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市场调查报告书
商品编码
1321517
下一代 IVD 全球市场(2023-2033):按产品、类型、用途、最终用户和地区进行分析和预测Next-Generation IVD Market - A Global and Regional Analysis: Focus on Products, Type, Application, End User, and Regional Analysis - Analysis and Forecast, 2023-2033 |
主要市场统计数据 | |
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开始年份 | 2023年 |
预测年份 | 2033 |
推出当年的市场规模 | 901.3 亿美元(2023 年) |
市场规模预测 | 1,526.2亿美元(2033年) |
年复合成长率(%): | 5.41% |
下一代IVD市场规模预计将从2022年的862.1亿美元增长到2033年的1526.2亿美元,预测期内年复合成长率为5.41%。
下一代IVD(体外诊断)是指用于人体外诊断测试的先进创新技术。
这些最先进的诊断工具提高了各种疾病和病症检测和监测的准确性、效率和可靠性。下一代IVD行业面临着严格的监管、行业整合、新的医疗改革和不断变化的人口结构等挑战,其出现有可能重振市场的增长。分子诊断、基因组学和NGS预计将成为这一增长的主要驱动力。
除了IVD技术的进步外,人口老龄化的加剧、慢性病的流行、个性化医疗需求的增加以及对更高效诊断解决方案的需求也在推动预测的增长。
此外,新兴国家的增长对下一代 IVD 市场产生重大影响。这些地区越来越需要加强医疗基础设施、改善获得高质量诊断的机会以及采用先进技术来有效对抗疾病。这些因素为新兴国家的市场发展提供了机会。此外,监管环境和报销政策在推动下一代 IVD 的全球采用和扩展方面发挥着关键作用。有利的监管和报销框架有助于将这些技术无缝集成到日常医疗保健运营中,也可以显着促进市场增长。
按类型划分,核心实验室部门将于 2022 年以 69.90% 的份额领先市场。 IVD的核心实验室技术包括一系列用于集中实验室检测的分析仪器和平台。这些技术在临床诊断和患者护理中发挥着重要作用。核心实验室诊断包括免疫测定、血液学和临床化学等技术。
按产品划分,消耗品细分市场将在2022年以69.94%的份额引领市场。下一代 IVD 使用各种消耗品,可用于任何实验室实验中的样品测试和分析。这些消耗品对于 IVD 技术的准确有效的性能至关重要。 IVD 检测试剂盒等消耗品由特定诊断测试所需的试剂、化学品和材料等基本消耗品组成。这些检测试剂盒旨在提供标准化组件和方案,以确保结果一致且可靠。
按地区划分,北美地区预测将在 2022 年以 3597 万美元的市场规模引领全球市场,并在预测期内保持主导地位。另一方面,预计亚太地区在预测期内将呈现最高增长,年复合成长率为 7.05%。
本报告审视了全球下一代 IVD 市场,包括市场和产品定义和概述、市场影响因素和市场机会分析、监管和报销环境、市场规模趋势和预测以及各个细分市场和地区。 、竞争格局、主要企业概况等
“Global Next-Generation IVD Market to Reach $152.62 Billion by 2033.”
The next-generation IVD market was valued at $86.21 billion in 2022 and is expected to reach $152.62 billion by 2033, growing at a CAGR of 5.41% between 2023 and 2033. Next-generation in-vitro diagnostics (IVDs) refer to advanced and innovative technologies that are utilized for diagnostic testing outside the human body. These cutting-edge diagnostic tools represent a significant advancement in the field, offering enhanced accuracy, efficiency, and reliability in detecting and monitoring various diseases and conditions. Moreover, the next-generation IVD industry also faces challenges such as stringent regulations, industry consolidation, new healthcare reforms, and ever-changing demographics. However, despite these challenges, the advent of new technologies being used for diagnosis and innovations has the potential to invigorate the growth of the next-generation IVD market. Molecular diagnostics, genomics, and NGS are expected to be primary facilitators of this growth by providing new avenues for improved disease diagnosis, hence, redefining patient outcomes.
KEY MARKET STATISTICS | |
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Start Year | 2023 |
Forecast Year | 2033 |
Start Value | $90.13 Billion in 2023 |
Forecast Value | $152.62 Billion by 2033 |
CAGR % | 5.41% |
The market for next-generation in-vitro diagnostics (IVD) holds considerable growth potential, driven by multiple factors. These include advancements in technology used for IVD, rising ageing population, a growing prevalence of chronic diseases, increasing demand for personalized medicine, and the need for more efficient diagnostic solutions. Further, global IVD market has exhibited consistent growth, and the introduction of next-generation IVD technologies is expected to further fuel market expansion. Market is projected to maintain a robust growth trajectory in the years ahead.
The industrial impact for growth in emerging countries, including developing nations, is substantial for next-generation in-vitro diagnostics (IVDs) market. These regions is experiencing a growing need for enhanced healthcare infrastructure, improved access to high-quality diagnostics, and the adoption of advanced technologies to address diseases effectively. This factor holds an opportunity for market to develop more in these countries. Further, the regulatory environment and reimbursement policies plays a crucial role in shaping the adoption and expansion of next-generation IVDs globally. Favourable regulations and reimbursement frameworks that facilitate the seamless integration of these technologies into routine healthcare practices can significantly boost market growth.
The next-generation IVD market based on type is led by the core laboratories, with a 69.90% share in 2022. Core laboratory technologies in IVD encompass a range of analytical instruments and platforms used for centralized testing in laboratory settings. These technologies play a crucial role in clinical diagnostics and patient care. Core laboratory diagnostics include technologies such as immunoassay, hematology, and clinical chemistry, among others.
The next-generation IVD market based on product is led by consumables panels based on product, with a 69.94% share in 2022. Next-generation in-vitro diagnostics (NG-IVD) uses a various range of consumables that are instrumental in conducting sample testing and analysis for any experiment undertaken in the laboratories. These consumables are essential for ensuring the precise and effective implementation of IVD technologies. Consumables such as assay kits used for in-vitro diagnostics comprise of essential consumables that include reagents, chemicals, and materials necessary for specific diagnostic tests. These assay kits are designed to provide standardized components and protocols, ensuring consistent and reliable results.
As of 2022, the global next-generation IVD market (by application) was dominated by the oncology/cancer segment, holding a 34.95% market share, and is growing with a CAGR of 5.10%. Increasing prevalence of cancer cases across the globe and efforts by the diagnostics companies for carrying out treatment regimen for treating cancer is driving the market growth of this segment.
The next-generation IVD market by end user is led by hospitals and clinics, with a 44.14% share in 2022. Hospitals and clinics are the major end users for the next-generation IVD market. Apart from the central laboratory testing at hospitals, IVD is being increasingly adopted for the rapid and bed side analysis for various parameters. These are usually performed by the non-laboratory trained individuals such as nurses, paramedics, and physicians, among others. Hospitals and clinics rely extensively on next-generation in-vitro diagnostics (IVD) as an integral part of their daily functioning. These diagnostic tests play a vital role in ensuring accurate disease diagnosis, monitoring patient well-being, and informing treatment strategies. IVD is essential in various healthcare settings.
In 2022, the North America next-generation IVD market dominated the global market with a market value of $35.97 million in 2022, and it is expected to hold its dominance throughout the forecast period 2023-2033. However, the Asia-Pacific (APAC) region, constituting several emerging economies, is expected to register the highest CAGR of 7.05% during the forecast period 2023-2033.
Technological Advancements in Next-Generation In-Vitro Diagnostics Transforming Healthcare System: The field of in vitro diagnostics (IVD) has been transformed by ongoing technological advancements, including genomics, proteomics, and molecular diagnostics. These advancements, such as Next Generation Sequencing (NGS), digital PCR, and other pioneering techniques, have significantly enhanced the precision, sensitivity, and efficiency of diagnostic testing. Consequently, these improvements have played a vital role in stimulating the expansion of the Next-Generation IVD market.
Furthermore, IVD and advancements in the technology being used are having a profound impact on the healthcare system, revolutionizing medical diagnoses and the delivery of healthcare. Technological progress in IVD, including molecular diagnostics, genomics, and proteomics, has significantly boosted the precision and accuracy of diagnostic tests. This empowers healthcare professionals to make more dependable diagnoses, leading to targeted and appropriate treatment plans. IVD technologies generate vast amounts of data, which, when effectively analyzed and interpreted, can provide valuable insights for healthcare providers. Advanced analytics and machine learning algorithms can extract meaningful information from this data, supporting clinical decision-making, treatment selection, and population health management.
Technological advancements in next-generation IVD have given rise to portable and handheld devices that enable testing to be conducted remotely and at the point of care. This is particularly advantageous in resource-limited settings and remote areas where access to centralized laboratories is limited. Point-of-care testing delivers rapid results, enabling immediate clinical decision-making and timely interventions.
IVD technologies, such as wearable devices and home testing kits, enable remote monitoring of patients' health conditions. This permits continuous monitoring of chronic diseases and facilitates remote disease management. Patients can track their health parameters and transmit data to healthcare providers for timely interventions and adjustments to treatment plans. In conclusion, the ongoing technological advancements in in-vitro diagnostics are transforming the healthcare system by improving precision and accuracy, enabling early disease detection, supporting personalized medicine, facilitating remote and point-of-care testing, driving data-driven healthcare, enhancing workflow efficiency, and enabling remote monitoring and disease management. These advancements have the potential to enhance patient outcomes, optimize resource utilization, and reshape the delivery of healthcare services.
Rising Demand of POC testing Boosting Next-Generation In-Vitro Diagnostics Market: The healthcare industry is witnessing an increasing need for quick and convenient diagnostic testing directly at the point of care. Next-Generation in vitro diagnostics (IVD) technologies, including portable and handheld devices, have emerged to fulfill this demand. These advanced devices enable real-time testing at the site of care, leading to reduced turnaround times for results and facilitating immediate clinical decision-making. The demand for point-of-care (POC) testing in in vitro diagnostics (IVD) is on the rise, with an increasing number of healthcare providers adopting this approach.
POC testing refers to diagnostic tests performed at or near the patient's location, providing immediate results that can guide clinical decision-making. Several factors contribute to the growing demand for POC testing in next-generation IVD. The rising demand and increasing utilization of POC testing in in-vitro diagnostics are driven by the need for rapid diagnoses, improved patient management, convenience, accessibility, effectiveness in remote settings, infectious disease control, and the availability of advanced POC testing devices. This trend is expected to continue as technology continues to advance, enabling more efficient and accurate testing at the point of care.
Growing Incidence of Chronic and Acute Diseases Demanding for Early Treatment: Next-Generation IVD technologies enable the early identification of diseases, even before symptoms become apparent. This early detection allows for timely interventions, resulting in improved patient outcomes and potentially reduced treatment costs. Screening tests for conditions like cancer, infectious diseases, and genetic disorders are increasingly sensitive and specific, facilitating early intervention and preventive measures. Next-Generation In-vitro Diagnostics (IVDs) are highly beneficial in monitoring the efficacy of treatments and making necessary adjustments to therapies. They enable the evaluation of treatment response, drug levels, and the development of drug resistance, enabling personalized and precise therapeutic interventions. According to the published article in PubMed in American College of Rheumatology in 2020, approximately half of the population in the United States is affected by chronic diseases, which has led to an epidemic. Moreover, a significant 86% of healthcare expenses can be attributed to these chronic conditions. Unfortunately, the medical profession and its leaders have not adequately acknowledged or addressed the increasing prevalence of chronic diseases.
Boost in the Next-Generation IVD Market during COVID-19 Pandemic: The COVID-19 pandemic had a substantial impact on the field of in vitro diagnostics (IVD), leading to the accelerated development and adoption of next-generation IVD technologies. Heightened demand for diagnostic testing during the pandemic created an urgent requirement for precise and rapid diagnostic tests for COVID-19. This demand has driven the innovation of advanced next-generation IVD technologies, such as nucleic acid-based tests such as PCR and RT-PCR, which have played a crucial role in detecting the SARS-CoV-2 virus.
Furthermore, the need for quick testing in diverse settings, including hospitals, clinics, and non-medical facilities, has spurred the development of next-generation point-of-care testing devices. These devices enable swift and accurate testing at the location where patients are receiving care, reducing the time taken to obtain test results and facilitating prompt decision-making. Pandemic has underscored the significance of molecular diagnostics in the detection and monitoring of infectious diseases. Next-generation molecular diagnostic technologies, such as high-throughput sequencing, digital PCR, and CRISPR-based diagnostics, have witnessed substantial advancements and found applications in COVID-19 testing. These technologies offer enhanced sensitivity, specificity, and the ability to detect multiple targets simultaneously.
Regulatory Hurdles Related to Next-Generation IVD Technologies: The development, adoption, and implementation of next-generation in vitro diagnostics (IVD) encounter various challenges. Securing regulatory approvals and adhering to rigorous regulations present significant hurdles for these advanced IVD technologies. The intricate nature of these technologies, particularly those incorporating novel platforms or innovative biomarkers, often necessitates additional validation studies and regulatory procedures to ensure their efficacy and safety are thoroughly established.
Under the In Vitro Diagnostic Regulation (IVDR), manufacturers will face increased requirements and stricter oversight from notified bodies, resulting in additional costs to successfully market IVD products in compliance with the new regulations. Manufacturers have to carefully assess and streamline their IVD portfolios, which may lead to limitations on the availability of certain assays or product types for a temporary period.
Poor Reimbursement Scenario: The manufacturers of in-vitro diagnostics tests face specific challenges to boost payers to cover in-vitro diagnostics tests and to set payment rates that comply with the cost required to perform such tests. In-vitro diagnostics tests and kits have been recognized as an integral part of medical care and are currently reimbursed by a number of federal and private sector health care insurers. However, the reimbursement rates are non-specific for any particular IVD test. They vary significantly with different reimbursing agencies. While the policies for coding, billing, and payment for IVD tests/kits remain similar to pharmaceutical drugs and medical devices, these policies are indistinct in nature and vary from payer to payer.
Rising Number of Next-Generation IVD Companies involved in Business Expansion: The expanding business of next-generation vitro diagnostics (IVD) market can be attributed to the escalating prevalence of chronic diseases and infectious conditions. In the present economic situation, there has been a noticeable increase in chronic ailments like diabetes, cancer, heart disease, and tuberculosis. The utilization of next-generation in vitro diagnostics (IVD) technologies holds promise for the early identification of diseases, facilitating timely interventions and preventive actions. Next-generation IVD technologies are instrumental in the early detection, monitoring, and management of these ailments which is helping companies to expand their IVD business.
Inclination of Emerging Companies Towards Next-Generation In-vitro Diagnostics: Emerging companies within the in vitro diagnostics (IVD) sector are placing their focus on several key areas to drive innovation and advancements in the field. Emerging companies in the IVD sector are dedicated to technological innovation, personalized medicine, digital health integration, point-of-care testing, novel biomarker development, and harnessing the potential of data analytics and artificial intelligence (AI). Their collective efforts are directed towards advancing next-generation IVD technologies to transform disease diagnosis, monitoring, and management.
The companies that are profiled have been selected based on inputs gathered from primary experts and analyzing company coverage, product portfolio, and market penetration.
The top next-generation IVD market type segment players who are leading capture around 69.90% of the presence in the market. Players in other industries, such as POC testing, and molecular diagnostics, account for approximately 12.24% and 17.86% of the presence in the market.
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