Biologics Outsourcing Global Market: Global Industry, Trends, Market Size, Forecast up to 2030

Japan, Japan, Thu, 06 Jan 2022 00:20:41 / Comserve Inc. / -- Even though biologics are highly expensive when compared to the conventional small molecule drugs, these target specific therapeutics have proven to be very beneficial for patients and also ensure higher profit margins to the drug manufacturers.

The biologics outsourcing global market is expected to grow at low teen CAGR to reach $87.5 billion by 2028. Biologics are the therapeutic entities composed of sugars, proteins, or nucleic acids and made from natural sources such as human, animal or microorganisms. Biologics also include live attenuated microorganisms (vaccines), allergenic extracts (allergy shots), human cells and tissues (for transplantation), cell and gene therapeutics. Similar to the conventional therapeutics, these drugs help in treating several diseases but are highly specific and more efficient in their disease healing mechanisms. The biologic entities like monoclonal antibodies and recombinant proteins target specific areas during their molecular mechanism of disease curing.

Even though biologics are highly expensive when compared to the conventional small molecule drugs, these target specific therapeutics have proven to be very beneficial for patients and also ensure higher profit margins to the drug manufacturers. The escalating adoption of biologics and elevating demand for the highly efficient biotherapeutics from the value-centric patient population across the globe, increasing investments on research and developmental activities of biologics and advanced, next-generation biotherapeutics, a favorable and streamlined regulatory environment that is expediting the novel product approval process and the expansion of biosimilar market have all led to the rapid growth of the biopharmaceutical market.

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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. This fast pacing biologic industry coupled with insufficient or lack of in house biologic development and manufacturing capabilities and capacities of biopharmaceutical companies has spurred these companies to outsource the different parts of biologic development and manufacturing process to highly efficient service providing organizations. 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 and manufacturing process gets much faster and convenient; thus bringing the life-saving drugs to the market and the needy patients at the earliest.

In 2019, seven out of the 10 blockbuster drugs were biologics, outnumbering small molecule drugs. Some of the top-selling biologics in 2019 include Humira ($19.1 billion), Keytruda ($11.0 billion), Avastin ($7.28 billion) and Opdivo ($7.20 billion). The growth of biologics market indirectly indicates the huge demand for services spanning all stages of biologic development starting from the preclinical stage to commercial manufacturing. The high complexity associated with development and manufacturing of biologics and requirement of specialized equipments and skills for biomanufacturing is prompting the biopharma companies to turn to outsourcing as a viable option. Thus the CMO's offering quality compliant, rapid bioproduction and supply services, scalable and flexible capacities with stable capabilities at competitive costs will become an integral part of the biopharmaceutical company. 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.
The biologics outsourcing global market has been segmented based on the developmental phase, product, end users and geography. Among the discovery, pre-clinical, clinical and commercial phases of biologics development, Commercial Phase outsourcing commanded the largest revenue in 2020. It is also the fastest growing segment and is expected to grow at low teen CAGR during the forecasted period. The biological outsourcing market by product type is segmented into Antibody, Proteins, Vaccines, Gene therapy, cell therapy and others. Among these, the antibody outsourcing segment accounted for the largest share of revenue in 2020 and is expected to grow at low teen CAGR during the forecasted period. Gene therapeutics segment is expected to be the fastest emerging market growing at low teen CAGR during the forecasted period. Based on end – users, the biologics outsourcing market is segmented into Therapeutics, Diagnostics and Research. Therapeutics is the largest and fastest growing segment and is expected to grow at low teen CAGR from 2020 to 2028. Geographically, North America dominated the biologics outsourcing market with the highest revenue in 2020 and is expected to grow at double digit CAGR from 2020 to 2028. Asia Pacific region is expected to be the fastest emerging market growing at mid teen CAGR during the forecasted period.
The report specifically emphasizes on the rapidly evolving and high growth potential biologics contract manufacturing services market and cell line development services market. Biologics contract biomanufacturing services global market is expected to reach $57.1 billion by 2028 growing at a low teen CAGR from 2020 to 2028. The cell line development service global market is expected to reach $1,702.2 million by 2028 growing at a double digit CAGR from 2020 to 2028.

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