Makampani opanga mankhwala abwino ndi gawo lazachuma lopanga mankhwala abwino mumakampani opanga mankhwala, zomwe zimasiyana ndi zinthu wamba kapena mankhwala ambiri. Makampani opanga mankhwala abwino ndi chimodzi mwa zizindikiro zofunika kwambiri zaukadaulo wadziko lonse. Makhalidwe ake oyambira ndi kupanga mankhwala abwino apamwamba, amitundu yambiri, apadera kapena ambiri ogwira ntchito zachuma padziko lonse lapansi komanso moyo wa anthu pogwiritsa ntchito ukadaulo wapamwamba komanso watsopano. Makampani opanga mankhwala abwino ali ndi ukadaulo wambiri komanso phindu lalikulu. Kuyambira m'ma 1970, mayiko ena otukuka m'mafakitale asintha motsatizana cholinga chachikulu cha chitukuko cha makampani opanga mankhwala kukhala makampani opanga mankhwala abwino, ndipo kufulumizitsa chitukuko cha makampani opanga mankhwala abwino kwakhala chizolowezi padziko lonse lapansi. Mankhwala abwino akuphatikizapo mankhwala ophera tizilombo, mankhwala, utoto (ma pigments), ndi zina zotero. Mankhwala apadera akuphatikizapo zowonjezera chakudya, zowonjezera chakudya, zomatira, zophimba, mankhwala ophera madzi, mankhwala a chikopa, mankhwala amafuta, mankhwala apakompyuta, mankhwala opangira mapepala ndi zina zoposa 50.

Mankhwala ophatikizana ndi mankhwala amatanthauza mankhwala apakatikati opangidwa mu njira yopangira mankhwala a mankhwala ndipo ndi a mankhwala abwino. Mankhwala ophatikizana ndi mankhwala amatha kugawidwa m'magulu ophatikizana ndi maantibayotiki, mankhwala oletsa kutupa ndi ochepetsa ululu, mankhwala a mtima, ndi mankhwala oletsa khansa malinga ndi momwe amagwiritsidwira ntchito. Makampani opitilira patsogolo a mankhwala ophatikizana ndi makampani oyambira mankhwala opangira mankhwala, pomwe makampani otsika ndi makampani opanga mankhwala a API ndi kukonzekera. Monga chinthu chachikulu, mtengo wa zinthu zoyambira za mankhwala umasinthasintha kwambiri, zomwe zimakhudza mwachindunji mtengo wopanga wa mabizinesi. Mankhwala ophatikizana ndi ogawidwa m'magulu oyambira ndi apamwamba, oyambira chifukwa cha zovuta zaukadaulo wopanga si okwera, mitengo ndi yotsika, ndipo mtengo wowonjezera muzochitika zochulukirapo, opitilira patsogolo ndi mankhwala oyambira apakati, poyerekeza ndi oyambira, kapangidwe kovuta, sitepe imodzi kapena zingapo zokonzekera zinthu zotsika mtengo kwambiri, mulingo wake wonse ndi wapamwamba kuposa phindu lonse la makampani ophatikizana. Popeza ogulitsa oyambira apakati amatha kupereka kupanga kosavuta kwapakati, ali kumapeto kwa unyolo wamafakitale okhala ndi kuthamanga kwakukulu kwa mpikisano ndi kuthamanga kwamitengo, ndipo mtengo Kusinthasintha kwa zinthu zopangira mankhwala kumakhudza kwambiri. Koma ogulitsa apakati akuluakulu, sikuti ali ndi mphamvu zogulira zinthu zazikulu kuposa ogulitsa aang'ono okha, komanso chofunika kwambiri, amapanga zinthu zapamwamba kwambiri zomwe zili ndiukadaulo wapamwamba ndipo amasunga ubale wolimba ndi makampani apadziko lonse lapansi, kotero kusinthasintha kwa mitengo ya zinthu zopangira sikuwakhudza kwambiri. Osagwiritsa ntchito zinthu zapakati pa gmp ndi GMP akhoza kugawidwa m'magulu malinga ndi kuchuluka kwa mphamvu pa khalidwe lomaliza la API. Osagwiritsa ntchito zinthu zapakati pa gmp amatanthauza mankhwala apakati asanayambe kugwiritsa ntchito zinthu zoyambira za API; GMP amatanthauza mankhwala apakati opangidwa motsatira zofunikira za GMP, ndiko kuti, chinthu chomwe chimapangidwa pambuyo pa zinthu zoyambira za API, panthawi ya API synthesis, ndipo chimadutsa kusintha kwa mamolekyu kapena kukonzedwanso kwambiri chisanakhale API.

Chiwopsezo chachiwiri cha patent cliff chidzapitiriza kulimbikitsa kufunikira kwa anthu ogwirizana ndi mtsinje wa m'mphepete mwa nyanja
Makampani opanga mankhwala apakati amasinthasintha chifukwa cha kufunikira kwa makampani opanga mankhwala omwe ali pansi, ndipo nthawi yake imagwirizana ndi makampani opanga mankhwala. Izi zitha kugawidwa m'magulu akunja ndi amkati: zinthu zakunja makamaka zimatanthauza nthawi yovomerezeka ya mankhwala atsopano pamsika; Zinthu zamkati makamaka zimatanthauza nthawi yotetezedwa kwa patent ya mankhwala atsopano. Kuthamanga kwa kuvomerezedwa kwa mankhwala atsopano ndi mabungwe olamulira mankhwala monga FDA kumakhudzanso makampaniwa. Nthawi yovomerezedwa kwa mankhwala atsopano ndi kuchuluka kwa mankhwala atsopano ovomerezeka ikakhala yabwino kwa makampani opanga mankhwala, kufunikira kwa ntchito zogulitsa mankhwala kunja kudzapangidwa. Kutengera kuchuluka kwa mankhwala atsopano a mankhwala ndi mankhwala atsopano achilengedwe omwe avomerezedwa ndi THE FDA m'zaka khumi zapitazi, kuchuluka kwa kuvomerezedwa kwa mankhwala atsopano kudzapitiliza kupangitsa kufunikira kwa mankhwala apakati apamwamba, motero kuthandizira makampaniwa kuti apitirire kukula kwambiri. Chitetezo cha patent cha mankhwala atsopano chikatha, mankhwala wamba adzasinthidwa kwambiri, ndipo opanga apakati adzasangalalabe ndi kukula kwakukulu kwa kufunikira kwakanthawi kochepa. Malinga ndi ziwerengero za Evaluate, akuti kuyambira 2017 mpaka 2022, padzakhala ma yuan 194 biliyoni pamsika wa mankhwala osokoneza bongo womwe ukukumana ndi vuto la kutha kwa patent, komwe ndi chiwopsezo chachiwiri cha patent kuyambira 2012.

M'zaka zaposachedwapa, ndi kukula ndi kapangidwe ka mankhwala kovuta, kafukufuku watsopano wa mankhwala ndi kupambana kwa chitukuko chachepa, kuwonjezeka mwachangu kwa kafukufuku watsopano wa mankhwala ndi ndalama zopangira chitukuko cha McKinsey mu Nat. Rev. DrugDiscov. "Tatchula, mu 2006-2011, kafukufuku watsopano wa mankhwala ndi chitukuko cha kupambana ndi 7.5% yokha, kuyambira 2012 mpaka 2014, chifukwa cha macromolecules achilengedwe kusankha bwino komanso poizoni wochepa wa miss distance (mankhwala omwe ali kumapeto kwa chitukuko, ndiko kuti, kuyambira gawo lachitatu lachipatala mpaka kuvomerezedwa kulembetsa ali ndi chiwopsezo cha 74%), kafukufuku wa mankhwala ndi chitukuko cha kuchuluka kwa kupambana konse kwawonjezeka pang'ono, koma kumakhala kovuta kubwerera ku chiwopsezo cha 16.40% m'masekondi 90. Mtengo wolembetsa bwino mankhwala atsopano wakwera kuchoka pa $1.188 biliyoni mu 2010 kufika pa $2.18 biliyoni mu 2018, pafupifupi kawiri. Pakadali pano, chiwopsezo cha kubweza mankhwala atsopano chikupitirirabe kuwirikiza kawiri. Mu 2018, makampani akuluakulu opanga mankhwala padziko lonse lapansi a TOP12 adangopanga chiwopsezo cha 1.9% pakuyika ndalama mu kafukufuku ndi chitukuko.

Kukwera kwa ndalama zogulira mankhwala ndi kutsika kwa phindu la ndalama zogulira mankhwala kwabweretsa mavuto aakulu kwa makampani opanga mankhwala, kotero adzasankha kupereka ntchito yopangira kwa makampani a CMO mtsogolo kuti achepetse ndalama. Malinga ndi ChemicalWeekly, njira yopangira mankhwala imapanga pafupifupi 30% ya mtengo wonse wa mankhwala oyamba. CMO/CDMO chitsanzo chingathandize makampani opanga mankhwala kuchepetsa mtengo wonse wa zinthu zokhazikika, kugwiritsa ntchito bwino zinthu, anthu ogwira ntchito, satifiketi, kuwunika ndi zina ndi 12-15%. Kuphatikiza apo, KUVOMEREZA njira ya CMO/CDMO kungathandize makampani opanga mankhwala kukonza phindu la reaction, kufupikitsa nthawi yosungira katundu ndikuwonjezera chitetezo, chomwe chingasunge nthawi yosinthira kupanga, kufupikitsa nthawi yogulira mankhwala atsopano, kufulumizitsa liwiro la malonda a mankhwala, ndikulola makampani opanga mankhwala kusangalala ndi ma patent ambiri.

Makampani a CMO aku China ali ndi zabwino monga mtengo wotsika wa zinthu zopangira ndi ntchito, njira yosinthasintha komanso ukadaulo, ndi zina zotero, ndipo kusamutsa makampani apadziko lonse lapansi a CMO kupita ku China kumalimbikitsa kukulitsa gawo la msika wa CMO waku China. Msika wapadziko lonse wa CMO/CDMO ukuyembekezeka kupitirira $102.5 biliyoni mu 2021, ndi chiwopsezo chowonjezeka cha pafupifupi 12.73% mu 2017-2021, malinga ndi zomwe South adaneneratu.

Mu msika wa mankhwala abwino padziko lonse mu 2014, mankhwala ndi mankhwala ophera tizilombo ndi mankhwala ophera tizilombo ndi makampani awiri apamwamba kwambiri m'makampani opanga mankhwala abwino, omwe ndi 69% ndi 10% motsatana. China ili ndi makampani amphamvu opanga mafuta ndi mankhwala ambiri opangira zinthu zopangira mankhwala, omwe apanga magulu a mafakitale, zomwe zimapangitsa mitundu yambiri ya zinthu zopangira ndi zothandizira zomwe zimafunikira popanga mankhwala abwino apamwamba omwe amapezeka ku China, zomwe zimapangitsa kuti magwiridwe antchito azigwira ntchito bwino komanso kuchepetsa mtengo wonse. Nthawi yomweyo, China ili ndi makina okwanira a mafakitale, omwe amapangitsa kuti mtengo wa zida zamakemikolo, zomangamanga ndi kukhazikitsa ku China ukhale wotsika kwambiri kuposa wa mayiko otukuka kapena mayiko ambiri omwe akutukuka, motero kuchepetsa ndalama zogulira ndi kupanga. Kuphatikiza apo, China ili ndi mainjiniya ambiri a mankhwala ndi ogwira ntchito m'mafakitale. Makampani apakati ku China apita patsogolo kuchokera ku kafukufuku wasayansi ndi chitukuko mpaka kupanga ndi kugulitsa makina athunthu a makina okwanira, kupanga mankhwala a zinthu zopangira mankhwala ndi mankhwala ophera tizilombo kungathe kupanga makina athunthu, ochepa okha ndi omwe amafunika kutumizidwa kunja, amatha kupanga mankhwala ophera tizilombo, mankhwala ophera tizilombo ndi magulu ena akuluakulu 36, kuposa Pali mitundu 40000 ya zinthu zogulitsa pakati, zomwe zimagulitsidwa kunja kwa dziko lonse, zomwe zimagulitsa kunja kwa dziko lonse zokwana matani oposa 5 miliyoni pachaka, ndipo zakhala zinthu zogulitsa pakati padziko lonse lapansi komanso zogulitsa kunja.

Makampani opanga mankhwala ku China akhala akutukuka kwambiri kuyambira mu 2000. Panthawiyo, makampani opanga mankhwala m'maiko otukuka ankayang'ana kwambiri kafukufuku wazinthu, chitukuko, ndi chitukuko cha msika monga mpikisano wawo waukulu ndipo anafulumizitsa kusamutsa mankhwala ophatikizana ndi kupanga mankhwala ogwirira ntchito kumayiko otukuka ndi ndalama zochepa. Chifukwa chake, makampani opanga mankhwala ku China agwiritsa ntchito mwayi uwu kuti apeze chitukuko chabwino kwambiri. Pambuyo pa zaka zoposa khumi za chitukuko chokhazikika, China yakhala maziko ofunikira opanga mankhwala padziko lonse lapansi m'makampani opanga mankhwala mothandizidwa ndi malamulo apadziko lonse ndi mfundo zosiyanasiyana. Kuyambira 2012 mpaka 2018, kutulutsa kwa makampani opanga mankhwala ku China kunakwera kuchoka pa matani pafupifupi 8.1 miliyoni okhala ndi kukula kwa msika wa pafupifupi 168.8 biliyoni ya yuan kufika pa matani pafupifupi 10.12 miliyoni okhala ndi kukula kwa msika wa 2017 biliyoni ya yuan. Makampani opanga mankhwala ku China apeza mpikisano wamphamvu pamsika, ndipo ngakhale opanga ena opanga mankhwala akwanitsa kupanga mankhwala ophatikizana okhala ndi kapangidwe kovuta ka mamolekyulu komanso zofunikira kwambiri zaukadaulo. Zinthu zambiri zodziwika bwino zayamba kulamulira msika wapadziko lonse lapansi. Komabe, zonse, makampani apakati aku China akadali munthawi yokonza ndi kukweza kapangidwe ka zinthu, ndipo ukadaulo ukadali wochepa. Zinthu zambiri zomwe zili mumakampani opanga mankhwala akadali ma intermediates oyambira, pomwe ambiri apakati opanga mankhwala apamwamba komanso othandizira mankhwala atsopano omwe ali ndi patent ndi osowa.