Kev lag luam tshuaj zoo yog qhov chaw lag luam ntawm kev tsim cov tshuaj zoo hauv kev lag luam tshuaj, uas txawv ntawm cov khoom siv tshuaj dav dav lossis cov tshuaj loj. Kev lag luam tshuaj zoo yog ib qho ntawm cov cim tseem ceeb ntawm lub teb chaws qib kev siv tshuab dav dav. Nws cov yam ntxwv tseem ceeb yog tsim cov tshuaj zoo, ntau hom, tshwj xeeb lossis ntau yam ua haujlwm rau kev lag luam thoob ntiaj teb thiab tib neeg lub neej nrog cov thev naus laus zis siab thiab tshiab. Kev lag luam tshuaj zoo muaj cov thev naus laus zis siab thiab muaj txiaj ntsig ntxiv. Txij li xyoo 1970, qee lub teb chaws tsim kev lag luam tau hloov pauv qhov kev tsom mus rau kev txhim kho kev lag luam tshuaj mus rau kev lag luam tshuaj zoo, thiab kev ua kom nrawm dua kev txhim kho kev lag luam tshuaj zoo tau dhau los ua qhov sib txawv thoob ntiaj teb. Cov tshuaj zoo suav nrog cov tshuaj tua kab, tshuaj, cov xim (cov xim), thiab lwm yam. Cov tshuaj tshwj xeeb suav nrog cov khoom noj ntxiv, cov khoom noj ntxiv, cov nplaum, cov tshuaj surfactants, cov tshuaj kho dej, cov tshuaj tawv, cov tshuaj roj av, cov tshuaj hluav taws xob, cov tshuaj ua ntawv thiab lwm yam ntau dua 50 qhov chaw.

Cov tshuaj intermediates yog cov tshuaj intermediates uas ua los ntawm cov txheej txheem ntawm kev tsim tshuaj lom neeg thiab koom nrog cov khoom siv tshuaj zoo. Cov tshuaj intermediates tuaj yeem muab faib ua cov tshuaj tua kab mob intermediates, tshuaj tiv thaiv kub thiab tshuaj analgesic intermediates, tshuaj cardiovascular intermediates, thiab tshuaj tiv thaiv kab mob cancer intermediates raws li lawv daim ntawv thov. Kev lag luam upstream ntawm cov tshuaj intermediates yog cov khoom siv raw tshuaj yooj yim, thaum kev lag luam downstream yog cov tshuaj API thiab kev lag luam npaj. Raws li cov khoom lag luam loj, tus nqi ntawm cov khoom siv raw tshuaj yooj yim hloov pauv ntau heev, uas cuam tshuam ncaj qha rau tus nqi tsim khoom ntawm cov tuam txhab. Cov tshuaj intermediates thiab muab faib ua cov tshuaj intermediates thawj zaug thiab cov tshuaj intermediates siab heev, cov tshuaj intermediates thawj zaug vim muaj teeb meem thev naus laus zis tsim khoom tsis siab, tus nqi qis, thiab tus nqi ntxiv hauv qhov xwm txheej oversupply, cov tshuaj intermediates siab heev yog cov khoom siv tshuaj tiv thaiv thawj zaug, piv nrog cov tshuaj intermediate thawj zaug, cov qauv nyuaj, tsuas yog ib lossis ob peb kauj ruam rau kev npaj cov khoom lag luam downstream muaj nqis ntxiv, nws cov nyiaj tau los tag nrho siab dua li cov nyiaj tau los tag nrho ntawm kev lag luam intermediates. Raws li cov neeg muab khoom intermediate thawj zaug tsuas yog muab cov khoom lag luam yooj yim xwb, lawv nyob rau ntawm qhov kawg ntawm cov saw hlau kev lag luam nrog kev sib tw loj tshaj plaws thiab kev nyuaj siab ntawm tus nqi, thiab kev hloov pauv ntawm tus nqi ntawm cov tshuaj raw yooj yim. Cov ntaub ntawv muaj feem cuam tshuam loj heev rau lawv. Cov neeg muag khoom nruab nrab laus, ntawm qhov tod tes, tsis yog tsuas yog muaj hwj chim sib tham zoo dua li cov neeg muag khoom qis dua, tab sis qhov tseem ceeb dua, lawv dais cov khoom nruab nrab siab heev nrog cov ntsiab lus siab thiab khaws kev sib raug zoo nrog cov tuam txhab thoob ntiaj teb, yog li qhov kev hloov pauv ntawm cov nqi ntawm cov khoom siv raw muaj feem cuam tshuam tsawg dua rau lawv. Cov khoom nruab nrab tsis yog gmp thiab GMP tuaj yeem faib ua pawg raws li qib kev cuam tshuam rau qhov zoo kawg API. Cov khoom nruab nrab tsis yog gmp txhais tau tias yog cov tshuaj nruab nrab ua ntej cov khoom pib API; GMP txhais tau tias yog cov tshuaj nruab nrab tsim raws li cov kev cai ntawm GMP, uas yog, cov tshuaj uas tsim tawm tom qab cov khoom pib API, thaum lub sijhawm API synthesis, thiab uas dhau los ntawm kev hloov pauv molecular ntxiv lossis kev ua kom zoo dua ua ntej dhau los ua API.

Lub ncov thib ob ntawm patent cliff yuav txuas ntxiv txhawb nqa qhov kev thov rau cov khoom siv nruab nrab sab saud
Kev lag luam tshuaj nruab nrab hloov pauv raws li kev xav tau ntawm kev lag luam tshuaj qis, thiab nws lub sijhawm yog qhov sib xws nrog kev lag luam tshuaj. Cov kev cuam tshuam no tuaj yeem muab faib ua cov yam ntxwv sab nraud thiab cov yam ntxwv sab hauv: cov yam ntxwv sab nraud feem ntau yog hais txog lub voj voog kev pom zoo ntawm cov tshuaj tshiab hauv khw; cov yam ntxwv sab hauv feem ntau yog hais txog lub voj voog kev tiv thaiv patent ntawm cov tshuaj tshiab. Qhov ceev ntawm kev pom zoo tshuaj tshiab los ntawm cov koom haum tswj hwm tshuaj xws li FDA kuj muaj qee yam cuam tshuam rau kev lag luam. Thaum lub sijhawm ntawm kev pom zoo tshuaj tshiab thiab tus lej ntawm cov tshuaj tshiab pom zoo zoo rau cov tuam txhab tshuaj, qhov kev thov rau cov kev pabcuam tshuaj outsourcing yuav tsim. Raws li tus lej ntawm cov tshuaj tshiab thiab cov tshuaj tshiab biological pom zoo los ntawm FDA hauv kaum xyoo dhau los, ntau cov tshuaj tshiab pom zoo yuav txuas ntxiv tsim kev thov rau cov tshuaj nruab nrab, yog li txhawb nqa kev lag luam kom tswj tau qhov kev vam meej siab. Thaum kev tiv thaiv patent ntawm cov tshuaj tshiab tas sij hawm, cov tshuaj generic yuav zoo dua heev, thiab cov chaw tsim khoom nruab nrab tseem yuav txaus siab rau kev loj hlob ntawm kev thov hauv lub sijhawm luv luv. Raws li Evaluate cov ntaub ntawv, kwv yees tias txij xyoo 2017 txog 2022, yuav muaj 194 billion yuan ntawm kev ua lag luam tshuaj uas ntsib qhov xwm txheej ntawm daim ntawv pov thawj tas sij hawm, uas yog qhov thib ob ntawm daim ntawv pov thawj txij li xyoo 2012.

Cov kev hloov pauv nyob rau xyoo tas los no, nrog rau kev nthuav dav thiab cov qauv tshuaj nyuaj, kev tshawb fawb tshuaj tshiab thiab kev txhim kho kev vam meej txo qis, kev nce sai ntawm kev tshawb fawb tshuaj tshiab thiab kev txhim kho nqi ntawm McKinsey hauv Nat. Rev. DrugDiscov. "Hais tias, xyoo 2006-2011, kev tshawb fawb thiab kev tsim tshuaj tshiab tsuas yog 7.5% xwb, txij li xyoo 2012 txog 2014, vim yog cov tshuaj macromolecules zoo xaiv tau thiab tsis muaj tshuaj lom (tshuaj nyob rau theem kawg ntawm kev tsim tshuaj, uas yog, los ntawm theem kho mob III mus rau kev pom zoo muaj 74% kev vam meej), kev tshawb fawb thiab kev tsim tshuaj tag nrho kev vam meej ntawm kev nce me ntsis, tab sis tseem nyuaj rau rov qab mus rau 16.40% kev vam meej hauv xyoo 90. Tus nqi ntawm kev ua tiav kev teev cov tshuaj tshiab tau nce ntawm US $ 1.188 billion hauv xyoo 2010 mus rau US $ 2.18 billion hauv xyoo 2018, yuav luag ob npaug. Lub caij no, tus nqi rov qab ntawm cov tshuaj tshiab tseem poob qis. Xyoo 2018, cov tuam txhab tshuaj thoob ntiaj teb TOP12 tsuas yog ua tus nqi rov qab ntawm 1.9% ntawm kev nqis peev hauv kev tshawb fawb thiab kev tsim kho."

Kev nce nqi ntawm kev tshawb fawb thiab kev nqis peev hauv kev tshawb fawb thiab kev lag luam tau poob qis ua rau muaj kev nyuaj siab rau cov tuam txhab tshuaj, yog li lawv yuav xaiv los ua haujlwm rau cov tuam txhab CMO yav tom ntej kom txo cov nqi. Raws li ChemicalWeekly, cov txheej txheem tsim khoom suav txog li 30% ntawm tag nrho cov nqi ntawm cov tshuaj qub. Tus qauv CMO / CDMO tuaj yeem pab cov tuam txhab tshuaj txo cov nqi tag nrho ntawm cov khoom siv ruaj khov, kev ua haujlwm zoo ntawm kev tsim khoom, cov peev txheej tib neeg, daim ntawv pov thawj, kev tshuaj xyuas thiab lwm yam los ntawm 12-15%. Tsis tas li ntawd, kev siv hom CMO / CDMO tuaj yeem pab cov tuam txhab tshuaj txhim kho cov tshuaj tiv thaiv, luv lub voj voog khaws cia thiab nce qhov kev nyab xeeb, uas tuaj yeem txuag lub sijhawm ntawm kev hloov kho ntau lawm, luv lub voj voog tshawb fawb thiab kev lag luam tshiab, ua kom nrawm ntawm kev lag luam tshuaj, thiab ua rau cov tuam txhab tshuaj txaus siab rau ntau cov nyiaj faib patent.

Cov lag luam CMO Suav muaj qhov zoo xws li tus nqi qis ntawm cov khoom siv raw thiab cov neeg ua haujlwm, cov txheej txheem thiab thev naus laus zis yooj ywm, thiab lwm yam, thiab kev hloov pauv ntawm kev lag luam CMO thoob ntiaj teb mus rau Tuam Tshoj txhawb kev nthuav dav ntxiv ntawm Tuam Tshoj cov feem ntawm kev ua lag luam CMO. Kev ua lag luam CMO / CDMO thoob ntiaj teb yuav tshaj US $ 102.5 billion hauv xyoo 2021, nrog rau kev loj hlob ntawm kwv yees li 12.73% hauv xyoo 2017-2021, raws li South qhov kev kwv yees.

Xyoo 2014, kev lag luam tshuaj lom neeg thoob ntiaj teb, tshuaj thiab nws cov khoom siv nruab nrab, tshuaj tua kab thiab nws cov khoom siv nruab nrab yog ob lub lag luam tseem ceeb ntawm kev lag luam tshuaj lom neeg zoo, suav txog 69% thiab 10% feem. Tuam Tshoj muaj kev lag luam petrochemical muaj zog thiab ntau lub tuam txhab tsim khoom siv tshuaj lom neeg, uas tau tsim cov pawg lag luam, ua rau ntau hom khoom siv raw thiab cov khoom siv pabcuam xav tau rau kev tsim cov tshuaj zoo muaj nyob hauv Tuam Tshoj, txhim kho kev ua haujlwm zoo thiab txo cov nqi tag nrho. Tib lub sijhawm, Tuam Tshoj muaj lub kaw lus lag luam tiav, uas ua rau tus nqi ntawm cov khoom siv tshuaj lom neeg, kev tsim kho thiab kev teeb tsa hauv Tuam Tshoj qis dua li ntawm cov tebchaws tsim kho lossis txawm tias feem ntau cov tebchaws tsim kho, yog li txo cov nqi peev thiab cov nqi tsim khoom. Tsis tas li ntawd, Tuam Tshoj muaj ntau tus kws ua haujlwm tshuaj lom neeg muaj peev xwm thiab tus nqi qis thiab cov neeg ua haujlwm hauv kev lag luam. Kev lag luam nruab nrab hauv Tuam Tshoj tau tsim los ntawm kev tshawb fawb thiab kev txhim kho mus rau kev tsim khoom thiab kev muag khoom ntawm cov txheej txheem tiav, kev tsim tshuaj ntawm cov khoom siv tshuaj lom neeg thiab cov khoom siv nruab nrab rau qhov yooj yim tuaj yeem tsim cov txheej txheem tiav, tsuas yog ob peb qhov xav tau los ntawm kev xa khoom, tuaj yeem tsim cov tshuaj nruab nrab, tshuaj tua kab nruab nrab thiab lwm yam 36 pawg loj, ntau dua 40000 hom Muaj ntau yam khoom nruab nrab, ua tiav ntau tus neeg xa khoom, xa khoom nruab nrab ntau dua 5 lab tons txhua xyoo, tau dhau los ua lub ntiaj teb cov khoom nruab nrab loj tshaj plaws thiab xa tawm.

Txij li xyoo 2000 los, Tuam Tshoj txoj kev lag luam tshuaj intermediates tau tsim kho zoo heev. Lub sijhawm ntawd, cov tuam txhab tshuaj hauv cov tebchaws tsim kho tau them ntau dua rau kev tshawb fawb thiab kev tsim khoom thiab kev lag luam ua lawv qhov kev sib tw tseem ceeb thiab ua kom nrawm dua kev hloov pauv ntawm cov tshuaj intermediates thiab kev tsim tshuaj nquag mus rau cov tebchaws tsim kho uas muaj tus nqi qis dua. Yog li ntawd, Tuam Tshoj txoj kev lag luam tshuaj intermediates tau siv lub sijhawm no los txais kev txhim kho zoo heev. Tom qab ntau tshaj kaum xyoo ntawm kev txhim kho ruaj khov, Tuam Tshoj tau dhau los ua lub hauv paus tseem ceeb ntawm kev tsim khoom nruab nrab hauv kev faib ua haujlwm thoob ntiaj teb hauv kev lag luam tshuaj nrog kev txhawb nqa ntawm lub tebchaws txoj cai thiab ntau txoj cai. Txij xyoo 2012 txog 2018, cov khoom tsim tawm ntawm Tuam Tshoj txoj kev lag luam tshuaj intermediates tau nce ntxiv los ntawm kwv yees li 8.1 lab tons nrog qhov loj me ntawm kev ua lag luam ntawm kwv yees li 168.8 billion yuan mus rau kwv yees li 10.12 lab tons nrog qhov loj me ntawm kev ua lag luam ntawm 2017 billion yuan. Tuam Tshoj txoj kev lag luam tshuaj intermediates tau ua tiav kev sib tw muaj zog hauv kev ua lag luam, thiab txawm tias qee lub tuam txhab tsim khoom intermediates tau tsim cov tshuaj intermediates nrog cov qauv molecular nyuaj thiab cov kev xav tau siab. Muaj ntau yam khoom muaj hwj chim tau pib tswj hwm kev lag luam thoob ntiaj teb. Txawm li cas los xij, tag nrho, Tuam Tshoj txoj kev lag luam nruab nrab tseem nyob rau lub sijhawm tsim kho cov qauv khoom zoo thiab txhim kho, thiab qib thev naus laus zis tseem qis. Feem ntau ntawm cov khoom lag luam hauv kev lag luam tshuaj tseem yog cov tshuaj nruab nrab thawj zaug, thaum muaj ntau cov tshuaj nruab nrab siab heev thiab cov tshuaj nruab nrab txhawb nqa ntawm cov tshuaj tshiab patented yog tsawg.