Pharmaceutical Intermediates Industry Overview

Mankhwala apakatikati
Zomwe zimatchedwa pharmaceutical intermediates kwenikweni zimakhala zopangira mankhwala kapena mankhwala omwe amayenera kugwiritsidwa ntchito popanga mankhwala. Mankhwalawa amatha kupangidwa m'mafakitale wamba osapeza chilolezo chopanga mankhwala, ndipo atha kugwiritsidwa ntchito popanga ndi kupanga mankhwala malinga ngati zizindikiro zaukadaulo zikwaniritsa zofunikira zina. Ngakhale kaphatikizidwe ka mankhwala kumagweranso m'gulu lamankhwala, zofunikira zake zimakhala zolimba kwambiri kuposa zamankhwala wamba. Opanga mankhwala omalizidwa ndi ma API ayenera kuvomereza chiphaso cha GMP, pomwe opanga ma intermediates satero, chifukwa chapakati akadali kaphatikizidwe ndi kupanga zinthu zopangira mankhwala, zomwe ndizofunika kwambiri komanso zotsika kwambiri pagulu lopanga mankhwala, ndipo sizingakhalepo. amatchedwa mankhwala komabe, kotero iwo safuna GMP certification, amenenso amachepetsa lolowera polowera opanga intermediates.

Makampani apakatikati a Pharmaceutical
Makampani opanga mankhwala omwe amapanga ndi kukonza ma organic/inorganic intermediates kapena ma API amakampani opanga mankhwala kuti apange mankhwala omalizidwa ndi mankhwala kapena biological synthesis molingana ndi miyezo yoyenera. Apa mankhwala apakatikati agawidwa m'mafakitale awiri a CMO ndi CRO.

Mtengo CMO
Contract Manufacturing Organisation imatanthawuza bungwe lopanga makontrakiti, zomwe zikutanthauza kuti kampani yopanga mankhwala imatulutsa njira zopangira kwa mnzake. Bizinesi yamabizinesi amakampani a CMO nthawi zambiri imayamba ndi zida zapadera zamankhwala. Makampani omwe ali mgululi amayenera kutulutsa zida zoyambira zamankhwala ndikuzipanga kukhala zida zapadera zamankhwala, zomwe zimasinthidwa kukhala zida zoyambira za API, ma cGMP intermediates, APIs ndi ma formulations. Pakalipano, makampani akuluakulu ogulitsa mankhwala amitundu yosiyanasiyana amakonda kukhazikitsa mgwirizano wanthawi yayitali ndi ochepa omwe amapereka chithandizo chachikulu, ndipo kupulumuka kwa makampani mumakampaniwa kumawonekera kwambiri kudzera mwa anzawo.

CRO
Contract (Clinical) Research Organisation imanena za bungwe lofufuza za makontrakitala, pomwe makampani opanga mankhwala amatulutsa gawo lofufuzira kwa anzawo. Pakalipano, makampaniwa amachokera pakupanga makonda, machitidwe a R&D komanso kafukufuku wamapangano azamankhwala ndi malonda. Mosasamala kanthu za njira, kaya mankhwala apakatikati a mankhwala ndi mankhwala opangidwa mwatsopano kapena ayi, mpikisano waukulu wa kampaniyo umayesedwabe ndi teknoloji ya R & D monga chinthu choyamba, chomwe chikuwonetsedwa mu makasitomala akumunsi a kampani kapena ogwirizana nawo.

Pharmaceutical product value chain
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(Chithunzi kuchokera ku Qilu Securities)

Makampani opanga mankhwala apakati pamakampani
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(Chithunzi chochokera ku China Industry Information Network)

Pharmaceutical intermediates gulu
Mankhwala apakatikati atha kugawidwa m'magulu akulu malinga ndi magawo ogwiritsira ntchito, monga ma intermediates a maantibayotiki, ophatikizira antipyretic ndi analgesic mankhwala, apakati pamankhwala amtima ndi mitsempha yamagazi ndi othandizira odana ndi khansa. Pali mitundu yambiri ya intermediates yeniyeni mankhwala, monga imidazole, furan, phenolic intermediates, onunkhira intermediates, pyrrole, pyridine, biochemical reagents, sulfure munali, nayitrogeni, mankhwala halogen, heterocyclic mankhwala, wowuma, mannitol, lactocrystalline cellulose. , dextrin, ethylene glycol, ufa wa shuga, mchere wa inorganic, ethanol intermediates, stearate, amino acid, ethanolamine, mchere wa potaziyamu, mchere wa sodium ndi zina zapakati, etc.
Mwachidule za chitukuko cha makampani intermediates mankhwala ku China
Malinga ndi IMS Health Incorporated, kuyambira 2010 mpaka 2013, msika wamankhwala padziko lonse lapansi udapitilirabe kukula, kuchokera ku US $ 793.6 biliyoni mu 2010 mpaka US $ 899.3 biliyoni mu 2013, msika wamankhwala ukuwonetsa kukula mwachangu kuyambira 2014, makamaka chifukwa cha msika waku US. . Ndi CAGR ya 6.14% kuyambira 2010-2015, msika wapadziko lonse wamankhwala ukuyembekezeka kulowa pang'onopang'ono kuyambira 2015-2019. Komabe, popeza mankhwala akufunika kwambiri, kukula kokwanira kukuyembekezeka kukhala kolimba kwambiri mtsogolomo, msika wapadziko lonse wamankhwala ukuyandikira US $ 1.22 thililiyoni pofika 2019.
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Pakalipano, ndi kukonzanso mafakitale kwa makampani akuluakulu opanga mankhwala amitundu yosiyanasiyana, kusamutsidwa kwa kupanga mayiko osiyanasiyana komanso kukonzanso kugawanika kwa ntchito zapadziko lonse lapansi, China yakhala yofunika kwambiri yapakatikati yopanga gawo lapadziko lonse la ogwira ntchito m'makampani opanga mankhwala. Makampani opanga mankhwala ku China apanga dongosolo lathunthu kuyambira kafukufuku ndi chitukuko mpaka kupanga ndi kugulitsa. Kuyambira chitukuko cha intermediates mankhwala mu dziko, China lonse ndondomeko luso mlingo akadali otsika, ambiri apamwamba intermediates mankhwala ndi setifiketi mankhwala atsopano kuthandiza intermediates kupanga mabizinesi ndi ang'onoang'ono, ali mu siteji ya chitukuko cha mankhwala dongosolo kukhathamiritsa ndi kukweza. .
Linanena bungwe la mankhwala intermediates makampani mankhwala ku China kuyambira 2011 mpaka 2015
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(Chithunzi chochokera ku China Business Industry Research Institute)
Mu 2011-2015, China mankhwala mankhwala intermediates makampani linanena bungwe linakula chaka ndi chaka, mu 2013, China mankhwala intermediates linanena bungwe mankhwala anali 568,300 matani, zimagulitsidwa matani 65,700, ndi 2015 China mankhwala mankhwala intermediates to76 linanena bungwe anali pafupifupi 40.
2011-2015 China mankhwala mankhwala intermediates makampani kupanga ziwerengero
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(Chithunzi chochokera ku China Merchant Industry Research Institute)
Kupereka kwapakati pazamankhwala ku China ndikodziwika kwambiri kuposa kufunikira, ndipo kudalira kugulitsa kunja kukuchulukirachulukira. Komabe, zogulitsa kunja kwa China zimakhazikika kwambiri pazinthu zambiri monga vitamini C, penicillin, acetaminophen, citric acid ndi mchere wake ndi esters, ndi zina zotere. Zogulitsazi zimadziwika ndi kutulutsa kwakukulu kwazinthu, mabizinesi opanga zambiri, mpikisano wowopsa wamsika, mtengo wotsika wazinthu komanso kuonjezera mtengo, komanso kupanga kwawo kwakukulu kwapangitsa kuti pakhale kufunikira kochulukirapo pamsika wapakatikati wamankhwala apanyumba. Zogulitsa zomwe zili ndiukadaulo wapamwamba zimadalirabe kuitanitsa.
Kuteteza amino acid intermediates mankhwala, ambiri mabizinesi zoweta kupanga ndi mtundu umodzi mankhwala osiyanasiyana ndi kusakhazikika khalidwe, makamaka makampani akunja biopharmaceutical makonda kupanga mankhwala. Mabizinesi ena okha omwe ali ndi kafukufuku wamphamvu komanso mphamvu zachitukuko, malo opangira zotsogola komanso odziwa zambiri pakupanga kwakukulu atha kupeza phindu lalikulu pampikisano.
Kusanthula kwamakampani aku China opanga mankhwala

1, njira zopangira mankhwala zapakati pamakampani
Choyamba, kutenga nawo mbali pa kafukufuku wamakasitomala ndi chitukuko cha mankhwala atsopano, zomwe zimafuna R & D pakati pa kampaniyo ili ndi luso lamakono.
Kachiwiri, kwa kasitomala woyendetsa malonda amplification, kukumana ndondomeko njira kupanga lalikulu, zomwe zimafuna kampani luso matalikidwe a mankhwala ndi luso la mosalekeza ndondomeko kusintha kwa makonda mankhwala luso pa nthawi ina, kuti kukwaniritsa zosowa za kupanga zinthu, kuchepetsa mtengo wopangira ndikupititsa patsogolo kupikisana kwazinthu.
Chachitatu, ndikukumba ndikuwongolera momwe zinthu zimayendera popanga makasitomala ambiri, kuti akwaniritse miyezo yamakampani akunja.

2. Makhalidwe a makampani opanga mankhwala aku China
Kupanga mankhwala kumafuna mankhwala ambiri apadera, omwe ambiri adapangidwa ndi makampani opanga mankhwala okha, koma ndikukula kwa magawano a anthu ogwira ntchito komanso kupita patsogolo kwa ukadaulo wopanga, makampani opanga mankhwala adasamutsira ena ophatikizira mankhwala kumakampani opanga mankhwala. za kupanga. Mankhwala apakati ndi mankhwala abwino, ndipo kupanga mankhwala opangira mankhwala kwakhala makampani akuluakulu pamakampani apadziko lonse lapansi. Pakali pano, makampani opanga mankhwala ku China amafunikira mitundu pafupifupi 2,000 ya zinthu zopangira mankhwala ndi zapakati chaka chilichonse, zomwe zimafunikira matani opitilira 2.5 miliyoni. Monga kutumiza kunja kwa mankhwala intermediates mosiyana ndi katundu mankhwala adzakhala pansi pa zoletsa zosiyanasiyana m'mayiko kunja, komanso dziko kupanga intermediates mankhwala ku mayiko osauka, panopa Chinese mankhwala zofunika kupanga mankhwala zopangira mankhwala ndi intermediates akhoza kwenikweni kufanana. , gawo laling'ono chabe lofunika kuitanitsa. Ndipo chifukwa cha chuma chochuluka cha China, mitengo ya zinthu zopangira ndi yotsika, pali ambiri ophatikizira mankhwala omwe adakwanitsanso kuchuluka kwa zogulitsa kunja.

Pakalipano, China ikufunika mankhwala othandizira zipangizo ndi intermediates a mitundu yoposa 2500, kufunika pachaka anafika matani 11.35 miliyoni. Pambuyo pazaka zopitilira 30 zachitukuko, zopangira zamankhwala zaku China zopangira mankhwala ndi zopangira zapakatikati zatha kufanana. Kupanga kwapakati ku China kumakhala makamaka mu antibacterial ndi antipyretic mankhwala.

Mu makampani, China mankhwala intermediates makampani ali makhalidwe sikisi: Choyamba, ambiri mabizinezi ndi mabizinezi payekha, kusintha ntchito, sikelo ndalama si lalikulu, makamaka pakati pa mamiliyoni mmodzi kapena ziwiri miliyoni Yuan; Chachiwiri, kugawa malo mabizinezi ndi moikirapo, makamaka Taizhou, Zhejiang Province ndi Jintan, Jiangsu Province monga likulu; Chachitatu, ndi chidwi chowonjezeka cha dzikoli pa chitetezo cha chilengedwe, kukakamizidwa kwa mabizinesi kuti amange malo otetezera zachilengedwe akuwonjezeka Chachinayi, liwiro la kukonzanso katundu liri mofulumira, ndipo phindu lidzatsika kwambiri pambuyo pa zaka 3 mpaka 5 pamsika, kukakamiza mabizinesi. kupanga zatsopano kapena kukonza njira mosalekeza kuti mupeze phindu lalikulu; Chachisanu, popeza kupanga phindu la intermediates mankhwala ndi apamwamba kuposa mankhwala ambiri mankhwala, ndi kupanga ndondomeko kwenikweni chimodzimodzi, mabizinesi ang'onoang'ono mankhwala amalowa m'gulu la kupanga intermediates mankhwala, chifukwa kuchulukirachulukira okhwima mpikisano makampani. , poyerekeza ndi API, malire a phindu la kupanga apakati ndi otsika, ndipo njira yopangira API ndi mankhwala opangira mankhwala ndi ofanana, choncho mabizinesi ena samangotulutsa zapakati, komanso amagwiritsa ntchito ubwino wawo kuti ayambe kupanga API. Akatswiri adanenanso kuti kupanga mankhwala opangira mankhwala kuti apite patsogolo pa chitukuko cha API ndizochitika zosapeŵeka. Komabe, chifukwa cha kugwiritsidwa ntchito kamodzi kwa API, ndi makampani opanga mankhwala amakhudza kwambiri, mabizinesi apakhomo nthawi zambiri amapanga zinthu koma osagwiritsa ntchito zochitikazo. Chifukwa chake, opanga ayenera kukhazikitsa ubale wokhazikika wanthawi yayitali ndi makampani opanga mankhwala, kuti awonetsetse kuti malonda akugulitsidwa bwino.

3, zolepheretsa kulowa m'makampani
①Zolepheretsa kasitomala
Makampani opanga mankhwala amayendetsedwa ndi makampani angapo opanga mankhwala amitundumitundu. Oligarchs azamankhwala amakhala osamala kwambiri pakusankha kwawo opereka chithandizo kunja ndipo nthawi zambiri amakhala ndi nthawi yayitali yowunika kwa ogulitsa atsopano. Makampani opanga mankhwala a CMO ayenera kukumana ndi njira zoyankhulirana za makasitomala osiyanasiyana, ndipo amayenera kuwunika nthawi yayitali asanalandire chikhulupiliro cha makasitomala akumunsi, kenako kukhala ogulitsa awo enieni.
②Zolepheretsa zaukadaulo
Kuthekera kopereka chithandizo chaukadaulo wapamwamba kwambiri ndiye maziko a kampani yopereka chithandizo chamankhwala. Makampani opanga mankhwala a CMO akuyenera kudutsa zopinga zaukadaulo kapena zotchinga m'njira zawo zoyambirira ndikupereka njira zopangira mankhwala kuti achepetse mtengo wopangira mankhwala. Popanda ndalama zanthawi yayitali, zotsika mtengo pakufufuza ndi chitukuko ndi nkhokwe zaukadaulo, ndizovuta kuti makampani omwe ali kunja kwamakampaniwo alowedi mumakampani.
③Zolepheretsa talente
Ndizovuta kwa makampani a CMO kupanga mpikisano wa R&D ndi gulu lopanga munthawi yochepa kuti akhazikitse mtundu wabizinesi wogwirizana ndi cGMP.
④Zoletsa zamakhalidwe abwino
A FDA ndi mabungwe ena owongolera mankhwala ayamba kukhala okhwimitsa zinthu pazofunikira zawo zowongolera zabwino, ndipo zinthu zomwe sizingapambane pakuwunika sizingalowe m'misika yamayiko omwe akutumiza kunja.
⑤ Zolepheretsa kuwongolera chilengedwe
Makampani opanga mankhwala omwe ali ndi njira zakale adzakhala ndi ndalama zambiri zowononga kuwononga chilengedwe komanso kukakamizidwa kwa malamulo, ndipo makampani opanga mankhwala omwe amawononga kwambiri, kugwiritsa ntchito mphamvu zambiri komanso mankhwala otsika mtengo (mwachitsanzo penicillin, mavitamini, ndi zina zotero) adzayang'anizana ndi kuchotsedwa kwachangu. Kutsatira njira zatsopano komanso kupanga ukadaulo wobiriwira wamankhwala kwakhala njira yamtsogolo yamakampani opanga mankhwala a CMO.

4. Zapakhomo mankhwala intermediates kutchulidwa mabizinesi
Kuchokera pagulu lamakampani, makampani 6 omwe adatchulidwa amankhwala abwino omwe amapanga mankhwala apakatikati onse ali kumapeto kwenikweni kwamakampani. Kaya ndi akatswiri opereka ntchito zakunja kapena ku API ndi kukulitsa mawonekedwe, mphamvu zaukadaulo ndiye zomwe zimayendetsa nthawi zonse.
Pankhani ya mphamvu yaukadaulo, makampani omwe ali ndiukadaulo pamlingo wotsogola wapadziko lonse lapansi, mphamvu zosungirako zolimba komanso ndalama zambiri mu R&D amakondedwa.
Gulu I: Lianhua Technology ndi Arbonne Chemical. Lianhua Technology ili ndi matekinoloje asanu ndi atatu oyambira monga ammonia oxidation ndi fluorination monga maziko ake aukadaulo, pomwe hydrogen oxidation ili pamlingo wotsogola padziko lonse lapansi. Abenomics ndi mtsogoleri wapadziko lonse wa mankhwala a chiral, makamaka mu teknoloji yake yogawanitsa mankhwala ndi racemization, ndipo ali ndi ndalama zambiri za R&D, zomwe zimapanga 6.4% ya ndalama.
Gulu II: Wanchang Technology ndi Yongtai Technology. Wanchang Technology wa zinyalala gasi hydrocyanic asidi njira ndi mtengo wotsika kwambiri ndi njira zapamwamba kwambiri kupanga prototrizoic asidi esters. Yongtai Technology, kumbali ina, imadziwika ndi mankhwala ake abwino a fluorine.
Gulu lachitatu: Tianma Fine Chemical ndi Bikang (omwe kale ankadziwika kuti Jiuzhang).
Kuyerekeza luso luso la makampani otchulidwa
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Kuyerekeza kwamakasitomala ndi mitundu yotsatsa yamakampani omwe adatchulidwa apakatikati
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Kufananiza kufunikira kwa kutsika ndi moyo wapatent wazinthu zomwe zalembedwa zamakampani
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Kuwunika kwa mpikisano wazinthu zamakampani omwe adatchulidwa
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Njira yopititsira patsogolo ma Chemical intermediates
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(Zithunzi ndi zida zochokera ku Qilu Securities)
Chiyembekezo cha chitukuko cha makampani opanga mankhwala ku China
Monga makampani ofunikira pamakampani opanga mankhwala abwino, kupanga mankhwala kwakhala cholinga cha chitukuko ndi mpikisano m'zaka zapitazi za 10, ndikupita patsogolo kwa sayansi ndi ukadaulo, mankhwala ambiri apangidwa mosalekeza kuti apindule ndi anthu, kaphatikizidwe kake. mwa mankhwalawa amadalira kupanga kwapakatikati kwamankhwala atsopano, apamwamba kwambiri, kotero kuti mankhwala atsopanowa amatetezedwa ndi ma patent, pomwe apakati nawo alibe mavuto, kotero ophatikizira atsopano azachipatala kunyumba ndi kunja amalonjeza kwambiri.
Zithunzi

Pakali pano, kufufuza malangizo a intermediates mankhwala makamaka zimaonekera mu kaphatikizidwe heterocyclic mankhwala, fluorine munali mankhwala, chiral mankhwala, zamoyo mankhwala, etc. Pali kusiyana pakati pa chitukuko cha intermediates mankhwala ndi zofunika makampani mankhwala. ku China. Zinthu zina zomwe zili ndi zofunikira zapamwamba zaukadaulo sizingakonzedwe kuti zipangidwe ku China ndipo zimadalira kuitanitsa, monga anhydrous piperazine, propionic acid, etc. mtengo ndi khalidwe sizili muyeso, zomwe zimakhudza mpikisano wa mankhwala a mankhwala ndipo zimafunika kukonza njira zopangira, monga TMB, p-aminophenol, D-PHPG, etc.
Zikuyembekezeka kuti m'zaka zingapo zikubwerazi, kafukufuku watsopano wamankhwala padziko lonse lapansi aziyang'ana m'magulu 10 otsatirawa a mankhwala: mankhwala opititsa patsogolo ntchito yaubongo, odana ndi nyamakazi ya nyamakazi, anti-AIDS, anti-hepatitis ndi mankhwala ena a virus, lipids. -kutsitsa mankhwala, odana ndi thrombotic mankhwala, odana ndi chotupa mankhwala, kupatsidwa zinthu za m`mwazi activating factor antagonists, glycoside mtima stimulants, antidepressants, odana ndi psychotic ndi odana ndi nkhawa mankhwala, etc. chitukuko cha intermediates mankhwala ndi njira yofunika kukulitsa malo atsopano msika.