製劑開發外包的全球市場，市場規模與成長趨勢，企業(2025年～2033年)

製劑開發外包市場趨勢及總結

全球製劑開發外包市場規模預計將從2024年的336億美元增至2033年的647.4億美元，2025年至2033年的複合年增長率為7.56%。市場擴張的主要推動因素包括研發成本上升、專業知識需求增加、藥物開發速度加快、監管複雜性增加以及製藥業的擴張。

製劑開發外包市場的推動因素

專業知識需求不斷成長

許多藥廠可能缺乏處理日益複雜的藥物製劑所需的專業知識和尖端技術。例如，業內人士表示，印度製藥公司正在全球出口仿製藥和生物相似藥，並可能調整策略以進一步拓展國際市場，尤其是美國市場。為此，印度製藥公司從美國食品藥物管理局（FDA）的 "製劑開發指南" 中受益匪淺。 "製劑開髮指南" 草案列出了藥物製劑（尤其是針對美國市場）的最佳實踐和監管要求。遵循這些建議，除了確保合規性之外，還能提高藥品的品質和療效。

印度製藥業的專家表示，該指南是打造符合國際標準的優質製劑的路線圖，從而提升了尋求國際擴張的印度製藥公司的合法性和競爭力。製劑開發外包市場的前景看好，因為外包合作夥伴能夠提供開發複雜藥物所需的先進技術和專業知識，進而提升藥品的品質和療效。

加強監理合規性

擁有監管經驗的外包合作夥伴可以有效率地處理嚴格法規要求的完整製劑流程，確保符合法規要求。例如，印度衛生部宣布，印度製藥公司將被要求在2024年滿足新的生產要求，但由於財務負擔，中小企業正在尋求延期。更新後的Schedule M標準將要求製藥公司將產品缺陷、變質、製造缺陷以及藥品召回通知許可機構。此前，尚無辦法將藥品召回情況通知許可機構。預計這也將擴大市場。

研發費用增加

由於研發成本高昂，製藥公司將配方開發外包以降低成本並更有效地利用資源。例如，根據業內估計，默克公司2023財年的銷售額將達到601億美元，研發費用達到高峰305億美元。該公司的研發費用目前佔其23財年總收入的50.8%，光是一年就成長了驚人的126%。同樣，強生公司（J&J）在2023年也表現出健康的財務成長，並在銷售額方面領先製藥業。這家製藥巨頭在研發方面投入了創紀錄的151億美元，使其成為研發支出第三大公司。製藥業的成長對製劑開發外包市場產生了正面的影響。

製劑開發外包市場的課題

溝通障礙與專案延遲

製劑開發外包領域專案的成功取決於有效的溝通。然而，由於語言障礙、時差、物理距離等原因，申辦者和外包夥伴可能會出現嚴重的溝通錯誤。這些溝通問題常常導致開發任務執行不規範、回饋循環延遲以及專案目標不一致。由於缺乏定期、透明且記錄在案的互動，重要的配方細節可能會被誤解，導致代價高昂的修改、延誤和品質問題。此外，決策和協調的速度可能會受到公司流程中文化差異的影響。為了緩解這些問題，申辦方需要建立強有力的溝通程序、頻繁的審核和通用的數位平台，以確保藥物開發流程的開放性和協作性。

本報告提供全球製劑開發外包市場相關調查，成長推動因素與課題，各市場區隔的分析，主要企業的分析等資訊。

目錄

第1章 簡介

第2章 調查手法

第3章 摘要整理

第4章 市場動態

• 成長促進因素
• 課題

第5章 全球製劑開發外包市場

• 過去的市場趨勢
• 市場預測

第6章 製劑開發外包的市場佔有率分析

• 各類服務
• 各劑型
• 各治療領域
• 各最終用途
• 各國

第7章 服務

• 配方開發
• 預配方

第8章 劑型

• 口服
• 注射
• 其他

第9章 治療領域

• 腫瘤
• 感染疾病
• 神經
• 血液
• 呼吸系統
• 心血管
• 皮膚科
• 其他

第10章 最終用途

• 製藥企業，生物醫藥品企業
• 政府，學術機構
• 其他

第11章 國家

• 北美
  • 美國
  • 加拿大
• 歐洲
  • 法國
  • 德國
  • 義大利
  • 西班牙
  • 英國
  • 比利時
  • 荷蘭
  • 土耳其
• 亞太地區
  • 中國
  • 日本
  • 印度
  • 韓國
  • 泰國
  • 馬來西亞
  • 印尼
  • 澳洲
  • 紐西蘭
• 南美
  • 巴西
  • 墨西哥
  • 阿根廷
• 中東·非洲
  • 沙烏地阿拉伯
  • 阿拉伯聯合大公國
  • 南非

第12章 波特的五力分析

第13章 SWOT分析

第14章 主要企業的分析

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

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