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    Home > Active Ingredient News > Drugs Articles > Sullivan: Research Report on the Development Status and Future Trend of CDMO Industry

    Sullivan: Research Report on the Development Status and Future Trend of CDMO Industry

    • Last Update: 2022-10-14
    • Source: Internet
    • Author: User
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    Under the boom of innovation and research and development, the competition in the pharmaceutical industry is becoming increasingly fierce, and the division of labor in the pharmaceutical industry chain is gradually specialized, refined and customized
    .
    With its own technical advantages and production capabilities to help pharmaceutical companies achieve from concept to product, from process development to large-scale production, commissioning CDMO enterprises has become an important path
    for innovative research and development and production.
    Start-ups and large pharmaceutical companies can benefit from the quality services provided by CDMO, which also follows the rapid changes in the pharmaceutical market, continuously optimizing its technology platform, expanding its business scope and extending the industrial chain to meet the actual needs
    of different types of customers 。 On September 28, 2022, Frost & Sullivan (hereinafter referred to as "Sullivan") officially released the "CDMO Market Development Status and Future Trend Research Report" (hereinafter referred to as the "Report"), which provides in-depth analysis of China's CDMO industry, excavates the industry value of CDMO from many aspects such as industry overview, capital heat and competitive landscape, explores the driving force behind the development of the industry, and tracks the iterative context of production process technology
    。 This report focuses on the overall operation of the CDMO industry, while focusing on the development status
    of each CDMO segment.

    PART 01 CDMO Industry Overview

    PART 01 CDMO Industry Overview

    CDMO Introduction - Multiple factors have spawned the CDMO industry, and the industry has entered a stage of stable development

    CDMO Introduction - Multiple factors have spawned the CDMO industry, and the industry has entered a stage of stable development

    CDMO from the CMO evolution, iterative upgrade, with the increasingly fierce competition between pharmaceutical companies, the traditional CMO enterprises to carry out simple foundry production can not meet the needs of pharmaceutical companies to reduce costs and increase efficiency, on this basis, can use their own production equipment and technical advantages to help pharmaceutical companies optimize the production process, CDMO enterprises for customized large-scale production followed
    .
    The CDMO industry has been developing since the beginning of its inception and has now entered a period
    of stable development.

    CDMO service scope - CDMO provides pharmaceutical companies with multi-dimensional drug research and development and production work, and the service field continues to extend to the upstream and downstream of the industry

    CDMO service scope - CDMO provides pharmaceutical companies with multi-dimensional drug research and development and production work, and the service field continues to extend to the upstream and downstream of the industry

    CDMO provides R&D services and capacity support with added value to technology throughout all phases
    of R&D.
    The service scope of CDMO enterprises for pharmaceutical companies includes CMC services in the pre-clinical and clinical stages, process development, production and packaging services for APIs, intermediates, and preparations
    .
    In the drug development stage, CDMO can improve the efficiency of drug development and reduce the cost of drug research and development; In the stage of drug commercialization, CDMO can reduce the production cost and improve production efficiency of enterprises through continuous process optimization, while ensuring product quality and supply stability
    .

    CDMO segmentation – Due to the differences in R&D and production of various types of drugs, the CDMO industry is gradually subdivided into small molecules, large molecules and CGT CDMO

    CDMO segmentation – Due to the differences in R&D and production of various types of drugs, the CDMO industry is gradually subdivided into small molecules, large molecules and CGT CDMO

    According to the type of drug, the current CDMO subdivision can be mainly divided into three categories
    : small molecule CDMO, large molecule CDMO (including peptides/antibodies/proteins/vaccines, etc.
    ) and cell gene therapy (CGT) CDMO 。 Small molecule drugs have simple structure, strong detachability of chemical synthesis steps, and most compounds have the characteristics of high stability and convenient transportation, so small molecule CDMO products have a standardized process, follow the product preparation path of "basic chemicals - Non-GMP intermediates - GMP intermediates - APIs - preparations", and the production path is easy to industrialize; Compared with small molecule chemical drugs, the structure of macromolecular biological drugs is more complex, its development cost and production/imitation difficulty are higher, and leading enterprises of macromolecular CDMO occupy a higher market share with advantages such as technology and production capacity; The cell and gene therapy production process is complex, the technical barriers are high, and it is still in the early stage of development, but its global pipeline under research is growing rapidly, and the CDMO industry, which relies on the CGT industry trend, has also developed rapidly
    .

    CDMO industry chain and service advantages - CDMO is the core participant of the drug research and development industry chain, and cooperation with CDMO can enhance the core competitiveness of pharmaceutical enterprises

    CDMO industry chain and service advantages - CDMO is the core participant of the drug research and development industry chain, and cooperation with CDMO can enhance the core competitiveness of pharmaceutical enterprises

    The upstream of the CDMO industry is a fine chemical company responsible for providing basic chemical raw materials, and special pharmaceutical raw materials
    can be prepared through classified processing.
    The preparation of APIs is the basis of drug research and development, and its main purpose is to provide qualified APIs for pharmacology and toxicology, preparation, clinical and other research in the process of drug research and development, to provide information for quality research, and to ensure the stability and feasibility
    of the production process.
    CDMO enterprises carry out quality verification of raw materials, and process professional pharmaceutical raw materials to starting materials, intermediates, APIs, and preparations to downstream pharmaceutical enterprises, biotechnology companies, and academic research and development institutions
    .

    The report explains that the CDMO industry, as an important participant in pharmaceutical R&D and production, will empower pharmaceutical companies from the following four aspects: assisting R&D and production, reducing enterprise costs, improving service efficiency, and promoting technology iteration
    .

    PART 02 CDMO Industry Market Size and Development Trends

    PART 02 CDMO Industry Market Size and Development Trends

    Global and China CDMO Industry Market Size Analysis - China's overall CDMO market size will be expanded at a growth rate exceeding the global growth rate, and its share of the global market will continue to rise

    Global and China CDMO Industry Market Size Analysis - China's overall CDMO market size will be expanded at a growth rate exceeding the global growth rate, and its share of the global market will continue to rise

    From a global perspective, the CDMO industry is in a trend of continuous volume development and maintains a high market momentum, from 2017 to 2021, the global CDMO market size will grow from US$39.
    4 billion to US$63.
    2 billion, with a compound annual growth rate of 12.
    5%, and is expected to reach US$124.
    3 billion in 2025 and US$231 billion
    in 2030.

    The report estimates the size of the global and Chinese CDMO markets,

    CDMO plays an important role in the drug innovation industry chain, with the rapid development of China's innovative drug research and development format, CDMO industry development momentum is strong, in recent years ushered in rapid growth, from 2017 to 2021, China's CDMO market size from 13.
    2 billion yuan to 47.
    3 billion yuan, the compound annual growth rate of 37.
    7%.

    It is expected to reach $157.
    1 billion in 2025 and $355.
    9 billion
    in 2030.
    China's CDMO industry has shown rapid growth higher than the global level, and the proportion of China's CDMO market in the global market has increased
    year by year.
    China's CDMO market accounted for only 5.
    0% of the total global CDMO market in 2017, has expanded to 13.
    2% by 2021, and is expected to occupy one-fifth of
    the global market after 2025.

    China CDMO Market Driver Analysis

    China CDMO Market Driver Analysis

    The report will cut into the driving factors
    behind the development of the CDMO industry from the four core perspectives of pharmaceutical R&D investment, industry policy dividends, talent and cost advantages and technology platform innovation.

    The report will cut into the driving factors
    behind the development of the CDMO industry from the four core perspectives of pharmaceutical R&D investment, industry policy dividends, talent and cost advantages and technology platform innovation.

    Pharmaceutical R&D investment: In recent years, the scale of pharmaceutical R&D investment in China has shown a steady growth trend, which has increased from US$14.
    3 billion in 2017 to US$29 billion
    .
    The increasing R&D expenditure provides more active and abundant financial resources for innovative drug research and development, benefiting from the prosperity of the overall pharmaceutical market and the research and development of innovative drugs, and the CDMO market will be further expanded in the future
    .

    Industry policy dividend: The promulgation of a series of pharmaceutical industry policies and the implementation of the system have created opportunities
    for the development of the CDMO industry.
    The implementation of policies such as the drug marketing authorization holder system (MAH system), the reform of the new drug review and approval system, the procurement with quantity and medical insurance negotiation has created a favorable environment
    for the development of China's CDMO industry.

    Talent and cost advantages: CDMO is a technology-intensive industry, and a large number of professional and technical personnel
    are required for drug development and production process optimization.
    China's CDMO industry has both a considerable number of human resources and significant cost advantages, which can meet the needs of pharmaceutical companies for cost control when choosing production outsourcing services, and to a certain extent, ensure the growth space
    of China's CDMO industry.

    Technology Platform Innovation: The CDMO industry undertakes the process development and production functions of pharmaceutical companies, and compared with CMO companies with a single capacity output, CDMO companies pay more attention to the innovation ability
    of production processes in the R&D process.
    Industry players are also constantly upgrading their industries and providing more diversified services
    by innovating technology platforms and R&D capabilities.

    Analysis of the development trend of China's CDMO market

    Analysis of the development trend of China's CDMO market

    Based on the current situation of the market and the overall trend, the report looks forward to the future development trend of the CDMO industry from three important dimensions:

    The report looks forward to the future development trend of the CDMO industry from three important dimensions:

    Through horizontal integration, we will expand production capacity, accumulate customer resources, and accelerate the pace of global expansion

    Multi-path extends the business scope, lays out a complete industrial service chain, and builds a one-stop service platform

    Business and service models continue to innovate to create distinctive and differentiated advantages
    .

    PART 03 CDMO Industry Segments

    PART 03 CDMO Industry Segments

    Subdivision - small molecule chemical drug CDMO

    Subdivision - small molecule chemical drug CDMO

    Modern drug research and development starts from chemical drugs, chemical drug technology tends to mature, and its progress in the transformation process of scientific research results is relatively fast
    .
    Despite the rapid development of emerging fields such as biopharmaceuticals and cell gene therapy in recent years, chemical drugs are still the mainstream forms of
    drugs.

    With the deepening of the research on the disease mechanism, drug research and development has gradually entered the era of precision treatment for target research and development, and the corresponding new drug properties have undergone more obvious changes: drugs have more accurate and selective targeted effects, and the components of highly active drugs have increased; The molecular weight of the drug has become significantly larger and the structure is more complex; The water solubility and permeability of the drug become low
    .
    A series of changes in the properties of new chemical drugs also need to be followed up
    by corresponding emerging synthesis and formulation technologies.
    In addition, the difficulty of exploring and discovering new molecular solid drugs has brought about higher investment costs in new drug research and development, increased risk factors, market competition tends to be fierce, drug research and development has thus entered the era of drug preparation innovation, the research and production of new high-end complex preparations has also brought new challenges to the chemical pharmaceutical process, and the small molecule CDMO industry has also built a series of advanced process technology platforms with these new drug molecules to expand its series of service capabilities
    from laboratory to laboratory 。 The report subsequently summarizes the service scope and main service advantages of small molecule chemical drug CDMO, and further reflects the comprehensive service capability
    of small molecule chemical drug CDMO by emulating a series of technologies and equipment that CDMO enterprises can provide in the R&D and production process.
    In addition, the report includes the development of the global and Chinese small molecule chemical CDMO market size in recent years, as well as the forecast
    of future growth space trends.

    The report subsequently summarizes the service scope and main service advantages of small molecule chemical drug CDMO, and further reflects the comprehensive service capability
    of small molecule chemical drug CDMO by emulating a series of technologies and equipment that CDMO enterprises can provide in the R&D and production process.
    In addition, the report includes the development of the global and Chinese small molecule chemical CDMO market size in recent years, as well as the forecast
    of future growth space trends.

    Subdivision - Peptide Drug CDMO

    Subdivision - Peptide Drug CDMO

    The advantages of peptide drugs compared to small molecule chemicals and protein drugs have been gradually explored in the process of their development, close to small molecule drugs in terms of quality control level, close to protein drugs in terms of activity, and have the advantages of both, because peptide drugs have high activity and selectivity, which has obvious
    advantages in the treatment of complex diseases.

    Due to the biological activity and unique advantages, the research of peptide pharmaceutical process has become a hot spot in the current research of polypeptides, and its synthesis and separation and purification technology is in the process of continuous iteration, but there are still high barriers to
    large-scale production.
    The report elaborates the technical barriers faced by peptide drugs in large-scale commercial production from the two stages of synthesis and isolation and purification, summarizes the service range of peptide drug CDMO as a third-party service provider and its main service advantages, in addition, the report analyzes and predicts the market size of
    peptide CDMO.

    The report elaborates the technical barriers faced by peptide drugs in large-scale commercial production from the two stages of synthesis and isolation and purification, summarizes the service range of peptide drug CDMO as a third-party service provider and its main service advantages, in addition, the report analyzes and predicts the market size of
    peptide CDMO.

    Subdivision - CGT CDMO

    Subdivision - CGT CDMO

    Cell gene therapy (CGT) has become a breakthrough precision treatment for a new generation with significant therapeutic advantages, and clinical transformation and commercialization are accelerating
    .
    Up to now, the US FDA has approved a total of 25 CGT products, including more than 10 products containing viral vector modification, and the growth of the number of listed products will quickly open up the CGT market scale and accelerate the pace
    of CGT therapy from research and development to commercial production.
    At the same time, as a hot research and development field, the rapid expansion of the research pipeline has spawned a huge demand for research and development, with the regulatory system becoming clearer, the R&D investment gradually increasing and the overall vigorous development of the innovation industry, there will be more CGT products in China in the future into the clinical research and development stage
    .

    The commercial development of CGT products needs to achieve large-scale production and sustainable supply, taking the production process of CAR-T cell products, which is currently the most rapid commercialization process, as an example, the report deeply analyzes the main reasons that limit its feasibility:

    The commercial development of CGT products needs to achieve large-scale production and sustainable supply, taking the production process of CAR-T cell products, which is currently the most rapid commercialization process, as an example, the report deeply analyzes the main reasons that limit its feasibility:

    The production process and process are complex, and the dilemma of insufficient production capacity needs to be solved urgently

    Drug research and development and production costs are high, and R&D enterprises have a strong willingness to reduce costs

    The production process of CGT products involves three independent process plates: plasmid process, viral vector process and cell process, and the "Report" summarizes the key difficulties and technical breakthrough points in each production link, and tracks the future process development direction
    of the current CGT field.
    For the development and production of CGT drugs for emerging therapies, the service advantages provided by CDMO services highlight its necessity, and the report sorts out the service content of CGT CDMO and its core advantages, and analyzes and forecasts
    the market size of CGT CDMO.

    The "Report" summarizes the key difficulties and technological breakthrough points in each production link, and tracks the future process development direction
    of the current CGT field.
    The report sorts out the service content of CGT CDMO and its core advantages, and analyzes and forecasts
    the market size of CGT CDMO.

    Segmentation - Antibody/Protein/Non-Nucleic Acid Vaccine CDMO

    Segmentation - Antibody/Protein/Non-Nucleic Acid Vaccine CDMO

    With the excellent efficacy of biological drugs, under the rapid development of biotechnology and the increase in R&D investment, a series of biological products represented by antibodies have gradually become the focus of development of the global pharmaceutical industry in recent years, and the market size of biological products has risen
    steadily.

    Among them, antibody drugs have entered a stage of vigorous development, and the market scale has expanded rapidly, growing from 11.
    8 billion yuan to 58.
    5 billion yuan from 2017 to 2021, with an annual compound growth rate of 49.
    2%.

    Subdivision track antibody conjugated drugs (ADCs) are a hot field in the research and development of anti-cancer drugs in recent years, and the market size has also achieved leapfrog growth
    .
    The report summarizes the service content and core advantages of biomacromolecule drug CDMO, and subsequently analyzes and predicts the market size of the industry in recent years and in the
    future.

    The report summarizes the service content and core advantages of biomacromolecule drug CDMO, and subsequently analyzes and predicts the market size of the industry in recent years and in the
    future.

    PART 04 CDMO Industry Capital Market Performance

    PART 04 CDMO Industry Capital Market Performance

    CDMO enterprise competitiveness is mainly concentrated in R & D capabilities, emerging technology development and application, quality system, raw material supply, cost optimization and production capacity and other aspects, in order to further improve their own industry competitiveness, to provide customers with better solutions, CDMO enterprises continue to expand production capacity, expand business scope, extend the service chain
    through endogenous development and epitaxial mergers and acquisitions and strategic model.
    The "Report" summarizes the financing, key mergers and acquisitions and service cases
    of many CDMO companies in the industry in recent years.

    The "Report" summarizes the financing, key mergers and acquisitions and service cases
    of many CDMO companies in the industry in recent years.

    Financing: The domestic CDMO industry has a number of large-scale financing events, the injection of capital has helped the rapid development of the CDMO industry, from the perspective of subdivision, the field of biopharmaceutical research and development is hot, bringing great opportunities to the CDMO industry, and the capital market has a high
    degree of popularity for biopharmaceutical CDMO and CGT CDMO enterprises.

    Financing:

    M&A events: Large domestic pharmaceutical companies acquire CDMO enterprises to extend the industry chain, optimize the strategic layout, and seek business transformation; Continuous expansion of production capacity and further improvement of technical capabilities
    through M&A activities.

    M&A Events:

    Order transaction events: The CDMO industry continues to empower pharmaceutical companies to provide a series of customized R&D and production services; Under the impact of the new crown epidemic, CDMO companies have received a large number of orders
    for new crown vaccines and therapeutic drugs.

    Order Trading Events:

    PART 05 Introduction of some CDMO companies in China

    PART 05 Introduction of some CDMO companies in China

    WuXi AppTec: Founded in Wuxi in 2000, WuXi AppTec started from the compound discovery business, extended its business to preclinical CRO, clinical CRO, CDMO and other fields through business extension, epitaxial mergers and acquisitions, etc.
    , and has become an international leading technology platform company
    that provides comprehensive integrated laboratory R&D and production services from drug discovery, development to marketization.
    Its business coverage mainly includes five modules
    : chemical business, biology business, testing business, cell and gene therapy CTDMO business, and domestic new drug research and development services.

    WuXi AppTec:

    WuXi Biologics: WuXi Biologics is the world's leading open, integrated biopharmaceutical capabilities and technology empowerment platform, providing a full range of end-to-end services with an excellent and unique CRDMO model, helping partners discover, develop and produce biologics, realize the entire process from concept to commercial production, accelerate the global biopharmaceutical research and development process, and reduce R&D costs
    .

    WuXi Biologics:

    Kanglong Chemical Formation: Founded in 2004, Kanglong Chemical Formation is a leading integrated service provider
    of pharmaceutical R&D and production outsourcing.
    Starting from the experimental chemistry business in the drug discovery stage, the company continues to build a deeply integrated "whole process, integrated, and international" drug research and development service platform
    .
    According to the main business type, Kanglong Chemical has set up four major service segments: laboratory services, CMC (small molecule CDMO) services, clinical research services, macromolecules and cell and gene therapy services
    .
    The global business scope provides comprehensive R&D and production services for global pharmaceutical companies and new drug R&D institutions to accelerate drug innovation
    .

    Kang Long Chemical Formation:

    Dongyao Pharmaceutical: Founded in 2010, Dongyao Pharmaceutical focuses on the development and commercialization of innovative oncology drugs and therapies, and is committed to becoming a professional CDMO partner
    for global drug development customers 。 Dongyao Pharmaceutical adheres to the service concept of "quality to help innovation and grow together", with rich practical experience and mature technology platform and quality system, can provide customized service solutions according to the needs of different partners, through a perfect technology transfer process, high-specification GMP production platform, complete GMP quality system, experienced regulatory support and mature and stable technical team, to provide one-stop CDMO solutions for biopharmaceuticals, especially antibody-conjugated drugs (ADCs) from research and development to commercial production.
    Empower partners and promote high-quality industrial development
    .

    Dongyao Pharmaceutical:

    Yaohai Biologics: Founded in 2010, Yaohai Biologics is a professional microbial expression system CDMO service provider, committed to creating CRO/CDMO/MAH OPEN, ALL-ROUND AND INTEGRATED PRODUCTION AND RESEARCH SERVICE PLATFORM
    。 The company continuously improves and improves the R&D, production, quality management and control service system, builds a characteristic platform technology, and provides domestic and foreign pharmaceutical companies with full-life cycle CDMO services from process development to commercial production with comprehensive service capabilities, rich project experience and scale leading advantages, boosting the smooth progress of customer new drug projects and continuously empowering
    the development of the biomedical industry.

    Yaohai Biology:

    Heyuan Biologics: Founded in 2013, Heyuan Bio is a biotechnology company focusing on the field of gene therapy, focusing on providing CRO services such as gene therapy vector development, gene function research, drug target and efficacy research for the basic research of gene therapy, and CDMO services
    such as process development and testing, IND-CMC pharmaceutical research, and clinical sample GMP production for the research and development of gene drugs.

    Heyuan Biology:

    Kailaiying: Kailaiying Pharmaceutical Group is a world-leading CDMO company, providing high-quality one-stop service for the research and development and production of new drugs around the
    world.
    With the mission of accelerating the listing of new drugs and prolonging the quality of life, relying on continuous technological innovation, we provide one-stop CMC services for the whole life cycle of drugs for domestic and foreign pharmaceutical companies and biotechnology companies, and accelerate the development and application
    of new drugs.

    Kai Laiying:

    Spectrum New Biology: Focusing on the field of cell therapy drugs, Spectrum New Biology has independently developed a series of cell therapy-related technology platform systems to provide customers with one-stop cell therapy CDMO services and help more projects reach the next milestone
    earlier and faster.
    At present, the CDMO services provided by the company are mainly divided into CAR-T cell CDMO service and CAR-NK cell CDMO service, covering plasmids, lentiviruses and cells
    .

    Spectrum of new creatures:

    Boten Pharmaceutical: Founded in 2005, Boten Pharmaceutical is a leading CDMO enterprise in China, committed to providing global pharmaceutical companies, new drug research and development institutions with pharmaceutical intermediates and API customized research and development and customized production services required from early clinical research to the whole life cycle of drug listing
    .

    Boten Pharmaceuticals:

    GenProBio, a biomedical contract R&D and production organization (CDMO) of Kingsra, has a one-stop biopharmaceutical R&D and production platform, mainly committed to providing end-to-end services
    from target development to commercial production for antibody drugs and gene and cell therapy drugs.

    Kingsley:

    Hepalink: Founded in Shenzhen in 1998, Hepalink is a leading multinational pharmaceutical company with an A+H dual financing platform, whose main business covers the investment, development and commercialization of
    heparin industry chain, biomacromolecule CDMO and innovative drugs.
    The company's three business segments work together to drive unmet clinical needs and are committed to providing high-quality, safe, effective drugs and services to patients around the world to protect health
    .
    Hepalink operates the fast-growing CDMO business through the CDMO platforms of its two wholly owned subsidiaries, Saiwan Biologics and SPL, to capture growth opportunities in the global biopharmaceutical industry and to support the clinical development
    of the company's innovative pipeline of drugs.

    Hepalink:

    Obery: Founded in 2013, Mindray is a one-stop outsourcing service provider for biodrug research and development and GMP production, the company mainly provides users with a series of bio-drug development and production outsourcing services such as monoclonal antibodies, recombinant proteins, antibody drug coupling, etc.
    , in addition, provides cytotoxin synthesis, link sub-production to coupling of the whole process of
    antibody drug conjugation (ADC) drug research and development process.

    Melbery:

    Viva Biologics: Founded in 2008, Viva Biologics leverages its technological strengths in structure-based drug discovery (SBDD) to provide leading CRO drug discovery services to partners around the world, as well as CDMO services
    throughout the drug manufacturing process.
    Zhejiang Longhua Pharmaceutical Co.
    , Ltd.
    , a subsidiary of Weiya Biologics, is committed to providing professional CDMO services, from APIs to preparations, from preclinical to commercial supply, covering the entire life cycle of drugs with efficient, flexible and high-quality one-stop solutions
    .

    Viva Biologics:
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