Formulation Development Outsourcing Market by Services Type (Pre-Formulation and Formulation Development), Route of Formulation (Oral, Injectable, and Others), End-user (Pharmaceutical Industries and Research and Academic Institutes), and Regional Analysis (North America, Europe, Asia-Pacific, and LAMEA) Global Opportunity Analysis and Industry Forecast, 2022-2031

Global Formulation Development Outsourcing Market Analysis

The Global Formulation Development Outsourcing Market Size was $22,452.5 million in 2021 and is predicted to grow with a CAGR of 9.0%, by generating a revenue of $51,901.3 million by 2031.

Global Formulation Development Outsourcing Market Synopsis

Significant factors driving market expansion include the increasing relevance of novel drug development as a result of the increasing patent expirations of important pharmaceuticals and the increased outsourcing of formulation development services by the majority of pharmaceutical and biotechnological companies. To reduce the risk involved and save both, time and money as the drug develops, majority of the biopharmaceutical companies work with outsourcing services in their early phases of the process. The rising need for novel medications as a result of the significant burden of infectious and chronic diseases is one of the main factors driving the demand for formulation development. These factors are anticipated to boost the formulation development outsourcing growth in the upcoming years.            

However, high total R&D expenses are a result of protracted development times and dismal success rates. The pharmaceutical industry's structural changes and a lack of funds to complete the drug development process through formulation development are the main reasons preventing their market expansion.

Development services are still in high demand, and for over the past few years, formulation and bioavailability-related development services have seen significant increase. Pharmaceutical companies are playing an important role in the formulation development outsourcing market by innovating and focusing on cancer formulation development and other medication development. The major players are working together to produce effective medications and gene treatments that will benefit biotech. Furthermore, the adoption of new techniques and pharmaceutical services by key market players will accelerate market size throughout the forecast period. Some of the important players provide clinics, drug substance development, and medical items to patients. Furthermore, formulation development outsourcing market competitors are competing to increase their revenue by developing and creating many innovative products that drive customer demand.

According to regional analysis, the North America formulation development outsourcing market accounted for highest market share in 2021. The expansion of the regional market can be ascribed to higher R&D spending and increased use of cutting-edge technology. Due to the high prevalence of chronic diseases, the demand for biotechnology and pharmaceutical services outsourcing services is rising quickly in the region.

Formulation Development Outsourcing Overview

The pharmaceutical and biotechnology sectors are seeing an increase in the technique of outsourcing drug development. The formulation development outsourcing market has grown due to an increase in the number of biopharmaceutical and pharmaceutical companies that outsource their work. Small and medium-sized pharmaceutical companies that have the necessary resources frequently use formulation development outsourcing services. The process of product development is sped up through outsourcing, which is also a more affordable option than hiring a specialist personnel.

COVID-19 Impact on Global Formulation Development Outsourcing Market

Since pharmaceuticals fell under the category of essential services and were spared from the limits imposed by the statewide lockdown, the impact of COVID-19 on the pharma sector has been less severe than that seen in the other sectors. However, the COVID-19 pandemic slowed down major pharmaceutical companies' production, their supply chain, and the export of some crucial APIs and medications.  It also brought to light, the world's reliance on China for various pharmaceuticals' APIs. Due to lockdown measures implemented by the Chinese government during the outbreak, 44 Chinese firms were judged to be inactive. It had an effect on China's exports of important materials. It has caused several countries to launch plans for domestic API production, and countries around the EU have reviewed its healthcare systems to combat pandemics and guarantee a steady flow of API production. Leading pharmaceutical firms are adapting their business strategies and providing solutions based on key performance indicators as needed by each nation. Pharmaceutical companies had to adjust their business strategies to serve a sizable patient base as a result of rising healthcare expenditures and the current COVID-19 pandemic. For the API sector to be able to utilize operations in the event of exceptional conditions, the production process needs to be restructured. The COVID-19 virus provided pharmaceutical businesses with the ideal opportunity to evaluate their position, prepare for upcoming problems, and realign their reliance on various supply chains.

Growing Chronic Diseases and Increase in Clinical Trials Drives the Growth of the Market

The primary cause of disability and death worldwide are diseases like chronic respiratory diseases (CRD), diabetes, chronic kidney diseases (CKD), cancer, cardiac strokes, and neurological disorders. Researchers are now facing new obstacles and opportunities as a result of the emergence and spread of numerous infectious and chronic diseases. These diseases require early diagnosis, prevention, and treatment, which calls for the development of novel diagnostic tools, tests, medications, and vaccinations. The other two major infectious diseases are hepatitis and HIV. The World Health Organization (WHO) estimates that as of October 2017, 71 million people worldwide were believed to be infected with hepatitis C. The WHO also reported that 36.7 million people worldwide were HIV-positive. These elements support the expansion of the global clinical trials market.

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Limited Funds for Formulation Development Outsourcing to Restrain the Market Growth    

Drug development is a lengthy, expensive, and difficult process with no guarantee that a drug will be successful. Funding is needed at every stage of the drug development process. High total R&D expenses are a result of protracted development times and dismal success rates.  Treatment development is a time-consuming, costly, and complex process that is full of uncertainty about whether or not a drug will be successful. Every stage of the drug development process necessitates funding. Long development timeframes and low success rates result in high total R&D expenses. The key constraints restricting market growth are structural changes in the pharmaceutical sector and a lack of funds to complete the medication development process through formulation development.

Increasing Demand For Medications of Chronic Diseases to Drive Excellent Opportunity

Chronic diseases and conditions are becoming increasingly widespread all over the world. Europe's pharmaceutical and biotechnology businesses have boosted their R&D spending in recent years in response to the growing demand for novel drugs. This might be attributed to an aging population, chronic diseases, and infectious diseases. The creation of anti-cancer pharmaceutical formulations is crucial since formulation includes stability, solubility, and bioavailability throughout drug development.

To know more about global formulation development outsourcing market opportunities, get in touch with our analysts here.

Global Formulation Development Outsourcing Market, by Services Type

Based on services type, the market has been divided into pre-formulation and formulation development. Among these, the formulation development segment accounted for the highest market share in 2021 whereas the pre-formulation sub-segment is estimated to show the fastest growth during the forecast period.

Global Formulation Development Outsourcing Market Size, by Services Type, 2021

Source: Research Dive Analysis

The formulation development segment accounted for the largest market share in 2021. The process of formula development is crucial because it entails creating a stable and patient-acceptable drug preparation and form. On behalf of Informa Pharma Intelligence, Rentschler Biopharma SE, and Leukocare AG, Informa Engage conducted a survey in 2018 to assess the current state, significance, and future of formulation in the development of pharmaceutical products. Participants in the poll who were active in the biopharmaceutical business provided insightful responses. Pharmaceutical formulations are clinically relevant when they significantly affect patients' quality of life, illness outcomes, and adherence to treatment regimens.

The pre-formulation segment is anticipated to show the fastest growth by during the forecast period. Pre-formulation research can be divided into a number of categories.  The phase of development during which the physicochemical qualities of the drug material are described and established is known as preformulation. The optimal formulation and delivery technique for pre-Clinical trials are determined by knowledge of the relevant physiochemical and biopharmaceutical characteristics.

Global Formulation Development Outsourcing Market, by Route of Formulation

Based on route of formulation, the market has been divided into oral, injectable, and others. Among these, the oral segment is expected to show a fastest CAGR during the forecast period.

Global Formulation Development Outsourcing Market Share, by Route of Formulation, 2021

Source: Research Dive Analysis

The oral segment accounted for the largest market share in 2021. A licensed product that is administered orally and absorbed through the stomach, intestine, or gastrointestinal tract is referred to as an oral formulation. This includes, but is not limited to, the introduction of substances using tablets, capsules, controlled time-release preparations, liquid suspensions, and sublingual administration.  Oral formulations are self-administering and do not require the assistance of a trained physician for medication administration, which is one of the primary reasons for their worldwide popularity. Furthermore, as compared to others, these formulations provide greater formulation design flexibility.

Global Formulation Development Outsourcing Market, by End-user

Based on end-user, the market has been divided into pharmaceutical industries and research and academic institutes. Among these, the pharmaceutical industries segment accounted for highest revenue share in 2021.

Global Formulation Development Outsourcing Market Forecast, by End-user, 2021

Source: Research Dive Analysis

The pharmaceutical industries segment accounted for the largest market share in 2021. The purpose of pharmaceutical industries is to cure, immunize, or treat patients' symptoms, and hence, it finds, develops, manufactures, and promotes medicines or pharmaceutical drugs for usage as medications.  Pharmaceutical industries provide medicines for the individual treatment of various types of diseases. Personalized medicine, also known as precision medicine, aims to provide medical care depending on a patient's unique features and genetic composition. Precision treatments are becoming more popular as companies abandon the one-size-fits-all model for common medical conditions. GSK, Teva Pharmaceuticals, and AstraZeneca are among the major pharmaceutical firms investing in the development of personalized medicines.

Global Formulation Development Outsourcing Market, Regional Insights

The formulation development outsourcing market was investigated across North America, Europe, Asia-Pacific, and LAMEA.

Global Formulation Development Outsourcing Market Size & Forecast, by Region, 2021-2031 (USD Million)

Source: Research Dive Analysis

The Market for Formulation Development Outsourcing in North America to be the Most Dominant

The market is anticipated to expand significantly in the North America region due to the spread of chronic diseases. Additionally, this region has a highly developed healthcare system and cutting-edge technical advancements. The region's demand for formulation development outsourcing is expanding due to an increase in the number of approved drugs and the development of a vaccine. Countries such as China and India are leading the industry and driving market growth. The rising trend of outsourcing medical services is a significant driver in the expansion of the North American pharmaceutical contract manufacturing market. Another important element that significantly contributes to the market expansion is the patent cliff. The increasing patent expirations of numerous medications, along with the shrinking profit margins on branded medications, are prompting a majority of healthcare organizations to outsource manufacturing in order to reduce costs.

Competitive Scenario in the Global Formulation Development Outsourcing Market

Investment and agreement are common strategies followed by major market players. For instance, in January 2022, Coriolis Pharma launched new ATMP Formulation Development Facilities. The proximity of the new facilities to Coriolis' Martinized headquarters will greatly enhance the company's capacity for ATMP development.

Source: Research Dive Analysis

Some of the leading formulation development outsourcing market players are Charles River Laboratories. Syngene International Limited, Catalent, Inc, Piramal Pharma Ltd., Intertek Group plc, Thermo Fisher Scientific, Eurofins Scientific, Laboratory Corporation of America Holdings.,Dr. Reddy’s Laboratories Ltd.,and EMERGENT.