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市场调查报告书
商品编码
1494911
到 2030 年体外诊断 (IVD) 市场预测:按产品、检体、技术、应用、最终用户和地区进行的全球分析In Vitro Diagnostics (IVD) Market Forecasts to 2030 - Global Analysis By Product (Instruments, Reagents & Kits and Software), Specimen (Blood, Urine, Stool, Saliva, Tissue Biopsies and Other Specimens), Technology, Application, End User and By Geography |
根据Stratistics MRC的数据,2024年全球体外诊断(IVD)市场规模为1,041亿美元,预计到2030年将达到1,485亿美元,预测期内复合年增长率为6.1%。
体外诊断 (IVD) 是对从人体采集的样本(例如血液、尿液或组织)进行的医学测试,以检测疾病、状况或感染疾病。这些测试在体外、受控的实验室环境中进行,在现代医疗保健和个人化医疗中发挥重要作用,为诊断、治疗监测和疾病预防提供关键资讯。
根据美国生物技术资讯中心(NCBI)的报告,体外诊断(IVD)测试在临床实践中很有价值,88%的患者用于初步诊断,77%用于治疗监测,72%的患者用于治疗用于治疗后续观察。这凸显了 IVD 在病患管理和医疗保健中的重要角色。
慢性病增加
糖尿病、心血管疾病和癌症等慢性疾病的上升趋势是体外诊断(IVD)市场的关键驱动因素。这些疾病需要定期监测和早期诊断,体外诊断 (IVD) 测试有助于实现这一目标。随着世界人口老化以及与生活方式相关的健康问题的增加,对准确、高效的诊断工具的需求不断增加,推动了市场的扩张。
诊断平台高成本
先进诊断平台的高成本是体外诊断市场的主要限制因素。这些平台通常需要大量投资,包括初始设置、维护和熟练人员。较小的医疗机构和新兴市场可能会发现难以承担实施这些技术的成本,从而限制了采用并可能减缓市场成长。此外,成本因素可能会阻碍新技术的频繁升级和整合。
新兴市场的成长
新兴市场代表了 IVD 市场的主要成长机会。亚太、拉丁美洲和非洲部分地区等地区经济快速发展,卫生基础建设不断改善,卫生支出不断增加。这些因素,加上人们对早期疾病检测和预防保健意识的增强,为体外诊断 (IVD) 产品和服务的扩展提供了肥沃的土壤。在这些地区投资的公司可以开拓到许多服务不足的患者。
严格的法律规范
管理体外诊断的核准和商业化的严格法律规范是市场成长的主要威胁。 FDA 和 EMA 等监管机构制定了严格的标准,以确保诊断测试的安全性和有效性。这些法规虽然保护病人安全,但也延长了核准流程并增加了製造商的成本。违规可能导致产品召回、法律问题和市场信心丧失。
COVID-19 大流行极大地推动了 IVD 市场的发展,对 PCR、NGS 和基于血清学的快速检测等诊断检测的需求激增。这次疫情加速了就地检验和远距离诊断的采用,凸显了快速、准确的诊断解决方案的重要性。需求激增导致对 IVD 技术和基础设施的投资增加,为未来的成长开创了先例。
试剂和套件细分市场预计将成为预测期内最大的细分市场
试剂和套件领域预计将主导 IVD 市场,因为它在诊断测试中发挥重要作用。试剂是各种体外诊断测试中用于检测和测量患者样本中特定分析物的关键组件。常规诊断程序对这些消耗品的持续需求,加上试剂配方的进步和新检测套组的推出,正在推动该领域的成长。
免疫测量领域预计在预测期内复合年增长率最高
免疫测量领域由于其广泛的应用,包括感染疾病、癌症生物标记和荷尔蒙水平的检测,预计将出现最高的复合年增长率。免疫检测具有较高的敏感性和特异性,对于临床诊断至关重要。自动免疫检测系统等技术进步和多重分析的市场开拓进一步提高了其效率和采用率,促进了市场的快速成长。
北美由于其先进的医疗基础设施、高昂的医疗成本以及主要 IVD 公司的存在,在 IVD 市场占据主导地位。该地区对早期疾病检测、个人化医疗和先进诊断技术引进的关注正在推动市场成长。此外,政府的支持政策和慢性病的高盛行率也促进了北美的主要市场占有率。
由于医疗保健投资增加、医疗保健基础设施改善以及预防医学意识不断增强,预计亚太地区 IVD 市场将快速成长。慢性病和感染疾病患者的上升、经济的发展和中产阶级的壮大正在推动对先进诊断解决方案的需求。政府为改善医疗保健的可近性和可负担性所做的努力进一步支持了该地区的高复合年增长率。
According to Stratistics MRC, the Global In Vitro Diagnostics (IVD) Market is accounted for $104.1 billion in 2024 and is expected to reach $148.5 billion by 2030 growing at a CAGR of 6.1% during the forecast period. In Vitro Diagnostics (IVD) refers to medical tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are conducted outside the body, in a controlled laboratory environment, to provide crucial information for diagnosis, treatment monitoring, and disease prevention, playing a vital role in modern healthcare and personalized medicine.
According to a report by the National Center for Biotechnology Information (NCBI), IVD testing is valuable in clinical practice, with 88% of patients using it for initial diagnosis, 77% for treatment monitoring, and 72% for follow-up. This highlights the indispensable role of IVDs in patient management and healthcare outcomes.
Increasing prevalence of chronic diseases
The rising prevalence of chronic diseases such as diabetes, cardiovascular diseases, and cancer is a significant driver for the In Vitro Diagnostics (IVD) market. These conditions require regular monitoring and early diagnosis, which IVD tests facilitate. As the global population ages and lifestyle-related health issues increase, the demand for accurate and efficient diagnostic tools continues to grow, thereby driving market expansion.
High cost of diagnostic platforms
The high cost of advanced diagnostic platforms poses a significant restraint to the IVD market. These platforms often require substantial investment in terms of initial setup, maintenance, and skilled personnel. Smaller healthcare facilities and developing regions may find it challenging to afford these technologies, limiting their adoption and slowing market growth. Additionally, the cost factor can deter frequent upgrades and integration of new technologies.
Growth in emerging markets
Emerging markets present substantial growth opportunities for the IVD market. Regions such as Asia-Pacific, Latin America, and parts of Africa are experiencing rapid economic development, improved healthcare infrastructure, and increased healthcare spending. These factors, combined with a growing awareness of early disease detection and preventive healthcare, create a fertile ground for the expansion of IVD products and services. Companies investing in these regions can tap into a large, underserved patient population.
Stringent regulatory framework
The stringent regulatory framework governing the approval and commercialization of IVD products is a significant threat to market growth. Regulatory bodies like the FDA and EMA impose rigorous standards to ensure the safety and efficacy of diagnostic tests. While these regulations protect patient safety, they also lead to lengthy approval processes and increased costs for manufacturers. Non-compliance can result in product recalls, legal issues, and loss of market credibility.
The COVID-19 pandemic significantly boosted the IVD market, with a sharp rise in demand for diagnostic tests such as PCR, NGS, and serology-based rapid tests. The pandemic accelerated the adoption of point-of-care testing and remote diagnostics, highlighting the importance of rapid and accurate diagnostic solutions. This surge in demand led to increased investments in IVD technologies and infrastructure, setting a precedent for future growth.
The reagents & kits segment is expected to be the largest during the forecast period
The reagents and kits segment is anticipated to dominate the IVD market due to their essential role in diagnostic testing. Reagents are critical components used in various IVD tests to detect and measure specific analytes in patient samples. The continuous need for these consumables in routine diagnostic procedures, coupled with advancements in reagent formulations and the introduction of new test kits, drives the segment's growth.
The immunoassays segment is expected to have the highest CAGR during the forecast period
The immunoassays segment is projected to experience the highest CAGR due to its widespread application in detecting infectious diseases, cancer biomarkers, and hormone levels. Immunoassays offer high sensitivity and specificity, making them indispensable in clinical diagnostics. Technological advancements, such as the development of automated immunoassay systems and multiplex assays, further enhance their efficiency and adoption, contributing to rapid market growth.
North America is positioned to dominate the IVD market due to its advanced healthcare infrastructure, high healthcare expenditure, and the presence of major IVD companies. The region's focus on early disease detection, personalized medicine, and the adoption of advanced diagnostic technologies drives market growth. Additionally, supportive government policies and a high prevalence of chronic diseases contribute to North America's leading market share.
The Asia Pacific region anticipates rapid growth in the IVD market, driven by increasing healthcare investments, improving healthcare infrastructure, and a growing awareness of preventive healthcare. The rising prevalence of chronic and infectious diseases, coupled with economic development and expanding middle-class populations, fuels the demand for advanced diagnostic solutions. Government initiatives to enhance healthcare access and affordability further support the region's high CAGR.
Key players in the market
Some of the key players in In Vitro Diagnostics (IVD) market include Roche Diagnostics, Siemens Healthineers, Abbott Laboratories, Danaher Corporation (Beckman Coulter), Thermo Fisher Scientific, Becton, Dickinson and Company (BD), bioMerieux SA, Sysmex Corporation, Johnson & Johnson (Ortho Clinical Diagnostics), Bio-Rad Laboratories, Qiagen N.V., Hologic, Inc., Grifols, Illumina, Inc., and Agilent Technologies.
In December 2023, Thermo Fisher Scientific Inc., the world leader in serving science, announced the launch of the Thermo Scientific(TM) KingFisher(TM) Apex(TM) Dx, an automated nucleic acid purification instrument, and Applied Biosystems(TM) MagMAX(TM) Dx Viral/Pathogen NA Isolation Kit for the isolation and purification of viral and bacterial pathogens from respiratory biological specimens. Together these products provide laboratories with an in vitro diagnostic (IVD) and in vitro diagnostic regulation (IVD-R) approved automated sample preparation solutions for increased confidence in downstream results.
In November 2023, Roche announced the launch of the LightCycler(R) PRO System based on the proven gold standard technology of the LightCycler(R) Systems that came before it. This new system raises the bar for performance and usability while bridging the gap between translational research and in vitro diagnostics. The LightCycler PRO System further complements Roche's molecular PCR testing portfolio, which includes solutions for a variety of healthcare professionals - from those performing research, to those testing patients for cancer, infectious diseases, and other public health challenges.
In June 2023, Hologic announced FDA 510(k) clearance of its Panther Fusion SARS-CoV-2/Flu A/B/RSV assay. The news came months after the FDA granted an emergency use authorization for a COVID/flu/RSV test from BD.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.