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市场调查报告书
商品编码
1383359
2030 年体外诊断市场预测:按产品/服务、技术、应用、最终用户和地区进行的全球分析Invitro Diagnostics Market Forecasts to 2030 - Global Analysis By Product and Service, Technology, Application, End User and By Geography. |
根据 Stratistics MRC 的数据,2023 年全球体外诊断市场规模为 981.4 亿美元,预计到 2030 年将达到 1,485.4 亿美元,预测期内复合年增长率为 6.1%。
体外诊断是指使用血液、尿液和组织等生物样本的一类医学检查和诊断技术。这些测试用于监测和识别自体免疫疾病、感染疾病和各种其他医疗状况。它也用于分析药物治疗的变化。此外,它还可以准确、及时地进行诊断,有助于改善健康状况、降低医疗成本、防止疾病传播。
根据国际糖尿病联盟 (IDF) 的数据,2021 年全球有 5.37 亿人患有糖尿病,预计到 2030 年将增加至 6.43 亿人。
新兴国家对早期疾病诊断的认识不断提高,成为体外製药市场的关键驱动因素。随着这些地区医疗保健意识和教育的提高,越来越多的人正在寻求预防性医疗保健措施和疾病的早期发现。早期诊断通常会带来更好的治疗效果、降低医疗成本并改善整体健康。这种意识不仅使个人受益,还鼓励卫生系统和政府投资于诊断基础设施,从而推动对体外诊断产品和服务的需求。此外,随着新兴国家扩大医疗保健覆盖范围,对具有成本效益且易于使用的诊断解决方案的需求不断增加,满足这一需求正在推动体外诊断领域的创新和市场成长。
开发、製造和购买体外药物测试和设备所涉及的成本可能很高。这些成本通常会转嫁给医疗保健提供者和患者,从而导致经济挑战。报销不足和医疗保健预算有限进一步加剧了经济负担。因此,获得基本诊断服务的机会可能会减少,特别是在资源匮乏的地区,疾病的早期发现和管理可能会受到阻碍。因此,这将阻碍市场需求。
诊断技术的持续创新透过提高准确性、效率和可及性正在彻底改变医疗保健。分子诊断、晶片实验室平台和晶载次世代定序等先进技术可实现更快、更准确的测试结果。便携式和即时检测设备的发展使诊断更加方便,特别是在偏远和资源有限的地区。此外,体外药物与数位健康平台和人工智慧的整合将进一步增强资料分析和解释。这些进步不仅改善了病患护理,也降低了医疗成本。投资研发以利用这些技术的体外诊断公司可以获得竞争优势,并开拓新兴市场以获得尖端诊断解决方案。
严格的法规和法律指南对体外诊断市场构成重大威胁。这些指南通常是为了确保诊断测试的安全性和有效性而实施的,但可能会导致合规成本增加、核准流程更长以及体外诊断製造商的市场进入障碍。违规还可能导致罚款和产品召回。此外,不断变化的法规可能使公司难以适应不断变化的标准,从而影响产品开发和创新。
在 COVID-19大流行期间,多个行业都受到了积极和消极的影响。分子诊断的使用增加对市场产生了正面影响,抵消了其他类别的负面影响。此外,对检测套组和消耗品的需求不断增长,以监测住院的 COVID-19 患者的血糖值和肌钙蛋白水平。由于分子和即时检测销售额的大幅成长,参与公司的收益大幅成长。然而,全球医院和实验室进行的常规检测大幅减少,导致一些大公司的收益利润率下降。
预计糖尿病领域将占最大份额。糖尿病是一种慢性代谢疾病,代表了体外诊断市场的重要部分。糖尿病的诊断测试对于疾病的早期发现、监测和管理至关重要。糖尿病体外药品市场包括血糖值监测设备、HbA1c 测试以及评估血糖值的各种其他测试。随着全球糖尿病盛行率持续上升,该领域正在稳步增长。此外,体外诊断的创新正在帮助患者和医疗保健专业人员有效控製糖尿病、减少併发症、提高数百万糖尿病患者的生活质量,为双方提供准确、便捷的工具发挥重要作用。
预计临床实验室部门在预测期内将出现良好成长。临床实验室是体外诊断市场的基本部分。这些专业设施对血液、尿液和组织等患者样本进行各种诊断测试,以帮助诊断、治疗和监测疾病。临床实验室在医疗保健中发挥关键作用,为医疗保健提供者提供决策所需的关键资讯。此外,我们的临床实验室提供广泛的测试,包括化学、微生物学、血液学、免疫学和分子诊断。由于对准确、及时的患者照护和医疗服务的需求不断增加,临床实验室行业正在不断增长。
在估计期间,亚太地区占据最大的市场占有率。亚太地区是全球体外诊断市场中快速成长且充满活力的部门。该地区是中国、印度和日本等人口众多的多元化国家的所在地,卫生基础设施正在显着扩张,卫生支出也在增加。促成这一增长的因素包括疾病盛行率上升、早期疾病检测意识增强以及获得医疗保健服务的机会增加。此外,政府倡议和监管改革正在提高诊断测试的品质和可及性。随着检测需求的激增,COVID-19 大流行也凸显了该地区体外诊断的重要性。
由于完善的医疗保健行业和不断增加的慢性病数量,预计北美在预测期内将实现盈利增长。该地区的特点是竞争形势,拥有雅培实验室、赛默飞世尔科技和罗氏诊断等知名公司。此外,该市场专注于研究和开发,从而引入尖端的诊断测试和技术。美国FDA 等监管机构负责确保品质和安全标准。此外,COVID-19 大流行凸显了体外诊断测试对该地区感染疾病诊断、追踪和管理的重要性。
According to Stratistics MRC, the Global In vitro Diagnostics Market is accounted for $98.14 billion in 2023 and is expected to reach $148.54 billion by 2030 growing at a CAGR of 6.1% during the forecast period. In vitro diagnostics (IVD) refers to a category of medical tests and diagnostic techniques on biological samples such as blood, urine, and tissues. These tests are used to monitor and identify autoimmune diseases, infectious diseases, and a variety of other medical conditions. They may also be used to analyse changes in drug therapy. Moreover, they enable precise and timely diagnoses, contributing to improved health outcomes, reduced healthcare costs, and the prevention of disease spread.
According to the International Diabetes Federation (IDF), in 2021, there were 537 million people across the globe suffering from diabetes, and the number is expected to increase to 643 million by 2030.
The growing awareness of early disease diagnosis in emerging economies stands out as a significant driver of the in vitro diagnostics (IVD) market. As healthcare awareness and education improve in these regions, more people are seeking preventive healthcare measures and early disease detection. Early diagnosis often results in better treatment outcomes, reduced healthcare costs, and improved overall health. This awareness not only benefits individuals but also prompts healthcare systems and governments to invest in diagnostic infrastructure, thus boosting the demand for IVD products and services. Moreover, as emerging economies expand their healthcare access, there is a greater need for cost-effective and accessible diagnostic solutions, driving innovation and market growth in the IVD sector to meet these demands.
The expenses associated with developing, producing, and procuring IVD tests and equipment can be substantial. These costs are often passed on to healthcare providers and patients, leading to affordability challenges. Inadequate reimbursement and limited healthcare budgets further exacerbate the financial burden. This can result in reduced access to essential diagnostic services, particularly in resource-constrained settings, hindering early disease detection and management. Therefore, this will hamper market demand.
Continuous innovation in diagnostic technologies is revolutionising healthcare by enhancing accuracy, efficiency, and accessibility. Advanced techniques, such as molecular diagnostics, lab-on-a-chip platforms, and next-generation sequencing, allow for quicker and more precise test results. The development of portable and point-of-care testing devices makes diagnostics more convenient, especially in remote or resource-limited areas. Additionally, the integration of IVD with digital health platforms and artificial intelligence further enhances data analysis and interpretation. These advancements not only improve patient care but also reduce healthcare costs. IVD companies that invest in research and development to leverage these technologies can gain a competitive edge and tap into the expanding market for cutting-edge diagnostic solutions
Stringent regulatory and legal guidelines pose a significant threat to the in vitro diagnostics (IVD) market. These guidelines often imposed to ensure the safety and efficacy of diagnostic tests, can lead to increased compliance costs, lengthy approval processes, and market entry barriers for IVD manufacturers. Non-compliance can result in fines and product recalls. Additionally, evolving regulations can make it challenging for companies to keep up with changing standards, impacting product development and innovation.
During the COVID-19 pandemic, several segments witnessed both positive and negative effects. The market experienced a positive impact due to the increased use of molecular diagnostics, which counteracted the negative effects of other categories. Furthermore, among hospitalised COVID-19 patients, there was a rise in the need for test kits and consumables for monitoring blood glucose and troponin levels. Participants have experienced a significant increase in sales of molecular and point-of-care tests, which has resulted in a significant increase in their earnings. However, a significant drop in routine testing carried out in hospitals and laboratories globally caused some major firms to see a dip in their revenue margins.
The Diabetes segment is estimated to hold the largest share. Diabetes, a chronic metabolic disorder, represents a significant segment of the in vitro diagnostics (IVD) market. Diagnostic tests for diabetes are vital for the early detection, monitoring, and management of the condition. The IVD market for diabetes includes blood glucose monitoring devices, HbA1c tests, and various other assays for assessing blood sugar levels. As the global prevalence of diabetes continues to rise, this segment experiences consistent growth. Furthermore, IVD innovations play a crucial role in delivering precise and convenient tools for both patients and healthcare professionals to effectively control diabetes, reduce complications, and enhance the quality of life for millions of individuals affected by the disease.
The Clinical Laboratories segment is anticipated to have lucrative growth during the forecast period. Clinical laboratories are a fundamental segment of the in vitro diagnostics (IVD) market. These specialised facilities conduct various diagnostic tests on patient samples, such as blood, urine, and tissue, to aid in disease diagnosis, treatment, and monitoring. They play a crucial role in healthcare, providing essential information to healthcare providers for decision-making. Moreover, clinical laboratories offer a wide range of tests, including chemistry, microbiology, haematology, immunology, and molecular diagnostics. The clinical laboratory industry is growing due to the growing need for accurate and timely patient care as well as the need for healthcare services.
Asia Pacific commanded the largest market share during the extrapolated period. The Asia-Pacific region represents a rapidly growing and dynamic sector within the global in vitro diagnostics (IVD) market. With diverse and populous countries, such as China, India, and Japan, this region is witnessing significant expansion in healthcare infrastructure and increasing healthcare expenditures. Factors contributing to the growth include rising disease prevalence, increasing awareness of early disease detection, and growing access to healthcare services. Moreover, government initiatives and regulatory reforms are driving quality and accessibility in diagnostic testing. The COVID-19 pandemic has also emphasised the importance of IVD in the region, with a surge in demand for testing.
North America is expected to witness profitable growth over the projection period, owing to the well-established healthcare industry and the rising prevalence of chronic diseases. The region is characterised by a competitive landscape with prominent companies like Abbott Laboratories, Thermo Fisher Scientific, and Roche Diagnostics. Moreover, the market benefits from a strong focus on research and development, leading to the introduction of cutting-edge diagnostic tests and technologies. Regulatory bodies, such as the FDA in the United States, ensure quality and safety standards. Additionally, the COVID-19 pandemic has underscored the importance of IVD tests in the region for diagnosing, tracking, and managing infectious diseases.
Some of the key players in the In vitro Diagnostics Market include: Freenome Holdings, Inc., Agilent Technologies, Inc., Natera, Inc., Exact Sciences Corporation, F. Hoffmann-La Roche Ltd., Abbott Laboratories, Sysmex Corporation, Siemens Healthineers AG, BD (Becton, Dickinson, and Company), Quest Diagnostics Incorporated, Bio-Rad Laboratories, Inc., Alere, Inc., InterVenn Biosciences, Guardant Health, Thermo Fisher Scientific, Inc., NeoGenomics Laboratories, Invitae Corporation, Beckman Coulter, Danaher and Illumina, Inc.
In May 2023, Freenome, a privately held biotech company, announced that it has acquired Oncimmune Ltd, a UK-based global immunodiagnostics developer with a commercialized CE-IVD marked EarlyCDT Lung blood test, autoantibody platform and research and development pipeline of 7+ cancer detection signatures.
In November 2022, Thermo Fisher Scientific (US) launched the rapid RT-PCR Accula Flu A/Flu B Test designed to enable healthcare providers to detect and differentiate influenza A and B in about 30 minutes.
In October 2022, Thermo Fisher Scientific (US) entered a definitive agreement to acquire The Binding Site Group, a global leader in specialty diagnostics. The Binding Site provides specialty diagnostic assays and instruments to improve the diagnosis and management of blood cancers and immune system disorders.
In September 2022, Sysmex Corporation (Japan) launched the UF-1500 Fully Automated Urine Particle Analyzer (UF-1500) for urine sediment testing. The UF-1500 inherits the high levels of functionality and usability of the UF-5000 Fully Automated Urine Particle Analyzer (UF-5000).
In August 2022, Al-Futtaim Health (Dubai) and Abbott Laboratories (US) entered into a strategic partnership to improve the standards of advanced laboratory diagnostics in Dubai.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.