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 yabaphakathi abaphakathi kunye nabaphambili abaphambili, abaphakathi abaphambili ngenxa yobunzima beteknoloji yemveliso ayikho phezulu, amaxabiso aphantsi, kunye nexabiso elongezelelweyo kwimeko yokugqithiswa, abaphakathi abaphambili yimveliso ephambili yokusabela ephakathi, xa kuthelekiswa ne-primar.Isakhiwo esiphakathi, esintsokothileyo, inyathelo elinye okanye ambalwa ekulungiseleleni iimveliso zexabiso elongeziweyo ezantsi komsinga, inqanaba lomda walo wexabiso liphezulu kunomda wegross yeshishini eliphakathi. ekupheleni kwekhonkco lezoshishino kunye noxinzelelo olukhulu olukhuphisanayo kunye noxinzelelo lwexabiso, kunye nokuguquguquka kwexabiso lezinto ezisisiseko zemichiza kunempembelelo enkulu kubo.Ababoneleli abaphakathi abaphezulu, kwelinye icala, abanalo kuphela igunya eliqinileyo lokuxoxisana ngaphezu kwabancinci. ababoneleli, kodwa okona kubaluleke kakhulu, bathwala imveliso yabaphakathi abaphambili kunye nomxholo ophezulu wezobugcisa kwaye bagcine ubudlelwane obusondeleyo kunye neenkampani zamazwe ngamazwe, ngoko ke ukuguquguquka kwexabiso lezinto eziluhlaza kunempembelelo encinci kubo. iqondo lempembelelo kumgangatho wokugqibela we-API.I-Non-gmp ephakathi ibhekisa kwi-befo ephakathi yamayeza.kwakhona i-API yokuqalisa imathiriyeli; i-GMP ephakathi ibhekisa kumayeza aphakathi awenziwe phantsi kweemfuno ze-GMP, oko kukuthi, into eveliswa emva kwe-API yokuqalisa imathiriyeli, ngexesha lamanyathelo e-API synthesis, kwaye ityhubela utshintsho olongezelelekileyo kwimolekyuli okanye ukucokiswa ngaphambi kokuba ibe. i 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 neshishini labasebenzi.I-Intermediates e-China liphuhliswe ukusuka kuphando lwezenzululwazi kunye nophuhliso ukuya kwi-prukukhutshwa kunye nokuthengiswa kweseti epheleleyo yenkqubo epheleleyo, ukuveliswa kwamachiza ezinto eziluhlaza kunye neziphakathi kwisiseko kunokwenza isethi epheleleyo, kuphela imfuneko embalwa yokungenisa, inokuvelisa i-pharmaceutical intermediates, i-pesticide intermediates kunye nezinye iindidi ezinkulu ze-36, ngaphezu 40000 iintlobo intermediates, kukho ezininzi imveliso intermediate oluphunyeziweyo inani elikhulu kumazwe angaphandle, kumazwe angaphandle phakathi kweetoni ezingaphezu kwezigidi ezi-5 ngonyaka, iye yaba intermediates inkulu ehlabathini imveliso kunye nomthengisi.

Ishishini laseTshayina eliphakathi kwezamayeza liphuhliswe kakhulu ukusukela ngo-2000. Ngelo xesha, iinkampani zamachiza kumazwe aphuhlileyo zanikela ingqalelo ngakumbi nangakumbi kuphando lwemveliso kunye nophuhliso kunye nophuhliso lwentengiso 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. abaphakathi iUmzi-mveliso uzuze ukhuphiswano oluluqilima kwimarike, kwaye kwanabanye abavelisi abaphakathi bakwazile ukuvelisa abaphakathi abanesakhiwo 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.