I-Pharmaceutical Intermediates Industry Overview

Abaphakathi kwezemithi
Okubizwa ngokuthi ama-pharmaceutical intermediates empeleni kuyizinto zokusetshenziswa zamakhemikhali noma imikhiqizo yamakhemikhali okudingeka isetshenziswe ohlelweni lokuhlanganiswa kwezidakamizwa. Le mikhiqizo yamakhemikhali ingakhiqizwa ezitshalweni zamakhemikhali ezijwayelekile ngaphandle kokuthola ilayisensi yokukhiqiza izidakamizwa, futhi ingasetshenziswa ekuhlanganiseni nasekukhiqizeni imithi inqobo nje uma izinkomba zobuchwepheshe zihlangabezana nezimfuneko ezithile zezinga. Nakuba ukuhlanganiswa kwemithi nakho kuwela ngaphansi kwesigaba samakhemikhali, izidingo ziqine kakhulu kunalezo zemikhiqizo yamakhemikhali evamile. Abakhiqizi bemithi eqediwe kanye nama-API badinga ukwamukela isitifiketi se-GMP, kuyilapho abakhiqizi bezinto ezimaphakathi bengakwenzi, ngoba abaphakathi baseseyinhlanganisela kuphela nokukhiqizwa kwezinto ezingavuthiwe zamakhemikhali, okuyimikhiqizo eyisisekelo nephansi kakhulu ochungechungeni lokukhiqiza izidakamizwa, futhi ngeke ezibizwa ngezidakamizwa okwamanje, ngakho-ke azidingi isitifiketi se-GMP, okwehlisa nomkhawulo wokungena kubakhiqizi abaphakathi.

Imboni yezokwenziwa kwemithi
Izinkampani zamakhemikhali ezikhiqiza futhi zicubungule i-organic/inorganic intermediates noma ama-API ezinkampani ezenza imithi ukuze zenze imikhiqizo eqediwe yemithi ngamakhemikhali noma nge-biological synthesis ngokuvumelana nezindinganiso eziqinile zekhwalithi. Lapha ama-intermediate emithi ahlukaniswe izimboni ezimbili ezingaphansi kwe-CMO kanye ne-CRO.

I-CMO
I-Contract Manufacturing Organisation isho inhlangano ekhiqiza izinkontileka, okusho ukuthi inkampani eyenza imithi ikhiphela uzakwethu inqubo yokukhiqiza. Iketanga lebhizinisi lemboni ye-CMO yezemithi ngokuvamile liqala ngezinto ezisetshenziswayo ezikhethekile zemithi. Izinkampani embonini kudingeka ukuthi zithole izinto zokusetshenziswa zamakhemikhali eziyisisekelo futhi zizicubungule zibe izithako zemithi ezikhethekile, ezibe sezicutshungulwa zibe izinto zokuqala ze-API, i-cGMP intermediates, ama-API kanye nokwakheka. Njengamanje, izinkampani ezinkulu zamazwe ngamazwe ezithaka imithi zivame ukusungula ubambiswano lwesu lwesikhathi eside nenani elincane labaphakeli abayinhloko, futhi ukusinda kwezinkampani kule mboni kubonakala kakhulu ngabalingani bazo.

I-CRO
I-Contract (Clinical) Research Organisation ibhekisela enhlanganweni yocwaningo lwenkontileka, lapho izinkampani ezithaka imithi zikhiphela uzakwethu ingxenye yocwaningo. Njengamanje, imboni isekelwe ikakhulukazi ekukhiqizeni ngokwezifiso, i-R&D yangokwezifiso kanye nocwaningo lwenkontileka yezemithi kanye nokudayiswa. Kungakhathalekile ukuthi iyiphi indlela, noma ngabe umkhiqizo ophakathi kwezemithi ungumkhiqizo osemusha noma cha, ukuncintisana okuyisisekelo kwenkampani kusahlulelwa ubuchwepheshe be-R&D njengento yokuqala, ebonakala kumakhasimende angezansi noma ozakwethu benkampani.

Uchungechunge lwenani lemakethe yemikhiqizo yezemithi
Isithombe
(Isithombe esivela ku-Qilu Securities)

Uchungechunge lwezimboni lwemboni yezemithi ephakathi
Isithombe
(Isithombe esivela ku-China Industry Information Network)

Izigaba zemithi ephakathi
Abaxhumanisi bemithi bangahlukaniswa ngezigaba ezinkulu ngokuya ngezinkambu ezisetshenziswayo, njengeziphakathi zama-antibiotics, izimaphakathi zemithi elwa nokuvuvukala kanye ne-analgesic, izimaphakathi zemithi yesimiso senhliziyo nemithambo yegazi nezimaphakathi zemithi zokulwa nomdlavuza. Kunezinhlobo eziningi zezinqamuleli ezithile zemithi, njenge-imidazole, i-furan, i-phenolic intermediates, i-aromatics intermediates, i-pyrrole, i-pyridine, ama-biochemical reagents, aqukethe isulfure, aqukethe i-nitrogen, ama-halogen compounds, ama-heterocyclic compounds, isitashi, i-mannitol, i-microcrystalline cellulose. , i-dextrin, i-ethylene glycol, impushana kashukela, usawoti we-inorganic, i-ethanol intermediates, i-stearate, ama-amino acids, i-ethanolamine, usawoti we-potassium, usawoti wesodium nezinye izixhumi, njll.
Uhlolojikelele ukuthuthukiswa kwemboni intermediate kwemithi eChina
Ngokusho kwe-IMS Health Incorporated, kusukela ngo-2010 kuya ku-2013, imakethe yemithi yomhlaba wonke iqhubekile nokukhula, isuka ku-$793.6 billion ngo-2010 yaya ku-$899.3 billion ngo-2013, imakethe yemithi ikhombisa ukukhula ngokushesha kusukela ngo-2014, ikakhulukazi ngenxa yemakethe yaseMelika. . Nge-CAGR ka-6.14% kusukela ngo-2010-2015, imakethe yezemithi yamazwe ngamazwe kulindeleke ukuthi ingene emjikelezweni wokukhula kancane kusukela ngo-2015-2019. Kodwa-ke, njengoba imithi idingeka kakhulu, ukukhula okuphelele kulindeleke ukuthi kuqine kakhulu esikhathini esizayo, njengoba imakethe yomhlaba wonke yemithi isondela ku-$1.22 trillion ngo-2019.
Isithombe
(Isithombe esivela ku-IMS Health Incorporated)
Njengamanje, ngokwakhiwa kabusha kwezimboni kwezinkampani ezinkulu ezithaka imithi zamazwe ngamazwe, ukudluliswa kokukhiqizwa kwamazwe ngamazwe kanye nokuthuthukiswa okuqhubekayo kwesigaba sabasebenzi bamazwe ngamazwe, i-China isibe isizinda esibalulekile sokukhiqiza esimaphakathi emkhakheni womhlaba wonke wabasebenzi embonini yezemithi. Imboni yaseShayina ephakathi kwemithi yenze uhlelo oluphelele uma kuqhathaniswa kusukela ocwaningweni nasekuthuthukisweni kuya ekukhiqizeni nasekuthengisweni. Kusukela ekuthuthukisweni kwabaphakathi kwezemithi emhlabeni, izinga lobuchwepheshe benqubo yonke yaseShayina lisephansi uma kuqhathaniswa, inani elikhulu lemithi ephakathi kwemithi ethuthukisiwe kanye nemithi emisha enelungelo lobunikazi esekela amabhizinisi okukhiqiza amaphakathi mancane uma kuqhathaniswa, isesigabeni sokuthuthuka sokuthuthukiswa kwesakhiwo somkhiqizo nokuthuthukiswa. .
Inani lomphumela wemboni yamakhemikhali e-Pharmaceutical intermediates e-China kusukela ngo-2011 kuya ku-2015
Isithombe
(Isithombe esivela eChina Business Industry Research Institute)
Phakathi 2011-2015, China amakhemikhali intermediates embonini okukhipha embonini yanda unyaka nonyaka, ngo-2013, China chemical pharmaceutical intermediates okukhipha kwaba amathani 568,300, kwamanye amazwe amathani 65,700, by 2015 China amakhemikhali ekhemikhali intermediates to66 okukhipha kwaba mayelana 40.
2011-2015 Izibalo zokukhiqiza embonini yamakhemikhali e-China amakhemikhali aphakathi nendawo
Isithombe
(Isithombe esivela eChina Merchant Industry Research Institute)
Ukunikezwa kwemithi ephakathi kwemithi e-China kugqame kakhulu kunesidingo, futhi ukuncika ekuthumeleni kwamanye amazwe kukhula kancane kancane. Kodwa-ke, ukuthunyelwa kwe-China kwamanye amazwe kugxile kakhulu emikhiqizweni eyinqwaba efana no-vitamin C, i-penicillin, i-acetaminophen, i-citric acid nosawoti wayo nama-ester, njll. Le mikhiqizo ibonakala ngokuphuma kwemikhiqizo emikhulu, amabhizinisi amaningi okukhiqiza, ukuncintisana kwezimakethe ezinamandla, intengo ephansi yomkhiqizo kanye inani elengeziwe, kanye nokukhiqizwa kwawo ngobuningi kubangele isimo sokuhlinzekwa kwezidingo ezidlula isidingo emakethe yasekhaya yemithi ephakathi. Imikhiqizo enokuqukethwe kobuchwepheshe obuphezulu isathembele kakhulu ekungenweni kwamanye amazwe.
Ukuze kuvikelwe abaphakathi kwezemithi ye-amino acid, amabhizinisi amaningi okukhiqiza asekhaya anomkhiqizo owodwa ohlukahlukene kanye nekhwalithi engazinzile, ikakhulukazi izinkampani zakwamanye amazwe ze-biopharmaceutical ukwenza ngokwezifiso ukukhiqizwa kwemikhiqizo. Amabhizinisi athile kuphela anamandla okucwaninga aqinile namandla entuthuko, izindawo zokukhiqiza ezithuthukile kanye nolwazi lokukhiqiza ngezinga elikhulu angathola inzuzo ephezulu emqhudelwaneni.
Ukuhlaziywa kwemboni yaseShayina ephakathi kwemithi

I-1, inqubo yokukhiqiza inkambiso yemboni yemithi ephakathi nendawo
Okokuqala, ukubamba iqhaza ocwaningweni lwekhasimende nasekuthuthukisweni kwesigaba semithi emisha, okudinga ukuthi isikhungo senkampani se-R & D sinekhono elinamandla lokuqamba izinto ezintsha.
Okwesibili, ekuthuthukisweni komkhiqizo womshayeli wekhasimende, ukuhlangabezana nomzila wenqubo wokukhiqiza okukhulu, okudinga ikhono lenkampani lokukhulisa ubunjiniyela lomkhiqizo kanye nekhono lokuthuthukiswa kwenqubo eqhubekayo yobuchwepheshe bomkhiqizo owenziwe ngezifiso esikhathini esizayo, ukuze ukuhlangabezana nezidingo zokukhiqizwa kwesikali somkhiqizo, ngokuqhubekayo unciphisa izindleko zokukhiqiza futhi uthuthukise ukuncintisana komkhiqizo.
Okwesithathu, kuwukugaya nokwenza ngcono inqubo yemikhiqizo esigabeni sokukhiqizwa ngobuningi bamakhasimende, ukuze kuhlangatshezwane namazinga ekhwalithi ezinkampani zangaphandle.

2. Izici zemboni yaseShayina ehlanganisa imithi
Ukukhiqizwa kwemithi kudinga inani elikhulu lamakhemikhali akhethekile, iningi lawo ekuqaleni ayekhiqizwa imboni yezemithi ngokwayo, kodwa ngokujula kokuhlukaniswa kwezenhlalo yabasebenzi kanye nenqubekelaphambili yobuchwepheshe bokukhiqiza, imboni yezokwelapha idlulisele abanye abaphakathi kwezemithi emabhizinisini amakhemikhali. zokukhiqiza. Abaphakathi kwezemithi bayimikhiqizo emihle yamakhemikhali, futhi ukukhiqizwa kweziphakathi kwezemithi sekuphenduke imboni enkulu embonini yamakhemikhali yamazwe ngamazwe. Njengamanje, imboni yemithi yaseShayina idinga izinhlobo ezingaba ngu-2,000 zezinto ezingavuthiwe zamakhemikhali kanye neziphakathi minyaka yonke, nesidingo samathani angaphezu kwezigidi ezingu-2.5. Njengoba ukuthunyelwa kwamanye amazwe kwemithi ngokungafani nokuthunyelwa kwezidakamizwa kuzokuba ngaphansi kwemingcele ehlukahlukene emazweni angenisayo, kanye nokukhiqizwa komhlaba wonke kwabaxhumanisi bemithi emazweni asathuthuka, izidingo zamanje zokukhiqizwa kwemithi yaseShayina zezinto zokusetshenziswa zamakhemikhali neziphakathi zingahambisana ngokuyisisekelo. , ingxenye encane kuphela yesidingo sokungenisa. Futhi ngenxa yemithombo eminingi yaseShayina, amanani entengo yempahla eluhlaza aphansi, kukhona abaxhumanisi bemithi abaningi futhi bathole inani elikhulu lokuthunyelwa kwamanye amazwe.

Njengamanje, i-China idinga amakhemikhali asekela izinto zokusetshenziswa kanye nabaphakathi kwezinhlobo ezingaphezu kuka-2500, isidingo sonyaka sifinyelele amathani ayizigidi ezingu-11.35. Ngemva kweminyaka engaphezu kwengu-30 yentuthuko, izidingo zokukhiqizwa kwemithi yaseShayina yezinto zokusetshenziswa zamakhemikhali kanye nezimaphakathi sezikwazile ukuhambisana. Ukukhiqizwa kwama-intermediates e-China ikakhulukazi kuzidakamizwa ze-antibacterial kanye ne-antipyretic.

Kuyo yonke imboni, imboni yaseShayina ehlanganisa imithi inezici eziyisithupha: Okokuqala, iningi lamabhizinisi angamabhizinisi azimele, ukusebenza okuguquguqukayo, isikali sokutshala izimali asisikhulu, ngokuyisisekelo siphakathi kwezigidi kuya kwesigidi esisodwa noma ezimbili zamayuan; Okwesibili, ukusatshalaliswa ngokwendawo kwamabhizinisi kugxile kakhulu, ikakhulukazi eTaizhou, eSifundazweni saseZhejiang naseJintan, esiFundazweni saseJiangsu njengesikhungo; Okwesithathu, ngokunaka kwezwe okwandayo ekuvikelweni kwemvelo, ingcindezi emabhizinisini yokwakha izindawo zokwelapha imvelo iyanda Okwesine, isivinini sokuvuselela umkhiqizo siyashesha, futhi umkhawulo wenzuzo uzokwehla kakhulu ngemuva kweminyaka emi-3 kuye kweyi-5 emakethe, okuphoqa amabhizinisi. ukuthuthukisa imikhiqizo emisha noma ukuthuthukisa inqubo ngokuqhubekayo ukuze uthole inzuzo ephezulu; Okwesihlanu, njengoba inzuzo yokukhiqiza yemithi ephakathi kwemithi iphezulu kunemikhiqizo yamakhemikhali ejwayelekile, futhi inqubo yokukhiqiza iyafana, amabhizinisi amancane kakhulu amakhemikhali angenela umkhakha wokukhiqiza abaphakathi kwezemithi, okuholela ekuqhudelaneni okushubile embonini Okwesithupha. , uma kuqhathaniswa ne-API, i-margin yenzuzo yokukhiqiza i-intermediates iphansi, futhi inqubo yokukhiqiza ye-API kanye ne-intermediate yemithi iyafana, ngakho-ke amanye amabhizinisi awakhiqizi nje kuphela abaphakathi, kodwa futhi asebenzise izinzuzo zabo siqu ukuqala ukukhiqiza i-API. Ochwepheshe baveze ukuthi ukukhiqizwa kwama-intermediate emithi ekuqondiseni ukuthuthukiswa kwe-API kuwumkhuba ongenakugwemeka. Kodwa-ke, ngenxa yokusetshenziswa okukodwa kwe-API, yizinkampani zemithi zinomthelela omkhulu, amabhizinisi asekhaya avame ukuthuthukisa imikhiqizo kodwa abekho abasebenzisi balo mkhuba. Ngakho-ke, abakhiqizi kufanele basungule ubudlelwano besikhathi eside obuzinzile bokunikezela ngezinkampani ezenza imithi, ukuze kuqinisekiswe ukuthengiswa kwemikhiqizo okushelelayo.

3, izithiyo zokungena embonini
①Izithiyo zekhasimende
Imboni eyenza imithi iphethwe yizinkampani ezimbalwa zamazwe ngamazwe ezithaka imithi. I-oligarchs yezemithi iqaphe kakhulu ekukhetheni kwabo abahlinzeki besevisi yangaphandle futhi ngokuvamile banesikhathi eside sokuhlolwa kwabahlinzeki abasha. Izinkampani zemithi ye-CMO zidinga ukuhlangabezana namaphethini okuxhumana amakhasimende ahlukene, futhi zidinga ukuhlolwa isikhathi eside ngaphambi kokuba zithole ukwethenjwa amakhasimende angezansi, bese ziba abahlinzeki bazo abayinhloko.
②Izithiyo zobuchwepheshe
Ikhono lokuhlinzeka ngezinsizakalo ezingeziwe zobuchwepheshe obuphezulu yisisekelo senkampani yesevisi yokukhipha imithi. Izinkampani ze-CMO ezenza imithi zidinga ukunqamula izithiyo noma izithiyo emigwaqweni yazo yasekuqaleni futhi zinikeze imizila yokuthuthukisa inqubo yemithi ukuze kwehliswe ngempumelelo izindleko zokukhiqiza izidakamizwa. Ngaphandle kokutshalwa kwezimali kwesikhathi eside, okumba eqolo ocwaningweni nasekuthuthukisweni nasekugcinweni kobuchwepheshe, kunzima ezinkampanini ezingaphandle kwemboni ukuthi zingene ngempela embonini.
③Izithiyo zamathalente
Kunzima ngezinkampani ze-CMO ukwakha i-R&D eqhudelanayo nethimba lokukhiqiza ngesikhathi esifushane ukusungula imodeli yebhizinisi ethobela i-cGMP.
④Izithiyo zokulawula ikhwalithi
I-FDA kanye nezinye izikhungo ezilawula izidakamizwa seziqine kakhulu ezidingweni zazo zokulawula ikhwalithi, futhi imikhiqizo engaphumeleli ekuhlolweni kwezimali ayikwazi ukungena ezimakethe zamazwe angenisayo.
⑤ Izithiyo zokulawula imvelo
Izinkampani ezenza imithi ezinezinqubo ezidlulelwe yisikhathi zizothwala izindleko eziphezulu zokulawula ukungcola kanye nengcindezi yokulawula, futhi izinkampani zendabuko ezithaka imithi ezikhiqiza ikakhulukazi ukungcola okuphezulu, ukusetshenziswa kwamandla okuphakeme kanye nemikhiqizo enenani eliphansi (isb. i-penicillin, amavithamini, njll.) zizobhekana nokuqedwa ngokushesha. Ukubambelela ekucubunguleni izinto ezintsha kanye nokuthuthukisa ubuchwepheshe bemithi obuluhlaza sekuphenduke inkomba yentuthuko yesikhathi esizayo yemboni yezemithi ye-CMO.

4. Amabhizinisi afakwe ohlwini lwezemithi aphakathi
Kusukela esikhundleni sochungechunge lwezimboni, izinkampani ezisohlwini eziyisi-6 zamakhemikhali amahle akhiqiza abaphakathi kwezemithi zonke zisekupheleni kochungechunge lwemboni. Kungakhathaliseki ukuthi kumhlinzeki wesevisi yokukhipha umsebenzi ochwepheshe noma ku-API nesandiso sokwakhiwa, amandla obuchwepheshe angamandla okushayela avamile.
Ngokwamandla ezobuchwepheshe, izinkampani ezinobuchwepheshe ezingeni elihamba phambili lamazwe ngamazwe, amandla okugcina aqinile kanye nokutshalwa kwezimali okuphezulu ku-R&D kuyathandwa.
Iqembu I: I-Lianhua Technology ne-Arbonne Chemical. I-Lianhua Technology inobuchwepheshe obuyisishiyagalombili obuyisisekelo obufana ne-ammonia oxidation kanye ne-fluorination njengomgogodla wayo wezobuchwepheshe, lapho i-hydrogen oxidation isezingeni elihamba phambili lamazwe ngamazwe. I-Abenomics ingumholi wamazwe omhlaba ezidakamizweni ze-chiral, ikakhulukazi kubuchwepheshe bayo bokuhlukanisa amakhemikhali kanye nobuhlanga, futhi inotshalomali oluphakeme kakhulu lwe-R&D, olubalelwa ku-6.4% wemali engenayo.
Iqembu II: I-Wanchang Technology ne-Yongtai Technology. Indlela ye-Wanchang Technology ye-waste gas hydrocyanic acid iyinqubo ebiza kancane nethuthuke kakhulu yokukhiqizwa kwe-prototrizoic acid esters. Ngakolunye uhlangothi, iYongtai Technology, yaziwa ngamakhemikhali ayo amahle e-fluorine.
Iqembu III: I-Tianma Fine Chemical ne-Bikang (phambilini eyayaziwa ngokuthi i-Jiuzhang).
Ukuqhathaniswa kwamandla ezobuchwepheshe ezinkampani ezisohlwini
Isithombe
Ukuqhathaniswa kwamakhasimende namamodeli wokumaketha wezinkampani ezisohlwini zemithi ephakathi
Isithombe
Ukuqhathaniswa kokufunwa phansi komfula kanye nomjikelezo wempilo yelungelo lobunikazi lemikhiqizo yezinkampani ezisohlwini
Izithombe
Ukuhlaziywa kokuncintisana komkhiqizo kwezinkampani ezisohlwini
Izithombe
Indlela eya ekuthuthukisweni kwama-intermediate amakhemikhali amahle
Izithombe
(Izithombe nezinto zokwakha ezivela ku-Qilu Securities)
Amathemba okuthuthukisa embonini yaseShayina ephakathi kwemithi
Njengemboni ebalulekile emkhakheni wemboni yamakhemikhali emihle, ukukhiqizwa kwemithi sekugxile ekuthuthukisweni nasekuqhudelwaneni eminyakeni eyi-10 edlule, ngokuqhubeka kwesayensi nobuchwepheshe, imithi eminingi iye yathuthukiswa ngokuqhubekayo ukuze kuzuze isintu, ukuhlanganisa. yale mithi incike ekukhiqizweni kwemithi emisha, esezingeni eliphezulu ephakathi kwemithi, ngakho-ke imithi emisha ivikelwe ngamalungelo obunikazi, kuyilapho abaphakathi nayo bengenazo izinkinga, ngakho-ke abaphakathi kwemithi emisha ekhaya naphesheya Indawo yokuthuthukiswa kwemakethe nethuba lokufaka isicelo. zithembisa kakhulu.
Izithombe

Njengamanje, isiqondiso socwaningo sama-intermediates ezidakamizwa sibonakala ikakhulukazi ekuhlanganiseni kwe-heterocyclic compounds, i-fluorine-containing compounds, i-chiral compounds, i-biological compounds, njll. eChina. Eminye imikhiqizo enezidingo eziphezulu zezinga lobuchwepheshe ayikwazi ukuhlelwa ukuthi ikhiqizwe eShayina futhi ngokuyisisekelo ithembele ekungenweni kwamanye amazwe, njenge-anhydrous piperazine, i-propionic acid, njll. Nakuba eminye imikhiqizo ingahlangabezana nezidingo zemboni yezokwelapha yasekhaya ngokwenani, kodwa ephakeme izindleko nekhwalithi azikho ezingeni elifanele, okuthinta ukuncintisana kwemikhiqizo yezemithi kanye nesidingo sokuthuthukisa inqubo yokukhiqiza, efana ne-TMB, p-aminophenol, D-PHPG, njll.
Kulindeleke ukuthi eminyakeni embalwa ezayo, ucwaningo olusha lwezidakamizwa emhlabeni lugxile kulezi zigaba ezingu-10 zezidakamizwa: izidakamizwa zokuthuthukisa ukusebenza kobuchopho, izidakamizwa ezilwa nesifo samathambo, imishanguzo ye-AIDS, i-hepatitis nezinye izidakamizwa ezibangelwa amagciwane, i-lipid. -izidakamizwa ezinciphisa, izidakamizwa ezilwa ne-thrombotic, izidakamizwa ze-anti-tumor, ama-platelet-activating factor antagonists, izikhuthazi zenhliziyo ze-glycoside, ama-antidepressants, ama-anti-psychotic kanye nama-anti-anxiety drugs, njll. ukuthuthukiswa kwabaphakathi kwemithi kanye nendlela ebalulekile yokwandisa indawo yemakethe entsha.