Biologics Contract Development Market Size, Share & Trends Analysis Report By Source (Mammalian, Microbial), By Product Service Type, By Indication (Oncology, Immunological Disorders), By Region And Segment Forecasts, 2022 - 2030

Report Overview

The global biologics contract development market size was valued at USD 5.5 billion in 2021 and is anticipated to exhibit a compound annual growth rate (CAGR) of 10.5% over the forecast period. 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.

An increase in the number of mergers and collaborations has increased pharma and biopharma outsourcing, with major industry players expanding into developing regions. For instance, in May 2019, Thermo Fisher Scientific, Inc. acquired Brammer Bio, a leading viral vector contract developer for gene and cell therapies, which would help the company strengthen its market position in the area of gene therapy.

The prevalence of diseases, such as neurological disorders, gynecological disorders, cancer, ophthalmic disorders, and cardiovascular disorders, are witnessing a steady rise. For instance, according to WHO, cancer is one of the leading causes of death worldwide and accounted for over 10 million deaths in 2020. The Cancer Tomorrow states that in the years to come the number of cancer cases is expected to rise. As per the estimates of Cancer Tomorrow, over 19.3 million cancer cases were reported in 2020 and this number is expected to rise to 30.2 million by 2040. In such cases, healthcare CDMOs play a vital role in patient care, as many biopharma companies are wanting to develop novel therapies or first-in-class products for the treatment of diseases.

The Pharma R&D Annual Review 2021, reports that there is a consistent rise in the pipeline of drugs. For instance, in 2020, 17,737 drugs were in pipeline where as of 2021, over 18,582 drugs were in pipeline. The growing number of drugs in pipelines is expected to create opportunities for market growth.

Furthermore, developing countries, such as India and China, have proven to be an attractive choice for outsourcing clinical trials as these countries have a large population with diverse disease burdens, which helps in conducting efficient clinical studies and create ease for patient recruitment. According to Pharmaceutical Outsourcing, China, India, and Korea are the most active settings for clinical trials among developing nations due to increased market access and thus remain prime destinations for clinical research outsourcing. Governments in these countries support outsourcing as it brings in foreign investment. Moreover, regulatory bodies in developing countries are harmonizing their policies with EMA and FDA standards, thereby accelerating the process of approval and creating credibility. Thus promoting the market growth in these countries.

There was a high demand for COVID-19 vaccines at the start of the pandemic. Owing to this several CROs have undergone partnerships and collaboration agreements to speed up the research of COVID-19 vaccines in 2020. However, in the post-pandemic period, CROs are undergoing alliances for research of other diseases such as cancer, Alzheimer's, and other diseases. For instance, in April 2022, Labcorp, collaborated with, Xcell Biosciences, in order to support the company in developing cell and gene therapies for treating Parkinson’s, cancer, and other rare diseases. This is expected to improve the research on these diseases in the post-pandemic period.

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 73.3% 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 37.2% 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 13.7% 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

Biologics Contract Development Market Report Scope

Global Biologics Contract Development Market Segmentation

This report forecasts revenue growth at regional & country levels and provides an analysis of the industry trends in each of the sub-segments from 2018-2030. For this study, Grand View Research has segmented the global biologics contract development market based on source, product service, indication, and region:

• Source Outlook (Revenue, USD Million, 2018 - 2030)

  • Microbial

  • Mammalian

  • Others

• Product Service Outlook (Revenue, USD Million, 2018 - 2030)

  • 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 Outlook (Revenue, USD Million, 2018 - 2030)

  • Oncology

  • Immunological disorders

  • Cardiovascular disorders

  • Hematological disorders

  • Others

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE