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SaMD（軟件即醫療設備）市場 - 預測 2023-2028
市場調查報告書
商品編碼
1295343

SaMD（軟件即醫療設備）市場 - 預測 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個工作天內

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簡介目錄

SaMD（軟件即醫療設備）市場預計在預測期內復合年增長率為 51.88%。

SaMD（軟件即醫療設備）市場預計在預測期內將呈指數級增長。這種增長是由於對遠程患者監控和遠程醫療的需求所驅動的數字醫療解決方案的需求不斷增長而推動的。COVID-19 大流行加速了虛擬醫學的採用，為 SaMD 應用創造了有利的環境。世界各地的監管機構已經認識到 SaMD 的潛力，並正在實施簡化監管流程的舉措。例如，FDA 的數字健康資格預審計劃旨在鼓勵 SaMD 創新和市場進入。

此外，SaMD 開發中人工智能 (AI) 和機器學習算法的集成也越來越受到關注。人工智能驅動的 SaMD 系統在皮膚癌檢測和醫學成像數據分析等各個醫療領域表現出了令人印象深刻的性能。此類技術進步和監管支持正在推動 SaMD 市場的增長，徹底改變醫療保健服務，並為個性化、遠程和高效的患者護理鋪平道路。

SaMD（軟件即醫療設備）市場是由醫療保健領域越來越多地採用物聯網推動的。

隨著醫療保健中物聯網的採用不斷增加，SaMD 市場預計將在預測期內實現健康增長。物聯網在醫療保健中的應用包括持續監測血壓、心率、體溫和呼吸頻率，在慢性病情況下持續收集特定參數以及提供遠程協助。這些物聯網設備的日益普及是由於全球慢性病的患病率不斷上升，以及患有各種與年齡相關的殘疾的老年人口不斷增加，特別是對患者的遠程監控正在支持醫療保健的增長。此外，對物聯網的投資不斷增加，繼續推動醫療保健領域的創新，包括人工智能和大數據分析等創新，這反過來又對推動全球 SaMD 市場的增長產生重大影響。

此外，隨著消費者對複雜可穿戴設備的偏好不斷增加，隨著預測期內全球客戶可支配收入的增加，聯網設備在醫療保健領域的受歡迎程度也隨之增加。此外，世界各國政府越來越接受將物聯網 (IoT) 技術集成到醫療保健管理中。例如，美國衛生與公眾服務部(HHS) 通過採購用於客戶支持的Salesforce Service Cloud、用於分析和BI 的MicroStrategy Platform Analytics 以及用於銷售自動化、CRM 和銷售參與的Salesforce Sales Cloud 來證明這一承諾。這些投資以及相關 IT 決策者和主要利益相關者的積極參與反映了利用物聯網潛力來增強醫療保健運營和服務交付的共同努力。

市場趨勢：

  • 2020 年 3 月，總部位於波士頓的數字治療領導者 Biofourmis 獲得 1 億美元，用於開發、商業化和擴展其人工智能驅動的治療平台。
  • 2021年11月，醫療初創公司HoneyNaps推出醫療計算機軟件，利用人工智能算法自動分析多導睡眠圖測量的數據，以診斷、預測和預防疾病，並宣布發布“SOMNUM”。

預計個人電腦/筆記本電腦市場在預測期內將出現強勁增長。

SaMD 廣泛應用於各種技術平台，包括 PC 和筆記本電腦。增加獲得醫療保健的機會和增加對個性化護理的需求是預測期內推動這一增長的主要因素。隨著遠程醫療和遠程患者監護的興起，醫療保健提供者越來越依賴技術來提供護理。遠程醫療和遠程患者監控使醫療保健專業人員能夠訪問醫療記錄、與患者溝通並實時諮詢其他醫療保健專業人員。它還允許患者訪問醫療信息、與醫療保健提供者共享信息以及參與遠程醫療。在 SaMD 市場中使用 PC 和筆記本電腦使醫療保健提供者能夠接觸到偏遠和服務欠缺地區的患者。這對於由於地理障礙而無法獲得醫療保健的患者（例如生活在農村地區的患者）尤其重要。通過使用技術提供護理，醫療保健提供者可以擴大其覆蓋範圍，並使弱勢患者更容易獲得護理。

SaMD（軟件即醫療設備）市場尤其以美國為主導。

按地區劃分，SaMD（軟件即醫療設備）市場分為美洲、歐洲、中東和非洲以及亞太地區。

醫療和保健行業繼續採用先進技術來實現更好的診斷和治療，這對美國對 SaMD（軟件即醫療設備）的需求產生了積極影響。互聯網和智能手機的普及也推動了對 SaMD 的需求。通過在智能手機上安裝此類軟件，您可以查看從 MRI 醫療設備獲得的圖像。根據Consumer Technology Association的數據，2020 年美國智能手機出貨量將達到 1.66 億部，比 2019 年增長 2%。促進該國商業活動的有利政府政策進一步促進了 SaMD 市場的增長。最近，2021 年 11 月，FDA 發布了新指南，描述了評估設備軟件安全性和有效性的關鍵因素。

目錄

第 1 章 簡介

  • 市場概況
  • COVID-19 情景
  • 市場定義
  • 調查範圍
  • 貨幣
  • 先決條件
  • 基準年和預測年的時間表

第二章研究方法論

  • 調查設計
  • 次要信息
  • 確認

第三章主要發現

第四章市場動態

  • 分割
  • 促進者
    • 醫療保健領域越來越多地採用物聯網
    • SaMD 的監管動態
    • 對醫學誤診的擔憂
  • 克制
    • 數據安全和隱私問題
    • 醫療器械開發和審批的嚴格監管程序
  • 市場機會
    • 醫學創新
    • 擴大家庭醫療服務
    • 市場：增加利益相關者投資
  • 波特五力分析
  • 產品管線
  • 行業法規
  • 生命週期分析 - 區域快照
  • 市場吸引力

5. SaMD（軟件即醫療設備）市場，按設備類型

  • 介紹
  • 個人電腦/筆記本電腦
  • 智能手機/平板電腦
  • 可穿戴設備

6. SaMD（軟件即醫療設備）市場（按應用）

  • 介紹
  • 診斷
  • 臨床管理

7. SaMD（軟件即醫療設備）市場，按實施情況

  • 介紹
  • 雲
  • 本地

8. SaMD（軟件即醫療設備）市場，按地區

  • 介紹
  • 美洲
    • 美國
    • 其他
  • 歐洲/中東/非洲
    • 英國
    • 德國
    • 法國
    • 其他
  • 亞太地區
    • 日本
    • 中國
    • 其他

第九章競爭格局與分析

  • 主要公司及戰略分析
  • 合併、收購、協議與合作
  • 供應商競爭力矩陣

第十章公司簡介

  • 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.
簡介目錄
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