제제 개발 아웃소싱 시장 보고서 : 서비스별, 제형별, 용도별, 최종사용자별, 지역별(2025-2033년)

The global formulation development outsourcing market size reached USD 25.5 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 41.0 Billion by 2033, exhibiting a growth rate (CAGR) of 5.4% during 2025-2033. The increasing research and development (R&D) costs, the rising need for specialized expertise, accelerated drug development timelines, growing regulatory complexities, and the growing pharmaceutical sector are some of the major factors propelling the growth of the market.

Formulation Development Outsourcing Market Trends:

Rising Research and Development (R&D) Costs

Pharmaceutical companies face high costs in research and development (R&D), prompting them to outsource formulation development to reduce expenses and allocate resources more efficiently. For instance, according to industry reports, Merck & Co's revenues reached $60.1bn in FY 2023, with research and development (R&D) investments peaking at $30.5bn. Displaying a staggering 126% growth over the course of one year, the company's research and development (R&D) investments now represent 50.8% of its total revenue for 2023. Similarly, in 2023 Johnson & Johnson (J&J) displayed strong financial growth and was the leading pharmaceutical company in terms of revenues. The pharma giant ranked third in terms of R&D expenditure, investing approximately $15.1bna record-breaking figure for the company. The pharmaceutical industry's expansion is positively enhancing the formulation development outsourcing market revenue.

Increasing Need for Specialized Expertise

The growing complexity of drug formulations requires specialized expertise and advanced technologies, which many pharmaceutical companies may lack internally. For instance, according to industry reports, Indian pharma's global presence in generic medicine exports among others like biosimilars will indicate a strategic shift toward further expansion in the international markets, particularly the US. To this end, the guidance from the US FDA on formulation development serves as a crucial enabler for Indian pharma companies in this pursuit. The draft guidance on formulation development outlines the regulatory requirements and best practices for developing drug formulations, especially those intended for the US market. Adhering to these guidelines not only ensures compliance but also enhances the quality and efficacy of pharmaceutical products. According to Indian pharma industry experts, for Indian pharmaceutical firms eyeing global expansion, such guidance provides a roadmap for developing high-quality formulations that meet international standards, thereby bolstering their credibility and competitiveness in the global arena. Outsourcing partners offer the necessary skills and cutting-edge technologies to develop sophisticated drug formulations that enhance the quality and efficacy of pharmaceutical products, thereby creating a positive formulation development outsourcing market outlook.

Growing Regulatory Compliance

Stringent regulatory requirements necessitate comprehensive and compliant formulation processes, which outsourcing partners with regulatory expertise can effectively manage. For instance, according to industry reports, Indian pharmaceutical companies must meet new manufacturing standards in 2024, as per a Union Health Ministry notification, although small companies have asked for a delay, citing their debt load. Under the revised Schedule M guidelines, pharmaceutical companies will have to inform the licensing authority about recalling a drug and report product defects, deterioration, or faulty production. Till now there was no provision for informing the licensing authority about drug recall. This is further expected to facilitate the market growth.

Formulation Development Outsourcing Market Segmentation:

Breakup by Service:

• Pre-formulation Services
  • Discovery and Preclinical Services
  • Analytical Services
• Formulation Optimization
  • Phase I
  • Phase II
  • Phase III
  • Phase IV

Formulation Optimization accounts for the majority of the market share

The demand for formulation optimization in the market is driven by the need for enhanced drug efficacy, stability, and bioavailability. Increasing regulatory scrutiny necessitates robust and compliant formulations. Additionally, the rise of complex and personalized medicines requires precise formulation techniques. Outsourcing provides access to specialized expertise and advanced technologies, enabling efficient optimization. Moreover, the pressure to accelerate time-to-market and reduce development costs further fuels the demand for optimized formulations in the pharmaceutical industry. For instance, in July 2024, Pfizer announced that it had selected its preferred once-daily modified-release formulation for danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist. Looking ahead, Pfizer plans to conduct dose optimization studies in the second half of 2024, evaluating multiple doses of the preferred modified release formulation to inform the registration enabling studies.

Breakup by Dosage Form:

• Injectable
• Oral
• Topical
• Others

Injectable holds the largest share of the industry

The demand for injectable dosage forms in the market is driven by the growing prevalence of chronic diseases and the need for targeted and controlled drug delivery. Injectable forms offer rapid absorption and bioavailability, essential for critical care and biologic drugs. Additionally, the rise in biologics and biosimilars, which are predominantly administered via injection, fuels this demand. Outsourcing provides access to specialized manufacturing capabilities and regulatory expertise, ensuring high-quality and compliant injectable formulations. This, in turn, is enhancing the overall formulation development outsourcing market value.

Breakup by Application:

• Oncology
• Genetic Disorders
• Neurology
• Infectious Diseases
• Respiratory
• Cardiovascular
• Others

Oncology represents the leading market segment

The demand for formulation development outsourcing in oncology is driven by the complexity of cancer treatments and the need for specialized expertise. Advancements in targeted therapies and personalized medicine require innovative formulation techniques. High research and development (R&D) costs and stringent regulatory requirements also necessitate outsourcing to manage these challenges efficiently which is driving the formulation development outsourcing demand. Additionally, the urgency to accelerate time-to-market for new cancer drugs pushes pharmaceutical companies to seek external partners with advanced technologies and experience in oncology formulation development.

Breakup by End User:

• Pharmaceutical and Biopharmaceutical Companies
• Government and Academic Institutes

Pharmaceutical and biopharmaceutical companies exhibits a clear dominance in the market

The demand for formulation development outsourcing in pharmaceutical and biopharmaceutical companies is driven by high research and development (R&D) costs, the need for specialized expertise, and advanced technologies. Outsourcing helps accelerate drug development timelines and ensures regulatory compliance. The complexity of new drug formulations, including biologics and personalized medicines, necessitates external expertise which is further influencing formulation development outsourcing market growth positively. Additionally, outsourcing allows companies to focus on core competencies while leveraging innovative solutions from specialized partners to enhance drug efficacy, stability, and market readiness.

Breakup by Region:

• North America
  • United States
  • Canada
• Asia-Pacific
  • China
  • Japan
  • India
  • South Korea
  • Australia
  • Indonesia
  • Others
• Europe
  • Germany
  • France
  • United Kingdom
  • Italy
  • Spain
  • Russia
  • Others
• Latin America
  • Brazil
  • Mexico
  • Others
• Middle East and Africa

North America leads the market, accounting for the largest formulation development outsourcing market share

The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia, and others); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia, and others); Latin America (Brazil, Mexico, and others); and the Middle East and Africa. According to the report, North America represents the largest regional market for formulation development outsourcing.

The high research and development (R&D) costs and the need for specialized expertise to develop complex drug formulations are driving the market growth in the region. The region's stringent regulatory environment necessitates compliance with rigorous standards, which outsourcing partners can manage efficiently. Additionally, the rise of biotechnology and personalized medicine requires advanced formulation solutions, further boosting the demand for outsourcing. According to the formulation development outsourcing market forecast across the region, the pressure to accelerate drug development timelines and reduce time-to-market also contributes to the growth of this market. For instance, in May 2024, Coriolis Pharma, a globally operating service provider for R&D and GMP drug product development, R&D and GMP analytics, and sterile drug product manufacturing support, announced the launch of a U.S. entity that allows customers to combine the convenience of a local service with the advantages of international expertise. U.S. customers will be served by the U.S.-based Coriolis commercial organization, which consists of business development and client project management professionals.

Competitive Landscape:

• The market research report has also provided a comprehensive analysis of the competitive landscape in the market. Detailed profiles of all major companies have also been provided. Some of the major market players in the formulation development outsourcing industry include Aizant Drug Research Solutions Private Limited, Catalent Inc., Charles River Laboratories, Dr. Reddy's Laboratories Ltd., Emergent BioSolutions Inc., Intertek Group plc, Irisys LLC (Recro Pharma), Laboratory Corporation of America Holdings, Lonza Group AG, Piramal Pharma Solutions, Quotient Sciences, Syngene International Limited (Biocon Limited) and Thermo Fisher Scientific Inc.
• The market for formulation development outsourcing is highly competitive, with numerous players offering specialized services. These formulation development outsourcing companies include Catalent, Lonza, and Charles River Laboratories, known for their extensive expertise and advanced technologies. Emerging firms and niche providers also compete by offering tailored solutions and innovative approaches. For instance, in April 2024, Charles River Laboratories launched its Alternative Methods Advancement Project (AMAP), an initiative to develop alternatives to reduce animal testing and to drive a new standard for drug discovery and development. The company's initial investment was $200 million over the past four years and its five-year goal is to invest an additional $300 million. This investment spans a portfolio of technology innovations, partnerships, and advocacy efforts to reduce the use of animal testing.

Key Questions Answered in This Report

• 1.How big is the formulation development outsourcing market?
• 2.What is the future outlook of the formulation development outsourcing market?
• 3.What are the key factors driving the formulation development outsourcing market?
• 4.Which region accounts for the largest formulation development outsourcing market share?
• 5.Which are the leading companies in the global formulation development outsourcing market?

Table of Contents

1 Preface

2 Scope and Methodology

• 2.1 Objectives of the Study
• 2.2 Stakeholders
• 2.3 Data Sources
  • 2.3.1 Primary Sources
  • 2.3.2 Secondary Sources
• 2.4 Market Estimation
  • 2.4.1 Bottom-Up Approach
  • 2.4.2 Top-Down Approach
• 2.5 Forecasting Methodology

3 Executive Summary

4 Introduction

• 4.1 Overview
• 4.2 Key Industry Trends

5 Global Formulation Development Outsourcing Market

• 5.1 Market Overview
• 5.2 Market Performance
• 5.3 Impact of COVID-19
• 5.4 Market Forecast

6 Market Breakup by Service

• 6.1 Pre-formulation Services
  • 6.1.1 Market Trends
  • 6.1.2 Key Segments
    • 6.1.2.1 Discovery and Preclinical Services
    • 6.1.2.2 Analytical Services
  • 6.1.3 Market Forecast
• 6.2 Formulation Optimization
  • 6.2.1 Market Trends
  • 6.2.2 Key Segments
    • 6.2.2.1 Phase I
    • 6.2.2.2 Phase II
    • 6.2.2.3 Phase III
    • 6.2.2.4 Phase IV
  • 6.2.3 Market Forecast

7 Market Breakup by Dosage Form

• 7.1 Injectable
  • 7.1.1 Market Trends
  • 7.1.2 Market Forecast
• 7.2 Oral
  • 7.2.1 Market Trends
  • 7.2.2 Market Forecast
• 7.3 Topical
  • 7.3.1 Market Trends
  • 7.3.2 Market Forecast
• 7.4 Others
  • 7.4.1 Market Trends
  • 7.4.2 Market Forecast

8 Market Breakup by Application

• 8.1 Oncology
  • 8.1.1 Market Trends
  • 8.1.2 Market Forecast
• 8.2 Genetic Disorders
  • 8.2.1 Market Trends
  • 8.2.2 Market Forecast
• 8.3 Neurology
  • 8.3.1 Market Trends
  • 8.3.2 Market Forecast
• 8.4 Infectious Diseases
  • 8.4.1 Market Trends
  • 8.4.2 Market Forecast
• 8.5 Respiratory
  • 8.5.1 Market Trends
  • 8.5.2 Market Forecast
• 8.6 Cardiovascular
  • 8.6.1 Market Trends
  • 8.6.2 Market Forecast
• 8.7 Others
  • 8.7.1 Market Trends
  • 8.7.2 Market Forecast

9 Market Breakup by End User

• 9.1 Pharmaceutical and Biopharmaceutical Companies
  • 9.1.1 Market Trends
  • 9.1.2 Market Forecast
• 9.2 Government and Academic Institutes
  • 9.2.1 Market Trends
  • 9.2.2 Market Forecast

10 Market Breakup by Region

• 10.1 North America
  • 10.1.1 United States
    • 10.1.1.1 Market Trends
    • 10.1.1.2 Market Forecast
  • 10.1.2 Canada
    • 10.1.2.1 Market Trends
    • 10.1.2.2 Market Forecast
• 10.2 Asia-Pacific
  • 10.2.1 China
    • 10.2.1.1 Market Trends
    • 10.2.1.2 Market Forecast
  • 10.2.2 Japan
    • 10.2.2.1 Market Trends
    • 10.2.2.2 Market Forecast
  • 10.2.3 India
    • 10.2.3.1 Market Trends
    • 10.2.3.2 Market Forecast
  • 10.2.4 South Korea
    • 10.2.4.1 Market Trends
    • 10.2.4.2 Market Forecast
  • 10.2.5 Australia
    • 10.2.5.1 Market Trends
    • 10.2.5.2 Market Forecast
  • 10.2.6 Indonesia
    • 10.2.6.1 Market Trends
    • 10.2.6.2 Market Forecast
  • 10.2.7 Others
    • 10.2.7.1 Market Trends
    • 10.2.7.2 Market Forecast
• 10.3 Europe
  • 10.3.1 Germany
    • 10.3.1.1 Market Trends
    • 10.3.1.2 Market Forecast
  • 10.3.2 France
    • 10.3.2.1 Market Trends
    • 10.3.2.2 Market Forecast
  • 10.3.3 United Kingdom
    • 10.3.3.1 Market Trends
    • 10.3.3.2 Market Forecast
  • 10.3.4 Italy
    • 10.3.4.1 Market Trends
    • 10.3.4.2 Market Forecast
  • 10.3.5 Spain
    • 10.3.5.1 Market Trends
    • 10.3.5.2 Market Forecast
  • 10.3.6 Russia
    • 10.3.6.1 Market Trends
    • 10.3.6.2 Market Forecast
  • 10.3.7 Others
    • 10.3.7.1 Market Trends
    • 10.3.7.2 Market Forecast
• 10.4 Latin America
  • 10.4.1 Brazil
    • 10.4.1.1 Market Trends
    • 10.4.1.2 Market Forecast
  • 10.4.2 Mexico
    • 10.4.2.1 Market Trends
    • 10.4.2.2 Market Forecast
  • 10.4.3 Others
    • 10.4.3.1 Market Trends
    • 10.4.3.2 Market Forecast
• 10.5 Middle East and Africa
  • 10.5.1 Market Trends
  • 10.5.2 Market Breakup by Country
  • 10.5.3 Market Forecast

11 SWOT Analysis

• 11.1 Overview
• 11.2 Strengths
• 11.3 Weaknesses
• 11.4 Opportunities
• 11.5 Threats

12 Value Chain Analysis

13 Porters Five Forces Analysis

• 13.1 Overview
• 13.2 Bargaining Power of Buyers
• 13.3 Bargaining Power of Suppliers
• 13.4 Degree of Competition
• 13.5 Threat of New Entrants
• 13.6 Threat of Substitutes

14 Price Analysis

15 Competitive Landscape

• 15.1 Market Structure
• 15.2 Key Players
• 15.3 Profiles of Key Players
  • 15.3.1 Aizant Drug Research Solutions Private Limited
    • 15.3.1.1 Company Overview
    • 15.3.1.2 Product Portfolio
  • 15.3.2 Catalent Inc.
    • 15.3.2.1 Company Overview
    • 15.3.2.2 Product Portfolio
    • 15.3.2.3 Financials
    • 15.3.2.4 SWOT Analysis
  • 15.3.3 Charles River Laboratories
    • 15.3.3.1 Company Overview
    • 15.3.3.2 Product Portfolio
    • 15.3.3.3 Financials
    • 15.3.3.4 SWOT Analysis
  • 15.3.4 Dr. Reddy's Laboratories Ltd.
    • 15.3.4.1 Company Overview
    • 15.3.4.2 Product Portfolio
    • 15.3.4.3 Financials
    • 15.3.4.4 SWOT Analysis
  • 15.3.5 Emergent BioSolutions Inc.
    • 15.3.5.1 Company Overview
    • 15.3.5.2 Product Portfolio
    • 15.3.5.3 Financials
    • 15.3.5.4 SWOT Analysis
  • 15.3.6 Intertek Group plc
    • 15.3.6.1 Company Overview
    • 15.3.6.2 Product Portfolio
    • 15.3.6.3 Financials
    • 15.3.6.4 SWOT Analysis
  • 15.3.7 Irisys LLC (Recro Pharma)
    • 15.3.7.1 Company Overview
    • 15.3.7.2 Product Portfolio
  • 15.3.8 Laboratory Corporation of America Holdings
    • 15.3.8.1 Company Overview
    • 15.3.8.2 Product Portfolio
    • 15.3.8.3 Financials
    • 15.3.8.4 SWOT Analysis
  • 15.3.9 Lonza Group AG
    • 15.3.9.1 Company Overview
    • 15.3.9.2 Product Portfolio
    • 15.3.9.3 Financials
    • 15.3.9.4 SWOT Analysis
  • 15.3.10 Piramal Pharma Solutions
    • 15.3.10.1 Company Overview
    • 15.3.10.2 Product Portfolio
    • 15.3.10.3 Financials
  • 15.3.11 Quotient Sciences
    • 15.3.11.1 Company Overview
    • 15.3.11.2 Product Portfolio
  • 15.3.12 Syngene International Limited (Biocon Limited)
    • 15.3.12.1 Company Overview
    • 15.3.12.2 Product Portfolio
    • 15.3.12.3 Financials
  • 15.3.13 Thermo Fisher Scientific Inc.
    • 15.3.13.1 Company Overview
    • 15.3.13.2 Product Portfolio
    • 15.3.13.3 Financials
    • 15.3.13.4 SWOT Analysis