À¯·´ÀÇ ¾à¹°°¨½Ã ¹× ÀǾàǰ ¾ÈÀü¼º ¼ÒÇÁÆ®¿þ¾î ½ÃÀå º¸°í¼­ : ¹üÀ§, ºÎ¹®, ¿ªÇÐ, °æÀï ºÐ¼®(2021-2031³â)
Europe Pharmacovigilance and Drug Safety Software Market Report 2021-2031 by Scope, Segmentation, Dynamics, and Competitive Analysis
»óǰÄÚµå : 1819689
¸®¼­Ä¡»ç : The Insight Partners
¹ßÇàÀÏ : 2025³â 07¿ù
ÆäÀÌÁö Á¤º¸ : ¿µ¹® 224 Pages
 ¶óÀ̼±½º & °¡°Ý (ºÎ°¡¼¼ º°µµ)
US $ 3,450 £Ü 4,962,000
PDF (Single User License) help
PDF º¸°í¼­¸¦ 1¸í¸¸ ÀÌ¿ëÇÒ ¼ö ÀÖ´Â ¶óÀ̼±½ºÀÔ´Ï´Ù.
US $ 4,450 £Ü 6,400,000
PDF (Site License) help
PDF º¸°í¼­¸¦ µ¿ÀÏ »ç¾÷ÀåÀÇ ¸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.
US $ 5,450 £Ü 7,838,000
PDF (Enterprise License) help
PDF º¸°í¼­¸¦ 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.


Çѱ۸ñÂ÷

¾à¹°°¨½Ã ¹× ÀǾàǰ ¾ÈÀü¼º ¼ÒÇÁÆ®¿þ¾î ½ÃÀåÀº 2023³â¿¡´Â ¾à 5,238¸¸ ´Þ·¯·Î Æò°¡µÇ¾ú°í, 2031³â±îÁö´Â 8,467¸¸ ´Þ·¯, ÀÌ ±â°£ µ¿¾È ¿¬Æò±Õ ¼ºÀå·ü(CAGR) 6.2%·Î ¼ºÀåÇÒ °ÍÀ¸·Î ¿¹»óµË´Ï´Ù.

¾à¹°°¨½ÃÀÇ ¼¼°èÈ­ - ½ÃÀå ¼ºÀåÀÇ Ä«Å»¸®½ºÆ®

ÀǾàǰ ºÎÀÛ¿ë(ADR)ÀÇ ¸ð´ÏÅ͸µ°ú Æò°¡¸¦ Æ÷ÇÔÇÑ ¾à¹°°¨½Ã´Â ÀǾàǰ ±ÔÁ¦, ÀÓ»ó ½Çõ, °øÁߺ¸°Ç Ȱµ¿¿¡ Áß¿äÇÑ Ãø¸éÀÔ´Ï´Ù. ¾à¹°°¨½ÃÀÇ ¼¼°èÈ­´Â ±ÔÁ¦ ´ç±¹, ÀÇ·á Á¦°øÀÚ, Á¦¾à±â¾÷ µî ´Ù¾çÇÑ ÀÌÇØ°ü°èÀÚ°£ÀÇ ¿¬°è °­È­¸¦ ÃËÁøÇϰí ÀÖ½À´Ï´Ù. ¿¹¸¦ µé¾î, À¯·´ ÀǾàǰû(EMA)Àº ÀǾàǰÀÇ ¾ÈÀü¼º, °Ë»ç ¹× °ü·Ã Á¤º¸ ±³È¯¿¡ ÃÊÁ¡À» ¸ÂÃá ÀǾàǰ ±ÔÁ¦ ´ç±¹ °£ÀÇ ±¹Á¦ Çù·ÂÀÇ Á߿伺À» Á¡Á¡ °­Á¶Çϰí ÀÖ½À´Ï´Ù. ÀÌ Çù·Â ÇÁ·¹ÀÓ¿öÅ©´Â µ¥ÀÌÅÍ °øÀ¯¸¦ ÃËÁøÇÒ »Ó¸¸ ¾Æ´Ï¶ó ÀǾàǰÀÇ ¾ÈÀü¼º ÇÁ·ÎÆÄÀÏ¿¡ ´ëÇÑ Àü¹ÝÀûÀÎ ÀÌÇØ¸¦ Çâ»ó½Ãŵ´Ï´Ù.

±â¾÷ÀÌ ÀÌ·¯ÇÑ ¼¼°è ³×Æ®¿öÅ©¸¦ Ȱ¿ëÇÏ´Â °ÍÀ» ¸ñÇ¥·Î Çϰí Àֱ⠶§¹®¿¡ ±¹°æÀ» ³Ñ¾î È¿°úÀûÀ¸·Î ±â´ÉÇÏ´Â ÅëÇÕ ¾à¹°°¨½Ã ¼Ö·ç¼Ç¿¡ ´ëÇÑ ¼ö¿ä°¡ ÇöÀúÇØÁö°í ÀÖ½À´Ï´Ù. ¼¼°è °¢±¹ÀÇ Á¤ºÎ´Â ÀǾàǰ ¾ÈÀü¼º È®º¸¿¡ À־ÀÇ ¾à¹°°¨½ÃÀÇ Áß¿äÇÑ ¿ªÇÒÀ» ÀνÄÇϰí, °¢±¹ÀÇ ±ÔÁ¦±â°ü°ú Á¦ÈÞÇÏ¿© ¾à¹°°¨½Ã ÇÁ·Î±×·¥À» ½Ç½ÃÇß½À´Ï´Ù. °¢±¹ÀÇ ¾à¹°°¨½ÃÀÇ ¸ð¹ü »ç·Ê¿¡ ´ëÇÑ Àνİú äÅà Áõ°¡´Â Àü¹®ÀûÀÎ ¼ÒÇÁÆ®¿þ¾î ¼Ö·ç¼Ç¿¡ ´ëÇÑ ¼ö¿ä¸¦ ÇöÀúÇÏ°Ô ³ô¿©ÁÖ°í ÀÖ½À´Ï´Ù. Ưº°ÇÑ ¿¹·Î´Â ÀÌÅ»¸®¾ÆÀÇ ÀÇ·á ±â°üÀÌ ÀÖ½À´Ï´Ù. ÀÌ ±â°üÀº 2022³â 6¿ù ADRÀÇ ÇøÀǸ¦ °¨ÁöÇϱâ À§ÇÑ Àü±¹ ¾à¹°°¨½Ã ³×Æ®¿öÅ©(RNF)¸¦ ½ÃÀÛÇß½À´Ï´Ù. ÀÌ ½Ã½ºÅÛ¿¡´Â ADR º¸°í¸¦ °ü¸®ÇÏ°í ºÐ¼®Çϱâ À§ÇÑ °í±Þ ±â´ÉÀÌ ³»ÀåµÇ¾î ÀÖ¾î ÀǾàǰÀÇ ¾ÈÀü¼ºÀ» Á¤È®ÇÏ°Ô Æò°¡ÇÒ ¼ö ÀÖ½À´Ï´Ù. ¶ÇÇÑ À¯·´ ±¹°¡¿¡¼­ »ç¿ëµÇ´Â EudraVigilance ½Ã½ºÅÛÀº ADRÀÇ Àǽɿ¡ ´ëÇÑ º¸°í¼­¸¦ ÀÛ¼ºÇÏ°í ¾à¹°°¨½ÃÀÇ ³ë·ÂÀ» ´õ¿í °­È­ÇÕ´Ï´Ù.

¾à¹°°¨½ÃÀÇ ¼¼°èÈ­´Â ±¹°æÀ» ³ÑÀº ¿¬°èµµ ÃËÁøÇÕ´Ï´Ù. BeNeLuxA, ºÏÀ¯·´ °øµ¿ ¿¬±¸, ¹ß·¹Å¸ ¼±¾ð µî À¯·´ÀÇ ÀϺΠÀÌ´Ï¼ÅÆ¼ºê´Â Çõ½ÅÀûÀÎ Ä¡·á¹ý¿¡ ´ëÇÑ È¯ÀÚÀÇ Á¢±Ù¼ºÀ» Çâ»ó½ÃŰ´Â °ÍÀ» ¸ñÇ¥·Î Çϰí ÀÖ½À´Ï´Ù. ¿¹¸¦ µé¾î BeNeLuxA ÀÌ´Ï¼ÅÆ¼ºê´Â º§±â¿¡, ³×´ú¶õµå, ·è¼ÀºÎ¸£Å©, ¿À½ºÆ®¸®¾Æ, ¾ÆÀÏ·£µå °£ÀÇ Çù·ÂÀ» °­È­Çϰí Á߼ҵ汹ÀÌ ´õ ³ªÀº ¾à°¡ Çù»óÀ» ¼öÇàÇϰí Á¤Ã¥ Àü¹® Áö½ÄÀ» °øÀ¯ÇÒ ¼ö ÀÖµµ·Ï ÇÕ´Ï´Ù. ÀÌ·¯ÇÑ Çù·ÂÀûÀÎ ³ë·ÂÀº Á¾ÇÕÀûÀÎ ÀÇ·á ±â¼ú Æò°¡¸¦ Áö¿øÇϰí ÀǾàǰ ¸¶ÄÉÆÃÀÇ Åõ¸í¼ºÀ» Çâ»ó½Ãŵ´Ï´Ù. ADRÀ» ¼¼°èÀûÀ¸·Î °ü¸®ÇÏ°í º¸°íÇÒ ¼ö ÀÖ´Â °ß°íÇÑ ¾à¹°°¨½Ã ½Ã½ºÅÛÀÇ È®¸³Àº ¾à¹°°¨½ÃÀÇ ¼¼°èÈ­¸¦ ÃßÁøÇϴµ¥ ÇʼöÀûÀ̸ç, ¾à¹°°¨½Ã ¹× ÀǾàǰ ¾ÈÀü¼º ¼ÒÇÁÆ®¿þ¾î ½ÃÀåÀÇ ¼ºÀåÀ» °¡¼ÓÇϰí ÀÖ½À´Ï´Ù.

À¯·´ÀÇ ¾à¹°°¨½Ã ¹× ÀǾàǰ ¾ÈÀü¼º ¼ÒÇÁÆ®¿þ¾î ½ÃÀå °³¿ä

À¯·´ÀÇ ¾à¹°°¨½Ã ¹× ÀǾàǰ ¾ÈÀü¼º ¼ÒÇÁÆ®¿þ¾î¿¡ ´ëÇÑ ¼ö¿ä Áõ°¡´Â ¾ö°ÝÇÑ ±ÔÁ¦ ¿ä±¸ »çÇ×, ÀǾàǰ ½ÂÀÎ Áõ°¡, ȯÀÚ ¾ÈÀü¿¡ ´ëÇÑ °ü½É Áõ°¡, ±â¼ú Áøº¸ µî ¿©·¯ ¿äÀÎÀ¸·Î ÀÎÇØ ¹ß»ýÇÕ´Ï´Ù. EUÀÇ ¾à¹°°¨½ÃÀÇ Æ²Àº ¼¼°èÀûÀ¸·Î º¸¾Æµµ °¡Àå Á¤±³Çϰí ÀÖÀ¸¸ç, EMA¿Í °°Àº ±ÔÁ¦±â°üÀÌ ¾ö°ÝÇÑ ¾à¹°°¨½Ã ±âÁØÀ» ½Ç½ÃÇϰí Àֱ⠶§¹®¿¡ ÷´Ü ¼ÒÇÁÆ®¿þ¾î ¼Ö·ç¼ÇÀÇ µµÀÔÀÌ ÇÊ¿äÇÕ´Ï´Ù. EU ¾à¹°°¨½Ã Áöħ(2010/84/EU) ¹× ±ÔÄ¢(EU) No 1235/2010Àº ADR¿¡ ´ëÇÑ º¸´Ù ¾ö°ÝÇÑ ¸ð´ÏÅ͸µ ±ÔÄ¢À» µµÀÔÇÏ°í ¾ÈÀü µ¥ÀÌÅ͸¦ ½Ç½Ã°£À¸·Î º¸°íÇϵµ·Ï Àǹ«È­ÇÏ°í ´ë·®ÀÇ µ¥ÀÌÅ͸¦ ó¸®ÇÒ ¼ö ÀÖ´Â È¿À²ÀûÀÎ ¼ÒÇÁÆ®¿þ¾î ½Ã½ºÅÛ¿¡ ´ëÇÑ Çʿ伺À» ³ôÀ̰í ÀÖ½À´Ï´Ù.

À¯·´ Á¦¾à ºÎ¹®¿¡¼­´Â ½Å¾à ½ÂÀÎÀÌ ±ÞÁõÇÏ°í ¾ÈÀü¼º µ¥ÀÌÅ͸¦ È¿À²ÀûÀ¸·Î ¸ð´ÏÅ͸µÇÏ´Â ¾à¹°°¨½Ã ¹× ÀǾàǰ ¾ÈÀü¼º ¼ÒÇÁÆ®¿þ¾î¿¡ ´ëÇÑ ¼ö¿ä°¡ ´õ¿í ³ô¾ÆÁö°í ÀÖ½À´Ï´Ù. ¿¹¸¦ µé¾î 2023³â 2ºÐ±â¿¡ EMA¿Í ¹Ì±¹ FDA´Â 21°³ ÀÌ»óÀÇ »õ·Î¿î Ç×¾ÏÁ¦¸¦ ½ÂÀÎÇß½À´Ï´Ù. ´õ ¸¹Àº Á¦Ç°ÀÌ ½ÃÀå¿¡ ÁøÀÔÇÏ´Â µ¿¾È, Á¦¾à ȸ»ç´Â ÀÌ·¯ÇÑ ÀǾàǰÀÇ ¾ÈÀü°ú È¿°ú¸¦ º¸ÀåÇϱâ À§ÇØ °­·ÂÇÑ ¼ÒÇÁÆ®¿þ¾î ¼Ö·ç¼ÇÀÌ ÇÊ¿äÇÕ´Ï´Ù. Oracle Corp¿Í °°Àº ´ë±â¾÷Àº »õ·Î ½ÂÀÎµÈ Á¦Ç°ÀÇ ¾ÈÀü¼º ¸ð´ÏÅ͸µ ±â´ÉÀ» °­È­Çϱâ À§ÇØ ¾à¹°°¨½Ã ¼ÒÇÁÆ®¿þ¾î¿¡ ¸¹Àº ÅõÀÚ¸¦ Çϰí ÀÖÀ¸¸ç, Oracle Argus Safety³ª Veeva Vault Safety µîÀÇ Ç÷§ÆûÀ» Ȱ¿ëÇÏ¿© È¿°úÀûÀÎ À¯ÇØ À̺¥Æ® °ü¸®¸¦ ½Ç½ÃÇß½À´Ï´Ù.

¶ÇÇÑ À¯·´ Á¤ºÎ´Â ƯÈ÷ EU ÀÏ¹Ý µ¥ÀÌÅÍ º¸È£ ±ÔÄ¢(GDPR(EU °³ÀÎÁ¤º¸º¸È£±ÔÁ¤))ÀÇ µµÀÔ°ú ÇÔ²² ¼ÒÇÁÆ®¿þ¾î µ¥ÀÌÅ͸¦ º¸È£Çϱâ À§ÇÑ ±ÔÁ¤ Áؼö Á¶Ä¡¸¦ ÃëÇϰí ÀÖ½À´Ï´Ù. ÀÌ ±ÔÁ¦´Â ¾à¹°°¨½Ã ¹× ÀǾàǰ ¾ÈÀü¼º ¼ÒÇÁÆ®¿þ¾î°¡ ±ÔÁ¦ ±âÁØÀ» ÃæÁ·ÇÒ »Ó¸¸ ¾Æ´Ï¶ó µ¥ÀÌÅÍ ÇÁ¶óÀ̹ö½Ã¸¦ º¸È£Çϸ鼭 ¾÷¹« È¿À²¼ºÀ» È®º¸ÇÒ °ÍÀ» Àǹ«È­ÇÕ´Ï´Ù. GDPR(EU °³ÀÎÁ¤º¸º¸È£±ÔÁ¤)À» ÁؼöÇÏ´Â °ÍÀº ȯÀÚ ¹× ±ÔÁ¦ ±â°ü°úÀÇ ½Å·Ú °ü°è¸¦ À¯ÁöÇÏ´Â µ¥ ¸Å¿ì Áß¿äÇϹǷΠÀ¯·´ Àü¿ª¿¡¼­ ¾à¹°°¨½Ã ¼ÒÇÁÆ®¿þ¾îÀÇ µµÀÔÀ» ÃËÁøÇÕ´Ï´Ù.

ÀΰøÁö´É(AI), ¸Ó½Å·¯´×(ML) ¹× ±âŸ ÷´Ü±â¼úÀÇ ÅëÇÕÀº ¾à¹°°¨½Ã ÇÁ·Î¼¼½º¿¡ Çõ¸íÀ» °¡Á®¿É´Ï´Ù. ÀÌ·¯ÇÑ Çõ½ÅÀº ÀÚµ¿ µ¥ÀÌÅÍ Ã³¸®, ½Ç½Ã°£ ½ÅÈ£ °¨Áö, °í±Þ ºÐ¼®À» ¿ëÀÌÇÏ°Ô ÇÏ¸ç ¾ÈÀü µ¥ÀÌÅÍ °ü¸® ¹× ±ÔÁ¦ ¿ä±¸ »çÇ× Áؼö¸¦ °£¼ÒÈ­ÇÕ´Ï´Ù. ¿¹¸¦ µé¾î, ArisGlobalÀÇ LifeSphere Ç÷§ÆûÀº AI¸¦ Ȱ¿ëÇÏ¿© »ç·Ê 󸮸¦ ÀÚµ¿È­ÇÏ°í ½Ã±×³Î °ËÃâ ±â´ÉÀ» °­È­Çϰí À¯·´ÀÇ ¾à¹°°¨½Ã ¹× ÀǾàǰ ¾ÈÀü ¼ÒÇÁÆ®¿þ¾î ¼ö¿ä¸¦ ´õ¿í ÃËÁøÇϰí ÀÖ½À´Ï´Ù.

½ÃÀå ¼¼ºÐÈ­ ºÐ¼®

À¯·´ÀÇ ¾à¹°°¨½Ã ¹× ÀǾàǰ ¾ÈÀü¼º ¼ÒÇÁÆ®¿þ¾î ½ÃÀåÀº ¿ÀÆÄ¸°, Àü°³, ±â¾÷ ±Ô¸ð, ÇüÅÂ, ±â´É, ÃÖÁ¾ »ç¿ëÀÚ, ±¹°¡ µî ´Ù¾çÇÑ ±âÁØ¿¡ µû¶ó ¼¼ºÐÈ­µË´Ï´Ù.

½ÃÀåÀÇ ÁÖ¿ä ±â¾÷

À¯·´ÀÇ Pharmaco Vigilance ¹× Á¦¾à ¾ÈÀü ¼ÒÇÁÆ®¿þ¾î ½ÃÀåÀÇ ÁÖ¿ä ±â¾÷Àº Veeva Systems Inc, IQVIA Holdings Inc, AB Cube SAS, ArisGlobal LLC, Oracle Corp, Max Application, ICON Plc, Cognizant Technology Solutions Corp, Accenture Plc, Syneos Health Corp. Holdings, Parexel International Corp, Qinecsa Solutions, Clinevo Technologies µîÀÌ ÀÖ½À´Ï´Ù.

¸ñÂ÷

Á¦1Àå ¼­·Ð

Á¦2Àå ÁÖ¿ä ¿ä¾à

Á¦3Àå Á¶»ç ¹æ¹ý

Á¦4Àå À¯·´ÀÇ ¾à¹°°¨½Ã ¹× ÀǾàǰ ¾ÈÀü¼º ¼ÒÇÁÆ®¿þ¾î ½ÃÀå »óȲ

Á¦5Àå À¯·´ÀÇ ¾à¹°°¨½Ã ¹× ÀǾàǰ ¾ÈÀü¼º ¼ÒÇÁÆ®¿þ¾î ½ÃÀå : ÁÖ¿ä ½ÃÀå ¿ªÇÐ

Á¦6Àå À¯·´ÀÇ ¾à¹°°¨½Ã ¹× ÀǾàǰ ¾ÈÀü¼º ¼ÒÇÁÆ®¿þ¾î ½ÃÀå - ºÐ¼®

Á¦7Àå À¯·´ÀÇ ¾à¹°°¨½Ã ¹× ÀǾàǰ ¾ÈÀü¼º ¼ÒÇÁÆ®¿þ¾î ½ÃÀå ºÐ¼® - Á¦°ø Á¦Ç°º°

Á¦8Àå À¯·´ÀÇ ¾à¹°°¨½Ã ¹× ÀǾàǰ ¾ÈÀü¼º ¼ÒÇÁÆ®¿þ¾î ½ÃÀå ºÐ¼® - Àü°³º°

Á¦9Àå À¯·´ÀÇ ¾à¹°°¨½Ã ¹× ÀǾàǰ ¾ÈÀü¼º ¼ÒÇÁÆ®¿þ¾î ½ÃÀå ºÐ¼® - ±â¾÷ ±Ô¸ðº°

Á¦10Àå À¯·´ÀÇ ¾à¹°°¨½Ã ¹× ÀǾàǰ ¾ÈÀü¼º ¼ÒÇÁÆ®¿þ¾î ½ÃÀå ºÐ¼® - Çüź°

Á¦11Àå À¯·´ÀÇ ¾à¹°°¨½Ã ¹× ÀǾàǰ ¾ÈÀü¼º ¼ÒÇÁÆ®¿þ¾î ½ÃÀå ºÐ¼® - ±â´Éº°

Á¦12Àå À¯·´ÀÇ ¾à¹°°¨½Ã ¹× ÀǾàǰ ¾ÈÀü¼º ¼ÒÇÁÆ®¿þ¾î ½ÃÀå ºÐ¼® - ÃÖÁ¾ »ç¿ëÀÚº°

Á¦13Àå À¯·´ÀÇ ¾à¹°°¨½Ã ¹× ÀǾàǰ ¾ÈÀü¼º ¼ÒÇÁÆ®¿þ¾î ½ÃÀå : ±¹°¡º° ºÐ¼®

Á¦14Àå °æÀï ±¸µµ

Á¦15Àå ¾÷°è Á¤¼¼

Á¦16Àå ±â¾÷ ÇÁ·ÎÆÄÀÏ

Á¦17Àå ºÎ·Ï

SHW
¿µ¹® ¸ñÂ÷

¿µ¹®¸ñÂ÷

The pharmacovigilance and drug safety software market in Europe was valued at approximately US$ 52.38 million in 2023, with projections indicating it will grow to US$ 84.67 million by 2031, reflecting a compound annual growth rate (CAGR) of 6.2% during this period.

Globalization of Pharmacovigilance: A Catalyst for Market Growth

Pharmacovigilance, which involves the monitoring and assessment of adverse drug reactions (ADRs), is a critical aspect of drug regulation, clinical practice, and public health initiatives. The globalization of pharmacovigilance is fostering enhanced collaboration among various stakeholders, including regulatory authorities, healthcare providers, and pharmaceutical companies. For example, the European Medicines Agency (EMA) has increasingly emphasized the importance of international cooperation among pharmaceutical regulators, focusing on medicine safety, inspections, and the exchange of pertinent information. This collaborative framework not only facilitates data sharing but also improves the overall understanding of drug safety profiles.

As companies aim to capitalize on these global networks, the demand for integrated pharmacovigilance solutions that can function effectively across borders is becoming more pronounced. Governments worldwide are implementing pharmacovigilance programs in partnership with their national regulatory bodies, recognizing the vital role of pharmacovigilance in ensuring drug safety. The growing awareness and adoption of best practices in pharmacovigilance across various countries have significantly increased the demand for specialized software solutions. A notable example is Italy's Medical Agency, which launched the National Pharmacovigilance Network (RNF) in June 2022 to detect suspected ADRs. This system incorporates advanced functionalities for managing and analyzing ADR reports, ensuring accurate assessments of medicine safety. Additionally, the EudraVigilance System, utilized across European nations, generates reports on suspected ADRs, further enhancing pharmacovigilance efforts.

The globalization of pharmacovigilance also promotes cross-border collaboration. Several European initiatives, such as BeNeLuxA, the Nordic collaborations, and the Valletta Declaration, aim to improve patient access to innovative therapies. The BeNeLuxA initiative, for instance, enhances cooperation among Belgium, the Netherlands, Luxembourg, Austria, and Ireland, allowing middle-income countries to negotiate better drug pricing and share policy expertise. These collaborative efforts support comprehensive health technology assessments and improve transparency in pharmaceutical marketing. The establishment of robust pharmacovigilance systems capable of managing and reporting ADRs on a global scale is essential for advancing the globalization of pharmacovigilance, thereby driving the growth of the pharmacovigilance and drug safety software market.

Overview of the Europe Pharmacovigilance and Drug Safety Software Market

The increasing demand for pharmacovigilance and drug safety software in Europe can be attributed to several factors, including stringent regulatory requirements, a rise in drug approvals, a heightened focus on patient safety, and technological advancements. The EU's pharmacovigilance framework is among the most sophisticated globally, with regulatory bodies like the EMA enforcing rigorous pharmacovigilance standards that necessitate the adoption of advanced software solutions. The EU Pharmacovigilance Directive (2010/84/EU) and Regulation (EU) No 1235/2010 have introduced stricter monitoring rules for ADRs, compelling companies to report safety data in real-time and increasing the need for efficient software systems capable of handling large data volumes.

The European pharmaceutical sector has witnessed a surge in new drug approvals, further driving the demand for pharmacovigilance and drug safety software to monitor safety data effectively. For instance, in the second quarter of 2023, the EMA and the US FDA approved over 21 new oncology drugs. As more products enter the market, pharmaceutical companies require robust software solutions to ensure the safety and efficacy of these drugs. Major companies, such as Oracle Corp, are heavily investing in pharmacovigilance software to enhance their safety monitoring capabilities for newly approved products, utilizing platforms like Oracle Argus Safety and Veeva Vault Safety for effective adverse event management.

Moreover, European governments are implementing compliance measures to protect software data, particularly with the introduction of the EU General Data Protection Regulation (GDPR). This regulation mandates that pharmacovigilance and drug safety software not only meet regulatory standards but also ensure operational efficiency while safeguarding data privacy. Adhering to GDPR is crucial for maintaining trust with patients and regulatory bodies alike, thereby boosting the adoption of pharmacovigilance software across Europe.

The integration of artificial intelligence (AI), machine learning (ML), and other advanced technologies is revolutionizing pharmacovigilance processes. These innovations facilitate automated data processing, real-time signal detection, and advanced analytics, simplifying the management of safety data and compliance with regulatory requirements. For example, ArisGlobal's LifeSphere platform leverages AI to automate case processing and enhance signal detection capabilities, further driving the demand for pharmacovigilance and drug safety software in Europe.

Market Segmentation Analysis

The Europe pharmacovigilance and drug safety software market is segmented based on various criteria, including offering, deployment, enterprise size, form, functionality, end user, and country.

Key Players in the Market

Leading companies in the Europe pharmacovigilance and drug safety software market include Veeva Systems Inc, IQVIA Holdings Inc, AB Cube S.A.S., ArisGlobal LLC, Oracle Corp, Max Application, ICON Plc, Cognizant Technology Solutions Corp, Accenture Plc, Syneos Health Inc, Genpact Ltd., Laboratory Corp of America Holdings, Parexel International Corp, Qinecsa Solutions, and Clinevo Technologies.

Table Of Contents

1. Introduction

2. Executive Summary

3. Research Methodology

4. Europe Pharmacovigilance and Drug Safety Software Market Landscape

5. Europe Pharmacovigilance and Drug Safety Software Market - Key Market Dynamics

6. Europe Pharmacovigilance and Drug Safety Software Market - Analysis

7. Europe Pharmacovigilance and Drug Safety Software Market Analysis - by Offering

8. Europe Pharmacovigilance and Drug Safety Software Market Analysis - by Deployment

9. Europe Pharmacovigilance and Drug Safety Software Market Analysis - by Enterprise Size

10. Europe Pharmacovigilance and Drug Safety Software Market Analysis - by Form

11. Europe Pharmacovigilance and Drug Safety Software Market Analysis - by Functionality

12. Europe Pharmacovigilance and Drug Safety Software Market Analysis - by End User

13. Europe Pharmacovigilance and Drug Safety Software Market - Country Analysis

14. Competitive Landscape

15. Industry Landscape

16. Company Profiles

17. Appendix

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