Formulation Development Outsourcing Market Drivers Fueled by Drug Patent Expirations and Expansion of Biopharmaceutical Research

InsightAce Analytic Pvt. Ltd. announces the release of a market assessment report on the "Global Formulation Development Outsourcing Market Size, Share & Trends Analysis Report By Service (Preformulation, Formulation Development), Application (Oncology, Neurology, Infectious Disease, Respiratory, Dermatology) And Formulation (Injectable, Topical, Inhaled, Oral) Market Outlook And Industry Analysis 2035"

Global Formulation Development Outsourcing Market Size is valued at USD 43.22 billion in 2025 and is predicted to reach USD 92.23 billion by the year 2035 at a 8.0% CAGR during the forecast period for 2026 to 2035.

Get Free Access to Demo Report, Excel Pivot and ToC: https://www.insightaceanalytic.com/request-sample/1848

Fluctuations in the pricing and demand of pharmaceutical products and raw materials exert a significant impact on the dynamics of formulation development outsourcing. Companies operating within this sector have strategically leveraged opportunities arising from the expiration of drug patents to drive market growth. In recent years, demand for specialized development services-particularly those focused on formulation optimization and enhancement of bioavailability-has increased markedly.

Pharmaceutical firms continue to play a central role in the market, emphasizing the development and production of innovative formulations and therapeutic solutions. Collaborative initiatives among industry stakeholders have been critical in advancing the delivery of effective pharmaceuticals and gene therapies, thereby strengthening the broader biotechnology landscape. Additionally, the adoption of advanced technologies and value-added pharmaceutical services by leading market participants is anticipated to further accelerate sector growth over the forecast period.

To sustain a competitive advantage, formulation development outsourcing providers are increasingly focused on diversifying and expanding their service portfolios. This strategy is designed to meet evolving client requirements and support sustainable revenue growth across the market.

List of Key Players in the Formulation Development Outsourcing Market:
• SGS S.A.
• Intertek Group plc
• Recipharm
• Lonza
• Charles River Laboratories International, Inc.
• Eurofins Scientific SE
• Element
• Labcorp
• Thermo Fisher Scientific, Inc. (Patheon)
• Catalent Inc.

Expert Knowledge, Just a Click Away: https://calendly.com/insightaceanalytic/30min?month=2025-04

Market Dynamics
Drivers:
The formulation development outsourcing market is experiencing steady growth and is projected to register a strong compound annual growth rate (CAGR) over the forecast period. This expansion is primarily fueled by increasing demand across key therapeutic segments, including oncology, infectious diseases, and respiratory care. The pharmaceutical industry is expected to remain the principal contributor, accounting for a significant portion of the global market share throughout the forecast horizon.

Further supporting market growth are the continued expansion of research institutions and advancements within the biopharmaceutical sector. These factors collectively underpin the sustained development of the global formulation development outsourcing industry, driving innovation and operational efficiency in pharmaceutical product development.

Challenges:
Despite favorable growth prospects, the market faces several challenges that may constrain its trajectory. Substantial initial capital requirements, coupled with limited awareness of formulation development services in emerging economies, continue to restrict market penetration. Additionally, the COVID-19 pandemic disrupted global pharmaceutical operations, affecting production capacities, delaying supply chains, and constraining the export of critical medications.

Notably, stringent lockdown measures in China led to significant shortages of essential raw materials. In response, several countries have initiated strategies to strengthen domestic active pharmaceutical ingredient (API) manufacturing capabilities. Furthermore, European Union member states have undertaken comprehensive assessments of their healthcare systems to enhance preparedness for future public health crises and ensure a resilient API supply chain.

Regional Trends:
North America is expected to maintain its leading position in terms of revenue generation, driven by a high prevalence of chronic diseases and the presence of major pharmaceutical and biopharmaceutical companies, particularly in the United States. As several blockbuster drug patents near expiration, industry leaders are increasingly investing in outsourced formulation development to facilitate the introduction of novel pharmaceutical products, thereby supporting regional market growth. In Europe, the United Kingdom currently holds the largest market share, while Germany is emerging as the fastest-growing country, reflecting rising investments in pharmaceutical research, development, and contract formulation services.

Recent Development:
• In 2021, Catalent announced it had engaged in a definitive agreement to acquire Acorda Therapeutics, Inc.'s manufacturing and packaging operations. The acquisition bolsters Catalent's position as a leading U.S. partner for dry powder inhaled dosage form manufacturers. Catalent has also signed a long-term supply agreement with Acorda Therapeutics to continue commercial production of INBRIJA® (levodopa inhalation powder) at its Chelsea facility.
• In 2021, Quotient Bioscience also disclosed plans to acquire Arcinova, a United Kingdom-based business. With the acquisition, Quotient Bioscience can offer more services, such as medical goods, clinical testing, and drug substance development.
• In 2020, Catalent, Inc. announced the completion of its acquisition of MaSTherCell Global, Inc., establishing Catalent as a leading technology, development, and manufacturing partner for innovators of advanced biotherapeutics. Catalent is well-positioned to lead the industry with its cell & gene therapy platforms after acquiring MaSTherCell's novel portfolio of autologous and allogeneic cell therapy-related capabilities, technologies, and analytical services.

Unlock Your GTM Strategy: https://www.insightaceanalytic.com/customisation/1848

Segmentation of Formulation Development Outsourcing Market:
Service Outlook
• Preformulation
• Formulation Development
By Formulation -
• Injectable
• Oral
• Topical
• Inhaled
• Others
By Application -
• Oncology
• Genetic Disorders
• Neurology
• Infectious Disease
• Respiratory
• Cardiovascular
• Other application
By Region-
North America-
• The US
• Canada
• Mexico
Europe-
• Germany
• The UK
• France
• Italy
• Spain
• Rest of Europe
Asia-Pacific
• China
• Japan
• India
• South Korea
• South East Asia
• Rest of Asia Pacific
Latin America-
• Brazil
• Argentina
• Rest of Latin America
Middle East & Africa-
• GCC Countries
• South Africa
• Rest of the Middle East and Africa

Read Overview Report- https://www.insightaceanalytic.com/report/formulation-development-outsourcing-market-/1848

About Us:
InsightAce Analytic is a market research and consulting firm that enables clients to make strategic decisions. Our qualitative and quantitative market intelligence solutions inform the need for market and competitive intelligence to expand businesses. We help clients gain competitive advantage by identifying untapped markets, exploring new and competing technologies, segmenting potential markets and repositioning products. Our expertise is in providing syndicated and custom market intelligence reports with an in-depth analysis with key market insights in a timely and cost-effective manner.

Contact us:
InsightAce Analytic Pvt. Ltd.
Visit: https://www.insightaceanalytic.com/
Tel : +1 607 400-7072
Asia: +91 79 72967118
info@insightaceanalytic.com

This release was published on openPR.