Biologics CDMO Market

Biologics CDMO Market Size by Product Type (Monoclonal Antibodies (mAbs), Vaccines, Cell and Gene Therapies, Recombinant Proteins, Biosimilars and Other Biologics), Service Type (Contract Manufacturing, Contract Development, Fill-Finish Services, and Analytical & Quality Control Services), End-User (Pharmaceutical & Biotechnology Companies and Research Organizations & Institutes), Regions, Global Industry Analysis, Share, Growth, Trends, and Forecast 2025 to 2034

Base Year: 2024 Historical Data: 2021-23
  • Report ID: TBI-14672
  • Published Date: Mar, 2025
  • Pages: 231
  • Category: Healthcare
  • Format: PDF
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Segment Analysis

Regional segmentation analysis

The regions analyzed for the market include North America, Europe, South America, Asia Pacific, the Middle East, and Africa. North America emerged as the most significant global biologics CDMO market, with a 38% market revenue share in 2024.

North America leads the biologics Contract Development and Manufacturing Organization (CDMO) market because of its premier biopharmaceutical sector together with excellent infrastructure and major research and development investments. The United States leads globally in biologic production because pharmaceutical giants including Pfizer together with Amgen and Moderna strongly support monoclonal antibodies and gene therapies and biosimilar research and development. Market growth in the region continues to expand because these companies maintain more development services and manufacturing contracts with CDMOs. The United States Food and Drug Administration (FDA) regulates the region with its established Biologics License Application (BLA) approval system serving as a major reason for North America's pharmaceutical leadership. Massive financial support from both government agencies and private organizations for biopharmaceutical research in North America drives sustained developments of novel biologics that need large-scale production systems.

North America Region Biologics CDMO Market Share in 2024 - 38%

 

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  • The development of a new GMP biologics manufacturing facility in Mississauga, Ontario, to produce protein therapeutics and monoclonal antibodies (mAbs) for clinical and commercial purposes was announced by Eurofins CDMO Alphora Inc. The facility will strengthen Canada's biomanufacturing capabilities and readiness for future pandemics, as well as the country's biologics ecosystem and job base. This investment has been bolstered by significant support from the Federal Government of Canada and a contribution through the Strategic Initiative Fund (SIF).

Product Type Segment Analysis

The product type segment is divided into monoclonal antibodies (mAbs), vaccines, cell and gene therapies, recombinant proteins, biosimilars and other biologics. The monoclonal antibodies (mAbs) segment dominated the market, with a market share of around 34% in 2024. Monoclonal antibodies serve multiple disease conditions including cancers and autoimmune diseases and infectious pathogens. The pharmaceutical industry accepts monoclonal antibodies due to their capability to adjust immune responses and stop disease progression as well as supply specific therapeutic approaches. The escalating demand for biologic research and development of monoclonal antibodies drives pharmaceutical companies to seek out large-scale manufacturing services which Contract Development and Manufacturing Organisations (CDMOs) are perfectly positioned to deliver. Industry demand for mAbs increases because biotechnology advancement like recombinant DNA technology and hybridoma techniques enhance both production efficiency and therapeutic capability. Monoclonal antibodies will keep maintaining their position as the dominating sector in the biologics CDMO market because of sustained innovation and increasing international market demand.

  • At the BIO-Europe 2024 conference, which was held in Stockholm, Scinai Immunotherapeutics Ltd., a biopharmaceutical company that specializes in inflammation and immunology (I&I) biological products and offers CDMO services through its Scinai Bioservices unit, announced that it will be exhibiting its CDMO services and showcasing its innovative I&I product pipeline in partnership meetings.

Service type Segment Analysis

The service type segment is divided into contract manufacturing, contract development, fill-finish services, and analytical & quality control services. The contract manufacturing segment dominated the market, with a market share of around 38% in 2024. The biologics CDMO market receives most of its business from contract manufacturing because manufacturing biologics poses significant challenges in terms of cost and complexity and regulatory requirements. The complex manufacturing procedures together with specialized production facilities as well as demanding quality control requirements make in-house production of biologics an expensive operation beyond the capabilities of many pharmaceutical and biotech companies. Many companies now choose CDMO outsourcing because it enables them to access specialized contract manufacturing facilities together with dedicated expertise in order to achieve superior business results. The dominance of contract manufacturing results mainly from increasing market requirements for biologic therapies that include monoclonal antibodies and vaccines and gene therapies. The worldwide increase of approved biologic drugs requires pharmaceutical companies to develop large-scale productive capabilities for global market distribution. CDMOs offer complete manufacturing solutions by handling product production and packaging operations through their fill-finish services and upstream and downstream processes to maintain GMP compliance for efficient operations. 

  • Oklahoma-based Cytovance Biologics and California-based Celltheon have teamed up to provide an enhanced, integrated solution that combines Celltheon's industry-leading CHO-K1-based cell line development platform with Cytovance's fully integrated CDMO services in order to better support the growing demand for the development and manufacturing of more complex biologics, particularly in US-based facilities.

End user Segment Analysis

The end user segment is divided into pharmaceutical & biotechnology companies and research organizations & institutes. The pharmaceutical & biotechnology companies segment dominated the market, with a market share of around 58% in 2024. The dominant role in the biologics Contract Development and Manufacturing Organization (CDMO) market belongs to pharmaceutical and biotechnology companies since they require outsourced biologics development and production services extensively. The dominance of biotech sector is directly linked to the activities of small and mid-sized businesses who conduct drug research while lacking the capabilities to produce on larger manufacturing levels. CDMOs enable pharmaceutical clients to develop drugs more quickly by providing manufacturing services at lower costs thus reducing time to market with no need to build their own facilities. Pharmaceutical organizations are now turning to CDMOs regularly to develop their biologics product ranges while satisfying international market requirements since biologics manufacturing depends on modern production standards and increasing regulatory requirements. 

  • An unnamed European biopharmaceutical company and Samsung Biologics Co., the largest contract drugmaker in the world, inked two medication manufacturing contracts totalling USD 668 million.

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This study forecasts revenue at global, regional, and country levels from 2021 to 2034. The Brainy Insights has segmented the global biologics CDMO market based on below mentioned segments:

Global Biologics CDMO Market by Product Type:

  • Monoclonal Antibodies (mAbs)
  • Vaccines
  • Cell and Gene Therapies
  • Recombinant Proteins
  • Biosimilars
  • Other Biologics

Global Biologics CDMO Market by Service Type:

  • Contract Manufacturing
  • Contract Development
  • Fill-Finish Services
  • Analytical & Quality Control Services

Global Biologics CDMO Market by End User:

  • Pharmaceutical & Biotechnology Companies
  • Research Organizations & Institutes

Global Biologics CDMO Market by Region:

  • North America
    • U.S.
    • Canada
    • Mexico
  • Europe
    • Germany
    • France
    • U.K.
    • Italy
    • Spain
  • Asia-Pacific
    • Japan
    • China
    • India
  • South America
    • Brazil
  • Middle East and Africa  
    • UAE
    • South Africa

Methodology

Research has its special purpose to undertake marketing efficiently. In this competitive scenario, businesses need information across all industry verticals; the information about customer wants, market demand, competition, industry trends, distribution channels etc. This information needs to be updated regularly because businesses operate in a dynamic environment. Our organization, The Brainy Insights incorporates scientific and systematic research procedures in order to get proper market insights and industry analysis for overall business success. The analysis consists of studying the market from a miniscule level wherein we implement statistical tools which helps us in examining the data with accuracy and precision. 

Our research reports feature both; quantitative and qualitative aspects for any market. Qualitative information for any market research process are fundamental because they reveal the customer needs and wants, usage and consumption for any product/service related to a specific industry. This in turn aids the marketers/investors in knowing certain perceptions of the customers. Qualitative research can enlighten about the different product concepts and designs along with unique service offering that in turn, helps define marketing problems and generate opportunities. On the other hand, quantitative research engages with the data collection process through interviews, e-mail interactions, surveys and pilot studies. Quantitative aspects for the market research are useful to validate the hypotheses generated during qualitative research method, explore empirical patterns in the data with the help of statistical tools, and finally make the market estimations.

The Brainy Insights offers comprehensive research and analysis, based on a wide assortment of factual insights gained through interviews with CXOs and global experts and secondary data from reliable sources. Our analysts and industry specialist assume vital roles in building up statistical tools and analysis models, which are used to analyse the data and arrive at accurate insights with exceedingly informative research discoveries. The data provided by our organization have proven precious to a diverse range of companies, facilitating them to address issues such as determining which products/services are the most appealing, whether or not customers use the product in the manner anticipated, the purchasing intentions of the market and many others.

Our research methodology encompasses an idyllic combination of primary and secondary initiatives. Key phases involved in this process are listed below:

MARKET RESEARCH PROCESS

Data Procurement:

The phase involves the gathering and collecting of market data and its related information with the help of different sources & research procedures.

The data procurement stage involves in data gathering and collecting through various data sources.

This stage involves in extensive research. These data sources includes:

Purchased Database: Purchased databases play a crucial role in estimating the market sizes irrespective of the domain. Our purchased database includes:

  • The organizational databases such as D&B Hoovers, and Bloomberg that helps us to identify the competitive scenario of the key market players/organizations along with the financial information.
  • Industry/Market databases such as Statista, and Factiva provides market/industry insights and deduce certain formulations. 
  • We also have contractual agreements with various reputed data providers and third party vendors who provide information which are not limited to:
    • Import & Export Data
    • Business Trade Information
    • Usage rates of a particular product/service on certain demographics mainly focusing on the unmet prerequisites

Primary Research: The Brainy Insights interacts with leading companies and experts of the concerned domain to develop the analyst team’s market understanding and expertise. It improves and substantiates every single data presented in the market reports. Primary research mainly involves in telephonic interviews, E-mail interactions and face-to-face interviews with the raw material providers, manufacturers/producers, distributors, & independent consultants. The interviews that we conduct provides valuable data on market size and industry growth trends prevailing in the market. Our organization also conducts surveys with the various industry experts in order to gain overall insights of the industry/market. For instance, in healthcare industry we conduct surveys with the pharmacists, doctors, surgeons and nurses in order to gain insights and key information of a medical product/device/equipment which the customers are going to usage. Surveys are conducted in the form of questionnaire designed by our own analyst team. Surveys plays an important role in primary research because surveys helps us to identify the key target audiences of the market. Additionally, surveys helps to identify the key target audience engaged with the market. Our survey team conducts the survey by targeting the key audience, thus gaining insights from them. Based on the perspectives of the customers, this information is utilized to formulate market strategies. Moreover, market surveys helps us to understand the current competitive situation of the industry. To be precise, our survey process typically involve with the 360 analysis of the market. This analytical process begins by identifying the prospective customers for a product or service related to the market/industry to obtain data on how a product/service could fit into customers’ lives.

Secondary Research: The secondary data sources includes information published by the on-profit organizations such as World bank, WHO, company fillings, investor presentations, annual reports, national government documents, statistical databases, blogs, articles, white papers and others. From the annual report, we analyse a company’s revenue to understand the key segment and market share of that organization in a particular region. We analyse the company websites and adopt the product mapping technique which is important for deriving the segment revenue. In the product mapping method, we select and categorize the products offered by the companies catering to domain specific market, deduce the product revenue for each of the companies so as to get overall estimation of the market size. We also source data and analyses trends based on information received from supply side and demand side intermediaries in the value chain. The supply side denotes the data gathered from supplier, distributor, wholesaler and the demand side illustrates the data gathered from the end customers for respective market domain.

The supply side for a domain specific market is analysed by:

  • Estimating and projecting penetration rates through analysing product attributes, availability of internal and external substitutes, followed by pricing analysis of the product.
  • Experiential assessment of year-on-year sales of the product by conducting interviews.

The demand side for the market is estimated through:

  • Evaluating the penetration level and usage rates of the product.
  • Referring to the historical data to determine the growth rate and evaluate the industry trends

In-house Library: Apart from these third-party sources, we have our in-house library of qualitative and quantitative information. Our in-house database includes market data for various industry and domains. These data are updated on regular basis as per the changing market scenario. Our library includes, historic databases, internal audit reports and archives.

Sometimes there are instances where there is no metadata or raw data available for any domain specific market. For those cases, we use our expertise to forecast and estimate the market size in order to generate comprehensive data sets. Our analyst team adopt a robust research technique in order to produce the estimates:

  • Applying demographic along with psychographic segmentation for market evaluation
  • Determining the Micro and Macro-economic indicators for each region 
  • Examining the industry indicators prevailing in the market. 

Data Synthesis: This stage involves the analysis & mapping of all the information obtained from the previous step. It also involves in scrutinizing the data for any discrepancy observed while data gathering related to the market. The data is collected with consideration to the heterogeneity of sources. Robust scientific techniques are in place for synthesizing disparate data sets and provide the essential contextual information that can orient market strategies. The Brainy Insights has extensive experience in data synthesis where the data passes through various stages:

  • Data Screening: Data screening is the process of scrutinising data/information collected from primary research for errors and amending those collected data before data integration method. The screening involves in examining raw data, identifying errors and dealing with missing data. The purpose of the data screening is to ensure data is correctly entered or not. The Brainy Insights employs objective and systematic data screening grades involving repeated cycles of quality checks, screening and suspect analysis.
  • Data Integration: Integrating multiple data streams is necessary to produce research studies that provide in-depth picture to the clients. These data streams come from multiple research studies and our in house database. After screening of the data, our analysts conduct creative integration of data sets, optimizing connections between integrated surveys and syndicated data sources. There are mainly 2 research approaches that we follow in order to integrate our data; top down approach and bottom up approach.

Market Deduction & Formulation: The final stage comprises of assigning data points at appropriate market spaces so as to deduce feasible conclusions. Analyst perspective & subject matter expert based holistic form of market sizing coupled with industry analysis also plays a crucial role in this stage.

This stage involves in finalization of the market size and numbers that we have collected from data integration step. With data interpolation, it is made sure that there is no gap in the market data. Successful trend analysis is done by our analysts using extrapolation techniques, which provide the best possible forecasts for the market.

Data Validation & Market Feedback: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helps us finalize data-points to be used for final calculations.

The Brainy Insights interacts with leading companies and experts of the concerned domain to develop the analyst team’s market understanding and expertise. It improves and substantiates every single data presented in the market reports. The data validation interview and discussion panels are typically composed of the most experienced industry members. The participants include, however, are not limited to:

  • CXOs and VPs of leading companies’ specific to sector
  • Purchasing managers, technical personnel, end-users
  • Key opinion leaders such as investment bankers, and industry consultants

Moreover, we always validate our data and findings through primary respondents from all the major regions we are working on.

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