Press release
Formulation Development Outsourcing Market Forecasted to Hit USD 83.55 Billion by 2034, Growing at a CAGR of 8.4%
Polaris Market Research announces the release of its latest research report titled, "Formulation Development Outsourcing Market Size, Share, & Industry Analysis Report: By Formulation, By Service (Preformulation and Formulation Development), By Therapeutic Area, By End Use, and By Region - Market Forecast, 2025-2034."The report analyzes the market for formulation development outsourcing to register a CAGR of 8.4% during 2025-2034. The market was valued at USD 37.23 billion in 2024 and is projected to grow to USD 83.55 billion by 2034.
Market Introduction
Formulation development outsourcing refers to pharmaceutical companies hiring external specialized providers, known as contract development and manufacturing organizations (CDMOs), to handle the process of designing and creating the final drug dosage form. Outsourcing can involve the entire formulation development process or its specific parts, such as pre-formulation, stability studies, or clinical supply manufacturing. Pharmaceutical companies often outsource to reduce costs and access specialized expertise. Outsourcing of formulation development also allows these companies to speed up development timelines and leverage advanced technologies.
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Market Dynamics
Growth in Biopharmaceutical and Generic Drug Development: The growth in biopharmaceutical and specialty drug development has resulted in a significant increase in demand for efficient and cost-efficient formulation strategies. With increased demand, companies aim to develop products at faster speeds and lower costs. These drugs often need complex formulations to ensure stability and bioavailability, which many firms lack the internal resources to handle. This, in turn, drives the formulation development outsourcing market demand.
Advancements in Formulation Technologies: Advancements in formulation technologies are transforming how drugs are developed and delivered. This has created new opportunities in the field of formulation development outsourcing. Innovations like solid dispersion, lipid-based delivery systems, and sustained reliance help improve drug solubility and effectiveness. Developing these formulations needs specialized equipment and knowledge, prompting companies to turn to expert service providers who offer tailored solutions.
Market Key Players
The market has the presence of both established players and new entrants. A few of the leading market participants are:
• Catalent Inc.
• Charles River Laboratories International, Inc.
• Element
• Eurofins Scientific SE
• Intertek Group plc
• Labcorp
• Lonza
• Recipharm
• SGS S.A.
• Thermo Fisher Scientific, Inc.
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Formulation Development Outsourcing Market Report Highlights
• By therapeutic area, in 2024, the oncology segment held the largest share due to the surge in demand for precision oncology therapeutics and the rapid pace of clinical pipeline expansion.
• Based on end use, the government and academic institutes segment is expected to witness the highest CAGR during the forecast period due to their expanding role in translational research and early-stage drug discovery.
• In 2024, Asia Pacific held the largest share due to a surge in regional biopharmaceutical innovation and rapidly expanding generics industry.
• The North America formulation development outsourcing market is projected to register the highest CAGR during the forecast period, driven by an upsurge in biotech venture capital.
Market Segmentation
Formulation Development Outsourcing Market, Formulation Outlook (Revenue - USD Billion, 2020-2034)
• Oral
• Injectable
• Topical
• Others
Formulation Development Outsourcing Market, Service Outlook (Revenue - USD Billion, 2020-2034)
• Preformulation
• Formulation Development
Formulation Development Outsourcing Market, End-use Outlook (Revenue - USD Billion, 2020-2034)
• Pharmaceutical and Biopharmaceutical Companies
• Government and Academic Institutes
• Others
Formulation Development Outsourcing Market, Therapeutic Area Outlook (Revenue - USD Billion, 2020-2034)
• Oncology
• Infectious Disease
• Neurology
• Hematology
• Respiratory
• Cardiovascular
• Dermatology
• Others
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Regional Analysis
By region, the study provides the formulation development outsourcing market insights into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.
Asia Pacific held the largest share of the global market in 2024. This is primarily due to the regional biopharmaceutical innovation and a rapidly expanding generics industry. The proliferation of global outsourcing firms in major economies further contributes to the region's leading market share.
North America is projected to register the highest CAGR from 2025 to 2034. This is driven by an upsurge in biotech venture capital and accelerated drug pipelines. The strategic focus on complex and high-value formulations contributes to the region's robust market growth.
• North America (U.S., Canada)
• Europe (France, Germany, UK, Italy, Netherlands, Spain, Russia)
• Asia Pacific (Japan, China, India, Malaysia, Indonesia. South Korea)
• Latin America (Brazil, Mexico, Argentina)
• Middle East & Africa (Saudi Arabia, UAE, Israel, South Africa)
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