Indasitiri yemakemikari akanaka inzvimbo yehupfumi yekugadzira makemikari akanaka muindasitiri yemakemikari, izvo zvakasiyana nezvigadzirwa zvemakemikari zvakajairika kana makemikari akawanda. Indasitiri yemakemikari akanaka ndeimwe yezviratidzo zvakakosha zvedanho rehunyanzvi renyika. Hunhu hwayo hukuru ndeyekugadzira makemikari akanaka emhando yepamusoro, akasiyana-siyana, akakosha kana akawanda anoshanda zvakanaka ehupfumi hwepasi rose nehupenyu hwevanhu netekinoroji yepamusoro uye itsva. Indasitiri yemakemikari akanaka ine huwandu hwakawanda hwetekinoroji uye kukosha kwakawedzerwa. Kubva kuma1970, dzimwe nyika dzakabudirira mumaindasitiri dzakachinja zvakanyanya chinangwa chekuvandudza indasitiri yemakemikari kuenda kuindasitiri yemakemikari akanaka, uye kukurumidzisa kufambira mberi kweindasitiri yemakemikari akanaka kwave kufarirwa pasi rose. Makemikoro akanaka anosanganisira mishonga yekuuraya zvipembenene, mishonga, madhayi (pigments), nezvimwewo. Makemikoro akakosha anosanganisira zvinowedzera zvekudya, zvinowedzera zvekudya, zvinonamatira, zvinonamira, makemikari ekurapa mvura, makemikari eganda, makemikari emumunda wemafuta, makemikari emagetsi, makemikari ekugadzira mapepa nezvimwe zvinopfuura makumi mashanu.

Mishonga inopindirana inoreva makemikari akagadzirwa panguva yekugadzira mishonga yemakemikari uye ndeyezvigadzirwa zvemakemikari zvakanaka. Mishonga inopindirana inogona kukamurwa kuita mishonga inorwisa mabhakitiriya, mishonga inorwisa pyretic uye inonyaradza marwadzo, mishonga inopindirana nemwoyo, uye mishonga inorwisa kenza zvichienderana neminda yavo yekushandisa. Indasitiri yepamusoro yemishonga inopindirana ndiyo indasitiri yemakemikari, nepo indasitiri iri pasi iri indasitiri yemakemikari yeAPI nekugadzirira. Sezvinhu zvakawanda, mutengo wezvinhu zvemakemikari zvinochinja-chinja zvakanyanya, izvo zvinokanganisa zvakananga mutengo wekugadzira wemabhizinesi. Mishonga inopindirana uye yakakamurwa kuita mishonga inopindirana neinopindirana, inonyanya kupindirana nekuda kwekuoma kwehunyanzvi hwekugadzira haisi yakakwira, mitengo yakaderera, uye kukosha kwakawedzerwa mumamiriro ezvinhu akawandisa, mishonga inopindirana ndiyo mishonga inopindirana neinopindirana, ine chimiro chakaoma, nhanho imwe chete kana mashoma ekugadzirira zvigadzirwa zvinopindirana neinopindirana, gross margin level yayo yakakwira kupfuura gross margin yeindasitiri. Sezvo vatengesi vepakati vekutanga vachigona kupa kugadzirwa kuri nyore kwepakati, vari pamberi pecheni yeindasitiri nechisimba chikuru chemakwikwi uye kumanikidzwa kwemitengo, uye mutengo Kuchinja-chinja kwezvinhu zvemakemikari zvakakosha kunovabatsira zvikuru. Kune rumwe rutivi, vatengesi vakuru vepakati havana simba guru rekutaurirana pamusoro pevatengesi vechidiki chete, asi chinonyanya kukosha, vanotakura kugadzirwa kwevagadziri vepamusoro vane zvemukati zvehunyanzvi uye vanochengetedza hukama hwepedyo nemakambani epasi rose, saka kuchinja kwemitengo yezvinhu zvisina kugadzirwa hakuna simba guru pavari. Vagadziri vepakati vasiri vegmp uye vagadziri vepakati veGMP vanogona kupatsanurwa zvichienderana nehuwandu hwesimba pamhando yekupedzisira yeAPI. Vagadziri vepakati vasiri vegmp vanoreva vagadziri vepakati vemishonga vasati vatanga API; GMP vagadziri vepakati vanoreva vagadziri vepakati vemishonga vakagadzirwa pasi pezvinodiwa neGMP, kureva kuti, chinhu chinogadzirwa mushure mekutanga API, panguva yematanho ekugadzira API, uye chinochinja mamwe mamorekuru kana kunatswa chisati chava API.

Chikamu chechipiri che patent cliff chicharamba chichikurudzira kudiwa kwemakambani ari pakati nepakati
Indasitiri yemishonga inochinja-chinja nekuda kwezvinodiwa neindasitiri yemishonga iri pasi, uye nguva yaro inoenderana neyainoshandiswa neindasitiri yemishonga. Izvi zvinogona kukamurwa kuita zvinhu zvekunze nezvinhu zvemukati: zvinhu zvekunze zvinonyanya kureva kutenderera kwekubvumidzwa kwemishonga mitsva pamusika; Zvinhu zvemukati zvinonyanya kureva kutenderera kwekuchengetedzwa kwepatent yemishonga mitsva. Kumhanya kwekubvumidzwa kwemishonga mitsva nemasangano anodzora mishonga akadai seFDA kunewo simba paindasitiri. Kana nguva yekubvumidzwa kwemishonga mitsva nehuwandu hwemishonga mitsva inotenderwa zvakanakira makambani emishonga, kuda kwemabasa ekutengesa mishonga kunze kuchagadzirwa. Zvichienderana nehuwandu hwemishonga mitsva yemakemikari nemishonga mitsva yebhayoloji yakatenderwa neFDA mumakore gumi apfuura, huwandu hwakawanda hwekutenderwa kwemishonga mitsva hucharamba huchigadzira kudiwa kwemishonga yepamusoro, nokudaro zvichitsigira indasitiri kuti irambe ichikura zvakanyanya. Kana kuchengetedzwa kwepatent kwemishonga mitsva kwapera, mishonga yemagetsi ichavandudzwa zvikuru, uye vagadziri vepakati vacharamba vachifarira kukura kwekuda kwenguva pfupi. Zvichienderana nenhamba dzeEvaluate, zvinofungidzirwa kuti kubva muna 2017 kusvika 2022, pachava nemayuan 194 bhiriyoni emusika wemishonga akatarisana nemamiriro ekupera kwezvibvumirano zvepatent, inova ndiyo nhanho yechipiri yepamusoro yezvibvumirano zvepatent kubvira muna 2012.

Kuongororwa kwakaitwa mumakore achangopfuura, nekuwedzera uye chimiro chemishonga chakaoma, kutsvagisa mishonga mitsva uye mwero wekubudirira mukugadzirwa kwayo waderera, kuwedzera nekukurumidza kwemari yekutsvaga mishonga mitsva nekugadzirwa kweMcKinsey muNat. Rev. DrugDiscov. "Zvataurwa, muna 2006-2011, kutsvagurudza kwemishonga mitsva nekubudirira mukukura kwayo i7.5% chete, kubva muna 2012 kusvika 2014, nekuda kwekusarudzika kwakanaka kwema macromolecules ebhayoloji uye chepfu shoma ye miss distance (mishonga iri muchikamu chekupedzisira chekugadzirwa, kureva kuti, kubva pachikamu chechitatu chekiriniki kusvika pakunyoreswa kwakatenderwa ine chiyero che74% chekubudirira), kutsvagurudza kwemishonga nekubudirira kwayo kuwedzera zvishoma, asi zvichiri kuoma kudzosera kusvika pa16.40% yekubudirira mumasekondi makumi mapfumbamwe. Mutengo wekubudirira mukunyora mushonga mutsva wakawedzera kubva pamadhora $1.188 bhiriyoni muna 2010 kusvika pamadhora $2.18 bhiriyoni muna 2018, wakapetwa kaviri. Panguva iyi, mwero wekudzoka kwemishonga mitsva unoramba uchiderera. Muna 2018, ma pharmaceutical giants epasi rose e TOP12 akaita kudzoka kwe1.9% chete pakudyara mukutsvaga nekuvandudza."

Kuwedzera kwemitengo yer&d uye kudzikira kwekudzoka kwemari yer&d zvakaunza kumanikidzwa kukuru kumakambani emishonga, saka vachasarudza kupa nzira yekugadzira kune maCMO makambani mune ramangwana kuderedza mitengo. Sekureva kweChemicalWeekly, nzira yekugadzira inobhadhara inenge 30% yemutengo wese wemishonga yekutanga. CMO/CDMO modhi inogona kubatsira makambani emishonga kuderedza mutengo wese wezvinhu zvakagadziriswa, kushanda zvakanaka kwekugadzira, zviwanikwa zvevanhu, chitupa, kuongororwa nezvimwe zvinhu ne12-15%. Pamusoro pezvo, KUGADZIRWA kweCMO/CDMO mode kunogona kubatsira makambani emishonga kuvandudza goho rekuita, kupfupisa kutenderera kwestocking uye kuwedzera safety factor, izvo zvinogona kuchengetedza nguva yekugadzirisa kugadzirwa, kupfupisa kutenderera kwer&d kwemishonga mitsva, kukurumidzisa kumhanya kwekushambadzira kwemishonga, uye kugonesa makambani emishonga kunakidzwa nemigove yakawanda yepatenti.

Makambani eCMO ekuChina ane zvakanakira zvakaita semutengo wakaderera wezvinhu zvakagadzirwa uye vashandi, maitiro anochinjika uye tekinoroji, nezvimwewo, uye kutamiswa kweindasitiri yepasi rose yeCMO kuenda kuChina kunokurudzira kuwedzera kwemusika weCMO weChina. Musika wepasi rose weCMO/CDMO unotarisirwa kudarika $102.5 bhiriyoni muna 2021, nekukura kwakabatana kweinenge 12.73% muna 2017-2021, zvichienderana nekufungidzira kweSouth.

Mumusika wepasi rose wemakemikari akanaka muna 2014, mishonga yemishonga nemidziyo yayo yemishonga yezvipembenene nemidziyo yayo yemishonga ndiyo indasitiri mbiri dzepamusoro dzeindasitiri yemakemikari akanaka, ichiita 69% ne10% zvichiteerana. China ine indasitiri yakasimba yemafuta nemakemikari uye nhamba huru yevagadziri vezvinhu zvemakemikari, izvo zvakaumba maindasitiri, zvichiita kuti mhando dzakawanda dzezvinhu zvisina kugadzirwa uye zvekubatsira zvinodiwa pakugadzira makemikari akanaka emhando yepamusoro anowanikwa muChina, zvichivandudza kushanda zvakanaka uye zvichideredza mutengo wese. Panguva imwe chete, China ine sisitimu yakakwana yeindasitiri, iyo inoita kuti mutengo wemidziyo yemakemikari, kuvaka uye kuisa muChina uve wakaderera zvikuru pane wenyika dzakabudirira kana kunyange nyika zhinji dziri kusimukira, nokudaro ichideredza mari yekudyara nekugadzira. Pamusoro pezvo, China ine nhamba huru yevanjiniya vemakemikari vane hunyanzvi uye vane mutengo wakaderera uye vashandi veindasitiri. Indasitiri yepakati muChina yakabudirira kubva pakutsvagisa kwesainzi nekusimudzira kusvika pakugadzira nekutengesa seti yakazara yesisitimu yakakwana, kugadzirwa kwemishonga yezvinhu zvemakemikari nemidziyo yepakati yepakutanga kunogona kuumba seti yakazara, vashoma chete vanoda kupinza, vanogona kugadzira mishonga yepakati, mishonga yezvipembenene nezvimwe zvikamu zvikuru makumi matatu nematanhatu, kupfuura Kune marudzi 40000 ezvigadzirwa zvepakati, kune zvigadzirwa zvakawanda zvepakati zvakawanikwa nehuwandu hwakawanda hwekutengeswa kunze kwenyika, huwandu hwepakati hwekutengeswa kunze kwenyika hunopfuura matani mamiriyoni mashanu pagore, hwave huwandu hukuru hwezvigadzirwa zvepakati nepakati uye hunotengesa kunze kwenyika.

Indasitiri yemishonga yeChina yave ichikura zvikuru kubvira mugore ra2000. Panguva iyoyo, makambani emishonga munyika dzakabudirira akanyanya kutarisisa kutsvaga nekugadzira zvigadzirwa nekukura kwemusika senzvimbo yavo huru yekukwikwidzana uye akakurumidzisa kutamiswa kwemishonga yepakati nepakati uye kugadzirwa kwemishonga inoshanda kunyika dziri kusimukira nemitengo yakaderera. Nokudaro, indasitiri yemishonga yepakati nepakati yeChina yatora mukana uyu kuti iwane budiriro yakanaka. Mushure memakore anopfuura gumi ekukura kwakasimba, China yave nzvimbo yakakosha yekugadzira pakati nepakati muchikamu chepasi rose chevashandi muindasitiri yemishonga nerutsigiro rwemitemo yenyika yese uye marongero akasiyana-siyana. Kubva muna 2012 kusvika 2018, kubuda kweindasitiri yemishonga yepakati nepakati yeChina kwakawedzera kubva pamatani angangoita mamiriyoni 8.1 nehukuru hwemusika hwemayuan angangoita mabhiriyoni 168.8 kusvika pamatani angangoita mamiriyoni 10.12 nehukuru hwemusika hwemayuan mabhiriyoni 2017. Indasitiri yemishonga yepakati yeChina yakawana kukwikwidza kwakasimba mumusika, uye kunyangwe vamwe vagadziri vemishonga vakakwanisa kugadzira mishonga yepakati ine chimiro chakaoma chemorekuru uye zvinodiwa zvepamusoro zvehunyanzvi. Zvigadzirwa zvakawanda zvine simba zvakatanga kutonga pamusika wepasi rose. Zvisinei, indasitiri yepakati yeChina ichiri munguva yekuvandudzwa kwechimiro chezvigadzirwa, uye hunyanzvi hwekugadzira huchiri hwakaderera. Zvizhinji zvezvigadzirwa muindasitiri yemishonga zvichiri zvepakati pemishonga, nepo huwandu hwakawanda hwezvigadzirwa zvepamusoro zvemishonga pamwe nezvigadzirwa zvemishonga mitsva ine patent zvisingawanzoitiki.