세계의 제제개발 아웃소싱 시장 - 산업 규모, 점유율, 동향, 기회, 예측 : 서비스별, 제제별, 치료영역별, 지역별, 경쟁별(2020-2030년)

Global Formulation Development Outsourcing market was valued at USD 40.25 Billion in 2024 and is expected to reach USD 57.31 Billion by 2030 with a CAGR of 6.02%. The global Formulation Development Outsourcing market has witnessed significant growth in recent years, driven primarily by the pharmaceutical industry's increasing focus on cost efficiency, time-to-market reduction, and access to specialized expertise. As drug development becomes more complex, pharmaceutical companies are increasingly outsourcing formulation development to contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) to leverage advanced technologies, scalable resources, and regulatory compliance expertise. This strategic shift enables companies to streamline their R&D processes, reduce capital expenditure, and accelerate product commercialization.

Key trends shaping the market include the rising demand for personalized medicine and biologics, which require sophisticated formulation techniques and specialized handling. Additionally, advancements in nanotechnology, drug delivery systems, and continuous manufacturing are fueling innovation in outsourced formulation development. The growing prevalence of chronic diseases and an aging global population are further amplifying the demand for novel and effective drug formulations. Moreover, increasing investments in emerging markets and favorable government policies supporting pharmaceutical outsourcing are creating new growth avenues.

Despite these positive factors, the market faces challenges such as stringent regulatory requirements, concerns about intellectual property protection, and quality control issues. Variability in outsourcing partner capabilities and geographical risks can also hinder seamless collaboration. Furthermore, supply chain disruptions and delays in clinical trials pose operational risks to formulation development outsourcing projects.

Key Market Drivers

Cost Efficiency and Reduction of Capital Expenditure

Cost efficiency and reduction of capital expenditure are among the primary drivers propelling the growth of the global formulation development outsourcing market. Pharmaceutical companies face increasing pressure to optimize their operational costs while accelerating drug development timelines. Outsourcing formulation development allows these companies to significantly lower upfront investments in infrastructure, equipment, and skilled personnel, which are often costly and time-consuming to establish internally. By leveraging the capabilities of specialized contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs), pharmaceutical firms can avoid heavy capital expenditure associated with setting up and maintaining state-of-the-art laboratories and manufacturing facilities.

This strategic shift toward outsourcing enables companies to convert fixed costs into variable costs, providing greater financial flexibility and risk mitigation. Instead of committing large sums to build in-house capabilities that may not be fully utilized at all times, companies pay for services as needed, improving cash flow management. Moreover, outsourcing partners typically possess established, validated processes and regulatory know-how, which can help reduce costly delays and potential compliance issues, further contributing to overall cost savings.

Key Market Challenges

Stringent Regulatory Compliance and Approval Processes

Stringent regulatory compliance and approval processes represent one of the most significant challenges in the global formulation development outsourcing market. The pharmaceutical industry operates under rigorous regulations set by authorities such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other regional regulatory bodies. These regulations ensure the safety, efficacy, and quality of drug formulations, but they also impose complex requirements on every stage of formulation development. For companies outsourcing these activities, navigating this regulatory landscape can be particularly demanding.

Outsourcing partners must adhere strictly to Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and other quality standards to meet regulatory expectations. Any deviation or non-compliance can lead to severe consequences, including delays in product approvals, costly recalls, or legal penalties. Pharmaceutical companies rely on their CROs and CDMOs to maintain transparency and documentation accuracy throughout the development process to satisfy these stringent criteria.

Additionally, regulatory agencies require comprehensive and robust data submissions covering formulation composition, stability, bioavailability, and manufacturing processes. Coordinating these requirements with external partners often results in complex communication channels and extensive documentation efforts, increasing the risk of errors or omissions. This complexity is further magnified when multiple regulatory jurisdictions are involved, each with unique standards and procedural nuances.

Key Market Trends

Rise of Personalized Medicine and Biologics

The rise of personalized medicine and biologics is a major trend driving the evolution of the formulation development outsourcing market. Personalized medicine focuses on tailoring treatments to individual patients based on their genetic profile, lifestyle, and disease characteristics, moving away from the traditional "one-size-fits-all" approach. This shift demands highly specialized formulation techniques that can accommodate unique drug delivery mechanisms, dosage forms, and stability requirements.

Biologics, which include complex molecules such as monoclonal antibodies, vaccines, and gene therapies, represent a rapidly growing segment within pharmaceuticals. These drugs are inherently more sensitive and challenging to formulate compared to conventional small-molecule drugs. Their development requires advanced technology platforms and stringent control over manufacturing conditions to maintain efficacy and safety.

Pharmaceutical companies often lack the in-house capabilities or the necessary infrastructure to efficiently develop and manufacture these complex biologics and personalized therapies. As a result, they increasingly turn to contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs) that possess the specialized expertise, technology, and regulatory knowledge needed to manage such complexities.

Outsourcing formulation development in this context helps companies accelerate innovation, reduce development risks, and optimize costs while ensuring high-quality standards. Moreover, these external partners are equipped to handle the stringent regulatory requirements associated with biologics and personalized medicines, facilitating faster approval processes.

Key Market Players

• Charles River Laboratories
• Aizant Drug Research Solutions Private Limited
• Catalent Inc.
• Laboratory Corporation of America Holdings
• Syngene International Ltd.
• Irisys LLC
• Intertek Group PLC
• Piramal Pharma Solutions
• Qiotient Sciences Ltd.
• Patheon Inc.
• Emergent BioSolutions Inc.
• Lonza Group

Report Scope:

In this report, the Global Formulation Development Outsourcing Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

Formulation Development Outsourcing Market, By Service:

• Preformulation
• Formulation Development

Formulation Development Outsourcing Market, By Formulation:

• Oral
• Injectable
• Topical
• Others

Formulation Development Outsourcing Market, By Therapeutic Area:

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

Formulation Development Outsourcing Market, By Region:

• North America
  • United States
  • Canada
  • Mexico
• Europe
  • France
  • United Kingdom
  • Italy
  • Germany
  • Spain
• Asia-Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
• South America
  • Brazil
  • Argentina
  • Colombia
• Middle East & Africa
  • South Africa
  • Saudi Arabia
  • UAE

Competitive Landscape

Company Profiles: Detailed analysis of the major companies presents in the Global Formulation Development Outsourcing Market.

Available Customizations:

Global Formulation Development Outsourcing market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report:

Company Information

• Detailed analysis and profiling of additional market players (up to five).

Table of Contents

1. Product Overview

• 1.1. Market Definition
• 1.2. Scope of the Market
  • 1.2.1. Markets Covered
  • 1.2.2. Years Considered for Study
  • 1.2.3. Key Market Segmentations

2. Research Methodology

• 2.1. Objective of the Study
• 2.2. Baseline Methodology
• 2.3. Key Industry Partners
• 2.4. Major Association and Secondary Sources
• 2.5. Forecasting Methodology
• 2.6. Data Triangulation & Validation
• 2.7. Assumptions and Limitations

3. Executive Summary

• 3.1. Overview of the Market
• 3.2. Overview of Key Market Segmentations
• 3.3. Overview of Key Market Players
• 3.4. Overview of Key Regions/Countries
• 3.5. Overview of Market Drivers, Challenges, Trends

4. Voice of Customer

5. Global Formulation Development Outsourcing Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Service (Preformulation, Formulation Development)
  • 5.2.2. By Formulation (Oral, Injectable, Topical, Others)
  • 5.2.3. By Therapeutic Area (Oncology, Infectious Disease, Neurology, Hematology, Respiratory, Cardiovascular, Dermatology, Others)
  • 5.2.4. By Region
  • 5.2.5. By Company (2024)
• 5.3. Market Map

6. North America Formulation Development Outsourcing Market Outlook

• 6.1. Market Size & Forecast
  • 6.1.1. By Value
• 6.2. Market Share & Forecast
  • 6.2.1. By Service
  • 6.2.2. By Formulation
  • 6.2.3. By Therapeutic Area
  • 6.2.4. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Formulation Development Outsourcing Market Outlook
    • 6.3.1.1. Market Size & Forecast
      • 6.3.1.1.1. By Value
    • 6.3.1.2. Market Share & Forecast
      • 6.3.1.2.1. By Service
      • 6.3.1.2.2. By Formulation
      • 6.3.1.2.3. By Therapeutic Area
  • 6.3.2. Canada Formulation Development Outsourcing Market Outlook
    • 6.3.2.1. Market Size & Forecast
      • 6.3.2.1.1. By Value
    • 6.3.2.2. Market Share & Forecast
      • 6.3.2.2.1. By Service
      • 6.3.2.2.2. By Formulation
      • 6.3.2.2.3. By Therapeutic Area
  • 6.3.3. Mexico Formulation Development Outsourcing Market Outlook
    • 6.3.3.1. Market Size & Forecast
      • 6.3.3.1.1. By Value
    • 6.3.3.2. Market Share & Forecast
      • 6.3.3.2.1. By Service
      • 6.3.3.2.2. By Formulation
      • 6.3.3.2.3. By Therapeutic Area

7. Europe Formulation Development Outsourcing Market Outlook

• 7.1. Market Size & Forecast
  • 7.1.1. By Value
• 7.2. Market Share & Forecast
  • 7.2.1. By Service
  • 7.2.2. By Formulation
  • 7.2.3. By Therapeutic Area
  • 7.2.4. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. Germany Formulation Development Outsourcing Market Outlook
    • 7.3.1.1. Market Size & Forecast
      • 7.3.1.1.1. By Value
    • 7.3.1.2. Market Share & Forecast
      • 7.3.1.2.1. By Service
      • 7.3.1.2.2. By Formulation
      • 7.3.1.2.3. By Therapeutic Area
  • 7.3.2. United Kingdom Formulation Development Outsourcing Market Outlook
    • 7.3.2.1. Market Size & Forecast
      • 7.3.2.1.1. By Value
    • 7.3.2.2. Market Share & Forecast
      • 7.3.2.2.1. By Service
      • 7.3.2.2.2. By Formulation
      • 7.3.2.2.3. By Therapeutic Area
  • 7.3.3. Italy Formulation Development Outsourcing Market Outlook
    • 7.3.3.1. Market Size & Forecast
      • 7.3.3.1.1. By Value
    • 7.3.3.2. Market Share & Forecast
      • 7.3.3.2.1. By Service
      • 7.3.3.2.2. By Formulation
      • 7.3.3.2.3. By Therapeutic Area
  • 7.3.4. France Formulation Development Outsourcing Market Outlook
    • 7.3.4.1. Market Size & Forecast
      • 7.3.4.1.1. By Value
    • 7.3.4.2. Market Share & Forecast
      • 7.3.4.2.1. By Service
      • 7.3.4.2.2. By Formulation
      • 7.3.4.2.3. By Therapeutic Area
  • 7.3.5. Spain Formulation Development Outsourcing Market Outlook
    • 7.3.5.1. Market Size & Forecast
      • 7.3.5.1.1. By Value
    • 7.3.5.2. Market Share & Forecast
      • 7.3.5.2.1. By Service
      • 7.3.5.2.2. By Formulation
      • 7.3.5.2.3. By Therapeutic Area

8. Asia-Pacific Formulation Development Outsourcing Market Outlook

• 8.1. Market Size & Forecast
  • 8.1.1. By Value
• 8.2. Market Share & Forecast
  • 8.2.1. By Service
  • 8.2.2. By Formulation
  • 8.2.3. By Therapeutic Area
  • 8.2.4. By Country
• 8.3. Asia-Pacific: Country Analysis
  • 8.3.1. China Formulation Development Outsourcing Market Outlook
    • 8.3.1.1. Market Size & Forecast
      • 8.3.1.1.1. By Value
    • 8.3.1.2. Market Share & Forecast
      • 8.3.1.2.1. By Service
      • 8.3.1.2.2. By Formulation
      • 8.3.1.2.3. By Therapeutic Area
  • 8.3.2. India Formulation Development Outsourcing Market Outlook
    • 8.3.2.1. Market Size & Forecast
      • 8.3.2.1.1. By Value
    • 8.3.2.2. Market Share & Forecast
      • 8.3.2.2.1. By Service
      • 8.3.2.2.2. By Formulation
      • 8.3.2.2.3. By Therapeutic Area
  • 8.3.3. Japan Formulation Development Outsourcing Market Outlook
    • 8.3.3.1. Market Size & Forecast
      • 8.3.3.1.1. By Value
    • 8.3.3.2. Market Share & Forecast
      • 8.3.3.2.1. By Service
      • 8.3.3.2.2. By Formulation
      • 8.3.3.2.3. By Therapeutic Area
  • 8.3.4. South Korea Formulation Development Outsourcing Market Outlook
    • 8.3.4.1. Market Size & Forecast
      • 8.3.4.1.1. By Value
    • 8.3.4.2. Market Share & Forecast
      • 8.3.4.2.1. By Service
      • 8.3.4.2.2. By Formulation
      • 8.3.4.2.3. By Therapeutic Area
  • 8.3.5. Australia Formulation Development Outsourcing Market Outlook
    • 8.3.5.1. Market Size & Forecast
      • 8.3.5.1.1. By Value
    • 8.3.5.2. Market Share & Forecast
      • 8.3.5.2.1. By Service
      • 8.3.5.2.2. By Formulation
      • 8.3.5.2.3. By Therapeutic Area

9. South America Formulation Development Outsourcing Market Outlook

• 9.1. Market Size & Forecast
  • 9.1.1. By Value
• 9.2. Market Share & Forecast
  • 9.2.1. By Service
  • 9.2.2. By Formulation
  • 9.2.3. By Therapeutic Area
  • 9.2.4. By Country
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil Formulation Development Outsourcing Market Outlook
    • 9.3.1.1. Market Size & Forecast
      • 9.3.1.1.1. By Value
    • 9.3.1.2. Market Share & Forecast
      • 9.3.1.2.1. By Service
      • 9.3.1.2.2. By Formulation
      • 9.3.1.2.3. By Therapeutic Area
  • 9.3.2. Argentina Formulation Development Outsourcing Market Outlook
    • 9.3.2.1. Market Size & Forecast
      • 9.3.2.1.1. By Value
    • 9.3.2.2. Market Share & Forecast
      • 9.3.2.2.1. By Service
      • 9.3.2.2.2. By Formulation
      • 9.3.2.2.3. By Therapeutic Area
  • 9.3.3. Colombia Formulation Development Outsourcing Market Outlook
    • 9.3.3.1. Market Size & Forecast
      • 9.3.3.1.1. By Value
    • 9.3.3.2. Market Share & Forecast
      • 9.3.3.2.1. By Service
      • 9.3.3.2.2. By Formulation
      • 9.3.3.2.3. By Therapeutic Area

10. Middle East and Africa Formulation Development Outsourcing Market Outlook

• 10.1. Market Size & Forecast
  • 10.1.1. By Value
• 10.2. Market Share & Forecast
  • 10.2.1. By Service
  • 10.2.2. By Formulation
  • 10.2.3. By Therapeutic Area
  • 10.2.4. By Country
• 10.3. Middle East & Africa: Country Analysis
  • 10.3.1. South Africa Formulation Development Outsourcing Market Outlook
    • 10.3.1.1. Market Size & Forecast
      • 10.3.1.1.1. By Value
    • 10.3.1.2. Market Share & Forecast
      • 10.3.1.2.1. By Service
      • 10.3.1.2.2. By Formulation
      • 10.3.1.2.3. By Therapeutic Area
  • 10.3.2. Saudi Arabia Formulation Development Outsourcing Market Outlook
    • 10.3.2.1. Market Size & Forecast
      • 10.3.2.1.1. By Value
    • 10.3.2.2. Market Share & Forecast
      • 10.3.2.2.1. By Service
      • 10.3.2.2.2. By Formulation
      • 10.3.2.2.3. By Therapeutic Area
  • 10.3.3. UAE Formulation Development Outsourcing Market Outlook
    • 10.3.3.1. Market Size & Forecast
      • 10.3.3.1.1. By Value
    • 10.3.3.2. Market Share & Forecast
      • 10.3.3.2.1. By Service
      • 10.3.3.2.2. By Formulation
      • 10.3.3.2.3. By Therapeutic Area

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Recent Developments (If Any)
• 12.2. Product Launches (If Any)
• 12.3. Mergers & Acquisitions (If Any)

13. Global Formulation Development Outsourcing Market: SWOT Analysis

14. Competitive Landscape

• 14.1. Charles River Laboratories
  • 14.1.1. Business Overview
  • 14.1.2. Product & Service Offerings
  • 14.1.3. Recent Developments
  • 14.1.4. Financials (If Listed)
  • 14.1.5. Key Personnel
  • 14.1.6. SWOT Analysis
• 14.2. Aizant Drug Research Solutions Private Limited
• 14.3. Catalent Inc.
• 14.4. Laboratory Corporation of America Holdings
• 14.5. Syngene International Ltd.
• 14.6. Irisys LLC
• 14.7. Intertek Group PLC
• 14.8. Piramal Pharma Solutions
• 14.9. Qiotient Sciences Ltd.
• 14.10.Patheon Inc.
• 14.11.Emergent BioSolutions Inc.
• 14.12.Lonza Group

15. Strategic Recommendations

16. About Us & Disclaimer