体外诊断市场全球性分析及规模预测 (24.04)

In Vitro Diagnostics Market by Product & Service (instruments, Kits, Software), Technology(lmmunoassay, Hematology, Urinalysis), Specimen (Blood, Saliva), Test Type, Application (Oncology，Autoimmune, CVD, Infectious Diseases) & Region - Global Forecast to 2029
体外诊断市场分析及5年发展预测——涉及体外诊断产品及服务（仪器、试剂盒和检测软件）、送检样本（血液、唾液）、检测方式、应用领域（肿瘤、免疫性疾病、心血管疾病及感染病）

The global in vitro diagnostics market in terms of revenue was estimated to be worth $85.2 bilion in 2024 and is poised to reach $119.4 bilion by 2029, growing at a CAGR of 6.9% from 2024 to 2029. The new research study consists of industry trends, pricing analysis, patent analysis, conference and webinar materials, key stakeholders, and buying behaviour in the market. Growth in the in vitro diagnostics (lVD) market is driven by growing prevalence of chronic & infectious diseases, the increasing geriatric population in developed and developing regions, and rising demand for point-of-care testing. However, an unfavorable reimbursement scenario will restrain the growth of the lVD market to a certain extent during the forecast period.
2024年全球体外诊断市场总营收约为852亿美元，2029年的总营收预计达到1,194亿美元，2024-2029年间的年复合增长率为6.9%。最新研究报告包括产业走向、产品价格及专利分析、会议报道资料、专家人士以及市场买卖行为等内容。主要结论是，慢性病和传染性疾病发病率的上升、发达地区和发展中地区老龄化程度加剧、即时检测需求量增加等因素驱动着体外诊断（IVD）市场的发展。但是，医保报销制度可能在一定程度上会限制IVD市场的发展。

DRIVER: Increasing geriatric population and subsequent risen chronic & infectious diseases
IVD市场驱动力：老龄化程度加剧，及其慢性病和感染性疾病发病率不断上升
With the rapid growth in the geriatric population globally, the prevalence of age-associated diseases is expected to increase significantly. According to the United Nations Department of Economic and Social Affairs (UN DESA) at the world level in 2022, approximately 10 percent of people worldwide are aged 65 or over. The proportion of older persons in the world is projected to reach nearly 12 percent in 2030 and 16 percent in 2050.
全球老龄化程度正在快速加剧，预计相关疾病的发病率也会显著上升。就联合国经社部（UN DESA）全球性的调查数据显示，在2022年，65岁及以上老人占全球总人口的比例约10%，预计到2030年和2050年，该数字可能会上升到12%和16%。

With age, the risk of developing diseases increases proportionate——for instance, nearly 80% of the elderly population in the US suffers from at least one chronic condition (Source: CDC). According to the National Council On Aging (NCOA) research, 94.9% percent of adults aged 60 and older have at least one condition, while 78.7% have two or more.
随着老龄化的加剧，其患病风险也会增加——比如，在美国，患有一次或多次慢性病的老年人比例约为80%（信息来源：美国疾病控制与预防中心CDC）。据全国老龄委员会（NCOA）的研究报道，60岁及以上的老年人患一次或多次慢性病的比例高达94.9%，两次或多次的比例达78.7%。

Having high blood cholesterol raises the risk for heart disease, the leading cause of death, and for stroke, the fifth leading cause of death. Diabetes is another chronic disease that affects the senior population since this population is prone to endocrine disorders due to hormonal fluctuations. Hence, the growth in the geriatric population is expected to increase the prevalence of several chronic conditions worldwide and drive the growth of the lVD market.
高血脂增加了心脏疾病（“死亡头号杀手”）和中风（致死疾病排名第五）的患病风险。由于大多数老年人存在激素水平紊乱导致内分泌失调的问题，因此多数人患有糖尿病。总之，不断增加的老龄化人群导致慢性疾病患者的数目越来越高，而这也驱动了IVD市场的发展。

RESTRAlNT: Unfavourable reimbursement
不利因素：报销制度不支持
Medicare does not currently provide genetic testing coverage for individuals without a history of cancer. Similarly, according to MedPAC (Medicare Payment Advisory Commission), medical testing has seen a 40% decline in reimbursement over the last 40 years. This decline and additional budgetary concerns among healthcare systems will be a major obstacle to implementing novel diagnostic techniques in clinical laboratories. Besides, the rules governing reimbursement have been tightened in a number of European nations. The restrictions are severe, particularly for creators of innovative diagnostics whose coverage assessment procedure is opaque and differs throughout insurers. The standards for the caliber of evidence required for reimbursement are unclear to inventors of novel diagnostics. This has led to inefficiencies in the creation of innovative diagnoses and a commensurate rise in needless R&D expenses. These changes in the reimbursement scenario are expected to adversely affect growth of the IVD market.
除癌症外，当前医保的覆盖范围不包含个人的基因诊断业务。同样，据美国医疗保险支付咨询委员会（MedPAC）报道，医疗检测的报销费用在过去40年内下滑了40%。对于未来要推广到临床实验室的新兴诊断技术而言，报销比例缩减以及医疗保健系统对预算的担忧将会对其产生很大的阻碍。此外，欧洲一些国家也收紧了报销规定。当前的规定非常严苛，其主要针对产品评估流程不透明以及在各保险公司中规定不一的新兴诊断公司。但目前报销所需要的材料标准仍较模糊。这些不利措施拖慢了新兴诊断公司在产品研发上的速度，而且也造成了部分不必要的研发投入。因此，当前医保制度不利于IVD市场的发展。

OPPORTUNITY: Growth opportunities in emerging markets
机遇：发展中国家潜力巨大
Major players in the IVD industry should expect growth opportunities from developing economies including India, Brazil, China, South Korea, Turkey, Russia, South Africa, and Mexico. This can be attributed the high disease prevalence, large patient population, improved healthcare infrastructure, increasing disposable income, and growing medical tourism in these countries.
The incidence of tropical diseases, such as Zika, malaria, and chikungunya, has increased significantly in these countries, with South American nations accounting for the highest number of cases. However, the Asia Pacific has emerged as an adaptive and business-friendly hub due to its relatively less-stringent regulations and data requirements. Currently, China is one of the largest investors in R&D. Moreover, various market players are strategically expanding their product portfolios across emerging countries through product launches & approval collaborations, and expansion. This will support the installation of diagnostic systems in laboratories and contribute to the adoption of IVD.
IVD公司应该从发展中国家中寻找销售机遇，比如印度、中国、东南亚、土耳其、俄罗斯、东亚地区以及墨西哥。这些地区各类疾病发病率较高，患病人群数量较多，医疗卫生设施急需完善，而当地居民的可支配收入增加，医疗旅游业也在不断增长，因此存在较大的机遇。
上述地区的热带疾病的发病率（比如：寨卡、疟疾、基孔肯雅热）也呈显著上升的趋势，其中南美地区患病人数最高。而且，亚太地区国家的法规和数据监管政策都较为宽松，因此，该地区已经成了诊断产业发展的商业友好型基地。当前，中国是全球最大的IVD研发投资国之一。值得一提的是，市场资本在这些地区已经开始了产品布局，包括产品上市&审批合作，以及产品推广。这些动作为实验室诊断系统的搭建以及IVD产品的推广应用提供了支持。
 
CHALLENGE: Operational Barriers
挑战：操作步骤繁琐复杂
Clinical laboratories across major markets are still evolving; technicians face operational challenges in ensuring effective sample procurement, storage, and transportation, especially while adopting novel technologies such as NGS and lab-on-a-chip PCR devices. Laboratory space also needs to be reconfigured to meet the requirements of conducting specific diagnostic tests used for pathogen detection to avoid cross-contamination and ensure efficient time management. This results in considerable cost escalation to maintain and operate advanced molecular diagnostic instruments, particularly those capable of handling a single sample type.
However, the shortage of skilled laboratory technicians to operate advanced diagnostic products has hindered overall adoption of in vitro diagnostics, particularly in emerging markets.
市面上运营的医疗实验室一直在升级。由于涉及样本快速处理、储存、运输以及NGS和芯片实验室(lab-on-a-chip)PCR等设备的操作，技术人员面临着很多操作方面上的挑战。为了满足病原微生物诊断过程中避免交叉感染和有效时间管理的需求，实验室的布局可能也需要进行重新配置。因此，对于公司而言，单在高级分子诊断设备维护和运转方面上的投入成本就很大，而对于只能处理一种样本的设备来说，相对投入成本会更高。

Blood, serum, and plasma segment accounted for the largest share of the in vitro diagnostics industry in 2023, by specimen.
2023年体外诊断样本中，血液、血清和血浆占比最大
Based on specimen, the IVD market is segmented into blood, serum, and plasma, urine, saliva, and other specimens. The blood, serum, and plasma segment accounted for the largest share in the IVD market in 2023. The significant share of the segment can be attributed to the growing number of blood donations. Also, blood is the most widely collected sample for IVD diagnostic procedures, and these are preferred health conditions, such as genetic disorders, cardiovascular diseases, for overall health screening as they provide information on various cancer, and diabetes.
IVD市场上的样本类型可以被划分为血液、血清、血浆、尿液、唾液以及其他分类。其中，2023年，前三种样本类型占比最高。这一方面可能要归因于居民献血比例的上升；另一个原因是，由于IVD诊断可以提供各种癌症和糖尿病信息，因此该诊断是遗传病、心血管疾病等多种疾病进行全面体检的首选检测项目，而在IVD诊断业务中，血液是最常使用的标本。

Hospital & clinics segment accounted for the largest share in the in vitro diagnostics industry in 2023, by end user.
2023年体外诊断样本中，医院和临床的送检样本比例最大
Based on end user, the IVD market is segmented into hospital &clinics, clinical laboratories, blood banks, home care settings, pharmaceutical & biotechnology companies, academic institutes, and other end users. In 2023, hospital & clinics accounted for the largest share in the IVD market. Rising number of patient admissions due to infectious diseases have increased the adoption and use of in vitro diagnostic tests across hospital laboratories, thereby driving the market growth.
IVD市场根据终端用户可以划分为医院及临床、临床实验室、采供血机构、家居护理设备、制药和生物技术公司、科研院校以及其他。2023年，医院及临床的送检样本比例最大。由于感染传染病患者入院人数增加，导致医院实验室内进行体外诊断检测的次数大幅上升，继而推动了IVD市场的发展。

North America accounted for the largest share of the in vitro diagnostics industry in 2023
2023年体外诊断样本中，北美的送检样本比例最大
Based on region, the IVD market is segmented into six major regions-Noth America, Europe, Asia Pacific, Latin America, Middle East &Africa, and the GCC Countries. In 2023, North America accounted for the largest share in the IVD market. The large share of this region in the global IVD market is mainly attributed to the highly developed healthcare system in the US and Canada, the presence of many leading national clinical laboratories, and the easy accessibility to technologically advanced instruments. However, healthcare coverage expansions made by Medicare, Medicaid, and private health insurance companies in the region are also expected to play a significant role in fueling the growth of the IVD market.
IVD市场可以划分为六大区域——北美、欧洲、亚太地区、拉丁美洲、中东和亚洲、以及海湾阿拉伯国家合作委员会国家（GCC Countries）。2023年，北美地区的送检样本占比最大，这主要归因于美国和加拿大拥有高度发达的医疗体系、国际型顶尖临床实验室、以及随处可见的高端设备。此外，医疗保险（Medicare）、医疗补助(Medicaid)和私人医疗保险公司也扩大了医疗保险覆盖范围，以期在IVD产业发展的过程中发挥重要作用。

报告机构：Markets and Markets
文章来源：https://www.marketsandmarkets.com/Market-Reports/ivd-in-vitro-diagnostics-market-703.html?gad_source=1&gclid=Cj0KCQjwn7mwBhCiARIsAGoxjaKDLXX5OdARtmOdsOlM0PzaW1ctOPeF5_qKJxTzVzjrW5R6DkKihaEaAnekEALw_wcB