세계의 제제 개발 아웃소싱 시장 규모, 성장 동향, 기업(2025-2033년)

Formulation Development Outsourcing Market Trends & Summary

Formulation Development Outsourcing Market is expected to reach US$ 64.74 billion by 2033 from US$ 33.6 billion in 2024, with a CAGR of 7.56% from 2025 to 2033. Some of the key drivers driving the market's expansion include the rising expenses of research and development (R&D), the growing need for specialist knowledge, the expedited timeframes for drug development, the complexity of regulations, and the expanding pharmaceutical industry.

Formulation Development Outsourcing Global Market Report by Service (Formulation Development, Preformulation), Formulation (Oral, Injectable, Others), Therapeutic Area (Oncology, Infectious Diseases, Neurology, Hematology, Respiratory, Cardiovascular, Dermatology, Others), End Use (Pharmaceutical and Biopharmaceutical Companies, Government and Academics Institutes, Others), Countries and Company Analysis, 2025-2033.

Global Formulation Development Outsourcing Industry Overview

Due to the growing complexity of pharmaceutical formulations and the growing need for affordable medication development, the worldwide formulation development outsourcing market is expanding significantly. In order to expedite time-to-market, obtain cutting-edge knowledge, and streamline procedures, pharmaceutical and biotechnology businesses are increasingly outsourcing formulation duties to specialized contract development and manufacturing organizations (CDMOs). Small and mid-sized businesses that lack internal R&D resources are particularly affected by this trend. Pre-formulation research, stability testing, and regulatory support are just a few of the early and late-stage drug development activities that outsourcing facilitates. The growing number of specialized, biologic, and generic medications is another factor driving growth. The market is dominated by North America and Europe, but Asia-Pacific is growing quickly because of its lower costs and growing technological prowess.

With contract development and manufacturing organizations (CDMOs) broadening their scope beyond conventional formulation development services, the industry is observing a discernible move toward integrated end-to-end service offerings. The industry's shift toward holistic solution providers is reflected in major efforts like Skyepharma Productions SAS's announcement in February 2021 to build a center of excellence for product formulation and development. In order to address the increasingly complicated needs of contemporary drug development, service integration has become essential.

Investments in research and development still have a big influence on the market environment. Pharmaceutical innovation is becoming increasingly important in global markets, as evidenced by the United Kingdom's pledge to raise public investment for research and development by 15% for the fiscal year 2021 and more than double the existing amount to EUR 22 billion by 2024-2025. The need for specialized formulation development services is being driven by this increase in R&D spending, which is also opening up new market expansion potential.

The market is undergoing a surge of technical advancements and strategic expansions meant to improve formulation development skills. One example of how the industry has responded to changing market expectations is Formulationbio's April 2021 expansion into formulation development and analytical services, which offers full solutions including particle size analysis, stability analysis, and solid dosage form development. As a result of these advancements, the market is becoming more competitive and innovative, which forces service providers to constantly improve their technological prowess and range of services.

Growth Drivers for the Formulation Development Outsourcing Market

Growing Requirement for Specialized Knowledge

Many pharmaceutical businesses may lack the specialist knowledge and cutting-edge technologies needed to handle the increasingly complicated medication compositions. For example, industry sources state that Indian pharmaceutical companies' global exports of generic medications, together with biosimilars, will signal a strategy change toward further international market growth, especially in the US. In order to do this, Indian pharmaceutical businesses greatly benefit from the US FDA's formulation development guidelines. The best practices and regulatory requirements for creating medicinal formulations, particularly for the US market, are described in the draft guidelines on formulation development. Following these recommendations improves the quality and effectiveness of pharmaceutical goods in addition to ensuring compliance.

Experts in the Indian pharmaceutical sector claim that such guidelines offer a road map for creating premium formulations that satisfy international standards, enhancing the legitimacy and competitiveness of Indian pharmaceutical companies seeking to expand internationally. The market forecast for formulation development outsourcing is favorable since outsourcing partners provide the advanced technology and expertise needed to create complex medication formulations that improve the quality and effectiveness of pharmaceutical products.

Increasing Adherence to Regulations

Outsourcing partners with regulatory experience can efficiently handle the thorough and compliant formulation procedures required by strict regulatory regulations. For example, a Union Health Ministry announcement mandates that Indian pharmaceutical companies fulfill new production requirements by 2024, yet small businesses have requested a postponement, citing their financial load. Pharmaceutical businesses will be required by the updated Schedule M standards to notify the licensing authorities of medicine recalls as well as product faults, deterioration, or defective manufacture. Up until today, there was no way to notify the licensing body about medication recalls. It is also anticipated that this will support market expansion.

Growing Expenses for Research and Development (R&D)

Pharmaceutical businesses outsource formulation development in order to cut costs and more effectively deploy resources since research and development (R&D) is expensive. For example, industry estimates state that Merck & Co.'s FY 2023 revenues reached $60.1 billion, with a peak of $30.5 billion spent on research and development. The company's research and development (R&D) spending currently account for 50.8% of its total revenue for 2023, a startling 126% increase in only one year. Similar to this, Johnson & Johnson (J&J) had robust financial growth in 2023 and topped the pharmaceutical industry in terms of sales. The pharmaceutical behemoth invested a record $15.1 billion in R&D, placing it third in terms of R&D spending. The growth of the pharmaceutical sector is favorably impacting the outsourcing market for formulation development.

Challenges in the Formulation Development Outsourcing Market

Communication Gaps and Project Delays

Project success in the formulation development outsourced sector depends on efficient communication. However, sponsors and outsourcing partners may have serious miscommunications due to language hurdles, time zone differences, and physical distance. These communication problems frequently lead to irregular development task execution, delayed feedback loops, and mismatched project objectives. Important formulation details may be misunderstood in the absence of regular, transparent, and well-documented interactions, which might result in expensive modifications, delays, or problems with quality. Additionally, decision-making speed and cooperation may be impacted by cultural variations in corporate procedures. Sponsors must set up strong communication procedures, frequent check-ins, and common digital platforms to guarantee openness and coordination during the formulation development process in order to lessen these problems.

Limited Customization and Flexibility

The lack of customization and flexibility provided by certain contract development and manufacturing organizations (CDMOs) is a major obstacle in outsourcing formulation development. The special technical or regulatory requirements of a sponsor's drug candidate may not be adequately met by many providers' reliance on standardized development frameworks and service packages. This lack of flexibility might impede innovation, limit the use of new excipients or delivery systems, and result in formulation strategies that are compromised. Rigorous service models might not provide enough scientific depth or assistance for customized solutions for complicated or specialized items, such biologics or specialty pharmaceuticals. Sponsors could thus experience setbacks, inefficiencies, or less than ideal results. Achieving effective and unique formulations requires choosing partners that are quick and adaptable.

United States Formulation Development Outsourcing Market

The market for outsourcing formulation development in the US is rising rapidly because to the increased need for specialized knowledge, cost effectiveness, and quicker drug development schedules. To handle the complexity of preclinical and clinical formulation activities, pharmaceutical and biotechnology businesses are increasingly using contract development and manufacturing organizations (CDMOs). This covers technology for controlled release, bioavailability optimization, and solubility improvement. Outsourcing is especially popular among small and mid-sized businesses that don't have internal R&D facilities. Furthermore, the need for sophisticated formulation skills is being driven by the increased emphasis on complicated therapies, such as biologics and customized medicine. Because of the market's robust regulatory environment and established healthcare system, the United States is a major location for collaborations in formulation development.

Germany Formulation Development Outsourcing Market

Germany's strong pharmaceutical sector, cutting-edge research facilities, and emphasis on innovation make it one of Europe's top outsourcing destinations for formulation development. Large and medium-sized pharmaceutical enterprises can benefit from the specialist preformulation and formulation development services provided by the nation's reputable contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs). In the outsourcing landscape, therapeutic specialties including neurology, infectious diseases, and cancer are particularly prevalent. Germany's appeal as an outsourcing location is further increased by its robust regulatory environment and dedication to high standards. The nation's standing in the worldwide formulation development outsourcing market is being driven by the increasing demand for sophisticated formulations, such as biologics and customized medications.

India Formulation Development Outsourcing Market

India's strong pharmaceutical sector, affordable services, and highly qualified workforce are all contributing to the country's notable rise in the formulation development outsourcing market. For both local and foreign pharmaceutical businesses, the country's reputable contract development and manufacturing organizations (CDMOs) provide specialized preformulation and formulation development services. In the outsourcing landscape, therapeutic specialties including neurology, infectious diseases, and cancer are particularly prevalent. India's appeal as an outsourcing location is further increased by its robust regulatory environment and dedication to high standards. The nation's standing in the worldwide formulation development outsourcing market is being driven by the increasing demand for sophisticated formulations, such as biologics and customized mdications.

United Arab Emirates Formulation Development Outsourcing Market

Due to the nation's strategic efforts and investments in the pharmaceutical industry, the United Arab Emirates (UAE) formulation development outsourcing market is expanding significantly. The "Make it in the Emirates" campaign was started by the UAE government with the goal of increasing domestic production and lowering reliance on imports, especially in the pharmaceutical industry. This program is in line with the larger "Operation 300bn" plan, which aims to significantly raise the industrial sector's share of the national GDP by 2031. A favorable climate for outsourcing formulation development services has been created by these laws, which have drawn pharmaceutical businesses from both domestic and foreign markets to open offices in the United Arab Emirates. The nation's sophisticated infrastructure, compliance with global regulations, and highly qualified personnel further contribute to its allure as a location for outsourcing formulation development.

Recent Developments in Formulation Development Outsourcing Industry

• Together, AGC Biologics, a CDMO, and BioConnection, a CMO, decided in May 2024 to use AGC Biologics's development and manufacturing experience and BioConnection's specialized aseptic filling capabilities to offer end-to-end biopharmaceutical development and manufacturing capabilities for drug substances and drug products.
• CoreRx Inc. paid USD 130 million to buy Societal CDMO Inc. in April 2024. Societal CDMO focuses on solving difficult manufacturing and formulation problems, especially for small molecule treatments. For the benefit of both current and potential customers, this purchase improved CoreRx's capacities in formulation research, early-stage production, clinical trial services, commercial-scale manufacturing, and a range of packaging options.

Formulation Development Outsourcing Market Segments

Service

• Formulation Development
• Preformulation

Formulation

• Oral
• Injectable
• Others

Therapeutic Area

• Oncology
• Infectious Diseases
• Neurology
• Hematology
• Respiratory
• Cardiovascular
• Dermatology
• Others

End Use Channel

• Pharmaceutical and Biopharmaceutical Companies
• Government and Academics Institutes
• Others

Country

North America

• United States
• Canada

Europe

• France
• Germany
• Italy
• Spain
• United Kingdom
• Belgium
• Netherlands
• Turkey

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Thailand
• Malaysia
• Indonesia
• New Zealand

Latin America

• Brazil
• Mexico
• Argentina

Middle East & Africa

• South Africa
• Saudi Arabia
• United Arab Emirates

All the Key players have been covered from 4 Viewpoints:

• Overview
• Key Persons
• Recent Development & Strategies
• Revenue Analysis

Company Analysis:

• SGS S.A.
• Intertek Group plc
• Recipharm
• Lonza
• Charles River Laboratories International, Inc
• Eurofins Scientific SE
• Labcorp
• Thermo Fisher Scientific, Inc.

Table of Contents

1. Introduction

2. Research Methodology

• 2.1 Data Source
  • 2.1.1 Primary Sources
  • 2.1.2 Secondary Sources
• 2.2 Research Approach
  • 2.2.1 Top-Down Approach
  • 2.2.2 Bottom-Up Approach
• 2.3 Forecast Projection Methodology

3. Executive Summary

4. Market Dynamics

• 4.1 Growth Drivers
• 4.2 Challenges

5. Global Formulation Development Outsourcing Market

• 5.1 Historical Market Trends
• 5.2 Market Forecast

6. Formulation Development Outsourcing Market Share Analysis

• 6.1 By Service
• 6.2 By Formulation
• 6.3 By Therapeutic Area
• 6.4 By End Use
• 6.5 By Countries

7. Service

• 7.1 Formulation Development
• 7.2 Preformulation

8. Formulation

• 8.1 Oral
• 8.2 Injectable
• 8.3 Others

9. Therapeutic Area

• 9.1 Oncology
• 9.2 Infectious Diseases
• 9.3 Neurology
• 9.4 Hematology
• 9.5 Respiratory
• 9.6 Cardiovascular
• 9.7 Dermatology
• 9.8 Others

10. End Use

• 10.1 Pharmaceutical and Biopharmaceutical Companies
• 10.2 Government and Academics Institutes
• 10.3 Others

11. Countries

• 11.1 North America
  • 11.1.1 United States
  • 11.1.2 Canada
• 11.2 Europe
  • 11.2.1 France
  • 11.2.2 Germany
  • 11.2.3 Italy
  • 11.2.4 Spain
  • 11.2.5 United Kingdom
  • 11.2.6 Belgium
  • 11.2.7 Netherlands
  • 11.2.8 Turkey
• 11.3 Asia Pacific
  • 11.3.1 China
  • 11.3.2 Japan
  • 11.3.3 India
  • 11.3.4 South Korea
  • 11.3.5 Thailand
  • 11.3.6 Malaysia
  • 11.3.7 Indonesia
  • 11.3.8 Australia
  • 11.3.9 New Zealand
• 11.4 Latin America
  • 11.4.1 Brazil
  • 11.4.2 Mexico
  • 11.4.3 Argentina
• 11.5 Middle East & Africa
  • 11.5.1 Saudi Arabia
  • 11.5.2 UAE
  • 11.5.3 South Africa

12. Porter's Five Forces Analysis

• 12.1 Bargaining Power of Buyers
• 12.2 Bargaining Power of Suppliers
• 12.3 Degree of Rivalry
• 12.4 Threat of New Entrants
• 12.5 Threat of Substitutes

13. SWOT Analysis

• 13.1 Strength
• 13.2 Weakness
• 13.3 Opportunity
• 13.4 Threat

14. Key Players Analysis

• 14.1 SGS S.A.
  • 14.1.1 Overview
  • 14.1.2 Key Persons
  • 14.1.3 Recent Development & Strategies
  • 14.1.4 Revenue Analysis
• 14.2 Intertek Group plc
  • 14.2.1 Overview
  • 14.2.2 Key Persons
  • 14.2.3 Recent Development & Strategies
  • 14.2.4 Revenue Analysis
• 14.3 Recipharm
  • 14.3.1 Overview
  • 14.3.2 Key Persons
  • 14.3.3 Recent Development & Strategies
  • 14.3.4 Revenue Analysis
• 14.4 Lonza
  • 14.4.1 Overview
  • 14.4.2 Key Persons
  • 14.4.3 Recent Development & Strategies
  • 14.4.4 Revenue Analysis
• 14.5 Charles River Laboratories International, Inc
  • 14.5.1 Overview
  • 14.5.2 Key Persons
  • 14.5.3 Recent Development & Strategies
  • 14.5.4 Revenue Analysis
• 14.6 Eurofins Scientific SE
  • 14.6.1 Overview
  • 14.6.2 Key Persons
  • 14.6.3 Recent Development & Strategies
  • 14.6.4 Revenue Analysis
• 14.7 Labcorp
  • 14.7.1 Overview
  • 14.7.2 Key Persons
  • 14.7.3 Recent Development & Strategies
  • 14.7.4 Revenue Analysis
• 14.8 Thermo Fisher Scientific, Inc.
  • 14.8.1 Overview
  • 14.8.2 Key Persons
  • 14.8.3 Recent Development & Strategies
  • 14.8.4 Revenue Analysis