Imboni yakamuva yokuxilongwa kwe-in vitro isebenzisa isikhathi sokuthuthuka okusheshayo

Inoveli coronavirus pneumonia novel coronavirus pneumonia kuyinto ebaluleke kakhulu phakathi kwezinto ezibalulekile. Imboni yenoveli coronavirus pneumonia (IVD) izokhula ngokushesha ngokuthuthuka okusheshayo kobuchwepheshe obusha obuhlukahlukene kanye ne-catalysis ye-new crown pneumonia. Kulindeleke ukuthi ibe ngomunye wemakethe esebenza kakhulu futhi esheshayo esathuthuka embonini yedivayisi yezokwelapha ngokuzayo.

Ubuchwepheshe obusha, imodi entsha nokufunwa okusha kuvula isikhala esisha

Ngokuthuthuka okusheshayo kwe-biotechnology, isikali semakethe yemboni yokuxilongwa kwe-in vitro yomhlaba sikhula ngokushesha. Ngokuya ngemininingwane ye-China in vitro diagnostic network (caivd), ngo-2013, usayizi wemakethe wemboni yokuxilonga i-in vitro yomhlaba wawucishe ube amaRandi ayizigidi eziyizinkulungwane ezingama-60, futhi wedlule ama-US $ 80 billion ngonyaka wezi-2019, ngezinga elijwayelekile lokukhula ngonyaka kokungu-6%. Kulindeleke ukuthi usayizi wemakethe uzodlula ama-US $ 90 billion ngo-2020 (bona Umfanekiso 1 we 

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Ngokuya ngemigomo nezindlela zokuthola, ingahlukaniswa ngemikhakha emikhulu eyisithupha: i-immunodiagnosis, ukuxilongwa kwamakhemikhali, ukuxilongwa kwegazi, ukuxilongwa kwamangqamuzana, ukuxilongwa kwe-microbiological kanye nokuxilongwa okusheshayo (POCT). Kusukela ekuthuthukisweni kwemakethe yokuxilonga i-vitro global, eminyakeni yamuva nje, isabelo semakethe sokuxilongwa kwamakhemikhali nokwelashwa kwe-immunodiagnosis sehle kancane, kanti isabelo semakethe sokukhonjwa kwe-nucleic acid, microbiology, histology kanye ne-flow cytometry sikhuphuke unyaka nonyaka, ngezinga lokukhula lonyaka elihlanganisiwe elingaphezu kuka-10%. Ngo-2019, i-immunodiagnosis inesabelo esikhulu kunazo zonke emakethe, ibalwa ngama-23%, ilandelwa ukuxilongwa kwamakhemikhali, i-accounting engu-17% (bona umfanekiso 2 ngemininingwane).

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Eminyakeni yamuva nje, ubuchwepheshe obusha kanye namamodeli wemboni yomhlaba yokuxilonga i-in vitro bekulokhu kuvela. Ubuchwepheshe bokuxilongwa kwamangqamuzana obumele izizukulwane ezimbili zokulandelana kwezakhi zofuzo (NGS), imikhiqizo yokuthola isikhathi sangempela emelwe ngamachips we-microfluidic, kanye nobuchwepheshe obusha namamodeli afana nokuphathwa kwezempilo kwanamuhla nokunakekelwa ngokunemba kwezokwelapha, okumelwe yidatha enkulu kanye ne-Intanethi plus, kuvuliwe igumbi elisha lomkhakha wokuxilonga we-in vitro. Ngokuthuthuka okuqhubekayo kobuchwepheshe be-in vitro diagnostic kanye nokusetshenziswa okubanzi kwesayensi nobuchwepheshe obunqenqemeni obuhlobene, imakethe yokuhlonza in vitro yomhlaba izogcina ukuthambekela kokukhula okuqhubekayo. Ngaphezu kwalokho, isibalo sabantu emhlabeni wonke siyakhula, futhi nezigameko zezifo ezingamahlalakhona, umdlavuza nezinye izifo ziyakhula. Iphinde ikhuthaze ukuthuthukiswa okuqhubekayo kwemakethe yokuxilonga i-in vitro.

Iqhutshwa ukusheshisa kokuguga kwabantu, ukuqhamuka kobuchwepheshe obusha kanye nokwahlukaniswa kwenqubomgomo, imboni yokuxilongwa kwe-in vitro eChina ibilokhu ithuthuka ngokuqhubekayo. Eminyakeni yakamuva, imboni yokuhlonza i-in vitro yasekhaya ithuthuke ngokushesha, amanye amabhizinisi endawo enze intuthuko kwezobuchwepheshe, kanti amanye amabhizinisi endawo akhuphuke ngokushesha ngenxa yesidingo esikhulu semakethe yasekhaya. Ngaphezu kwalokho, eminyakeni yamuva nje, iChina ikhiphe ngokulandelana izinqubomgomo zokuxhasa ukwenziwa kwemboni yokuxilongwa kwe-in vitro. Isibonelo, kunezinqubomgomo ezihambisanayo ezihambisanayo ohlelweni lweminyaka eyisi-13 lwensiza yokwelapha yesayensi nobuchwepheshe, uhlelo lwe-13 leminyaka emihlanu lokusungula i-biotechnology kanye nohlaka lokuhlela lwe-China 2030 olunempilo, oluqhubeka nokukhuthaza ubungqabavu bomkhakha.

 

Izimakethe ezikhulayo zinamandla

Sekukonke, ukuthuthukiswa kwemakethe ye-IVD yomhlaba akulingani ngokweqile. Ngokombono wokusatshalaliswa kwezifunda, iNyakatho Melika, iNtshonalanga Yurophu nezinye izifunda ezithuthukile kwezomnotho zibala ngaphezu kuka-60% wesabelo semakethe; ngokubuka kwesabelo semakethe yamabhizinisi, cishe uhhafu wesabelo semakethe uthathwa yiRoche, Abbott, Siemens kanye neDanaher. I-China iyimakethe evelayo yemboni yokuxilongwa kwe-in vitro, esesikhathini sokukhula ngokushesha okwamanje futhi kungalindelwa ngokuzayo.

Njengamanje, iminotho ethuthukile efana neNyakatho Melika kanye neNtshonalanga Yurophu ibanga ngaphezu kuka-60% wemakethe yokuxilonga i-in vitro yomhlaba. Kodwa-ke, amazwe athuthukile nezimakethe zesifunda zingene esigabeni esivuthiwe ngentuthuko ezinzile futhi nokukhula okuhamba kancane. Emazweni asathuthuka, njengemboni evelayo, ukuxilongwa kwe-vitro kunezimpawu zesisekelo esincane kanye nezinga lokukhula eliphakeme. Kulindeleke ukuthi ezimakethe ezisafufusa ezimelwe yiChina, India namanye amazwe kanye nezifunda, izinga lokukhula kwemakethe yokuxilongwa kwe-in vitro lizohlala ku-15% ~ 20%. Imakethe esakhulayo izoba ngenye yezindawo ezingaba namandla kakhulu embonini yokuxilongwa kwe-in vitro.

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Imboni yokuhlonza i-in vitro yaseChina yaqala ngasekupheleni kweminyaka yama-1970 futhi manje isesikhathini sokuthuthuka okusheshayo. Ku-2019, isikali semakethe semboni yokuxilongwa kwe-in vitro yaseChina icishe ibe ama-yuan angama-90 billion, ngesilinganiso sonyaka sokukhula kwenhlanganisela esingaphezu kuka-20%. Eminyakeni eyi-10 eyedlule, amabhizinisi angaphezulu kwama-20 e-vitro diagnostic asezuze ngempumelelo i-IPO, kanti iMindray yezokwelapha, i-Antu biological, i-BGI kanye neWanfu begazi sebengamabhizinisi ahamba phambili ezigabeni zabo. Ezinye izinto ezisetshenziswa kakhulu (njengokuxilongwa kwamakhemikhali nokwelashwa ngokushesha) zifinyelele ezingeni eliphakeme lamazwe omhlaba ngesikhathi esifanayo. Ngokufana nemakethe yamazwe omhlaba, i-Roche, Abbott, Danaher, Siemens ne-hysenmecon akhawunti engaphezu kuka-55% wemakethe ye-IVD yaseChina. Izinkampani zamazwe omhlaba zisebenzisa izinzuzo zazo emikhiqizweni, ezobuchwepheshe kanye nezinsizakalo ukwengeza ngokuqhubekayo utshalomali lwabo eChina, ikakhulukazi ezibhedlela zasekhaya zasekhaya nakwezinye izimakethe ezisezingeni eliphakeme, lapho intengo ngokuvamile iphakeme kunaleyo yemikhiqizo efanayo yasekhaya. Ekuvinjelweni nasekulawuleni i-coronavirus pneumonia yenoveli yonyaka, amabhizinisi okuxilonga angaphandle kwe-vitro akhombisa amehlo awo akhanyayo. Inkampani yokuhlola yomuntu wesithathu isithuthukisile isimo sayo ohlelweni lwezokwelapha, futhi kulindeleke ukuthi yenze umsebenzi omningi wokuxilongwa kwezifo.

 

Ama-reagents wokuxilonga i-in vitro yizimpahla zabathengi ezilahlwayo, futhi isidingo semakethe yamasheya ngeke sinciphe. Imakethe yokuhlonza in vitro yasekhaya ikude kakhulu nokufinyelela “ophahleni”. Kusenemikhakha eminingi engakasekelwa okufanele isungulwe, futhi imboni izogcina inkambiso yentuthuko ezinzile futhi esheshayo ngokuzayo.

 

Amathemba amahle ezigaba ezintathu ezinkulu

Esikhathini sesifo esiwubhadane, imboni yokuxilongwa kwe-in vitro yaseChina izongena esikhathini sokuthuthuka okunamandla ekuxilongweni kwamangqamuzana, i-immunodiagnosis kanye nokuxilongwa okusheshayo.

 

Ukuxilongwa kwamangqamuzana

Njengamanje, ukukhula kwemakethe kwemboni yokuxilongwa kwamangqamuzana eChina kuyashesha, ukugxila embonini kuphansi, igebe lobuchwepheshe phakathi kwamabhizinisi asekhaya nakwamanye amazwe lincane, futhi ibhizinisi ngalinye linomkhakha walo wobuchwepheshe.

 

Ngokwezibalo, ngo-2019, isilinganiso semakethe semboni yokuxilongwa kwamangqamuzana yaseChina cishe siyi-11.58 billion yuan; isilinganiso sonyaka sokukhula kwenhlanganisela sisuka ku-2011 kuye ku-2019 sizofinyelela ku-27%, cishe kabili izinga lokukhula komhlaba. Emakethe yaseChina yokuxilongwa kwamangqamuzana, amabhizinisi axhaswa amazwe angaphandle abanga u-30% wemakethe, ikakhulukazi egxile enyukeni lochungechunge lwezimboni, ngemikhiqizo yeRoche, i-PCR yokulinganisa ka-Abbott kanye nomlandeli we-IL Lumina omele; amabhizinisi endawo enza i-70% yemakethe yomkhiqizo, futhi ibhizinisi labo ligxila kakhulu kuma-reagents wokuxilonga we-PCR kanye nezinsizakalo zokuxilonga i-ngs. Amabhizinisi amele abandakanya i-Kaipu biology, i-aide biology, isakhi sofuzo i-Huada, isakhi sofuzo seberry, i-Zhijiang biology, i-Daan gene, njll.

 

Baningi ababambiqhaza emakethe yokuxilongwa kwamangqamuzana eChina, futhi ukuhlushwa komkhakha kuphansi. Isizathu esiyinhloko salesi simo ukuthi izidingo zomtholampilo ezibandakanyeka ekuxilongweni kwamangqamuzana ziningi futhi ziyinkimbinkimbi, futhi umhlanganyeli ngamunye wemakethe unezici zakhe zobuchwepheshe nezindawo zobungcweti, ngakho-ke kunzima ukumboza ngokugcwele wonke amabhizinisi, ngakho-ke kunzima ukwakha iphethini yokuncintisana evelele.

 

Ubuchwepheshe bokuxilongwa kwamangqamuzana ikakhulukazi buhlanganisa i-PCR, inhlanzi, ukulandelana kofuzo kanye ne-chip chip. Ngokuhamba kwesikhathi, isikhala sokuthuthuka sobuchwepheshe bokulandelana kwezakhi zofuzo sibanzi, kepha izindleko zaso ziphakeme. Ubuchwepheshe be-PCR busengubuchwepheshe obujwayelekile emkhakheni wokuxilongwa kwamangqamuzana. Ukuze wenze umsebenzi omuhle ekuvikeleni nasekulawuleni ubhadane lwezifo, amabhizinisi amaningi okuxilongwa kwamangqamuzana akhiqize ngokulandelana athuthukise amakhithi amasha wokuthola i-coronavirus nucleic acid, futhi iningi lala makhithi lisebenzisa ubuchwepheshe be-PCR obuningi obunamandla, obudlala indima ebalulekile ekuvikeleni ubhubhane futhi ukulawula, futhi kuqhuba yonke imboni yokuxilongwa kwamangqamuzana ukuthi ibe nethemba elihle.

Ukuxilongwa kwe-Immunodiagnosis

Njengamanje, imakethe ye-immunodiagnosis yingxenye emakethe enkulu kunazo zonke embonini yokuxilongwa kwe-in vitro eChina, ebala cishe i-38% yayo yonke imakethe yokuxilongwa kwe-vitro.

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Ngaphezu kuka-60% wamasheya emakethe we-immunodiagnosis e-China kuhlala amabhizinisi axhaswa ngezimali angaphandle, kuyilapho kuphela u-30% wamasheya emakethe wamabhizinisi endawo afana neMindray medical, Mike biological, Antu biological, njll. ukuhlushwa kuphezulu. Amabhizinisi axhaswa ngemali angaphandle athatha ama-80% ~ 90% esabelo semakethe esezingeni eliphakeme se-immunodiagnosis eChina ngezinzuzo zabo zobuchwepheshe bemikhiqizo iminyaka eminingi, futhi amakhasimende abo ngokuyinhloko izibhedlela zemfundo ephakeme; amabhizinisi endawo asheshisa inqubo yokufakwa esikhundleni kwasekhaya ngokusebenzisa izinzuzo zokusebenza kwezindleko kanye nama-reagents afanayo.

 

Ukuxilongwa ngokushesha

Imakethe yokuxilongwa kwesikhathi sangempela yaseChina iqale sekwedlule isikhathi, futhi isilinganiso semakethe jikelele sincane. Kodwa-ke, eminyakeni yamuva nje, izinga lokukhula kwemakethe belilokhu ligcinwe ku-10% ~ 20%, ephakeme kakhulu kunezinga lokukhula komhlaba wonke le-6% ~ 7%. Ngokusho kwedatha, ngo-2018, imakethe yokuxilonga yaseChina yangempela izofinyelela kuma-yuan ayizigidi eziyizinkulungwane ezingu-6.6, ifinyelele kuma-yuan ayizigidi eziyizinkulungwane eziyi-7.7 ngo-2019; I-Roche, Abbott, merier kanye namanye amabhizinisi axhaswa ngezimali zakwamanye amazwe azoba sesikhundleni esiphakeme emakethe yase-China yokuthola izifo ezisezingeni eliphakeme, ngesabelo semakethe cishe esingu-90%; amabhizinisi endawo ancipha kancane kancane ejikeni ngezinzuzo zawo zamanani kanye nobuchwepheshe obusha.

 

Ukuxilongwa okusheshayo kungaveza imiphumela ngokushesha, okungakhawulelwe yisiza sokuhlola, kepha futhi kudinga amakhono aphansi opharetha opharetha. Ifanele izikhungo zezokwelapha ezisebenza ngotshani, kanye nezibhedlela ezinkulu, ezinjengezimo eziphuthumayo, iziguli ezingalali, ukuhlolwa kwezifo ezithathelwanayo ngaphambi kokuhlinzwa, ukuqapha ukutheleleka kososomia, ukungena okuphuma kusayithi, ukungena kwabaphuma ekuzihloleni kanye nezinye izimo . Ngakho-ke, elula, eyenziwe nge-miniaturized futhi efanelekile ukuxilongwa okusheshayo kwemikhiqizo yokuhlola yesikhathi sangempela izodlala indima ebaluleke kakhulu ekwakhiweni kwemboni yokuxilongwa kwe-in vitro ngokuzayo. Njengamanje, amabhizinisi amele ukuxilongwa kwesikhathi sangempela eChina afaka i-Wanfu biology, i-Jidan biology, i-Mingde biology, i-Ruilai biology, i-Dongfang gene, i-Aotai biology, njll.

 

Ngokucutshungulwa okuphelele komthelela wesifo esiwumshayabhuqe kanye nethemba lokuthuthukiswa kwemakethe, singathola ukuthi ukuthambekela kokuthuthukiswa kwemakethe kanye neThembiso lokuxilongwa kwamangqamuzana, ukuxilongwa komzimba nokuxilongwa ngokushesha kuhle. Ngeqhaza elibalulekile ekuvikeleni nasekulawuleni ubhadane, ukuxilongwa kwe-in vitro kuzokhathazeka kakhulu futhi kubonwe yimakethe, futhi kuzoba ngenye yezindawo ezinamandla kakhulu embonini yamathuluzi wezokwelapha eminyakeni embalwa ezayo.


Isikhathi Iposi: Dec-18-2020