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IgG4 °ü·Ã Áúȯ ½ÃÀå - ½ÃÀå ÀλçÀÌÆ®, ¿ªÇÐ, ½ÃÀå ¿¹Ãø(2034³â)IgG4-Related Disease - Market Insight, Epidemiology, and Market Forecast - 2034 |
º» º¸°í¼´Â IgG4 °ü·Ã Áúȯ ½ÃÀåÀ» Á¶»çÇÏ¿© ¹Ì±¹, EU 4°³±¹(µ¶ÀÏ, ÇÁ¶û½º, ÀÌÅ»¸®¾Æ, ½ºÆäÀÎ, ¿µ±¹, ÀϺ»ÀÇ ½ÃÀå µ¿Çâ°ú ÇÔ²² °ú°Å ¿ªÇÐ ¹× ¿¹Ãø¿¡ ´ëÇÑ »ó¼¼ÇÑ ÀÌÇØ¸¦ Á¦°øÇÕ´Ï´Ù. ÇöÀç Ä¡·á¹ý, ½Å¾à, °³º° Ä¡·á¹ýÀÇ ½ÃÀå Á¡À¯À², 2020³â¿¡¼ 2034³â±îÁö ÁÖ¿ä 7°³±¹ÀÇ ÇöÀç ¹× ¿¹Ãø ½ÃÀå ±Ô¸ð¸¦ Á¦°øÇÕ´Ï´Ù. ¶ÇÇÑ, ÇöÀç Ä¡·á¹ý/¾Ë°í¸®Áò, ¹ÌÃæÁ· ÀÇ·á ¼ö¿ä¸¦ Æ÷°ýÇÏ¿© ÃÖÀûÀÇ ±âȸ¸¦ ¹ß±¼ÇÏ°í ½ÃÀå ÀáÀç·ÂÀ» Æò°¡ÇÕ´Ï´Ù.
IgG4-RD´Â Ç÷Àå ³» IgG4 ³óµµÀÇ »ó½Â À¯¹«¿¡ °ü°è¾øÀÌ, °¨¿°µÈ Á¶Á÷¿¡¼ IgG4 ¾ç¼º ÇüÁú¼¼Æ÷ÀÇ ¹ÐÁý ħÀ±À» Ư¡À¸·Î ÇÏ´Â Àü½Å¼º ¼¶À¯¼º ¿°Áõ¼º ÁúȯÀÔ´Ï´Ù. ¸¸¼º ¼¶À¯¼º ¿°Áõ¼º ÁúȯÀ¸·Î ´Ù¾çÇÑ Àå±â¿¡ ¿µÇâÀ» ¹ÌĨ´Ï´Ù. Ç÷û IgG4 ³óµµÀÇ »ó½Â°ú IgG4 ¹ßÇö ÇüÁú¼¼Æ÷ÀÇ Ç³ºÎÇÑ Ä§À±Àº ÀÌ ÀÚ°¡¸é¿ªÁúȯÀÇ ÁÖ¿ä Áø´ÜÀû Ư¡À̸ç, IgG4-RDÀÇ ÈçÇÑ Àå±â º´º¯Àº ħ»ù, ÃéÀå ¹× ´ã°üÀ̸ç, °£ º´º¯Àº Àß ¾Ë·ÁÁ® ÀÖÁö ¾Ê½À´Ï´Ù.
IgG4-RD´Â ¹ÌÄð¸®Ã÷º´, ÀÚ°¡¸é¿ª¼º ÃéÀå¿°, °©»ó¼±±â´ÉÀúÇÏÁõ, ¸®µ¨ °©»ó¼±¿°, °£Áú¼º Æó·Å, °£Áú¼º ½Å¿°, Àü¸³¼±¿°, ¸²ÇÁÀý ºÎÁ¾, Èĺ¹¸· ¼¶À¯Áõ, ¿°Áõ¼º ´ëµ¿¸Æ·ù, ¿°Áõ¼º °¡¼ºÁ¾¾ç µî ´Ù¾çÇÑ ÁúȯÀ» ¾Î°í Àִ ȯÀÚ¿¡¼ ÀÏÁ¤ ºñÀ²·Î ¹ß°ßµÉ ¼ö ÀÖ½À´Ï´Ù.
IgG4-RD´Â ¿©·¯ Àå±â¸¦ µ¿½Ã¿¡ ħ¹üÇÒ ¼ö Àֱ⠶§¹®¿¡ Áø´ÜÀÌ ¾î·Æ½À´Ï´Ù. Áø´ÜÀ» À§Çؼ´Â ÀÓ»ó °Ë»ç, ³»½Ã°æ °Ë»ç, X¼± °Ë»ç, Ç÷ûÇÐÀû °Ë»ç, Àå±â º´º¯ ¹× ¸»ÃÊ Àå±â Àå¾Ö(È£¸£¸ó ±ÕÇü Àå¾Ö µî)¸¦ °Ë»çÇØ¾ß ÇÕ´Ï´Ù. Á¶Á÷ Áø´ÜÀ» À§Çؼ´Â ÇǺθ¦ Æ÷ÇÔÇÑ È¯ºÎ Á¶Á÷ÀÇ »ý°ËÀÌ ÇÊ¿äÇÕ´Ï´Ù. Ç÷¾× °Ë»ç¿¡¼ Ç÷û IgG4 ³óµµÀÇ »ó½Â°ú ¸»ÃÊ È£»ê±¸ Áõ°¡°¡ °üÂûµÉ ¼ö ÀÖ½À´Ï´Ù.
Ç÷û IgG4 ³óµµ´Â °¡Àå Áß¿äÇÑ ¹ÙÀÌ¿À¸¶Ä¿·Î, ÃÖ´ë 90%ÀÇ È¯ÀÚ¿¡¼ ³ôÀº ¼öÄ¡¸¦ º¸ÀÌÁö¸¸, ±× ¼öÄ¡´Â ´Ù¾çÇϸç, IgG4 ³óµµÀÇ °¨¼Ò´Â Á¾Á¾ Ä¡·á È¿°ú¸¦ ³ªÅ¸³»Áö¸¸, Àå±â°£ »ýÁ¸ÇÏ´Â ÇüÁú¼¼Æ÷·Î ÀÎÇØ °üÇØ±â¿¡µµ Á¤»óÀ¸·Î µ¹¾Æ¿ÀÁö ¾ÊÀ» ¼ö ÀÖ½À´Ï´Ù. IgG1, IgE, È£»ê±¸ Áõ°¡, º¸Ã¼ ¼öÁØ(C3 ¹× C4)°ú °°Àº ´Ù¸¥ ¹ÙÀÌ¿À¸¶Ä¿µµ Áúº´ Ȱµ¿À» ¹Ý¿µÇÒ ¼ö ÀÖÀ¸¸ç, IgG4 °ü·Ã ½ÅÀå Áúȯ¿¡¼ Àúº¸Ã¼Ç÷ÁõÀº µÎµå·¯Áö°Ô ³ªÅ¸³³´Ï´Ù. º¸Ç÷ÁõÀº µÎµå·¯Áö°Ô ³ªÅ¸³³´Ï´Ù.
IgG4-RDÀÇ °æ¿ì Ä¡·á°¡ ¹Ýµå½Ã ÇÊ¿äÇÑ °ÍÀº ¾Æ´Ï¸ç, ¹«Áõ»óÀÎ °æ¿ì ÁÖÀÇ ±í°Ô ÁöÄѺ¸´Â °ÍÀÌ ÀûÀýÇÑ °æ¿ìµµ ÀÖ½À´Ï´Ù. ¹Ý¸é, IgG4-RD´Â ÁÖ¿ä Àå±âÀÇ ±â´ÉºÎÀüÀ̳ª Àå¾Ö¸¦ À¯¹ßÇÒ ¼ö Àֱ⠶§¹®¿¡ Áß¿äÇÑ Àå±â°¡ °ü·ÃµÇ¾î Àְųª ȯÀÚ°¡ Áõ»óÀ» º¸ÀÌ´Â °æ¿ì ½Å¼ÓÇÑ Ä¡·á°¡ ÇÊ¿äÇÕ´Ï´Ù.
IgG4-RD Ä¡·á¿¡ ´ëÇÑ ±¹Á¦ÀûÀÎ ÇÕÀǹ®¿¡ µû¸£¸é, ±Û·çÄÚÄÚ¸£Æ¼ÄÚÀ̵å´Â ´ëºÎºÐÀÇ ÃéÀå ¹× ÃéÀå ¿Ü Áúȯ¿¡¼ ±ØÀûÀÎ ÀÓ»óÀû È¿°ú°¡ Àֱ⠶§¹®¿¡ ÀÏÂ÷ ¼±Åà ¾à¹°ÀÔ´Ï´Ù. µû¶ó¼ ´Ù¾çÇÑ ±Û·çÄÚÄÚ¸£Æ¼ÄÚÀ̵带 º¸Á¸ÇÏ´Â ¾à¹°ÀÌ ´Ù¾çÇÑ ÇØºÎÇÐÀû ¿µ¿ª¿¡¼ °üÇØ À¯Áö ¾à¹°·Î »ç¿ëµÇ°í ÀÖÀ¸¸ç(¿¹: ¾ÆÀÚÆ¼¿ÀÇÁ¸°, ¸ðÆäÆ¿ ¹ÌÄÚÆä³î»ê, ¸ÞÅ䯮·º¼¼ÀÌÆ®, »çÀÌŬ·ÎÆ÷½ºÆÄ¹Ìµå, º¸¸£Å×Á¶¹Ó), ±× °á°ú´Â ´Ù¾çÇÕ´Ï´Ù.
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±Û·çÄÚÄÚ¸£Æ¼ÄÚÀ̵å Ä¡·á¿¡ ´ëÇÑ ºü¸¥ ¹ÝÀÀÀÌ Æ¯Â¡ÀûÀÎ ¼Ò°ßÀ¸·Î ÁöÀûµÈ AIPÀÇ Ãʱ⠱â¼ú ÀÌÈÄ, ±Û·çÄÚÄÚ¸£Æ¼ÄÚÀ̵å´Â IgG4-RDÀÇ ÀÏÂ÷ Ä¡·áÁ¦·Î °£ÁÖµÇ¾î ¿Ô½À´Ï´Ù. ¹ßÇ¥µÈ IgG4-RD °ü¸®¿¡ °üÇÑ ÇÕÀǹ®¿¡ µû¸£¸é, ´ë´Ù¼öÀÇ IgG4-RD Àü¹®°¡µéÀº Ä¡·áµÇÁö ¾ÊÀº Ȱµ¿¼º Áúȯ¿¡ ´ëÇÑ 1Â÷ ¼±Åà ¾à¹°ÀÌ ±Û·çÄÚÄÚ¸£Æ¼ÄÚÀ̵å¶ó°í ¹Ï°í ÀÖ½À´Ï´Ù. ÇÁ·¹µå´Ï¼ÕÀº °üÇØ µµÀÔÀÇ Ã¹ ´Ü°è·Î ÀÚÁÖ »ç¿ëµË´Ï´Ù. ´ëºÎºÐÀÇ È¯ÀÚ´Â ±Û·çÄÚÄÚ¸£Æ¼ÄÚÀ̵å Ä¡·á¿¡ ¸çÄ¥¿¡¼ ¸î ÁÖ À̳»¿¡ ¹ÝÀÀÇϸç, ´ëºÎºÐÀº ¸î ´Þ À̳»¿¡ °üÇØ¿¡ µµ´ÞÇÕ´Ï´Ù.
¿Àº¤¼¿¸®¸¿(XmAb5871) : Á¦³ª½º ¹ÙÀÌ¿ÀÆÄ¸¶¿Í ºê¸®½ºÅç ¸¶À̾ ½ºÄûºê(Bristol Myers Squibb)
¿Àº¤¼¼¸®¸¿(XmAb5871)Àº B¼¼Æ÷°è¿¡ ³Î¸® Á¸ÀçÇÏ´Â CD19¿Í FcRIIb¿¡ ¸ðµÎ °áÇÕÇϵµ·Ï ¼³°èµÈ ÀÌÁß ±â´É¼º ´ÜŬ·ÐÇ×ü·Î, ¸¹Àº ÀÚ°¡¸é¿ªÁúȯ¿¡ °ü¿©ÇÏ´Â ¼¼Æ÷ÀÇ È°¼ºÀ» °í°¥½ÃŰÁö ¾Ê°í ¾ïÁ¦ÇÕ´Ï´Ù. ÀÌ µ¶Æ¯ÇÑ ÀÛ¿ë ±âÀü°ú ÀÚ°¡ Åõ¿© °¡´ÉÇÑ SC ÁÖ»ç ¿ä¹ýÀº ¸¸¼º ÀÚ°¡¸é¿ªÁúȯ¿¡¼ B¼¼Æ÷ °è¿ÀÇ º´¿ø¼º ¿ªÇÒ¿¡ ±¤¹üÀ§Çϰí È¿°úÀûÀ¸·Î ´ëóÇÒ ¼ö ÀÖ´Â ÀáÀç·ÂÀ» °¡Áö°í ÀÖ½À´Ï´Ù.
ÇöÀç Zenas´Â IgG4-RD, ´Ù¹ß¼º °æÈÁõ, Àü½Å¼º È«¹Ý¼º ·çǪ½º ¹× ¿Â¿¼º ÀÚ°¡¸é¿ª¼º ¿ëÇ÷¼º ºóÇ÷À» Æ÷ÇÔÇÑ ¿©·¯ ÀÚ°¡¸é¿ªÁúȯ¿¡¼ ¿Àº¤¼¼¸®¸¿¿¡ ´ëÇÑ ¿©·¯ ÀÓ»ó II»ó ¹× III»ó ½ÃÇèÀ» ÁøÇàÇϰí ÀÖ½À´Ï´Ù. ·ù¸¶Åç·ÎÁö(Rheumatology)Áö´Â IgG4-RD ȯÀÚ¸¦ ´ë»óÀ¸·Î ¿Àº¤¼¼¸®¸¿ÀÇ Ä¡·á È¿°ú¸¦ Æò°¡ÇÑ ÀÓ»ó 2»ó °á°ú¸¦ ¹ßÇ¥Çß½À´Ï´Ù. ÀÌ·¯ÇÑ °á°ú¸¦ ¹ÙÅÁÀ¸·Î IgG4-RD ȯÀÚ¸¦ ´ë»óÀ¸·Î ¿Àº¤¼¼¸®¸¿À» SC ÁÖ»çÁ¦·Î Åõ¿©ÇßÀ» ¶§ È¿°ú¿Í ¾ÈÀü¼ºÀ» Ãß°¡ÀûÀ¸·Î °ËÅäÇϱâ À§ÇÑ ÀÓ»ó 3»ó ½ÃÇèÀÌ ÁøÇà ÁßÀÔ´Ï´Ù.
¾ÆÇø®ÀÚ³ª(¼ººÐ¸í: À̳׺ñ¸®ÁÖ¸¿) : Amgen
¾÷¸®ÀÚ³ª´Â Àΰ£È ´ÜŬ·ÐÇ×ü·Î¼, ±âÀúÁúȯ °úÁ¤¿¡ ±â¿©ÇÏ´Â ÁÖ¿ä ¼¼Æ÷(ÇüÁú¸ð¼¼Æ÷ ¹× ÀϺΠÇüÁú¼¼Æ÷¸¦ Æ÷ÇÔÇÑ ÀÚ°¡Ç×ü¸¦ »ý»êÇÏ´Â CD19 B¼¼Æ÷)¸¦ Ç¥ÀûÀ¸·Î ÇÏ¿© Áö¼ÓÀûÀ¸·Î °í°¥½ÃŰ´Â ¿ªÇÒÀ» ÇÕ´Ï´Ù. ȯÀÚ´Â µÎ ¹øÀÇ Ãʱâ ÁÖÀÔ ÈÄ 6°³¿ù¸¶´Ù ÇÑ ¹ø¾¿ ¾ÖÇø®ÀÚ³ª¸¦ Åõ¿©ÇØ¾ß ÇÕ´Ï´Ù. ¾ÖÇø®ÁÖ³ª´Â ÇöÀç ½Ã½Å°æÃ´¼ö¿° Ä¡·áÁ¦·Î ½ÂÀεƽÀ´Ï´Ù. ÇöÀç ÀÌ ¾àÀº ÀÓ»ó 3»ó ½ÃÇèÀ» ¿Ï·áÇßÀ¸¸ç, FDA´Â PDUFA ¹ßÈ¿ÀÏÀ» 2025³â 4¿ù 3ÀÏ·Î Á¤Çß½À´Ï´Ù.
¾ÖÇø®ÁÖ³ª´Â ÇöÀç IgG4-RD¿¡ ´ëÇÑ Ä¡·á ¿É¼ÇÀÇ ½É°¢ÇÑ °ÝÂ÷¸¦ ÇØ¼ÒÇϰí, ȯÀÚ¿¡°Ô Å« ÇýÅÃÀ» Á¦°øÇÏ´Â µ¿½Ã¿¡ ÀÌ º¹ÀâÇϰí Á¾Á¾ ¼è¾àÇØÁö´Â Áõ»óÀ» °ü¸®Çϱâ À§ÇØ ½ÂÀÎµÈ ÃÖÃÊÀÇ ÇÙ½É Ä¡·áÁ¦°¡ µÉ °ÍÀ¸·Î ±â´ëµË´Ï´Ù. ÇâÈÄ ¿Àº¤¼¼¸®¸¿ÀÌ ½ÂÀεǾî ÀÌÁß±â´É Ç¥Àû Ä¡·áÁ¦·Î °æÀïÇÒ °¡´É¼ºÀÌ ÀÖ½À´Ï´Ù.
ÇöÀç IgG4-RDÀÇ ½Å¾à ÇöȲÀº ¼¼ °¡Áö ¾à¹°ÀÌ ÀÖ½À´Ï´Ù. ±× Áß CD-19¸¦ Ç¥ÀûÀ¸·Î ÇÏ´Â °ÍÀº ¿Àº¤¼¼¸®¸¿(À̱â´É¼º)°ú ¾ÖÇø®ÁÖ³ª·Î, B¼¼Æ÷¿¡ Á¸ÀçÇÏ´Â ´Ü¹éÁúÀÎ CD19¸¦ Ç¥ÀûÀ¸·Î ÇÏ´Â Ä¡·á´Â IgG4-RDÀÇ ¹ßº´¿¡ °ü¿©ÇÏ´Â °ÍÀ¸·Î ¿©°ÜÁö´Â B¼¼Æ÷¸¦ °¨¼Ò½ÃÅ´À¸·Î½á IgG4-RDÀÇ Ä¡·áÁ¦·Î¼ À¯¸ÁÇÑ Ä¡·á¹ýÀÔ´Ï´Ù. ƯÈ÷, CD19¸¦ Ç¥ÀûÀ¸·Î ÇÏ´Â Ç×üÀÎ ¾ÖÇø®ÀÚ³ª´Â IgG4-RD ȯÀÚÀÇ Àç¹ßÀ» ¾ïÁ¦ÇÏ°í °üÇØ¿¡ µµ´ÞÇÏ´Â È¿°ú¸¦ ÀÔÁõÇß½À´Ï´Ù.
IgG4-RDÀÇ º´ÀÎÀº ¾ÆÁ÷ ¹àÇôÁöÁö ¾Ê¾ÒÀ¸¸ç, ÇöÀç ¿¬±¸ ÁßÀ̱⠶§¹®¿¡ ƯÁ¤ ¾à¹°·Î Ä¡·áÇÒ ¼ö ¾øÀ¸¸ç, ÇöÀç IgG4-RD ȯÀÚ¸¦ À§ÇØ ½ÂÀÎµÈ Ä¡·áÁ¦´Â ½ÃÆÇµÇ°í ÀÖÁö ¾Ê½À´Ï´Ù. ÃÖ±Ù ¹ßÇ¥µÈ "IgG4-RD °ü¸® ¹× Ä¡·á¿¡ °üÇÑ ±¹Á¦ ÇÕÀÇ Áöħ ¹× °¡À̵å¶óÀÎ"Àº IgG4 ¼öÄ¡·Î ÀÎÇÑ Áúº´À» ½Äº°ÇÏ´Â ±âÁذú ȯÀÚ Ä¡·á¿¡ ´ëÇÑ ±ÇÀå »çÇ×À» »ó¼¼È÷ ¼³¸íÇÕ´Ï´Ù.
Ȱµ¿¼º ¶Ç´Â Ä¡·á¹ÞÁö ¾ÊÀº IgG4-RD ȯÀÚ´Â ÀϹÝÀûÀ¸·Î ±Û·çÄÚÄÚ¸£Æ¼ÄÚÀ̵带 1Â÷ ¼±Åà ¾àÁ¦·Î Åõ¿©ÇÕ´Ï´Ù. º´ÀÇ ÁßÁõµµ¿Í ±ä±Þ¼º¿¡ µû¶ó ´Ù¸£Áö¸¸, °üÇØ À¯µµ¿¡´Â ÇÁ·¹µå´Ï¼Õ 30-40mg/ÀÏ ¶Ç´Â üÁß Á¶Àý ¿ë·®À¸·Î 0.6mg/kgÀ» ¸ÅÀÏ Åõ¿©ÇÏ´Â °æ¿ì°¡ ¸¹½À´Ï´Ù.
°æ¿ì¿¡ µû¶ó IgG4-RDÀÇ Ä¡·á¿¡´Â ±âÁ¸ÀÇ "Áúº´ Á¶Àý Ç×·ù¸¶Æ¼½ºÁ¦Á¦"(DMARDs)°¡ »ç¿ëµË´Ï´Ù. ÇüÁú¼¼Æ÷´Â ¸ðµç ·ù¸¶Æ¼½º Áúȯ¿¡¼ È¿°úÀûÀÎ ¹ÙÀÌ¿À¸¶Ä¿°¡ µÉ ¼ö ÀÖ´Â ÃÖÃÊÀÇ ¼¼Æ÷À̸ç, B¼¼Æ÷ÀÇ ¸ÂÃãÇü Ä¡·á´Â Áúº´ Ȱµ¿À» ÃßÀûÇϱâ À§ÇØ ÃÑ ÇüÁú¼¼Æ÷ ³óµµ¸¦ ÀÌ¿ëÇÕ´Ï´Ù.
IgG4-RD¸¦ °ü¸®Çϱâ À§ÇÑ ¼ö¸¹Àº ÀáÀçÀû Ä¡·á¹ýÀÌ Á¶»çµÇ°í Àֱ⠶§¹®¿¡ ¿¹Ãø ±â°£ µ¿¾È Ä¡·á ¿µ¿ªÀÌ Å©°Ô ÀçÆíµÉ °ÍÀÓ¿¡ Ʋ¸²¾ø½À´Ï´Ù. ±×·¯³ª °¡°Ý Ã¥Á¤ ¹× »óȯ°ú °ü·ÃµÈ ¹®Á¦°¡ ÀÌ ¸ðµç ÆÄÀÌÇÁ¶óÀÎ Ä¡·áÁ¦ÀÇ ¿î¸í°ú Àüü ¼öÀÍ¿¡ ¹ÌÄ¡´Â ¿µÇâÀ» °áÁ¤ÇÏ°Ô µÉ °ÍÀÔ´Ï´Ù.
Zenas BioPharma, Amgen, Sanofi¿Í °°Àº ÁÖ¿ä °³¹ß»çµéÀº °¢±â ´Ù¸¥ ÀÓ»ó °³¹ß ´Ü°è¿¡¼ ÁÖ¿ä Èĺ¸¹°ÁúÀ» Æò°¡Çϰí ÀÖ½À´Ï´Ù. À̵é ȸ»ç´Â IgG4-RD¸¦ Ä¡·áÇϱâ À§ÇØ ÀÚ»ç Á¦Ç°À» ¿¬±¸ÇÏ´Â °ÍÀ» ¸ñÇ¥·Î Çϰí ÀÖ½À´Ï´Ù.
º» º¸°í¼´Â ÁÖ¿ä 7°³±¹ÀÇ IgG4 °ü·Ã Áúȯ ½ÃÀåÀ» Á¶»çÇÏ¿© ½ÃÀå °³¿ä¿Í ÇÔ²² ¿ªÇÐ, ȯÀÚ µ¿Çâ, »õ·Î¿î Ä¡·á¹ý, 2034³â±îÁöÀÇ ½ÃÀå ±Ô¸ð ¿¹Ãø, ¹ÌÃæÁ· ÀÇ·á ¼ö¿ä µîÀ» Á¶»çÇÏ¿© ÀüÇØµå¸³´Ï´Ù.
DelveInsight's "IgG4-Related Disease (IgG4-RD) - Market Insights, Epidemiology and Market Forecast - 2034" report delivers an in-depth understanding of historical and forecasted epidemiology as well as market trends in the United States, EU4 (Germany, France, Italy, Spain) and the United Kingdom, and Japan. IgG4-RD market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM market size from 2020 to 2034. The report also covers current treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.
Study Period: 2020-2034
IgG4-RD Understanding and Treatment
IgG4-RD Overview
IgG4-RD is a systemic fibro inflammatory disease characterized by dense infiltration of IgG4-positive plasma cells in the affected tissue(s) with or without elevated plasma levels of IgG4. It is a chronic fibroinflammatory disorder affecting a wide range of organs. Elevation of serum IgG4 concentrations and abundant infiltration of IgG4-expressing plasma cells are key diagnostic features of this autoimmune disease. Although common organ involvement of IgG4-RD includes the salivary glands, pancreas, and bile duct, hepatic involvement is less well established.
IgG4-RD may be present in a certain proportion of patients with a wide variety of diseases, including Mikulicz's disease, autoimmune pancreatitis, hypophysitis, Riedel thyroiditis, interstitial pneumonitis, interstitial nephritis, prostatitis, lymphadenopathy, retroperitoneal fibrosis, inflammatory aortic aneurysm, and inflammatory pseudotumor.
IgG4-RD Diagnosis
IgG4-RD is challenging to diagnose since it may simultaneously affect several organs. Clinical, endoscopic, radiographic, and serological testing are required to diagnose the illness to examine organ involvement and end-organ damage (such as hormonal imbalances). A biopsy of the afflicted organ tissues, including the skin, is necessary for tissue diagnosis. Blood testing may reveal elevated serum IgG4 levels and peripheral eosinophilia.
Serum IgG4 concentration is the most important biomarker, with elevated levels found in up to 90% of patients, though this can vary. While a drop in IgG4 levels often signals treatment response, it may never return to normal, even in remission, due to long-lived plasma cells. Elevated IgG4 can also occur in other conditions, so its value must be considered within the broader clinical context. Other biomarkers, such as IgG1, IgE, eosinophilia, and complement levels (C3 and C4), can also reflect disease activity, with hypocomplementemia notably seen in IgG4-related kidney disease.
IgG4-RD Treatment
In individuals with IgG4-RD, treatment is not always essential, and in some asymptomatic instances, attentive waiting is appropriate. IgG4-RD, on the other hand, can induce major organ malfunction and failure, necessitating prompt therapy when essential organs are implicated or individuals exhibit symptoms.
According to the International Consensus Statement on the treatment of IgG4-RD, glucocorticoids represent the first-line therapy because they lead to dramatic clinical responses in most cases with pancreatic and extra-pancreatic diseases. Thus, a variety of glucocorticoid-sparing agents have been employed in different anatomical districts as remission-maintenance drugs (e.g., azathioprine, mycophenolate mofetil, methotrexate, cyclophosphamide, and bortezomib), with alternate results.
The use of steroid-sparing medications such as azathioprine, mycophenolate mofetil, and methotrexate are used to alleviate the adverse effects of glucocorticoids and to sustain remission; however, there is insufficient proof of their efficacy. Rituximab therapy is a more recent, promising alternative; it depletes CD20-positive plasmablast precursors; as there are fewer plasmablasts, IgG4 synthesis declines.
Since the earliest description of AIP, when a quick response to glucocorticoid treatment was noted as a distinctive finding, glucocorticoids have been regarded as the first-line therapy in IgG4-RD. The majority of IgG4-RD experts continue to believe that glucocorticoid is the first-line therapy for an active, untreated illness, according to the published consensus statement on the management of IgG4-RD. Prednisone is frequently used as the first step in remission induction. Most patients have a response to glucocorticoid treatment within a few days or weeks, and the majority of them reach remission within a few months.
As the market is derived using a patient-based model, the IgG4-RD epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total diagnosed prevalent cases of IgG4-RD, gender-specific diagnosed prevalent cases of IgG4-RD, and age-specific diagnosed prevalent cases of IgG4-RD in the 7MM covering the United States, EU4 countries (Germany, France, Italy, Spain) and the United Kingdom, and Japan from 2020 to 2034.
The drug chapter segment of the IgG4-RD report encloses a detailed analysis of IgG4-RD marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the IgG4-RD clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.
Emerging Drugs
Obexelimab (XmAb5871): Zenas BioPharma and Bristol Myers Squibb
Obexelimab (XmAb5871) is a bifunctional monoclonal antibody designed to bind both CD19 and Fc?RIIb, which are broadly present across B-cell lineage, to inhibit the activity of cells that are implicated in many autoimmune diseases without depleting them. This unique mechanism of action and self-administered SC injection regimen may broadly and effectively address the pathogenic role of B-cell lineage in chronic autoimmune disease.
Currently, Zenas is conducting multiple Phase II and Phase III trials of obexelimab in several autoimmune diseases, including IgG4-RD, multiple sclerosis, systemic lupus erythematosus, and warm autoimmune hemolytic anemia. In August 2023, The Lancet Rheumatology published findings from a Phase II study evaluating obexelimab for the treatment of patients with IgG4-RD. Based on these results, a Phase III study in patients with IgG4-RD is ongoing to investigate further the efficacy and safety of obexelimab administered as an SC injection.
UPLIZNA (inebilizumab): Amgen
UPLIZNA is a humanized monoclonal antibody that causes targeted and sustained depletion of key cells that contribute to the underlying disease process (autoantibody-producing CD19+ B cells, including plasmablasts and some plasma cells). After two initial infusions, patients need one dose of UPLIZNA every 6 months. UPLIZNA is currently approved for the treatment of Neuromyelitis Optica. Currently, the drug has completed its Phase III results, and the FDA has granted a PDUFA action date of April 3, 2025.
UPLIZNA is anticipated to be the first approved cornerstone therapy for managing this complex and often debilitating condition, providing significant benefits to patients while addressing a critical gap in current treatment options for IgG4-RD. In the future, the drug could face competition with the approval of obexelimab, which operates through a bifunctional targeting mechanism of action.
Drug Class Insights
The current IgG4-RD emerging landscape has only three drugs. Among them, obexelimab (bifunctionally) and UPLIZNA target CD-19. Targeting CD19, a protein found in B cells, shows promise as a treatment for IgG4-RD by depleting B cells, which are thought to play a role in the disease's pathogenesis. Specifically, UPLIZNA, a CD19-targeted antibody, has demonstrated efficacy in reducing flares and achieving remission in IgG4-RD patients.
As the etiology of IgG4-RD is unclear and still being studied, no particular medications can cure the disease. For people with IgG4-RD, there are no approved treatments on the market at this time. The criteria for identifying the disease caused by IgG4 levels and patient treatment recommendations were recently detailed in the guidelines released by the "International Consensus Guidance Statement on the Management and Treatment of IgG4-RD."
Patients with IgG4-RD that are active or untreated typically get glucocorticoids as their first line of therapy. Depending on the severity of the condition and the urgency of the situation, remission induction is frequently started with 30-40 mg/day of prednisone or a weight-adjusted dosage of 0.6 mg/kg of body weight each day.
In certain instances, conventional "Disease-Modifying Anti-Rheumatic Drugs" (DMARDs) are utilized to treat IgG4-RD. Plasmablasts are the first cell in any rheumatologic disorder to serve as an effective biomarker, and tailored therapy in B-cell employs total plasmablast concentration to track disease activity.
As numerous potential therapies are being investigated to manage IgG4-RD, it is safe to predict that the treatment space will experience significant reconstitution during the forecast period. However, the challenges of pricing and reimbursement accompanied by will decide the fate of all these pipeline therapies and the impact they will have on overall revenue generation.
Key players such as Zenas Biopharma, Amgen, and Sanofi are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products to treat IgG4-RD.
Key Updates
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034. The landscape of IgG4-RD treatment has experienced a profound transformation with the uptake of novel drugs. These innovative therapies are redefining standards of care. Furthermore, the increased uptake of these transformative drugs is a testament to the unwavering dedication of physicians, oncology professionals, and the entire healthcare community in their tireless pursuit of advancing cancer care. This momentous shift in treatment paradigms is a testament to the power of research, collaboration, and human resilience.
IgG4-RD Pipeline Development Activities
The report provides insights into different therapeutic candidates in Phase III, Phase II/III, Phase II, Phase I/II, and Phase I. It also analyzes key players involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers detailed information on collaborations, acquisitions and mergers, licensing, and patent details for IgG4-RD emerging therapies.
KOL Views
To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Some of the leaders like MD, PhD, Research Project Manager, Director, and others. Their opinion helps to understand and validate current and emerging therapies and treatment patterns or IgG4-RD market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.
Delveinsight's analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the Massachusetts General Hospital, Hopital La Timone, Harvard Medical School, Hospital Universitari Vall d'Hebron, Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital, etc., were contacted. Their opinion helps understand and validate IgG4-RD epidemiology and market trends.
Qualitative Analysis
We perform qualitative and market Intelligence analysis using various approaches, such as SWOT and conjoint analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.
The analyst analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry.
In efficacy, the trial's primary and secondary outcome measures are evaluated.
Further, the therapies' safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials.
Market Access and Reimbursement
The cost of newly approved medications is usually high, and because of it, patients escape from proper treatment or opt for off-label and cheap medications. It affects market access to newly launched medications, and reimbursement is crucial. The decision to reimburse often comes down to the drug's price relative to the benefit it produces in treated patients. Market access and reimbursement options can differ depending on regulatory status, target population size, the setting of care, unmet needs, the magnitude of incremental benefit claims, and costs.
The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.