市場調查報告書
商品編碼
1503318
到 2030 年 ELISA 方法的市場預測:按方法、技術、應用、最終用戶和地區進行的全球分析Elisa Tests Market Forecasts to 2030 - Global Analysis By Method, Technology, Application, End User and By Geography |
根據 Stratistics MRC 的數據,2024 年全球 ELISA 市場規模將達到 27.8 億美元,預計 2030 年將達到 46.3 億美元,預測期內複合年成長率為 8.9%。
酵素結合免疫吸附檢測法或 ELISA 測試經常用於醫學診斷,以確定生物檢體是否含有抗體、抗原、蛋白質或荷爾蒙。抗原-抗體相互作用的原理描述了酶聯抗體如何與樣本中的目標分子結合,並且是這種高度靈敏和特異性測定的基礎。目標物質的存在和含量透過酶促反應產生的可測量訊號(通常是顏色變化)來指示。此外,ELISA 方法是診斷自體免疫疾病、過敏、感染疾病和其他健康狀況的有用設備。
根據美國心臟協會的數據,心臟病是美國男性、女性以及大多數種族和民族的人死亡的主要原因。
感染疾病增加
由於都市化、國際旅行和人口成長等原因,全球範圍內感染疾病的增加凸顯了及時、準確診斷(例如 ELISA 方法)的重要性。此外,遏制 COVID-19 等流行病的持續努力正在加速診斷技術的研究和開發,促進了最先進的 ELISA 檢測方法的創建和使用,用於感染疾病監測、診斷和監測。
合規和監管問題
ELISA 市場面臨監管障礙和合規挑戰,特別是在產品註冊、品質保證和滿足各個地區嚴格法規方面。如果新的檢測或現有檢測的修改需要耗時且資源密集的監管核准流程,產品上市或市場進入可能會被推遲。此外,隨著標準和法規環境的變化,製造商和開發商必須不斷監控和調整以確保合規性,從而導致業務和財務負擔增加。
個人化醫療和生物標記識別
由於對個人化醫療和生物標記主導的醫療保健計劃的日益關注,ELISA 方法有機會發現、驗證和臨床實施。為了實現個人化治療選擇和患者分層,ELISA 檢測對於發現和測量與疾病診斷、預後和治療效果相關的生物標記至關重要。此外,蛋白質組學、代謝體學和基因組學等體學技術的進步推動了對高通量ELISA檢驗技術可以檢驗候選生物標記並將其轉化為臨床有用的測試,這些技術為生物標記的發現提供了大量資料。
價格競爭與市場飽和
由於有多家提供可比較產品的製造商,ELISA 市場面臨市場飽和和激烈的價格競爭。在高度商品化的細分市場中,大量競爭對手爭奪市場佔有率,這會壓縮淨利率並壓低價格。學名藥的出現進一步加劇了這種情況,導致假冒偽劣檢測氾濫,損害了知名品牌的聲譽和經濟成功。
ELISA 市場受到了 COVID-19 大流行的嚴重影響,這導致對診斷測試解決方案的需求空前高漲,以識別 SARS-CoV-2 感染並追蹤疾病進展。疫情最初擾亂了 ELISA 檢測的所有生產、分銷和全球供應鏈。然而,製造商很快就透過增加產量、提高產能、加快開發COVID-19特異性ELISA方法來應對需求激增。
診斷細分市場預計將在預測期內成為最大的細分市場
通常,診斷領域佔據 ELISA(酵素結合免疫吸附檢測法)檢測市場的最大佔有率。許多疾病,如自體免疫疾病、過敏、荷爾蒙失衡和感染疾病等都可以使用 ELISA 方法進行診斷。此外,這些測定法由於其在測量目標分子方面的高靈敏度、特異性和準確性而受到青睞。 ELISA檢驗用於篩檢、診斷和追蹤疾病的診斷,使其成為世界各地臨床實驗室的支柱。
預計製藥和生技公司領域在預測期內將呈現最高的複合年成長率
在 ELISA 市場中,製藥和生物技術公司領域通常表現出最高的複合年成長率。這些公司主要依賴ELISA檢驗來進行臨床前研究、臨床試驗和藥物開發等應用。在藥物發現過程的早期階段,ELISA 在識別和檢驗潛在標靶和生物標記方面發揮重要作用。此外,生物技術和製藥公司還使用 ELISA 方法來監測參與臨床試驗的患者的生物標記濃度,並評估候選藥物的安全性和有效性。
就 ELISA 銷售而言,北美通常佔據最大的市場佔有率。上述優勢歸因於多種因素,包括強大的醫療基礎設施、先進診斷技術的採用增加、研發的大量投資以及製藥和生物技術公司的集中。此外,政府對醫療保健計劃的大力支持、有利的報銷做法以及對疾病早期發現和管理重要性的日益認知也使該地區受益。
亞太地區的 ELISA 市場複合年成長率通常最高。推動這一成長的因素有很多,包括慢性病和感染疾病發病率上升、醫療保健成本上升、醫療保健服務的改善以及研發投資的增加。此外,由於該地區人口不斷成長,特別是在中國和印度等國家,對包括ELISA檢驗在內的診斷檢測用品的需求很大。此外,由於大量技術純熟勞工、技術進步和醫療基礎設施的改善等因素,亞太地區的 ELISA 市場正在快速成長。
According to Stratistics MRC, the Global Elisa Tests Market is accounted for $2.78 billion in 2024 and is expected to reach $4.63 billion by 2030 growing at a CAGR of 8.9% during the forecast period. Enzyme-linked immunosorbent assays, or Elisa tests, are frequently used in medical diagnostics to find out whether biological samples contain antibodies, antigens, proteins, or hormones. The antigen-antibody interaction principle, which describes how an enzyme-linked antibody attaches to a target molecule in the sample, is the basis for this incredibly sensitive and specific assay. The presence and amount of the target substance are indicated by a measurable signal produced by the enzyme reaction, which is usually a color change. Moreover, Elisa tests are useful instruments for the diagnosis of autoimmune diseases, allergies, infectious diseases, and other health conditions.
According to the American Heart Association, Heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States.
Rising infectious disease prevalence
The rise in infectious diseases around the world, driven by causes like urbanization, international travel, and population growth, emphasizes how important it is to have timely and accurate diagnostics like Elisa tests. Additionally, continuous efforts to contain pandemics, like COVID-19, have sped up research and development in diagnostic technologies, encouraging the creation and use of cutting-edge Elisa assays for infectious disease surveillance, diagnosis, and monitoring.
Issues with compliance and regulatory difficulties
The market for Elisa tests is confronted with regulatory obstacles and compliance challenges, specifically pertaining to product registration, quality assurance, and compliance with strict regulations in various geographical areas. Product launches and market entry may be delayed if new assays or changes to existing ones require lengthy and resource-intensive regulatory approval processes. Furthermore, as standards and regulatory environments change, manufacturers and developers must continually monitor and adjust to ensure compliance, which increases their operational and financial burdens.
Personalized health care and biomarker identification
Elisa tests have opportunities in biomarker discovery, validation, and clinical implementation due to the increasing focus on personalized medicine and biomarker-driven approaches to healthcare. In order to enable individualized treatment choices and patient stratification, Elisa assays are essential in locating and measuring biomarkers linked to disease diagnosis, prognosis, and treatment response. Moreover, the need for high-throughput Elisa assays that can validate and convert biomarker candidates into clinically useful tests is being driven by the development of omics technologies, including proteomics, metabolomics, and genomics, which offer a plethora of data for biomarker discovery.
Price competition and market saturation
Due to the existence of multiple manufacturers offering comparable products, the Elisa test market is vulnerable to market saturation and intense price competition. In highly commoditized market segments, the multitude of competitors fighting for market share can result in pressure on margins and price erosion. Additionally, the situation is made worse by the availability of generic and less expensive alternatives, as well as by the surge in fake or inferior assays that damage the reputation and financial success of well-known brands.
The market for Elisa tests has been significantly impacted by the COVID-19 pandemic, which has resulted in an unparalleled need for diagnostic testing solutions to identify SARS-CoV-2 infection and track the progression of the disease. Elisa assay production, distribution, and the global supply chain were all initially disrupted by the pandemic. However, manufacturers quickly responded to the spike in demand by increasing production, building up their capacity, and speeding up the development of COVID-19-specific Elisa tests.
The Diagnostics segment is expected to be the largest during the forecast period
The diagnostics segment usually holds the largest share of the market for ELISA (enzyme-linked immunosorbent assay) tests. Many diseases, such as autoimmune disorders, allergies, hormone imbalances, and infectious diseases, can be diagnosed with ELISA tests. Moreover, these assays are preferred due to their high sensitivity, specificity, and precision in measuring target molecules. As ELISA assays are used in the diagnostics segment to screen, diagnose, and track diseases, they are a mainstay in clinical laboratories across the globe.
The Pharmaceutical and Biotech Companies segment is expected to have the highest CAGR during the forecast period
In the ELISA test market, the pharmaceutical and biotech company segment usually shows the highest CAGR. These businesses mainly rely on ELISA assays for preclinical research, clinical trials, and drug development, among other uses. Early on in the drug discovery process, ELISA tests play a crucial role in identifying and validating potential targets and biomarkers. Additionally, ELISA assays are also used by biotech and pharmaceutical companies to monitor biomarker levels in patients participating in clinical trials and to assess the safety and efficacy of drug candidates.
When it comes to ELISA test sales, North America usually commands the largest market share. The aforementioned dominance can be attributed to multiple factors, such as the existence of a robust healthcare infrastructure, elevated adoption rates of sophisticated diagnostic technologies, substantial investments in research and development endeavors, and a substantial concentration of pharmaceutical and biotechnology enterprises. Furthermore, strong government support for healthcare initiatives, advantageous reimbursement practices, and a growing understanding of the significance of early disease detection and management also benefit the region.
In the market for ELISA tests, the Asia-Pacific region usually shows the highest CAGR. Numerous factors, such as the rising incidence of chronic illnesses and infectious diseases, rising healthcare costs, greater access to healthcare services, and rising investments in R&D, are driving this growth. Moreover, there is a huge need for diagnostic testing supplies, including ELISA assays, due to the region's expanding population, especially in nations like China and India. Moreover, the Asia-Pacific region's ELISA test market is growing quickly due to factors like the availability of a large pool of skilled labor, technological advancements, and improvements in healthcare infrastructure.
Key players in the market
Some of the key players in Elisa Tests market include F. Hoffmann-La Roche Ltd., BioLegend, Inc, Siemens Healthineers, Enzo Life Sciences, Inc, Bio-Rad Laboratories, Inc., Merck KGaA , Abbott Laboratories, Eurofins Scientific, General Electric, PerkinElmer, Inc., BioMerieux SA, Sysmex Corporation, Agilent Technologies, Inc., Ortho Clinical Diagnostics, Danaher Corporation, ZEUS Scientific, Inc., R&D Systems, Inc and Thermo Fisher Scientific.
In June 2024, Siemens Healthineers and Hermes Medical Solutions, a molecular imaging software developer, have entered into an agreement to provide Siemens customers with access to Hermia dosimetry products. Hermia Organ Dosimetry will be integrated on syngo.via, the Siemens Healthineers vendor-neutral imaging software platform for 2D, 3D, and 4D reading and advanced visualization.
In May 2024, Merck KGaA has announced it has signed a definitive agreement to acquire Mirus Bio in a deal worth $600m, which will complement its current portfolio of novel modalities. Anticipated to close in the third quarter of 2024, the transaction will help to advance Merck's viral vector manufacturing therapies from preclinical through to commercial production.
In December 2023, Roche announced the entry into a definitive merger agreement to acquire Carmot Therapeutics, Inc. ("Carmot"), a privately owned US company based in Berkeley, California. Carmot's R&D portfolio includes clinical stage subcutaneous and oral incretins with best-in-class potential to treat obesity in patients with and without diabetes, as well as a number of preclinical programs.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.