Biologics Outsourcing Market Size – By Product (Antibodies, Recombinant Proteins, Vaccines), Service (Cell & Process Development, Analytical Testing), Source (Mammalian, Microorganism), Application, End-user, Global Forecast, 2023 – 2032

Biologics Outsourcing Market Size

Biologics Outsourcing Market size accounted for USD 20.5 billion in 2022 and is estimated to grow at 14.1% to reach USD 75 billion by 2032. Increasing demand for biologics and the complexity of their development and manufacturing processes have led many pharmaceutical and biotechnology companies to outsource these activities to specialized contract research organizations (CROs) and contract manufacturing organizations (CMOs).
 

Outsourcing enables companies to access specialized expertise, advanced technologies, and state-of-the-art facilities, reducing the time and costs associated with in-house development. Additionally, the growing pipeline of biologic drugs, particularly in the fields of oncology, autoimmune disorders, and infectious diseases, has created a robust demand for biologics outsourcing services.
 

Biologics refer to a class of medical products derived from living organisms, such as proteins, antibodies, and vaccines, used for treating various diseases and medical conditions. These complex substances are produced through biotechnological processes and exhibit high specificity and efficacy. They are a class of therapeutic products derived from living organisms, such as proteins, antibodies, vaccines, and cell therapies. Biologics outsourcing refers to the practice of contracting or delegating certain activities related to the development, manufacturing, or testing of biologic drugs to external service providers or specialized contract research organizations (CROs). This outsourcing model allows pharmaceutical companies to leverage the expertise and resources of contract manufacturing organizations (CMOs) and contract research organizations (CROs) to streamline the production and development of biologic therapies.
 

COVID-19 Impact

The COVID-19 pandemic had a significant impact on the biologics outsourcing market. One of the key effects of the pandemic has been the increased demand for biologics and the subsequent need for outsourcing services. The race to develop effective vaccines and therapies against the virus has created a surge in the demand for biologics manufacturing and development capabilities, leading many pharmaceutical companies to outsource these services to specialized contract development and manufacturing organizations (CDMOs). This disruption forced many pharmaceutical companies to seek alternative outsourcing options to ensure a continuous supply of biologics products.
 

Biologics Outsourcing Market Trends

The growing complexity of biologics has significantly increased outsourcing services in the biologics industry. Biologics, which include vaccines, therapeutic proteins, and monoclonal antibodies, are highly intricate and require specialized expertise and advanced technologies for their development, manufacturing, and quality control. The complexity arises from factors such as the use of living cells or organisms, intricate purification processes, and the need for stringent regulatory compliance.
 

As a result, biopharmaceutical companies are increasingly relying on outsourcing partners with the necessary expertise and infrastructure to navigate the complexities of biologics development and production. For instance, in February 2021, Affibody AB, a company focused on developing next-generation biopharmaceuticals partnered with Biovian Oy, a CDMO, for ABY-062 recombinant protein for clinical trial.
 

Biologics Outsourcing Restraint

Varying regulatory requirements across regions pose a significant threat on the biologics outsourcing market. Biologics are subject to stringent regulations to ensure safety and efficacy. However, these regulations can differ significantly from one region to another. Each country or region has its own set of guidelines, standards, and approval processes for biologics, which creates challenges for outsourcing companies operating in multiple jurisdictions.
 

Complying with varying regulatory requirements across regions adds complexity and cost to the biologics outsourcing process. Companies must invest significant resources in understanding and navigating the unique regulatory landscapes of different markets. This includes conducting thorough assessments of regulatory frameworks, preparing extensive documentation, and engaging in lengthy approval processes.
 

Biologics Outsourcing Market Analysis

By product, the biologics outsourcing market is classified into antibodies, vaccines, cell and gene therapeutics, recombinant proteins, blood and blood products, and other biologics. The antibodies accounted for 60.9% market share in 2022. Antibodies are utilized as therapeutic agents to target specific disease-causing molecules, aiding in the treatment of various conditions like cancer, autoimmune diseases, and infectious diseases.
 

Antibodies are widely used for target validation, characterization, and quantification of proteins during the drug discovery, development process and various other applications. These antibodies enable researchers to understand the role and function of these targets in disease progression and aid in the identification of potential target therapeutics. Furthermore, outsourcing of antibodies helps the companies to focus on their core competencies, such as drug discovery, pre-clinical and clinical research and various other R&D activities, while ensuring compliance with regulations and reducing regulatory risks.
 

Based on service, the biologics outsourcing market is segmented into analytical testing, process development, cell development, cGMP manufacturing, and other services. The cell development segment accounting for USD 4.2 billion in 2022 and is anticipated to witness high growth at a CAGR of 15.8% by 2032 attributed to several factors such as advancements in cell engineering technologies, the need for cost-effective and efficient manufacturing processes, and the rising trend of outsourcing cell development services. Furthermore, with the increasing demand for biologic therapies and the complexity involved in their development, pharmaceutical and biotechnology companies are increasingly relying on outsourcing partners specializing in cell development services.
 

Based on source, the biologics outsourcing market is segmented into mammalian and microorganisms. The mammalian segment is expected to witness notable expansion to reach USD 62.8 billion by 2032. Outsourcing to CDMOs with extensive experience in mammalian cell culture ensures that the desired protein modifications are accurately replicated, enhancing the safety and efficacy of the final desired product. Additionally, mammalian cell culture systems offer scalability, allowing for flexible manufacturing capacity to meet varying production demands.
 

Based on application, the biologics outsourcing market is segmented into Oncology, immunological disorders, infectious diseases, vaccine development, cell and gene therapy, blood related product development, stem cell research, and other applications. The oncology segment held a market share of 30.1% in 2022 and is anticipated to progression at a CAGR of 15.5% by 2032. Biologics offer targeted and personalized approaches to cancer treatment, making them highly effective in combating various types of malignancies. With an increasing number of pharmaceutical companies focusing on oncology drug development, the need for outsourcing services in this segment is expected to surge.
 

Based on end-user, the biologics outsourcing market is segmented into pharmaceutical and biopharmaceutical companies and biotechnological companies. The biotechnological company’s segment is projected to grow at a CAGR of 15.3% by 2032 attributed to advancements in biotechnology research and development that has increased demand for biologics outsourcing services. These companies are turning to specialized service providers to capitalize on their expertise allowing them to focus on their core competencies. Biotechnological companies, both large and small, are leveraging outsourcing partnerships to streamline their operations, accelerate time-to-market, and enhance their competitive edge.
 

North America region held a significant biologics outsourcing market share of 46.3% in 2022 and is projected to expand at 12.2% CAGR by 2032. The region's robust healthcare infrastructure, cutting-edge research and development facilities, and a strong emphasis on innovation have contributed to this upward trajectory. The increasing demand for biologics, including monoclonal antibodies, vaccines, and cell therapies, coupled with the high cost of in-house manufacturing, has driven pharmaceutical and biotechnology companies to outsource their biologic production processes. Additionally, North America's strategic geographic location and the availability of highly skilled workforce has made it an attractive destination for biologics outsourcing. The region's emphasis on quality control, adherence to stringent regulatory standards, and efficient supply chain management.
 

Biologics outsourcing Market Share

Major market players operating in the biologics outsourcing market include:

• AbbVie Inc
• Thermo Fisher Scientific
•  Boehringer Ingelheim
• International GmbH
•  Merck & Co.,
•  Lonza Group AG
•  Catalent Inc
   

Biologics Outsourcing Industry News:

• In December 2022, AbbVie partnered with AbCellera Biologics Inc. The partnership leverage AbCellera’s antibody discovery and development engine to deliver optimized development candidates for up to five targets selected by AbbVie across multiple indications. This helped the company to enhance its service offerings.
   
• In December 2022, Thermo Fisher expanded its biologics and steriles manufacturing capabilities in China. The facility offers integrated clinical and commercial drug substance and drug product capabilities. This includes process development, cell line development, biologics drug substance manufacturing, and sterile fill-finish. This helped the company expand its geographic presence.
   

The biologics outsourcing market research report includes an in-depth coverage of the industry with estimates & forecast in terms of revenue in USD from 2018 to 2032, for the following segments:

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By Product

• Antibodies
  • Monoclonal antibodies
  • Polyclonal antibodies
  • Antibody drug conjugates 
• Vaccines
• Cell and gene therapeutics
• Recombinant proteins
• Blood and blood products
• Other biologics

By Service  

• Analytical testing
• Process development
• Cell development
• cGMP manufacturing
• Other services

By Source 

• Mammalian
  • Animals
  • Human 
• Microorganisms

By Application

• Oncology
• Immunological disorders
• Infectious diseases
• Vaccine development
• Cell and gene therapy
• Blood related product development
• Stem cell research
• Other applications

By End-user

• Pharmaceutical and biopharmaceutical companies
• Biotechnological companies

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

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