The global biologics contract development market size was USD 7.3 Billion in 2022 and is likely to reach USD 14.71 Billion by 2031, expanding at a CAGR of 8.1% during 2023-2031. Biologics contract development organizations (CDOs) are provide full services from cell line production to long-term industrial procurement of biological products. Services include the production of cell lines, upstream and downstream systems, analytical and bioanalytical approaches, formulation and quality evaluation, and regulatory support.
Biologics Contract Development Market Trends, Drivers, Restraints, and Opportunities
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Increasing introduction of new technology for biological processing, rising M&A practices, growing outsourcing of R&D operations by pharmaceutical and biopharma firms, and favorable regulatory climate for clinical trials in developing countries are driving the growth of the biologics contract development market.
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Growing number of mergers and collaborations has expanded the outsourcing of pharmaceuticals and biopharmaceuticals to major manufacturing players in emerging regions.
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Regulatory authorities in developed countries are harmonizing their regulations with those of the European Medicines Agency (EMA) and The US Food and Drug Administration (FDA) requirements, speeding the approval process, and building legitimacy. The use of contract laboratories for biologics and dependence on clinical trial operations are expected to improve drug processes, thus boosting the market.
Scope of Biologics Contract Development Market Report
The report on biologics contract development market includes an assessment of the market, size, share, trends, segments and regional markets. Overview and dynamics have been included in the report.
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Attributes
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Details
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Base Year
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2022
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Historic Data
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2016 & 2021
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Forecast Period
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2023–2031
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Regional Scope
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Asia Pacific, North America, Europe, Latin America, and Middle East & Africa
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Report Coverage
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Market scope, analysis, share, competitive analysis, growth facts, restraints, opportunities and revenue forecast.
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Biologics Contract Development Market Segment Insights
The mammalian source segment is projected to hold significant market share
In the terms of sources, the biologics contract development market has been segmented into microbial, mammalian, and others. The mammalian segment is projected to grow at significant pace during the forecast period. This is due to the fact that the use of mammalian cells for protein expression can provide the significant benefit of being able to generate mammalian proteins with all the necessary post-translational modifications to have a native structure.
Demand for process development to fuel segment growth
On the basis of product services, the market has been segregated into cell line development, process development, and others. The cell line development segment is divided into microbial, mammalian, and others. The process development segment is segmented into upstream, downstream, product, and others. The upstream sub-segment is further segmented into microbial, mammalian, and others. The downstream sub-segment is segregated into impurity, isolation, & identification, physicochemical characterization, pharmaceutical analysis, and others. The product sub-segment is further fragmented into MABs, recombinant proteins, and others. The process development segment is projected to expand at a significant pace during the forecast period due to the introduction of emerging innovations, such as automated expression systems, enhanced bioprocessing systems, and single-use technologies to minimize costs and meet the growing demand.
Rising prevalence of immunological disorders propels segment growth
Based on disease indications, the biologics contract development market is fragmented into oncology, immunological disorders, cardiovascular disorders, hematological disorders, and others. The oncology segment holds significant share of the market, while the immunological disorder disease segment is projected to expand at a substantial CAGR during the forecast period. Immunological condition is caused by immune system dysfunction and involves allergies, asthma, and autoimmune diseases, affecting about 7.6% to 9.4% of the world's population.
North America constituted a dominant share of the biologics contract development market
In terms of regions, the global biologics contract development market is classified as North America, Europe, Latin America, Asia Pacific, and Middle East & Africa. North America accounts for a considerable share of the global market. The development of the CDOs due to increasing outsourcing activities and rising number of clinical trials in the region fuel the market in North America. The demand for biologics contract development in Asia Pacific is expected to rise at a significant pace due to numerous reforms introduced by regulatory organizations to adjust the criteria for clinical trial appraisal in line with global requirements and several major players are investing in the region.
Segments
The global biologics contract development market has been divided based on sources, product services, diseases indications, and regions.
By Sources
- Microbial
- Mammalian
- Others
By Product Services
- Cell Line Development
- Microbial
- Mammalian
- Others
- Process Development
- Upstream
- Microbial
- Mammalian
- Others
- Downstream
- Impurity, isolation, & identification
- Physicochemical characterization
- Pharmaceutical analysis
- Others
- Product
- MABs
- Recombinant proteins
- Others
- Others
By Diseases Indications
- Oncology
- Immunological Disorders
- Cardiovascular Disorders
- Hematological Disorders
- Others
By Regions
- North America
- Europe
- Latin America
- Asia Pacific
- Middle East & Africa
Key Players in the market
- Abzena Ltd.
- AGC Biologics
- Bionova Scientific
- Boehringer Ingelheim BioXcellence
- Fujifilm Diosynth Biotechnologies
- Genscript Biotech Corporation
- KBI Biopharma
- LakePharma
- SE Thermo Fisher (Patheon)
- STC Biologics Inc.
- WuXi Biologics
Competitive Landscape
Key players in the biologics contract development market include Abzena Ltd., AGC Biologics, Bionova Scientific, Boehringer Ingelheim BioXcellence, Fujifilm Diosynth Biotechnologies, Genscript Biotech Corporation, KBI Biopharma, LakePharma, SE Thermo Fisher (Patheon), STC Biologics, Inc., and WuXi Biologics. These players engage in mergers & acquisitions, collaborations, agreements, and partnerships to strengthen their geographical presence.
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