Biologics Outsourcing Global Market - Forecast to 2030

Increased Therapeutic Value of Biologics and Huge Potential of Biologics Outsourcing has Resulted in Biopharma Companies Focusing on New Partnerships & Collaborations with CDMOs

The biologics outsourcing global market is expected to grow at a double digit CAGR from 2022 to 2030 to reach $106.7 billion by 2030. Major drivers for the biologics outsourcing market include increasing trend of outsourcing among the biopharma companies for gaining an economical access to advanced biologics development and manufacturing capacities and capabilities, advanced bioprocessing capabilities of bioservice providers, increasing approvals and adoption of biologics, increasing R&D spend of biopharma companies and escalating approvals and uptake of biosimilars. Factors like emergence of next generation biotherapeutics, development of personalized and orphan indication therapies and the persistently escalating prevalence of chronic, communicable and autoimmune diseases are expected to boost the market growth. However, increasing focus on in-house biologics manufacturing, huge capital investments for capacity and capability development and compliance with stringent regulatory guidelines are restraining the market.

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 various phases of biologic development and manufacturing process to highly efficient service provider organizations. To tap this market of high growth potential as the advantageous first movers or to increase accessibility in this rapidly growing market without making huge capital investments and by eclipsing the various risks associated with complex bio-molecule production, the large, medium, small or virtual biopharma companies are all increasingly adopting the trend of outsourcing so as to meet the accelerated biopharmaceutical development and production demand effectively. 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 the biologic development and manufacturing processes to contract research organizations (CROs), contract development and manufacturing organizations (CDMOs) and contract manufacturing organizations (CMOs). Thus the need to accelerate time to market of their novel biologic products and gain a competitive edge in the market by gaining economical and timely access to technologically advanced biologic development and biomanufacturing capabilities, flexible capacities and technical expertise of CDMOs is fuelling the biologic outsourcing market growth.

The biologics outsourcing global market has been segmented based on the developmental phase, product, end users and geography. Based on the phase, biologics outsourcing global market segmented into discovery, pre-clinical, clinical and commercial phases of biologics development. Among these, Commercial Phase outsourcing commanded the highest revenue in 2022 and is expected to grow at a double digit CAGR from 2022 to 2030. Clinical outsourcing segment is expected grow early teen CAGR from 2022 to 2030. Based on the product type, biologics outsourcing global market is segmented into Antibody, Proteins, Vaccines, Gene therapy, cell therapy and others. Among these, the antibody outsourcing segment accounted for the highest revenue in 2022 and is expected to grow at a high single digit CAGR from 2022 to 20230. Gene therapeutics segment is expected grow at a high double digit CAGR from 2022 to 2030. Based on end-users, biologics outsourcing global market is segmented into Therapeutics, Diagnostics and Research. Among these, Therapeutics accounted for the highest revenue in 2022 and is expected to grow at a double digit CAGR from 2022 to 2030.

The increased therapeutic value of biologics and huge potential of biologics outsourcing global market has resulted in biopharma companies focusing on new partnerships and collaborations with CDMOs. For instance, in October 2021, Enzolytics (ENZC), a drug development company and Samsung Biologics, a CDMO have signed a strategic CDMO partnership to commercializing multiple proprietary therapeutics to treat debilitating infectious diseases. The CDMOs and CROs are expanding their outsourcing capabilities either by launching new advanced services or collaborating with other biotechnology companies to add advanced capabilities. For instance, in December 2021, Curia launched messenger RNA (mRNA) services, which includes discovery, process development and mRNA drug substance production, through large-scale lipid manufacturing, lipid nanoparticle (LNP) formulation and development for full-scale sterile fill-finish services.

Currently, traditional biologics modalities such as monoclonal antibodies, recombinant proteins and vaccines are dominating the biologics market. However, in recent years emerging advanced biologics modalities such as gene therapy, cell therapy, antibody drug conjugates, RNA therapy, m-RNA vaccines and others are gaining more importance due to their potential therapeutic abilities in treating non-infectious diseases and infectious diseases. As these advanced modalities are gaining importance, biologics CDMO are giving more attention to gain extra capabilities in CGT service offerings to tap the potential market. Some of the CDMO are following in-organic strategies like acquisition to provide end-to-end gene and cell therapy services. For instance, in March 2021, Charles River Laboratories International, Inc acquired Cognate BioServices, Inc, a premier, cell and gene therapy contract development and manufacturing organization (CDMO) offering comprehensive manufacturing solutions for cell therapies, as well as for production of plasmid DNA and other inputs in the CDMO value chain. Some of the CDMO are combing their capabilities to provide end-end to CGT services.

For instance, in August 2022, RoslinCT, a cell and gene therapy CDMO developing life-changing therapies and Lykan Bioscience, an innovative CDMO focused on cell-based therapies have entered into a business combination agreement to form global leading innovative advanced therapies CDMO. The combined group will offer process development expertise and cGMP manufacturing for a broad range of autologous and allogeneic cell therapies, with unparalleled expertise in gene editing and industry-leading induced Pluripotent Stem Cell (iPSC) capabilities. Along with this, CDMO are collaborating with biotechnology companies to enhance their CGT services areas. Also, some of the CDMO are investing heavily to expand their gene and cell therapies development and manufacturing facilities. For instance, in August 2021, Yposkesi is investing $71 million to build its second commercial facility to manufacture cell and gene therapies at its campus in Corbeil-Essonnes, France. The facility will increase the company’s manufacturing capacity to meet growing demand for gene therapy treatments for rare and common diseases, as well as supporting its expansion in the global biopharmaceutical market. Apart from these, some of the CDMO are receiving funding to expand cell and gene therapy development platforms. Along with CGT and other advanced therapies, antibody drug conjugates have taken a huge leap and their potential in biologics market is very huge.

To cater the evolving needs of ADC outsourcing companies, the CMO’s are constantly upgrading and expanding their capabilities, capacities and technical expertise.

By seeing potential growth in the biologics particularly in advanced therapeutic modalities such as cell therapy, gene therapy, m-RNA vaccines and others, some of the small molecules CDMO are also entering into biologics by following in-organic strategies like acquisition. For instance, in February 2022, Recipharm a small molecule CDMO acquired GenIbet, a Portuguese CDMO, specializing in the manufacturing of biological clinical trial material and novel modalities such as viral vectors, RNA and microbiome. This acquisition forms part of Recipharm’s strategy to grow in the Biologics market, with a particular focus on drug substance manufacturing of novel ATMPs (advanced therapy medicinal products).

Based on geography, biologics outsourcing global market is segmented into North America, Europe, Asia-Pacific and RoW. North America dominated the biologics outsourcing market with the highest revenue in 2022 and is expected to grow at high single digit CAGR 2022 to 2030. Whereas, Asia Pacific region is expected to be grow at an early teen CAGR from 2022 to 2030.

The report specifically emphasizes on the rapidly evolving and high growth potential biologics contract manufacturing services market and cell line development services market. The biologics contract manufacturing global market is expected to grow at double digit CAGR from 2022 to 2030. The contract biomanufacturing global market is driven by the increasing trend of outsourcing among the biopharmaceutical companies, availability of advanced bioprocessing capabilities among the contract bioservice providers, expansion of manufacturing facilities, and the escalating approval and adoption of biologics and the cost effective biosimilars among the value centric global patient pool leading to huge volume demand for biologics. Emergence of advanced biotherapeutics, increasing R&D investments by the biopharma companies, development of precision and orphan indication therapies and the persistently increasing prevalence of chronic, communicable and autoimmune diseases are also boosting contract biomanufacturing market growth.

The biologics outsourcing global market is fragmented with the top six players occupying a modest share of the market and the remaining other players occupying the major part of the market. The top players in biologics outsourcing global market are Lonza (Switzerland), Catalent (U.S.), SamSung Biologics (South Korea), WuXi Biologics (China), Thermo Fisher (Patheon N.V.+Brammer Bio) (U.S.), FUJIFILM Holdings Corporation (FujiFilm Diosynth) (Japan), Merck KGaA (Germany), Boehringer Ingelheim (Germany), Laboratory Corporation of America Holdings (U.S.), Charles River Laboratories (U.S.), JSR corporation (U.S.), WuXi Apptech (China), Genscript Biotech Corporation (China), Emergent Biosciences (U.S.), Asahi Glass Company (AGC Biologics) (Japan) and others.