製剂开发外包的全球市场，市场规模与成长趋势，企业(2025年～2033年)

製剂开发外包市场趋势及总结

全球製剂开发外包市场规模预计将从2024年的336亿美元增至2033年的647.4亿美元，2025年至2033年的复合年增长率为7.56%。市场扩张的主要推动因素包括研发成本上升、专业知识需求增加、药物开发速度加快、监管复杂性增加以及製药业的扩张。

製剂开发外包市场的推动因素

专业知识需求不断成长

许多药厂可能缺乏处理日益复杂的药物製剂所需的专业知识和尖端技术。例如，业内人士表示，印度製药公司正在全球出口仿製药和生物相似药，并可能调整策略以进一步拓展国际市场，尤其是美国市场。为此，印度製药公司从美国食品药物管理局（FDA）的 "製剂开发指南" 中受益匪浅。 "製剂开髮指南" 草案列出了药物製剂（尤其是针对美国市场）的最佳实践和监管要求。遵循这些建议，除了确保合规性之外，还能提高药品的品质和疗效。

印度製药业的专家表示，该指南是打造符合国际标准的优质製剂的路线图，从而提升了寻求国际扩张的印度製药公司的合法性和竞争力。製剂开发外包市场的前景看好，因为外包合作伙伴能够提供开发复杂药物所需的先进技术和专业知识，进而提升药品的品质和疗效。

加强监理合规性

拥有监管经验的外包合作伙伴可以有效率地处理严格法规要求的完整製剂流程，确保符合法规要求。例如，印度卫生部宣布，印度製药公司将被要求在2024年满足新的生产要求，但由于财务负担，中小企业正在寻求延期。更新后的Schedule M标准将要求製药公司将产品缺陷、变质、製造缺陷以及药品召回通知许可机构。此前，尚无办法将药品召回情况通知许可机构。预计这也将扩大市场。

研发费用增加

由于研发成本高昂，製药公司将配方开发外包以降低成本并更有效地利用资源。例如，根据业内估计，默克公司2023财年的销售额将达到601亿美元，研发费用达到高峰305亿美元。该公司的研发费用目前占其23财年总收入的50.8%，光是一年就成长了惊人的126%。同样，强生公司（J&J）在2023年也表现出健康的财务成长，并在销售额方面领先製药业。这家製药巨头在研发方面投入了创纪录的151亿美元，使其成为研发支出第三大公司。製药业的成长对製剂开发外包市场产生了正面的影响。

製剂开发外包市场的课题

沟通障碍与专案延迟

製剂开发外包领域专案的成功取决于有效的沟通。然而，由于语言障碍、时差、物理距离等原因，申办者和外包伙伴可能会出现严重的沟通错误。这些沟通问题常常导致开发任务执行不规范、回馈循环延迟以及专案目标不一致。由于缺乏定期、透明且记录在案的互动，重要的配方细节可能会被误解，导致代价高昂的修改、延误和品质问题。此外，决策和协调的速度可能会受到公司流程中文化差异的影响。为了缓解这些问题，申办方需要建立强有力的沟通程序、频繁的审核和通用的数位平台，以确保药物开发流程的开放性和协作性。

本报告提供全球製剂开发外包市场相关调查，成长推动因素与课题，各市场区隔的分析，主要企业的分析等资讯。

目录

第1章 简介

第2章 调查手法

第3章 摘要整理

第4章 市场动态

• 成长促进因素
• 课题

第5章 全球製剂开发外包市场

• 过去的市场趋势
• 市场预测

第6章 製剂开发外包的市场占有率分析

• 各类服务
• 各剂型
• 各治疗领域
• 各最终用途
• 各国

第7章 服务

• 配方开发
• 预配方

第8章 剂型

• 口服
• 注射
• 其他

第9章 治疗领域

• 肿瘤
• 感染疾病
• 神经
• 血液
• 呼吸系统
• 心血管
• 皮肤科
• 其他

第10章 最终用途

• 製药企业，生物医药品企业
• 政府，学术机构
• 其他

第11章 国家

• 北美
  • 美国
  • 加拿大
• 欧洲
  • 法国
  • 德国
  • 义大利
  • 西班牙
  • 英国
  • 比利时
  • 荷兰
  • 土耳其
• 亚太地区
  • 中国
  • 日本
  • 印度
  • 韩国
  • 泰国
  • 马来西亚
  • 印尼
  • 澳洲
  • 纽西兰
• 南美
  • 巴西
  • 墨西哥
  • 阿根廷
• 中东·非洲
  • 沙乌地阿拉伯
  • 阿拉伯联合大公国
  • 南非

第12章 波特的五力分析

第13章 SWOT分析

第14章 主要企业的分析

• 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