The biologics contract development market size is estimated to be USD 5,672.1 million in 2022 and is expected to witness a CAGR of 10.71% during the forecast period 2023-2033. Rising M&A activity, expanding adoption of cutting-edge technologies for biological production, increase in the outsourcing of R&D by pharmaceutical and biopharma companies, and a supportive regulatory environment for clinical trials in developing countries are factors contributing to the market growth. Furthermore, increase in the incidence of disorders such neurological disorders, gynaecological disorders, cancer, ophthalmic disorders, and cardiovascular problems and rising collaboration of CROs for research is predicted to support the market growth. However, lack of knowledge regarding the usage of products and high price of production is expected to hinder the growth.

Increase in the incidence of disorders such neurological disorders, gynaecological disorders, cancer, ophthalmic disorders, and cardiovascular problems is projected to spur the market. For instance, the WHO reports that one of the major causes of death worldwide and the cause of more than 10 million deaths in 2020 was cancer. According to Cancer Tomorrow, additional cancer cases are anticipated in the years to come. Over 19.3 million incidences of cancer were reported in 2020, and based on estimates from Cancer Tomorrow, this number is projected to increase to 30.2 million by 2040. In these circumstances, healthcare CDMOs are essential to the patient’s care since many biopharma companies aim to create advance treatments.

Rising collaboration of CROs for research is expected to fuel the market growth. Furthermore, CROs are forming alliances for the study of other diseases like cancer, Alzheimer’s, and other diseases in the post-pandemic era. For instance, in April 2022, Labcorp and Xcell Biosciences collaborated to help the other’s initiatives to develop cell and gene therapies for the treatment of Parkinson’s, cancer, and other uncommon diseases. In the post-pandemic era, this should enhance study on these diseases.

Segmentation

By Product Service

The market is categorized into process development, cell line development, and others. In 2022, the process development segment accounted for the highest revenue share due to the fact that many companies are preferring to outsource the manufacturing of recombinant proteins and monoclonal antibodies. Upstream and downstream process development are the 2 methods that comprise biologics process development. AGC Biologics, Curia Global, Inc., and Bionova Scientific are a few businesses that provide upstream process development for large-scale manufacturing of mammalian and microbial products. The cell line development segment is expected to grow with the fastest rate. According to NCBI, cell lines are rigorously used in the production of vaccines, drug metabolism and cytotoxicity studies, the formation of artificial tissues (such as artificial skin), the investigation of gene function, the production of antibodies, and the synthesis of biological compounds.

By Indication

The market is categorized into cardiovascular disorder, oncology, haematological disorders, immunological disorders, and others. In the global market, the oncology segment accounted for the largest revenue share in 2022 owing to increasing investment in novel cancer treatments by various pharmaceutical and biopharmaceutical companies. Any organ in the body can develop cancer, thus there is a great demand for treatment. As a result, companies are increasing their R&D and outsourcing expenditure. The segment for immunological disorder diseases is anticipated to increase at the quickest rate during the projected period. Asthma, allergies, autoimmune disorders, and other conditions are examples of immunological diseases or conditions brought on by immune system failure. According to NCBI, 7.6% to 9.4% of the world’s population, particularly young and middle-aged women, are affected by autoimmune inflammatory diseases.

By Source

The market is divided into mammalian, microbial, and others. In 2022, the mammalian segment accounted for the largest revenue share owing to the major advantage of manufacturing mammalian proteins with appropriate post-translational modifications that provide a native structure when using mammalian cells for protein expression. Mammalian cells, such as Chinese Hamster Ovary (CHO) cell lines, are among the most popular; over 70.0% of protein therapies are produced using CHO cells. A total of 650 protein medicines have received global approval to date, 400 of which were from microbial recombinant technologies. Additionally, microbial sources, which are predominantly used by CDMOs to manufacture cytokines, hormones, enzymes, and MABs, are responsible for the production of about 48.0% of biologics for manufacturing. These factors are promoting segment growth.

Regional Markets

In 2022, North America region accounted for the highest revenue in the biologics contract development market and is expected to maintain its dominance during the forecast period. This is attributed to the rising R&D expenditures, local presence of multinational corporations, and their efforts to get new patents. The expansion of contract development organisations (CDO) can be primarily attributable to the region’s rising clinical trial activity and outsourcing activity. For instance, almost 32% of all trials performed worldwide as of July 2022, according to ClinicalTrial.Gov, were undertaken in the United States alone. Numerous studies carried out in the United States are contributing to the expansion of the local market. The market for biologics contract development is anticipated to exhibit the highest CAGR of 13.7% in Asia Pacific during the forecast period. The motivation of the biotechnology companies to invest in the Asia Pacific region is being spurred by various regulatory organisation adjustments to change clinical trial evaluation standards in accordance with worldwide requirements.

Competitor Insights

Some of the key players operating in the biologics contract development market are Abzena Ltd, Fujifilm Diosynth Biotechnologies, AGC Biologics, Thermo Fisher Scientific Inc., Bionova Scientific, Inc., WuXi Biologics, Curia Global, Inc., Genscript, KBI Biopharma, BioXcellence (Boehringer Ingelheim Biopharmaceuticals GmbH), and STC Biologics.

To increase their market position, key companies in this market are using a variety of strategies, such as alliances through mergers and acquisitions, geographic expansion, and strategic collaborations.

• For instance, in September 2021, LakePharma Inc., a California-based biologics drug discovery, development, and manufacturing company, was acquired by Curia Global, Inc., previously AMRI, a top contract research, development, and manufacturing company.

This comprehensive research report focuses on the global and regional market size and forecasts of diverse segments including product service, indication, and source from 2023 to 2033.

Report Scope:

Segmentation: Biologics Contract Development Market Report 2022 – 2033

Product Service (Revenue, USD Million), 2022 – 2033

• Process Development
  • Downstream
  • Upstream
  • By Product
  • Others
• Cell Line Development
  • Mammalian
  • Microbial
  • Others
• Others

Indication (Revenue, USD Million), 2022 – 2033

• Cardiovascular Disorder
• Oncology
• Haematological Disorders
• Immunological Disorders
• Others

Source (Revenue, USD Million), 2022 – 2033

• Mammalian
• Microbial
• Others

By Region (Revenue, USD Million), 2022 – 2033

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