Biotechnology Contract Manufacturing Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Service (Manufacturing, Formulation and Fill-Finish, Packaging and Labeling, Other services), By Type (Biologic Drug Substance Manufacturing, Biologic Drug Product Manufacturing) , By Scale of Operation (Commercial Operations, Clinical Operations), By Therapeutic Area (Autoimmune Diseases, Cardiovascular Diseases, Metabolic Diseases, Infectious Diseases, Neurology, Other Therapeutic Areas), By Region and Competition, 2020-2030F

Market Overview

The Global Biotechnology Contract Manufacturing Market, valued at USD 22.15 Billion in 2024, is projected to experience a CAGR of 7.48% to reach USD 34.15 Billion by 2030. Biotechnology contract manufacturing involves the outsourcing of specialized services for drug development and manufacturing to third-party organizations, enabling biopharmaceutical companies to concentrate on core competencies such as research and development. These services typically encompass cell line development, process optimization, manufacturing, formulation, fill-finish operations, and packaging. The market's growth is primarily driven by the increasing demand for complex biopharmaceuticals and biologics, escalating research and development investments by pharmaceutical entities, the need for scalable and cost-effective manufacturing solutions, and access to specialized expertise and advanced technologies offered by contract manufacturers. According to the European Federation of Pharmaceutical Industries and Associations, in 2023, the pharmaceutical industry in Europe invested an estimated €50,000 million in research and development, contributing significantly to the pipeline that fuels contract manufacturing demand.

A significant challenge impeding market expansion includes the intricate landscape of intellectual property rights, as companies engaging contract manufacturers must meticulously navigate the protection and sharing of proprietary information. Additionally, the complexities associated with complying with diverse and evolving global regulatory frameworks present considerable operational hurdles for contract development and manufacturing organizations.

Key Market Drivers

The global biotechnology contract manufacturing market is significantly shaped by the escalating demand for biologics and advanced therapies. This growing focus on complex biological products, including monoclonal antibodies and cell and gene therapies, drives biopharmaceutical companies to seek specialized expertise and advanced manufacturing capabilities from contract development and manufacturing organizations. This trend is underscored by significant regulatory milestones; according to the FDA, in 2024, biologics represented 32% of all new drug approvals, demonstrating their increasing prominence. Concurrently, according to DCAT Value Chain Insights, in 2024, Novo Holdings acquired Catalent for $16.5 billion, reflecting the heightened value and expansion efforts within the industry.

The expanding pharmaceutical research and development pipeline also serves as a critical catalyst for the biotechnology contract manufacturing market. Increased investment in discovering and developing novel therapeutics, particularly for chronic and complex diseases, necessitates robust and scalable manufacturing support. As new entities progress through clinical stages, many biopharmaceutical innovators, especially smaller and mid-sized firms, outsource production to leverage a CDMO’s specialized infrastructure and expertise. This dynamic is further evidenced by substantial industry commitment to innovation; according to the Massachusetts Biotechnology Council, in its 2024 Biopharma Funding & Pipeline Report, Massachusetts-headquartered companies received $7.89 billion in venture capital funding in 2024, fueling new drug candidates often requiring external manufacturing partnerships.

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Key Market Challenges

The intricate landscape of intellectual property (IP) rights presents a significant challenge to the growth of the Global Biotechnology Contract Manufacturing Market. Biopharmaceutical companies engaging third-party organizations must meticulously navigate the protection and sharing of proprietary information, which often involves complex agreements and substantial legal costs. This complexity introduces hesitancy and can delay outsourcing decisions for critical drug development and manufacturing projects, directly impacting market expansion.

This is further exacerbated by the substantial financial investment required for IP. According to a June 2025 report by the Pharmaceutical Research and Manufacturers of America (PhRMA), biopharmaceutical companies invest over $12 million for every patent issued by the U. S. Patent and Trademark Office. Such considerable outlays, coupled with the potential for disputes over proprietary technologies, directly impact the willingness of innovators to transfer sensitive projects to contract manufacturers. The necessity of robust IP strategies and protection measures thus becomes an operational hurdle, diverting valuable resources and slowing the pace of collaborative innovation within the market.

Key Market Trends

The Global Biotechnology Contract Manufacturing Market is experiencing notable shifts driven by a heightened emphasis on global supply chain resilience and the pervasive adoption of advanced bioprocessing and automation. These trends reflect a strategic evolution in how biopharmaceuticals are developed and manufactured, moving beyond traditional models.

A significant trend involves the strengthening of global supply chain resilience and the move towards distributed manufacturing. Biopharmaceutical companies are actively seeking to mitigate risks associated with geopolitical instabilities and logistical challenges, driving investments in more localized and diversified production networks. According to Cytiva’s 2023 Global Biopharma Resilience Index, overall supply chain resilience improved slightly from 6.72 in 2021 to 6.84 in 2023, indicating ongoing industry efforts to fortify manufacturing capabilities. This strategic imperative is exemplified by major investments such as Johnson & Johnson's $55 billion U. S. manufacturing expansion, which includes a $2 billion biologics facility in North Carolina, as reported by AInvest in August 2025, aimed at countering tariff pressures and enhancing supply chain stability. This decentralization helps ensure consistent access to critical materials and manufacturing capacity.

Concurrently, the biotechnology contract manufacturing market is being transformed by the increasing adoption of advanced bioprocessing technologies and automation. This trend is geared towards improving manufacturing efficiency, reducing human error, and accelerating time to market for complex biologics. Automation in bioprocessing is deemed essential for enhancing quality, consistency, and cost-effectiveness by minimizing operational errors, thus leading to more reliable production, as highlighted by the BioPlan Associates 22nd Annual Report, referenced in BioPharm International in September 2025. Further underscoring this trend, Sartorius Stedim Biotech opened a new Center for Bioprocess Innovation in Marlborough, Massachusetts, in December 2024. This facility is designed to foster collaboration and co-development with customers, leveraging advanced bioprocessing tools and workflows to streamline the path to clinical trials.

Segmental Insights

The Manufacturing segment is a key driver within the Global Biotechnology Contract Manufacturing Market, experiencing rapid expansion. This growth is primarily fueled by the increasing global demand for complex biologics and novel advanced therapies, such as cell and gene therapies and monoclonal antibodies. Biopharmaceutical companies increasingly outsource manufacturing activities to manage capacity, reduce substantial capital expenditure on specialized facilities, and leverage the intricate expertise and advanced technological platforms offered by contract manufacturing organizations. This strategic reliance on contract manufacturers also helps companies achieve greater operational efficiency, adhere to stringent regulatory requirements from bodies like the US FDA, and concentrate on core research and development, thereby accelerating product commercialization.

Regional Insights

North America leads the global biotechnology contract manufacturing market, driven by its robust pharmaceutical and biotechnology sectors. The region's dominance stems from its advanced manufacturing capabilities and a significant technological presence, which enable the adoption of sophisticated biomanufacturing processes. A favorable regulatory environment, including consistent approvals from bodies such as the U. S. Food and Drug Administration, further promotes innovation and market growth. This is complemented by substantial investments in research and development and a high demand for biologics, encouraging outsourcing to specialized providers within the region who benefit from a skilled workforce and strong infrastructure.

Recent Developments

• In August 2025, Bionova Scientific, a full-service biologics contract development and manufacturing organization (CDMO) and a subsidiary of Asahi Kasei, inaugurated a new 10,000 square-foot plasmid DNA (pDNA) development and production facility in The Woodlands, Texas. This state-of-the-art facility was established to design, develop, and manufacture research-grade pDNA materials, which are crucial starting materials for advanced therapeutics like mRNA and viral vector-based cell and gene therapies. This expansion enabled Bionova Scientific to extend its services beyond mammalian protein production and offer clinical to commercial-scale Current Good Manufacturing Practice (cGMP) production of pDNA by the fourth quarter of 2025.

• In March 2025, WuXi Biologics, a leading global contract research, development, and manufacturing organization (CRDMO), reported robust annual results for the year ended December 31, 2024. The company achieved a 9.6% year-over-year revenue growth, with non-COVID revenue increasing by 13.1%. This growth was driven by the successful acquisition of 151 new integrated projects, including 13 in late-stage and commercial phases, bringing its total integrated projects to 817. The company also highlighted the ramp-up of its manufacturing sites in Europe, leveraging expanded capacities to strengthen its global manufacturing pipeline.

• In October 2024, Lonza, a prominent global manufacturing partner in the pharmaceutical and biotech sectors, announced a significant long-term extension of its collaboration with a major biopharmaceutical company. This agreement focused on the commercial-scale manufacturing of Antibody-Drug Conjugates (ADCs). The extended partnership included plans for constructing a new, dedicated bioconjugation suite at Lonza's Ibex® Biopark in Visp, Switzerland. Additionally, Lonza committed to providing commercial-scale monoclonal antibody manufacturing services for a new ADC therapy. This development reinforced Lonza's role as a leading contract development and manufacturing organization (CDMO) for bioconjugates.

• In October 2024, Thermo Fisher Scientific introduced Accelerator Drug Development, a new offering providing comprehensive contract development and manufacturing organization (CDMO) and contract research organization (CRO) drug development solutions. This launch, showcased at CPHI Milan, followed strategic expansions earlier in the year. The company expanded sites in Cincinnati, Ohio, and Bend, Oregon, to enhance capabilities for oral solid dose drug formulations, encompassing research and development, manufacturing, and testing. These integrated services aimed to support pharmaceutical and biotechnology companies throughout the entire drug development lifecycle, emphasizing speed, quality, and efficiency in addressing global health challenges.

Key Market Players

• Lonza Group Ltd.
• Thermo Fisher Scientific, Inc.
• Wuxi Biologics Co., Ltd.
• Catalent, Inc.
• Samsung Biologics Co., Ltd.
• Boehringer Ingelheim International GmbH
• Fujifilm Holdings Corporation
• Abbvie Inc.
• Eurofins Scientific SE
• Genscript Biotech Corporation

Report Scope:

In this report, the Global Biotechnology Contract Manufacturing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Biotechnology Contract Manufacturing Market, By Service:

o   Manufacturing

o   Formulation and Fill-Finish

o   Packaging and Labeling

o   Other services

• Biotechnology Contract Manufacturing Market, By Type:

o   Biologic Drug Substance Manufacturing

o   Biologic Drug ProductManufacturing

• Biotechnology Contract Manufacturing Market, By Scale of Operation:

o   Commercial Operations

o   Clinical Operations

• Biotechnology Contract Manufacturing Market, By Therapeutic Area:

o   Autoimmune Diseases

o   Cardiovascular Diseases

o   Metabolic Diseases

o   Infectious Diseases

o   Neurology

o   Other Therapeutic Areas

• Biotechnology Contract Manufacturing Market, By Region:

o   North America

§  United States

§  Canada

§  Mexico

o   Europe

§  France

§  United Kingdom

§  Italy

§  Germany

§  Spain

o   Asia Pacific

§  China

§  India

§  Japan

§  Australia

§  South Korea

o   South America

§  Brazil

§  Argentina

§  Colombia

o   Middle East & Africa

§  South Africa

§  Saudi Arabia

§  UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Biotechnology Contract Manufacturing Market.

Available Customizations:

Global Biotechnology Contract Manufacturing Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

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