查看购物车
  • Traditional Chinese
  • English
  • Japanese
  • Korean
SaMD（软件即医疗设备）市场 - 预测 2023-2028
市场调查报告书
商品编码
1295343

SaMD（软件即医疗设备）市场 - 预测 2023-2028

Software as a Medical Device (SaMD) Market - Forecasts from 2023 to 2028
出版日期: | 出版商: Knowledge Sourcing Intelligence | 英文 125 Pages | 商品交期: 最快1-2个工作天内

价格
简介目录

SaMD（软件即医疗设备）市场预计在预测期内復合年增长率为 51.88%。

SaMD（软件即医疗设备）市场预计在预测期内将呈指数级增长。这种增长是由于对远程患者监控和远程医疗的需求所驱动的数字医疗解决方案的需求不断增长而推动的。COVID-19 大流行加速了虚拟医学的采用，为 SaMD 应用创造了有利的环境。世界各地的监管机构已经认识到 SaMD 的潜力，并正在实施简化监管流程的举措。例如，FDA 的数字健康资格预审计划旨在鼓励 SaMD 创新和市场进入。

此外，SaMD 开发中人工智能 (AI) 和机器学习算法的集成也越来越受到关注。人工智能驱动的 SaMD 系统在皮肤癌检测和医学成像数据分析等各个医疗领域表现出了令人印象深刻的性能。此类技术进步和监管支持正在推动 SaMD 市场的增长，彻底改变医疗保健服务，并为个性化、远程和高效的患者护理铺平道路。

SaMD（软件即医疗设备）市场是由医疗保健领域越来越多地采用物联网推动的。

随着医疗保健中物联网的采用不断增加，SaMD 市场预计将在预测期内实现健康增长。物联网在医疗保健中的应用包括持续监测血压、心率、体温和呼吸频率，在慢性病情况下持续收集特定参数以及提供远程协助。这些物联网设备的日益普及是由于全球慢性病的患病率不断上升，以及患有各种与年龄相关的残疾的老年人口不断增加，特别是对患者的远程监控正在支持医疗保健的增长。此外，对物联网的投资不断增加，继续推动医疗保健领域的创新，包括人工智能和大数据分析等创新，这反过来又对推动全球 SaMD 市场的增长产生重大影响。

此外，随着消费者对复杂可穿戴设备的偏好不断增加，随着预测期内全球客户可支配收入的增加，联网设备在医疗保健领域的受欢迎程度也随之增加。此外，世界各国政府越来越接受将物联网 (IoT) 技术集成到医疗保健管理中。例如，美国卫生与公众服务部(HHS) 通过采购用于客户支持的Salesforce Service Cloud、用于分析和BI 的MicroStrategy Platform Analytics 以及用于销售自动化、CRM 和销售参与的Salesforce Sales Cloud 来证明这一承诺。这些投资以及相关 IT 决策者和主要利益相关者的积极参与反映了利用物联网潜力来增强医疗保健运营和服务交付的共同努力。

市场趋势：

  • 2020 年 3 月，总部位于波士顿的数字治疗领导者 Biofourmis 获得 1 亿美元，用于开发、商业化和扩展其人工智能驱动的治疗平台。
  • 2021年11月，医疗初创公司HoneyNaps推出医疗计算机软件，利用人工智能算法自动分析多导睡眠图测量的数据，以诊断、预测和预防疾病，并宣布发布“SOMNUM”。

预计个人电脑/笔记本电脑市场在预测期内将出现强劲增长。

SaMD 广泛应用于各种技术平台，包括 PC 和笔记本电脑。增加获得医疗保健的机会和增加对个性化护理的需求是预测期内推动这一增长的主要因素。随着远程医疗和远程患者监护的兴起，医疗保健提供者越来越依赖技术来提供护理。远程医疗和远程患者监控使医疗保健专业人员能够访问医疗记录、与患者沟通并实时咨询其他医疗保健专业人员。它还允许患者访问医疗信息、与医疗保健提供者共享信息以及参与远程医疗。在 SaMD 市场中使用 PC 和笔记本电脑使医疗保健提供者能够接触到偏远和服务欠缺地区的患者。这对于由于地理障碍而无法获得医疗保健的患者（例如生活在农村地区的患者）尤其重要。通过使用技术提供护理，医疗保健提供者可以扩大其覆盖范围，并使弱势患者更容易获得护理。

SaMD（软件即医疗设备）市场尤其以美国为主导。

按地区划分，SaMD（软件即医疗设备）市场分为美洲、欧洲、中东和非洲以及亚太地区。

医疗和保健行业继续采用先进技术来实现更好的诊断和治疗，这对美国对 SaMD（软件即医疗设备）的需求产生了积极影响。互联网和智能手机的普及也推动了对 SaMD 的需求。通过在智能手机上安装此类软件，您可以查看从 MRI 医疗设备获得的图像。根据Consumer Technology Association的数据，2020 年美国智能手机出货量将达到 1.66 亿部，比 2019 年增长 2%。促进该国商业活动的有利政府政策进一步促进了 SaMD 市场的增长。最近，2021 年 11 月，FDA 发布了新指南，描述了评估设备软件安全性和有效性的关键因素。

目录

第 1 章 简介

  • 市场概况
  • COVID-19 情景
  • 市场定义
  • 调查范围
  • 货币
  • 先决条件
  • 基准年和预测年的时间表

第二章研究方法论

  • 调查设计
  • 次要信息
  • 确认

第三章主要发现

第四章市场动态

  • 分割
  • 促进者
    • 医疗保健领域越来越多地采用物联网
    • SaMD 的监管动态
    • 对医学误诊的担忧
  • 克制
    • 数据安全和隐私问题
    • 医疗器械开发和审批的严格监管程序
  • 市场机会
    • 医学创新
    • 扩大家庭医疗服务
    • 市场：增加利益相关者投资
  • 波特五力分析
  • 产品管线
  • 行业法规
  • 生命週期分析 - 区域快照
  • 市场吸引力

5. SaMD（软件即医疗设备）市场，按设备类型

  • 介绍
  • 个人电脑/笔记本电脑
  • 智能手机/平板电脑
  • 可穿戴设备

6. SaMD（软件即医疗设备）市场（按应用）

  • 介绍
  • 诊断
  • 临床管理

7. SaMD（软件即医疗设备）市场，按实施情况

  • 介绍
  • 云
  • 本地

8. SaMD（软件即医疗设备）市场，按地区

  • 介绍
  • 美洲
    • 美国
    • 其他
  • 欧洲/中东/非洲
    • 英国
    • 德国
    • 法国
    • 其他
  • 亚太地区
    • 日本
    • 中国
    • 其他

第九章竞争格局与分析

  • 主要公司及战略分析
  • 合併、收购、协议与合作
  • 供应商竞争力矩阵

第十章公司简介

  • Arterys Inc.
  • Qlarity Imaging Llc
  • Viz.Ai, Inc.
  • Imagen Technologies
  • Apple, Inc.
  • iSchemaView, Inc.
  • Digital Diagnostics Inc.
  • Maxq Ai, Ltd.
  • Greenfinch Technology
  • Siemens Healthineers AG
  • Koninklijke Philips N.V.
简介目录
Product Code: KSI061610646

The software as a medical device (SaMD) market is estimated to grow at a CAGR of 51.88% during the forecast period.

The software as a medical device (SaMD) market is estimated to grow exponentially during the forecast period. This growth can be attributed to the increasing demand for digital health solutions, driven by the need for remote patient monitoring and telehealth. The COVID-19 pandemic has accelerated the adoption of virtual care, creating a conducive environment for SaMD applications. Regulatory bodies worldwide are recognizing the potential of SaMD and implementing initiatives to streamline the regulatory process. For instance, the FDA's Digital Health Pre-Cert Program aims to facilitate innovation and market access for SaMD.

Additionally, integrating artificial intelligence (AI) and machine learning algorithms in SaMD development has garnered attention. AI-powered SaMD systems have demonstrated impressive performance in various medical domains, including detecting skin cancer and analyzing medical imaging data. These advancements in technology and regulatory support are driving the growth of the SaMD market, revolutionizing healthcare delivery, and paving the way for personalized, remote, and efficient patient care.

The software as a medical device (SaMD) market is driven by the rising adoption of IoT in healthcare.

The software as a medical device market is expected to witness healthy growth over the forecast period with the growing adoption of IoT in healthcare. Some of the applications of IoT in healthcare include continuous monitoring of blood pressure, heartbeat, body temperature, respiration rate, an ongoing collection of certain parameters in case of chronic illnesses, and providing remote assistance, among other applications. The growing adoption of these IoT devices is driven by the increasing prevalence of chronic diseases worldwide and the growing geriatric population suffering from various age-associated disorders, especially in remote monitoring of patients, fueling the market growth as well. Additionally, the increasing investments in IoT are continuing to fuel the innovations in the field of healthcare, which include the innovations such as AI and big data analytics and are thus having a significant impact on fueling the growth of global software as a medical device market.

Furthermore, with the growing consumer preferences for sophisticated wearables, the popularity of connected devices in healthcare is increasing with the rise in customers' disposable income worldwide during the forecast period. Additionally, governments worldwide are increasingly embracing the integration of Internet of Things (IoT) technologies into healthcare management. For example, the U.S. Department of Health and Human Services (HHS) has demonstrated this commitment by procuring Salesforce Service Cloud for Customer Support, MicroStrategy Platform Analytics for Analytics and BI, and Salesforce Sales Cloud for Sales Automation, CRM, and Sales Engagement. These investments and the active engagement of relevant IT decision-makers and key stakeholders reflect a concerted effort to leverage IoT's potential in enhancing healthcare operations and service delivery.

Market Developments:

  • In March 2020, Biofourmis, a Boston-based digital therapeutics leader, landed $100 million to develop, commercialize, and expand its AI-powered therapeutics platform.
  • In November 2021, HoneyNaps, a healthcare startup, announced the launch of "SOMNUM," a medical computer software to diagnose, predict, and prevent diseases by automatically analyzing data measured by Polysomnography using artificial intelligence algorithms.

The PCs/Laptops segment will witness robust growth during the forecast period.

Software as a medical device is widely used across a broad range of technological platforms, including PCs and Laptops. Increasing accessible healthcare and the growing demand for personalized treatment are the prime factors driving this growth during the forecast period. With the rise of telemedicine and remote patient monitoring, healthcare providers rely more on technology to deliver care. They enable healthcare professionals to access medical records, communicate with patients, and consult other healthcare providers in real-time. They also allow patients to access medical information, share with healthcare providers, and participate in telemedicine visits. Using PCs or laptops in the SaMD market also enables healthcare providers to offer care to patients in remote or underserved areas. This is particularly important for patients who may not have access to healthcare due to geographical barriers, such as those living in rural areas. By using technology to deliver care, healthcare providers can extend their reach and offer more accessible care to needy patients.

Americas accounted for a major share of the software as a medical device (SaMD) market, especially in the United States.

By geography, the software as a medical device (SaMD) market has been segmented into the Americas, Europe, the Middle East and Africa, and the Asia Pacific.

The growing adoption of advanced technologies in the medical & healthcare sector for better diagnosis and treatment is positively impacting the demand for software as a medical device (SAMD) in the United States. The growing internet and smartphone penetration is also boosting the SAMD demand. Such software can be installed in smartphones, allowing them to view images obtained from MRI medical devices. According to the Consumer Technology Association, 2020 smartphone shipments in the US stood at 166 million units, representing a 2% increase compared to 2019. Favorable government policies to boost the country's business activities further contribute to the SaMD market's growth. Recently, in November 2021, the FDA published a new guideline describing the important factors in evaluating the safety and effectiveness of device software.

Market Segmentation:

BY DEVICE TYPE

  • PCs/Laptops
  • Smartphones/Tablets
  • Wearable Devices

BY APPLICATION

  • Diagnostics
  • Clinical Management

BY DEPLOYMENT

  • Cloud
  • On-premise

BY GEOGRAPHY

  • Americas
  • United States
  • Others
  • Europe, Middle East and Africa
  • United Kingdom
  • Germany
  • France
  • Others
  • Asia Pacific
  • Japan
  • China
  • Others

TABLE OF CONTENTS

1. Introduction

  • 1.1 Market Overview
  • 1.2. Covid-19 Scenario
  • 1.3. Market Definition
  • 1.4. Scope of The Study
  • 1.5. Currency
  • 1.6. Assumptions
  • 1.7. Base, And Forecast Years Timeline

2. Research Methodology

  • 2.1. Research Design
  • 2.2. Secondary Sources
  • 2.3. Validation

3. Key Findings

4. Market Dynamics

  • 4.1. Segmentation
  • 4.2. Drivers
    • 4.2.1. Rising adoption Of IoT in healthcare
    • 4.2.2. Developments in regulations of Software as a Medical Device
    • 4.2.3. Concerns regarding misdiagnosis in healthcare
  • 4.3. Restraints
    • 4.3.1. Concerns regarding data security and privacy
    • 4.3.2. Strict regulatory procedures for the development and approval of medical devices
  • 4.4. Market Opportunities
    • 4.4.1. Innovations in healthcare
    • 4.4.2. Growing trend of home healthcare
    • 4.4.3. Rising investments by the market players
  • 4.5. Porter's Five Forces Analysis
    • 4.5.1. Bargaining Power of Suppliers
    • 4.5.2. Bargaining Power of Buyers
    • 4.5.3. Threat of New Entrants
    • 4.5.4. Threat of Substitutes
    • 4.5.5. Competitive Rivalry in the Industry
  • 4.6. Product Pipeline
  • 4.7. Industry Regulations
  • 4.8. Life Cycle Analysis - Regional Snapshot
  • 4.9. Market Attractiveness

5. Software as a Medical Device Market By Device Type

  • 5.1. Introduction
  • 5.2. PCs/Laptops
  • 5.3. Smartphones/Tablets
  • 5.4. Wearable Devices

6. Software as a Medical Device Market By Application

  • 6.1. Introduction
  • 6.1. Diagnostics
  • 6.2. Clinical Management

7. Software as a Medical Device Market By Deployment

  • 7.1. Introduction
  • 7.1. Cloud
  • 7.2. On-Premise

8. Software as a Medical Device Market By Geography

  • 8.1. Introduction
  • 8.2. Americas
    • 8.2.1. United States
    • 8.2.2. Others
  • 8.3. Europe, Middle East and Africa
    • 8.3.1. United Kingdom
    • 8.3.2. Germany
    • 8.3.3. France
    • 8.3.4. Others
  • 8.4. Asia Pacific
    • 8.4.1. Japan
    • 8.4.2. China
    • 8.4.3. Others

9. Competitive Environment And Analysis

  • 9.1. Major Players and Strategy Analysis
  • 9.2. Mergers, Acquisitions, Agreements, and Collaborations
  • 9.3. Vendor Competitiveness Matrix

10. Company Profiles

  • 10.1. Arterys Inc.
    • 10.1.1. Overview
    • 10.1.2. Products and Services
    • 10.1.3. Recent Developments
  • 10.2. Qlarity Imaging Llc
    • 10.2.1. Overview
    • 10.2.2. Products and Services
    • 10.2.3. Recent Developments
  • 10.3. Viz.Ai, Inc.
    • 10.3.1. Overview
    • 10.3.2. Products and Services
    • 10.3.3. Recent Developments
  • 10.4. Imagen Technologies
    • 10.4.1. Overview
    • 10.4.2. Products and Services
    • 10.4.3. Key Developments
  • 10.5. Apple, Inc.
    • 10.5.1. Overview
    • 10.5.2. Products and Services
    • 10.5.3. Financials
    • 10.5.4. Key Developments
  • 10.6. iSchemaView, Inc.
    • 10.6.1. Overview
    • 10.6.2. Products and Services
    • 10.6.3. Key Developments
  • 10.7. Digital Diagnostics Inc.
    • 10.7.1. Overview
    • 10.7.2. Products and Services
    • 10.7.3. Recent Developments
  • 10.8. Maxq Ai, Ltd.
    • 10.8.1. Overview
    • 10.8.2. Products and Services
    • 10.8.3. Recent Developments
  • 10.9. Greenfinch Technology
    • 10.9.1. Overview
    • 10.9.2. Products and Services
    • 10.9.3. Recent Developments
  • 10.10. Siemens Healthineers AG
    • 10.10.1. Overview
    • 10.10.2. Products and Services
    • 10.10.3. Financials
    • 10.10.4. Recent Developments
  • 10.11. Koninklijke Philips N.V.
    • 10.11.1. Overview
    • 10.11.2. Products and Services
    • 10.11.3. Financials