Ishishini lemichiza elungileyo licandelo loqoqosho lokuvelisa imichiza elungileyo kushishino lweekhemikhali, olwahlukileyo kwimveliso yeekhemikhali eziqhelekileyo okanye iikhemikhali ezininzi.Ishishini lemichiza elungileyo lelinye leempawu ezibalulekileyo zenqanaba letekhnoloji elibanzi lelizwe. Iimpawu zayo ezisisiseko kukuvelisa umgangatho ophezulu, iindidi ezininzi, iikhemikhali ezikhethekileyo okanye ezininzi ezisebenzayo kuqoqosho lwehlabathi kunye nobomi babantu kunye nobuchwepheshe obuphezulu kunye obutsha.Ishishini lemichiza elilungileyo linobuninzi bezobuchwepheshe kunye nexabiso eliphezulu elongezelelweyo.Ukusukela ngo-1970, amanye amazwe aphuhlileyo kwimizi-mveliso atshintshe ngokulandelelana ugqaliselo lwesicwangciso sophuhliso loshishino lweekhemikhali ukuya kushishino lwemichiza elungileyo, kunye nokukhawulezisa uphuhliso lweshishini lemichiza elungileyo liyinto yehlabathi jikelele. izongezo zokutya, izongezo zokutya, izinto zokuncamathelisa, iikhemikhali zokunyanga amanzi, iikhemikhali zesikhumba, iikhemikhali ze-oilfield, iikhemikhali zombane, iikhemikhali zokwenza amaphepha kunye nezinye ezingaphezu kwama-50.

Amayeza aphakathi abhekiselele kwiikhemikhali eziphakathi ezenziwe kwinkqubo yokudityaniswa kwamachiza ekhemikhali kwaye ziyinxalenye yeemveliso zemichiza elungileyo.Izahlulo zeMichiza zinokwahlulwa zibe ngamayeza okubulala iintsholongwane, i-antipyretic kunye ne-analgesic intermediates, i-cardiovascular intermediates, kunye ne-anticancer intermediates ngokwemimandla yesicelo sabo.Ishishini elingasentla. amayeza aphakathi kushishino lwemichiza esisiseko yemathiriyeli ekrwada, ngelixa ishishini elisezantsi lishishini le-API yemichiza kunye noshishino lokulungiselela. Njengempahla eninzi, ixabiso lezinto ezisisiseko zemichiza ekrwada liguquguquka kakhulu, elichaphazela ngqo ixabiso lemveliso yamashishini. yahlulwe yaba intermediates eziphambili neziphambili, eziphambili intermediate ngenxa yobunzima iteknoloji imveliso ayikho phezulu, amaxabiso aphantsi, kunye nexabiso elongezelelweyo kwimeko oversupply, intermediates phambili yimveliso ephambili yokusabela ephakathi, xa kuthelekiswa nesiseko esiphakathi, isakhiwo esinzima, nje Inyathelo elinye okanye ambalwa ekulungiseleleni iimveliso ezisezantsi zexabiso elongeziweyo, inqanaba lomda walo liphezulu kunomda weshishini eliphakathi. Njengoko ababoneleli abaphakathi abaphambili banokubonelela kuphela ngemveliso elula ephakathi, basekupheleni kweshishini. ikhonkco elinoxinzelelo olukhulu lokhuphiswano kunye noxinzelelo lwexabiso, kunye nokuguquguquka kwexabiso lezinto ezisisiseko zemichiza ekrwada kunempembelelo enkulu kubo.Ababoneleli abaphakathi abaphezulu abaphakathi, kwelinye icala, abanalo kuphela igunya elilomeleleyo lengxoxo kubaxhasi abancinci, kodwa okona kubaluleke kakhulu, thwala imveliso yabaphakathi abaphambili kunye nomxholo ophezulu wobugcisa kwaye ugcine ubudlelwane obusondeleyo kunye neenkampani zamazwe ngamazwe, ngoko ke ukuguquguquka kwexabiso lezinto eziluhlaza kunempembelelo encinane kubo.Abaphakathi be-GMP kunye nabaphakathi be-GMP banokuhlelwa ngokomlinganiselo wempembelelo ekugqibeleni. Umgangatho we-API.I-Non-gmp ephakathi ibhekisa kumbindi wamayeza phambi kokuba i-API iqale imathiriyeli;I-GMP ephakathi ibhekisa kumayeza aphakathi awenziwe phantsi kweemfuno ze-GMP, oko kukuthi, into eveliswa emva kwesixhobo sokuqala se-API, ngexesha le-API synthesis. amanyathelo, kwaye oko kwenzeka utshintsho olongezelelweyo lwemolekyuli okanye ukulungiswa ngaphambi kokuba ibe yi-API.

Incopho yesibini ye-patent cliff iya kuqhubeka ivuselela imfuno yabaphakathi abaphezulu
Ishishini eliphakathi lamachiza liyaguquguquka phantsi kwempembelelo yemfuno epheleleyo yoshishino lwamayeza asezantsi, kwaye i-periodicity yayo ngokusisiseko ihambelana neshishini lamayeza.Ezi mpembelelo zinokwahlulwa zibe yimiba yangaphandle kunye nezinto zangaphakathi: imiba yangaphandle ibhekisa ikakhulu ekuvunyweni. Umjikelo wamachiza amatsha kwimarike;Imiba yangaphakathi ikakhulu ibhekisa kumjikelo wokhuselo lwelungelo elilodwa lomenzi wechiza olutsha.Isantya sokuvunywa kwechiza elitsha zii-arhente ezilawula amachiza ezifana ne-FDA nazo zinempembelelo ethile kushishino. Xa ixesha lokuvunywa kwechiza elitsha kunye nenani lamachiza amatsha avunyiweyo lilungele iinkampani zoxubo mayeza, imfuno yeenkonzo zokukhupha amayeza iya kwenziwa. Ngokusekwe kwinani lamachiza amatsha echiza kunye namachiza amatsha ebhayoloji avunywe yi-FDA Kwiminyaka elishumi edlulileyo, inani elikhulu lolwamkelo lwamachiza amatsha lizakuqhuba nokuvelisa imfuno yabaphakathi abaphezulu, ngaloo ndlela ixhasa ishishini ukugcina ukuchuma okuphezulu. Nje ukuba ukhuselo lwelungelo elilodwa lomenzi wechiza olutsha luphelelwe lixesha, amachiza enziwe afana nalawo aveliswe ngabenzi azakwenziwa aphuculwe kakhulu, kwaye abavelisi abaphakathi bayakuthi. basakonwabela ukukhula okugqabhukileyo kwemfuno kwixesha elifutshane. Ngokwezibalo zoVavanyo, kuqikelelwa ukuba ukusuka ku-2017 ukuya ku-2022, kuya kubakho i-194 yeebhiliyoni zeeyuan kwintengiso yamachiza ejongene nemeko yokuphelelwa kwelungelo elilodwa lomenzi wechiza, eyincopho yesibini ye-patent cliff ukusukela ngo-2012.

I-Ariations kwiminyaka yakutshanje, kunye nokwanda kunye nokwakhiwa kwechiza kuyinkimbinkimbi, uphando olutsha lwechiza kunye nezinga lempumelelo yophuhliso liyehla, ukunyuka okukhawulezileyo kophando olutsha lwechiza kunye neendleko zophuhliso lweMcKinsey eNat. Umfundisi DrugDiscov. "Kukhankanywe, ngo-2006-2011, uphando olutsha lweziyobisi kunye nophuhliso lwezinga lempumelelo yi-7.5% kuphela, ukususela ngo-2012 ukuya ku-2014, ngenxa ye-biological macromolecules ukukhetha okulungileyo kunye netyhefu ephantsi yokuphosa umgama (iziyobisi kwisigaba sophuhliso emva kwexesha, oko kukuthi, ukusuka isigaba seklinikhi III ukuya kuluhlu oluvunyiweyo lunezinga lempumelelo ye-74%), uphando lweziyobisi kunye nophuhliso lwezinga lempumelelo lilonke lokunyuka kancinci, kodwa kunzima ukubuyisela kwi-16.40% izinga lempumelelo kwi-90 s. Iindleko zokudwelisa ngempumelelo entsha Iyeza linyukile ukusuka kuthi i-1.188 yeebhiliyoni zeedola ngo-2010 ukuya kuthi i-2.18 yeebhiliyoni zeedola ngo-2018, phantse iphindwe kabini. Ngeli xesha, izinga lokubuya kwamachiza amatsha liyaqhubeka nokuhla. Ngo-2018, i-TOP12 ye-global giants ye-pharmaceutical giants yenza kuphela ireyithi yembuyekezo ye-1.9% kutyalo-mali kuphando nophuhliso.

Ukwenyuka kweendleko ze-r&d kunye nokwehla kwembuyekezo kutyalo-mali lwe-r&d kwazisa uxinzelelo olukhulu kwiinkampani zamayeza, ngoko ke ziya kukhetha ukukhupha inkqubo yokuvelisa kumashishini e-CMO kwixesha elizayo ukunciphisa iindleko. Ngokutsho kwe-ChemicalWeekly, inkqubo yokuvelisa i-akhawunti malunga ne-30% yeendleko ezipheleleyo zamachiza okuqala.Imodeli ye-CMO / CDMO inokunceda iinkampani zonyango zinciphise iindleko ezipheleleyo zokufakwa kwe-asethi esisigxina, ukusebenza kakuhle kwemveliso, izibonelelo zabantu, isatifikethi, uphicotho kunye nezinye iinkalo. ngo-12-15%.Ukongezelela, i-ADOPTION ye-CMO / CDMO mode inokunceda iinkampani zamachiza ukuba ziphucule isivuno sokusabela, ukunciphisa umjikelo we-stocking kunye nokwandisa into yokhuseleko, enokugcina ixesha lokwenziwa kwemveliso, ukunciphisa umjikelezo we-r & d amayeza amatsha, akhawulezise isantya sokuthengisa amachiza, kwaye enze ukuba iinkampani ezixuba amayeza zonwabele izabelo zamalungelo awodwa omenzi wechiza.

Amashishini eCMO yaseTshayina aneenzuzo ezifana nexabiso eliphantsi lezinto ezisetyenziswayo kunye nabasebenzi, inkqubo eguquguqukayo kunye nobuchwepheshe, njl. njl., kunye nokudluliselwa kweshishini le-CMO lamazwe ngamazwe ukuya e-China kukhuthaza ukwanda kwesabelo semarike ye-CMO yaseChina.Imarike ye-CMO / CDMO yehlabathi ilindeleke. ukudlula kuthi $ 102.5 billion ngo 2021, kunye izinga lokukhula compound malunga 12.73% ngo 2017-2021, ngokutsho uqikelelo South.

Kwimarike yeekhemikhali ezilungileyo zehlabathi ngo-2014, amayeza kunye nabaphakathi, i-pesticide kunye nabaphakathi bayo ngamashishini amancinci amabini aphezulu oshishino lweekhemikhali ezilungileyo, ezibalelwa kwi-69% kunye ne-10% ngokulandelanayo.I-China inoshishino oluqinileyo lwepetrochemical kunye nenani elikhulu abavelisi bemichiza ekrwada, abathe babumba amaqela emizi-mveliso, benza uninzi lweentlobo zezinto ezikrwada kunye nezincedisayo ezifunekayo ukuveliswa kweekhemikhali zodidi oluphezulu ezifumaneka eTshayina, ziphucula ukusebenza kakuhle kunye nokunciphisa iindleko zizonke. Ngelo xesha, iChina inexabiso elilinganayo inkqubo yemizi-mveliso epheleleyo, eyenza iindleko zezixhobo zemichiza, ulwakhiwo kunye nofakelo e-China liphantsi kakhulu kunelo lamazwe aphuhlileyo okanye amazwe amaninzi asaphuhlayo, ngaloo ndlela ukunciphisa iindleko zotyalo-mali kunye nemveliso.Ukongezelela, i-China inenani elikhulu elikwaziyo neliphantsi- Iinjineli zeekhemikhali zeendleko kunye nabasebenzi bemizi-mveliso.I-Intermediates ishishini e-China liphuhliswe ukusuka kuphando lwezenzululwazi kunye nophuhliso ukuya kwimveliso kunye nokuthengiswa kweseti epheleleyo yenkqubo epheleleyo, imveliso yamayeza emveliso yeekhemikhali ekrwada kunye nabaphakathi kwisiseko banokwenza iseti epheleleyo, bambalwa kuphela. kufuneka ukungenisa, ukuvelisa intermediates amayeza, intermediates zinambuzane kunye nezinye iindidi ezinkulu 36, ngaphezu 40000 iintlobo intermediates, kukho ezininzi iimveliso intermediate eziphunyeziweyo inani elikhulu kumazwe angaphandle, ukuthunyelwa phakathi kumazwe angaphandle ngaphezu kwe-5 yezigidi zeetoni ngonyaka, iye yaba ehlabathini lonke. imveliso enkulu ephakathi kunye nomthengisi ngaphandle.

Ishishini laseTshayina eliphakathi kwezamayeza liye laphuhliswa kakhulu ukususela ngo-2000. Ngelo xesha, iinkampani zamachiza kumazwe aphuhlileyo zanikela ingqalelo ngakumbi nangakumbi kuphando lwemveliso kunye nophuhliso nophuhliso lwemarike njengokhuphiswano lwazo olungundoqo kwaye zakhawulezisa ukudluliselwa kwamaziko aphakathi kunye nokudityaniswa kweziyobisi kumazwe asakhasayo. ngeendleko eziphantsi.Ngoko ke, ishishini laseTshayina eliphakathi kwezamayeza ukuba lithathe eli thuba lokufumana uphuhliso olugqwesileyo.Emva kweminyaka engaphezu kweshumi yophuhliso oluzinzileyo, iChina iye yaba sisiseko esibalulekileyo semveliso ephakathi kulwahlulo lwehlabathi labasebenzi kushishino lwamayeza ngenkxaso ummiselo jikelele wesizwe kunye nemigaqo-nkqubo eyahlukeneyo.Ukusukela ngo-2012 ukuya ku-2018, imveliso yoshishino lwamayeza ase-China yanda ukusuka malunga ne-8.1 yezigidi zeetoni kunye nobungakanani bemarike malunga ne-168.8 yeebhiliyoni zeeyuan ukuya malunga ne-10.12 yezigidi zeetoni kunye nobukhulu bemarike ye-2017 yezigidigidi ze-yuan. ishishini eliphakathi liphumelele ukhuphiswano oluluqilima kwimarike, kwaye kwanabanye abavelisi abaphakathi baye bakwazi ukuvelisa abaphakathi kunye nesakhiwo esintsonkothileyo semolekyuli kunye neemfuno eziphezulu zobugcisa. Inani elikhulu leemveliso ezinempembelelo sele ziqalisile ukulawula imarike yezizwe ngezizwe.Noko kunjalo, xa lilonke, ishishini eliphakathi laseTshayina lisekwixesha lophuhliso lokuphucula ubume bemveliso kunye nophuculo, kwaye umgangatho wetekhnoloji usesezantsi.Ininzi yeemveliso kwimveliso ushishino lwamayeza aphakathi kumayeza asengawo aphakathi kumachiza aphambili, ngeli lixa inani elikhulu labaphakathi boxubo mayeza kunye nabaphakathi abaxhasayo bamachiza amatsha anelungelo elilodwa lomenzi banqabile.