Biologics Contract Manufacturing Market Forecast Report 2025-2035 | Investments in Niche Biologics Grow in US and China

The biologics contract manufacturing market offers robust opportunities driven by the shift towards complex biologics and a rising demand for outsourcing. Key growth areas include mammalian expression systems and commercial scale operations. North America leads, but Asia-Pacific shows high growth potential.

Dublin, Oct. 21, 2025 (GLOBE NEWSWIRE) -- The "Biologics Contract Manufacturing Market Industry Trends and Global Forecasts to 2035, by Type of Service Offered, Type of Biologic Manufactured, Type of Expression System Used, Scale of Operation, Company Size and Key Geographical Regions" report has been added to ResearchAndMarkets.com's offering.

The global biologics contract manufacturing market is estimated to grow from USD 23.8 billion in 2025, to USD 55.0 billion by 2035, at a CAGR of 8.8% during the forecast period, till 2035.

The biologics contract manufacturing sector has seen significant growth in recent years due to the several benefits offered by biological products, such as specificity, efficacy and safety. It is worth mentioning that the biopharmaceutical industry has witnessed a shift from small-molecule drugs to complex biologics like monoclonal antibodies, vaccines, cell and gene therapies, and biosimilars. In fact, the USFDA approved over 50 biological products (including monoclonal antibodies and recombinant proteins) in 2024. This growing pipeline of new therapies, coupled with the increasing number of biologics approvals, drives the demand for external manufacturing capacity.

Despite the success of biopharmaceutical products, producing biologics is technically challenging and requires significant capital investment in specialized facilities, equipment, and expertise, such as long development timelines, regulatory and compliance-related issues, and inconsistencies related to the quality attributes of the final product. As a result, an increasing number of biopharmaceutical drug developers are relying on contract manufacturers for comprehensive solutions, encompassing bioprocess development and optimization. With outsourcing becoming increasingly recognized as a practical and advantageous business model in this sector, substantial market growth for biologics contract manufacturing is expected throughout the forecast period.

Biologics Contract Manufacturing Market: Key Insights

The report delves into the current state of the biologics contract manufacturing market and identifies potential growth opportunities within industry.

Some key findings from the report include:

• Currently, more than 305 contract manufacturing organizations (CMOs) are engaged in the production of biologics; over 90% of such players provide FDF manufacturing services.
• Around 70% of the stakeholders operate at all scales of operation to cater to the diverse needs of customers; notably, mammalian cell-based expression systems have emerged as a popular choice among CMOs.

• The competition among service providers that claim to be focused on the niche and upcoming drug classes is fierce; it is primarily influenced by the success of several blockbuster therapies in the recent past.
• In the past decade, a shift in trend has been observed in the biopharmaceutical contract manufacturing industry as more players have set up their manufacturing facilities in developing regions across Asia-Pacific.
• Over the last five years, more than 695 deals have been inked by biologics CMOs; most of the collaborations were inked for the manufacturing of vaccines, antibodies and cell therapies.
• In order to maintain a competitive edge and establish themselves as one-stop-shops, players are expanding their existing capabilities and service portfolios; the domain has witnessed over 135 mergers and acquisitions.
• Considering the enormous opportunities associated with biologics contract manufacturing, investors have actively extended funds, amounting to USD 7.5 billion, across more than 90 funding instances in the past eight years.
• Driven by the growing demand, CMOs have made elaborate investments to expand their existing capacities and capabilities, primarily for niche biologics; this trend is most pronounced in the US and China.
• More than 215 initiatives were undertaken by big pharma players; more than 80% of such initiatives were focused on partnerships and expansions.

• Though the existing installed capacity is sufficient to meet the current annual demand for biologics, we anticipate that CMOs are likely to invest in installing incremental capacity to meet the long-term demand.
• The global installed biopharmaceutical contract manufacturing capacity is spread across various geographies; notably, large players account for 80% of the total capacity.
• With the growing pipeline of biologics and the increased preference for outsourcing, the biopharmaceutical contract manufacturing services market is anticipated to witness steady growth in the foreseen future.
• As more developers outsource various aspects of their respective manufacturing operations, we expect the biologics CMOs market to grow at an annualized rate of 8.8% in the coming decade.

Biologics Contract Manufacturing Market: Research Coverage

• Market Sizing and Opportunity Analysis: The report features a thorough analysis of the global biologics contract manufacturing market, in terms of the key market segments, including type of services offered, type of biologic manufactured, type of expression system used, scale of operation, company size and key geographical regions.
• Market Landscape: An in-depth assessment of the companies involved in biologics contract manufacturing market, based on several relevant parameters, such as year of establishment, company size, location of headquarters, type of service offered, type of biologic manufactured, scale of operation, type of expression systems used, type of bioreactor used and mode of operation of bioreactor.
• Regional Capability Analysis: A comprehensive analysis of biopharmaceutical manufacturing facilities established across the key geographical regions, such as North America, Europe, Asia-Pacific, and Rest of the world.
• Company Profiles: Detailed profiles of key service providers across North America, Europe and Asia-Pacific engaged in the biologics contract manufacturing market, focused on parameters such as company overview, financial information (if available), service portfolio, manufacturing facilities and recent developments and an informed future outlook.
• Case Study - Niche Pharmaceutical Sectors: A comprehensive evaluation of the primary enablers within this industry, highlighting specific niche products such as antibody-drug conjugates (ADCs), bispecific antibodies, cell therapies, gene therapies, and viral vectors.
• Case Study - In-house Manufacturing: A detailed review of various factors that need to be taken into consideration by biopharmaceutical developers while deciding whether to manufacture their respective products in-house or engage the services of a biologics CMO.
• Make Versus Buy Framework: An elaborate study of the various biopharmaceutical-focused manufacturing initiatives undertaken by top big pharma players, highlighting trends across various parameters, such as number of initiatives, year of initiative, purpose of initiative, type of initiative, scale of operation and type of biologic manufactured.
• Partnerships and Collaborations: An in-depth analysis of the recent collaborations within the biologics contract manufacturing market, based on several relevant parameters, such as year of partnership, type of partnership, type of biologic manufactured, therapeutic area, most active players and regional distribution of partnership activity that have taken place in this industry.
• Mergers and Acquisitions: A detailed analysis of the various mergers and acquisitions that have taken place within this industry, based on several relevant parameters, such as year of agreement, type of deal, geographical location of companies, type of acquisition, type of biologic manufactured and key value drivers.
• Recent Expansions: A detailed analysis of expansion initiatives undertaken by biologics CMO, during the period along with information on several relevant parameters, such as year of expansion, purpose of expansion, type of biologic manufactured and location of expanded facility.
• Recent Developments: An analysis of the recent developments within the biologics contract manufacturing market, highlighting information on the funding investments made and information on the technology advancements related to biomanufacturing.
• Capacity Analysis: An estimate of the overall installed capacity for the manufacturing of biopharmaceuticals, highlighting the distribution of the available capacity, based on size of manufacturer, type of expression system used and geography.
• Demand Analysis: An informed estimate of the annual demand for biologics, based on various relevant parameters, such as target patient population, dosing frequency and dose strength.
• Total Cost of Ownership: A detailed analysis of the total cost of ownership for biologics CMO.
• SWOT Analysis: A discussion on affiliated trends, key drivers and challenges, under an elaborate SWOT analysis, which are likely to impact the industry's evolution.
• Case Study - Virtual Pharmaceutical Companies: A case study on the virtual business model concept, along with its role in the overall biopharmaceutical industry.

Players in the Biologics Contract Manufacturing Market Profiled in the Report Include

• AGC Biologics
• Boehringer Ingelheim
• Catalent
• Cell Therapies
• Charles River Laboratories
• FUJIFILM Diosynth Biotechnologies
• KBI Biopharma
• Kemwell Biopharma
• Lonza
• Miltenyi Biotec
• Minaris Regenerative Medicine
• Samsung Biologics
• Sandoz
• Vetter Pharma
• Wuxi Biologics

Key Questions Answered in this Report

• How many companies are currently engaged in this market?
• Which are the leading companies in this market?
• What factors are likely to influence the evolution of this market?
• What is the current and future market size?
• What is the CAGR of this market?
• How is the current and future market opportunity likely to be distributed across key market segments?

Additional Benefits

• Complimentary PPT Insights Packs
• Complimentary Excel Data Packs for all Analytical Modules in the Report
• 15% Free Content Customization
• Detailed Report Walkthrough Session with Research Team

Report Segmentation

Type of Service Offered

• API Manufacturing
• FDF Manufacturing

Type of Biologic Manufactured

• Antibodies
• Cell Therapies
• Vaccines
• Other Biologics

Type of Expression System Used

• Mammalian
• Microbial
• Others

Scale of Operation

• Preclinical / Clincal
• Commercial

Company Size

• Small
• Mid-sized
• Large and Very Large

Geographical Regions

• North America
• Europe
• Asia-Pacific
• Middle East and North Africa
• Latin America

For more information about this report visit https://www.researchandmarkets.com/r/7ig2kf

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Attachments

• Regional Capability Assessment
• Biologics Contract Manufacturing - Scale of Operation

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