Indasteri ea lik'hemik'hale e ntle ke sebaka sa moruo sa ho hlahisa lik'hemik'hale tse ntle indastering ea lik'hemik'hale, tse fapaneng le lihlahisoa tsa lik'hemik'hale tse akaretsang kapa lik'hemik'hale tse ngata.Indasteri e ntle ea lik'hemik'hale ke e 'ngoe ea matšoao a bohlokoa a boemo bo pharaletseng ba theknoloji ea naha.Litšobotsi tsa eona tsa mantlha ke ho hlahisa lik'hemik'hale tse ntle tsa boleng bo holimo, tse nang le mefuta e mengata, tse khethehileng kapa tse sebetsang ka bongata bakeng sa moruo oa lefats'e le bophelo ba batho ka theknoloji e phahameng le e ncha.Indasteri ea lik'hemik'hale e ntle e na le sesupo sa theknoloji e phahameng le boleng bo phahameng bo ekelitsoeng.Ho tloha ka bo-1970, linaha tse ling tse tsoetseng pele indastering li 'nile tsa fetola ka tatellano sepheo sa leano la nts'etsopele ea indasteri ea lik'hemik'hale ho indasteri e ntle ea lik'hemik'hale,' me ho potlakisa nts'etsopele ea indasteri e ntle ea lik'hemik'hale e fetohile mokhoa oa lefats'e ka bophara. li-additives, li-additives tsa lijo, li-adhesives, surfactants, lik'hemik'hale tse hloekisang metsi, lik'hemik'hale tsa letlalo, lik'hemik'hale tsa oli, lik'hemik'hale tsa elektroniki, lik'hemik'hale tsa pampiri le masimo a mang a fetang 50.

Li-intermediates tsa meriana li bua ka lik'hemik'hale tse bohareng tse entsoeng ka mokhoa oa ho kopanya lithethefatsi tsa lik'hemik'hale 'me ke tsa lihlahisoa tse ntle tsa lik'hemik'hale.Li-intermediate tsa meriana li ka aroloa ka li-antibiotic intermediates, antipyretic le analgesic intermediates, cardiovascular intermediates, le anticancer intermediates ho latela masimo a kopo ea bona. ea lipakeng tsa meriana ke indasteri ea mantlha ea lihlahisoa tsa lik'hemik'hale, athe indasteri e tlase ke indasteri ea lik'hemik'hale API le indasteri ea ho lokisa.Joaloka thepa e ngata, theko ea thepa ea mantlha ea lik'hemik'hale e fetoha haholo, e amang ka kotloloho litšenyehelo tsa tlhahiso ea likhoebo. e arotsoe ka li-intermediate tsa mantlha tsa mahareng le tse tsoetseng pele, tsa mantlha tsa lipakeng ka lebaka la bothata ba theknoloji ea tlhahiso ha li holimo, litheko li tlase, 'me boleng bo ekelitsoeng boemong ba ho fana ka thepa e ngata, li-intermediate tse tsoetseng pele ke lihlahisoa tsa mantlha tsa karabelo ea mahareng, ha li bapisoa le tsa mantlha.y sebopeho sa mahareng, se rarahaneng, mohato o le mong feela kapa tse seng kae ho lokisoa ha lihlahisoa tsa boleng bo holimo tse kenyellelitsoeng tlase ho noka, sekhahla sa eona se felletseng se phahame ho feta moeli o akaretsang oa indasteri ea lipakeng qetellong ea ketane ea indasteri e nang le khatello e kholo ka ho fetisisa ea tlhōlisano le khatello ea theko, 'me ho fetoha ha theko ea lisebelisoa tsa motheo tsa lik'hemik'hale ho na le tšusumetso e kholo ho bona. barekisi, empa habohlokoa le ho feta, ba jara tlhahiso ea li-intermediate tse tsoetseng pele tse nang le litaba tse phahameng tsa tekheniki 'me li boloka likamano tse haufi le lik'hamphani tsa lichaba tse ngata, kahoo ho fetoha ha theko ea thepa e tala ho na le tšusumetso e fokolang ho bona. tekanyo ea tšusumetso boleng ba ho qetela ba API.Non-gmp intermediate e bua ka befo e bohareng ea meriana.Bohareng ba GMP e bua ka setsi sa meriana se entsoeng tlas'a litlhoko tsa GMP, ke hore, ntho e hlahisoang ka mor'a lisebelisoa tse qalang tsa API, nakong ea mehato ea API synthesis, le e tsoelang pele ho fetoha kapa ho ntlafatsoa pele e e-ba teng. API.

Tlhōrō ea bobeli ea patent cliff e tla tsoela pele ho tsosa tlhokahalo ea li-intermediate tse holimo
Indasteri ea lipakeng tsa meriana e feto-fetoha tlas'a tšusumetso ea tlhoko e akaretsang ea indasteri ea meriana e tlase, 'me nako ea eona ea nakoana e lumellana hantle le ea indasteri ea meriana. potoloho ea meriana e mecha 'marakeng;Mabaka a ka hare haholo-holo a bua ka potoloho ea tšireletso ea patent ea lithethefatsi tse ncha.Lebelo la tumello e ncha ea lithethefatsi ke mekhatlo e laolang lithethefatsi joalo ka FDA le eona e na le tšusumetso e itseng indastering.Ha nako ea tumello ea meriana e mecha le palo ea litlhare tse ncha tse amohetsoeng li loketse lik'hamphani tsa meriana, tlhokahalo ea lits'ebeletso tsa ho ntša meriana e tla hlahisoa.Ho ipapisitsoe le palo ea litlhare tse ncha tsa lik'hemik'hale le litlhare tse ncha tsa baeloji tse amohetsoeng ke THE FDA lilemong tse leshome tse fetileng, palo e kholo ea tumello ea meriana e mecha e tla tsoela pele ho hlahisa tlhokahalo ea li-intermediate tse holimo, kahoo e tšehetsa indasteri ho boloka matla a phahameng. ba ntse ba natefeloa ke kholo e matla ea tlhokeho nakong e khuts'oane.Ho ea ka lipalo-palo tsa Evaluate, ho hakanngoa hore ho tloha ka 2017 ho isa ho 2022, ho tla ba le li-yuan tse limilione tse likete tse 194 tsa 'maraka oa lithethefatsi tse tobaneng le boemo ba ho fela ha patent, e leng tlhoro ea bobeli ea patent cliff ho tloha 2012.

Liphetoho lilemong tsa morao tjena, ka katoloso le sebopeho sa lithethefatsi se rarahane, lipatlisiso tse ncha tsa lithethefatsi le sekhahla sa katleho ea ntlafatso li fokotsehile, keketseho e potlakileng ea lipatlisiso tse ncha tsa lithethefatsi le litšenyehelo tsa ntlafatso ea McKinsey Nat.Moruti DrugDiscov."E boletsoeng, ka 2006-2011, lipatlisiso tse ncha tsa lithethefatsi le katleho ea tsoelo-pele ke 7.5% feela, ho tloha 2012 ho ea ho 2014, ka lebaka la macromolecules ea tlhaho e ntle le chefo e tlaase ea ho lahleheloa ke sebaka (lithethefatsi tse nakong ea tsoelo-pele, ke hore, ho tloha karolo ea kliniki ea III ho ea lethathamong le amohetsoeng e na le sekhahla sa katleho ea 74%), lipatlisiso tsa lithethefatsi le nts'etsopele ea kakaretso ea katleho ea keketseho hanyenyane, empa ho ntse ho le thata ho khutlela ho 16.40% tekanyo ea katleho lilemong tsa 90. Theko ea ho atleha ho thathamisa e ncha Setlhare se eketsehile ho tloha ho rona $ 1.188 bilione ka 2010 ho rona $ 2.18 bilione ka 2018, hoo e batlang e imena habeli.Ho sa le joalo, tekanyo ea ho khutla ha lithethefatsi tse ncha e ntse e theoha.Ka 2018, lik'hamphani tse kholo tsa lefats'e tsa TOP12 tsa meriana li entse feela sekhahla sa ho khutla sa 1.9% matsete a lipatlisiso le nts'etsopele.

Litšenyehelo tse ntseng li eketseha tsa r&d le ho fokotseha ha ho khutlela ho matsete a r&d ho ​​tlisitse khatello e kholo ho lik'hamphani tsa meriana, kahoo li tla khetha ho fana ka ts'ebetso ea tlhahiso ho likhoebo tsa CMO nakong e tlang ho fokotsa litšenyehelo.Ho ea ka ChemicalWeekly, ts'ebetso ea tlhahiso e nka hoo e ka bang 30% ea litšenyehelo tsohle tsa lithethefatsi tsa pele.Mohlala oa CMO / CDMO o ka thusa lik'hamphani tsa meriana ho fokotsa litšenyehelo tse felletseng tsa thepa e tsitsitseng, katleho ea tlhahiso, lisebelisoa tsa batho, setifikeiti, tlhahlobo le likarolo tse ling. ka 12-15% .Ho phaella moo, ADOPTION ea mokhoa oa CMO / CDMO e ka thusa lik'hamphani tsa meriana ho ntlafatsa tlhahiso ea karabelo, ho khutsufatsa potoloho ea li-stocking le ho eketsa ntlha ea tšireletso, e ka bolokang nako ea tlhahiso ea tlhahiso, ho khutsufatsa potoloho ea r & d ea Litlhare tse nchafalitsoeng, ho potlakisa lebelo la thekiso ea lithethefatsi, le ho nolofalletsa lik'hamphani tsa meriana ho thabela melemo e mengata ea litokelo tsa molao.

Likhoebo tsa Machaena tsa CMO li na le melemo e kang theko e tlase ea thepa e tala le basebetsi, ts'ebetso e feto-fetohang le theknoloji, joalo-joalo, 'me ho fetisetsoa ha indasteri ea machaba ea CMO ho ea Chaena ho khothalletsa katoloso e eketsehileng ea karolo ea' maraka ea CMO ea Chaena.'Maraka oa lefats'e oa CMO/CDMO o lebelletsoe. ho feta rona $ 102.5 bilione ka 2021, ka sekhahla sa khōlo e kopantsoeng ea hoo e ka bang 12.73% ka 2017-2021, ho latela ponelopele ea South.

Lefatšeng ka bophara marakeng oa lik'hemik'hale tse ntle ka 2014, meriana le li-intermediates tsa eona, chefo e bolaeang likokoanyana le li-intermediate tsa eona ke liindasteri tse peli tse ka sehloohong tsa indasteri e ntle ea lik'hemik'hale, tse ikarabellang bakeng sa 69% le 10% ka ho latellana.China e na le indasteri e matla ea petrochemical le palo e kholo ea bahlahisi ba lihlahisoa tsa lik'hemik'hale, ba thehileng lihlopha tsa indasteri, ba etsa mefuta e mengata ea lihlahisoa tse tala le tse thusang tse hlokahalang bakeng sa tlhahiso ea lik'hemik'hale tse ntle tse fumanehang Chaena, ho ntlafatsa katleho le ho fokotsa litšenyehelo ka kakaretso. tsamaiso ea liindasteri e feletseng, e etsang hore litšenyehelo tsa thepa ea lik'hemik'hale, kaho le ho kenya Chaena li fokotsehe haholo ho feta tsa linaha tse tsoetseng pele kapa esita le linaha tse ngata tse tsoelang pele, ka hona ho fokotsa litšenyehelo tsa lichelete le tlhahiso ea lihlahisoa.Ho phaella moo, Chaena e na le palo e kholo ea bokhoni le e tlaase- lienjineri tsa lik'hemik'hale tsa litšenyehelo le basebetsi ba indasteri.Indasteri ea Intermediates naheng ea China e tsoetse pele ho tloha lipatlisisong tsa mahlale le nts'etsopele ho isa ho production le thekiso ea sete e feletseng ea tsamaiso e batlang e feletseng, tlhahiso ea meriana ea lisebelisoa tse tala tsa lik'hemik'hale le li-intermediates bakeng sa motheo li ka theha sete e feletseng, ke ba seng bakae feela ba hlokang ho kenya, ba ka hlahisa li-intermediates tsa meriana, li-intermediates tsa meriana le lihlopha tse ling tse 36 tse kholo, ho feta 40000 mefuta e fapaneng ya intermediates, ho na le lihlahisoa tse ngata tse mahareng fihlellwa palo e kholo ea diyantle, diyantle mahareng tse fetang lithane tse limilione tse 5 selemo le selemo, e se e le kholo ka ho fetisisa lefatšeng intermediates tlhahiso le diyantle.

Indasteri ea meriana ea Chaena ea meriana e tsoetse pele haholo ho tloha ka 2000. Ka nako eo, lik'hamphani tsa meriana linaheng tse tsoetseng pele li ile tsa ela hloko haholoanyane lipatlisiso tsa lihlahisoa le nts'etsopele le nts'etsopele ea 'maraka e le tlhōlisano ea bona ea mantlha' me ea potlakisa phetisetso ea li-intermediates le motsoako o sebetsang oa lithethefatsi linaheng tse tsoelang pele. ka litšenyehelo tse tlase.Ka hona, indasteri ea lipakeng tsa meriana ea China ho nka monyetla ona ho fumana nts'etsopele e babatsehang.Ka mor'a lilemo tse fetang leshome tsa tsoelo-pele e tsitsitseng, Chaena e fetohile setsi sa bohlokoa sa tlhahiso ea lipakeng karolong ea lefats'e ea mosebetsi lefapheng la meriana ka tšehetso ea. molao oa naha ka kakaretso le maano a fapaneng. Ho tloha 2012 ho ea ho 2018, tlhahiso ea indasteri ea meriana ea Chaena e eketsehile ho tloha ho lithane tse ka bang limilione tse 8.1 ka boholo ba 'maraka bo ka bang li-yuan tse limilione tse likete tse 168,8 ho ea ho lithane tse ka bang limilione tse 10.12 ka boholo ba 'maraka oa li-yuan tse limilione tse likete tsa 2017. lipakeng keindasteri e fihletse tlholisano e matla 'marakeng, esita le bahlahisi ba bang ba lipakeng ba khonne ho hlahisa li-intermediate tse nang le sebopeho se rarahaneng sa limolek'hule le litlhoko tse phahameng tsa tekheniki.Palo e kholo ea lihlahisoa tse nang le tšusumetso e se e qalile ho laola 'maraka oa machaba.Leha ho le joalo, ka kakaretso, indasteri ea mahareng ea Chaena e ntse e le nakong ea nts'etsopele ea ntlafatso ea sebopeho sa sehlahisoa le ntlafatso,' me boemo ba theknoloji bo ntse bo le tlase haholo. indasteri ea lipakeng tsa meriana e ntse e le li-intermediate tsa mantlha tsa meriana, ha palo e kholo ea li-intermediate tse tsoetseng pele tsa meriana le li-intermediate tse tšehetsang tsa lithethefatsi tse ncha tse nang le tokelo ea molao li sa tloaeleha.