According to the Market Statsville Group (MSG), the global formulation development outsourcing market size is expected to grow from USD 31,135.6 billion in 2021 to USD 56,761.9 billion by 2030, at a CAGR of 6.9% from 2022 to 2030. Formulation development is a process of determining a pharmaceutical product’s patentability, lifespan, and success. It includes pre-formulation activities such as analytical test development and characterization, excipient screening to stabilize or improve product solubility, and dosage form development. It is frequently outsourced owing to time constraints and a lack of internal resources. Outsourcing formulation development has various advantages, such as shortening deadlines, gaining access to experts, and offering additional insurance against product failure.
Diabetes, arthritis, cancer, chronic obstructive pulmonary disease (COPD), asthma, and alzheimer’s are all rising, fueling the demand for new medication discovery and development. This, in turn, is one of the primary reasons formulation development services are being outsourced to contract research organizations (CROs) worldwide. Aside from that, there is a growing desire to reduce risk while saving time and money in the drug development pipeline. As a result, top pharmaceutical and biotechnology companies worldwide collaborate with outsourcing services in the early stages of drug development.
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This, combined with a large increase in the need to invent new medications when major drug patents expire, contributes to market expansion. Furthermore, increased healthcare spending by businesses and governments in various nations produces a positive market picture. Furthermore, the coronavirus disease (COVID-19) epidemic has increased the demand for clinical studies to develop an effective therapy for infectious sickness. This has led to significant expenditures in R&D to create treatments, which are expected to boost the market.
COVID–19 Impact on the Global Formulation Development Outsourcing Market
In the midst of the COVID-19 pandemic, countries’ healthcare systems are aggressively spending in R&D to battle the virus, which is having a big influence on the formulation development outsourcing industry. For example, AiPharma will join a worldwide coalition of pharmaceutical, manufacturing, and distribution companies in October 2020 to advance the oral antiviral Avigan/Reeqomus for COVID-19. AiPharma, as a member of the collaboration, commercializes all formulations of favipiravir, a broad-spectrum oral antiviral medication that targets COVID-19 and 11 other infectious disorders. As a result, the pandemic outbreak has benefited the formulation development outsourcing business tremendously.
Furthermore, according to an article titled “Pharmaceutical Technology, 2021 Outsourcing Resources Supplement,” published in August 2021, the pharmaceutical outsourcing market has seen an increase in vaccine development and manufacturing activity in the previous year, owing to the industry’s response to the COVID-19 pandemic. As a result, the number of formulation development outsourcing operations has increased, leading to market growth.
Global Formulation Development Outsourcing Market Dynamics
Drivers: Increasing patent protection expiration
The rising relevance of innovative drug development due to the increasing patent expiration of key medications and the increased outsourcing of formulation development services by most pharmaceutical and biotechnological businesses are significant drivers driving market expansion. Most biopharmaceutical businesses collaborate with outsourcing services in the early stages of drug development to mitigate risk and save time and money as the medicine progresses through the development process.
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Restraints: Limited funds
Drug development is a time-consuming, costly, and complex process full of uncertainty about whether or not a drug will succeed. Every stage of the drug development process requires funding. Long development times and poor success rates result in high total R&D costs. The major factors limiting the market growth are structural changes in the pharmaceutical industry and insufficient funding to conclude the drug development process through formulation development.
Opportunities: Burden of chronic diseases is increasing
Chronic diseases and conditions are on the increase all over the world. Because of the increasing need for innovative medications, Europe’s pharmaceutical and biotechnology sectors have increased their R&D investments in recent years. This might be due to an aging population, chronic ailments, and infectious diseases. Anti-cancer medication formulation development is critical because formulation comprises stability, solubility, and bioavailability throughout drug development.
Scope of the Global Formulation Development Outsourcing Market
The study categorizes the formulation development outsourcing market based on service, formulation, and therapeutic area at regional and global levels.
By Service Outlook (Sales, USD Billion, 2017–2030)
- Formulation Development
By Formulation Outlook (Sales, USD Billion, 2017–2030)
By Therapeutic Area Outlook (Sales, USD Billion, 2017–2030)
- Infectious Diseases
By Region Outlook (Sales, USD Billion, 2017–2030)
- North America
- The Netherlands
- Czech Republic
- Rest of Europe
- Asia Pacific
- South Korea
- Australia & New Zealand
- Rest of Asia Pacific
- South America
- Rest of South America
- The Middle East & Africa
- Saudi Arabia
- South Africa
- Northern Africa
- Rest of MEA
Oral segment accounts for the largest market share by formulation
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Based on the formulation, the market is divided into oral, injectable, topical, and others. In 2021, the oral segment led the formulation development outsourcing market, accounting for the largest market share due to treating common ailments such as migraines, fever, infectious disorders, and diabetes, among others. Oral formulations are self-administering and do not require the assistance of a skilled physician for medication administration, which is one of the primary reasons for their widespread popularity. Furthermore, these formulations offer greater formulation design flexibility than others, which increases their market demand for formulation development outsourcing. Tablets, capsules, syrups, and powders are examples of oral formulations.
Asia Pacific accounts for the highest CAGR during the forecast period by Region
Based on the regions, the global formulation development outsourcing market has been segmented across North America, Asia–Pacific, Europe, South America, and the Middle East & Africa. The Asia Pacific region is expected to have the fastest CAGR over the forecast period due to a substantial number of CROs offering cost-effective formulation development services. Furthermore, public institutions are taking steps to shorten the time it takes for drugs to be approved in the region. For example, the Department of Pharmaceuticals (India) issued new guidelines in October 2021 to cut the time necessary for the approval of innovative medicines by at least 50% during the following two years to strengthen the country’s R&D operations. Such activities are anticipated to increase demand in the nation for formulation development outsourced services.
As a result, such market trends are likely to assist Asia–Pacific in dominating the overall market.
Key Market Players in the Global Formulation Development Outsourcing Market
The global formulation development outsourcing market is highly competitive, with key industry players adopting strategies such as partnerships, product development, acquisitions, agreements, and expansion to strengthen their market positions. Most companies in the market are indulged in expanding business across regions, enhancing their capabilities, and molding strong partner relations.
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Major players in the global formulation development outsourcing market are:
- SGS S.A.
- Intertek Group plc
- Charles River Laboratories International, Inc.
- Eurofins Scientific SE
- Thermo Fisher Scientific, Inc. (Patheon)
- Catalent Inc.