세계의 SaMD(Software as a Medical Device) 시장 : 기기 유형별, 전개 방법별, 용도별-예측(2025-2030년)

The Software as a Medical Device Market was valued at USD 27.32 billion in 2023, expected to reach USD 30.26 billion in 2024, and is projected to grow at a CAGR of 11.34%, to USD 57.96 billion by 2030.

Software as a Medical Device (SaMD) refers to software that is intended for medical purposes and performs these functions independently of hardware medical devices. The scope of SaMD encompasses diagnostic, therapeutic, and management functions ranging from simple tracking systems to complex diagnostic algorithms. The necessity of SaMD lies in its agility and scalability, allowing for tailored medical solutions that adapt swiftly to evolving healthcare needs. Its applications are broad, including disease detection, chronic condition management, remote patient monitoring, and personalized medicine, with significant end-use potential in hospitals, clinics, and home care settings. Market growth is driven by increasing demand for advanced, cost-effective healthcare solutions, technological advancements in AI and machine learning, and the rising prevalence of chronic diseases that necessitate continuous monitoring. Moreover, regulatory movements towards standardizing SaMD practices present both opportunities and challenges; aligning with guidelines such as those from the FDA or EMA can aid market entry and growth. Innovation opportunities are abundant, especially in developing intuitive user interfaces, enhancing cybersecurity measures, and integrating with other health technologies like wearable devices and telemedicine platforms. However, challenges such as regulatory compliance intricacies, high development costs, and data privacy concerns can impede growth. To capitalize on the potential of SaMD, businesses should invest in R&D to create innovative functionalities that address specific clinical needs and enhance patient engagement. Collaborations and partnerships with healthcare providers and technology firms can also pave the way for more comprehensive and user-friendly solutions. Emphasizing robust cybersecurity and user data protection will be crucial for gaining trust among users and stakeholders in a market that is rapidly evolving and becoming increasingly digitalized. The market is inherently dynamic, characterized by ongoing technological progress and a shifting regulatory landscape, requiring continuous adaptation and strategic foresight.

Market Dynamics: Unveiling Key Market Insights in the Rapidly Evolving Software as a Medical Device Market

The Software as a Medical Device Market is undergoing transformative changes driven by a dynamic interplay of supply and demand factors. Understanding these evolving market dynamics prepares business organizations to make informed investment decisions, refine strategic decisions, and seize new opportunities. By gaining a comprehensive view of these trends, business organizations can mitigate various risks across political, geographic, technical, social, and economic domains while also gaining a clearer understanding of consumer behavior and its impact on manufacturing costs and purchasing trends.

• Market Drivers
  • Rise in prevalence of chronic diseases and genetic disorders across the world
  • Surge in government support for digital health services and telemedicine solutions
  • Inclinations towards personalized medicine solutions for the treatment of diseases
• Market Restraints
  • Limitations associated with performance and interoperability between different devices and software systems
• Market Opportunities
  • Advancements to improve the safety, performance, and functional features of software as a medical device
  • Approvals for medical devices and miniaturization of medical gadgets
• Market Challenges
  • Data security and privacy concerns

Porter's Five Forces: A Strategic Tool for Navigating the Software as a Medical Device Market

Porter's five forces framework is a critical tool for understanding the competitive landscape of the Software as a Medical Device Market. It offers business organizations with a clear methodology for evaluating their competitive positioning and exploring strategic opportunities. This framework helps businesses assess the power dynamics within the market and determine the profitability of new ventures. With these insights, business organizations can leverage their strengths, address weaknesses, and avoid potential challenges, ensuring a more resilient market positioning.

PESTLE Analysis: Navigating External Influences in the Software as a Medical Device Market

External macro-environmental factors play a pivotal role in shaping the performance dynamics of the Software as a Medical Device Market. Political, Economic, Social, Technological, Legal, and Environmental factors analysis provides the necessary information to navigate these influences. By examining PESTLE factors, businesses can better understand potential risks and opportunities. This analysis enables business organizations to anticipate changes in regulations, consumer preferences, and economic trends, ensuring they are prepared to make proactive, forward-thinking decisions.

Market Share Analysis: Understanding the Competitive Landscape in the Software as a Medical Device Market

A detailed market share analysis in the Software as a Medical Device Market provides a comprehensive assessment of vendors' performance. Companies can identify their competitive positioning by comparing key metrics, including revenue, customer base, and growth rates. This analysis highlights market concentration, fragmentation, and trends in consolidation, offering vendors the insights required to make strategic decisions that enhance their position in an increasingly competitive landscape.

FPNV Positioning Matrix: Evaluating Vendors' Performance in the Software as a Medical Device Market

The Forefront, Pathfinder, Niche, Vital (FPNV) Positioning Matrix is a critical tool for evaluating vendors within the Software as a Medical Device Market. This matrix enables business organizations to make well-informed decisions that align with their goals by assessing vendors based on their business strategy and product satisfaction. The four quadrants provide a clear and precise segmentation of vendors, helping users identify the right partners and solutions that best fit their strategic objectives.

Strategy Analysis & Recommendation: Charting a Path to Success in the Software as a Medical Device Market

A strategic analysis of the Software as a Medical Device Market is essential for businesses looking to strengthen their global market presence. By reviewing key resources, capabilities, and performance indicators, business organizations can identify growth opportunities and work toward improvement. This approach helps businesses navigate challenges in the competitive landscape and ensures they are well-positioned to capitalize on newer opportunities and drive long-term success.

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

This research report categorizes the Software as a Medical Device Market to forecast the revenues and analyze trends in each of the following sub-markets:

• Based on Device Type, market is studied across PCs or Laptop, Smartphone or Tablets, and Wearable Device.
• Based on Deployment Method, market is studied across Cloud and On-Premise.
• Based on Application, market is studied across Clinical Management, Diagnostic, and Monitoring & Alerting.
• Based on Region, market is studied across Americas, Asia-Pacific, and Europe, Middle East & Africa. The Americas is further studied across Argentina, Brazil, Canada, Mexico, and United States. The United States is further studied across California, Florida, Illinois, New York, Ohio, Pennsylvania, and Texas. The Asia-Pacific is further studied across Australia, China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan, Thailand, and Vietnam. The Europe, Middle East & Africa is further studied across Denmark, Egypt, Finland, France, Germany, Israel, Italy, Netherlands, Nigeria, Norway, Poland, Qatar, Russia, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.

The report offers a comprehensive analysis of the market, covering key focus areas:

1. Market Penetration: A detailed review of the current market environment, including extensive data from top industry players, evaluating their market reach and overall influence.

2. Market Development: Identifies growth opportunities in emerging markets and assesses expansion potential in established sectors, providing a strategic roadmap for future growth.

3. Market Diversification: Analyzes recent product launches, untapped geographic regions, major industry advancements, and strategic investments reshaping the market.

4. Competitive Assessment & Intelligence: Provides a thorough analysis of the competitive landscape, examining market share, business strategies, product portfolios, certifications, regulatory approvals, patent trends, and technological advancements of key players.

5. Product Development & Innovation: Highlights cutting-edge technologies, R&D activities, and product innovations expected to drive future market growth.

The report also answers critical questions to aid stakeholders in making informed decisions:

1. What is the current market size, and what is the forecasted growth?

2. Which products, segments, and regions offer the best investment opportunities?

3. What are the key technology trends and regulatory influences shaping the market?

4. How do leading vendors rank in terms of market share and competitive positioning?

5. What revenue sources and strategic opportunities drive vendors' market entry or exit strategies?

Table of Contents

1. Preface

• 1.1. Objectives of the Study
• 1.2. Market Segmentation & Coverage
• 1.3. Years Considered for the Study
• 1.4. Currency & Pricing
• 1.5. Language
• 1.6. Stakeholders

2. Research Methodology

• 2.1. Define: Research Objective
• 2.2. Determine: Research Design
• 2.3. Prepare: Research Instrument
• 2.4. Collect: Data Source
• 2.5. Analyze: Data Interpretation
• 2.6. Formulate: Data Verification
• 2.7. Publish: Research Report
• 2.8. Repeat: Report Update

3. Executive Summary

4. Market Overview

5. Market Insights

• 5.1. Market Dynamics
  • 5.1.1. Drivers
    • 5.1.1.1. Rise in prevalence of chronic diseases and genetic disorders across the world
    • 5.1.1.2. Surge in government support for digital health services and telemedicine solutions
    • 5.1.1.3. Inclinations towards personalized medicine solutions for the treatment of diseases
  • 5.1.2. Restraints
    • 5.1.2.1. Limitations associated with performance and interoperability between different devices and software systems
  • 5.1.3. Opportunities
    • 5.1.3.1. Advancements to improve the safety, performance, and functional features of software as a medical device
    • 5.1.3.2. Approvals for medical devices and miniaturization of medical gadgets
  • 5.1.4. Challenges
    • 5.1.4.1. Data security and privacy concerns
• 5.2. Market Segmentation Analysis
  • 5.2.1. Device Type: PCs and laptops are indispensable in clinical settings for their robustness and data-handling capabilities
  • 5.2.2. Application: Diverse application of Software as a medical device in diagnostics for improved diagnostic procedures and quick results
• 5.3. Porter's Five Forces Analysis
  • 5.3.1. Threat of New Entrants
  • 5.3.2. Threat of Substitutes
  • 5.3.3. Bargaining Power of Customers
  • 5.3.4. Bargaining Power of Suppliers
  • 5.3.5. Industry Rivalry
• 5.4. PESTLE Analysis
  • 5.4.1. Political
  • 5.4.2. Economic
  • 5.4.3. Social
  • 5.4.4. Technological
  • 5.4.5. Legal
  • 5.4.6. Environmental

6. Software as a Medical Device Market, by Device Type

• 6.1. Introduction
• 6.2. PCs or Laptop
• 6.3. Smartphone or Tablets
• 6.4. Wearable Device

7. Software as a Medical Device Market, by Deployment Method

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

8. Software as a Medical Device Market, by Application

• 8.1. Introduction
• 8.2. Clinical Management
• 8.3. Diagnostic
• 8.4. Monitoring & Alerting

9. Americas Software as a Medical Device Market

• 9.1. Introduction
• 9.2. Argentina
• 9.3. Brazil
• 9.4. Canada
• 9.5. Mexico
• 9.6. United States

10. Asia-Pacific Software as a Medical Device Market

• 10.1. Introduction
• 10.2. Australia
• 10.3. China
• 10.4. India
• 10.5. Indonesia
• 10.6. Japan
• 10.7. Malaysia
• 10.8. Philippines
• 10.9. Singapore
• 10.10. South Korea
• 10.11. Taiwan
• 10.12. Thailand
• 10.13. Vietnam

11. Europe, Middle East & Africa Software as a Medical Device Market

• 11.1. Introduction
• 11.2. Denmark
• 11.3. Egypt
• 11.4. Finland
• 11.5. France
• 11.6. Germany
• 11.7. Israel
• 11.8. Italy
• 11.9. Netherlands
• 11.10. Nigeria
• 11.11. Norway
• 11.12. Poland
• 11.13. Qatar
• 11.14. Russia
• 11.15. Saudi Arabia
• 11.16. South Africa
• 11.17. Spain
• 11.18. Sweden
• 11.19. Switzerland
• 11.20. Turkey
• 11.21. United Arab Emirates
• 11.22. United Kingdom

12. Competitive Landscape

• 12.1. Market Share Analysis, 2023
• 12.2. FPNV Positioning Matrix, 2023
• 12.3. Competitive Scenario Analysis
  • 12.3.1. Innovative Launch in Audio Technology By U&i Monopoly Series Earbuds and Super Series Neckband
  • 12.3.2. Aptar Digital Health Announces Immuno-Dermatology Partnership with Legit.Health
  • 12.3.3. Huma and Merck KGaA Collaborate to Deliver Cancer Care Management Tool
  • 12.3.4. AI surgery software developer Proprio raises USD 43 million
• 12.4. Strategy Analysis & Recommendation

Companies Mentioned

• 1. Apple, Inc.
• 2. Arterys Inc.
• 3. BenevolentAI by Odyssey
• 4. Biobeats Medical
• 5. Cambridge Cognition
• 6. Cloud DX
• 7. F. Hoffmann-La Roche AG
• 8. Fitbit
• 9. Greenfinch Technology by TEKenable
• 10. IDx Technologies Inc.
• 11. Imagen Technologies
• 12. iSchemaView, inc. (RAPID)
• 13. Johnson & Johnson Services, Inc.
• 14. Koninklijke Philips N.V.
• 15. MaxQ AI, Ltd.
• 16. Mogrify
• 17. PEAR Therapeutics
• 18. Qlarity Imaging LLC by Paragon Biosciences
• 19. S3 Connected Health
• 20. Samsung Electronics Co., Ltd.
• 21. Siemens Healthineers AG
• 22. Tietronix Software, Inc.
• 23. Velentium LLC
• 24. Viz.ai, Inc
• 25. Zuhlke Technology Group