Contract manufacturing organizations (CMOs) are companies that offer a broad spectrum of services ranging from drug development to drug manufacturing on contract basis to the pharmaceutical companies. Biopharmaceutical contract manufacturing involves the development and manufacture of biopharmaceutical molecules for biopharmaceutical companies. Biopharmaceuticals include pharmaceutical products such as proteins, nucleic acids, blood components, and vaccines developed from biological sources.
The biopharmaceutical contract manufacturing market is anticipated to expand robustly during the forecast period. Strong growth of the market can be attributed to the risk hedging nature of biopharmaceutical companies by outsourcing manufacturing to CMOs. This enables biopharmaceutical companies to balance their risk and buy time until key clinical trial milestones are met. Additionally, lack of manufacturing capabilities and high investments required in R&D of biopharmaceuticals induce new market entrants to outsource manufacturing activities. Moreover, strong technical capabilities of the CMOs in cell-line development, scale-up, and process development, and rich pipeline of biologics such as viral vectors, multispecific monoclonal antibodies, peptides, and other oligonucleotides drive the biopharmaceutical contract manufacturing market. However, lack of capacity of CMOs to manufacture large-volume biopharmaceutical drug substances, complexity in transferring biological components, and limited options available for biopharmaceutical companies for large-volume production are projected to hamper the growth of the market.
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The global biopharmaceutical contract manufacturing market can be segmented based on product type, platform, application, therapeutic area, services, and region. In terms of product type, the market can be classified into interferons, monoclonal antibodies, vaccines, recombinant hormones, growth factors, and others. Based on platform, the global biopharmaceutical contract manufacturing market can be categorized into mammalian and microbial. In terms of application, the market can be bifurcated into commercial and clinical. Based on therapeutic area, the global biopharmaceutical contract manufacturing market can be segmented into oncology, cardiovascular diseases, metabolic disorders, neurology, respiratory diseases, hematology, autoimmune diseases, and others. In terms of services, the market can be bifurcated into manufacturing and research. The manufacturing services segment can be further divided into bulk drugs and active pharmaceutical ingredient (API) manufacturing, packaging, advanced drug delivery formulations, and finished dose formulations.
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Geographically, the global biopharmaceutical contract manufacturing market can be segmented into five regions: North America, Latin America, Europe, Asia Pacific, and Middle East & Africa. North America accounted for the largest share of the global biopharmaceutical contract manufacturing market in terms of revenue in 2016. The trend is anticipated to continue during the forecast period. However, the market in Asia Pacific is anticipated to expand at a significant pace during the forecast period. Rise in investments by contract manufacturing organizations in the region, increase in the number of companies outsourcing manufacturing activities to CMOs, and business and regulatory reforms contribute to the growth of the market. For instance, in August 2017, Fujifilm Holdings announced expansion of its biopharmaceutical contract manufacturer business by doubling the capacity of culture tanks by 2019. Growth of the market in Asia Pacific is anticipated to be driven by India and China. Focus on the development of biologics pipelines by domestic companies in China and rise in adoption of newer technology platforms such as single-use technologies by CMOs have been contributing to the growth of the market in the country.
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Leading players operating in the global biopharmaceutical contract manufacturing market are Lonza Group, Samsung Biologics Co., Ltd., Rentschler Biotechnologie GmbH, Catalent, Inc., Fujifilm Diosynth Biotechnologies, Patheon N.V., Abzena plc, Ajinomoto Althea, Inc., Vetter Pharma International GmbH, WuXi Biologics, Boehringer Ingelheim GmbH, Pfizer CentreOne (contract manufacturing unit of Pfizer, Inc.,), and Cytovance Biologics, Inc., among others.
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