The global formulation development outsourcing market size was valued at $22.5 billion in 2021, and is projected to reach $51.9 billion by 2031, growing at a CAGR of 9% from 2022 to 2031. Due to time constraints and a lack of internal resources, it is frequently outsourced. Outsourcing formulation development has a lot of advantages as well, including shortened timescales, easier access to knowledge, and increased protection against defective products.
Drug developers at all levels are becoming interested in outsourcing pharmaceutical formulation development and manufacture, particularly in developing nations like India. 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. In addition, there is a strong emphasis on creating poorly water-soluble chemicals to increase bioavailability and patent expirations. The necessity for clinical trials to identify a cure for contagious viruses has also been influenced by the COVID-19 outbreak. As a result, substantial funds have been spent on R&D to create medicines, which are predicted to boost the industry.
It is anticipated that higher R&D expenses will raise demand for outsourcing formulation development. Small and medium-sized pharmaceutical enterprises that lack the requisite resources frequently use outsourcing services for formulation development. Due to trial-related expenses, the majority of pharmaceutical businesses use it to shorten the time spent on outsourcing services for formulation development. The pharmaceutical industry's growing reliance on collaborations with academic institutions is caused by the growth of the formulation development outsourcing industry.
The formulation development outsourcing market is expected to be restrained owing to high amount of budget required for outsourcing drug development by the companies. Additionally, the complexity of the substances is growing for formulators. Increases in the price and demand for various medicines and raw materials have the potential to have a substantial negative impact on the market value of formulation development outsourcing. Incorporating various active chemicals, tightening restrictions, shifting societal and customer preferences, and environmental considerations all have an impact on the creation of a product, as do usage and eventual decomposition. In addition to their total environmental impact, formulators are concerned with how their products will benefit consumers and patients.
The number of pharmaceutical and biopharmaceutical businesses outsourcing their work has led to an expansion of the formulation development outsourcing market. The COVID-19 pandemic is expected to have a positive impact on the formulation drug outsourcing market. The high demand for effective drug or vaccine discovery among healthcare professionals, researchers and scientists to treat the viral infection has boosted the research and development activities. Many contract formulation development outsourcing companies became active and started taking drug development formulation projects from major companies and even research institutes.
The key players profiled in this report include 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.
Key Benefits For Stakeholders
- This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the formulation development outsourcing market analysis from 2021 to 2031 to identify the prevailing formulation development outsourcing market opportunities.
- The market research is offered along with information related to key drivers, restraints, and opportunities.
- Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
- In-depth analysis of the formulation development outsourcing market segmentation assists to determine the prevailing market opportunities.
- Major countries in each region are mapped according to their revenue contribution to the global market.
- Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.
- The report includes the analysis of the regional as well as global formulation development outsourcing market trends, key players, market segments, application areas, and market growth strategies.
Key Market Segments
By Services Type
- Pre-Formulation
- Formulation Development
By Route of Formulation
- Oral
- Injectable
- Others
By End-user
- Pharmaceutical Industries
- Research and Academic Institutes
By Region
- North America
- U.S.
- Canada
- Mexico
- Europe
- Germany
- UK
- France
- Spain
- Italy
- Rest of Europe
- Asia-Pacific
- China
- Japan
- India
- South Korea
- Australia
- Rest of Asia-Pacific
- LAMEA
- Brazil
- Saudi Arabia
- United Arab Emirates
- South Africa
- Rest of LAMEA
Key Market Players
- Charles River Laboratories International, Inc.
- syngene international limited
- Catalent Inc
- Piramal Pharma Limited
- Intertek Group Plc
- Thermo Fisher Scientific Inc.
- Eurofins Scientific
- Laboratory Corporation of America Holdings
- Dr Reddy's Laboratories Ltd.
- Emergent BioSolutions, Inc.
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Table of Contents
Executive Summary
According to the report titled, “Formulation Development Outsourcing Market," the formulation development outsourcing market was valued at $22.5 billion in 2021, and is estimated to reach $51.9 billion by 2031, growing at a CAGR of 9% from 2022 to 2031.
Formulation development is a crucial aspect of product/drug development that affects a pharmaceutical product's patentability, lifetime, and success. To cut down on the amount of time and money spent on trials, the majority of pharmaceutical corporations outsource formulation services. Global regulatory authorities have established stringent requirements to assure data quality and integrity, which are defined by the FDA. Due in large part to the increasing number of key medications whose patents are expiring, as well as the rising outsourcing of formulation development services by the majority of pharmaceutical and biotechnological businesses, the industry is expected to grow. To reduce risk and save time and money while moving a medicine through the development phase, a majority of pharma companies collaborate with outsourcing services in the early stages of drug development.
The large number of formulation development outsourcing companies are partnering with Contract Development and Manufacturing Organization's to minimize the timeline needed for manufacturing of drugs or vaccines and to mitigate the risk. The formulation development outsourcing manufacturing and packaging offers complete analytical and technical support with enhanced launch capabilities and final distribution. The formulation development outsourcing facilitates development activities within compressed timeline with timely resolution of development challenges to facilitate the alignment of various components in the supply chain. Formulation development outsourcing facilitates early development activities to fasten the development activities and to accelerate the clinical trial entry. Additionally, several small pharmaceutical companies are outsourcing the formulation development outsourcing activities for the early phase development and clinical trials. The formulation development outsourcing companies are accelerating the development of technologies for both GMP and non-GMP products to facilitate the increasing scale demand of pharmaceutical products during the product development lifecycle. Thus, the formulation development outsourcing companies are implementing 'reserved capacity model' to provide access to formulation, manufacturing, and outsourcing activities that can boost the clinical and commercial supply chain. These factors are anticipated to generate excellent opportunities in the formulation development outsourcing market in the coming years.
Diabetes, chronic obstructive pulmonary disease (COPD), cancer, asthma, arthritis, and Alzheimer's disease are all on the rise, fueling the demand for new medication discovery and development. This, in turn, is one of the primary reasons why formulation development services are being outsourced to contract research organizations (CROs) all over the world. As a result, top pharmaceutical and biotechnology businesses throughout the world are collaborating with outsourcing services in the early stages of drug development. This, along with a significant increase in the need to innovate novel drugs on account of the rising patent expirations of major drugs, is contributing to market growth. All these factors are projected to create numerous growth prospects for the key players operating in the market.
The formulation development outsourcing market is segmented into services type, route of formulation, end user, and region. On the basis of service type, the market is categorized into pre-formulation and formulation development. On the basis of route of formulation, it is categorized into oral, injectable and other. On the basis of end user, it is bifurcated into pharmaceutical industries and research and academic institutes. Region wise, it is analyzed across North America (the U.S., Canada, and Mexico), Europe (the UK, Germany, Italy, France, Spain, and rest of Europe), Asia-Pacific (China, India, Japan, Australia, South Korea, and rest of Asia-Pacific), and LAMEA (Brazil, Saudi Arabia, United Arab Emirates, South Africa, and rest of LAMEA).
The key players profiled in the study include 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.
The players in the market have been actively engaged in the adoption various strategies such as acquisition, product launch and expansion to remain competitive and gain advantage over the competitors in the market. For instance, in June 2022 Lonza opened a new R&D centre in Bend to assist early-phase clinical studies.
Key Market Insights
- By services type, the formulation development segment was the highest revenue contributor to the market in 2021. However, the pre-formulation segment is estimated to be the fastest growing during the forecast period
- By route of formulation, the injectable segment dominated the global market in 2021 and oral segment is estimated to be the fastest growing during the forecast years
- Based on end-user, the pharmaceutical industries segment was the highest revenue contributor to the market in 2021 and is projected to be the fastest growing during the forecast period.
- Based on region, Asia-Pacific was the highest revenue contributor to the market in 2031, accounting for a market size of $17490.7 million
Companies Mentioned
- Charles River Laboratories International, Inc.
- Syngene International Limited
- Catalent Inc
- Piramal Pharma Limited
- Intertek Group PLC
- Thermo Fisher Scientific Inc.
- Eurofins Scientific
- Laboratory Corporation of America Holdings
- Dr Reddy's Laboratories Ltd.
- Emergent BioSolutions, Inc.
Methodology
The analyst offers exhaustive research and analysis based on a wide variety of factual inputs, which largely include interviews with industry participants, reliable statistics, and regional intelligence. The in-house industry experts play an instrumental role in designing analytic tools and models, tailored to the requirements of a particular industry segment. The primary research efforts include reaching out participants through mail, tele-conversations, referrals, professional networks, and face-to-face interactions.
They are also in professional corporate relations with various companies that allow them greater flexibility for reaching out to industry participants and commentators for interviews and discussions.
They also refer to a broad array of industry sources for their secondary research, which typically include; however, not limited to:
- Company SEC filings, annual reports, company websites, broker & financial reports, and investor presentations for competitive scenario and shape of the industry
- Scientific and technical writings for product information and related preemptions
- Regional government and statistical databases for macro analysis
- Authentic news articles and other related releases for market evaluation
- Internal and external proprietary databases, key market indicators, and relevant press releases for market estimates and forecast
Furthermore, the accuracy of the data will be analyzed and validated by conducting additional primaries with various industry experts and KOLs. They also provide robust post-sales support to clients.
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Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 240 |
| Published | February 2023 |
| Forecast Period | 2021 - 2031 |
| Estimated Market Value ( USD | $ 22.5 billion |
| Forecasted Market Value ( USD | $ 51.9 billion |
| Compound Annual Growth Rate | 8.7% |
| Regions Covered | Global |
| No. of Companies Mentioned | 10 |
