Biologics Outsourcing Market is expected to grow at double digit CAGR to reach $70.3 billion by 2025. Biologics are therapeutic entities composed of sugars, proteins, or nucleic acids made from natural sources such as human, animal or micro organisms. Biologics can also include live attenuated microorganisms (vaccines), allergenic extracts (allergy shots), human cells and tissues (transplantation), cell therapies and gene therapies. Like small molecule drugs, these drugs are intended for treatment of diseases and medical conditions. However, Biologics bring into picture higher range of specificity in treating a disease condition as the biologic entities like monoclonal antibodies and recombinant proteins target specific areas in the molecular mechanism of disease action.
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Although biologics are much costlier than small molecule drugs, these classes of drugs prove to be highly beneficial for the patient and also bring about 40% higher profit to the manufacturers when compared to small molecule drug treatments. Due to the increasing demand for biologics drugs and increased regulatory approvals for these drugs, there is huge demand for biologics manufacture and testing at various levels of clinical studies as well as commercial supply. The Large Biopharma companies are coming up with strategies to cut down on their operational costs and concentrate more on their core competencies by outsourcing this piece of work to contract research organizations (CROs), contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs). These organizations bridge the gap between demand and supply and ensure the drug discovery process gets much faster and convenient thus bringing life saving drugs to the market to reach the needy patients.
In 2016, eight out of 10 blockbuster drugs were biologics showing a steep growth in acceptance of biologics in comparison with small molecule drugs. Some of the top selling biologics in 2016 include Humira ($16 billion), Rituxan ($7.5 billion), Herceptin ($6.7 billion), Prevnar 13 ($6.0 billion). The growth of biologics market indirectly indicates the huge demand for services spanning all stages of biologics development starting preclinical stage to commercial manufacturing. The high complexity of biologics development and manufacture requiring huge technical expertise is prompting major biopharma companies turn to outsourcing as a viable option. Various stages of biological development require different types of services as listed below.
Discovery services- Includes lead identification and validation for identifying possible drug candidates targeting specific diseases. The process further involves steps such as target validation, screening preparation, hit generation and lead selection, lead optimization and characterization and finally lead selection.
Preclinical development services- Involves in vitro and in vivo studies of the biologic drug candidates before testing them on humans to test the safety, efficacy and biological functionality against the disease target. Preclinical services include cell line engineering, process development, product analytical characterization, cGMP cell banking, cell line characterization, animal model assay development and testing services.
Clinical development- Clinical development includes testing potential drug candidates on humans in phase I, II and II trials. Services at this stage include cGMP grade clinical supply of biologics such as Mab, or recombinant protein, stability testing, fill/finish and regulatory support.
Commercialization- Once the drug has passed all the necessary approvals, the manufacture, marketing and sale of commercial quantities is performed. Outsourcing partners here manufacture the commercial supply for product launch and sale.
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