U.S. Biopharmaceuticals Contract Manufacturing Market (By Service: Upstream, Downstream, Fill/Finish; By Source: Mammalian, Non-mammalian; By Product: Biologics, Biosimilar) - Industry Analysis, Size, Share, Growth, Trends, Revenue, Regional Outlook and Forecast 2024-2033

The U.S. biopharmaceuticals contract manufacturing market size was estimated at around USD 4.98 billion in 2023 and it is projected to hit around USD 7.46 billion by 2033, growing at a CAGR of 4.12% from 2024 to 2033.

Key Pointers

• By Source, the mammalian source segment held the largest revenue share of 57% in 2023.
• By Source, the non-mammalian segment is expected to expand at the highest CAGR from 2024 to 2033.
• By Service, the process development services had the largest market share of 33% in 2023.
• By Service, the biologics product segment registered the maximum market share of 82% in 2023.
• By Product, the biosimilar segment is poised for notable growth from 2024 to 2033

U.S. Biopharmaceuticals Contract Manufacturing Market Overview

The U.S. biopharmaceuticals contract manufacturing market stands at the forefront of the rapidly evolving pharmaceutical industry. As an integral component of the healthcare ecosystem, contract manufacturing plays a pivotal role in the development, production, and distribution of biopharmaceuticals. This overview aims to shed light on the key dynamics, trends, and factors shaping the landscape of the U.S. biopharmaceuticals contract manufacturing market.

U.S. Biopharmaceuticals Contract Manufacturing Market Growth

The U.S. Biopharmaceuticals Contract Manufacturing market has witnessed substantial growth, propelled by various key factors. One significant driver is the increasing demand for specialized expertise in biopharmaceutical production. As pharmaceutical companies focus on core competencies, outsourcing manufacturing processes to specialized contract manufacturing organizations (CMOs) becomes a strategic choice. This trend is further accentuated by the complexity of biopharmaceutical manufacturing, which often requires advanced technologies and specialized facilities. Additionally, the need for cost-effective and efficient production processes has led pharmaceutical companies to leverage the capabilities of contract manufacturers. The competitive landscape, stringent regulatory requirements, and the growing pipeline of biopharmaceutical products also contribute to the expanding role of contract manufacturing in the U.S. biopharmaceutical sector.

U.S. Biopharmaceuticals Contract Manufacturing Market Trends:

• Rising Outsourcing Trends: The U.S. biopharmaceuticals Contract Manufacturing market is experiencing a notable trend of increased outsourcing. Pharmaceutical companies are strategically opting for external partners to handle various stages of biopharmaceutical production, allowing them to focus on core competencies and enhance overall efficiency.
• Flexible Manufacturing Solutions: The demand for flexible manufacturing solutions is on the rise. Contract manufacturers are offering scalable and adaptable production processes to accommodate the variable needs of biopharmaceutical companies. This flexibility allows for efficient adjustment to changes in production volumes and product specifications.
• Biologics and Biosimilars Development: The increasing focus on the development of biologics and biosimilars is a prominent trend. Contract manufacturing plays a pivotal role in supporting the production of these complex and specialized pharmaceuticals, catering to the growing market demand for innovative and cost-effective biological drugs.
• Global Supply Chain Diversification: The market is witnessing a shift towards diversification of the global supply chain. Biopharmaceutical companies are increasingly relying on contract manufacturing partners with a global presence, providing access to diverse markets and mitigating risks associated with regional disruptions.
• Customization and Personalized Medicine: The trend towards personalized medicine is influencing the U.S. biopharmaceuticals contract manufacturing landscape. Contract manufacturers are adapting to the demand for customized production processes to support the development of personalized therapies, addressing specific patient needs.

Source Insights

In 2023, the mammalian source segment secured the highest share at 57%, primarily driven by the elevated costs associated with acquiring products from these sources. Key players offering contract services utilizing mammalian cell culture, such as AbbVie Contract Manufacturing, AMRI, Avid Bioservices, Boehringer Ingelheim Biopharmaceuticals Gmbh, and Catalent Pharma Solutions, contributed to this growth. Consequently, industry leaders like Lonza and Charles River Laboratories are making substantial investments to expand their manufacturing facilities for mammalian cell culture, specifically tailored for biologics and biosimilar development.

On the other hand, the non-mammalian segment is poised to experience the fastest Compound Annual Growth Rate (CAGR) throughout the forecast period. The widely adopted non-mammalian cell culture for biopharmaceutical production is non-mammalian cell line E. coli, recognized for its rapid accessibility and cost-effective cultivation. The development of transgenic non-mammalian expression systems presents an opportunistic avenue for market expansion. Notable Contract Manufacturing Organizations (CMOs) utilizing microbial cultures include Abbott Bioresearch, Avecia Biotechnology, BioReliance, Biovitrum AB, Dow Pharmaceutical, and Celltrion.

Service Insights

In 2023, process development services took the lead in the market, securing a substantial share of 33%. This dominance is attributed to the considerable capital expenditure involved in downstream processing. Downstream operations, critical for final product recovery and purification, demand meticulous attention to uphold product quality and minimize wastage. Contract Manufacturing Organizations (CMOs) have played a pivotal role by offering a comprehensive range of services to biopharmaceutical players, spanning from cell cultivation to the final packaging of the product.

Anticipated to experience the fastest Compound Annual Growth Rate (CAGR) from 2024 to 2033, the analytical & QC studies segment holds significant promise. This projection is driven by the escalating concerns about quality and regulatory changes in biopharmaceutical development, paving the way for future growth opportunities within this segment. Market players showcase analytical capabilities and expertise, offering a diverse array of technologies and services crucial for the successful market launch of products. These capabilities extend to Monoclonal Antibodies (MAbs), fusion proteins, chemically conjugated proteins, hormones, enzymes, and other biopharmaceuticals. Additionally, entities provide validated analytical methods to facilitate the release of early-phase clinical products.

Product Insights

In 2023, the biologics product segment emerged as the market leader, claiming a dominant share of over 82%. Contract manufacturers have played a pivotal role in the success of both biologics and biosimilars, a trend underscored by the substantial commercial success of biologics, as evidenced by the presence of numerous FDA-approved biologics in the market. Within the biologics category, Monoclonal Antibodies (MAb) took the lead in 2023, capturing the largest market share. The significant capital investment required for establishing a MAb plant has accelerated the adoption of contract services for MAb production, contributing significantly to the segment's predominant share.

The biosimilar segment is poised for notable growth from 2024 to 2033. Biosimilar production is regarded as a key strategy for business expansion, offering a quicker market reach for biopharmaceuticals compared to biologics. Additionally, biosimilars have been instrumental in supporting the biopharmaceutical Contract Manufacturing Organization (CMO) industry, thanks to their cost-saving advantages. The combination of lower production costs and the increasing expiration of patents for blockbuster biologics has further heightened the demand for manufacturing services, including outsourced services.

U.S. Biopharmaceuticals Contract Manufacturing Market Key Companies

• Lonza
• WuXi Biologics
• FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
• Boehringer Ingelheim
• Thermo Fisher Scientific Inc.
• Samsung BioLogics
• AGC Biologics
• Catalent Pharma Solutions
• Rentschler Biopharma SE
• Eurofins Scientific SE

Recent Developments

• In April 2022, Lonza extended the capability of its Coccon platform used in the manufacturing of automated cell therapy. The new capabilities included integrated capabilities in cell separation, cell binding, and bead removal.

• In March 2022, Cambrex, expanded its biopharmaceutical testing services business with the addition of 11 cGMP laboratories in its U.S. facility. The expansion included the addition of instruments for nanoparticle size analysis, qPCR, imaging, mass spectrometry, immunoblotting, and next-generation sequencing, as well as for other applications.

• In February 2022, Thermo Fisher Scientific, Inc. invested $40 million to build a bioprocessing manufacturing site in Millersburg, Pennsylvania for developing critical vaccines and biologics.

U.S. Biopharmaceuticals Contract Manufacturing Market Segmentations:

By Source

• Mammalian
• Non-mammalian

By Service

• Process Development
  • Downstream
  • Upstream
• Fill & Finish Operations
• Analytical & QC studies
• Packaging

By Product

• Biologics
  • Monoclonal antibodies (MABs)
  • Recombinant Proteins
  • Vaccines
  • Antisense, RNAi, & Molecular Therapy
  • Others
• Biosimilar