Formulation Development Outsourcing Market (By Service: Preformulation, Formulation Development; By Formulation: Topical, Oral, Injectable, Others; By Therapeutic Area: Oncology, Infectious Disease, Respiratory, Cardiovascular, Neurology, Hematology, Dermatology, Others; By End-User: Pharmaceutical Industries, Research and Academic Institutions) - Global Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2023-2032
The global formulation development outsourcing market size was evaluated at USD 37.4 billion in 2022 and it is expected to hit around USD 75.8 billion by 2032, poised to grow at a CAGR of 7.32% during the forecast period from 2023 to 2032.
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The desire for efficient drugs or vaccines among scientists, researchers, and healthcare professionals to treat viral infections has increased research and development activities. The rising requirement of drug formulation and innovation has boosted the demand for outsourcing agencies that can manage active contract formulation activities. Such outsourcing agencies can manage significant areas taking from patents for the drug development to the overall success of the formulated drug. Discovery, characterization, development and managing clinical area are a few responsibilities handed to the outsourcing agency. The largest share of the formulation development outsourcing market are held by group of companies, including Aizant Drug Research Solutions Private Limited, Charles River Laboratories, Catalent Inc., Syngene International Ltd, and Laboratory Corporation of America Holdings.
According to the International Organization for Standardization, the outsourcing of pharmaceutical activities can reduce up to 15% of cost required for the overall procedure. It also saves up on the area required for the firm along with the cost invested for other utilities in the pharmaceutical company.
The formulation development outsourcing market is expected to be accelerated with the rising requirement of commercial production of drugs and therapeutics along with the rising cases of disorders across the globe. Considering the rising cases of disorders, the America Cancer Society stated that in the United States, there will be 1,958,310 new cases of cancer in 2023. Moreover, the rapidly expiring pharma patients support the expansion of the market. The market is also expanding due to the trend of necessary pharmaceutical patent protection passing. The outsourcing of formulation development can limit the risk of financial loss by reducing the capital investment required from pharmaceutical companies. This element also acts as a major growth factor for the market.
Report Coverage | Details |
Market Size in 2023 | USD 40.14 Billion |
Market Size by 2032 | USD 75.8 Billion |
Growth Rate from 2023 to 2032 | CAGR of 7.32% |
Largest Market | Asia Pacific |
Base Year | 2022 |
Forecast Period | 2023 To 2032 |
Segments Covered | By Service, By Formulation, By Therapeutic Area, and By End-User |
Regions Covered | North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa |
Driver:
Rising demand for patent protection
The growing relevance of novel drug development due to the expanding number of essential medications whose patents are expiring and the rise in the outsourcing of formulation development services by most pharmaceutical and biotechnological businesses are significant market growth drivers. At the research and development stage, pharmaceutical companies rely heavily on patent protection to lower the risk of failure and to save investments done in the development activity. The most significant factor associated with outsourcing is cost saving. Outsourcing of formulation development allows companies to optimize its operational capabilities by reducing expenses and capital investments, which directly offers patent protection for the pharmaceutical company. Thus, the rising demand for patent protection is observed to act as a driver for the growth of the market.
Restraint:
Adverse effect of drugs
Unpleasant side effects of the medicine are known as adverse reactions. The degree of side effects can vary widely from little annoyances such as a short term allergies to potentially deadly circumstances, including a heart attack or liver damage. Adverse medication reactions impact the industry that outsources formulation development by increasing regulatory scrutiny, raising safety concerns, and perhaps delaying product deadlines, making outsourcing choices more cautious. Thus, adverse effects of drugs are considered to hamper the growth of the market by acting as a major restraint for the market.
Opportunity:
Increasing demand for medications for chronic diseases
The market for formulation development outsourcing has a sizable chance to grow with its offerings for pharmaceutical businesses that are looking for expertise in creating efficient therapies for chronic diseases. Companies can gain access to specialized knowledge, cut expenses, and speed up the drug development process by outsourcing formulation development, ultimately satisfying the expanding demands of patients with chronic illnesses. The prevalence of chronic diseases in increasing across the globe with a large number of patients of diabetes, cardiovascular disorders and cancer. Thus, the increasing demand for potential drug for chronic disease is expected to open a set of opportunities for the market.
The formulation development segment is expected to hold the largest share of the market during the forecast period. To create, optimize, and test pharmaceutical or chemical formulations, one needs specialized knowledge and experience. Many businesses contract outsource this part of their operations to specialized companies with devoted teams with the requisite training and expertise. Companies can lower the risk of regulatory issues or development failures by outsourcing formulation development.
Established outsourcing partners can assist in ensuring compliance because they have experience handling regulatory requirements. Companies can speed up their product development process by outsourcing formulation development. Specialized outsourcing companies have streamlined processes and quick access to cutting-edge technology, which has sped up product development.
On the other hand, the pre-formulation segment is expected to witness a notable growth rate during the forecast period. Outsourcing provides the scientific underpinning for formulation development and aids in defining the general features of the drug as well as the best dose form for the therapeutic molecule. The rapidly rising emphasis on research activities for novel drug development plays a significant role in the segment’s development.
The oral segment hold the largest share of the market, the segment is expected to witness the fastest rate of growth during the forecast period. The most prescribed and taken dosage forms of medication are tablets and capsules, necessitating the development of their formulations. It is simpler to traverse because the regulatory approval procedure for oral drugs is well-established and typically more uncomplicated than that for other dosage types. Oral dosage forms are the subject of substantial experience and knowledge among pharmaceutical firms and contract research organizations (CROs).
The injectable segment is expected to grow at a robust pace during the forecast period. The high bioavailability of injectable formulations causes the immediate beginning of the effect. Because of their direct delivery into the bloodstream, injectables have become essential in the pharmaceutical business by providing quick and accurate medication delivery. Injectables are crucial for outsourcing formulation development in the market since they need specialist knowledge in formulation, manufacturing, and regulatory compliance. Pharmaceutical businesses can utilize the expertise and infrastructure of seasoned partners when outsourcing the development of injectable formulations, which speeds up time to market and ensures high-quality products.
The oncology segment held the largest share of the market, the segment is expected to sustain its dominance throughout the forecast period. Cancer is a significant area for research and development, this focus has contributed to the rise of the oncology sector. As it assures the successful translation of these ground-breaking discoveries into patient-accessible medication solutions that are safe, effective, and quick to market, formulation development's role becomes even more crucial. Despite encouraging results in in vitro conditions, present formulations lack focused behavior in both in vivo and human studies, contributing to ineffective treatment. Thus, the sector is expected to adopt outsourcing services more often in the upcoming years to lower the risk of failure.
The infectious disease segment is expected to grow at a significant rate during the forecast period. Due to the rising demand for research, testing, and the development of new therapies and vaccines to battle these diseases, infectious diseases are a significant growth driver in the formulation development outsourcing market. Drug development is sped up via outsourcing, which enables pharmaceutical corporations to access specialized resources and experience.
For instance, In June 2022, to speed up research and development (R&D) for infectious diseases that disproportionately affect lower-income nations, GSK plc announced a commitment of £1 billion over ten years. This study will concentrate on cutting-edge vaccines and medications to prevent and treat neglected tropical diseases (NTDs), HIV (via ViiV Healthcare), tuberculosis, malaria, and anti-microbial resistance (AMR), which carry on having devastating effects on the most vulnerable and account for more than 60% of the burden of illness in many low-income countries.
The pharmaceutical industries segment is expected to hold the largest share of the market during the forecast period. Most pharmaceutical corporations outsource formulation services to cut down on the amount of time and money spent on trials. The pharmaceutical industry adopts and incorporates new scientific developments, technology, and information. Outsourcing of formulation development speeds up the development of sustainable solutions, encourages teamwork, and makes it easier to communicate research findings. The pharmaceutical business may enhance its innovation capacity by successfully transferring technologies and promoting long-term sustainability. The industry should conduct carefully planned clinical trials with a focus on patient safety, ethical standards, and scientific integrity to ensure the success of safe and effective treatments.
The research and academic institutions segment is the fastest-growing segment in the formulation development outsourcing market. High research productivity promotes innovation by quickening the development of new drugs and medical treatments. It allows the industry to address emerging healthcare challenges and improve patient outcomes. Continuously productive research is essential to the pharmaceutical industry's ability to innovate and meet shifting social demands.
Asia-Pacific has its largest revenue share in 2022 and is expected to sustain its position in the formulation development outsourcing market throughout the predicted timeframe. It is due to the pharmaceutical industry's expansion, cost-effectiveness, skilled labor force, and knowledge of regulatory compliances in the region. The location of the region is appealing for outsourcing pharmaceutical formulation development because of its supportive infrastructure and good regulatory climate. Moreover, the rising population along with the rapidly expanding pharmaceutical sector in Asia Pacific is observed to support the market’s growth.
North America is expected to expand at a robust pace during the forecast period. The market in the region is benefited from North America's well-established research and development structure, production, and clinical trial infrastructure. Moreover, the availability of a highly educated and skilled workforce has promoted the market’s expansion in the region. Additionally, the region offers a favorable regulatory environment that promotes the expansion and development of the pharmaceutical business.
Segments Covered in the Report:
By Service
By Formulation
By Therapeutic Area
By End-User
By Geography
Chapter 1. Introduction
1.1. Research Objective
1.2. Scope of the Study
1.3. Definition
Chapter 2. Research Methodology (Premium Insights)
2.1. Research Approach
2.2. Data Sources
2.3. Assumptions & Limitations
Chapter 3. Executive Summary
3.1. Market Snapshot
Chapter 4. Market Variables and Scope
4.1. Introduction
4.2. Market Classification and Scope
4.3. Industry Value Chain Analysis
4.3.1. Raw Material Procurement Analysis
4.3.2. Sales and Distribution Channel Analysis
4.3.3. Downstream Buyer Analysis
Chapter 5. COVID 19 Impact on Formulation Development Outsourcing Market
5.1. COVID-19 Landscape: Formulation Development Outsourcing Industry Impact
5.2. COVID 19 - Impact Assessment for the Industry
5.3. COVID 19 Impact: Global Major Government Policy
5.4. Market Trends and Opportunities in the COVID-19 Landscape
Chapter 6. Market Dynamics Analysis and Trends
6.1. Market Dynamics
6.1.1. Market Drivers
6.1.2. Market Restraints
6.1.3. Market Opportunities
6.2. Porter’s Five Forces Analysis
6.2.1. Bargaining power of suppliers
6.2.2. Bargaining power of buyers
6.2.3. Threat of substitute
6.2.4. Threat of new entrants
6.2.5. Degree of competition
Chapter 7. Competitive Landscape
7.1.1. Company Market Share/Positioning Analysis
7.1.2. Key Strategies Adopted by Players
7.1.3. Vendor Landscape
7.1.3.1. List of Suppliers
7.1.3.2. List of Buyers
Chapter 8. Global Formulation Development Outsourcing Market, By Service
8.1. Formulation Development Outsourcing Market, by Service, 2023-2032
8.1.1. Preformulation
8.1.1.1. Market Revenue and Forecast (2020-2032)
8.1.2. Formulation Development
8.1.2.1. Market Revenue and Forecast (2020-2032)
Chapter 9. Global Formulation Development Outsourcing Market, By Formulation
9.1. Formulation Development Outsourcing Market, by Formulation, 2023-2032
9.1.1. Topical
9.1.1.1. Market Revenue and Forecast (2020-2032)
9.1.2. Oral
9.1.2.1. Market Revenue and Forecast (2020-2032)
9.1.3. Injectable
9.1.3.1. Market Revenue and Forecast (2020-2032)
9.1.4. Others
9.1.4.1. Market Revenue and Forecast (2020-2032)
Chapter 10. Global Formulation Development Outsourcing Market, By Therapeutic Area
10.1. Formulation Development Outsourcing Market, by Therapeutic Area, 2023-2032
10.1.1. Oncology
10.1.1.1. Market Revenue and Forecast (2020-2032)
10.1.2. Infectious Disease
10.1.2.1. Market Revenue and Forecast (2020-2032)
10.1.3. Respiratory
10.1.3.1. Market Revenue and Forecast (2020-2032)
10.1.4. Cardiovascular
10.1.4.1. Market Revenue and Forecast (2020-2032)
10.1.5. Neurology
10.1.5.1. Market Revenue and Forecast (2020-2032)
10.1.6. Hematology
10.1.6.1. Market Revenue and Forecast (2020-2032)
10.1.7. Dermatology
10.1.7.1. Market Revenue and Forecast (2020-2032)
10.1.8. Others
10.1.8.1. Market Revenue and Forecast (2020-2032)
Chapter 11. Global Formulation Development Outsourcing Market, By End-User
11.1. Formulation Development Outsourcing Market, by End-User, 2023-2032
11.1.1. Pharmaceutical Industries
11.1.1.1. Market Revenue and Forecast (2020-2032)
11.1.2. Research and Academic Institutions
11.1.2.1. Market Revenue and Forecast (2020-2032)
Chapter 12. Global Formulation Development Outsourcing Market, Regional Estimates and Trend Forecast
12.1. North America
12.1.1. Market Revenue and Forecast, by Service (2020-2032)
12.1.2. Market Revenue and Forecast, by Formulation (2020-2032)
12.1.3. Market Revenue and Forecast, by Therapeutic Area (2020-2032)
12.1.4. Market Revenue and Forecast, by End-User (2020-2032)
12.1.5. U.S.
12.1.5.1. Market Revenue and Forecast, by Service (2020-2032)
12.1.5.2. Market Revenue and Forecast, by Formulation (2020-2032)
12.1.5.3. Market Revenue and Forecast, by Therapeutic Area (2020-2032)
12.1.5.4. Market Revenue and Forecast, by End-User (2020-2032)
12.1.6. Rest of North America
12.1.6.1. Market Revenue and Forecast, by Service (2020-2032)
12.1.6.2. Market Revenue and Forecast, by Formulation (2020-2032)
12.1.6.3. Market Revenue and Forecast, by Therapeutic Area (2020-2032)
12.1.6.4. Market Revenue and Forecast, by End-User (2020-2032)
12.2. Europe
12.2.1. Market Revenue and Forecast, by Service (2020-2032)
12.2.2. Market Revenue and Forecast, by Formulation (2020-2032)
12.2.3. Market Revenue and Forecast, by Therapeutic Area (2020-2032)
12.2.4. Market Revenue and Forecast, by End-User (2020-2032)
12.2.5. UK
12.2.5.1. Market Revenue and Forecast, by Service (2020-2032)
12.2.5.2. Market Revenue and Forecast, by Formulation (2020-2032)
12.2.5.3. Market Revenue and Forecast, by Therapeutic Area (2020-2032)
12.2.5.4. Market Revenue and Forecast, by End-User (2020-2032)
12.2.6. Germany
12.2.6.1. Market Revenue and Forecast, by Service (2020-2032)
12.2.6.2. Market Revenue and Forecast, by Formulation (2020-2032)
12.2.6.3. Market Revenue and Forecast, by Therapeutic Area (2020-2032)
12.2.6.4. Market Revenue and Forecast, by End-User (2020-2032)
12.2.7. France
12.2.7.1. Market Revenue and Forecast, by Service (2020-2032)
12.2.7.2. Market Revenue and Forecast, by Formulation (2020-2032)
12.2.7.3. Market Revenue and Forecast, by Therapeutic Area (2020-2032)
12.2.7.4. Market Revenue and Forecast, by End-User (2020-2032)
12.2.8. Rest of Europe
12.2.8.1. Market Revenue and Forecast, by Service (2020-2032)
12.2.8.2. Market Revenue and Forecast, by Formulation (2020-2032)
12.2.8.3. Market Revenue and Forecast, by Therapeutic Area (2020-2032)
12.2.8.4. Market Revenue and Forecast, by End-User (2020-2032)
12.3. APAC
12.3.1. Market Revenue and Forecast, by Service (2020-2032)
12.3.2. Market Revenue and Forecast, by Formulation (2020-2032)
12.3.3. Market Revenue and Forecast, by Therapeutic Area (2020-2032)
12.3.4. Market Revenue and Forecast, by End-User (2020-2032)
12.3.5. India
12.3.5.1. Market Revenue and Forecast, by Service (2020-2032)
12.3.5.2. Market Revenue and Forecast, by Formulation (2020-2032)
12.3.5.3. Market Revenue and Forecast, by Therapeutic Area (2020-2032)
12.3.5.4. Market Revenue and Forecast, by End-User (2020-2032)
12.3.6. China
12.3.6.1. Market Revenue and Forecast, by Service (2020-2032)
12.3.6.2. Market Revenue and Forecast, by Formulation (2020-2032)
12.3.6.3. Market Revenue and Forecast, by Therapeutic Area (2020-2032)
12.3.6.4. Market Revenue and Forecast, by End-User (2020-2032)
12.3.7. Japan
12.3.7.1. Market Revenue and Forecast, by Service (2020-2032)
12.3.7.2. Market Revenue and Forecast, by Formulation (2020-2032)
12.3.7.3. Market Revenue and Forecast, by Therapeutic Area (2020-2032)
12.3.7.4. Market Revenue and Forecast, by End-User (2020-2032)
12.3.8. Rest of APAC
12.3.8.1. Market Revenue and Forecast, by Service (2020-2032)
12.3.8.2. Market Revenue and Forecast, by Formulation (2020-2032)
12.3.8.3. Market Revenue and Forecast, by Therapeutic Area (2020-2032)
12.3.8.4. Market Revenue and Forecast, by End-User (2020-2032)
12.4. MEA
12.4.1. Market Revenue and Forecast, by Service (2020-2032)
12.4.2. Market Revenue and Forecast, by Formulation (2020-2032)
12.4.3. Market Revenue and Forecast, by Therapeutic Area (2020-2032)
12.4.4. Market Revenue and Forecast, by End-User (2020-2032)
12.4.5. GCC
12.4.5.1. Market Revenue and Forecast, by Service (2020-2032)
12.4.5.2. Market Revenue and Forecast, by Formulation (2020-2032)
12.4.5.3. Market Revenue and Forecast, by Therapeutic Area (2020-2032)
12.4.5.4. Market Revenue and Forecast, by End-User (2020-2032)
12.4.6. North Africa
12.4.6.1. Market Revenue and Forecast, by Service (2020-2032)
12.4.6.2. Market Revenue and Forecast, by Formulation (2020-2032)
12.4.6.3. Market Revenue and Forecast, by Therapeutic Area (2020-2032)
12.4.6.4. Market Revenue and Forecast, by End-User (2020-2032)
12.4.7. South Africa
12.4.7.1. Market Revenue and Forecast, by Service (2020-2032)
12.4.7.2. Market Revenue and Forecast, by Formulation (2020-2032)
12.4.7.3. Market Revenue and Forecast, by Therapeutic Area (2020-2032)
12.4.7.4. Market Revenue and Forecast, by End-User (2020-2032)
12.4.8. Rest of MEA
12.4.8.1. Market Revenue and Forecast, by Service (2020-2032)
12.4.8.2. Market Revenue and Forecast, by Formulation (2020-2032)
12.4.8.3. Market Revenue and Forecast, by Therapeutic Area (2020-2032)
12.4.8.4. Market Revenue and Forecast, by End-User (2020-2032)
12.5. Latin America
12.5.1. Market Revenue and Forecast, by Service (2020-2032)
12.5.2. Market Revenue and Forecast, by Formulation (2020-2032)
12.5.3. Market Revenue and Forecast, by Therapeutic Area (2020-2032)
12.5.4. Market Revenue and Forecast, by End-User (2020-2032)
12.5.5. Brazil
12.5.5.1. Market Revenue and Forecast, by Service (2020-2032)
12.5.5.2. Market Revenue and Forecast, by Formulation (2020-2032)
12.5.5.3. Market Revenue and Forecast, by Therapeutic Area (2020-2032)
12.5.5.4. Market Revenue and Forecast, by End-User (2020-2032)
12.5.6. Rest of LATAM
12.5.6.1. Market Revenue and Forecast, by Service (2020-2032)
12.5.6.2. Market Revenue and Forecast, by Formulation (2020-2032)
12.5.6.3. Market Revenue and Forecast, by Therapeutic Area (2020-2032)
12.5.6.4. Market Revenue and Forecast, by End-User (2020-2032)
Chapter 13. Company Profiles
13.1. SGS S.A.
13.1.1. Company Overview
13.1.2. Product Offerings
13.1.3. Financial Performance
13.1.4. Recent Initiatives
13.2. Eurofins Scientific SE
13.2.1. Company Overview
13.2.2. Product Offerings
13.2.3. Financial Performance
13.2.4. Recent Initiatives
13.3. Element
13.3.1. Company Overview
13.3.2. Product Offerings
13.3.3. Financial Performance
13.3.4. Recent Initiatives
13.4. Labcorp
13.4.1. Company Overview
13.4.2. Product Offerings
13.4.3. Financial Performance
13.4.4. Recent Initiatives
13.5. Thermo Fisher Scientific, Inc. (Patheon)
13.5.1. Company Overview
13.5.2. Product Offerings
13.5.3. Financial Performance
13.5.4. Recent Initiatives
13.6. Intertek Group plc
13.6.1. Company Overview
13.6.2. Product Offerings
13.6.3. Financial Performance
13.6.4. Recent Initiatives
13.7. Recipharm
13.7.1. Company Overview
13.7.2. Product Offerings
13.7.3. Financial Performance
13.7.4. Recent Initiatives
13.8. Lonza
13.8.1. Company Overview
13.8.2. Product Offerings
13.8.3. Financial Performance
13.8.4. Recent Initiatives
13.9. Charles River Laboratories International, Inc.
13.9.1. Company Overview
13.9.2. Product Offerings
13.9.3. Financial Performance
13.9.4. Recent Initiatives
13.10. Catalent Inc.
13.10.1. Company Overview
13.10.2. Product Offerings
13.10.3. Financial Performance
13.10.4. Recent Initiatives
Chapter 14. Research Methodology
14.1. Primary Research
14.2. Secondary Research
14.3. Assumptions
Chapter 15. Appendix
15.1. About Us
15.2. Glossary of Terms
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