BIOLOGICS OUTSOURCING MARKET ANALYSIS

Global Biologics Outsourcing market is estimated to be valued at US$ 19.67 Billion in 2023 and is expected to exhibit a CAGR of 12.9% during the forecast period (2023-2030). Growing trend of biological outsourcing by biopharma companies in order to adopt inorganic growth strategies such as partnership, is expected to drive the growth of the biologics outsourcing market over the forecast period. Moreover, the rising therapeutic value of biologics is expected to drive the market growth in the near future.

Analysts’ Views on Global Biologics Outsourcing Market:

Global Biologics Outsourcing market's growth is expected to propel over the forecast period, owing to increasing inorganic growth strategies such as partnership by the key market players. For instance, in October 2021, Enzolytics (ENZC), a drug development company, and Samsung Biologics, a CDMO, signed a strategic Contract Development & Manufacturing Organization (CDMO) partnership to commercialize multiple therapeutics to treat debilitating infectious diseases. Under the terms of the agreement, Samsung Biologics will provide end-to-end CDMO services from cell line development, clinical drug substance, and drug product manufacturing services to support IND filings for Anti-HIV and Anti-SARS-CoV-2 Monoclonal Antibodies for the treatment of HIV and SARS-CoV-2.

Figure 1. Global Biologics Outsourcing Market Share (%), By Application, 2023

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Global Biologics Outsourcing Market- Driver

Increasing approvals and adoption of biologics

Increase in regulatory approvals for biologics drives its demand at various levels of clinical trials and commercial studies and is expected to drive the market growth over the forecast period. For instance, on December 22, 2022, Genentech, a pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) had approved Lunsumio for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL). Lunsumio, a CD20xCD3 T-cell engaging bispecific antibody represents a new class of fixed-duration cancer immunotherapy.

Moreover, data published on February 1, 2023, on CMS.gov, a U.S. government website, stated that on December 23, 2022, the U.S. Food and Drug Administration (FDA) announced the approval of a new indication for Actemra, to treat hospitalized adult patients with severe COVID-19 illness.

Figure 2. Global Biologics Outsourcing Market Share (%), By Region, 2023

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Global Biologics Outsourcing Market- Regional Analysis

Among regions, North America is expected to dominate the market over the forecast period, due to North Americas’ 39.6% market share in 2022 and the increasing adoption of inorganic growth strategies such as partnership between key players operating in the market and pharmaceutical companies to address the shortage of pharmaceutical products. For instance, in July 2020, Piramal Critical Care, a subsidiary of Piramal Enterprises Limited, announced a strategic partnership with a U.S.-based pharmaceutical outsourcing facility, Medivant Healthcare, to help address the severe shortage of injectable drugs in hospitals across the U.S. As a part of this partnership, Piramal Critical Care and Medivant Healthcare are working together to distribute single-dose injectable drugs in approved states for COVID-19 patients that have fallen dangerously short in supply of injectable drugs in the U.S.

Europe region is expected to have a lucrative growth over the forecast period, due to an increasing adaptation of inorganic growth strategies such as acquisitions by key market players operating in the region, to expand manufacturing services. For instance, in January 2022, Pharmaron, a life science service company that provides drug research and development services, announced that it had acquired Aesica Pharmaceuticals Limited (‘The Cramlington Site’) from Recipharm group, one of the leading Contract Development and Manufacturing Organizations (CDMO) in the pharmaceutical industry. The acquisition will expand manufacturing services of Pharmaron. The integration of the Cramlington Site with Pharmaron’s existing service capabilities of process development, discovery, and early-stage cGMP API manufacturing at Hoddesdon, U.K. will enable a complete end-to-end chemistry and manufacturing service offering in the U.K. The addition will further strengthen global service network to provide customized solutions to meet Pharmaron’s partners’ strategic and geographic needs.

Global Biologics Outsourcing Market– Impact of Coronavirus (COVID-19) Pandemic

Coronavirus disease 2019 (COVID-19) is a highly contagious infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), according to World Health Organization (WHO) till February 15, 2023, about 756,291,327 people are affected worldwide.

Coronavirus (COVID-19) pandemic had negative impact on the global biologics outsourcing market, due to shortage of raw materials and disruption in supply chain of raw materials required for the production of biologics. According to an article published by the Exploratory Research in Clinical and Social Pharmacy journal, in June 2021, a study was carried out to evaluate the impact of COVID-19 on pharmaceutical systems and supply chain in resource-limited countries in Sub-Saharan countries such as Namibia. This study revealed negative impacts on the availability and access of essential drugs, sanitation and hygiene products, and antimicrobials. Most pharmaceutical companies and pharmacies in Namibia experienced delayed manufacturing and distribution of drugs, which is attributed to reduced inter-country transportation of pharmaceutical goods and limited in-country capacity to manufacture drugs.

Global Biologics Outsourcing Market Segmentation:

The global biologics outsourcing market report is segmented into product and service type, source, application, end user, and region.

Based on product and service type, the market is segmented into Product and Services. Out of which, Product segment is expected to dominate the Biologics Outsourcing market during the forecast period, increasing inorganic growth strategies such as partnership by the key market players.  

Based on source, the market is segmented into Mammalian and Microbial. Out of which, Mammalian segment is expected to dominate the market over the forecast period, due Increasing adoption of inorganic growth strategies such as acquisitions.

Based on application, the Biologics Outsourcing market is segmented into Oncology, Cellular and Gene Therapy, Blood & Blood-Related Products Development, Vaccine Development, Stem Cell Research and Others. Oncology segment is expected to dominate the market over the forecast period, due to increasing adaptation of inorganic growth strategies such as partnerships by key market players for the development of novel therapies for cancer.

Based on end user, the Biologics Outsourcing market is segmented into Pharmaceutical Industries, Biotechnology Industries, Contract Development & Manufacturing Organization (CDMO). Pharmaceutical Industries segment is expected to dominate the market over the forecast period, due to increasing launches of service models by companies that provide outsourcing facilities to pharmaceutical companies with time and cost-efficient preparedness strategy for overcoming supply chain risks

Based on Region, global biologics outsourcing market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. North America is expected to dominate the market over the forecast period, due to increasing adoption of inorganic growth strategies such as partnership between key players operating in the market and pharmaceutical companies to address the shortage of pharmaceutical products.

Among all segmentation, application segment has highest potential, due to increasing inorganic growth strategies such as partnership by the key market players. For instance, in July 2021, Samsung Biologics, offering state-of-the art contract development and manufacturing services, and Kineta Inc., a clinical-stage biotechnology company, signed a strategic partnership agreement to support IND (investigational new drug) filing for Kineta’s novel anti-VISTA antibody, KVA12.1, for the treatment of solid tumors. Samsung Biologics will provide a range of services from cell line development to clinical drug substance and drug product manufacturing.

Global Biologics Outsourcing Market- Cross Sectional Analysis:

In product and service type segment, Product segment is dominant in Europe region, due to increasing inorganic growth strategies such as partnership by the key market players in the region. For instance, in February 2021, Affibody AB, a biotech company focused on developing next generation biopharmaceuticals, partnered with Biovian Oy, a contract development & manufacturing organization (CDMO), as a partner for ABY-062 recombinant protein for clinical trial. The ABY-062 is a part of Affibody’s pipeline portfolio, and is a protein antibody.

In end user, Pharmaceutical Industries held as a dominant segment in North America region, due Launches of service models by companies that provide outsourcing facilities to pharmaceutical companies with time and cost-efficient preparedness strategy for overcoming supply chain risks. For instance, in May 2022, Societal CDMO, a contract development and manufacturing organization (CDMO) partner announced company’s new “20/80 Second Source Technical Transfer” service model launch. This new CDMO offering is designed to provide pharmaceutical companies with a time- and cost-efficient preparedness strategy for overcoming supply chain risks and vulnerabilities. Under this framework of Societal’s “20/80 Second Source Technical Transfer” model, pharmaceutical companies can collaborate with Societal CDMO to execute all sourcing and planning phase activities of a standard technical transfer process prior to the time required for product supply. By undertaking these activities in advance, customers of Societal CDMO can complete approximately half of the technical transfer process and can position themselves to initiate the transfer of material and commence the batch manufacturing (execution phase) of drug whenever new and/or additional finished drug product supply is required.

Global Biologics Outsourcing Market: Key Developments

In August 2021, Yposkesi, a contract development and manufacturing organization (CDMO), announced construction of 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 biologics outsourcing market.

In May 2021, WuXi Biologics, a CDMO, and OncoC4, Inc., a clinical-stage biopharmaceutical company, announced that the companies have entered into an exclusive contract development and manufacturing partnership for OncoC4's full pipeline of biologics including its late stage project, ONC-392, a next generation CTLA-4 antibody, which is under phase I clinical trials in the U.S. and China.

In October 2022, SAB Biotherapeutics, a clinical-stage biopharmaceutical company, announced partnership with Emergent, a CDMO. Emergent will provide contract development and manufacturing (CDMO) services to produce SAB’s fully-human polyclonal antibody products.

In September 2022, Abzena Ltd, announced an upgradation of its research and development capabilities in England, U.K. The company strengthens research and development capabilities by investment and implementation of primary B cell antibody discovery technologies named Berkley Lights’ Beacon system that supports rapid antibody discovery, by isolating single B cells from a target-primed cohort of lymphocytes.

In June 2022, Curia Global, Inc. a contract research and manufacturing organization, adopted Beacon Optofluidic system and workflows from Berkeley Lights, Inc., a digital cell biology company, to expand and accelerate its antibody-based drug discovery capabilities.

Global Biologics Outsourcing Market: Restraint

Technical and Logistics challenges

Increasing focus on in-house biologics manufacturing is expected to act as a restraint for the growth of the global biologics outsourcing market over the forecast period. For instance, on February 15, 2023, Genentech, a biotechnology company, announced the construction of new small-batch biologics manufacturing facility in California, U.S., which will be operational in early 2025. The new facility will be the first commercial biopharma manufacturing facility to incorporate the latest manufacturing technologies along with in-house process improvements for increased flexibility, speed, and output under one roof. The new facility is designed for the commercial production of biologics for smaller patient populations, including rare diseases and personalized medicines.

Global Biologics Outsourcing Market: Key Players

Major players operating in the global Biologics Outsourcing market include Thermo Fisher Scientific Inc., Abzena Ltd. Fujifilm Diosynth Biotechnologies, KBI Biopharma, EirGenix, Inc., Curia Global, Inc., Bionova Scientific, Inc., Boehringer Ingelheim International GmbH., STC Biologics., Abbvie Inc., Avid Bioservices, Inc., Catalent Inc., Emergent, Eurofins Scientific, Genentech, Inc., Genscript Biotech Corporation, JSR Corporation, Lonza, Merck KGaA, Rentschler Biopharma SE. 

*Definition: Biologics are a more complex class of medicines to manufacture, package, store, and distribute than their chemical counterparts. Outsourcing of any aspect of the supply chain means pharmaceutical companies and their chosen vendors need to work in true partnership, navigating the complex process together to speed up the biologics market growth.

Contract development and manufacturing organisations (CDMOs) offer highly useful services to the pharmaceutical and biotech industries by providing more research and manufacturing capacity, access to specialized expertise, and potential cost savings over in-house manufacturing. The CDMO sector offers a wide range of ancillary services, including clinical logistics and distribution, CMC (chemistry, manufacturing, and controls), and regulatory support, in addition to product development and characterization, clinical and commercial manufacturing of API and drug products, including final packaging.