The Global Biologics Contract Development Market is anticipated to expand at substantial CAGR during forecast period, between 2020 and 2027. 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.
Market Trends, Drivers, Restraints, and Opportunities:
- 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.
- Growing number of mergers and collaborations has expanded the outsourcing of pharmaceuticals and biopharmaceuticals to major manufacturing players in emerging regions.
- 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.
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.
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