市場調查報告書
商品編碼
1471127
軟體作為醫療設備市場:按設備類型、部署方法和應用分類 - 2024-2030 年全球預測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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預計2023年醫療設備軟體市場規模為273.2億美元,2024年達302.6億美元,預計2030年將達579.6億美元,複合年成長率為11.34%。
醫療保健產業中的軟體作為醫療設備SaMD 是指開發軟體解決方案,用於執行一個或多個醫療程序,而無需包含在硬體醫療設備中。 SaMD 用於診斷和治療目的,包括檢測疾病、管理患者資料以及支持和推薦治療方法的軟體。 SaMD 應用多種多樣,包括病患監測、臨床決策支援和疾病診斷系統。 SaMD 應用範圍從診斷和治療應用到病患監測和疾病管理。這些軟體解決方案面向醫療保健提供者、患者和醫療設備製造商。在醫院、診所、診斷中心和居家醫療中,SaMD 可用於各種環境,以改善醫療服務、患者治療結果和醫療實踐效率。慢性病盛行率的增加、對個人化和遠距醫療保健解決方案的需求以及人工智慧 (AI) 和機器學習 (ML) 在醫療保健中的整合是推動市場的因素。此外,監管部門對 SaMD 的核准增強了信任和信心,促進了醫療保健行業的更廣泛採用。然而,對於早期疾病檢測和管理的預測分析工具的進步、遠端患者監護領域 SaMD 應用的擴展以及利用區塊鏈進行安全患者資料交換的需求非常強烈。與科技公司合作建立方便用戶使用、可互通和可擴展的解決方案也代表了主要的業務成長趨勢。此外,探索以使用者為中心的設計和跨平台相容性以增強使用者體驗和可訪問性也很重要。此外,互通性標準和安全資料整合技術將支援下一波 SaMD 創新,並確保無縫且安全的醫療服務交付。
主要市場統計 | |
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基準年[2023] | 273.2億美元 |
預測年份 [2024] | 302.6億美元 |
預測年份 [2030] | 579.6億美元 |
複合年成長率(%) | 11.34% |
設備類型:個人電腦和筆記型電腦因其堅固耐用和資料處理能力而在臨床環境中不可或缺。
長期以來,個人電腦和筆記型電腦一直是醫療軟體的標準硬體,尤其是在臨床環境中。它提供強大的處理能力、大儲存容量以及複雜應用程式的可靠平台。這些設備主要用於診斷軟體、患者資料管理系統和遠端醫療平台。在醫院和臨床環境中,它非常適合資料密集型任務,例如診斷影像(MRI、 電腦斷層掃描)和電子健康記錄。這些設備具有攜帶性和可訪問性,徹底改變了醫療保健的提供方式。廣泛用於遠端患者監護、健康追蹤以及患者和醫療保健提供者之間的通訊。適用於門診病人護理、遠端患者監護和個人化醫療。非常適合為偏遠和服務不足的地區提供醫療保健服務。穿戴式裝置提供持續的即時健康監測和資料收集,並且正在經歷顯著成長。這些設備的範圍從健身追蹤器到具有先進健康監測功能的智慧型手錶。它非常適合持續健康監測、預防性護理和參與患者健康管理。非常適合監測生命徵象、身體活動和睡眠模式。
軟體作為醫療設備在應用診斷中的多樣化應用改進了診斷程序並提供更快的結果。
SaMD 領域的臨床管理應用程式為醫療保健專業人員提供了增強病患照護協調、病患資料管理並促進全面臨床工作流程的工具。這些解決方案通常與電子健康記錄(EHR) 系統整合,以簡化醫療機構業務並提高為患者提供的護理品質。對臨床管理應用程式的需求源於醫療保健服務日益複雜性以及對高效、錯誤最小化工具來支援即時決策的需求。 SaMD 的診斷應用程式利用演算法和人工智慧來幫助根據患者資料、影像和輸入診斷疾病和狀況。這些工具可以顯著減少診斷所需的時間,提高準確性,並有助於及早發現疾病。對診斷應用的需求是由對侵入性更小、更準確並提供更快診斷結果的改進診斷方法的不斷探索所驅動的。監控和警報 SaMD 包括連續監控患者健康資料並提醒醫療保健提供者註意可能表明需要立即就醫的異常情況的應用程式。這些應用在持續監測非常重要的情況下特別受歡迎,例如慢性病管理、老年護理和術後監測。
區域洞察
美國處於 SaMD 領域的前沿,大量投資刺激了研究和開發。對監管合規性的關注,尤其是 FDA 對 SaMD 的精確指導方針,正在塑造市場。然而,加拿大 SaMD 市場正在成長,重點關注類似於歐盟有關患者資料的 GDPR 的品質和安全標準。消費者對技術主導的醫療保健解決方案的信任正在推動需求,以及科技公司和醫療保健提供者合作開發創新解決方案的顯著趨勢。由於其嚴格的監管環境,包括醫療設備法規 (MDR),歐盟 (EU) 為 SaMD 提供了複雜但不斷成長的機會。歐盟對 SaMD 的需求是由人口老化和對具有成本效益的預防性醫療解決方案的關注所推動的。跨境研發合作是歐盟資金和舉措支持的趨勢。在醫療保健基礎設施和數位轉型舉措投資的推動下,中東的 SaMD 市場正在興起。儘管非洲 SaMD 市場尚處於起步階段,但由於對無障礙醫療解決方案的需求不斷成長,該市場潛力巨大。鑑於行動裝置的高普及,行動醫療(行動醫療 )應用程式尤其有前途。由於政府對醫療保健技術和強大的數位基礎設施的支持,中國、印度和日本等亞太地區的主要國家正在迅速擴張。該地區的市場不斷看到新興企業和小型企業透過遠端醫療、診斷解決方案、患者管理系統等方面的進步進行先進的創新,儘管它們面臨著監管清晰度和基礎設施的挑戰。
FPNV定位矩陣
FPNV定位矩陣對於評估醫療設備軟體市場至關重要。我們檢視與業務策略和產品滿意度相關的關鍵指標,以對供應商進行全面評估。這種深入的分析使用戶能夠根據自己的要求做出明智的決策。根據評估,供應商被分為四個成功程度不同的像限:前沿(F)、探路者(P)、利基(N)和重要(V)。
市場佔有率分析
市場佔有率分析是一種綜合工具,可以對軟體醫療設備市場供應商的現狀進行深入而深入的研究。全面比較和分析供應商在整體收益、基本客群和其他關鍵指標方面的貢獻,以便更好地了解公司的績效及其在爭奪市場佔有率時面臨的挑戰。此外,該分析還提供了對該行業競爭特徵的寶貴見解,包括在研究基準年觀察到的累積、分散主導地位和合併特徵等因素。詳細程度的提高使供應商能夠做出更明智的決策並制定有效的策略,從而在市場上獲得競爭優勢。
1. 市場滲透率:提供有關主要企業所服務的市場的全面資訊。
2. 市場開拓:我們深入研究利潤豐厚的新興市場,並分析其在成熟細分市場的滲透率。
3. 市場多元化:提供有關新產品發布、開拓地區、最新發展和投資的詳細資訊。
4.競爭評估與資訊:對主要企業的市場佔有率、策略、產品、認證、監管狀況、專利狀況、製造能力等進行全面評估。
5. 產品開發與創新:提供對未來技術、研發活動和突破性產品開發的見解。
1.醫療設備市場的市場規模與預測是多少?
2.在軟體醫療設備市場預測期內,需要考慮投資哪些產品、細分市場、應用程式和領域?
3.醫療設備軟體市場的技術趨勢和法規結構是什麼?
4.醫療設備軟體市場主要廠商的市場佔有率是多少?
5.進入醫療設備軟體市場合適的型態和策略手段是什麼?
[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?