Ishishini leekhemikhali ezintle licandelo lezoqoqosho lokuvelisa iikhemikhali ezintle kwishishini leekhemikhali, elahlukileyo kwiimveliso zeekhemikhali eziqhelekileyo okanye iikhemikhali ezinkulu. Ishishini leekhemikhali ezintle lilinye leempawu ezibalulekileyo zenqanaba letekhnoloji ebanzi yelizwe. Iimpawu zalo ezisisiseko kukuvelisa iikhemikhali ezintle ezikumgangatho ophezulu, ezahlukeneyo, ezikhethekileyo okanye ezininzi ezisebenzayo kuqoqosho lwehlabathi kunye nobomi babantu ngetekhnoloji ephezulu nentsha. Ishishini leekhemikhali ezintle linobuninzi betekhnoloji ephezulu kunye nexabiso elongezelelekileyo eliphezulu. Ukusukela ngeminyaka yoo-1970, amanye amazwe aphuhlileyo kwimizi-mveliso atshintshe ngokulandelelana ingqwalasela yesicwangciso sophuhliso lweshishini leekhemikhali ukuya kwishishini leekhemikhali ezintle, kwaye ukukhawulezisa uphuhliso lweshishini leekhemikhali ezintle kube yinto eqhelekileyo kwihlabathi liphela. Iikhemikhali ezintle ziquka izibulali-zinambuzane, amayeza, iidayi (iimibala), njl. Iikhemikhali ezikhethekileyo ziquka izongezo zokutya, izongezo zokutya, izincamathelisi, ii-surfactants, iikhemikhali zonyango lwamanzi, iikhemikhali zesikhumba, iikhemikhali ze-oyile, iikhemikhali ze-elektroniki, iikhemikhali zokwenza iphepha kunye nezinye iindawo ezingaphezu kwama-50.

Ii-Pharmaceutical intermediates zibhekisa kwiikhemikhali eziphakathi ezenziwe kwinkqubo yokwenziwa kwamayeza eekhemikhali kwaye zezemveliso zeekhemikhali ezintle. Ii-Pharmaceutical intermediates zinokwahlulwa zibe zii-antibiotic intermediates, ii-antipyretic kunye ne-analgesic intermediates, ii-cardiovascular intermediates, kunye nee-anticancer intermediates ngokweemfuno zazo. Ishishini eliphambili le-pharmaceutical intermediates lishishini elisisiseko lezinto ezikrwada zekhemikhali, ngelixa ishishini elisezantsi lishishini le-API yekhemikhali kunye nokulungiselela. Njengempahla enkulu, ixabiso lezinto ezikrwada zekhemikhali ezisisiseko liyatshintshatshintsha kakhulu, nto leyo echaphazela ngokuthe ngqo iindleko zemveliso yamashishini. Ii-Pharmaceutical intermediates kwaye zahlulwe zaba zii-primary intermediates kunye nee-advanced intermediates, i-primary intermediates ngenxa yobunzima betekhnoloji yemveliso ayiphezulu, amaxabiso aphantsi, kwaye ixabiso elongeziweyo kwimeko yokunikezelwa kakhulu, ii-advanced intermediates ziimveliso eziphambili ze-intermediate reaction, xa kuthelekiswa ne-primary intermediate, isakhiwo esiyinkimbinkimbi, inyathelo elinye okanye ambalwa lokulungiselela iimveliso eziphezulu ezongezwe ngexabiso eliphezulu, inqanaba layo le-gross margin liphezulu kune-gross margin yeshishini eliphakathi. Njengoko ababoneleli be-primary intermediate banokubonelela ngemveliso elula ye-intermediate, bakwisiphelo sangaphambili se-industrial chain enoxinzelelo olukhulu lokhuphiswano kunye noxinzelelo lwamaxabiso, kwaye ixabiso Ukuguquguquka kwezinto ezisisiseko zekhemikhali kunempembelelo enkulu kubo. Kwelinye icala, ababoneleli abaphakathi abaphezulu abanamandla amakhulu okuxoxisana kuphela ngababoneleli abaphantsi, kodwa okubaluleke ngakumbi, bathwala imveliso yabaphakathi abaphambili abanomxholo ophezulu wobugcisa kwaye bagcina ubudlelwane obusondeleyo neenkampani zamazwe ngamazwe, ngoko ke ukuguquguquka kwamaxabiso ezinto eziluhlaza kunempembelelo encinci kubo. Abaphakathi abangengabo i-gmp kunye nabaphakathi be-GMP banokwahlulwa ngokwenqanaba lempembelelo kumgangatho wokugqibela we-API. Abaphakathi abangengabo i-gmp babhekisa kwi-pharmaceutical intermediate ngaphambi kwezinto zokuqala ze-API; abaphakathi be-GMP babhekisa kwi-pharmaceutical intermediate eyenziwe phantsi kweemfuno ze-GMP, oko kukuthi, into eveliswa emva kwezinto zokuqala ze-API, ngexesha lamanyathelo okwenziwa kwe-API, kwaye edlula kutshintsho olongezelelweyo lwe-molecular okanye ukuphuculwa ngaphambi kokuba ibe yi-API.

Incopho yesibini ye-patent cliff iya kuqhubeka nokukhuthaza imfuno ye-upstream intermediates
Ishishini eliphakathi lamayeza liyatshintshatshintsha phantsi kwempembelelo yemfuno iyonke yeshishini lamayeza elisezantsi, kwaye ukuphindaphinda kwalo ngokusisiseko kuhambelana noko kweshishini lamayeza. Ezi mpembelelo zinokwahlulwa zibe zizinto zangaphandle kunye nezinto zangaphakathi: izinto zangaphandle zibhekisa ikakhulu kumjikelo wokuvunywa kwamayeza amatsha kwimarike; Izinto zangaphakathi zibhekisa ikakhulu kumjikelo wokukhuselwa kwelungelo lomenzi lamayeza amatsha. Isantya sokuvunywa kwamayeza amatsha ziiarhente ezilawula amayeza ezifana ne-FDA sikwanefuthe elithile kwishishini. Xa ixesha lokuvunywa kwamayeza amatsha kunye nenani lamayeza amatsha avunyiweyo lilungele iinkampani zamayeza, imfuno yeenkonzo zokuthumela amayeza ngaphandle iya kuveliswa. Ngokusekelwe kwinani lamayeza amatsha eekhemikhali kunye namayeza amatsha ebhayoloji avunyiweyo yi-FDA kwiminyaka elishumi edlulileyo, inani elikhulu lokuvunywa kwamayeza amatsha liya kuqhubeka nokuvelisa imfuno yamayeza amatsha asezantsi, ngaloo ndlela ixhasa imboni ukuba igcine ukukhula okuphezulu. Nje ukuba ukhuseleko lwelungelo lomenzi lamayeza amatsha luphele, amayeza aqhelekileyo aya kuphucuka kakhulu, kwaye abavelisi abaphakathi baya kuqhubeka nokonwabela ukukhula okukhulu kwemfuno kwixesha elifutshane. Ngokwezibalo ze-Evaluate, kuqikelelwa ukuba ukususela ngo-2017 ukuya ku-2022, kuya kubakho i-yuan eyi-194 yeebhiliyoni zeerandi kwimarike yamachiza ejongene nemeko yokuphelelwa kwelungelo lomenzi, elilincopho lesibini lelungelo lomenzi ukusukela ngo-2012.

Iingxelo kwiminyaka yakutshanje, njengoko ulwando kunye nolwakhiwo lwamayeza lunzima, izinga lempumelelo yophando lwamayeza amatsha kunye nophuhliso liyancipha, ukunyuka okukhawulezileyo kweendleko zophando lwamayeza amatsha kunye nophuhliso lweMcKinsey kwiNat. Rev. DrugDiscov. “Kukhankanyiwe, ngo-2006-2011, izinga lempumelelo yophando lwamayeza amatsha kunye nophuhliso liyi-7.5% kuphela, ukusuka ngo-2012 ukuya ku-2014, ngenxa yokuba ii-macromolecules zebhayoloji zikhetha kakuhle kwaye zinobuthi obuphantsi bokuphoswa komgama (amayeza akwinqanaba lokugqibela lophuhliso, oko kukuthi, ukusuka kwisigaba seklinikhi sesi-3 ukuya kuluhlu oluvunyiweyo lunezinga lempumelelo le-74%), uphando lwamayeza kunye nophuhliso izinga lempumelelo iyonke lonyuka kancinci, kodwa kusenzima ukubuyela kwinqanaba lempumelelo le-16.40% kwimizuzwana engama-90. Ixabiso lokufaka ngempumelelo ichiza elitsha linyuke ukusuka kwi-$1.188 yezigidigidi ngo-2010 ukuya kwi-$2.18 yezigidigidi ngo-2018, phantse liphindwe kabini. Okwangoku, izinga lokubuyela kwamayeza amatsha liyaqhubeka nokuhla. Ngo-2018, ii-TOP12 ezinkulu zemithi zehlabathi zenze izinga lokubuyela le-1.9% kuphela kutyalo-mali kuphando nophuhliso.

Ukunyuka kweendleko ze-r&d kunye nokwehla kwembuyekezo kutyalo-mali lwe-r&d kuzise uxinzelelo olukhulu kwiinkampani zamayeza, ngoko ke ziya kukhetha ukuthumela inkqubo yemveliso kumashishini e-CMO kwixesha elizayo ukuze kuncitshiswe iindleko. Ngokutsho kweChemicalWeekly, inkqubo yemveliso ithatha malunga ne-30% yeendleko zizonke zamayeza okuqala. Imodeli ye-CMO/CDMO inokunceda iinkampani zamayeza ukunciphisa iindleko zizonke zokufaka izinto ezisisigxina, ukusebenza kakuhle kwemveliso, abasebenzi, isiqinisekiso, uphicotho-zincwadi kunye nezinye izinto nge-12-15%. Ukongeza, UKWAMKELWA kwemo ye-CMO/CDMO kunokunceda iinkampani zamayeza ukuphucula isivuno sempendulo, ukunciphisa umjikelo wesitokhwe kunye nokwandisa ukhuseleko, olunokonga ixesha lokwenza ngokwezifiso imveliso, ukunciphisa umjikelo we-r&d wamayeza amatsha, ukukhawulezisa isantya sokuthengisa iziyobisi, kunye nokwenza iinkampani zamayeza zikwazi ukonwabela izabelo ezingaphezulu zepatent.

Amashishini e-CMO aseTshayina aneenzuzo ezifana neendleko eziphantsi zezinto ezikrwada kunye nabasebenzi, inkqubo eguquguqukayo kunye netekhnoloji, njl.njl., kwaye ukudluliselwa kweshishini le-CMO lamazwe ngamazwe eTshayina kukhuthaza ukwandiswa ngakumbi kwesabelo semarike ye-CMO yaseTshayina. Imarike yehlabathi ye-CMO/CDMO kulindeleke ukuba idlule i-$102.5 yeebhiliyoni ngo-2021, kunye nesantya sokukhula esidibeneyo esimalunga ne-12.73% ngo-2017-2021, ngokwesimo sezulu saseMzantsi.

Kwimarike yeekhemikhali ezikumgangatho ophezulu kwihlabathi liphela ngo-2014, amayeza kunye neziphakathi zayo, izibulala-zinambuzane kunye neziphakathi zayo zezona mboni zimbini ziphambili kwishishini leekhemikhali ezikumgangatho ophezulu, ezibalelwa kwi-69% kunye ne-10% ngokulandelelana. I-China inomzi-mveliso onamandla we-petrochemical kunye nenani elikhulu labavelisi bezinto eziluhlaza zekhemikhali, abaye benza amaqela emizi-mveliso, okwenza iintlobo ezininzi zezinto eziluhlaza nezincedisayo ezifunekayo ekuvelisweni kweekhemikhali ezikumgangatho ophezulu ezifumanekayo e-China, nto leyo ephucula ukusebenza kakuhle kwaye inciphisa iindleko zizonke. Kwangaxeshanye, i-China inenkqubo yemizi-mveliso epheleleyo, eyenza ixabiso lezixhobo zeekhemikhali, ukwakhiwa kunye nokufakwa e-China libe liphantsi kakhulu kunelo lamazwe aphuhlileyo okanye uninzi lwamazwe asaphuhlayo, ngaloo ndlela kunciphisa iindleko zotyalo-mali kunye nemveliso. Ukongeza, i-China inenani elikhulu leenjineli zeekhemikhali ezinobuchule nezingabizi kakhulu kunye nabasebenzi bemizi-mveliso. Imizi-mveliso ephakathi e-China iphuhlile ukusuka kuphando lwesayensi kunye nophuhliso ukuya kwimveliso kunye nokuthengiswa kweseti epheleleyo yenkqubo epheleleyo, imveliso yamayeza yezinto eziluhlaza zekhemikhali kunye neziphakathi zesiseko zinokwenza iseti epheleleyo, zimbalwa kuphela ezifuna ukungeniswa, zinokuvelisa iziphakathi zamayeza, iziphakathi zezinambuzane kunye nezinye iindidi eziphambili ezingama-36, ngaphezu Iintlobo ezingama-40000 ze-intermediates, kukho iimveliso ezininzi ze-intermediate ezifezekisiweyo inani elikhulu lee-exports, ii-exports ze-intermediate ezingaphezu kwe-5 yezigidi ngonyaka, ziye zaba yimveliso enkulu ye-intermediates kunye ne-exporter kwihlabathi.

Ishishini leemveliso zamayeza eTshayina liphuhliswe kakhulu ukusukela ngo-2000. Ngelo xesha, iinkampani zamayeza kumazwe aphuhlileyo zazinikela ingqalelo ngakumbi kuphando lwemveliso nophuhliso kunye nophuhliso lwemarike njengokhuphiswano lwazo oluphambili kwaye zakhawulezisa ukudluliselwa kwemveliso zamayeza aphuhlileyo kunye nokuhlanganiswa kwamayeza asebenzayo kumazwe asaphuhlayo ngeendleko eziphantsi. Ke ngoko, ishishini leemveliso zamayeza eTshayina lathatha eli thuba ukuze lifumane uphuhliso oluhle kakhulu. Emva kweminyaka engaphezu kweshumi yophuhliso oluzinzileyo, iTshayina ibe sisiseko esibalulekileyo semveliso yaphakathi kwicandelo lehlabathi labasebenzi kwishishini lamayeza ngenkxaso yomthetho wesizwe kunye nemigaqo-nkqubo eyahlukeneyo. Ukususela ngo-2012 ukuya ku-2018, imveliso yeshishini leemveliso zamayeza eTshayina inyuke ukusuka kwi-8.1 yezigidi zeetoni ngobukhulu bemarike obumalunga ne-168.8 yeebhiliyoni zeerandi ukuya kwi-10.12 yezigidi zeetoni ngobukhulu bemarike obungama-2017 eebhiliyoni zeerandi. Ishishini leemveliso zamayeza eTshayina lifikelele kukhuphiswano oluqinileyo kwimarike, kwaye nabanye abavelisi bemveliso zamayeza bakwazile ukuvelisa iimveliso zamayeza ezintsonkothileyo kunye neemfuno zobugcisa eziphezulu. Inani elikhulu leemveliso ezinempembelelo liqalile ukulawula imarike yamazwe ngamazwe. Nangona kunjalo, ngokubanzi, ishishini eliphakathi laseTshayina lisekwixesha lophuhliso lokuphucula nokuphucula ulwakhiwo lwemveliso, kwaye inqanaba lobuchwepheshe lisephantsi kakhulu. Uninzi lweemveliso kwishishini eliphakathi lamayeza zisezii-intermediate eziphambili zamayeza, ngelixa inani elikhulu le-intermediate eziphambili zamayeza kunye ne-intermediate ezixhasayo zamayeza amatsha anelungelo lomenzi zinqabile.