Formulation Development Outsourcing Market Report 2025

The formulation development outsourcing market size has grown strongly in recent years. It will grow from $29.83 billion in 2024 to $32.62 billion in 2025 at a compound annual growth rate (CAGR) of 9.4%. The growth in the historic period can be attributed to cost efficiency, focus on core competencies, regulatory compliance, accelerated drug development, and access to specialized expertise.

The formulation development outsourcing market size is expected to see rapid growth in the next few years. It will grow to $48.55 billion in 2029 at a compound annual growth rate (CAGR) of 10.4%. The growth in the forecast period can be attributed to the increased complexity of drug molecules, strategic partnerships, rising R&D costs, biopharmaceutical innovations, and flexible capacity. Major trends in the forecast period include integration of continuous manufacturing processes, outsourcing for modified-release formulations, collaborations for specialized drug delivery systems, regulatory expertise in outsourced services, and utilization of artificial intelligence (AI) in formulation design.

The increasing prevalence of chronic diseases is expected to drive the growth of the formulation development outsourcing market in the future. Chronic diseases are long-lasting conditions that require ongoing medical care and can limit daily activities. Developing effective formulations and therapies for these conditions demands specialized expertise and resources. Formulation development outsourcing involves collaborating with external experts or specialized companies to handle the research, development, and optimization of drug formulations aimed at treating chronic diseases. For example, in November 2023, Eurostat, a government agency in Luxembourg, reported that over one-third (36.1%) of individuals in the EU faced a long-term chronic health condition in 2022. Therefore, the rising incidence of chronic diseases is fueling the growth of the formulation development outsourcing market.

The formulation development outsourcing market is also expected to witness growth due to the increasing demand for drugs. Drugs, substances used for medical treatment, disease prevention, symptom relief, or recreational purposes, are central to the healthcare industry. Formulation development outsourcing plays a crucial role in drug development, supporting activities such as the development of biopharmaceuticals and novel drug delivery systems, accelerating the drug development process, and providing a cost-effective solution for pharmaceutical companies. In April 2022, according to Fierce Healthcare, total drug expenditure in the United States witnessed a 7.7% growth in 2021, reaching $576.9 billion, and is projected to experience an estimated increase ranging from 4% to 6% in 2022. Therefore, the growing demand for drugs is a significant factor driving the growth of the formulation development outsourcing market.

Technological advancements represent a prominent trend gaining traction in the formulation development outsourcing market. Companies within this market are embracing cutting-edge technologies, such as artificial intelligence (AI) and machine learning (ML), to maintain their competitive positions. For example, in March 2023, Nvidia, a US-based software technology company, introduced BioNeMo Cloud, a novel component in their AI Foundations suite. This service grants researchers access to pre-trained AI models, facilitating customization with private data to expedite life sciences research, drug discovery, and protein engineering. Notably, industry leaders such as Amgen and numerous startups are leveraging this technology as a cloud service, accelerating drug development processes.

Major players in the formulation development outsourcing market are strategically focusing on enhancing various outsourcing capabilities, including method development. Method development capabilities denote an organization's or laboratory's expertise, skills, and resources to create, optimize, and validate analytical methods for analyzing various substances. For instance, in February 2022, Berkshire Sterile Manufacturing (BSM), a US-based sterile filling contract manufacturer, bolstered its clients' drug production capabilities by incorporating formulation, lyophilization, and method development expertise. BSM is expanding its services to cover first-in-human formulation development, providing materials for preclinical studies, and conducting research-level stability studies. Additionally, BSM is offering services for formulation optimization, process development, optimization, and scale-up studies, utilizing materials and equipment indicative of future Good Manufacturing Practice (GMP) manufacturing.

In August 2022, Catalent Inc., a US-based pharmaceutical company, completed the acquisition of Metrics Inc. for $475 million. This strategic move broadened, diversified, and enriched Catalent's portfolio by adding capabilities in integrated oral solid formulation development, manufacturing, and packaging. This expansion aims to assist customers in simplifying and accelerating their programs while enhancing their capacity to handle highly potent compounds. Metrics Inc. is a US-based global pharmaceutical formulation development organization specializing in novel oral dosage forms.

Major companies operating in the formulation development outsourcing market include Syngene International Ltd., Aizant Drug Research Solutions Private Limited., Catalent Inc., Intertek Group plc, Recipharm AB, SGS S.A., Lonza Group AG, Eurofins Scientific SE, Laboratory Corporation of America Holdings, Charles River Laboratories International Inc., Emergent Biosolutions Inc., IRISYS LLC, Piramal Pharma Limited., Biocon Limited., Dr Reddy's Laboratories Ltd., Quotient Sciences Ltd., Almac Group, Patheon, Evonik Industries AG, Metrics Contract Services, Aenova Group, Fareva Group, Vetter Pharma International GmbH, Aesica Pharmaceuticals, WuXi AppTec, Formosa Laboratories Inc., Aptuit LLC, ProPharma Group, Laurus Labs Limited.

North America was the largest region in the global formulation development outsourcing market in 2024. The regions covered in the formulation development outsourcing market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the formulation development outsourcing market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Formulation development outsourcing involves the practice of enlisting external experts or organizations to manage the formulation and development process of a product. This outsourcing arrangement enables companies to tap into the specialized knowledge, resources, and expertise of external parties for the development or enhancement of their product formulations.

The primary services offered in formulation development outsourcing include pre-formulation and formulation development. Pre-formulation pertains to the developmental stage in pharmaceutical formulations, encompassing various therapeutic areas such as oncology, infectious disease, neurology, hematology, respiratory, cardiovascular, dermatology, among others. These formulations cover diverse administration methods, including oral, injectable, topical, and others. Formulation development outsourcing is utilized by various end-users, including pharmaceutical industries, research entities, and academic development.

The formulation development outsourcing research report is one of a series of new reports that provides formulation development outsourcing statistics, including formulation development outsourcing industry global market size, regional shares, competitors with a formulation development outsourcing share, detailed formulation development outsourcing segments, market trends, and opportunities, and any further data you may need to thrive in the formulation development outsourcing industry. This formulation development outsourcing research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The formulation development outsourcing market includes revenues earned by entities by providing services such as ingredient sourcing, stability studies, analytical testing, and regulatory support. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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