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市场调查报告书
商品编码
1503318
到 2030 年 ELISA 方法的市场预测:按方法、技术、应用、最终用户和地区进行的全球分析Elisa Tests Market Forecasts to 2030 - Global Analysis By Method, Technology, Application, End User and By Geography |
根据 Stratistics MRC 的数据,2024 年全球 ELISA 市场规模将达到 27.8 亿美元,预计 2030 年将达到 46.3 亿美元,预测期内复合年增长率为 8.9%。
酵素结合免疫吸附检测法或 ELISA 测试经常用于医学诊断,以确定生物检体是否含有抗体、抗原、蛋白质或荷尔蒙。抗原-抗体相互作用的原理描述了酶联抗体如何与样本中的目标分子结合,并且是这种高度灵敏和特异性测定的基础。目标物质的存在和含量透过酶促反应产生的可测量讯号(通常是颜色变化)来指示。此外,ELISA 方法是诊断自体免疫疾病、过敏、感染疾病和其他健康状况的有用设备。
根据美国心臟协会的数据,心臟病是美国男性、女性以及大多数种族和民族的人死亡的主要原因。
感染疾病增加
由于都市化、国际旅行和人口增长等原因,全球范围内感染疾病的增加凸显了及时、准确诊断(例如 ELISA 方法)的重要性。此外,遏制 COVID-19 等流行病的持续努力正在加速诊断技术的研究和开发,促进了最先进的 ELISA 检测方法的创建和使用,用于感染疾病监测、诊断和监测。
合规和监管问题
ELISA 市场面临监管障碍和合规挑战,特别是在产品註册、品质保证和满足各个地区严格法规方面。如果新的检测或现有检测的修改需要耗时且资源密集的监管核准流程,产品上市或市场进入可能会被推迟。此外,随着标准和法规环境的变化,製造商和开发商必须不断监控和调整以确保合规性,从而导致业务和财务负担增加。
个人化医疗和生物标记识别
由于对个人化医疗和生物标记主导的医疗保健计划的日益关注,ELISA 方法有机会发现、验证和临床实施。为了实现个人化治疗选择和患者分层,ELISA 检测对于发现和测量与疾病诊断、预后和治疗效果相关的生物标记至关重要。此外,蛋白质组学、代谢体学和基因组学等体学技术的进步推动了对高通量ELISA检验技术可以检验候选生物标记并将其转化为临床有用的测试,这些技术为生物标誌物的发现提供了大量资料。
价格竞争与市场饱和
由于有多家提供可比较产品的製造商,ELISA 市场面临市场饱和和激烈的价格竞争。在高度商品化的细分市场中,大量竞争对手争夺市场占有率,这会压缩净利率并压低价格。学名药的出现进一步加剧了这种情况,导致假冒伪劣检测氾滥,损害了知名品牌的声誉和经济成功。
ELISA 市场受到了 COVID-19 大流行的严重影响,这导致对诊断测试解决方案的需求空前高涨,以识别 SARS-CoV-2 感染并追踪疾病进展。疫情最初扰乱了 ELISA 检测的所有生产、分销和全球供应链。然而,製造商很快就透过增加产量、提高产能、加快开发COVID-19特异性ELISA方法来应对需求激增。
诊断细分市场预计将在预测期内成为最大的细分市场
通常,诊断领域占据 ELISA(酵素结合免疫吸附检测法)检测市场的最大份额。许多疾病,如自体免疫疾病、过敏、荷尔蒙失衡和感染疾病等都可以使用 ELISA 方法进行诊断。此外,这些测定法由于其在测量目标分子方面的高灵敏度、特异性和准确性而受到青睐。 ELISA检验用于筛检、诊断和追踪疾病的诊断,使其成为世界各地临床实验室的支柱。
预计製药和生技公司领域在预测期内将呈现最高的复合年增长率
在 ELISA 市场中,製药和生物技术公司领域通常表现出最高的复合年增长率。这些公司主要依赖ELISA检验来进行临床前研究、临床试验和药物开发等应用。在药物发现过程的早期阶段,ELISA 在识别和检验潜在标靶和生物标记方面发挥重要作用。此外,生物技术和製药公司还使用 ELISA 方法来监测参与临床试验的患者的生物标记浓度,并评估候选药物的安全性和有效性。
就 ELISA 销售而言,北美通常占据最大的市场占有率。上述优势归因于多种因素,包括强大的医疗基础设施、先进诊断技术的采用增加、研发的大量投资以及製药和生物技术公司的集中。此外,政府对医疗保健计划的大力支持、有利的报销做法以及对疾病早期发现和管理重要性的日益认识也使该地区受益。
亚太地区的 ELISA 市场复合年增长率通常最高。推动这一增长的因素有很多,包括慢性病和感染疾病发病率上升、医疗保健成本上升、医疗保健服务的改善以及研发投资的增加。此外,由于该地区人口不断增长,特别是在中国和印度等国家,对包括ELISA检验在内的诊断检测用品的需求很大。此外,由于大量技术纯熟劳工、技术进步和医疗基础设施的改善等因素,亚太地区的 ELISA 市场正在快速成长。
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.