Recombinant Protein Therapeutics CDMO Market

Recombinant Protein Therapeutics CDMO Market Size

Recombinant Protein Therapeutics CDMO Market size was USD 21 billion in 2023 and is set to register growth at 14% to reach USD 67.6 billion by 2032. Increasing prevalence of chronic diseases such as cancer, diabetes, and autoimmune disorders has led to a growing demand for effective protein-based treatments. This has resulted in a greater need for CDMOs with expertise in producing high-quality recombinant proteins, thereby enhancing the market growth.

For instance, the World Health Organization reported 20 million cancer cases worldwide in 2022, with projections of over 35 million new cases by 2050. This increasing burden of chronic diseases increases the demand for effective recombinant protein-based treatments, thereby contributing to the market's growth. Moreover, the rise in outsourcing of drug development and manufacturing activities by pharmaceutical and biotechnology companies is boosting the demand for CDMOs specializing in recombinant proteins. Furthermore, the growing pipeline of biologics, including recombinant protein therapeutics, is expected to fuel the demand for CDMO services in this market.

A recombinant protein therapeutics contract development and manufacturing organization (CDMO) is a specialized service provider that offers contract development and manufacturing services for recombinant protein-based therapeutics. Recombinant protein therapeutics are a class of biologic drugs produced by genetically engineering living cells to express proteins with therapeutic properties. CDMO’s provide a range of services tailored to support the development and manufacturing of these biologic drugs on behalf of pharmaceutical and biotechnology companies.

Recombinant Protein Therapeutics CDMO Market Trends

• Biologics are becoming increasingly favored in the pharmaceutical industry due to their high specificity, efficacy, and reduced side effects compared to traditional small-molecule drugs. This preference is particularly evident in the treatment of chronic diseases such as cancer, autoimmune disorders, and diabetes, where biologics offer targeted therapeutic approaches.
  
• For instance, as per the International Diabetes Federation, in 2021 around 537 million people lived with diabetes all over the world. Further, the number of diabetic patients is expected to reach 643 million and 783 million by 2030 and 2045 respectively.
  
• As the prevalence of these chronic conditions continues to rise globally, there is a growing demand for innovative biologic therapies. This surge in demand directly translates to increased manufacturing needs for recombinant protein therapeutics, driving growth in the CDMO market.
  
• Furthermore, with increasing demand for biologics the biopharmaceutical industries reliance on CDMOs for biologics outsourcing is expected to grow, further driving the demand for recombinant protein therapeutics CDMOs, thereby boosting the overall market growth.
  

Recombinant Protein Therapeutics CDMO Market Analysis

Based on type, the market is segmented into oncology agents, insulins, immunostimulating and immunosuppressive agents, autoimmune, interferons, vaccines, blood coagulation factors, growth hormones, and other types. The oncology agents segment was valued at USD 4.5 billion in 2023.

• The field of oncology has witnessed rapid advancements in biologic therapies, particularly monoclonal antibodies targeting cancer-specific antigens or signaling pathways. These biologics have demonstrated significant clinical efficacy and improved patient outcomes in various types of cancer, thereby increasing the demand for outsourcing services.
  
• As a result, pharmaceutical companies are investing heavily in the development of novel oncology biologics, including recombinant protein therapeutics. Thus, these factors are contributing to a higher market share for the oncology segment in the market.

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Based on source, the recombinant protein therapeutics CDMO market is classified into mammalian, E. coli, S. cerevisiae, and other sources. The mammalian segment dominated the market with 61.5% of business share in 2023.

• Mammalian cells, particularly Chinese hamster ovary (CHO) cells, are preferred to produce complex protein therapeutics such as cytokines and growth factors. Thus, the diversity and complexity of protein therapeutics produced using mammalian cells contribute to dominance of this segment.
  
• Moreover, protein therapeutics produced in mammalian cells have gained widespread clinical acceptance and regulatory approval, contributing to the highest market share.
  
• Additionally, mammalian cell culture systems offer scalability and manufacturing expertise necessary for large-scale production, further bolstering their adoption in CDMOs and biopharmaceutical companies.
  

Based on therapeutic areas, the recombinant protein therapeutics CDMO market is divided into oncology, metabolic disorders, immunological disorders, infectious diseases, haematological disorders, women health, and other therapeutic areas. The oncology segment is expected to grow at a CAGR of 15.3% from 2024 – 2032.

• Cancer is one of the leading causes of morbidity and mortality worldwide, with a continuously increasing prevalence. The rising incidence of various types of cancer, including breast, lung, colorectal, and prostate cancers, drives the demand for oncology therapeutics, including recombinant protein-based drugs.
  
• Additionally, recombinant protein therapeutics, such as monoclonal antibodies and cytokines, offer targeted and personalized treatment options with reduced toxicity compared to conventional chemotherapy, further enhancing the adoption and demand for such therapies.
  
• Thus, as the understanding of cancer biology and treatment modalities advances, there is a growing demand for biologic therapies tailored to specific molecular targets and patient populations, driving the oncology segment share.

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Based on service type, the recombinant protein therapeutics CDMO market is categorized into contract manufacturing and contract development. The contract manufacturing segment is anticipated to reach USD 43.6 billion by 2032.

• The increasing demand for recombinant protein therapeutics such as insulin, interferons, oncology agents among others in pharmaceutical and biotechnology companies significantly drives the growth of contract manufacturing segment.
  
• Additionally, several advantages offered by contract manufacturing services such as scalability, flexibility, cost-effectiveness, state-of-the-art facilities, equipment, and expertise supports the growth of this segment.
  

Based on end-user, the recombinant protein therapeutics CDMO market is segmented into pharmaceutical companies, biotechnology companies, and other end-users. The pharmaceutical companies segment held market share of 50.2% in 2023 and is anticipated to continue dominating the market.

• Outsourcing to CDMOs enables pharmaceutical firms to accelerate drug development timelines while focusing on their core competencies, driving demand for CDMO services in the market.
  
• Further, outsourcing manufacturing activities to CDMOs offers cost-effective solutions for pharmaceutical companies by eliminating the need for significant upfront investments in infrastructure, equipment, and personnel.

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North America recombinant protein therapeutics CDMO market exceeded USD 8.5 billion in 2023 and is anticipated to reach USD 26.7 billion by 2032.

• Access to advanced technologies, state-of-the-art infrastructure, and cutting-edge research capabilities solidify North America's position in the market.
  
• CDMOs in the region leverage these resources to provide innovative solutions and high-quality services to their clients.
  
• Additionally, the region boasts a robust ecosystem of pharmaceutical companies, biotechnology startups, academic research institutions coupled with several CDMOs. This favorable ecosystem of industries further aids in the regional market growth.
  
• Thus, with a long history of innovation and investment in biotechnology, North America has emerged as a global leader in biologic drug development and manufacturing, driving significant demand for CDMO services in the region.
  

Recombinant Protein Therapeutics CDMO Market Share

The recombinant protein therapeutics CDMO industry is characterized by a diverse mix of players, ranging from multinational corporations to small companies. Large multinational CDMOs, such as Lonza Group, Catalent, and WuXi Biologics, dominate a significant portion of the market share. These companies offer comprehensive services spanning from early-stage development to commercial-scale manufacturing, leveraging their global footprint, extensive infrastructure, and diversified service offerings to cater to a wide range of client needs.

Recombinant Protein Therapeutics CDMO Market Companies

Prominent players operating in the recombinant protein therapeutics CDMO industry include:

• Batavia Biosciences B.V.
• BIOVIAN
• Catalent, Inc
• Curia Global, Inc.
• Enzene Biosciences Ltd
• FUJIFILM Diosynth Biotechnologies
• HALIX B.V.
• Lonza
• Richter-Helm BioLogics
• WuXi Biologics
  

Recombinant Protein Therapeutics CDMO Industry News:

• In June 2023, Catalent announced expansion of its biologic’s services platform, OneBio which features capabilities for development and production of antibody and recombinant proteins, cell and gene therapies, and messenger RNA. This strategic move helped the company to enhance its offerings and revenue generation.
  
• In July 2022, Wuxi Biologics announced the addition of microbial fermentation to their CDMO offerings at Hangzhou. This plant at Hangzhou can produce recombinant proteins, enzymes, antibody fragments, virus-like particles, and plasmid DNA. This expansion helped the company to enhance their customer base and expand their geographic presence.
  

The recombinant protein therapeutics CDMO market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2021 to 2032 for the following segments:

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Market, By Type

• Oncology agents
• Insulins
• Immunostimulating and immunosuppressive agents
• Autoimmune
• Interferons
• Vaccines
• Blood coagulation factors
• Growth hormones
• Other types

Market, By Source

• Mammalian
• E. coli
• S. cerevisiae
• Other sources

Market, By Therapeutic Area

• Oncology
• Metabolic disorders
• Immunological disorders
• Infectious diseases
• Hematological disorders
• Women health
• Other therapeutic areas

Market, By Service Type

• Contract manufacturing
• Contract development

Market, By End-user

• Pharmaceutical companies
• Biotechnology companies
• Other end-users

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • Germany
  • UK
  • France
  • Spain
  • Italy
  • Rest of Europe
• Asia Pacific
  • China
  • Japan
  • India
  • Australia
  • Rest of Asia Pacific
• Latin America
  • Brazil
  • Mexico
  • Rest of Latin America
• Middle East and Africa
  • South Africa
  • Saudi Arabia
  • Rest of Middle East and Africa