全球 LAL 检测市场 – 行业趋势和 2031 年预测

LAL 测试市场分析和规模

受传染病日益流行、人们对药品和医疗器械产品安全性的日益关注以及各行各业越来越多地采用 LAL 测试等因素的推动，全球 LAL 测试市场预计将在未来几年出现显著增长。制药行业是市场增长的主要贡献者，因为 LAL 测试是确保药品安全和质量的关键步骤。此外，医疗器械行业越来越多地采用 LAL 测试来满足监管要求并提高产品安全性。由于拥有完善的医疗保健基础设施和严格的监管标准，北美目前在市场上占据主导地位。

2023 年全球 LAL 测试市场规模价值 2.1096 亿美元，预计到 2031 年将达到 4.2035 亿美元，2024 年至 2031 年预测期内的复合年增长率为 9%。除了对市场价值、增长率、细分、地理覆盖范围和主要参与者等市场情景的见解外，Data Bridge Market Research 策划的市场报告还包括深度专家分析、患者流行病学、管道分析、定价分析和监管框架。

报告范围和市场细分       

市场定义

Limulus amebocyte lysate (LAL) testing is a method used to detect bacterial endotoxins, specifically lipopolysaccharides (LPS), which are found in the cell walls of Gram-negative bacteria.  The LAL test utilizes a protein extracted from the blood cells (amebocytes) of the horseshoe crab Limulus polyphemus, which is highly sensitive to bacterial endotoxins. The test is widely used in the pharmaceutical and healthcare industries to ensure the safety of drugs, medical devices, and other products by detecting and quantifying the presence of endotoxins.          

LAL Testing Market Dynamics

Drivers

• Expansion of Pharmaceutical and Healthcare Industries 

With emerging economic growth and improvements in healthcare infrastructure, there is a corresponding increase in the production and use of pharmaceuticals and medical devices. This growth is fueled by factors such as increasing access to healthcare, rising disposable incomes, and a growing focus on healthcare quality and safety. As a result, there is a greater need for reliable and effective testing methods, such as LAL testing, to ensure the safety and efficacy of these products. Market players are thus focusing on expanding their presence in these regions to capitalize on the growing demand for LAL testing products and services.                

• Increasing Prevalence of Infectious Diseases 

With the global population increasing and becoming more interconnected, the spread of infectious diseases is becoming a major concern. In response, pharmaceutical companies are developing new drugs and medical devices to combat these diseases, increasing the need for rigorous testing to ensure their safety and efficacy. LAL testing plays a crucial role in this process, as it is used to detect the presence of bacterial endotoxins, which can cause serious infections if present in pharmaceuticals or medical devices. As a result, there is a growing demand for LAL testing in the market, with pharmaceutical companies and healthcare facilities increasingly relying on these tests to safeguard public health.

Opportunities

• Growing Awareness about Product Safety  

There is a growing understanding of the importance of ensuring that pharmaceuticals and medical devices are free from contaminants such as endotoxins. This recognition is driven by the increasing awareness among consumers and healthcare professionals about the crucial role of product safety. This awareness is leading to a greater focus on the use of LAL testing to detect and quantify endotoxins in these products. Healthcare professionals are increasingly recommending LAL testing to ensure the safety of their patients, while consumers are becoming more informed about the risks associated with contaminated products. As a result, there is a growing opportunity for LAL testing products and services as companies seek to address these concerns and demonstrate the safety and quality of their products.          

• Stringent Regulatory Standards for Use of LAL Testing 

Regulatory bodies around the world, such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), require pharmaceutical and medical device manufacturers to perform LAL testing to ensure that their products are free from harmful endotoxins. Compliance with these standards is essential for market players to gain regulatory approval for their products, making LAL testing a necessary and integral part of the manufacturing process. This has led to an increase in demand for LAL testing products and services, as companies strive to meet these regulatory requirements and ensure the safety and efficacy of their products, creating new opportunities for the market.

Restraints/Challenges

• Limited Availability of Horseshoe Crab Blood

The use of horseshoe crab blood in LAL testing is essential for detecting bacterial endotoxins in pharmaceuticals and medical devices. However, horseshoe crab populations are declining due to habitat loss, overharvesting, and climate change, making their blood a limited resource. Concerns about the sustainability of horseshoe crab populations and the ethical implications of blood harvesting have led to efforts to find alternative sources of LAL testing materials. The availability and cost of LAL testing products could be impacted by these factors, potentially leading to challenges in meeting the growing demand for LAL testing.               

• Complexity of Testing Procedures

LAL testing can be complex and require specialized equipment and trained personnel, which limits its implementation, particularly in smaller healthcare facilities and laboratories with limited resources. The testing process involves several steps, including sample preparation, reagent mixing, and incubation, which must be performed accurately to ensure reliable results. In addition, the interpretation of test results requires expertise to differentiate between positive and negative samples. The complexity of LAL testing procedures can be a barrier to adoption, particularly for facilities that lack the necessary resources or expertise.

This market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Recent Development

• 2024 年 3 月，AmeboGenesis 宣布在可持续阿米巴细胞生产方面取得重大成就。该公司推出了一项创新技术，无需采集鲎血即可生产用于医学内毒素检测的鲎血所需的生物同质阿米巴细胞。鲎血对于生产鲎阿米巴细胞裂解物 (LAL) 至关重要，而鲎血对于确保全球注射药物、疫苗和植入设备的安全至关重要。这项新技术代表了可持续性方面的重大进步，并有可能彻底改变鲎血的生产方式

LAL 检测市场范围

市场根据应用和测试方法进行细分。这些细分市场之间的增长情况将帮助您分析行业中增长缓慢的细分市场，并为用户提供有价值的市场概览和市场洞察，帮助他们做出战略决策，确定核心市场应用。

测试方法

• 凝胶凝块内毒素检测
• 显色内毒素检测
• 浊度法内毒素检测

应用                                                

• 医疗器械制造
• 制药制造业

LAL 测试市场区域分析/见解

对市场进行了分析，并按上述国家、应用和测试方法提供了市场规模见解和趋势。

市场覆盖的国家包括美国、加拿大、墨西哥、德国、法国、英国、荷兰、瑞士、比利时、俄罗斯、意大利、西班牙、土耳其、欧洲其他地区、中国、日本、印度、韩国、新加坡、马来西亚、澳大利亚、泰国、印度尼西亚、菲律宾、亚太其他地区、沙特阿拉伯、阿联酋、南非、埃及、以色列、中东和非洲其他地区、巴西、阿根廷和南美洲其他地区。

由于政府大力推动传染病研究，北美有望在市场上占据主导地位。该地区完善的医疗基础设施和先进的诊断技术也有助于其在市场上占据主导地位。      

由于医疗基础设施改善、人们对新型诊断技术的认识不断提高以及对预防性医疗保健措施的日益重视，预计亚太地区将在预测期内实现显著增长。中国和印度等国家可支配收入的增加和大量患者群体的存在进一步推动了该地区的市场增长。

报告的国家部分还提供了影响单个市场因素和国内市场监管变化，这些因素和变化会影响市场的当前和未来趋势。下游和上游价值链分析、技术趋势和波特五力分析、案例研究等数据点是用于预测单个国家市场情景的一些指标。此外，在提供国家数据的预测分析时，还考虑了全球品牌的存在和可用性以及它们因来自本地和国内品牌的激烈或稀缺竞争而面临的挑战、国内关税和贸易路线的影响。

医疗保健基础设施增长安装基础和新技术渗透

该市场还为您提供每个国家/地区资本设备医疗支出增长、市场上不同类型产品的安装基数、使用生命线曲线的技术影响以及医疗监管情景的变化及其对市场的影响的详细市场分析。数据适用于 2016-2021 年的历史时期。

竞争格局和 LAL 测试市场份额分析

市场竞争格局按竞争对手提供详细信息。详细信息包括公司概况、公司财务状况、产生的收入、市场潜力、研发投资、新市场计划、全球影响力、生产基地和设施、生产能力、公司优势和劣势、产品发布、产品宽度和广度、应用主导地位。以上提供的数据点仅与公司对市场的关注有关。

市场上的一些主要参与者包括：

• Pacific BioLabs（美国）
• 龙沙（瑞士）
• 尼尔森实验室有限责任公司（美国）
• Bio-Synthesis Inc（美国）
• Biogenuix（印度）
• GenScript (美国)
• Thermo Fisher Scientific, Inc（美国）
• SGS SOCIÉTÉ GÉNÉRALE DE SURVEILLANCE SA（瑞士）
• 药明康德 (中国)
• Sartorius AG（德国）
• 阿斯利康（英国）
• Novasep（法国）
• 默克集团（德国）
• Charles River Laboratories（英国）

SKU-55093