Imboni yamakhemikhali amahle iwumkhakha wezomnotho wokukhiqiza amakhemikhali amahle embonini yamakhemikhali, ehlukile emikhiqizweni yamakhemikhali ejwayelekile noma amakhemikhali ayinqwaba.Imboni yamakhemikhali amahle ingenye yezimpawu ezibalulekile zezinga lezobuchwepheshe eliphelele lezwe.Izici zayo eziyisisekelo ukukhiqiza amakhemikhali asezingeni eliphezulu, ezinhlobonhlobo, amakhemikhali akhethekile noma asebenza ngezindlela eziningi omnotho womhlaba kanye nempilo yabantu ngobuchwepheshe obuphezulu nobusha.Imboni yamakhemikhali emihle inobuningi bobuchwepheshe obuphezulu kanye nenani eliphakeme elingeziwe.Kusukela ngeminyaka yawo-1970, amanye amazwe athuthukile ezimbonini ashintshe ngokulandelana ukugxila kwesu lokuthuthukiswa kwemboni yamakhemikhali embonini yamakhemikhali enhle, futhi ukusheshisa ukuthuthukiswa kwemboni yamakhemikhali enhle sekuyinkambiso yomhlaba wonke.Amakhemikhali amahle ahlanganisa izibulala-zinambuzane, imithi, odayi (imibala), njll.Amakhemikhali akhethekile ahlanganisa izithasiselo zokudla, izithasiselo zokudla, izinto zokunamathisela, izinto ezisetshenziswayo, amakhemikhali okuhlanza amanzi, amakhemikhali esikhumba, amakhemikhali asezindaweni zikawoyela, amakhemikhali e-electronic, amakhemikhali okwenza iphepha nezinye izinkambu ezingaphezu kuka-50.

Imithi ephakathi kwemithi ibhekisela kumakhemikhali aphakathi enziwe ngesikhathi sokuhlanganiswa kwezidakamizwa zamakhemikhali futhi ayingxenye yemikhiqizo emihle yamakhemikhali.Imithi ephakathi kwemithi ingase ihlukaniswe yaba ama-antibiotic intermediate, antipyretic and analgesic intermediates, cardiovascular intermediates, and anticancer intermediates ngokuvumelana nezinkambu zabo zokusebenza.Imboni yasenhla nomfula. yamakhemikhali aphakathi nendawo iwumkhakha wezinto ezisetshenziswayo zamakhemikhali ayisisekelo, kuyilapho imboni ephansi komfula iyi-API yamakhemikhali kanye nemboni yokulungiselela.Njengempahla eningi, intengo yezinto ezisetshenziswayo zamakhemikhali ayisisekelo ishintshashintsha kakhulu, okuthinta ngokuqondile izindleko zokukhiqiza zamabhizinisi.Aphakathi kwezemithi kanye ihlukaniswe yaba abaphakathi okuyinhloko nabathuthukisiwe, okumaphakathi okuyinhloko ngenxa yobunzima bobuchwepheshe bokukhiqiza akuphakeme, amanani aphansi, kanye nenani elengeziwe esimweni sokutholakala ngokweqile, abaphakathi abathuthukisiwe yimikhiqizo eyinhloko yokusabela ephakathi, uma kuqhathaniswa ne-primar.y Isakhiwo esimaphakathi, esiyinkimbinkimbi, isinyathelo esisodwa noma ezimbalwa zokulungisa imikhiqizo esezingeni eliphezulu eyengezwe ezansi nomfula, isamba sayo semajini singaphezulu kwesamba semali yomkhakha ophakathi nendawo. emaphethelweni angaphambili ochungechunge lwezimboni ezinengcindezi enkulu yokuncintisana kanye nengcindezi yentengo, kanye nokuguquguquka kwentengo yezinto ezingavuthiwe zamakhemikhali kunomthelela omkhulu kubo.Abahlinzeki abakhulu abaphakathi nendawo, ngakolunye uhlangothi, abanawo amandla aqinile okuxoxisana kwabancane. abahlinzeki, kodwa okubaluleke nakakhulu, bathwala ukukhiqizwa kweziphakathi ezithuthukisiwe ezinokuqukethwe okuphezulu kobuchwepheshe futhi bagcina ubuhlobo obuseduze nezinkampani zamazwe ngamazwe, ngakho-ke ukushintshashintsha kwentengo yezinto zokusetshenziswa kunomthelela omncane kubo.Abaphakathi abangeyona i-gmp kanye nabaphakathi be-GMP bangahlukaniswa ngokuvumelana izinga lethonya kukhwalithi yokugcina ye-API.I-Non-gmp intermediate ibhekisela ku-befo emaphakathi yemithikabusha into yokuqala ye-API;I-GMP ephakathi isho indawo emaphakathi yemithi ekhiqizwe ngaphansi kwezidingo ze-GMP, okungukuthi, into ekhiqizwa ngemuva kwento yokuqala ye-API, ngesikhathi sezinyathelo ze-API synthesis, futhi eba nezinguquko ezengeziwe zamangqamuzana noma ukulungiswa ngaphambi kokuba ibe. i-API.

Isiqongo sesibili se-patent cliff sizoqhubeka nokugqugquzela isidingo sabaphakathi abakhuphuka nomfula
Imboni yezokwelapha emaphakathi iyashintshashintsha ngaphansi kwethonya lesidingo esiphelele semboni yezokwelapha esezingeni eliphansi, futhi ukwenzeka kwayo ngezikhathi ezithile kuyahambisana nalokho kwemboni yezokwenziwa kwemithi.Lawa mathonya angahlukaniswa abe yizici zangaphandle kanye nezici zangaphakathi: izici zangaphandle ikakhulukazi zibhekisela ekugunyazweni umjikelezo wemithi emisha emakethe;Izici zangaphakathi ikakhulukazi zibhekisela emjikelezweni wokuvikelwa kwelungelo lobunikazi bemithi emisha.Ijubane lokugunyazwa kwemishanguzo emisha ngama-ejensi alawula izidakamizwa njenge-FDA nalo linomthelela othile embonini.Lapho ubude besikhathi sokugunyazwa kwemithi emisha kanye nenani lemithi emisha egunyaziwe kufaneleka ezinkampanini ezikhiqiza imithi, kuzokwenziwa isidingo sezinsizakalo zokukhishwa kwemithi. Ngokusekelwe enanini lemithi emisha yenkampani yamakhemikhali kanye nemithi emisha yebhayoloji egunyazwe yi-FDA Ishumi leminyaka elidlule, inani elikhulu lokugunyazwa kwemithi emisha lizoqhubeka nokukhiqiza isidingo sabaphakathi abakhuphuka nomfula, ngaleyo ndlela kusekele imboni ukuthi igcine ukukhula okuphezulu. Uma ukuvikelwa kwelungelo lobunikazi kwemithi emisha kuphelelwa yisikhathi, imithi ejwayelekile izothuthukiswa kakhulu, futhi abakhiqizi abaphakathi bazo basajabulela ukukhula okushisayo kwesidingo esikhathini esifushane.Ngokwezibalo ze-Evaluate, kulinganiselwa ukuthi kusukela ngo-2017 kuya ku-2022, kuzoba nama-yuan ayizigidi eziyizinkulungwane ezingu-194 emakethe yezidakamizwa ebhekene nesimo sokuphelelwa yisikhathi selungelo lobunikazi, okuyisiqongo sesibili se-patent cliff kusukela ngo-2012.

I-Ariations eminyakeni yamuva nje, ngenxa yokwanda kanye nesakhiwo sezidakamizwa esiyinkimbinkimbi, ucwaningo olusha lwezidakamizwa kanye nezinga lempumelelo yentuthuko liyehla, ukukhuphuka okusheshayo kocwaningo lwezidakamizwa ezintsha nezindleko zokuthuthukiswa kwe-McKinsey e-Nat.Umfundisi DrugDiscov."okukhulunywe ngakho, ngo-2006-2011, ucwaningo olusha lwezidakamizwa kanye nezinga lokuthuthukiswa kwempumelelo lingama-7.5% kuphela, kusukela ngo-2012 kuya ku-2014, ngenxa ye-biological macromolecules ukukhetha okuhle kanye nobuthi obuphansi be-miss distance (izidakamizwa esigabeni sokukhula sekwephuzile, okungukuthi, kusukela isigaba somtholampilo III sokufakwa kuhlu okugunyaziwe sinezinga lempumelelo elingu-74%), ucwaningo lwezidakamizwa kanye nokuthuthukiswa kwezinga lempumelelo lilonke likhuphuka kancane, kodwa kusenzima ukubuyisela ku-16.40% izinga lempumelelo eminyakeni engu-90. Izindleko zokufaka kuhlu ngempumelelo entsha Isidakamizwa sikhuphuke sisuka kithi ngamabhiliyoni ayi-1.188 ngo-2010 safinyelela ku-$2.18 billion ngo-2018, cishe siphindeka kabili.Khonamanjalo, izinga lokubuya kwemithi emisha liyaqhubeka nokwehla.Ngo-2018, izikhondlakhondla zemithi ye-TOP12 emhlabeni wonke zenze isilinganiso sembuyiselo esingu-1.9% kuphela ekutshalweni kwezimali ocwaningweni nasekuthuthukisweni.

Ukwenyuka kwezindleko ze-r&d kanye nokwehla kwembuyiselo ekutshalweni kwezimali kwe-r&d kulethe ingcindezi enkulu ezinkampanini ezithaka imithi, ngakho zizokhetha ukukhipha inqubo yokukhiqiza kumabhizinisi e-CMO esikhathini esizayo ukuze zehlise izindleko.Ngokusho kwe-ChemicalWeekly, inqubo yokukhiqiza ihlanganisa cishe u-30% wezindleko eziphelele zemithi yokuqala.Imodeli ye-CMO/CDMO ingasiza izinkampani zemithi ukunciphisa inani lezindleko zokufakwa kwempahla engaguquki, ukusebenza kahle kokukhiqiza, izinsiza zabantu, isitifiketi, ukucwaninga nezinye izici. ngo-12-15%.Ngaphezu kwalokho, UKUMUKELA kwemodi ye-CMO/CDMO kungasiza izinkampani zemithi ukuthi zithuthukise isivuno sokusabela, zifinyeze umjikelezo wesitoko futhi zikhulise isici sokuphepha, esingasindisa isikhathi sokwenza ngokwezifiso ukukhiqizwa, sifinyeze umjikelezo we-r&d imithi emisha, isheshisa isivinini sokumaketha kwezidakamizwa, futhi inike amandla izinkampani ezenza imithi ukuthi zijabulele izinzuzo eziningi zelungelo lobunikazi.

Amabhizinisi e-CMO yamaShayina anezinzuzo ezifana nezindleko eziphansi zezinto zokusetshenziswa kanye nabasebenzi, inqubo evumelana nezimo nobuchwepheshe, njll., futhi ukudluliselwa kwemboni yamazwe ngamazwe ye-CMO e-China kukhuthaza ukunwetshwa kwesabelo semakethe ye-CMO yaseChina.Imakethe yomhlaba wonke ye-CMO/CDMO ilindeleke ukuze sidlule ku-$102.5 billion ngo-2021, ngesilinganiso sokukhula esiyinhlanganisela esingaba ngu-12.73% ngo-2017-2021, ngokusho kwesibikezelo saseNingizimu.

Emakethe yamakhemikhali amahle emhlabeni wonke ngo-2014, imithi kanye nabaphakathi bayo, isibulala-zinambuzane kanye nabaphakathi bayo yizimboni ezimbili ezihamba phambili zemboni yamakhemikhali emihle, ezibalelwa ku-69% no-10% ngokulandelana.I-China inemboni eqinile ye-petrochemical abakhiqizi bezinto ezingavuthiwe bamakhemikhali, abakhe amaqoqo ezimboni, benza inqwaba yezinhlobo zezinto ezingavuthiwe neziyisizayo ezidingekayo ukuze kukhiqizwe amakhemikhali asezingeni eliphakeme atholakala eChina, bathuthukise ukusebenza kahle futhi behlise izindleko zizonke.Ngasikhathi sinye, iChina inenani elilinganiselwe uhlelo oluphelele lwezimboni, okwenza izindleko zemishini yamakhemikhali, ukwakhiwa kanye nokufakwa kwe-China zibe phansi kakhulu kunalezo zamazwe athuthukile noma amazwe amaningi asathuthuka, ngaleyo ndlela kuncishiswe izindleko zokutshalwa kwezimali nezokukhiqiza.Ngaphezu kwalokho, i-China inenani elikhulu lamakhono asebenzayo futhi aphansi- onjiniyela bamakhemikhali ababizayo kanye nabasebenzi bezimboni.Imboni ye-Intermediates e-China iye yathuthukiswa kusukela ocwaningweni lwesayensi nokuthuthukiswa kuya ku-prukukhishwa nokuthengiswa kwesethi ephelele yesistimu ephelele, ukukhiqizwa kwemithi yezinto zokusetshenziswa kwamakhemikhali kanye neziphakathi eziyisisekelo zingakha isethi ephelele, abambalwa kuphela abadinga ukungenisa, bangakhiqiza abaphakathi kwemithi, abaphakathi kwezibulala-zinambuzane kanye nezinye izigaba ezinkulu ze-36, ngaphezu kwalokho 40000 izinhlobo Intermediates, kukhona imikhiqizo eminingi Lesisemkhatsini izuzwe inani elikhulu ezithunyelwa ngaphandle, ukuthunyelwa kwamanye amazwe Lesisemkhatsini amathani angaphezu kwezigidi ezingu-5 ngonyaka, isibe intermediates ngobukhulu ukukhiqizwa kanye isithekelisi emhlabeni.

Imboni yaseShayina ephakathi kwemithi iye yathuthukiswa kakhulu kusukela ngo-2000. Ngaleso sikhathi, izinkampani ezithaka imithi emazweni athuthukile zazinaka kakhulu ucwaningo lwemikhiqizo nokuthuthukiswa kanye nokuthuthukiswa kwezimakethe njengokuncintisana kwazo okuyinhloko futhi zasheshisa ukudluliswa kwemithi ephakathi kanye nesebenzayo emazweni asathuthuka. ngezindleko eziphansi.Ngakho-ke, imboni yaseShayina ephakathi kwemithi ukuthatha leli thuba ukuthola intuthuko enhle kakhulu.Ngemuva kweminyaka engaphezu kweshumi yentuthuko eqhubekayo, iShayina isibe isizinda sokukhiqiza esibalulekile esimaphakathi ekuhlukaniseni abasebenzi emhlabeni jikelele embonini yezemithi ngokwesekwa Umthethonqubo kazwelonke jikelele kanye nezinqubomgomo ezehlukene.Kusukela ngowezi-2012 kuya kowezi-2018, ukukhiqizwa kwemboni yaseShayina yabaxhumanisi bemithi kukhuphuke kusukela kumathani ayizigidi eziyisi-8.1 ngosayizi wemakethe olinganiselwa ku-yuan oyizigidi eziyizinkulungwane eziyi-168.8 kuya kumathani angaba yizigidi eziyi-10.12 ngosayizi wemakethe wama-yuan ayizigidi eziyizinkulungwane ezingama-2017.Isitolo semithi saseChina abaphakathi iIndustry izuze ukuncintisana okuqinile emakethe, futhi ngisho nabanye abakhiqizi abaphakathi bakwazile ukukhiqiza abaxhumanisi abanesakhiwo samangqamuzana esiyinkimbinkimbi kanye nezidingo eziphezulu zobuchwepheshe.Inani elikhulu lemikhiqizo enethonya seliqalile ukubusa ezimakethe zamazwe ngamazwe.Kodwa-ke, lilonke, imboni emaphakathi yaseShayina isesikhathini sokuthuthukiswa kokuthuthukiswa kwesakhiwo somkhiqizo nokuthuthukiswa, futhi izinga lobuchwepheshe lisephansi kakhulu.Iningi lemikhiqizo eku imboni yemithi ephakathi kwemithi iseyimaphakathi emithi eyinhloko, kuyilapho isibalo esikhulu semithi ethuthukisiwe emaphakathi kanye nabamaphakathi abasekelayo bemithi emisha enelungelo lobunikazi bayivelakancane.