Under the trend of innovative research and development, competition in the pharmaceutical industry is becoming increasingly fierce. The division of labor within the pharmaceutical industry chain is gradually becoming more specialized, refined, and customized.CDMO company With its own technical advantages and production capabilities, we assist pharmaceutical enterprises in realizing the transformation from concept to product, from process development to large-scale production. EntrustedCDMOEnterprises have become an important pathway for innovation, research and development, and production. Both start-up pharmaceutical companies and large pharmaceutical enterprises canCDMOBenefiting from the high-quality services providedCDMO company Along with the ever-changing pharmaceutical market, we continuously optimize our technology platform, expand our business scope, and extend our industrial chain to meet the actual needs of different types of customers.
On September 28, Frost & Sullivan (Frost &Mr. Li Dongyi, Director of Medical Consulting at Frost & Sullivan, officially released the 'Research Report on the Current Development and Future Trends of the CDMO Industry' (hereinafter referred to as the 'Report') at the 16th Frost & Sullivan Global GIL Summit · Biotechnology Investment Sub-forum.
Frost & Sullivan Healthcare Consulting Director Mr. Li Dongyi
"TheRelease Ceremony of the Research Report on the Current Development Status and Future Trends of the CDMO Industry
Kang Long Huacheng Securities' General Supervising Officer Yang (left), Dongyao Pharmaceutical's Financial Director Xiao Ben (middle), and Wang Manchao (right), Founder Partner, Director, and General Manager of Yaohai Biotechnology
The report on ChinaCDMOConduct an in-depth analysis of the industry, exploring various aspects such as industry overview, capital heatmaps, and competitive landscape.CDMOIndustry value, exploring the driving forces behind industry development, and tracking the iterative context of production process technologies. This report focuses onCDMOWhile the overall industry is operating in this manner, we focus on eachCDMOCurrent development status of segmented fields.
1
Overview of the CDMO Industry
01
Introduction to CDMO
CDMO companybyCMOEvolved and iteratively upgraded, as competition among pharmaceutical companies intensifies, traditionalCMOThe simple contract manufacturing production carried out by enterprises cannot meet the needs of pharmaceutical companies for cost reduction and efficiency improvement. On this basis, enterprises can utilize their own production equipment and technical advantages to help pharmaceutical companies optimize production processes and carry out customized large-scale production.CDMOEnterprises then emerged.CDMO The industry has been continuously developing since its infancy and has now entered a period of stable development.
Data source: Analysis by Frost & Sullivan
02
CDMO service scope
CDMO companyProvide R&D services with technical added value and capacity support, covering all stages of R&D.CDMO company The service scope built by the enterprise for pharmaceutical companies includes preclinical and clinical stages.CMCProcess development, production, packaging services for APIs, intermediates, and formulations. During the drug research and development phase,CDMO company It can improve drug R&D efficiency and reduce R&D costs; during the drug commercialization phase,CDMO company Continuous process optimization can reduce enterprise production costs, improve production efficiency, while ensuring product quality and supply stability.
Data source: Analysis by Frost & Sullivan
03
CDMO sub-sectors
According to the drug type, currentlyCDMOSub-sectors can be mainly divided into small molecules CDMO, macromolecules CDMO (including peptides/antibodies/proteins/vaccines, etc.) and Cell Gene Therapy (CGT) CDMO There are three main categories. Small molecule drugs have a simple structure, strong degradability of chemical synthesis steps, and most compounds are characterized by high stability and convenient transport. Therefore, small moleculesCDMOThe product has standardized processes and complies with "Basic chemicals —Non-GMP intermediate —GMP intermediate —Active Pharmaceutical Ingredients —preparation" The product preparation pathway is easy to industrialize; compared to small molecule chemical drugs, large molecule biologics have more complex structures, and their development costs and production/Higher imitation difficulty, macromoleculesCDMOLeading enterprises occupy a high market share with advantages such as technology and production capacity; cell and gene therapy production processes are complex and have high technical barriers, currently still in the early development stage. However, their global pipeline of research and development is growing rapidly, relying onCGTIndustrial trendsCDMOThe industry has also developed rapidly.
Data source: Analysis by Frost & Sullivan
04
CDMO industry chain and service advantages
CDMO companyThe upstream of the industry consists of fine chemical enterprises responsible for providing basic chemical raw materials. Through classified processing, they can prepare specialized pharmaceutical raw materials. The preparation of active pharmaceutical ingredients (APIs) is the foundation of drug research and development. Its main purpose is to provide qualified APIs for pharmacological and toxicological studies, formulation studies, clinical trials, etc., during the drug research and development process, to provide information for quality studies, and to ensure the stability and feasibility of production processes.CDMO company Enterprises conduct quality verification on raw materials and process specialized pharmaceutical raw materials into starting materials, intermediates, active pharmaceutical ingredients (APIs), and formulations to supply downstream pharmaceutical companies, biotech companies, academic research institutions, etc.
Data source: Analysis by Frost & Sullivan
The Report elaborates onCDMOAs an important participant in pharmaceutical R&D and production, the industry will empower pharmaceutical enterprises in the following four aspects: assisting in R&D and production, reducing enterprise costs, improving service efficiency, and promoting technological iteration.
Data source: Analysis by Frost & Sullivan
2
Market scale and development trend of the CDMO industry
01
Global and ChinaAnalysis of the Market Scale of the CDMO Industry
The Report on the Global and ChinaCDMOThe market size has been estimated. From a global perspective,CDMO company The industry is in a trend of continuous expansion and development, maintaining a high market prosperity level.2017 Year-end2021Year, globalCDMOMarket scale from394USD billion growth to632billion US dollars, with a compound annual growth rate of12.5%estimated2025Will reach in1,243billion US dollars2030 Will reach in2,310billion dollars.
Data source: Analysis by Frost & Sullivan
CDMO companyPlaying an important role in the drug innovation industry chain, with the rapid development of the innovative drug R&D business model in China,CDMO company The industry is developing strongly, having seen rapid growth in recent years.2017 Year-end2021year, ChinaCDMOMarket scale from132RMB billion growth to473yuan, with a compound annual growth rate of37.7%expected2025Will reach in1,571yuan,2030 Will reach in3,559yuan. ChinaCDMOThe industry has shown rapid growth at a level higher than the global average, ChinaCDMOThe market share has been increasing year by year compared to the global market.2017 Year in ChinaCDMOThe market accounts for only a fraction of the globalCDMOTotal market size 5.0%, to2021The year has been expanded to 13.2%, expected to be2025It will account for one-fifth of the global market after a year.
Data source: Analysis by Frost & Sullivan
02
chinaAnalysis of Drivers for the CDMO Market
The Report will start from four core perspectives: pharmaceutical R&D investment, industry policy dividends, talent and cost advantages, and technological platform innovation.CDMODriving factors behind industry development.
Medical R&D Investment
In recent years, the scale of pharmaceutical R&D investment in China has shown a steady growth trend, having grown from2017year143USD billion to290billions. The continuous increase in R&D expenditures provides more active and abundant financial resources for innovative drug research and development. Benefiting from the overall prosperity of the pharmaceutical market and the enthusiasm for innovative drug research and development, in the futureCDMOThe market will see further expansion.
Industry policy dividends
The promulgation of a series of pharmaceutical industry policies and the implementation of systems haveCDMOThe development of the industry creates opportunities. The Drug Marketing Authorization Holder System (Reform of the MAH system), reform of the new drug review and approval system, The implementation of policies such as volume-based procurement and medical insurance negotiations has benefited our countryCDMOThe development of the industry has created a favorable environment.
Talent and cost advantages
CDMOFor technology-intensive industries, such as drug development and production process optimization, a large number of professional technical talents are needed. In our countryCDMOThe industry boasts a considerable workforce and significant cost advantages, which can meet the cost control needs of pharmaceutical companies when choosing outsourcing services for production. To a certain extent, this ensures that ourCDMOIndustry growth potential.
Technological platform innovation
CDMOThe industry has taken over the process development and production functions of pharmaceutical enterprises, deviating from the previous model dominated by single-output capacity.CMOCompared with enterprises,CDMO company Enterprises place greater emphasis on the innovation capability of production processes during the R&D process. Participants in the industry are also continuously upgrading their industries by innovating technology platforms and R&D capabilities, providing more diversified services.
03
chinaAnalysis of the Development Trend of the CDMO Market
Based on the current market situation and overall trends, The Report makes an analysis from three important dimensions.CDMOProspectus on the future development trend of the industry:
By integrating horizontally, expanding production capacity, accumulating customer resources, and accelerating the pace of globalization expansion
Expand business scope through multiple paths, build a complete industrial service chain, and construct a one-stop service platform
Business and service models are constantly innovating to create distinctive and differentiated advantages
3
Sub-sectors of the CDMO industry
01
Segmented areas ——small molecule drugsCDMO company
Modern drug research and development began with chemical drugs, which have matured in technology and progressed rapidly in the process of transforming scientific research achievements into practical applications. Although emerging fields such as biopharmaceuticals and cell and gene therapies have developed rapidly in recent years, chemical drugs remain the mainstream form of medication.
Data source: Analysis by Frost & Sullivan
With the in-depth research into disease mechanisms, drug development has gradually entered an era of precision therapy targeting specific targets. Correspondingly, there have been significant changes in the nature of new drugs: drugs now have more accurate and selective targeting effects, with an increase in highly active drug components; the molecular weight of drugs has significantly increased and their structures have become more complex; the water solubility and permeability of drugs have decreased. A series of changes in the properties of new chemical drugs also require corresponding emerging synthesis and formulation technologies to keep up.
In addition, the increased difficulty in exploring and discovering new molecular entity drugs has led to higher research and development costs for new drugs. There are more risk factors, market competition tends to be fierce, and drug research and development have thus entered an era of pharmaceutical formulation innovation. The research and production of new high-end complex formulations also pose new challenges to chemical pharmaceutical processes, small moleculesCDMOThe industry has also built a series of advanced process technology platforms along with these new drug molecules, expanding its service capabilities from laboratory to laboratory.
The Report subsequently summarizes small moleculeized drugsCDMODescribe the service scope and its main service advantages, by way of examplesCDMOA series of technologies and equipment that enterprises can provide in the R&D and production process further reflect small molecule drugsCDMOThe comprehensive service capabilities. In addition, the Report includes a recent global and Chinese survey on small molecule drugsCDMOThe development of market scale, as well as predictions for future growth potential trends.
02
Segmented areas ——peptide drugCDMO company
The advantages of peptide drugs over small molecule and protein drugs have been gradually discovered during their development. They are close to small molecule drugs in terms of quality control levels and to protein drugs in terms of activity. Peptide drugs combine the advantages of both. Due to their high activity and selectivity, peptide drugs have an obvious advantage in treating complex diseases.
Data source: Analysis by Frost & Sullivan
Due to their biological activity and unique advantages, the research on peptide pharmaceutical processes has become a hot topic in current peptide research. While synthesis and separation purification technologies are continuously evolving, large-scale production still faces high barriers. The Report elaborates in detail on the technical barriers faced by peptide drugs during large-scale commercial production from two processes: synthesis and separation and purification, and summarizes peptide drugsCDMOAs for the service scope and main service advantages that third-party service providers can offer, in addition, the Report analyzes and predicts peptidesCDMOMarket scale.
03
Segmented areas —— CGT CDMO
Cell gene therapyCGT) has become a new generation of breakthrough precision treatment methods with significant therapeutic advantages, and related clinical translation and commercialization are accelerating. As of now, in the United StatesFDAApproved in total25modelCGT Products, including those modified with viral vectors, reaching 10The balance, with the growth in the number of listed products, will rapidly unlockCGTMarket scale, accelerateCGTThe pace of therapies moving from research and development to commercial production.
At the same time, as a hot research and development area, the rapid expansion of the R&D pipeline has generated huge demand for R&D and production. With the increasingly clear regulatory system, gradual increase in R&D investment, and the overall vigorous development of innovative industries, in the future, there will be moreCGTThe product has entered the clinical research and development phase.
Data source: Analysis by Frost & Sullivan
CGTThe commercial development of products requires large-scale production and sustainable supply, especially given the current rapid commercialization processCAR-TTaking the production process of cell products as an example, the Report deeply analyzes the main reasons that limit their feasibility:
· The production process and technology are complex, and the dilemma of insufficient production capacity urgently needs to be resolved.
· The production cost of drug research and development is high, and R&D enterprises have a strong willingness to reduce costs.
CGTThe production process of the product involves three relatively independent technological sectors: plasmid technology, viral vector technology, and cell technology. The Report summarizes the key difficulties and technological breakthroughs in each production link, tracking the current situationCGTThe future technological development direction of the field. For emerging therapiesCGTDrug research, development and productionCDMO company The service advantages provided by the service highlight its necessity. The Report sorts it outCGTCDMOThe service content and its core strengths, andCGT CDMOThe market scale was analyzed and predicted.
04
Segmented areas ——antibodyProtein/non-nucleic acid vaccine CDMO
Relying on the excellent efficacy of biologics, driven by the rapid development of biotechnology and increased R&D investment, a series of biological products represented by antibodies have gradually become the focus of global pharmaceutical industry development in recent years. The market size of biological products has been steadily increasing.
Data source: Analysis by Frost & Sullivan
Among them, antibody drugs have entered a period of vigorous development, with the market scale expanding rapidly.2017 Year-end2021Year from118RMB billion growth to585Yuan, with an annual compound growth rate of 49.2%. Antibody-drug conjugates (ADCs), a sub-segment of the oncology field, have been a hot area of research and development for anti-cancer drugs in recent years, with market size experiencing leapfrog growth. The Report summarizes bio-macromolecular drugsCDMOThe service content and core strengths are presented, followed by an analysis and prediction of the industry market size in recent years and for the future.
4
Performance of the capital market in the CDMO industry
CDMO companyThe competitiveness of enterprises mainly focuses on multiple aspects such as R&D capabilities, development and application of emerging technologies, quality systems, raw material supply, cost optimization, and production capacity. In order to further improve their industry competitiveness and provide customers with higher-quality solutions,CDMO company Enterprises continuously expand their production capacity, expand their business scope, and extend their service chain through a strategic model that combines endogenous development with external mergers and acquisitions. The Report summarizes several companies in the industry in recent yearsCDMOThe company's financing situation, key mergers and acquisitions events, and service cases.
Financing situation
domesticCDMOSeveral large-scale financing events have occurred consecutively in the industry, facilitated by capital injectionCDMOWith the rapid development of the industry, in terms of sub-sectors, the biopharmaceutical R&D field is particularly active.CDMOThe industry brings huge opportunities, and the capital market is bullish on biopharmaceuticalsCDMOandCGT CDMOThe company is quite popular.
M&A event
Domestic large pharmaceutical companies' acquisitionsCDMOEnterprises extend the industrial chain, optimize strategic layout, and seek business transformation; they continuously expand production capacity through mergers and acquisitions and further improve technical capabilities.
Order transaction event
CDMO companyThe industry continues to empower pharmaceutical enterprises, providing a series of customized R&D and production services; under the impact of the COVID-19 pandemic,CDMO company The enterprise has taken on a large number of orders for COVID-19 vaccines and therapeutic drugs.
5
domesticIntroduction to CDMO Companies
Wuxing Kangde: Mabtech is headquartered in2000Founded in Wuxi in [year], it started with compound discovery business and has expanded its business to preclinical areas through business extension, external mergers and acquisitions, etc. CRO, ClinicalCRO, CDMOIn fields such as biotechnology, the company has become an internationally leading technology platform providing comprehensive integrated laboratory R&D and production services from drug discovery and development to marketization. Its business coverage mainly includes chemical business, biological business, testing business, and cell and gene therapy.CTDMOBusiness, domestic new drug R&D services, five major modules.
Wuxing Biotech: Wuxing Biologics is a globally leading open and integrated biopharmaceutical capabilities and technology-enabled platform, offering excellence and uniquenessCRDMOThe model provides comprehensive end-to-end services to help partners discover, develop, and produce biopharmaceuticals, achieving the entire process from concept to commercial production, accelerating global biopharmaceutical R&D progress, and reducing R&D costs.
Kanglong Chemicals Kanglong Chemicals was founded in2004Founded in [year], it is a leading comprehensive pharmaceutical R&D and production outsourcing service provider in the industry. The company starts with experimental chemistry services at the drug discovery stage and continuously builds a deeply integrated "Full-process, integrated, and internationalized" A drug R&D service platform. Divided by main business type, Kanglong Chemical has established four major service sectors: laboratory services,CMC (small molecule CDMO) services, clinical research services, macromolecule and cell and gene therapy services. The business scope covers the globe, providing comprehensive R&D and production services for global pharmaceutical companies and new drug research institutions to accelerate drug innovation.
Dongyao Pharmaceutical: Dongyao Pharmaceutical was established in2010In [year], the company focused on the development and commercialization of innovative oncology drugs and therapies, aiming to become a professional provider of drug development services to clients around the world.CDMOPartnership. Dongyao Pharmaceutical adheres to"Quality Boost innovation Grow togetherWith the service concept of ”One-stop Solution for All Your Business Needs", relying on rich practical experience, mature technical platform and quality system, we can provide customized service solutions according to the needs of different partners. Through a perfect technology transfer process and high-standard GMP production platform, completeGMPThe quality system, experienced regulatory support, and mature and stable technical team provide biopharmaceuticals, especially antibody conjugatesOne-stop solution for ADC from R&D to commercial productionCDMOSolutions, empowering partners, and promoting high-quality industrial development.
Yaohai Biology: Yaohai Biology was established in2010Founded in [year], is a company specialized in microbial expression systemsCDMOService provider, dedicated to buildingCRO/CDMO/MAHAn open, comprehensive, and integrated R&D and production service platform. The company continuously improves and perfects its R&D, production, quality management, and control service systems, constructs distinctive platform technologies, and provides pharmaceutical companies at home and abroad with full lifecycle services from process development to commercial production, leveraging its comprehensive service capabilities, rich project experience, and leading scale advantages.CDMOServices, helping to smoothly advance customers' new drug projects and continuously empowering the development of the biopharmaceutical industry.
He Yuan Biology: He Yuan Biology was established in2013In [year], a biotechnology company focusing on the field of gene therapy, dedicated to providing basic research with gene therapy vectors development, gene function studies, drug target and efficacy research, etc.CROServices, providing process development and testing for the research and development of gene drugs,IND-CMC Pharmaceutical research, clinical samplesGMPproduction, etc.CDMOservice.
Kailaiying: Kailaiying Pharmaceutical Group is a global leaderCDMOThe company provides high-quality R&D and production services for new drugs globally, offering one-stop solutions to accelerate new drug launches and extend life quality. Relying on continuous technological innovation, it provides full lifecycle services for pharmaceutical companies and biotechnology companies at home and abroad.CMCServices, accelerating the development and application of new drugs.
Puxin Biology: Puxin Biotech focuses on the field of cell therapy drugs, independently developing a series of cell therapy-related technology platform systems, which can provide customers with one-stop cell therapy services.CDMOServices, helping more projects reach the next milestone earlier and more efficiently. Currently provided by the companyCDMOServices are mainly divided intoCAR-TcellCDMOservices andCAR-NK cellCDMOServices, products cover plasmids, lentiviruses, and cells.
Boteng Pharmaceutical: Boteng Pharmaceutical was established in2005In [year], it is a leading enterprise in ChinaCDMOThe enterprise is a national high-tech enterprise dedicated to providing customized research and development, as well as customized production services for pharmaceutical intermediates and bulk drugs required throughout the entire lifecycle, from early clinical research to drug launch, for global pharmaceutical companies and new drug R&D institutions.
Gensire: Kingsun Biotechnology(Gen ProBio)Genscript's Contract Research, Development and Manufacturing Organization for BiologicsCDMO), which has a one-stop biopharmaceutical R&D and production platform, is mainly committed to providing end-to-end services from target development to commercial production for antibody drugs as well as gene and cell therapy drugs.
Hiperu: Hiperu is located at1998Founded in Shenzhen inA+HA leading multinational pharmaceutical company with dual financing platforms, mainly covering the entire heparin industry chain and bio-macromoleculesCDMOInvesting in, developing, and commercializing innovative drugs. The company's three major business segments work together, driven by unmet clinical needs, aiming to provide high-quality safe and effective drugs and services for patients worldwide, thereby safeguarding health. Hypharma, through its two wholly-owned subsidiaries: Saiwan Biotechnology andSPLofCDMOThe platform jointly operates to drive rapid growthCDMOBusinesses aim to seize growth opportunities in the global biopharmaceutical industry and support the clinical research and development of innovative pipeline drugs.
Maberry: Maberry was established in2013In [year], a biopharmaceutical R&D andGMPA one-stop outsourcing service provider for production, the company mainly provides users with a range of biopharmaceutical R&D and production outsourcing services including monoclonal antibodies, recombinant proteins, antibody-drug conjugates, etc. In addition, it offers antibody-drug conjugation (A full-process solution for the synthesis of cytotoxins, linker production, and conjugation in ADC drug research and development.
Via Biology: ViaBio was established in2008In [year], leveraging structural-based drug discoverySBDD) technology leadership, and provide leadingCRODrug R&D services, and those that span the entire drug production processCDMOServices. Viva Biology's subsidiariesZhejiang Langhua Pharmaceutical Co., Ltd. is committed to providing professionalCDMOServices, from bulk drugs to formulations, from preclinical trials to commercial supply, covering the entire lifecycle of drugs with efficient, flexible, and high-quality one-stop solutions.
