Biologics Contract Development and Manufacturing Organization (CDMO) Market Analysis North America,Europe,Asia,Rest of World (ROW) - US,Germany,France,China,Japan - Size and Forecast 2024-2028

Biologics CDMO Market Size 2024-2028

The Global Biologics CDMO Market size is estimated to grow by USD 10.63 billion at a CAGR of 10.46% between 2023 and 2028. The efficiency of biologics in treating severe infections, malignancies, and immunological and hormonal disorders is encouraging manufacturers to invest in research and development to develop biologics. For instance, monoclonal antibodies constitute one of the fastest-growing segments among biological therapies. To date, 88 monoclonal antibodies have been approved for different indications.

Some of the examples are ICT-107 for glioblastoma, VGX-3100 for cervical cancer, NeuVax for breast cancer, NexVax2 for celiac disease, CRS-207 for pancreatic cancer, PEV7 for recurrent vulvovaginal candidiasis, and GI-4000 for pancreatic cancer. Apart from manufacturers that are actively involved in research on biologics, many research institutes are also engaged in developing novel biologics through industrial collaborations. Therefore, a strong research and development pipeline of biologics therapeutics is expected to drive the Biologics Contract Development Market Size during the forecast period. It also includes an in-depth Biologics Contract Development and Manufacturing market size analysis of drivers, trends, and challenges. Our market trends and analysis report examines historical data from 2018-2022, besides analyzing the current market scenario.

What will be the Biologics Contract Development Market Size during the Market Forecast Period?

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The Global Biologics CDMO Market is experiencing steady growth driven by the rising demand for biological medicinal products and small-molecule drugs. As biopharmaceutical companies seek specialized expertise in manufacturing, biologics CDMOs play a pivotal role in providing comprehensive clinical services and advanced technology solutions. With the increasing adoption of automation and Internet of Things (IoT) technologies, CDMOs are enhancing their capabilities in software development and process engineering to meet the evolving needs of the biopharmaceutical industry. Leveraging expertise in biology and tissue processing, these organizations offer end-to-end solutions for the development and manufacturing of biologics, addressing the complex requirements of diabetes patients and other therapeutic areas. As the Biologics Contract Development and Manufacturing Market Size continues to expand, fueled by advancements in biotechnology and growing demand for personalized medicine, it presents lucrative opportunities for innovation and collaboration within the pharmaceutical sector.

Biologics Contract Development Market Segmentation

In the type segment of the Biologics CDMO Market, pharmaceutical industry players rely on specialized services to meet the demands of diverse therapeutic categories. While small molecules continue to dominate traditional pharmaceuticals, the shift towards large molecules, including biologics, biosimilars, and cell and gene therapies, is evident. With a focus on cutting-edge cancer therapies, monoclonal antibodies, and treatments for chronic infectious diseases, biologics take center stage in the market. As pharma clients seek seamless integration into the supply chain, quality testing becomes paramount to ensure efficacy and safety. Advanced manufacturing technologies, such as single-use/disposable bioreactors, enable efficient production while reducing contamination risks. Leveraging therapeutic and technical expertise, smaller, niche BioCDMOs cater to specific needs, offering personalized solutions that meet the evolving demands of the pharmaceutical industry.

The Global Biologics Contract Development Industry Size is witnessing significant growth driven by the increasing demand for biological medications and therapeutic protein production. Mammalian cell cultures play a crucial role in the production of biologics, including vaccines, blood components, and tissues used in gene therapy. With a rise in allergies and metabolic illnesses, there's a growing need for biologics targeting specific cell receptors and metabolic syndrome. Biologics Contract Development and Manufacturing Market Size Analysis indicates a thriving Biologics Contract Development Industry Size, with companies specializing in the production of biological molecules, nucleic acids, and somatic cells. As the biologics market expands, the importance of efficient CDMOs in quick and reliable production processes becomes evident, ensuring the availability of high-quality biologic medications to meet global healthcare needs.

Biologics Contract Development and Manufacturing Market Size Analysis By Type

Mammalian

The Biologics Contract Development Market Size and Share growth by the mammalian segment will be significant during the forecast period. Mammalian cells are derived from the tissue of a mammal. Mammalian cell culture is the process of growing animal cells in vitro in a flask or dish. There are four types of mammalian cells, namely fibroblasts, epithelial cells, lymphocytes, and macrophages. 

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The mammalian segment was the largest and was valued at USD 5.74 billion in 2018. Mammalian cell culture technology is one of the well-established technologies for the production of vaccines in bulk. Hence, the use of this technology by biopharmaceutical companies for bulk vaccine production is supporting revenue generation in this Biologics Contract Development and Manufacturing market size and segment. In June 2020, Catalent Inc. signed an agreement with Spicona to develop a virus-like protein-based vaccine against COVID-19 by utilizing its proprietary GPEx cell line development technology to develop a cell line expressing the recombinant virus-like particles (VLP) at its facility in the US. Catalent provides mammalian cell line development, process development, process validation, formulation development, and drug substance manufacturing, ranging from preclinical to commercial stages. These factors will drive the growth of the mammalian segment in the global Biologics Contract Development and Manufacturing Market Size during the forecast period.

Biologics Contract Development and Manufacturing Market Size Analysis By Region

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North America is estimated to contribute 49% to the growth of the global Biologics Contract Development Market Size during the forecast period. Technavio’s analysts have elaborately explained the regional trends and drivers that will shape the Biologics CDMO Market during the forecast period. The active participation of the US government in providing reimbursements for some of the biologics, rising patient awareness about the benefits of the use of biologics, company collaborations, and the increased prevalence of chronic diseases in the US are the main reasons for the high market share of the country in the North American market. The US is the base for key players developing biologic therapeutics, including AbbVie, Elli Lilly, Merck, Pfizer, and Amgen. These companies have a variety of highly differentiated products, which include contract development and manufacturing solutions and innovative technology services. Various small and medium-sized pharmaceutical and biotechnology companies depend on the technologies and services provided by such CDMOs in the region.

In addition, the rise in the prevalence of major health disorders is mainly due to lifestyle changes and the increased consumption of alcohol and tobacco in the US. While in Canada, an increase in cases of breast cancer is triggering the demand for biologics for their therapeutic benefits. However, Biologics Contract Development Market Size growth is expected to be only gradual due to the patent expiry of major biologics present in the market. These factors will drive the Biologics CDMO Market in the region during the forecast period. 

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Biologics Contract Development Market Dynamics and Customer Landscape

The Biologics Contract Development Market Size is experiencing significant growth owing to advancements in the pharmaceutical industry. CDMOs specialize in manufacturing both small molecules and large molecules, including biologics and biosimilars, along with cutting-edge cell and gene therapies. With a focus on cancer therapies and monoclonal antibodies, CDMOs play a vital role in addressing chronic infectious diseases. They ensure a robust supply chain and adhere to stringent quality testing protocols to meet the requirements of pharma clients worldwide. Leveraging advanced manufacturing technologies, CDMOs contribute to the development and production of innovative biologic drugs for improved patient outcomes. There are multiple factors influencing Biologics CDMO Market growth. Our researchers analyzed the data with 2023 as the base year, along with the key drivers, trends, and challenges. 

Key Biologics Contract Development Market Drivers

The availability of cost-efficient resources in emerging markets is notably driving market growth. Countries such as China, India, Brazil, and Mexico have witnessed significant advances in their healthcare infrastructure and technological advances in their drug development processes. As a result, large and medium-sized pharmaceutical companies from developed countries are outsourcing various drugs and therapies' development and manufacturing operations to vendors in such countries. One of the key reasons for the increasing popularity of outsourcing these processes is the availability of labour at a comparatively lower price than in developed countries. 

Moreover, the rapidly evolving Biologics Contract Development and Manufacturing market size  and environment and the strong support of the Government of China help the country specialize in the research of drugs, including regenerative medicines and small-molecule-based drugs. Therefore, the market is expected to grow strongly during the forecast period.

Significant Biologics Contract Development Market Trends

Increasing approvals for new molecules and biosimilars is an emerging trend shaping the market growth. The loss of patent protection simply paves the way for the emergence of biosimilars in place of biologics in the next five years. Many manufacturers of biologics, such as Novartis and Pfizer, have already gone into the business of making biosimilars. The same is expected from other sponsors of biologics. To keep their businesses stagnant, they will start developing biosimilars, which meet both the demand and the cost of the consumers. The patent expiry will allow the manufacturers of biosimilars to seek FDA approvals. Some of the major drugs that are expected to lose patent protection in the US include LUCENTIS (in 2022), XGEVA (in 2022), SIMPONI (2024), and STELARA (in 2024).

In addition, the number of US FDA and EMA-approved biosimilars for patent-expired biologics declined due to COVID-19 in 2020. The US FDA approved only three new biosimilars in 2020. Therefore, the increasing approvals for new molecules and biosimilars drive market growth and trends during the forecast period, as seen in this Biologics Contract Development and Manufacturing market research report 

Major Biologics Contract Development Market Challenges

Serialization issues faced by CDMOs due to multiple production lines is a significant challenge hindering the market growth. The problem of drug or medicine adulteration and counterfeit drugs or medicine has been increasing across the globe. In addition, the growth in Internet sales and unsecured cyber and physical global supply chains led to the introduction of serialization requirements. Serialization is a comprehensive process that helps pharma and biotech enterprises track and trace the passage of drugs or medicines through the entire supply chain. Through serialization, a product can be identified using a unique serial number along with its origin, batch number, and shelf life. It is preferred by pharma and biotech enterprises and governments as it helps in reducing the counterfeiting of drugs or medicines significantly.

Furthermore, the process of serialization for CDMO can be time-consuming and complex, especially if the correct expertise and tools are not in place. The teams must also be trained properly to provide correct serialization to products. These elements make it difficult for CDMOs to provide robust serialization, which can impact the growth of the Biologics Contract Development and Manufacturing market size. Such factors are expected to restrict the market growth during the forecast period. 

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Key Biologics Contract Development Market Customer Landscape

The market research and growth report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the market Biologics Contract Development and Manufacturing market size analysis and report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their growth strategies.

Biologics Contract Development Market Customer Landscape

Key Market Players in the Biologics Contract Development Market

Companies are implementing various strategies, such as strategic alliances, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the market. The market forecasting report also includes detailed analyses of the competitive landscape of the market and information about 20 market companies, including:

AbbVie Inc. - The company offers biologics CDMO such as cell line development and cGMP manufacturing

• 3P BIOPHARMACEUTICALS S.L.U 
• AGC Biologics
• Binex Co. Ltd.
• Boehringer Ingelheim International GmbH
• Bora Pharmaceuticals Co. Ltd
• Catalent Inc.
• Evonik Industries AG
• FUJIFILM Corp.
• Grifols SA
• J RETTENMAIER and SOHNE GmbH and Co KG
• JSR Corp.
• Kemwell Biopharma Pvt. Ltd.
• Lonza Group Ltd.
• Novartis AG
• Rentschler Biopharma SE
• Samsung Electronics Co. Ltd.,
• Shenzhen Hepalink Pharmaceutical Co. Ltd.
• Toyobo Co. Ltd.
• WuXi Biologics Cayman Inc.

Qualitative and quantitative Biologics Contract Development and Manufacturing market size analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key market players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

Market Analyst Overview

The Biologics CDMO Market is witnessing robust growth fueled by advancements in the pharmaceutical industry, particularly in the development of small molecules, large molecules, and cutting-edge cell and gene therapies. As demand for specialized expertise and advanced technology rises, niche CDMOs and biopharmaceutical CDMOs are playing a pivotal role in providing quality testing and manufacturing services. With a focus on cancer therapies, infectious diseases, and evidence-based practice, these CDMOs are partnering with third-party logistic providers to streamline operations and ensure efficient delivery. Moreover, their expertise extends to non-mammalian (microbial) systems, reflecting their commitment to meeting the diverse needs of the biopharmaceutical sector.

Biologics CDMO Market is experiencing significant growth driven by the rising demand for novel therapies, particularly in areas such as recombinant proteins and antisense and molecular therapy. With an evolving disease landscape, there's a growing focus on chronic infectious diseases, prompting pharma clients to seek advanced manufacturing technologies and therapeutic expertise from Biologic CDMOs. These companies leverage cutting-edge technology and offer single-use/disposable bioreactors to meet the diverse needs of Pharma and biotech companies. Smaller, niche BioCDMOs play a crucial role, providing specialized services in biological medicinal products and small-molecule drugs, thus shaping the future of the biopharmaceutical industry.

Biologics CDMO Market is witnessing a surge in demand for therapeutic and technical expertise, particularly in catering to diabetes patients and the geriatric population facing multisystem functional decline. CDMOs offer a range of clinical services, leveraging automation and Internet of Things (IoT) technologies to enhance efficiency. They specialize in software development, process engineering, and biology, facilitating tissue processing, cell bank creation, and cell line engineering. With a focus on addressing age-related conditions like myelosuppression and cardiotoxicity, these companies play a vital role in supporting homeostatic processes and advancing medical solutions for aging populations worldwide.

Biologics Contract Development Market Segment Overview

The Biologics CDMO Market growth and forecasting report forecasts market growth by revenue at global, regional & country levels and provides an analysis of the latest trends and growth opportunities from 2018 to 2028. 

• Type Outlook
  • Mammalian
  • Microbial

• Product Type Outlook
  • Biologics
  • Biosimilars

• Region Outlook
  • North America
    • The U.S.
    • Canada
  • Europe
    • U.K.
    • Germany
    • France
    • Rest of Europe
  • Asia
    • China
    • India
  • Rest of World (ROW)
    • Brazil 
    • Argentina
    • Australia 

Biologics Contract Development and Manufacturing Organization (CDMO) Market Scope
Report Coverage	Details
Page number	163
Base year	2023
Historic period	2018-2022
Forecast period	2024-2028
Growth momentum & CAGR	Accelerate at a CAGR of 10.46%
Market Growth 2024-2028	USD 10.63 billion
Market structure	Fragmented
YoY growth 2023-2024(%)	9.65
Regional analysis	North America, Europe, Asia, and Rest of World (ROW)
Performing market contribution	North America at 49%
Key countries	US, Germany, France, China, and Japan
Competitive landscape	Leading Companies, Market Positioning of Companies, Competitive Strategies, and Industry Risks
Key companies profiled	3P BIOPHARMACEUTICALS S.L.U, AbbVie Inc., AGC Biologics, Binex Co. Ltd., Boehringer Ingelheim International GmbH, Bora Pharmaceuticals Co. Ltd, Catalent Inc., Evonik Industries AG, FUJIFILM Corp., Grifols SA, J RETTENMAIER and SOHNE GmbH and Co KG, JSR Corp., Kemwell Biopharma Pvt. Ltd., Lonza Group Ltd., Novartis AG, Rentschler Biopharma SE, Samsung Electronics Co. Ltd., Shenzhen Hepalink Pharmaceutical Co. Ltd., Toyobo Co. Ltd., and WuXi Biologics Cayman Inc.
Market dynamics	Parent market analysis and report, Biologics CDMO Market Forecast, Market growth inducers and obstacles, Fast-growing and slow-growing segment analysis, COVID-19 impact and recovery analysis and future consumer dynamics, and Market condition analysis for the forecast period.
Customization purview	If our Biologics CDMO Market Forecast report has not included the data that you are looking for, you can reach out to our analysts and get segments customized.

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What are the Key Data Covered in this Biologics Contract Development and Manufacturing Market Research Report?

• CAGR of the Biologics CDMO Market Forecast during the said period
• Detailed information on factors that will drive the growth of the Biologics CDMO Market between 2024 and 2028
• Precise estimation of the Biologics CDMO Market size and its contribution of the market in focus to the parent market
• Detailed analysis of customer landscape covering Diver of price sensitivity, Adoption of the lifecycle, and key purchase criteria and the Biologics Contract Development Industry Size
• Companies landscape comparing criticality of inputs and factors of differentiation
• Exclusive Matrix on companies position and classification
• Accurate predictions about upcoming trends and changes in consumer behavior
• Market growth analysis across North America, Europe, Asia, and Rest of World (ROW)
• A thorough analysis of the market’s competitive landscape and detailed information about companies
• Biologics CDMO Market Forecast of factors that will challenge the growth of Biologics CDMO Market companies

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