Biologics Outsourcing Market by Service Type (Contract Research Organization [CRO], Contract Manufacturing Organization [CMO], Contract Development and Manufacturing Organization [CDMO]), by Therapeutic Area (Oncology, Infectious Diseases, Immunology, Cardiology, Neurology), by End-User Industry (Pharmaceutical, Biotechnology, Healthcare, Medical Device Manufacturers, Research & Development), by Biologics Type (Monoclonal Antibodies [mAbs], Vaccines, Recombinant Proteins, Gene Therapy Products, Cell Therapy Products), and by Region; Global Insights & Forecast (2024 – 2030).

As per Intent Market Research, the Biologics Outsourcing Market was valued at USD 17.6 billion in 2023 and will surpass USD 47.3 billion by 2030; growing at a CAGR of 15.2% during 2024 - 2030.

The biologics outsourcing market is a dynamic sector that supports pharmaceutical and biotechnology companies in the development, manufacturing, and distribution of biologic drugs, such as monoclonal antibodies, vaccines, and recombinant proteins. With increasing demand for biologic products in therapeutic areas such as oncology, immunology, and neurology, outsourcing has become a critical strategy for companies seeking to optimize their operations, reduce costs, and enhance speed-to-market. Contract Research Organizations (CROs), Contract Manufacturing Organizations (CMOs), and Contract Development and Manufacturing Organizations (CDMOs) play pivotal roles in this ecosystem, offering a wide range of services from drug development to commercial production.

CRO Segment is Largest Owing to High Demand for Research Services

Contract Research Organizations (CROs) are the largest segment in the biologics outsourcing market, driven by the growing demand for comprehensive research services across the biologics development lifecycle. These organizations provide essential services, including preclinical and clinical research, regulatory support, and testing, which are crucial for bringing new biologic drugs to market. The increasing focus on biologic therapies, particularly monoclonal antibodies, has led to an uptick in outsourcing research to specialized firms. Additionally, the rise in clinical trials for biologics, especially in oncology and immunology, has further boosted the demand for CRO services. This trend is expected to continue as pharmaceutical and biotech companies increasingly prefer to outsource research functions to reduce costs and accelerate the development of complex biologic therapies.

Oncology Therapeutic Area is Fastest Growing Owing to Rising Cancer Incidence

Oncology is the fastest-growing therapeutic area in the biologics outsourcing market. The global rise in cancer cases, along with advancements in cancer immunotherapies such as checkpoint inhibitors and CAR-T cell therapies, has driven increased demand for biologics in oncology. Outsourcing of manufacturing, clinical trials, and research to specialized organizations has become a key strategy for companies in oncology to manage costs and scale production. The complexity of oncology treatments, particularly biologics like monoclonal antibodies, necessitates advanced manufacturing capabilities that outsourcing providers can offer. Furthermore, the increasing investments in cancer research and clinical trials, along with the rapid approval of new oncology drugs, have significantly contributed to the accelerated growth of this segment.

Pharmaceutical Industry is Largest End-User Industry Owing to High Biologics Demand

The pharmaceutical industry is the largest end-user of biologics outsourcing services, primarily due to the high demand for biologic drugs across various therapeutic areas. Pharmaceutical companies are at the forefront of developing new biologics, including monoclonal antibodies, vaccines, and recombinant proteins. These companies often lack the necessary expertise or resources to manage all aspects of biologic drug development and production in-house, which is why they turn to CROs, CMOs, and CDMOs for support. With increasing regulatory pressures and the high cost of in-house biologics manufacturing, outsourcing has become a cost-effective solution for pharmaceutical companies looking to scale up their biologics portfolios. Additionally, the growth of biologic drugs in areas such as oncology, immunology, and neurology has further fueled outsourcing in the pharmaceutical sector.

Monoclonal Antibodies (mAbs) is Largest Biologics Type Owing to Market Dominance

Monoclonal antibodies (mAbs) represent the largest biologics type in the outsourcing market. mAbs have become a cornerstone of modern biopharmaceutical therapies, particularly for treating diseases such as cancer, autoimmune disorders, and infectious diseases. These biologics are highly complex and require advanced manufacturing technologies, making outsourcing a crucial component of their development and production. The robust pipeline of mAb-based therapies and the increasing approvals from regulatory agencies have led to a surge in demand for outsourcing services related to mAb production. Given their dominant market share and broad therapeutic applications, monoclonal antibodies are expected to continue driving growth in the biologics outsourcing market for the foreseeable future.

North America is Largest Region for Biologics Outsourcing Market

North America is the largest region in the biologics outsourcing market, led by the United States, which has a highly developed pharmaceutical and biotechnology industry. The U.S. is home to many of the world's leading pharmaceutical and biotechnology companies, making it a key player in the outsourcing of biologics research, development, and manufacturing. The region’s advanced healthcare infrastructure, combined with a high level of expertise in biologics development and manufacturing, has made North America a hub for biologics outsourcing. Additionally, the U.S. Food and Drug Administration (FDA) provides a robust regulatory framework that supports the growth of biologics outsourcing services in the region. With the growing emphasis on biologic drugs, particularly monoclonal antibodies, and the increasing number of biologics clinical trials, North America is expected to maintain its dominance in the global market.

Competitive Landscape and Leading Companies in Biologics Outsourcing Market

The biologics outsourcing market is highly competitive, with several global players dominating the industry. Leading companies such as Lonza Group, WuXi AppTec, Samsung Biologics, and Boehringer Ingelheim have a strong presence in the market, providing comprehensive outsourcing services across the biologics development and manufacturing value chain. These companies are continually expanding their capabilities to meet the growing demand for complex biologics, particularly monoclonal antibodies, vaccines, and gene therapies. Many of these firms are investing in state-of-the-art facilities, strategic partnerships, and mergers and acquisitions to strengthen their position in the market. The competitive landscape is also characterized by increasing collaboration between CROs, CMOs, and CDMOs to provide end-to-end solutions for pharmaceutical and biotech companies. As biologic drugs continue to dominate the pharmaceutical sector, these companies are poised to benefit from the rising trend of outsourcing.

Recent Developments:

• Lonza Group announced the expansion of its biologics manufacturing capacity in North Carolina, aimed at supporting the growing demand for cell and gene therapies in the biopharma market.
• WuXi AppTec launched a new contract manufacturing service for the production of biopharmaceuticals, focusing on personalized medicine and gene therapies.
• Boehringer Ingelheim entered a strategic partnership with a leading biotech firm to develop next-generation biologics, enhancing its contract manufacturing capabilities.
• Samsung Biologics received regulatory approval from the FDA for its advanced biologics production facility in South Korea, further cementing its position in the global biologics outsourcing market.
• Catalent completed the acquisition of a biologics manufacturing facility from a major pharmaceutical company, expanding its global footprint in biologics services

List of Leading Companies:

• Lonza Group
• Samsung Biologics
• WuXi AppTec
• Catalent
• Boehringer Ingelheim
• Bayer AG
• Regeneron Pharmaceuticals
• WuXi Biologics
• Pfizer Inc.
• AbbVie Inc.
• Roche Holding AG
• Novartis International AG
• Teva Pharmaceutical Industries Ltd.
• Amgen Inc.
• Merck & Co., Inc

Report Scope: