Biologics Contract Development Market Size to Hit USD 13.9 Bn by 2030

 According to Nova one advisor, the global Biologics Contract Development market was valued at USD 5.8 billion in 2021 and it is expected to hit around USD 13.9 billion by 2030 with a CAGR of 10.7% during the forecast period 2022 to 2030.

Key Takeaways:

• By source, the U.S. Biologics Contract Development market was valued at USD 1.9 Billion in 2021 and expected to witness growth at a CAGR of 5.9% from 2022 to 2030.
• Mammalian source emerged as the largest product segment in 2021, as the majority of research activities are being carried out using mammalian cell lines
• The process development segment is expected to witness the highest CAGR over the forecast period, as many companies are opting to outsource for production of recombinant proteins and Monoclonal Antibodies (MABs)
• North America dominated the market in 2021. An increase in strategic acquisitions and partnerships and a rise in demand for specialized testing services are likely to have a positive impact on the market
• In Asia Pacific, the market is expected to encounter the highest CAGR over the forecast period

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Factors such as increasing adoption of advanced technologies for biological production; growing M&A activities; a rise in outsourcing of R&D activities by pharma and biopharma companies; and a favorable regulatory environment for clinical trials in developing countries are driving the market. The CROs in the post-COVID-19 period are trying to expand their presence in other countries to improve their position in the market. For instance, in July 2022, CRO Novotech expanded its presence in the U.S. by acquiring a US-based CRO, NCGS, providing research services in hematology, infectious disease, oncology, and CNS. Such expansions are expected to have a positive impact on the market in the post-pandemic period.

The market comprises organizations that offer services such as the development of cell lines, upstream and downstream processes, analytical methods, and formulations. These organizations specialize in developing and manufacturing stable cell lines that are extensively used in a number of important applications, including drug screening, gene functional studies, and biologic production.

The market is segmented on the basis of biological source, product service (upstream and downstream), and indication. Factors such as the increasing adoption of advanced technologies for biologic development, a favorable environment for clinical trials in developing countries; and an increase in outsourcing of R&D activities are paving the way for the growth of the market. During the COVID-19 pandemic, a significant number of CROs partnered with biotechnology companies for R&D in COVID-19 vaccines. In 2022, there will be a significant number of companies undergoing research for a potential COVID-19 vaccine owing to the rising cases. This is expected to have a positive impact on the market.

Growing M&A and collaboration activities between biopharma companies and CDOs are yet another factor assisting in market growth, allowing more financial stability and the amalgamation of advanced and specialized technologies. For instance, In September 2021, Curia Global, Inc., formerly AMRI, leading contract research, development, and manufacturing firm, acquired LakePharma Inc., a California-based biologics drug discovery, development, and manufacturing company. Many biopharma and pharma companies are increasingly looking to outsource their activities as it helps accelerate the workflow (speed) of the company, provides unique specialized services, decreases drug manufacturing costs, and provides expertise. These factors are expected to boost the biologics contract development organization market growth in the coming years.

During the COVID-19 pandemic, the majority of clinical trials were focused on developing new therapies for treating COVID-19. However, in the post-pandemic period, research is expected to focus on cancer owing to its rising incidence. Biologics such as monoclonal antibodies have gained significant popularity in treating cancer. According to the IQVIA report Oncology Trends 2022, the number of cancer clinical trials increased significantly in 2021. The high potential of biologics in treating cancer and the growing number of cancer studies are likely to support the growth of the market in the coming years.

Report Scope of the Biologics Contract Development Market

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Source Insights

The mammalian source segment accounted for the largest revenue share of 54.9% in 2021 in the market for biologics contract development. The segment is expected to witness a significant CAGR during the forecast period. This is due to the fact that using mammalian cells for protein expression has the major benefit of producing mammalian proteins with correct post-translational modifications that provide a native structure. Mammalian cells like Chinese Hamster Ovary (CHO) cell lines have been among the most preferred and about 70.0% of the protein therapeutics is developed from CHO cells.

The microbial source segment has gained a significant share in 2021. Microbial systems are widely used for producing recombinant protein therapeutics. Around 650 protein drugs have been approved worldwide to date, among which, about 400 were obtained from microbial recombinant technologies. Moreover, approximately 48.0% of biologics approved for manufacturing are produced by microbial sources, which are primarily used by CDMOs to produce cytokines, hormones, enzymes, and MABs. These factors are supporting the segment growth.

Product Services Insights

The process development services accounted for the largest revenue share of 73.6% in 2021 in the biologics contract development market. Biologics process development is characterized by two techniques-upstream process development and downstream process development. Upstream process development mainly includes the selection of the right cell line, culture medium, bioreactor systems, and operating parameters. Upstream process development services are provided by the majority of the biologics manufacturing organizations and are highly specific to the client's business needs, regulatory constraints, and project timeline. Companies, such as AGC Biologics, Curia Global, Inc., and Bionova Scientific, offer upstream process development for mammalian and microbial large-scale manufacturing services.

The cell line development service is expected to hold a significant share in the market in 2021. According to NCBI, cell lines are being rigorously used in, testing vaccine production, drug metabolism & cytotoxicity, generation of artificial tissues (e.g., artificial skin), study of gene function, antibody production, and synthesis of biological compounds. The usage of cell lines has revolutionized scientific research. The development of efficient cell lines is requisite, as they can be used to investigate anticipated clinical results. The production of efficient cell line influences productivity and product quality. Varied characteristics of cell lines also enhance process development to achieve target productivity and quality.

Indication Insights

Oncology accounted for the largest revenue share of 48.9% in 2021 in the market for biologics contract development. As cancers are formed through malfunctioning of the immune system, biologic therapy is stated to repair, stimulate, or enhance the immune response, and hence many pharmaceutical and biopharmaceutical companies are willing to invest in cancer-related novel treatments. Cancer can proliferate in any organ of the body, and thus there is an extensive need for treatment, which in turn is boosting investments in R&D and outsourcing by various companies.

The immunological disorder disease segment is anticipated rise with the fastest growth of 11% CAGR during the forecast period. Immunological diseases or conditions caused by dysfunction of the immune system include diseases such as asthma, allergy, autoimmune diseases, and others. According to NCBI, autoimmune inflammatory diseases affect approximately 7.6% to 9.4% of the world’s population, especially young and middle-aged women. Biologics medicines have gained significant importance in treating diseases such as arthritis, rheumatologic diseases, and others. The high efficiency and safety of these medications are likely to improve the demand for biologics for treating immunological disorders which is expected to have a positive impact on the market.

Regional Insights

North America dominated the market for biologics contract development in 2021 and accounted for a revenue share of 37.4% in 2021. The region is expected to showcase a significant CAGR over the forecast period. This is attributed to increasing R&D investments and the local presence of global players and their efforts to obtain new patents. The growth of the contract development organizations (CDO) can be primarily attributed to the increasing outsourcing activities and rise in the number of clinical trials in the region. For instance, as per ClinicalTrial.Gov as of July 2022, over 32% of the global studies were conducted in the U.S. alone. A high number of researches conducted in the U.S. is further supporting the regional market growth.

In Asia Pacific, the market for biologics contract development is expected to witness the highest CAGR of 13.9% over the forecast period. Various regulatory organization amendments to change clinical trial evaluation standards in accordance with global requirements are generating the interest of the biotechnology companies to invest in the Asia Pacific region. Asia Pacific countries have a large patient pool and the potential for advanced medical expertise. In comparison to western countries, the cost of conducting a clinical trial is very low here. These aforementioned factors are expected to contribute to the region's market growth.

Key Companies & Market Share Insights

The market for biologics contract development is highly competitive. One of the key factors driving competitiveness among market players is the rapid adoption of advanced technologies. For instance, CDOs are shifting toward Single-Use Bioreactors (SBUs) and smaller batch sizes, and smaller-volume bioreactor tank sizes for biopharmaceutical production.

Moreover, a prominent number of these players are rapidly opting for strategic collaborations and partnerships through mergers and acquisitions in emerging and economically favorable regions. For instance, In September 2021, Curia Global, Inc., formerly AMRI, leading contract research, development, and manufacturing firm, acquired LakePharma Inc., a California-based biologics drug discovery, development, and manufacturing company. Some of the prominent players in the biologics contract development market are:

• WuXi Biologics
• Abzena Ltd
• Fujifilm Diosynth Biotechnologies
• KBI Biopharma
• AGC Biologics
• Thermo Fisher Scientific Inc.
• Curia Global, Inc.
• Genscript
• Bionova Scientific, Inc.
• BioXcellence (Boehringer Ingelheim Biopharmaceuticals GmbH)
• STC Biologics

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2017 to 2030. For this study, Nova one advisor, Inc. has segmented the global Biologics Contract Development market

• Source
  • Microbial
  • Mammalian
  • Others
• Product Service
  • Cell Line Development
    • Microbial
    • Mammalian
    • Others
  • Process Development
    • Upstream
      • Microbial
      • Mammalian
      • Others
    • Downstream
      • Impurity, isolation, & identification
      • Physicochemical characterization
      • Pharmaceutical analysis
      • Others
    • By Product
      • MABs
      • Recombinant proteins
      • Others
    • Others
• Indication
  • Oncology
  • Immunological disorders
  • Cardiovascular disorders
  • Hematological disorders
  • Others

Report Objectives

• To define, describe, and forecast the global Biologics Contract Development market based on product, technique, methodology, category, and region
• To provide detailed information regarding the major factors influencing the market growth (drivers, restraints, growth opportunities, and challenges)
• To strategically analyze micromarkets1 with respect to individual growth trends, future prospects, and contributions to the overall market
• To analyze the opportunities in the market for key stakeholders and provide details of the competitive landscape for major market leaders
• To forecast the size of the market segments with respect to five main regions—North America (the US and Canada), Europe (Germany, the UK, France, Italy, Spain, and Rest of Europe), Asia Pacific (Japan, China, India, Australia, South Korea, and Rest of Asia Pacific), Latin America (Brazil, Mexico, and Rest of Latin America), and the Middle East and Africa
• To profile the key market players and comprehensively analyze their market shares and core competencies2
• To track and analyze competitive developments such as mergers and acquisitions, new product developments, partnerships, agreements, collaborations, and expansions in the global Biologics Contract Development market

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