市场调查报告书
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1471127
软体作为医疗设备市场:按设备类型、部署方法和应用划分 - 2024-2030 年全球预测Software as a Medical Device Market by Device Type (PCs or Laptop, Smartphone or Tablets, Wearable Device), Deployment Method (Cloud, On-Premise), Application - Global Forecast 2024-2030 |
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预计2023年医疗设备软体市场规模为273.2亿美元,2024年达302.6亿美元,预计2030年将达579.6亿美元,复合年增长率为11.34%。
医疗保健产业中的软体作为医疗设备SaMD 是指开发软体解决方案,用于执行一个或多个医疗程序,而无需包含在硬体医疗设备中。 SaMD 用于诊断和治疗目的,包括检测疾病、管理患者资料以及支持和推荐治疗方法的软体。 SaMD 应用多种多样,包括病患监测、临床决策支援和疾病诊断系统。 SaMD 应用范围从诊断和治疗应用到病患监测和疾病管理。这些软体解决方案面向医疗保健提供者、患者和医疗设备製造商。在医院、诊所、诊断中心和居家医疗中,SaMD 可用于各种环境,以改善医疗服务、患者治疗结果和医疗实践效率。慢性病盛行率的增加、对个人化和远距医疗保健解决方案的需求以及人工智慧 (AI) 和机器学习 (ML) 在医疗保健中的整合是推动市场的因素。此外,监管部门对 SaMD 的核准增强了信任和信心,促进了医疗保健行业的更广泛采用。然而,对于早期疾病检测和管理的预测分析工具的进步、远端患者监护领域 SaMD 应用的扩展以及利用区块链进行安全患者资料交换的需求非常强烈。与科技公司合作建立用户友好、可互通和可扩展的解决方案也代表了主要的业务成长趋势。此外,探索以使用者为中心的设计和跨平台相容性以增强使用者体验和可访问性也很重要。此外,互通性标准和安全资料整合技术将支援下一波 SaMD 创新,并确保无缝且安全的医疗服务交付。
主要市场统计 | |
---|---|
基准年[2023] | 273.2亿美元 |
预测年份 [2024] | 302.6亿美元 |
预测年份 [2030] | 579.6亿美元 |
复合年增长率(%) | 11.34% |
设备类型:个人电脑和笔记型电脑因其坚固耐用和资料处理能力而在临床环境中不可或缺。
长期以来,个人电脑和笔记型电脑一直是医疗软体的标准硬件,尤其是在临床环境中。它提供强大的处理能力、大储存容量以及复杂应用程式的可靠平台。这些设备主要用于诊断软体、患者资料管理系统和远端医疗平台。在医院和临床环境中,它非常适合资料密集型任务,例如诊断影像(MRI、 电脑断层扫描)和电子健康记录。这些设备具有便携性和可访问性,彻底改变了医疗保健的提供方式。广泛用于远端患者监护、健康追踪以及患者和医疗保健提供者之间的通讯。适用于门诊病人护理、远端患者监护和个人化医疗。非常适合为偏远和服务不足的地区提供医疗保健服务。穿戴式装置提供持续的即时健康监测和资料收集,并且正在经历显着增长。这些设备的范围从健身追踪器到具有先进健康监测功能的智慧型手錶。它非常适合持续健康监测、预防性护理和参与患者健康管理。非常适合监测生命征象、身体活动和睡眠模式。
软体作为医疗设备在应用诊断中的多样化应用改进了诊断程序并提供更快的结果。
SaMD 领域的临床管理应用程式为医疗保健专业人员提供了增强病患照护协调、病患资料管理并促进全面临床工作流程的工具。这些解决方案通常与电子健康记录(EHR) 系统集成,以简化医疗机构业务并提高为患者提供的护理品质。对临床管理应用程式的需求源于医疗保健服务日益复杂性以及对高效、错误最小化工具来支援即时决策的需求。 SaMD 的诊断应用程式利用演算法和人工智慧来帮助根据患者资料、影像和输入诊断疾病和状况。这些工具可以显着减少诊断所需的时间,提高准确性,并有助于及早发现疾病。对诊断应用的需求是由对侵入性更小、更准确并提供更快诊断结果的改进诊断方法的不断探索所驱动的。监控和警报 SaMD 包括连续监控患者健康资料并提醒医疗保健提供者註意可能表明需要立即就医的异常情况的应用程式。这些应用在持续监测非常重要的情况下特别受欢迎,例如慢性病管理、老年护理和术后监测。
区域洞察
美国处于 SaMD 领域的前沿,大量投资刺激了研究和开发。对监管合规性的关注,尤其是 FDA 对 SaMD 的精确指导方针,正在塑造市场。然而,加拿大 SaMD 市场正在成长,重点关注类似于欧盟有关患者资料的 GDPR 的品质和安全标准。消费者对技术主导的医疗保健解决方案的信任正在推动需求,以及科技公司和医疗保健提供者合作开发创新解决方案的显着趋势。由于其严格的监管环境,包括医疗设备法规 (MDR),欧盟 (EU) 为 SaMD 提供了复杂但不断增长的机会。欧盟对 SaMD 的需求是由人口老化和对具有成本效益的预防性医疗解决方案的关注所推动的。跨境研发合作是欧盟资金和倡议支持的趋势。在医疗保健基础设施和数位转型倡议投资的推动下,中东的 SaMD 市场正在兴起。儘管非洲 SaMD 市场尚处于起步阶段,但由于对无障碍医疗解决方案的需求不断增长,该市场潜力巨大。鑑于行动装置的高普及,行动医疗(行动医疗 )应用程式尤其有前途。由于政府对医疗保健技术和强大的数位基础设施的支持,中国、印度和日本等亚太地区的主要国家正在迅速扩张。该地区的市场不断看到新兴企业和小型企业透过远端医疗、诊断解决方案、患者管理系统等方面的进步进行先进的创新,儘管它们面临着监管清晰度和基础设施的挑战。
FPNV定位矩阵
FPNV定位矩阵对于评估医疗设备软体市场至关重要。我们检视与业务策略和产品满意度相关的关键指标,以对供应商进行全面评估。这种深入的分析使用户能够根据自己的要求做出明智的决策。根据评估,供应商被分为四个成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市场占有率分析
市场占有率分析是一种综合工具,可以对软体医疗设备市场供应商的现状进行深入而深入的研究。全面比较和分析供应商在整体收益、基本客群和其他关键指标方面的贡献,以便更好地了解公司的绩效及其在争夺市场占有率时面临的挑战。此外,该分析还提供了对该行业竞争特征的宝贵见解,包括在研究基准年观察到的累积、分散主导地位和合併特征等因素。详细程度的提高使供应商能够做出更明智的决策并制定有效的策略,从而在市场上获得竞争优势。
1. 市场渗透率:提供有关主要企业所服务的市场的全面资讯。
2. 市场开拓:我们深入研究利润丰厚的新兴市场,并分析其在成熟细分市场的渗透率。
3. 市场多元化:提供有关新产品发布、开拓地区、最新发展和投资的详细资讯。
4.竞争评估与资讯:对主要企业的市场占有率、策略、产品、认证、监管状况、专利状况、製造能力等进行全面评估。
5. 产品开发与创新:提供对未来技术、研发活动和突破性产品开发的见解。
1.医疗设备市场的市场规模与预测是多少?
2.在软体医疗设备市场预测期内,需要考虑投资哪些产品、细分市场、应用程式和领域?
3.医疗设备软体市场的技术趋势和法规结构是什么?
4.医疗设备软体市场主要厂商的市场占有率是多少?
5.进入医疗设备软体市场合适的型态和策略手段是什么?
[186 Pages Report] The Software as a Medical Device Market size was estimated at USD 27.32 billion in 2023 and expected to reach USD 30.26 billion in 2024, at a CAGR 11.34% to reach USD 57.96 billion by 2030.
Software as a medical device (SaMD) in the healthcare industry, comprises developing software solutions to perform one or more medical procedures without being part of a hardware medical device. SaMD is used for diagnostic and therapeutic purposes, encompassing software that aids in detecting diseases, managing patient data, and supporting or providing recommendations for treatment options. SaMD applications are varied and include systems for patient monitoring, clinical decision support, and disease diagnosis. SaMD applications range widely from diagnostic and therapeutic applications to patient monitoring and disease management. These software solutions cater to healthcare providers, patients, and medical device manufacturers. The hospitals, clinics, diagnostic centers, and home healthcare settings, reflecting the diverse utility of SaMD in enhancing healthcare delivery, patient outcomes, and medical practices efficiency. Increasing prevalence of chronic diseases, the demand for personalized and remote healthcare solutions, and the integration of artificial intelligence (AI) and machine learning (ML) in healthcare are the factors driving the market. Additionally, regulatory approvals for SaMD are fostering trust and credibility, facilitating greater adoption across the healthcare sector. However, there is a massive demand for advances in predictive analytics tools for early disease detection and management, expanding SaMD applications within the remote patient monitoring segment, and leveraging blockchain for secure patient data exchange. Collaboration with technology companies to create user-friendly, interoperable, and scalable solutions also presents significant business growth trends. Moreover, research into user-centric design and cross-platform compatibility to enhance user experience and accessibility is also crucial. Furthermore, interoperability standards and secure data integration techniques will underpin the next wave of SaMD innovations, ensuring seamless and safe healthcare service delivery.
KEY MARKET STATISTICS | |
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Base Year [2023] | USD 27.32 billion |
Estimated Year [2024] | USD 30.26 billion |
Forecast Year [2030] | USD 57.96 billion |
CAGR (%) | 11.34% |
Device Type: PCs and laptops are indispensable in clinical settings for their robustness and data-handling capabilities
PCs and laptops have long been the standard hardware for medical software, particularly in clinical settings. They offer robust processing capabilities, extensive storage, and a reliable platform for complex applications. These devices are predominantly used for diagnostic software, patient data management systems, and telehealth platforms. Preferred in hospital and clinical settings for data-intensive tasks like imaging diagnostics (MRI, CT scans) and electronic health records. These devices have revolutionized the way healthcare is delivered, offering portability and accessibility. They are widely used for remote patient monitoring, health tracking, and communication between patients and healthcare providers. Preferred for outpatient care, remote patient monitoring, and personalized medicine. Ideal for the delivery of healthcare services to remote or underserved areas. Wearable devices have seen significant growth, providing continuous, real-time health monitoring and data collection. These devices range from fitness trackers to smartwatches with advanced health monitoring capabilities. Highly preferred for continuous health monitoring, preventive care, and patient engagement in their health management. Ideal for monitoring vital signs, physical activity, and sleep patterns.
Application: Diverse application of Software as a medical device in diagnostics for improved diagnostic procedures and quick results
Clinical Management applications within the realm of SaMD provide healthcare professionals with tools to enhance patient care coordination, management of patient data, and facilitate comprehensive clinical workflows. These solutions often integrate with electronic health record (EHR) systems to streamline operations in healthcare facilities, enhancing the quality of care delivered to patients. The need for clinical management applications arises from the growing complexity of healthcare services and the need for efficient, error-minimizing tools that support decision-making in real-time. Diagnostic applications of SaMD utilize algorithms and artificial intelligence to assist in the diagnosis of diseases or medical conditions from patient data, images, or inputs. These tools can significantly reduce the time needed for diagnosis, increase accuracy, and help in early detection of ailments. The need for diagnostic applications is driven by the continual search for improved diagnostic procedures that are less invasive, more precise, and quicker in delivering results. Monitoring & Alerting SaMD includes applications that continuously monitor patient health data and alert healthcare providers of any anomalies that might indicate a need for immediate medical attention. The preference for these applications is especially high in managing chronic conditions, elderly care, and post-operative monitoring, where continuous supervision is crucial.
Regional Insights
The United States stands at the forefront in the SaMD sector, with substantial investments fueling research and development. The emphasis on regulatory compliance, particularly with the FDA's precise guidelines for SaMD, shapes the market. However, Canada's SaMD market is growing, with a focus on quality and safety standards similar to the European Union's GDPR for patient data. Consumer trust in technology-driven healthcare solutions drives demand, alongside a notable trend of partnerships between tech companies and healthcare providers to develop innovative solutions. The European Union presents a complex yet growing ground for SaMD, due to its rigorous regulatory landscape, including the Medical Device Regulation (MDR). The demand for SaMD in the EU is driven by the aging population and the focus on cost-effective, preventive healthcare solutions. Collaboration across borders in research and development is a trend, supported by EU funding and initiatives. The Middle East's SaMD market is emerging, fueled by investments in healthcare infrastructure and digital transformation initiatives. Africa's SaMD market is at a nascent stage but holds tremendous potential due to the widespread need for accessible healthcare solutions. Mobile health (mHealth) applications are particularly promising, given the high penetration of mobile devices. Major countries such as China, India, Japan in Asia-Pacific are rapidly expanding, driven by government support for healthcare technologies and a robust digital infrastructure. The market in the region is characterized by innovation by startups and SMEs highly involved in upgrading themselves through advancement such as telemedicine, diagnostic solutions, and patient management systems, despite facing challenges related to regulatory clarity and infrastructure.
FPNV Positioning Matrix
The FPNV Positioning Matrix is pivotal in evaluating the Software as a Medical Device Market. It offers a comprehensive assessment of vendors, examining key metrics related to Business Strategy and Product Satisfaction. This in-depth analysis empowers users to make well-informed decisions aligned with their requirements. Based on the evaluation, the vendors are then categorized into four distinct quadrants representing varying levels of success: Forefront (F), Pathfinder (P), Niche (N), or Vital (V).
Market Share Analysis
The Market Share Analysis is a comprehensive tool that provides an insightful and in-depth examination of the current state of vendors in the Software as a Medical Device Market. By meticulously comparing and analyzing vendor contributions in terms of overall revenue, customer base, and other key metrics, we can offer companies a greater understanding of their performance and the challenges they face when competing for market share. Additionally, this analysis provides valuable insights into the competitive nature of the sector, including factors such as accumulation, fragmentation dominance, and amalgamation traits observed over the base year period studied. With this expanded level of detail, vendors can make more informed decisions and devise effective strategies to gain a competitive edge in the market.
Key Company Profiles
The report delves into recent significant developments in the Software as a Medical Device Market, highlighting leading vendors and their innovative profiles. These include Apple, Inc., Arterys Inc., BenevolentAI by Odyssey, Biobeats Medical, Cambridge Cognition, Cloud DX, F. Hoffmann-La Roche AG, Fitbit, Greenfinch Technology by TEKenable, IDx Technologies Inc., Imagen Technologies, iSchemaView, inc. (RAPID), Johnson & Johnson Services, Inc., Koninklijke Philips N.V., MaxQ AI, Ltd., Mogrify, PEAR Therapeutics, Qlarity Imaging LLC by Paragon Biosciences, S3 Connected Health, Samsung Electronics Co., Ltd., Siemens Healthineers AG, Tietronix Software, Inc., Velentium LLC, Viz.ai, Inc, and Zuhlke Technology Group.
Market Segmentation & Coverage
1. Market Penetration: It presents comprehensive information on the market provided by key players.
2. Market Development: It delves deep into lucrative emerging markets and analyzes the penetration across mature market segments.
3. Market Diversification: It provides detailed information on new product launches, untapped geographic regions, recent developments, and investments.
4. Competitive Assessment & Intelligence: It conducts an exhaustive assessment of market shares, strategies, products, certifications, regulatory approvals, patent landscape, and manufacturing capabilities of the leading players.
5. Product Development & Innovation: It offers intelligent insights on future technologies, R&D activities, and breakthrough product developments.
1. What is the market size and forecast of the Software as a Medical Device Market?
2. Which products, segments, applications, and areas should one consider investing in over the forecast period in the Software as a Medical Device Market?
3. What are the technology trends and regulatory frameworks in the Software as a Medical Device Market?
4. What is the market share of the leading vendors in the Software as a Medical Device Market?
5. Which modes and strategic moves are suitable for entering the Software as a Medical Device Market?