The
global biologics CDMO market size was valued at USD
21.96 billion in 2024 and is expected to reach around USD 92.37 billion by
2034, representing a healthy CAGR of 15.45% during the forecast
period. The North America market size reached USD 7.91 billion in 2024 and is projected
to grow at a solid CAGR of 15.48%.
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Biologics CDMO Market Highlights:
· North America led the biologics CDMO market with the highest share of 36% in 2024.
· Asia- Pacific is projected to grow at a notable CAGR during the forecast period.
· By type, the mammalian segment dominated the market in 2024.
· By type, the microbial segment is growing at a significant CAGR during the forecast period.
· By molecule type, the monoclonal antibodies segment dominated the market in 2024.
· By molecule type, the recombinant proteins segment is observed to be the fastest growing during the forecast period.
· By product type, the biologics segment contributed the biggest market share of 61% in 2024.
· By indication, the oncology segment dominated the biologics CDMO market in 2024.
· By indication, the auto-immune diseases segment grows at a notable rate during the forecast period.
Market Overview and Industry Potential
The biologics CDMO refers to a contract development and manufacturing organization that offers pharmaceutical companies the development and manufacturing services for biological medical products. These services are also provided for the development and manufacturing of small-molecule drugs. Most of the pharmaceutical industries prefer collaborations with biologics CDMO for outsourcing several steps in the industrial processes. The companies aim to outsource at the time of any new drug discovery or scientific innovations. These services and solutions can address potential issues associated with the development processes and try to resolve them efficiently.
They are capable of handling various steps in drug discovery, development, and manufacturing processes. They offer comprehensive services related to research and development, drug formulation, dosage, drug stability, and manufacturing. The biologics CDMO market is remarkably growing due to its potential in dealing with commercial production, clinical trials, and pre-formulation. In June 2024, Bionova Scientific, the U.S. Biologics CDMO of the Asahi Kasei Group announced the launch of a new business facility in Texas for the process development and GMP manufacturing of plasmids.
Major Trends in the Biologics CDMO Market
Digital Automation and Flexible Manufacturing: The pharmaceutical companies are focusing on the changing regulatory and market needs. The industries are trying to stay agile, innovative, and responsive to emerging market needs. They are adopting cutting-edge technologies, employing continuous manufacturing and advanced process automation.
The incorporation of modern facilities and real-time monitoring is enabling them to stay competitive in production processes with quick response and efficient working. Thermo Fisher Scientific Inc. is the renowned CDMO service provider facilitating flexible manufacturing, cost efficiency, and specialized drug production. The pharma companies make partnerships with these CDMOs to focus on their core competencies and avoid building their state-of-the-art facilities or further infrastructure.
Increased Productivity of Pharmaceutical Companies by Biologics CDMO: Pharma 4.0 is the transformative industry shift that aims at making drug development more efficient, cost-effective, and patient-centric. This approach focuses on maintaining compliance standards and rigorous quality. The integral parts of this shift include data analytics, digital technologies, and the expanding digital workforce. With the help of these driving forces, pharma companies are making improvements and achieving success in R&D, supply chain management, and patient engagement.
Several pharma partners of the biologics CDMO adopt digital practices to reduce their drug development timelines, reduce R&D costs, and expand the chances of technical success across the early and late stages of drug development. Thermo Fisher Scientific Inc. offers integrated direct-to-patient services supply chain solutions to execute clinical trial strategies. The companies are using digital platforms for product tracking, data sharing, and patient communication in clinical trials with the help of the biologics CDMO market.
Role of Artificial Intelligence in the Biologics CDMO Market
Artificial intelligence optimizes the complex biological processes which involve the development of therapeutics and vaccines. AI enables scientists and R&D engineers to detect defects, control delicate procedures, and ensure the highest levels of quality and consistency. With the help of AI algorithms, scientists can efficiently produce high-quality strains and cell lines as a part of biomanufacturing.
AI can analyze vast datasets, identify patterns and deep insights, and utilize this information to predict, decide, and execute. AI tools can rapidly screen millions of chemical compounds which helps to recognize promising drug candidates. AI and the biologics CDMO assist clinicians to diagnose accurately and decide treatments for patients.
Key Regional Analysis:
United States Biologics CDMO Market Size Analysis 2025 to 2034
The United States biologics CDMO market size is predicted to grow from USD 5.53 billion in 2024 to approximately USD 23.60 billion by 2034.The market is expanding at a double-digit CAGR of 15.62% during the forecast period.
In June 2024, Bionova Scientific, the U.S. Biologics CDMO announced the establishment of new business facility in Texas for the process development and good manufacturing practices-based manufacturing of plasmids that will benefit to the pharmaceutical and biotechnology plasmid DNA research.
North America dominated the biologics CDMO market due to the presence of prominent pharmaceutical and biotechnology companies in this region. The U.S. leads due to the presence of companies like Pfizer, Johnson & Johnson, Amgen, etc. which offer excellent biologics CDMO operations. The U.S. Food and Drug Administration (USFDA) provided strict rules for the authorization and regulation of biologics. The investments in biologics and innovation are also increasing due to regulatory support.
• In September 2024, Eurofins CDMO Alphora Inc. announced the construction of its new GMP biologics manufacturing facility for the manufacturing of monoclonal antibodies (mAb) and targeted therapies for commercial and clinical applications.
• In July 2024, LOTTE Biologics, a CDMO based in South Korea, announced the use of its pharmaceutical manufacturing facility in East Syracuse, New York for the process development and manufacturing of biologics.
Asia Pacific is expected to be the fastest-growing region in the biologics CDMO market during the forecast period due to the rise in direct investments in biopharmaceutical industries. The establishment of manufacturing and R&D centers is possible due to the global corporations which benefit in lowering costs and accessing trained personnel in concerned areas.
The biologics manufacturing costs of this region are less than North America and Europe which further propels the market’s expansion. The need for reduced labor, fewer raw materials, and overall reduced operating costs favor the growth of the biologics CDMO market in this region.
• In March 2024, MilliporeSigma announced to allow 300 million euros for the new bioprocessing plant based in South Korea to establish 300 new jobs by the end of 2028.
• In November 2024, Lupin Manufacturing Solutions announced a plan to expand its therapeutic footprint in high-demand disease areas while in June 2023, Lupin entered into the CDMO business with the launch of its new subsidiary Lupin Manufacturing Solutions to establish its CDMO operations business in India.
Biologics CDMO Market Report Coverage
|
Report Attribute |
Key Statistics |
|
Base Year |
2024 |
|
Forecast Period |
2025 to 2034 |
|
Market Size in 2024 |
USD 21.96 Billion |
|
Market Size in 2025 |
USD 25.35 Billion |
|
Market Size by 2034 |
USD 92.37 Billion |
|
Market Growth Rate from 2025 to 2034 |
CAGR of 15.45% |
|
Dominating Region |
North America |
|
Fastest Growing Region |
Asia-Pacific |
|
Segments Covered |
Type, Molecule Type, Product Type, and Regions |
|
Regions Covered |
North America, Europe, Asia-Pacific, Latin America and Middle East & Africa |
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Biologics CDMO Market Segmentation Analysis:
Type Analysis
The mammalian segment dominated the biologics CDMO market due to the efficiency of mammalian cell-based biologics than other systems like yeast or bacterial cells. It enables the production of therapeutic proteins in structural and functional forms that are analogous to human proteins. They can offer excellent treatments for several diseases including cancer, autoimmune, and chronic illnesses. With the increased demand for biologics, the demand for CDMO services has also increased based on mammalian cell cultures.
The microbial segment is expected to grow at the fastest rate in the biologics CDMO market over the forecast period due to the rising demand for biosimilars and the expansion of patents for some popular biologics. The efficiency and affordability of microbial systems drive the demand and need for several biosimilars. The new biologics are expanding by using microbial systems including novel peptides and therapeutic proteins.
Molecule Type Analysis
The monoclonal antibodies segment dominated the biologics CDMO market due to large investments by venture capital firms into biotechnology businesses establishing mAbs. The government provides subsidies and funding for mAb research which supports this segmental growth. Advancements in upstream and downstream bioprocessing enhanced the efficiency and yield of mAb synthesis. The manufacturing flexibility is improved with the usage of single-use systems and it has reduced the chances of cross-contamination. The standard analytical techniques enhanced the characterization of mAbs and improved their production and quality.
The recombinant proteins segment is expected to be the fastest-growing in the biologics CDMO market during the forecast period due to the advancements in expression methods including insect, bacteria, yeast, and mammalian cell lines. The increased yield and productivity of recombinant protein synthesis drives this segmental growth. The success in cell-free protein synthesis, manufacturing, and single-use bioreactors improved production by reducing expenses and time.
Product Type Analysis
The biologics segment dominated the biologics CDMO market due to treatments for complex diseases like cancer, autoimmune disorders, and hereditary diseases. The biologics show greater efficacy and specificity towards vaccines, cell and gene treatments, recombinant proteins, and monoclonal antibodies. Biologics are in high demand due to the rising shift towards personalized therapy and patient-centric needs.
The biosimilars segment is expected to be the fastest-growing in the biologics CDMO market during the forecast period due to their offerings of low-cost medicines that make treatments accessible and improve the quality of life for patients. According to the Association for Accessible Medicines, biosimilars have the potential to save the U.S. healthcare system approximately USD 133 billion by 2025.
Indication Analysis
The oncology segment dominated the biologics CDMO market due to millions of new cancer cases observed annually. The rising incidence of diseases and the significant need for novel and efficient biological medicines drive this segmental growth. The need for cutting-edge cancer therapies fuels the market’s expansion along with the growing aged population globally. The significant investments by pharmaceutical and biotechnology businesses in oncology research and development also boost this segmental growth. Cancer research and biological treatments are supported by funding from nonprofit groups, public agencies, and private investors.
The autoimmune diseases segment is expected to grow over the forecast period in the biologics CDMO market due to the notable rates of lupus, rheumatoid arthritis, multiple sclerosis, and inflammatory bowel disease. This surge is driving the need for efficient biologic medicines and biologic therapies. A trends of personalized medicine and precision therapeutics also propels this segmental growth in the market. The high adoption of biologics fulfills the therapeutic needs of patients.
Discover Additional Market Trends with Our Related Reports:
• Biologics Contract Development Market Size, Share, and Trends 2024 to 2034: The global market size is estimated at USD 8.18 billion in 2024 and is anticipated to reach around USD 23.01 billion by 2034, expanding at a CAGR of 10.89% between 2024 and 2034.
• Pharmaceutical CDMO Market Size, Share, and Trends 2024 to 2034: The global market size is estimated at USD 184.90 billion in 2024 and is anticipated to reach around USD 368.70 billion by 2034, expanding at a CAGR of 7.2% between 2024 and 2034.
• U.S. Pharmaceutical CDMO Market Size, Share and Trends 2024 to 2034: The U.S. market size accounted for USD 40.52 billion in 2024 and is expected to exceed around USD 83.25 billion by 2034, growing at a CAGR of 7.50% from 2024 to 2034.
• Anti-Inflammatory Biologics Market Size, Share, and Trends to 2034: The global anti-Inflammatory biologics market size was valued at USD 104.81 billion in 2024 and is expected to reach around USD 176.02 billion by 2033, expanding at a CAGR of 5.93%.
• Topical Drugs CDMO Market Size, Share, and Trends 2025 to 2034: The global market size surpassed USD 42 billion in 2023 and is expected to hit around USD 124.18 billion by 2033, poised to grow at a CAGR of 11.50%.
• Cancer Biologics Market Size, Share, and Trends 2025 to 2034: The global cancer biologics market size was USD 102.01 billion in 2023, accounted for USD 109.46 billion in 2024, and is expected to reach around USD 221.43 billion by 2034, expanding at a CAGR of 7.3% from 2024 to 2034.
• Veterinary CRO And CDMO Market Size, Share, and Trends 2025 to 2034: The global market size was estimated at USD 7.13 billion in 2024 and is anticipated to reach around USD 15.98 billion by 2034, expanding at a CAGR of 8.40% from 2025 and 2034.
• Personal Care CMO and CDMO Market Size, Share and Trends 2024 to 2034: The global market size is worth around USD 28.02 billion in 2024 and is anticipated to reach around USD 44.86 billion by 2034, growing at a CAGR of 4.82% from 2024 to 2034.
Competitive Landscape and Major Breakthroughs in the Biologics CDMO Market
The biologics CDMO market continues to evolve rapidly and showcases significant advancements through innovations in 2023 and 2024, with a dynamic competitive landscape. Major players such as Samsung Electronics Co. Ltd., Evonik Industries AG, AGC Biologics, Catalent Inc., etc. hold a prominent position in the biologics CDMO market. These companies exhibit strong resources and technical expertise to conduct clinical research and R&D projects in diverse research areas and provide fruitful clinical and biopharmaceutical outcomes.
What is Going Around the Globe?
• In October 2024, AGC Biologics announced the approval by the U.S. FDA for a third biologics license application which concludes the pre-license inspection.
• In October 2024, Catalent Inc. made a strategic partnership with the UK-based biotechnology company IsomAb Ltd. for the development and supply of efficient treatments to patients all across the world.
The research report categorizes the biologics CDMO market into the following segments and subsegments:
By Type
• Mammalian
• Microbial
By Molecule Type
• Monoclonal Antibodies
• Recombinant Proteins
• Vaccines
• Hormones
• Others
By Product Type
• Biologics
• Biosimilars
By Indication
• Oncology
• Auto-Immune Diseases
• Infectious Diseases
• Neurology
• Others
By Geography
• North America
• Europe
• Asia Pacific
• Latin America
• Middle East & Africa (MEA)
Thanks for reading you can also get individual chapter-wise sections or region-wise report versions such as North America, Europe, or Asia Pacific.
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