Pharmaceutical Intermediates Industry Overview

Pharmaceutical intermediates
Izvo zvinodaidzwa kuti mishonga yepakati inonyatso makemikari zvigadzirwa kana zvigadzirwa zvemakemikari zvinoda kushandiswa mukugadzirisa kwemishonga.Izvi zvigadzirwa zvemakemikari zvinogona kugadzirwa mune zvakajairika zvidyarwa zvemakemikari pasina kuwana rezinesi rekugadzira zvinodhaka, uye zvinogona kushandiswa mukubatanidza nekugadzirwa kwemishonga chero bedzi zviratidzo zvehunyanzvi zvichisangana nezvimwe zvinodikanwa.Kunyangwe iyo synthesis yemishonga zvakare ichiwira pasi pechikamu chemakemikari, izvo zvinodikanwa zvakanyanya kuomarara kupfuura izvo zvezvakajairwa zvigadzirwa zvemakemikari.Vagadziri vemishonga yakapedzwa uye APIs vanofanirwa kugamuchira GMP certification, nepo vagadziri vepakati havadaro, nekuti vepakati vanongori musanganiswa uye kugadzirwa kwemakemikari ezvigadzirwa, izvo zvinonyanya kukosha uye zvepasi zvigadzirwa mucheni yekugadzira zvinodhaka, uye hazvigoneke. inonzi zvinodhaka zvakadaro, saka havadi GMP certification, iyo inoderedzawo mukana wekupinda wevagadziri vepakati.

Pharmaceutical intermediates industry
Makambani emakemikari anogadzira nekugadzirisa organic/inorganic intermediates kana maAPIs emakambani emishonga ekugadzira zvigadzirwa zvemishonga zvakapedzwa nemakemikari kana biological synthesis zvichienderana nehupamhi hwemhando.Pano mishonga yepakati yakakamurwa kuita maviri maindasitiri eCMO neCRO.

CMO
Contract Manufacturing Organization inoreva sangano rekugadzira kondirakiti, zvinoreva kuti kambani yemishonga inopa nzira yekugadzira kune mumwe wake.Iyo bhizinesi cheni yeindasitiri yemishonga CMO inowanzotanga nehunyanzvi hwemishonga yemishonga.Makambani ari muindastiri anosungirwa kuti atore machira emakemikari ekutanga uye azvigadzirise kuita zvine hunyanzvi zvemishonga, izvo zvinozogadziriswa kuita API yekutanga zvinhu, cGMP yepakati, APIs uye magadzirirwo.Parizvino, makambani makuru emishonga emarudzi akawanda anowanzo tanga kudyidzana kwenguva refu nenhamba shoma yevatengesi vepakati, uye kupona kwemakambani muindastiri iyi kunonyanya kuoneka kuburikidza nevavanodyidzana navo.

CRO
Contract (Clinical) Research Organisation inoreva sangano rekutsvagisa kondirakiti, uko makambani emishonga anopa chikamu chekutsvagisa kune mumwe wake.Parizvino, indasitiri iyi inonyanya kuenderana nekugadzirwa kwetsika, tsika R&D uye tsvakiridzo yekondirakiti yemishonga uye kutengesa.Kunyangwe iyo nzira, ingave chigadzirwa chepakati chemishonga chigadzirwa chekuvandudza kana kwete, kukwikwidza kwekambani kuchiri kutongwa neiyo R&D tekinoroji sechinhu chekutanga, icho chinoratidzwa muvatengi vekambani yepasi pasi kana vadyidzani.

Pharmaceutical chigadzirwa kukosha cheni
Mufananidzo
(Mufananidzo kubva kuQilu Securities)

Indasitiri ketani yemishonga yepakati indasitiri
Mufananidzo
(Mufananidzo kubva kuChina Industry Information Network)

Pharmaceutical intermediates classification
Mishonga yepakati inogona kupatsanurwa mumapoka makuru zvichienderana neminda yekushandiswa, senge yepakati yemishonga inorwisa mabhakitiriya, yepakati ye antipyretic uye analgesic zvinodhaka, zvepakati zvemoyo vascular system mishonga uye yepakati yemishonga yekurwisa cancer.Kune marudzi akawanda emishonga yepakati, yakadai se imidazole, furan, phenolic intermediates, anonhuwirira intermediates, pyrrole, pyridine, biochemical reagents, sulfur-containing, nitrogen-containing, halogen compounds, heterocyclic compounds, starch, mannitol, microcrystalline cellulose. , dextrin, ethylene glycol, shuga poda, inorganic munyu, ethanol intermediates, stearate, amino acids, ethanolamine, potassium munyu, sodium munyu uye zvimwe zviri pakati, nezvimwewo.
Mhedziso yekuvandudzwa kweindasitiri yemishonga yepakati muChina
Sekureva kweIMS Health Incorporated, kubva muna 2010 kusvika 2013, musika wepasi rose wemishonga wakaramba wakasimba, kubva paUS $793.6 bhiriyoni muna 2010 kusvika US$899.3 bhiriyoni muna 2013, nemusika wemishonga uchiratidza kukurumidza kukurumidza kubva 2014, kunyanya nekuda kwemusika weUS. .Iine CAGR ye6.14% kubva 2010-2015, musika wepasi rose wemishonga unotarisirwa kupinda mukukura kunononoka kubva 2015-2019.Zvakadaro, sezvo mishonga iri kudiwa zvakanyanya, kukura kwese kunotarisirwa kuve kwakasimba mune ramangwana, nemusika wepasi rose wemishonga unosvika US$1.22 trillion panosvika 2019.
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(Mufananidzo kubva kuIMS Health Incorporated)
Parizvino, nekugadziridzwa kwemaindasitiri emakambani makuru emishonga epasi rose, kufambiswa kwekugadzirwa kwemarudzi akawanda uye kumwe kunatsiridzwa kwechikamu chepasi rose chevashandi, China yave hwaro hwakakosha hwepakati hwekugadzira muchikamu chepasi rose chevashandi muindasitiri yemishonga.Indasitiri yeChina yemishonga yepakati yakagadzira hurongwa hwakakwana kubva pakutsvagisa nekusimudzira kusvika pakugadzira nekutengesa.Kubva mukuvandudzwa kwemishonga yepakati pasirese, China yehuwandu hwekuita tekinoroji nhanho ichiri yakadzikira, huwandu hukuru hwepamberi hwemishonga yepakati uye patent mishonga mitsva inotsigira epakati mabhizinesi ekugadzira idiki, iri mudanho rekuvandudza chigadzirwa chekugadzirisa uye kusimudzira. .
Kuburitsa kukosha kwekemikari yemishonga yepakati indasitiri muChina kubva 2011 kusvika 2015
Mufananidzo
(Mufananidzo kubva kuChina Business Industry Research Institute)
Munguva ya2011-2015, makemikari emuChina emushonga wepakati indasitiri yakawedzera gore negore, muna 2013, makemikari emuChina emishonga epakati akabuda aive 568,300 matani, akatengeswa kunze kwenyika 65,700 matani, ne2015 China chemakemikari mishonga yepakati to760 yakabuda, 40 yakabuda.
2011-2015 China chemikemikari yemishonga inopindirana neindasitiri yekugadzira nhamba
Mufananidzo
(Mufananidzo kubva kuChina Merchant Industry Research Institute)
Kupihwa kwemishonga yepakati muChina kwakakurumbira kupfuura kudiwa, uye kutsamira kune kunze kwenyika kuri kuwedzera zvishoma nezvishoma.Nekudaro, zvinotengeswa kunze kwenyika zveChina zvinonyanya kusanganisirwa muzvigadzirwa zvakawanda sevhitamini C, penicillin, acetaminophen, citric acid nemunyu wayo uye esters, nezvimwe. Zvigadzirwa izvi zvinoratidzwa nekubuda kukuru kwechigadzirwa, mamwe mabhizinesi ekugadzira, kukwikwidza kunotyisa kwemusika, mutengo wakaderera wechigadzirwa uye yakawedzera kukosha, uye kugadzirwa kwavo kwakawanda kwakonzera mamiriro ekupa kudarika kudiwa mumusika wepakati wemishonga wepakati.Zvigadzirwa zvine zvemhando yepamusoro tekinoroji zvichiri kunyanya kuvimba nekunze.
Nekuchengetedza amino acid yemishonga yepakati, mazhinji emabhizinesi ekugadzira epamba ane chimwe chigadzirwa chakasiyana uye chisina kugadzikana mhando, kunyanya kune ekunze biopharmaceutical makambani kugadzirisa kugadzirwa kwezvigadzirwa.Chete mamwe mabhizinesi ane simba rekutsvagisa uye simba rekusimudzira, zvivakwa zvekugadzira zvepamberi uye ruzivo mukugadzirwa kwakakura anogona kuwana purofiti yakakura mumakwikwi.
Ongororo yeChina's pharmaceutical intermediates industry

1, mishonga yepakati indasitiri tsika yekugadzira maitiro
Chekutanga, kutora chikamu mukutsvagisa kwemutengi nekuvandudza danho remishonga mitsva, izvo zvinoda kambani yeR & D centre ine simba rekuvandudza rakasimba.
Chechipiri, kumutengi wemutyairi wechigadzirwa kukwidziridzwa, kusangana negwara rekugadzira hukuru-hukuru, izvo zvinoda kambani yeinjiniya yekuwedzera kugona kwechigadzirwa uye kugona kwekuenderera mberi kwekuvandudza kweiyo yakasarudzika chigadzirwa tekinoroji pane imwe nguva inotevera, kuti kusangana nezvinodiwa zvechigadzirwa chiyero chekugadzirwa, ramba uchidzikisira mutengo wekugadzira uye kuwedzera kukwikwidza kwechigadzirwa.
Chechitatu, ndeye kugaya nekuvandudza maitiro ezvigadzirwa muchikamu chekugadzirwa kwevatengi, kuitira kuti zvisangane nemhando dzemhando dzemakambani ekunze.

2. Hunhu hweChina chemishonga yepakati indasitiri
Kugadzirwa kwemishonga kunoda huwandu hukuru hwemakemikari akakosha, mazhinji awo akatanga kugadzirwa neindasitiri yemishonga pachayo, asi nekudzika kwekupatsanurwa kwevashandi pamwe nekufambira mberi kwehunyanzvi hwekugadzira, indasitiri yemishonga yakaendesa mamwe epakati emishonga kumabhizinesi emakemikari. zvekugadzira.Pharmaceutical intermediate zvigadzirwa zvakanaka zvemakemikari, uye kugadzirwa kwemishonga yepakati kwave indasitiri huru muindasitiri yemakemikari yepasirese.Parizvino, indasitiri yemishonga yeChina inoda marudzi zviuru zviviri zvemakemikari ezvigadzirwa uye zvepakati gore rega rega, paine kudiwa kwematani anopfuura mamirioni maviri nemazana mashanu.Sezvo kutengeswa kunze kwenyika kwemishonga yepakati kusiyana nekutengeswa kunze kwenyika kwemishonga kuchange kuri pasi pezvirambidzo zvakasiyana-siyana munyika dzinopinza, pamwe nekugadzirwa kwepasi rose kwemishonga yepakati kune nyika dzichiri kusimukira, ikozvino kuChina kwekugadzirwa kwemishonga kunodiwa kwemakemikari akabikwa uye epakati anogona kunyatsoenderana. , chikamu chiduku chete chekuda kuunza kunze.Uye nekuda kwezviwanikwa zveChina zvakawanda, mitengo yezvigadzirwa yakaderera, kune akawanda epakati emishonga akawanawo huwandu hukuru hwekutengesa kunze.

Parizvino, China inoda makemikari anotsigira mbishi zvinhu uye pakati pemarudzi anopfuura 2500, kudiwa kwepagore kwakasvika 11.35 miriyoni matani.Mushure meanopfuura makore makumi matatu ebudiriro, kuChina kugadzirwa kwemishonga zvinodiwa zvemakemikari mbishi zvinhu uye zvepakati zvakakwanisa kuenderana.Kugadzirwa kwepakati muChina kwakanyanya mune antibacterial uye antipyretic zvinodhaka.

Muindasitiri yose, China mishonga intermediates indasitiri ane zvinhu zvitanhatu: Kutanga, mazhinji emabhizimisi mabhizimisi ega ega, flexible oparesheni, chiyero chekudyara hachina kukura, pakati pemamiriyoni kune imwe kana zviuru zviviri zveyuan;Chechipiri, kugoverwa kwenzvimbo kwemabhizinesi kwakanyanyisa, kunyanya muTaizhou, Zhejiang Province uye Jintan, Jiangsu Province sepakati;Chechitatu, nekuwedzera kuri kuita nyika kutarisisa kuchengetedzwa kwezvakatipoteredza, kudzvanywa kwevemabhizinesi kuvaka kuchengetedzwa kwezvakatipoteredza nzvimbo dzekurapa kuri kuwedzera Chechina, kukurumidza kuvandudzwa kwechigadzirwa kuri kukurumidza, uye mubairo wepurofiti uchadonha zvakanyanya mushure memakore matatu kusvika mashanu mumusika, kumanikidza mabhizinesi. kugadzira zvigadzirwa zvitsva kana kuvandudza maitiro nguva nenguva kuitira kuti uwane purofiti yepamusoro;Chechishanu, sezvo purofiti yekugadzirwa kwemishonga yepakati yakakwira kupfuura yezvigadzirwa zvemakemikari akajairwa, uye maitiro ekugadzira akafanana, mabhizinesi emakemikari madiki anowedzera anopinda muchikamu chekugadzira epakati pemishonga, zvichikonzera kuwedzera kukwikwidza kunotyisa muindasitiri Yechitanhatu. , kana ichienzaniswa neAPI, iyo purofiti yepakati yekugadzira yepakati yakaderera, uye nzira yekugadzira yeAPI uye yepakati yemishonga yakafanana, saka mamwe mabhizinesi haangobudisi vepakati, asi zvakare anoshandisa zvawo zvakanakira kutanga kugadzira API.Nyanzvi dzakaratidza kuti kugadzirwa kwemishonga yepakati kune nzira yekuvandudza API inzira isingadzivisiki.Nekudaro, nekuda kwekushandiswa kumwe chete kweAPI, nemakambani emishonga ane simba rakakura, mabhizinesi epamba anowanzo gadzira zvigadzirwa asi pasina vashandisi vechiitiko ichi.Naizvozvo, vagadziri vanofanirwa kumisa hukama hwenguva refu hwakagadzikana hwekugovera nemakambani emishonga, kuitira kuti vaone kutengesa kwakanaka kwechigadzirwa.

3, indasitiri yekupinda zvipingamupinyi
①Mutengi zvipingamupinyi
Indasitiri yemishonga inodzorwa nemakambani mashoma epasi rose anogadzira mishonga.Iwo emishonga oligarchs anongwarira zvikuru mukusarudza kwavo kwevanopa masevhisi ekunze uye kazhinji vane nguva yakareba yekuongorora kune vatengesi vatsva.Makambani eMishonga eCMO anofanirwa kusangana nemaitiro ekutaurirana evatengi vakasiyana, uye anofanirwa kuita nguva yakareba yekuenderera mberi ongororo vasati vawana kuvimba nevatengi vepasi, uye vozova vatengesi vavo vepakati.
②Technical zvipingamupinyi
Iko kugona kupa yakakwira tekinoroji kukosha-yakawedzerwa masevhisi ndiyo nheyo yekambani yemishonga yekushambadzira sevhisi kambani.Makambani eMishonga eCMO anofanirwa kupaza mabhodhoro ehunyanzvi kana kuvharika munzira dzawo dzekutanga uye nekupa nzira dzekugadzirisa mishonga yekudzikisa zvinobudirira mutengo wekugadzira zvinodhaka.Pasina kwenguva refu, yakadhura mari mukutsvaga nekusimudzira uye tekinoroji reserves, zvakaoma kuti makambani ari kunze kweindasitiri anyatsopinda muindasitiri.
③Zvipinganidzo zvetarenda
Zvakaoma kumakambani eCMO kuvaka inokwikwidza R&D uye timu yekugadzira munguva pfupi yekumisikidza cGMP-inoenderana bhizinesi modhi.
④Zvipingaidzo zvehunhu
Iyo FDA uye mamwe masangano anodzora zvinodhaka ave kuwedzera kuomarara mune yavo yemhando yekudzora zvinodiwa, uye zvigadzirwa zvisingapfuure kuongororwa hazvigone kupinda mumisika yenyika dzinopinza.
⑤ Zvipingamupinyi zvekuchengetedza zvakatipoteredza
Makambani emishonga ane maitiro echinyakare achatakura mari yekudzora kusvibiswa kwakakwira uye kudzvanywa kwemitemo, uye makambani emishonga echinyakare anonyanya kuburitsa kusvibiswa kwakanyanya, kushandiswa kwesimba rakawanda uye zvigadzirwa zvakaderera-zvinowedzera (semuenzaniso penicillin, mavhitamini, nezvimwewo) zvichatarisana nekukurumidza kubviswa.Kuomerera pakugadzirisa hunyanzvi uye kugadzira girinhi yemishonga tekinoroji yave nzira yekuvandudza yeramangwana remishonga yeCMO indasitiri.

4. Domestic pharmaceutical intermediates akanyorwa mabhizinesi
Kubva pachinzvimbo cheindasitiri cheni, makambani matanhatu akanyorwa emakemikari akanaka anogadzira epakati pemishonga ese ari pamucheto wakaderera weindastiri cheni.Kungave kune nyanzvi yekuburitsa sevhisi sevhisi kana kuAPI uye yekuwedzera yekugadzira, simba rehunyanzvi ndiro rinogara riri musimboti wekutyaira simba.
Panyaya yesimba retekinoroji, makambani ane tekinoroji padanho rinotungamira repasi rose, simba rakasimba rekuchengetedza uye kudyara kwakanyanya muR&D anofarirwa.
Boka I: Lianhua Technology uye Arbonne Chemical.Lianhua Technology ine masere epakati matekinoroji akadai seammonia oxidation uye fluorination semusimboti wayo wetekinoroji, iyo hydrogen oxidation iri padanho rinotungamira repasi rose.Abenomics mutungamiriri wepasi rese mumishonga yechiral, kunyanya mumakemikari ayo ekutsemura uye racemization tekinoroji, uye ine yakanyanya mari yeR&D, inoverengera 6.4% yemari.
Boka II: Wanchang Technology uye Yongtai Technology.Wanchang Technology's tsvina gasi hydrocyanic acid nzira ndiyo yakaderera mutengo uye yakanyanya kufambira mberi maitiro ekugadzirwa kweprototrizoic acid esters.Yongtai Technology, kune rumwe rutivi, inozivikanwa neayo fluorine yakanaka makemikari.
Boka III: Tianma Fine Chemical uye Bikang (yaimbozivikanwa seJiuzhang).
Kuenzanisa kwesimba rehunyanzvi remakambani akanyorwa
Mufananidzo
Kuenzanisa kwevatengi uye mhando dzekushambadzira dzemakambani akanyorwa emishonga epakati
Mufananidzo
Kuenzanisa kwekudzika kudiwa uye kutenderera kwehupenyu hwepatent yezvigadzirwa zvemakambani akanyorwa
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Ongororo yemakwikwi echigadzirwa emakambani akanyorwa
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Iyo nzira yekukwidziridzwa kweakanaka makemikari epakati
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(Mifananidzo uye zvinhu kubva kuQilu Securities)
Matarisiro ebudiriro yeindasitiri yemishonga yepakati yeChina
Seindasitiri yakakosha mumunda weindasitiri yemakemikari yakanaka, kugadzirwa kwemishonga kwave kutarisisa kwekusimudzira nemakwikwi mumakore gumi apfuura, nekufambira mberi kwesainzi uye tekinoroji, mishonga mizhinji yakagadziridzwa nguva nenguva kuitira kubatsira vanhu, iyo synthesis. yemishonga iyi inoenderana nekugadzirwa kwemitsva, yemhando yepamusoro yemishonga yepakati, saka mishonga mitsva inodzivirirwa nematenti, nepo vepakati navo vasina matambudziko, saka mitsva yemishonga yepakati kumba nekune dzimwe nyika Iyo nzvimbo yekuvandudza musika uye tarisiro yekushandisa. vanovimbisa zvikuru.
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Parizvino, tsvakurudzo yekutsvakurudza kwemishonga yepakati inonyanya kuratidzwa mukugadzirwa kweheterocyclic compounds, fluorine-containing compounds, chiral compounds, biological compounds, nezvimwewo. Pachine imwe nzvimbo pakati pekugadzirwa kwemishonga yemishonga uye zvinodiwa zveindasitiri yemishonga. muChina.Zvimwe zvigadzirwa zvine yakakwirira tekinoroji zvinodiwa hazvigone kurongeka kuti zvigadzirwe muChina uye zvakanyanya kuvimba nekunze, seanhydrous piperazine, propionic acid, nezvimwe. mutengo uye mhando hazvisi kusvika pachiyero, izvo zvinokanganisa kukwikwidza kwezvigadzirwa zvemishonga uye zvinoda kuvandudza maitiro ekugadzira, akadai seTMB, p-aminophenol, D-PHPG, nezvimwe.
Zvinotarisirwa kuti mumakore mashoma anotevera, tsvakiridzo yemishonga yepasi rose ichatarisa pazvikamu gumi zvinotevera zvemishonga: mishonga yekuvandudza kushanda kwehuropi, anti-rheumatoid arthritis drugs, anti-AIDS drugs, anti-hepatitis nemamwe mishonga yemavhairasi, lipid. -kuderedza zvinodhaka, anti-thrombotic zvinodhaka, anti-bundu zvinodhaka, platelet-activating factor antagonists, glycoside cardiac stimulants, antidepressants, anti-psychotic uye anti-anxiety zvinodhaka, etc. kuvandudzwa kwemishonga yepakati uye nzira yakakosha yekuwedzera nzvimbo itsva yemusika.