Increasing Complexity of Drug Formulations
The development of complex biologics, personalized medicines, and advanced formulations requires specialized manufacturing expertise and state-of-the-art equipment. Many pharmaceutical companies lack in-house capabilities for such sophisticated production, leading them to rely on contract manufacturers with the necessary technical knowledge and regulatory compliance infrastructure.
Growing Generic Drug Market
The demand for generic drugs continues to rise globally, driven by the expiration of blockbuster drug patents and the need for affordable medicines. Contract manufacturers play a key role in scaling up production for generics quickly and cost-effectively, accelerating market access and enabling companies to respond to competitive pricing pressures.
Regulatory Compliance and Quality Standards
Adhering to stringent regulations from agencies such as the FDA, EMA, and WHO is a significant challenge for pharmaceutical companies. Contract manufacturing organizations (CMOs) invest heavily in compliance and quality systems, making them attractive partners for companies seeking reliable production while mitigating regulatory risks.
Technological Advancements
The integration of advanced technologies, including continuous manufacturing, automation, and process analytical technology (PAT), has enhanced production efficiency and scalability in contract manufacturing. Pharmaceutical companies benefit from these innovations without significant investment, driving the adoption of outsourcing strategies.
Get a sneak peek at the pharmaceutical contract manufacturing market dynamics @ Pharmaceutical Contract Manufacturing Market Dynamics Analysis
Regional Pharmaceutical Contract Manufacturing Market Insights
North America is projected to account for the largest share of the pharmaceutical contract manufacturing market, driven by several key factors. The region’s dominance is attributed mainly to the growing population suffering from chronic and infectious diseases, as well as the increasing emphasis on drug discovery and development. The rising demand for biologics and biopharmaceuticals, along with a surge in R&D spending, is significantly contributing to market expansion.
Additionally, the market is being propelled by heightened research investments from major pharmaceutical companies within the region. The United States, in particular, leads globally in clinical research, representing 29% of all clinical trials worldwide, with 159,403 trials listed as of 2025 (ClinicalTrials.gov). The surge in clinical trials is fueling the need for pharmaceutical contract manufacturing services, including API production, PK/PD studies, dosage development, and immunogenicity testing, which are essential for establishing drug safety and efficacy.
In response, leading industry players are broadening their service portfolios. For instance, in August 2024, SGS introduced new specialized pharmaceutical contract manufacturing services in North America. These offerings cover every phase of drug development—from early discovery to Phase I–III trials—and include method transfer, development and validation, PK/PD bioanalysis, ELISA, multiplex assays, immunogenicity evaluations, and other key bioassays.
Collectively, these factors are cementing North America’s position as a dominant market for pharmaceutical contract manufacturing, fueled by robust healthcare demand, significant R&D activity, and the growing need for advanced and effective therapies across the region.
To know more about why North America is leading the market growth in the pharmaceutical contract manufacturing market, get a snapshot of the Pharmaceutical Contract Manufacturing Market Outlook
Recent Developmental Activities in the Pharmaceutical Contract Manufacturing Market
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In October 2024, Samsung Biologics, a leading global contract development and manufacturing organization (CDMO), announced its largest-ever contract manufacturing deal with a major Asia-based pharmaceutical company. The production for this significant partnership will be carried out at Samsung Biologics’ state-of-the-art biomanufacturing facility in Songdo, South Korea.
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In September 2024, Samsung Biologics launched its innovative biologics development platforms S-AfuCHO™ and S-OptiCharge™. S-AfuCHO™ is an innovative cell line platform designed to produce fucosylated antibodies, which demonstrate enhanced antibody-dependent cellular cytotoxicity (ADCC) activity, leading to increased therapeutic efficacy. In parallel, S-OptiCharge™ serves as an upstream process platform capable of modulating a molecule’s charge variant distribution.
Pharmaceutical Contract Manufacturing Overview
Pharmaceutical contract manufacturing refers to the outsourcing of drug manufacturing processes to a third-party company, commonly called a contract manufacturing organization (CMO). These organizations produce drugs in various dosage forms on behalf of pharmaceutical companies, which may lack manufacturing facilities or choose to outsource for strategic reasons.
Outsourcing to CMOs offers several advantages, including cost savings, increased operational efficiency, and access to specialized technologies and regulatory expertise. Pharmaceutical companies benefit from the flexibility to scale production up or down without heavy capital investment, allowing them to focus more on research, drug development, and commercialization. This model also supports faster time-to-market, especially important in today’s competitive and innovation-driven pharmaceutical landscape.
Report Metrics
Details
Coverage
Global
Study Period
2022–2032
Pharmaceutical Contract Manufacturing Market CAGR
~9%
Pharmaceutical Contract Manufacturing Market Size by 2032
~USD 362 Billion
Key Pharmaceutical Contract Manufacturing Companies
Lonza, Pfizer Inc., Catalent, Inc., Boehringer Ingelheim International GmbH, Samsung Biologics, WuXi AppTec, Thermo Fisher Scientific Inc., Baxter, Recipharm AB, Merck KGaA, CordenPharma, Siegfried Holding AG, Aenova Group, Almac Group, Alcami Corporation, FUJIFILM Holdings Corporation, Novartis AG, Avery Dennison Corporation, Danaher Corporation, Syntegon Technology GmbH, and others
Pharmaceutical Contract Manufacturing Market Assessment
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Pharmaceutical Contract Manufacturing Market Segmentation
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Porter’s Five Forces Analysis, Product Profiles, Case Studies, KOL’s Views, Analyst’s View
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Table of Contents
1
Pharmaceutical Contract Manufacturing Market Report Introduction
2
Pharmaceutical Contract Manufacturing Market Executive Summary
3
Competitive Landscape
4
Regulatory Analysis
5
Pharmaceutical Contract Manufacturing Market Key Factors Analysis
6
Pharmaceutical Contract Manufacturing Market Porter’s Five Forces Analysis
7
Pharmaceutical Contract Manufacturing Market Layout
8
Pharmaceutical Contract Manufacturing Market Company and Product Profiles
9
KOL Views
10
Project Approach
11
About DelveInsight
12
Disclaimer & Contact Us
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SOURCE DelveInsight Business Research, LLP