SaMD(Software as a Medical Device) ½ÃÀå : ¹èÆ÷ À¯Çüº°, ¿ëµµº°, ÃÖÁ¾»ç¿ëÀÚº° : ¼¼°è ±âȸ ºÐ¼®°ú »ê¾÷ ¿¹Ãø(2024-2033³â)
Software as a Medical Device Market By Deployment Type , By Application By End User : Global Opportunity Analysis and Industry Forecast, 2024-2033
»óǰÄÚµå : 1566925
¸®¼­Ä¡»ç : Allied Market Research
¹ßÇàÀÏ : 2024³â 07¿ù
ÆäÀÌÁö Á¤º¸ : ¿µ¹® 233 Pages
 ¶óÀ̼±½º & °¡°Ý (ºÎ°¡¼¼ º°µµ)
US $ 4,425 £Ü 6,250,000
PDF (Business License) help
PDF º¸°í¼­¸¦ 1¸í¸¸ ÀÌ¿ëÇÒ ¼ö ÀÖ´Â ¶óÀ̼±½ºÀÔ´Ï´Ù. Àμâ´Â 5ȸ °¡´ÉÇϸç, Àμ⹰ÀÇ ÀÌ¿ë ¹üÀ§´Â PDF ÀÌ¿ë ¹üÀ§¿Í µ¿ÀÏÇÕ´Ï´Ù. 2¸í ÀÌ»óÀÌ ÀÌ¿ëÇÒ °æ¿ì, Ãß°¡ ¿ä±ÝÀ» ÁöºÒÇÏ¿© ¶óÀ̼±½º ¾÷±×·¹À̵å·Î ÃÖ´ë 5¸í±îÁö ÀÌ¿ë °¡´ÉÇÕ´Ï´Ù.
US $ 7,412 £Ü 10,469,000
PDF (Enterprise User License) & Excel (Data Pack) & Free Update help
PDF º¸°í¼­ ¹× Excel µ¥ÀÌÅ͸¦ µ¿ÀÏ ±â¾÷ÀÇ ¸ðµç ºÐÀÌ ÀÌ¿ëÇÒ ¼ö ÀÖ´Â ¶óÀ̼±½ºÀÔ´Ï´Ù. Àμ⠰¡´ÉÇϸç Àμ⹰ÀÇ ÀÌ¿ë ¹üÀ§´Â PDF ÀÌ¿ë ¹üÀ§¿Í µ¿ÀÏÇÕ´Ï´Ù. º¸°í¼­ ¾÷µ¥ÀÌÆ® ¼­ºñ½º°¡ ¹«·á·Î Á¦°øµË´Ï´Ù.


Çѱ۸ñÂ÷

SaMD(Software as a Medical Device) ½ÃÀå

SaMD(Software as a Medical Device) ½ÃÀåÀº 2023³â¿¡ 1,950¸¸ ´Þ·¯·Î Æò°¡µÇ¸ç, 2024-2033³â CAGR 17.3%·Î ¼ºÀåÇϸç, 2033³â¿¡´Â 9,620¸¸ ´Þ·¯¿¡ ´ÞÇÒ °ÍÀ¸·Î ¿¹ÃøµË´Ï´Ù.

SaMD(Software as a Medical Device)´Â ÀÇ·á¿ëÀ¸·Î ¼³°èµÈ Àü¿ë ¼ÒÇÁÆ®¿þ¾î·Î Çϵå¿þ¾î ÀÇ·á±â±â ¾øÀ̵µ ±â´ÉÀ» ¼öÇà ÇÒ ¼ö ÀÖÀ¸¸ç, ȯÀÚÀÇ °Ç°­ µ¥ÀÌÅ͸¦ °ü¸®ÇÏ°í °Ç°­ »óŸ¦ Áø´ÜÇϰí Ä¡·á¹ýÀ» ÃßõÇÏ´Â µ¥ µµ¿òÀ» ÁÙ ¼ö ÀÖ½À´Ï´Ù. ÀÌ ¼ÒÇÁÆ®¿þ¾î´Â ½º¸¶Æ®Æù ¹× ÅÂºí¸´°ú °°Àº ¹ü¿ë ÄÄÇ»ÆÃ Ç÷§Æû¿¡¼­ ½±°Ô ¾×¼¼½ºÇÒ ¼ö ÀÖÀ¸¹Ç·Î ´Ù¿ëµµÇÏ°í ½±°Ô Á¢±Ù ÇÒ ¼ö ÀÖÀ¸¸ç, SaMDÀÇ ÁÖ¿ä Æ¯Â¡Àº ÀÇ·á ¸ñÀûÀ» µ¶ÀÚÀûÀ¸·Î ´Þ¼º ÇÒ ¼öÀÖ´Â ÀáÀç·ÂÀ» °¡Áö°íÀÖ¾î Çö´ë ÀÇ·á ½Ã½ºÅÛÀÇ ¹üÀ§¿Í È¿À²¼ºÀ» °¡¼ÓÈ­ ÇÒ ¼ö ÀÖ´Ù´Â °ÍÀÔ´Ï´Ù. ¹üÀ§¿Í È¿À²¼ºÀ» °¡¼ÓÈ­ÇÕ´Ï´Ù.

¿ø°ÝÀÇ·á ¹× ¿ø°Ý ȯÀÚ ¸ð´ÏÅ͸µÀÇ Ã¤Åà Áõ°¡´Â SaMD(Software as a Medical Device) ½ÃÀåÀÇ ÁÖ¿ä ÃËÁø¿äÀÎÀÔ´Ï´Ù. ¶ÇÇÑ ½ÄǰÀǾ౹ ¹× À¯·´ ¿¬ÇÕ°ú °°Àº ¿©·¯ ±ÔÁ¦±â°üÀÇ Áö¿øÀº SaMD¿¡ ´ëÇÑ ¼ö¿ä¸¦ Áõ°¡½Ã۰í ÀÖ½À´Ï´Ù. ÀÇ·á ¼­ºñ½º ÇÁ·Î¹ÙÀÌ´õÀÇ Áö¿øÀ» Çâ»ó½Ã۱â À§ÇØ ÀÓ»ó ÀÇ»ç°áÁ¤ Áö¿ø ½Ã½ºÅÛ(CDSS)À» ÅëÇÕÇÏ´Â °ÍÀÌ ½ÃÀåÀÇ »õ·Î¿î µ¿ÇâÀÌ µÇ°í ÀÖÀ¸¸ç, CDSSÀÇ ±â´ÉÀº Áõ°Å¿¡ ±â¹ÝÇÑ ÀÓ»óÀû ÆÇ´Ü¿¡ µµ¿òÀ» ÁÖ¾î Áø´Ü Á¤È®µµ¸¦ ³ôÀ̰í Ä¡·á ÀýÂ÷¸¦ ÃÖÀûÈ­ÇÏ´Â µ¥ µµ¿òÀÌ µË´Ï´Ù.

±×·¯³ª ±âÁ¸ ÀÇ·á ±â·Ï°ú ÇコÄÉ¾î µ¥ÀÌÅ͸¦ SaMD¿¡ ÅëÇÕÇÏ´Â µ¥ ¸¹Àº ½Ã°£°ú ºñ¿ëÀÌ ¼Ò¿äµÇ¹Ç·Î SaMD(Software as a Medical Device) ½ÃÀå °³Ã´¿¡ °É¸²µ¹·Î ÀÛ¿ëÇϰí ÀÖ½À´Ï´Ù. ¶ÇÇÑ ¹Ì±¹ ½ÄǰÀǾ౹(FDA)ÀÇ ¾ö°ÝÇÑ ±ÔÁ¦ Áؼö ¿ä°Ç, ½ÃÆÇ Àü ½ÂÀÎ, ¾ö°ÝÇÑ Ç°Áú °Ë»ç, ½ÃÆÇ ÈÄ Á¶»ç, »çÀ̹ö º¸¾È ¿ä°Ç, ƯÁ¤ ¼ÒÇÁÆ®¿þ¾î ¼öÁ¤ ¹× ¾÷µ¥ÀÌÆ® µî FDAÀÇ ±ÔÁ¦ ¿ä°Çµµ SaMD °³¹ßÀڵ鿡°Ô Å« µµÀüÀÌ µÇ°í ÀÖ½À´Ï´Ù. ¾÷µ¥ÀÌÆ®°¡ Æ÷ÇԵ˴ϴÙ. ÀÌ·¯ÇÑ ¿ä±¸»çÇ×Àº ¸ðµÎ SaMDÀÇ ½Å·Ú¼º°ú À¯È¿¼ºÀ» º¸ÀåÇϰí Áß¿äÇÑ ÀÇ·á µ¥ÀÌÅÍ¿Í È¯ÀÚ ±â·ÏÀÇ À¯ÃâÀ» ¹æÁöÇÏ´Â µ¥ µµ¿òÀÌ µË´Ï´Ù.

ºÎ¹® ¸®ºä

SaMD(Software as a Medical Device) ½ÃÀåÀº ¹èÆ÷ À¯Çü, ¿ëµµ, ÃÖÁ¾»ç¿ëÀÚ, Áö¿ªÀ¸·Î ºÐ·ùµË´Ï´Ù. ¹èÆ÷ À¯Çü¿¡ µû¶ó ½ÃÀåÀº Ŭ¶ó¿ìµå ±â¹Ý°ú ¿ÂÇÁ·¹¹Ì½º·Î ³ª´¹´Ï´Ù. ¿ëµµ¿¡ µû¶ó ½ºÅ©¸®´× ¹× Áø´Ü, ¸ð´ÏÅ͸µ ¹× °æ°í, ¸¸¼ºÁúȯ °ü¸®, µðÁöÅÐ Ä¡·á, ±âŸ·Î ±¸ºÐµË´Ï´Ù. ÃÖÁ¾»ç¿ëÀÚ¿¡ µû¶ó º´¿ø ¹× Ŭ¸®´Ð, ȨÄɾî ȯ°æ, ±âŸ·Î ºÐ·ùµË´Ï´Ù. Áö¿ªº°·Î´Â ºÏ¹Ì, À¯·´, ¾Æ½Ã¾ÆÅÂÆò¾ç, LAMEA·Î ºÐ¼®µË´Ï´Ù.

ÁÖ¿ä Á¶»ç °á°ú

¹èÄ¡ À¯Çüº°·Î º¸¸é Ŭ¶ó¿ìµå ±â¹Ý ºÎ¹®ÀÌ SaMD(Software as a Medical Device) ½ÃÀåÀ» ÁÖµµÇϰí ÀÖ½À´Ï´Ù.

¿ëµµº°·Î º¸¸é ½ºÅ©¸®´× ¹× Áø´Ü ºÐ¾ß°¡ ³ôÀº ½ÃÀå Á¡À¯À²À» Â÷ÁöÇϰí ÀÖ½À´Ï´Ù.

ÃÖÁ¾»ç¿ëÀÚº°·Î´Â º´¿ø ¹× Ŭ¸®´ÐÀÌ ³ôÀº Á¡À¯À²À» Â÷ÁöÇϰí ÀÖ½À´Ï´Ù.

Áö¿ªº°·Î´Â ºÏ¹Ì°¡ SaMD(Software as a Medical Device) ½ÃÀå¿¡¼­ °¡Àå ³ôÀº ¸ÅÃâÀ» âÃâÇϰí ÀÖ½À´Ï´Ù.

º» ¸®Æ÷Æ®·Î °¡´ÉÇÑ Ä¿½ºÅ͸¶ÀÌÁî(Ãß°¡ ºñ¿ë°ú ½ºÄÉÁÙÀÌ ÇÊ¿äÇÕ´Ï´Ù.)

¸ñÂ÷

Á¦1Àå ¼­·Ð

Á¦2Àå °³¿ä

Á¦3Àå ½ÃÀå ±¸µµ

Á¦4Àå SaMD(Software as a Medical Device) ½ÃÀå : ¹èÆ÷ À¯Çüº°

Á¦5Àå SaMD(Software as a Medical Device) ½ÃÀå : ¿ëµµº°

Á¦6Àå SaMD(Software as a Medical Device) ½ÃÀå : ÃÖÁ¾»ç¿ëÀÚº°

Á¦7Àå SaMD(Software as a Medical Device) ½ÃÀå : Áö¿ªº°

Á¦8Àå °æÀï ±¸µµ

Á¦9Àå ±â¾÷ °³¿ä

KSA
¿µ¹® ¸ñÂ÷

¿µ¹®¸ñÂ÷

(SaMD) Software as a Medical Device Market

The (SaMD) software as a medical device market was valued at $19.5 million in 2023 and is projected to reach $96.2 million by 2033, growing at a CAGR of 17.3% from 2024 to 2033.

Software as a medical device (SaMD) is dedicated software designed for medical use through which functions are performed without the requirement of a hardware medical device. SaMD aids in managing patient health data, diagnosing health conditions, and recommending treatments. The software is highly versatile and accessible as it is easily accessible on general-purpose computing platforms such as smartphones and tablets. A key characteristic of SaMD is its potential to independently accomplish medical objectives, thereby accelerating the scope and efficiency of modern healthcare systems.

Increase in the adoption of telehealth and remote patient monitoring is a major driver of the (SaMD) software as a medical device market. In addition, support from several regulatory bodies such as the Food and Drug Administration and the European Union is boosting the demand for SaMD. To improve the healthcare providers' assistance, the incorporation of Clinical Decision Support Systems (CDSS) is an emerging trend in the market. The capabilities of CDSS help in making evidence-based clinical decisions, thereby enhancing diagnostic accuracy and optimizing treatment procedures.

However, the integration of existing medical records and healthcare data into SaMD is a time-consuming and costly process, hence hampering the development of the (SaMD) software as a medical device market. Furthermore, usage of the software is subject to rigorous regulatory compliance by the U.S. Food and Drug Administration (FDA), which presents significant challenges for the SaMD developers. The regulatory requirements of FDA include premarket approval, strict quality check, post-market surveillance, cybersecurity requirements, and specific software modifications & updates. All these requirements ensure the reliability and efficacy of SaMD, thus preventing compromise with critical health data and patient records.

Segment Review

The (SaMD) software as a medical device market is segmented into deployment type, application, end user, and region. On the basis of deployment type, the market is bifurcated into cloud based and on premise. Depending on application, it is divided into screening & diagnosis, monitoring & alerting, chronic disease management, digital therapeutics, and others. As per end user, it is classified into hospitals & clinics, home care settings, and others. Region wise, it is analyzed across North America, Europe, Asia-Pacific, and LAMEA.

Key Findings

On the basis of deployment type, the cloud-based segment dominates the (SaMD) software as a medical device market.

Depending on application, the screening & diagnosis segment accounts for a high market share.

As per end user, the hospitals & clinics segment acquires a high stake in the market.

Region wise, North America is the highest revenue generator in the (SaMD) software as a medical device market.

Competition Analysis

The major players operating in the global (SaMD) software as a medical device market include MindMaze , Siemens, Biofourmis, BrightInsight, Inc., 4S Information Systems Ltd, Viz.ai, Inc., F. Hoffmann-La Roche Ltd, Koninklijke Philips N.V., Orthogonal, and Zuhlke Engineering AG. These players have adopted various key developmental strategies such as business expansion, new product launches, and partnerships to strengthen their foothold in the market.

Additional benefits you will get with this purchase are:

Possible Customization with this report (with additional cost and timeline, please talk to the sales executive to know more)

Key Market Segments

By Deployment Type

By Application

By End User

By Region

Key Market Players:

TABLE OF CONTENTS

CHAPTER 1: INTRODUCTION

CHAPTER 2: EXECUTIVE SUMMARY

CHAPTER 3: MARKET LANDSCAPE

CHAPTER 4: SOFTWARE AS A MEDICAL DEVICE (SAMD) MARKET, BY DEPLOYMENT TYPE

CHAPTER 5: SOFTWARE AS A MEDICAL DEVICE (SAMD) MARKET, BY APPLICATION

CHAPTER 6: SOFTWARE AS A MEDICAL DEVICE (SAMD) MARKET, BY END USER

CHAPTER 7: SOFTWARE AS A MEDICAL DEVICE (SAMD) MARKET, BY REGION

CHAPTER 8: COMPETITIVE LANDSCAPE

CHAPTER 9: COMPANY PROFILES

(ÁÖ)±Û·Î¹úÀÎÆ÷¸ÞÀÌ¼Ç 02-2025-2992 kr-info@giikorea.co.kr
¨Ï Copyright Global Information, Inc. All rights reserved.
PC¹öÀü º¸±â