Biologics Contract Development Market Size, Share & Trends Analysis Report By Source (Mammalian, Microbial), By Product Service Type, By Disease Indication (Oncology, Immunological Disorders), By Region, And Segment Forecasts, 2020 - 2027

Report Overview

The global biologics contract development market size was valued at USD 5.6 billion in 2019 and is expected to grow at a compound annual growth rate (CAGR) of 8.8% from 2020 to 2027. Biologics CDOs are organizations that offer complete services from cell line development to long term commercial supply of biological products. The services include the development of cell lines, upstream and downstream processes, analytical and bioanalytical methods, formulations and quality assessment, and regulatory assistance. Factors such as increasing adoption of advanced technologies for biological production, growing M&A activities, rise in outsourcing of R&D activities by pharma and biopharma companies, and favorable regulatory environment for clinical trials in developing countries are driving the biologics contract development and manufacturing organization market.

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 March 2019, Thermo Fisher Scientific, Inc. announced that it will acquire Brammer Bio, a leading viral vector contract developer for gene and cell therapies, which would help the company, strengthen its product portfolio in the area of gene therapy. By product service type, the market for biologics contract development is broadly divided into cell line development, process development, and others.

The prevalence of diseases, such as cancer, neurological disorders, gynecological disorders, ophthalmic disorders, and cardiovascular disorders, is increasing every year. For instance, according to WHO, approximately 8.2 million people die each year due to cancer, accounting for 13.0% of deaths worldwide. Moreover, there will be an estimated 70.0% increase in new cancer cases over the next couple of decades. 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.

Pharmaceutical companies invested USD 79.6 billion in R&D, according to the 2019 PhRMA member annual survey. This investment in R&D drives advancements within biopharmaceutical companies for discovering new treatments and cures. Of all the molecules in the clinical phase in 2018, 74% are potentially first-in-class, meaning they represent a possible new pharmacological class for treating a disease. There were high percentages of potential first-in-class clinical-phase projects in many therapeutic categories, including cancer (79%), neurology (74%), and diabetes (69%).

Many biologics contract development companies are now shifting to Single-Use Bioreactors (SBUs) that provide lower up-front capital costs, greater manufacturing flexibility, and improved throughput. According to Genetic Engineering and Biotechnology News, the market for biologics contract development is following the trend of increased use of single-use technologies, more flexible and multiproduct facilities, and platform methods and technologies in CMOs. These are expected to increase the delivery speed. Moreover, this will help in improving manufacturing productivity and increasing yield of biologics. Increasing spending on R&D activities and optimization of process development has led to an increase in the adoption of advanced technologies. Antibody-drug conjugates, antisense, gene therapy, and cell therapy are novel biologic technologies with a significant pipeline scale.

Additionally, developing countries, such as India and China, have proven to be an attractive choice for outsourcing clinical trials as they have a large population with diverse disease burdens, which help in conducting efficient clinical studies and create ease 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 in and creating credibility. Setting up for biologics contract development facilities along with these clinical trials activities is expected to speed up the drug development process.

Product Service Insights

The process development services accounted for the largest revenue share of 70.3% in 2019 in the biologics contract development market. Biologics process development is characterized into two techniques-upstream process development and downstream process development. According to the 2016 Nice Insight Contract Development and Manufacturing Survey, which included nearly 600 biopharmaceutical professionals, stated that spending by pharmaceutical and biotechnology companies has increased on the outsourcing of process development services. CMOs/CDMOs are adopting new technologies, such as advanced expression systems, improved bioprocessing systems, and single-use technologies, to lower costs and meet demand more efficiently.

Upstream process development mainly includes the selection of the right cell line, culture medium, bioreactor systems, and its operating parameters. Upstream process development services are provided by the majority of the biologics manufacturing organizations and are highly specific to clients’ business needs, available resources, regulatory constraints, and project timeline. Companies, such as AGC Biologics, Lakepharma, Inc., and Bionova Scientific, offer upstream process development for mammalian and microbial large-scale manufacturing services.

Downstream processing is the process where the fermented medium containing the inoculum is purified and tested. Various quality assessments like impurity isolation & identification, physicochemical characterization, pharmaceutical analysis, validating polishing, and packaging are included in downstream process services. Other product services include packaging, labeling, and consultation services.

Disease Indication Insights

Oncology accounted for the largest revenue share of 48.7% in 2019 in the market for biologics contract development. In 2018, 79 therapeutic mAbs were approved by the U.S. FDA and are currently on the market, out of which 30 mAbs are for the treatment of cancer. Biologics such as Durvalumab manufactured by AstraZeneca was approved for the treatment of bladder cancer in 2018.

The immunological disorder disease segment is anticipated to witness the highest CAGR in the market for biologics contract development over the forecast period. The disorder is caused by dysfunction of the immune system and includes allergy, asthma, and autoimmune diseases, affecting approximately 7.6% to 9.4% of the world’s population.

Source Insights

The mammalian source segment accounted for the largest revenue share of 44.7% in 2019 in the market for biologics contract development. The segment is expected to witness a significant CAGR during the forecast period. This is attributed to the fact that using mammalian cells for protein expression can offer the major advantage of being able to produce mammalian proteins with all the 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.

Microbial cell lines are also widely used and about 48.0% of biologics approved for manufacturing are produced in microbial systems, including E.coli and Saccharomyces cerevisiae, and are mainly used for the production of cytokines, hormones, enzymes, and some MABs by CDMOs. Other sources of cell line development include insect, yeast, algal, and amphibian expression systems. Bacterial systems provide high yields of protein in a short time, mammalian systems are capable of producing proteins with complete human-like post-translational modifications.

Regional Insights

North America dominated the market for biologics contract development in 2019 and accounted for a revenue share of 39.1% in 2019. 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. In 2018, the National Cancer Institute (NCI) received USD 70.0 million from the government of America to identify genomic drivers in cancer and design their treatment approaches.

In Asia Pacific, the market for biologics contract development is expected to witness the highest CAGR of 12.0% over the forecast period. This is attributed to various amendments made by regulatory organizations to change clinical trial evaluation standards according to global requirements and many major players are investing in the Asia Pacific. Countries in the Asia Pacific have a dense patient pool and the potential to have advanced medical expertise. The cost of conducting a clinical trial is very low here as compared to western countries. These aforementioned factors will assist the biologics contract development and manufacturing organization market within the region. According to Business Line, in 2018, India contributed one-third (USD 18.3 billion) of the global R&D and services market.

Key Companies & Market Share Insights

The market for biologics contract development is highly competitive in nature. 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. In February 2020, LakePharma, Inc., and NJ Biopharmaceuticals LLC, a CRO providing integrated chemistry and biology services, announced a strategic alliance to offer streamlined Antibody-Drug Conjugate (ADC) development solutions for biotechnology and pharmaceutical sectors. Some of the prominent players in the biologics contract development market include:

• WuXi Biologics

• Abzena Ltd.

• Fujifilm Diosynth Biotechnologies

• KBI Biopharma

• AGC Biologics

• SE Thermo Fisher (Patheon)

• LakePharma

• Genscript Biotech Corporation

• Bionova Scientific

• Boehringer Ingelheim BioXcellence

• STC Biologics, Inc.

Biologics Contract Development Market Report Scope

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 2016 to 2027. Grand View Research has segmented the global biologics contract development market report on the basis of source, product service type, disease indication, and region:

• Source Outlook, (Revenue, USD Million, 2016 - 2027)

  • Microbial

  • Mammalian

  • Others

• Product Service Outlook (Revenue, USD Million, 2016 - 2027)

  • 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

• Disease Indication Outlook, (Revenue, USD Million, 2016 - 2027)

  • Oncology

  • Immunological disorders

  • Cardiovascular disorders

  • Hematological disorders

  • Others

• Regional Outlook (Revenue, USD Million, 2016 - 2027)

  • North America

    • The U.S.

    • Canada

  • Europe

    • The U.K.

    • Germany

    • France

    • Italy

    • Spain

  • Asia Pacific

    • India

    • Japan

    • China

    • Australia

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Colombia

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE