetes and obesity markers. They help in managing and treating diabetes in diabetic patients. The market is expected to witness significant growth due to the rising prevalence of diabetes among US citizens. According to the data published by the Centers for Disease Control and Prevention (CDC) in the 2023 National Diabetes Statistics Report, 37.3 million people have diabetes in the US, which accounts for 11.3% of the total US population. Also, the reports state that 96 million people aged 18 years or above are prediabetic, accounting for 38% of the US population. Thus, considering the prevalence of diabetes in the country, an increased demand for immunodiagnostics is anticipated, leading to market growth. There has been unprecedented growth in innovative and improved medical technologies in recent years. As a result, there have been developments in advanced diagnostics and the overall healthcare industry. Moreover, the US houses various companies developing cutting-edge products for point-of-care diagnosis, paving the way for the growth of the immunodiagnostics market. In April 2020, Bio-Rad Laboratories launched a blood-based immunoassay kit to identify antibodies to the SARS-CoV-2.
North America Immunodiagnostics Market Revenue and Forecast to 2030 (US$ Million)
North America Immunodiagnostics Market Segmentation
The North America immunodiagnostics market is segmented into product, clinical indication, end user, and country.
Based on product, the North America immunodiagnostics market is segmented into enzyme-linked immunosorbent assays (ELISA), chemiluminescence immunoassays (CLIA), radioimmunoassays (RIA), and others. In 2023, the enzyme-linked immunosorbent assays (ELISA) segment registered the largest share in the North America immunodiagnostics market. The chemiluminescence immunoassays (CLIA) segment is further segmented into vitamin D assay market, HIV detection market, HIV ag/ab combo assay market, and other tests.
Based on clinical indication, the North America immunodiagnostics market is segmented into infectious diseases, hepatitis+HIV, endocrinology, gastrointestinal, metabolics, and others. In 2023, the infectious diseases segment registered the largest share in the North America immunodiagnostics market. The infectious diseases segment is further segmented into COVID-19, tuberculosis, lyme, infection management, zika, treponema, torch, measles and mumps, VZV, and EBV. The endocrinology segment is further segmented into hypertension, growth, diabetes, thyroid, and reproductive endocrinology.
Based on end user, the North America immunodiagnostics market is segmented into hospitals, clinics, diagnostic laboratories, academic & research institutes, and others. In 2023, the hospitals segment registered the largest share in the North America immunodiagnostics market.
Based on country, the North America immunodiagnostics market is segmented into the US, Canada, Mexico. In 2023, the US registered the largest share in the North America immunodiagnostics market.
Abbott Laboratories; bioMerieux SA; Danaher Corp; DiaSorin SpA; F. Hoffmann-La Roche Ltd; PerkinElmer Inc; Shenzhen Mindray Bio-Medical Electronics Co., Ltd.; Siemens Healthcare GmbH; Svar Life Science AB; and Thermo Fisher Scientific Inc are some of the leading companies operating in the North America immunodiagnostics market.