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市场调查报告书
商品编码
1503439
到 2030 年核准药物测试 (LDT) 市场预测:按产品、测试类型、应用、最终用户和地区进行的全球分析Laboratory-Developed Testing Market Forecasts to 2030 - Global Analysis By Product (Mass Spectrometry, Microarrays and Next-Generation Sequencing ), Test Type, Application, End User and By Geography |
根据 Stratistics MRC 的数据,2024 年全球核准药物检测 (LDT) 市场规模为 58.6 亿美元,预计到 2030 年将达到 101.6 亿美元,预测期内复合年增长率为 9.6%。
核准药物测试 (LDT) 是在临床或研究环境中的单一实验室内创建、检验和执行的诊断测试。与商业化测试不同,LDT 通常旨在满足特定实验室或患者群体的特定需求。 LDT 的范围从简单的测定到复杂的分子测试,为疾病、遗传倾向和治疗方法提供了宝贵的见解。 LDT 在促进个人化医疗和缩小诊断能力差距方面发挥着重要作用。
根据世界卫生组织 (WHO) 的数据,癌症已成为 183 个国家中 112 个国家 70 岁以上人口的第一或第二大死因,并已成为其他 23 个国家的第三或第四大死因。
增加与遗传健康风险相关的产品供应
随着基因检测变得越来越普遍,人们对全面了解健康风险的需求也越来越大。这正在推动非核准测试(LDT)市场产品阵容的扩大。公司正在扩大其产品组合,包括评估更广泛的遗传健康风险的测试,以满足消费者的多样化需求。这些产品包括各种疾病易感性、药物基因组学、血统追踪等测试。透过提供多样化的产品,LDT 提供者旨在满足医疗保健专业人员和消费者不断变化的需求,同时满足人们对个人化医疗和预防性医疗保健策略日益增长的兴趣。
严格规定
严格的监管对 LDT 市场构成了重大限制,影响了创新和市场准入。这些法规通常由 FDA 等监管机构执行,要求对 LDT 进行严格的验证和合规标准,从而增加了开发时间和成本。公司在复杂的监管途径中面临障碍,限制了他们快速引入新测试的能力。此外,不断变化的法规需要不断适应,进一步增加了合规性挑战。
个人化医疗的持续研究
对个人化药物的持续研究正在非核准测试(LDT)市场创造重大机会。随着基因组学和分子生物学的进步加速,个人化治疗越来越成为现实。这一趋势推动了对准确诊断工具的需求,并促使实验室在 LDT 方面进行创新,以实现个人化治疗策略。透过持续研究,LDT 可以增强其分析基因突变和生物标记的能力,以帮助定製药物治疗方案。这一演变与精准医疗的转变相吻合,并为 LDT 领域的成长和创新提供了一条充满希望的途径。
执行诊断测试时面临的业务障碍
进行诊断测试时常会出现行政障碍。这些障碍包括法规遵循的复杂性、验证和品管的资源有限以及不同实验室标准化程序的挑战。此外,试剂和设备的一致供应链管理也是一个问题。现有医疗保健系统和资料管理平台的互通性问题使营运环境更加复杂。
COVID-19 的疫情对核准药物检测(LDT)市场产生了重大影响。随着对准确诊断测试的迫切需求,对LDT,特别是COVID-19检测套组的需求正在迅速增加。这种不断增长的需求导致了对 LDT 研发的投资增加,并加强了监管监督,以确保测试的准确性和可靠性。此外,疫情也刺激了 LDT 技术的创新,促进了更快、更灵敏、更扩充性的测试解决方案的开发。然而,供应链中断和监管挑战也阻碍了市场成长。
预计在预测期内重症加护行业将是最大的
由于多种因素,核准药物检测 (LDT) 市场的重症加护领域正在显着增长。医疗技术的进步推动了需求的成长,推动了更复杂的测试的开发,这些测试可以快速评估急诊患者的关键健康指标。慢性病的增加需要对重症患者进行频繁监测,并增加了对专门检测的需求。此外,COVID-19 大流行凸显了快速、准确诊断的重要性,进一步加速了 LDT 在重症加护中的采用。 LDT 提供的可自订性和灵活性使医疗保健专业人员能够根据特定患者的需求量身定制测试,从而增强临床决策。
预计遗传学在预测期内的复合年增长率最高
在核准药物检测(LDT)市场中,遗传学领域正在经历显着的成长。基因组研究的进展揭示了有关疾病机制和个人化医疗的新知识,增加了对基因检测的需求。此外,基因定序技术成本的下降使得医疗保健专业人员和患者更容易获得这些测试。此外,遗传疾病的日益普及以及人们对早期检测和预防重要性的认识不断增强,正在推动基因检测服务的采用。这些测试为疾病风险评估、诊断、治疗选择和监测提供了有价值的信息,使其对现代医疗保健至关重要。
最近的趋势表明,欧洲的核准药物检测(LDT)市场正在经历显着成长。这种成长是由多种因素推动的,包括对个人化医疗和诊断的需求增加、实现更复杂测试的技术进步以及对医疗保健品质和效率的日益关注。此外,欧洲的支持性法规环境和强大的医疗保健基础设施促进了 LDT 的创新和投资。因此,该地区检测设施激增,为各种临床需求提供专门的检测服务。
由于多种因素,北美核准药物检测(LDT)市场正在经历显着成长。对个人化医疗和精准诊断的需求不断增长正在推动 LDT 服务的扩展。此外,次世代定序和分子诊断等技术的进步正在扩大 LDT 产品的范围。该地区的监管灵活性也促进了创新并加速了 LDT 的采用。此外,COVID-19 的爆发凸显了非核准检测的重要性,进一步提振了市场。
According to Stratistics MRC, the Global Laboratory-Developed Testing Market is accounted for $5.86 billion in 2024 and is expected to reach $10.16 billion by 2030 growing at a CAGR of 9.6% during the forecast period. Laboratory-developed testing (LDT) refers to diagnostic tests created, validated, and performed within a single laboratory, often in clinical or research settings. Unlike commercially available tests, LDTs are typically designed to meet the specific needs of a particular laboratory or patient population. They can range from simple assays to complex molecular tests, providing valuable insights into diseases, genetic predispositions, and treatment options. LDTs play a crucial role in advancing personalized medicine and filling gaps in diagnostic capabilities.
According to the World Health Organization, cancer is the leading or second-leading cause of death for those over the age of 70 in 112 of 183 nations, and third or fourth in the other 23 countries.
Increasing product offerings related to genetic health risks
As genetic testing becomes more prevalent, there's a growing demand for comprehensive insights into health risks. This driver fuels the expansion of product offerings within the Laboratory-Developed Testing (LDT) market. Companies are broadening their portfolios to include tests that assess a wider range of genetic health risks, catering to diverse consumer needs. These offerings may encompass tests for predispositions to various diseases, pharmacogenomics, and ancestry tracing, among others. By diversifying their products, LDT providers aim to meet the evolving demands of healthcare professionals and consumers while also capitalizing on the increasing interest in personalized medicine and preventive healthcare strategies.
Stringent regulations
Stringent regulations pose significant restraints in the Laboratory Developed Testing (LDT) market, impacting innovation and market entry. These regulations, often enforced by regulatory bodies like the FDA, require rigorous validation and compliance standards for LDTs, increasing the time and cost of development. Companies face hurdles in navigating complex regulatory pathways, limiting their ability to introduce new tests swiftly. Moreover, the evolving nature of regulations necessitates continuous adaptation, further adding to compliance challenges.
Continuous research on personalized medicines
Continuous research on personalized medicines presents a significant opportunity within the Laboratory Developed Testing (LDT) market. As advancements in genomics and molecular biology accelerate, tailored therapies become increasingly viable. This trend drives the demand for precise diagnostic tools, prompting laboratories to innovate LDTs for individualized treatment strategies. With ongoing research, LDTs can enhance their capabilities to analyze genetic variations and biomarkers, aiding in the customization of medication regimens. This evolution aligns with the shift towards precision medicine, offering a promising avenue for growth and innovation in the LDT sector.
Operational barriers faced in conducting diagnostic tests
Operational barriers often arise when conducting diagnostic tests. These hurdles may include regulatory compliance complexities, limited resources for validation and quality control, and challenges in standardizing procedures across different laboratories. Additionally, ensuring consistent supply chain management for reagents and equipment can be problematic. Interoperability issues with existing healthcare systems and data management platforms further complicate the operational landscape.
The COVID-19 pandemic has significantly impacted the laboratory-developed testing (LDT) market. With the urgent need for accurate diagnostic testing, there has been a surge in demand for LDTs, particularly for COVID-19 testing kits. This heightened demand has led to increased investment in LDT research and development, as well as regulatory scrutiny to ensure test accuracy and reliability. Furthermore, the pandemic has spurred innovation in LDT technologies, driving the development of faster, more sensitive, and more scalable testing solutions. However, supply chain disruptions and regulatory challenges have also posed obstacles to market growth.
The critical care segment is expected to be the largest during the forecast period
The Critical Care segment within the Laboratory Developed Testing (LDT) market is experiencing notable growth due to several factors. Advancements in medical technology have enabled the development of more sophisticated tests that can rapidly assess critical health indicators in acutely ill patients, driving demand. The rising prevalence of chronic diseases necessitates frequent monitoring of patients in critical care settings, fueling the need for specialized tests. Additionally, the COVID-19 pandemic has underscored the importance of rapid and accurate diagnostics, further boosting the adoption of LDTs in critical care. The customization and flexibility offered by LDTs allow healthcare providers to tailor tests to specific patient needs, enhancing clinical decision-making.
The Genetics segment is expected to have the highest CAGR during the forecast period
In the Laboratory Developed Testing (LDT) market, the genetics segment is experiencing notable growth. Advances in genomic research have unveiled new insights into disease mechanisms and personalized medicine, driving demand for genetic testing. Moreover, the declining cost of genetic sequencing technologies has made such tests more accessible to healthcare providers and patients. Additionally, the increasing prevalence of genetic disorders and the growing awareness of the importance of early detection and prevention are fuelling the adoption of genetic testing services. These tests offer valuable information for disease risk assessment, diagnosis, treatment selection, and monitoring, making them integral to modern healthcare practices.
In recent years, Europe has experienced significant growth in the Laboratory-Developed Testing (LDT) market. This growth can be attributed to several factors, including increasing demand for personalized medicine and diagnostics, advancements in technology enabling more sophisticated testing methods, and a rising emphasis on healthcare quality and efficiency. Additionally, Europe's supportive regulatory environment and robust healthcare infrastructure have fostered innovation and investment in LDT. As a result, the region has witnessed a proliferation of laboratories offering specialized testing services, catering to diverse clinical needs.
The Laboratory-Developed Testing (LDT) market in North America has witnessed substantial growth driven by several factors. Increased demand for personalized medicine and precision diagnostics has propelled the expansion of LDT services. Additionally, advancements in technology, such as next-generation sequencing and molecular diagnostics, have widened the scope of LDT offerings. Regulatory flexibility in the region has also fostered innovation and accelerated the adoption of LDTs. Moreover, the COVID-19 pandemic has highlighted the importance of diagnostic testing, further boosting the market.
Key players in the market
Some of the key players in Laboratory-Developed Testing market include Abbott Laboratories, Adaptive Biotechnologies, Bio-Rad Laboratories, Inc., Bruker Corporation, Epic Sciences, Inc., Eurofins Scientific, F. Hoffmann-La Roche Ltd, Genoptix, Inc., Guardant Health, Illumina, Inc., OPKO Health Inc., Qiagen, Quidel Corporation, Rosetta Genomics Ltd., Siemens Healthcare Private Limited, Sonic Healthcare Ltd. and Thermo Fisher Scientific Inc.
In June 2024, Bruker Corporation launches the new top-of-the-line timsTOF Ultra 2 system with significantly further enhanced sensitivity for deep profiling of small cells, subcellular organelles, as well as increased sample loading flexibility. Together with new Spectronaut 19 software and the novel PreOmics ENRICHplus kit, Bruker is setting new 4D-Proteomics standards from highest sensitivity to large-scale, deep plasma proteomics.
In March 2024, Global healthcare leader Abbott has announced the launch of its innovative automation solutions, GLP systems Track, to support laboratories' high-volume needs. With this launch, Abbott aims to strike a balance between quality of care and efficient use of resources. Across different care settings, depending on laboratory size and patient pool, this automation solution can handle bulk test tubes per day.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.