沙利文：2025中国医药CDMO行业发展洞察蓝皮书

2025CDMO2025

CDMOCDMOCDMOCDMOCDMO2025CDMOCDMOCDMOCDMOCDMOCDMOCDMOCDMOMAHGMPCDMOAI→→→CDMOCDMOCDMOCGT

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25.011Humira

20.694Humira

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14.404Spikevax

17.675Keytruda

20.937Ozempic

13.917Keytruda

17.186Paxlovid

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12.206Revlimid

12.891Spikevax

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2013132019compound202320237,1552310.7%10,757206.8%CDMOCDMO1.31.41.51.51.82.22.42.42.02.32.32015201620172018201920202021202220232013

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2019

2020

2021

2022 2023

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2001

2002

2003

2004

2005

2006

2007

2008

2009

2010

2011

20122013

2014

2015

2016

2017

2018

2019

20202021

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20232418

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206633224

25301233215

16

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102.0114.0123.9131.325.450.238.950.653.665.677.689.498.8107.7115.0122.4129.92018

2019

2020

2021

2022

2023

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2016

2017

2018

2019

2020

2021

2022

2023

20242025CDMO

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2015-20240

1532021202310512454.4%

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2016

2017

2018

2019

2020

2021

2022

2023

2024

2015-20240642

20211721052.6%2015-2024

2024

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1158940.1%II

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2025CDMO

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2007

2008

2009

2010

2011

2012

2013

2014

2015

2016

2017

2018

2019

2020

2021

2022

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7020054202433695241CXOCXO2025CDMO

CDMO——

/12,0005,00056006g/3,000100mL/50%——SMO+CRCCMO——CRO——CRO

200+…………………………2025CDMO

ADC/XDCPROTAC2006CRO&CMC&CDMO

-CDMO+CDMO”ADC/XDC139,000DPROTAC769&I106CDMOCRO/CMC/CDMO

2024II

&IIIR

M17CDMO——

68GMPNon-GMP4CDMOGMPCDMO

GMPADC/XDC

CDMOADC

Payload-Linker

&

HPAPIADC

PDC

+GMP1FDA2021483

6350+NMPA3QP

GMP4GB/T29490SOPISO

27001EHSEcoVadisGCIPR2025CDMO10-100non-GMP&GMP55+

IND5

BLA113

sec-DMFs

150+ADC

ADC

Payload-Linker

CMC---

XDCThiomabPDCDACRDCXDC

CDMO——ADCCDMO2025

3ADCCDMOCDMO

ADCCDMOCDMOADCDNAIND14

+ADC2024150+

ADCADC——ADC

RC48CMC2021ADC12,900L120,000L-10ng/m³5

GMP>4,000LOEB5,

OELmgkgADCADC

GMPADCADCOEB5140.5-5kg/1500kg

3001

ADC20050ADC

Payload-LinkerADC-Payload-Linker

10260+990+ADCADC

50+CMCADCPayload

Linker

Payload-LinkerADCADC-CMC

CDMO

GMPADC2025CDMO

2013CROCMCGMP

CDMO/

CDMO——2021•41

GMP2023•

2013•2014•2015•A2016•2017GECDMO2018•CDMO2024•2022•2020•8GMP2019•GMP912,800+120,000+450+CDMO77,000

+AAVLVADVSPFGMP/

CDMO/CMOGMPGMPmRNA

Non-IND

IND-CMCCMCPre-INDAAV•GMPPost-IND

Post-INDPre-IND•CDMOCRO•——2025CDMO

CDMO

CROCRO/CDMOCRO

CDMOCDMOGMPCDMO

ExpressneOAAVeO

AAVAIAAVLVneORNA-LNPromRNA

circRNA

saRNA

RNALNPLNPIPSCytoMSC

HSC

iPSCiPSCiPSCCGT

CRO/CDMO•SPF•CRO/CDMOCDMO

450GMP11

GMP50L-2,000L30-600cm2

50L-500L18

B+A

C+Awave G-Rex••mRNACMCCRO/CDMOIP•IND

45FDA

13

IP

2025CDMO

2004CMCCDMO

CDMO——

CGTTop3CRO21/>3,000>21,000All

Top

20CGT>

20•••DMPK••••DMPKGLPGMPPK••I-II•14C-ADMEGMP••••PK/PD•/••PK/PD•GLPGMP/•I-IIIPK/•GMP•••PK/PD••••PK/PD/••GLPGMP•GMP/I-IIIPK/••••IND/BLAINDPCC2025CDMOI

ADCCDMOCDMO4,390/2,000200HTEADC————GMPCDMO——

CGT

CRO/CDMOCGTCDMO400CRO/CDMOCGTCDMO350Oligonucleotides

siRNA

ASOCDMOCDMO•70,000CDMO2024200L

2000LCGT

CRO/CDMO•CDMO•GMPCDMOcGMPMHRACDMO•DNA

RNACGTCGTGLP/GCP/GMPIIbI/IIIII•III2025CDMOGMP02030405CAR-T

TCR-TCAR-NKDCDNAOXGENETM

WuXi

XDCCRDMOADC

CDMO

GMPCMC

CTDMO

CDMO——

CRO2000CRO

CDMOCTDMOCDMO——

2025CDMO2024-25,0003

5,000

GMPDP17

GMPMFG6MFG6.22024MFG116

6,000

CDMO——

CRDMO

ADCWuXiBodyWuXiaWuXiUPWuXiUIWuXiHigh2024SDArBodY817151

2024817402243856621IIIIII2024RDMRResearchD&M

Development

&

ManufacturingWuXiBody50WuXia

CHO150150CMC

1,0005SDArBodyWuXiUP1,000-2,000L10,000-20,000L140+TTCE

CD5WuXiUI3-6TCE2,000LGMPBBerkeley

Light

BeaconWuXiHigh≥100

mg/mL230mg/mL

CDMO——2025CDMO

20125201711A20197FDA

GMP20203202235015028GMP202412

CROCDMOCDMOI-IIICRODELT/FBDD/AIDD/CMC/ResearchRDevelopment

&

ManufacturingD&MADCTPD2008201620182021202320251011993Chester

12WestGMP503GMP2025CDMO

CMC+++CDMO

CDMO——

4.563/GMPCDMO2008CMC502GMP2022GMPACS

CMO700IP7L

100L

500L

CETCCDMO2023

20241-ACS

CMO-3-200PMI20233--1-AI2025CDMO

2010CRDMOCRO/CDMO/MAHCRDMO/CRDMOCRDMO

CDMO——CRDMOINDNDAMAHMAHIND/GMP7L-2000LINDNDAFDA

EMACRDMOCRDMO

/CDMOCDMOCDMO••••••••••2025CDMO

CDMO——

20,000m2GMPNMPAFDA EMA

GMPCDMOCDMO6,0001,000

L7,500

L5m22,000

L10

L-100

L

200

L

500

LCDMO•1,500

m21,000500•1000

CRDMOFDACDMO

7229

III15

IIIND

I7-2,000LCDMOGMP2025CDMO

2015ATMPs)CDMOGMPATMPs100+ATMPsATMPsGMP100+20300+IND

CDMO——GATMPsCDMO100+CAR-T200+60+20INDGMP30000GMPGMPB+A

C+A10

+2015CGTCDMO201920212024202320222020GMP•GMP

AAVFDA

DMF•IND•GMP•20IND•GMPAAV

500L293XSHEK293TFDA

DMFCMCFDA

•GMP

DMF•GMP

•GMP2017GMPAAV

200LCAR-T

2025CDMO

GMPCMC30,000m2

GMPIIT

IND