Formulation Development Outsourcing Market: Information By Services (Pre Formulation Services (Formulation Discovery, Pre-Clinical Services, Analytical Services), Formulation Optimization (Phase I, Phase II, Phase III, Phase IV), By Dosage Form (Injectable, Oral, Topical, Inhaled, Others), By Application (Oncology, Genetic Disorders, Neurology, Infectious Disease, Respiratory, Cardiovascular, Others), By End User (Pharmaceutical and Biopharmaceutical, Government and Academic Institutes) and Region (Americas, Europe, Asia-Pacific, and the Middle East & Africa) - Forecast till 2027

Formulation Development Outsourcing Market Synopsis

Formulation Development Outsourcing Market is expected to register a CAGR of 8.19% during the assessment period of 2020 to 2027, to reach USD 13,530.01 Million by 2027. formulation development outsourcings is gaining popularity due to the increasing focus of biopharmaceutical companies establishing a partnership with academia, Contract Research Organizations (CROs), and biotechnology startup companies to develop formulation against diseases such as cancer are augmenting the growth of the formulation development outsourcing market. In addition, an increasing number of pharmaceutical and biopharmaceutical companies outsourcing their services in the industry have opened new opportunities for the formulation development outsourcing manufacturers.  

Market Dynamics

The patent protection expiration of major drugs is one of the factors driving the growth of the formulation development outsourcing market. There has been an increasing demand for drugs and medical devices because of the growing population, especially in emerging economies. The market around the globe is expanding, especially in developing countries such as India and China. There is a major patent cliff occurring in the healthcare market worldwide, more specifically, in the pharmaceutical industry. The patent cliff will result in cheaper generic versions in the market, which in turn will increase the demand for CMOs. The increased demand is expected to benefit the healthcare contract manufacturing industry, which is propelling the market growth. Due to patent expirations, it is assumed that drug sales will face a loss of approximately 75 USD billion between 2016 and 2023.

In addition, the rising demand for outsourcing of services from pharmaceutical companies and the presence of market players involved in new services and strategic collaborations are further contributing to the growth of the formulation development outsourcing market. However, structural changes in the pharmaceutical industry and insufficient funding to carry out the drug development process through formulation development outsourcing in emerging countries is restraining market growth.

Formulation Development Outsourcing Market, by services, 2019 (%)

Source: MRFR Analysis

Segmentation

The formulation development outsourcing market is segmented based on services, dosage form, application, and end user.

The global market based on the services has been divided into preformulation services and formulation optimization. Preformulation services is further bifurcated into formulation discovery, pre-clinical services, and analytical services. Formulation optimization is further segmented into Phase I, Phase II, Phase III, and Phase IV. Formulation optimization is a larger segment due to services it provides, such as solubility and pH profile studies, drug/excipient compatibility studies, preservative screening, selection, and testing, manufacture of lab-scale and feasibility batches, and feasibility studies. The formulation development outsourcing market, based on dosage form, has been segmented into injectable, topical, oral, inhaled, and others. The injectable segment was the largest segment in 2019, owing to the presence of market players involved in strategic collaborations. For instance, in 2017, Ferring Pharmaceuticals and Foresee Pharmaceuticals Co., Ltd entered into an exclusive agreement to develop a Stabilized Injectable Formulation platform (SIF) for the development of long duration, controlled release formulations of a peptide therapeutic. The formulation development outsourcing industry, based on application, is segmented into oncology, genetic disorders, neurology, infectious diseases, respiratory, cardiovascular, and others. The oncology segment was the largest and fastest segment owing to the rising incidence of cancer and the active participation of pharmaceutical companies to outsource their services. The formulation development outsourcing industry, based on end user, is segmented into pharmaceutical & biopharmaceutical companies, government and academic institutes. Pharmaceutical and biopharmaceutical companies were a larger and faster-growing segment due to the rising demand for outsourcing pharmaceutical formulation development and outsourcing among drug developers.

Western Europe Formulation Development Outsourcing Market Share, by Country, 2019 (%)

Source: MRFR Analysis

Regional Analysis

The formulation development outsourcing market, based on region, has been divided into the Americas, Europe, Asia-Pacific, and the Middle East & Africa.

The Americas has been segmented into North America and Latin America, with the North America market further divided into the US and Canada. The Americas spearheaded the market in 2019 and is likely to continue to command during the assessment period. This is attributed to the existence of a well-established healthcare system and the rising prevalence of chronic diseases & the need for drug development.

The Europe embolization particle market has been divided into Western Europe and Eastern Europe. The Western Europe formulation development outsourcing market has further been classified into Germany, France, the UK, Italy, Spain, and the Rest of Western Europe. Europe would follow the Americas in terms of value during the forecast period owing to the presence of favorable government initiatives, and large target population base, rising prevalence of chronic and lifestyle-associated conditions, and increasing adoption of formulation development outsourcing by pharmaceutical and biopharma companies.

The formulation development outsourcing market in Asia-Pacific has been segmented into China, India, Japan, South Korea, Australia, and the Rest of Asia-Pacific. Asia-Pacific is expected to witness the highest market growth potential over the forecast period due to increasing per capita health spending, the developing healthcare sector in China, India, and Australia, growing demand for the drug development process, and the rising number of pharmaceutical companies involved in drug development.

The Middle East & Africa formulation development outsourcing market is segmented into the Middle East and Africa. The gradual adoption rate of formulation development outsourcing is anticipated to drive the market growth in this region.

Key Players

The prominent players in the formulation development outsourcing market are Laboratory Corporation of America (US), Charles River Laboratories (US), Catalent, Inc. (US), and Intertek (US).

Some of the key strategies followed by players operating in the formulation development outsourcing were FDA approvals, joint ventures, acquisitions, expansions, and collaborations.

• In February 2020, Catalent, Inc. acquired MaSTherCell Global, Inc. to extend leadership positions in the biotech industry and offer leading gene therapy techniques. The acquisition will allow companies to deliver comprehensive development, manufacturing, analytical, fill-finish, and clinical supply solutions for innovators across the large molecule space.

• In May 2019, Intertek declared the expansion of its pharmaceutical services laboratory in Melbourne, near Cambridge.

Market Segmentation

Market for Formulation Development Outsourcing, By Services

• Pre formulation Services




• Formulation Discovery


• Preclinical Services


• Analytical Services




• Formulation optimization




• Phase I


• Phase II


• Phase III


• Phase IV

Market for Formulation Development Outsourcing, By Dosage form

• Injectable


• Oral


• Topical


• Inhaled


• Others

Market for Formulation Development Outsourcing, By Application

• Oncology


• Genetic Disorders


• Neurology


• Infectious Diseases


• Respiratory


• Cardiovascular


• Others

Market for Formulation Development Outsourcing, By End User

• Pharmaceutical and Biopharmaceutical Companies


• Government and Academic Institutes

Market for Formulation Development Outsourcing, By Region

• Americas




• North America




• US


• Canada




• Latin America

• Europe




• Western Europe




• Germany


• France


• UK


• Italy


• Spain


• Rest of Western Europe




• Eastern Europe

• Asia-Pacific




• Japan


• China


• India


• Australia


• South Korea


• Rest of Asia-Pacific

• Middle East & Africa




• Middle East


• Africa

Available Additional Customizations

• Impact of COVID-19 on the Formulation Development Outsourcing Market


• Mega Trends in the Market


• Investment Opportunities

Intended Audience

• Pharmaceutical companies


• Contract research organizations


• Research & development organizations


• Academic institutes

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