Imboni yamakhemikhali amahle iyinkambu yezomnotho yokukhiqiza amakhemikhali amahle embonini yamakhemikhali, ehlukile emikhiqizweni yamakhemikhali ejwayelekile noma amakhemikhali amaningi. Imboni yamakhemikhali amahle ingenye yezimpawu ezibalulekile zezinga lobuchwepheshe eliphelele lezwe. Izici zayo eziyisisekelo ukukhiqiza amakhemikhali amahle asezingeni eliphezulu, ahlukahlukene, akhethekile noma asebenzayo amaningi emnothweni womhlaba kanye nokuphila kwabantu ngobuchwepheshe obuphezulu nobusha. Imboni yamakhemikhali amahle inobuchwepheshe obuphezulu kanye nenani eliphezulu elengeziwe. Kusukela ngawo-1970, amanye amazwe athuthukile kwezimboni ashintshe ngokulandelana ukugxila kwesu lokuthuthukiswa kwemboni yamakhemikhali kwaba imboni yamakhemikhali amahle, futhi ukusheshisa intuthuko yemboni yamakhemikhali amahle sekuyinto ethandwayo emhlabeni wonke. Amakhemikhali amahle afaka phakathi izibulala-zinambuzane, imithi, udayi (izinhlayiya), njll. Amakhemikhali akhethekile afaka phakathi izithasiselo zokudla, izithasiselo zokudla, izinamathiseli, ama-surfactant, amakhemikhali okwelapha amanzi, amakhemikhali esikhumba, amakhemikhali asezindaweni zikawoyela, amakhemikhali kagesi, amakhemikhali okwenza amaphepha kanye neminye imikhakha engaphezu kwama-50.

Ama-intermediate emithi abhekisela kumakhemikhali aphakathi enziwe enkambisweni yokwenziwa kwemithi yamakhemikhali futhi ayingxenye yemikhiqizo yamakhemikhali emihle. Ama-intermediate emithi angahlukaniswa abe ama-intermediate emithi yokubulala amagciwane, ama-intermediate emithi yokubulala amagciwane kanye nemithi yokunciphisa ubuhlungu, ama-intermediate emithi yokwelapha inhliziyo, kanye nama-intermediate emithi yokwelapha umdlavuza ngokwezinkambu zawo zokusetshenziswa. Imboni ephezulu yama-intermediate emithi iyimboni eyisisekelo yezinto zokusetshenziswa zamakhemikhali, kuyilapho imboni engezansi iyimboni ye-API yamakhemikhali kanye nokulungiselela. Njengempahla enkulu, intengo yezinto zokusetshenziswa zamakhemikhali eziyisisekelo iyashintshashintsha kakhulu, okuthinta ngqo izindleko zokukhiqiza zamabhizinisi. Ama-intermediate emithi futhi ahlukaniswe abe ama-intermediate aphakathi nendawo aphambili, ama-intermediate ayinhloko ngenxa yobunzima bobuchwepheshe bokukhiqiza awaphezulu, amanani aphansi, futhi inani elengeziwe esimweni sokulethwa ngokweqile, ama-intermediate athuthukile yimikhiqizo yokusabela okuphakathi eyinhloko, uma kuqhathaniswa nesakhiwo esiphakathi nendawo esiyinkimbinkimbi, isinyathelo esisodwa noma ezimbalwa sokulungiselela imikhiqizo engezansi enenani eliphezulu, izinga layo le-gross margin liphakeme kune-gross margin yemboni yama-intermediate. Njengoba abahlinzeki abaphakathi abayinhloko benganikeza kuphela ukukhiqizwa okulula okuphakathi, basekuqaleni kochungechunge lwezimboni ngengcindezi enkulu yokuncintisana kanye nengcindezi yentengo, futhi intengo Ukuguquguquka kwezinto eziyisisekelo zokusetshenziswa kwamakhemikhali kunomthelela omkhulu kubo. Ngakolunye uhlangothi, abahlinzeki abaphakathi abaphezulu abanamandla amakhulu okuxoxisana ngabahlinzeki abancane, kodwa okubaluleke kakhulu, bathwala ukukhiqizwa kwabaphakathi abathuthukile abanokuqukethwe okuphezulu kobuchwepheshe futhi bagcina ubudlelwano obuseduze nezinkampani zamazwe ngamazwe, ngakho-ke ukuguquguquka kwentengo kwezinto zokusetshenziswa akunawo umthelela omncane kubo. Abaphakathi abangewona ama-gmp kanye nabaphakathi be-GMP bangahlukaniswa ngokwezinga lethonya kwikhwalithi yokugcina ye-API. Abaphakathi abangewona ama-gmp babhekisela ku-medicine intermediate ngaphambi kwezinto zokuqala ze-API; Abaphakathi be-GMP babhekisela ku-medicine intermediate eyenziwe ngaphansi kwezidingo ze-GMP, okungukuthi, into ekhiqizwa ngemuva kwezinto zokuqala ze-API, ngesikhathi sezinyathelo zokwenziwa kwe-API, futhi edlula ezinguqukweni ezengeziwe zama-molecule noma ukuhluzwa ngaphambi kokuba yi-API.

I-peak yesibili ye-patent cliff izoqhubeka nokukhuthaza isidingo sama-intermediate aphezulu
Imboni yezokwelapha ephakathi iyashintshashintsha ngaphansi kwethonya lesidingo esiphelele semboni yezokwelapha esezansi, futhi ukuphindaphinda kwayo kuhambisana kakhulu nemboni yezokwelapha. La mathonya angahlukaniswa abe yizici zangaphandle kanye nezici zangaphakathi: izici zangaphandle ikakhulukazi zibhekisela kumjikelezo wokuvunyelwa kwemithi emisha emakethe; Izici zangaphakathi ikakhulukazi zibhekisela kumjikelezo wokuvikelwa kwelungelo lobunikazi wemithi emisha. Ijubane lokuvunyelwa kwemithi emisha yizikhungo ezilawula izidakamizwa ezifana ne-FDA nalo linethonya elithile embonini. Lapho isikhathi sokuvunyelwa kwemithi emisha kanye nenani lemithi emisha evunyiwe livumelana nezinkampani zemithi, isidingo sezinsizakalo zokuthumela imithi ngaphandle sizokhiqizwa. Ngokusekelwe enanini lemithi emisha yamakhemikhali kanye nemithi emisha yebhayoloji evunyiwe yi-FDA eminyakeni eyishumi edlule, inani elikhulu lokuvunyelwa kwemithi emisha lizoqhubeka nokukhiqiza isidingo semithi esezingeni eliphezulu, ngaleyo ndlela kusekelwe imboni ukuthi igcine ukuchuma okukhulu. Uma ukuvikelwa kwelungelo lobunikazi kwemithi emisha sekuphelile, imithi ejwayelekile izothuthukiswa kakhulu, futhi abakhiqizi abaphakathi bazoqhubeka nokujabulela ukukhula okukhulu 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 kwelungelo lobunikazi, okuyi-peak yesibili yelungelo lobunikazi kusukela ngo-2012.

Izingxoxo eminyakeni yamuva nje, njengoba ukwanda kanye nesakhiwo semithi siyinkimbinkimbi, izinga lempumelelo yocwaningo lwemithi emisha kanye nentuthuko liyancipha, ukwanda okusheshayo kocwaningo lwemithi emisha kanye nezindleko zokuthuthukiswa kweMcKinsey ku-Nat. Rev. DrugDiscov. “okushiwo, ngo-2006-2011, izinga lempumelelo yocwaningo lwezidakamizwa ezintsha kanye nentuthuko liyi-7.5% kuphela, kusukela ngo-2012 kuya ku-2014, ngenxa yama-macromolecule ebhayoloji ukukhetha okuhle kanye nobuthi obuphansi bokuphuthelwa ibanga (izidakamizwa esigabeni sokuthuthukiswa sekwephuzile, okungukuthi, kusukela esigabeni sezokwelapha sesi-3 kuya ohlwini oluvunyiwe zinezinga lempumelelo elingu-74%)), ucwaningo lwezidakamizwa kanye nentuthuko izinga lempumelelo lilonke lokukhula kancane, kodwa kusanzima ukusekela izinga lempumelelo elingu-16.40% ngemizuzwana engama-90. Izindleko zokufaka ngempumelelo umuthi omusha ohlwini ziye zanda zisuka ku-$1.188 billion ngo-2010 zaya ku-$2.18 billion ngo-2018, cishe ziphindwe kabili. Okwamanje, izinga lokubuyiselwa kwemithi emisha liyaqhubeka nokwehla. Ngo-2018, izinkampani ezinkulu zemithi ze-TOP12 zomhlaba wonke zenze izinga lokubuyiselwa elingu-1.9% kuphela ekutshalweni kwezimali ocwaningweni nasekuthuthukisweni.

Ukwanda kwezindleko ze-r&d kanye nokwehla kwembuyiselo ekutshalweni kwezimali kwe-r&d kulethe ingcindezi enkulu ezinkampanini zemithi, ngakho-ke zizokhetha ukunikeza amabhizinisi e-CMO inqubo yokukhiqiza esikhathini esizayo ukuze kuncishiswe izindleko. Ngokusho kwe-ChemicalWeekly, inqubo yokukhiqiza ibiza cishe u-30% wezindleko eziphelele zemithi yokuqala. Imodeli ye-CMO/CDMO ingasiza izinkampani zemithi ukunciphisa izindleko eziphelele zokufakwa kwempahla engaguquki, ukusebenza kahle kokukhiqiza, izinsiza zabantu, isitifiketi, ukuhlolwa kwezimali kanye nezinye izici ngo-12-15%. Ngaphezu kwalokho, UKUTHATHWA kwemodi ye-CMO/CDMO kungasiza izinkampani zemithi ukuthuthukisa isivuno sokusabela, kufinyeze umjikelezo wesitoko futhi kwandise isici sokuphepha, okungonga isikhathi sokwenza ngokwezifiso ukukhiqiza, kufinyeze umjikelezo we-r&d wemithi emisha, kusheshiswe isivinini sokumaketha kwemithi, futhi kuvumele izinkampani zemithi ukuthi zijabulele izinzuzo eziningi ze-patent.

Amabhizinisi aseShayina e-CMO anezinzuzo ezifana nezindleko eziphansi zezinto zokusetshenziswa kanye nabasebenzi, inqubo eguquguqukayo kanye nobuchwepheshe, njll., kanye nokudluliselwa kwemboni yamazwe ngamazwe ye-CMO eShayina kukhuthaza ukwanda okwengeziwe kwesabelo semakethe ye-CMO yaseShayina. Imakethe yomhlaba wonke ye-CMO/CDMO kulindeleke ukuthi idlule u-$102.5 billion ngo-2021, ngesilinganiso sokukhula esihlanganisiwe esingaba ngu-12.73% ngo-2017-2021, ngokusho kwesibikezelo saseNingizimu.

Emakethe yamakhemikhali amahle emhlabeni wonke ngo-2014, izimboni zemithi kanye neziphakathi kwazo, izibulala-zinambuzane kanye neziphakathi kwazo ziyizimboni ezimbili eziphezulu embonini yamakhemikhali amahle, ezibalelwa ku-69% kanye no-10% ngokulandelana. I-China inomkhakha oqinile wamakhemikhali kaphethroli kanye nenani elikhulu labakhiqizi bezinto zokusetshenziswa zamakhemikhali, abenze amaqoqo ezimboni, okwenza izinhlobo eziningi zezinto zokusetshenziswa ezingavuthiwe nezisizayo ezidingekayo ekukhiqizweni kwamakhemikhali amahle aphezulu atholakala e-China, okuthuthukisa ukusebenza kahle kanye nokunciphisa izindleko zizonke. Ngesikhathi esifanayo, i-China inohlelo lwezimboni oluphelele, olwenza izindleko zemishini yamakhemikhali, ukwakhiwa kanye nokufakwa e-China zibe phansi kakhulu kunezamazwe athuthukile noma ngisho namazwe amaningi asathuthuka, ngaleyo ndlela kunciphisa izindleko zokutshalwa kwezimali kanye nokukhiqiza. Ngaphezu kwalokho, i-China inonjiniyela bamakhemikhali abanekhono nabangabizi kakhulu kanye nabasebenzi bezimboni. Imboni ephakathi e-China ithuthukile kusukela ocwaningweni lwesayensi kanye nentuthuko kuya ekukhiqizweni nasekuthengisweni kwesethi ephelele yesistimu ephelele, ukukhiqizwa kwemithi yezinto zokusetshenziswa zamakhemikhali kanye neziphakathi eziyisisekelo kungakha isethi ephelele, bambalwa kuphela abadinga ukungeniswa, bangakhiqiza iziphakathi zemithi, iziphakathi zemithi kanye nezinye izigaba ezinkulu ezingu-36, ngaphezu kwalokho Izinhlobo ezingu-40000 zemikhiqizo ephakathi, kunemikhiqizo eminingi ephakathi efinyelele inani elikhulu lokuthunyelwa kwamanye amazwe, ukuthunyelwa kwamanye amazwe okuphakathi kwamathani angaphezu kwezigidi ezi-5 ngonyaka, sekuyinto enkulu kunazo zonke emhlabeni ekukhiqizeni nasekuthumeleni kwamanye amazwe imikhiqizo ephakathi.

Imboni yezemithi eShayina ithuthukiswe kakhulu kusukela ngo-2000. Ngaleso sikhathi, izinkampani zezemithi emazweni athuthukile zazinaka kakhulu ucwaningo lomkhiqizo kanye nentuthuko kanye nentuthuko yemakethe njengokuncintisana kwazo okuyinhloko futhi zasheshisa ukudluliselwa kwezemithi emisha kanye nokuhlanganiswa kwezidakamizwa ezisebenzayo emazweni asathuthuka ngezindleko eziphansi. Ngakho-ke, imboni yezemithi eShayina yathatha leli thuba ukuthola intuthuko enhle kakhulu. Ngemva kweminyaka engaphezu kweyishumi yentuthuko eqhubekayo, iShayina isibe yisisekelo esibalulekile sokukhiqiza esiphakathi ekuhlukanisweni kwemisebenzi emhlabeni wonke embonini yezemithi ngokusekelwa komthethonqubo kazwelonke kanye nezinqubomgomo ezahlukahlukene. Kusukela ngo-2012 kuya ku-2018, umkhiqizo wemboni yezemithi eShayina ukhuphuke usuka kumathani ayizigidi ezingu-8.1 ngobukhulu bemakethe obungaba yizigidigidi ezingu-168.8 zama-yuan kuya kumathani ayizigidi ezingu-10.12 ngobukhulu bemakethe obungaba yizigidigidi zama-yuan ezingu-2017 zama-yuan. Imboni yezemithi eShayina ifinyelele ukuncintisana okunamandla emakethe, futhi ngisho nabanye abakhiqizi bezemithi bakwazile ukukhiqiza ezemithi emisha enesakhiwo esiyinkimbinkimbi sama-molecule kanye nezidingo zobuchwepheshe eziphezulu. Inani elikhulu lemikhiqizo enethonya seliqalile ukubusa imakethe yamazwe ngamazwe. Kodwa-ke, iyonke, imboni ephakathi yaseShayina isesesikhathini sokuthuthukiswa kokulungiswa nokuthuthukiswa kwesakhiwo somkhiqizo, futhi izinga lobuchwepheshe lisaphansi kakhulu. Iningi lemikhiqizo embonini ephakathi kwemithi iseseyimikhiqizo ephakathi kwemithi eyinhloko, kuyilapho inani elikhulu lemikhiqizo ephakathi kwemithi ethuthukisiwe kanye nemikhiqizo ephakathi esekelayo yemithi emisha enelungelo lobunikazi ayivamile.