生物製剂监管事务外包市场 - 全球产业规模、份额、趋势、机会和预测，按服务、阶段、方式、地区和竞争细分，2020-2030 年预测

2024 年全球生物製剂监管事务外包市场价值为 25.4 亿美元，预计到 2030 年将达到 41.7 亿美元，预测期内复合年增长率为 8.56%。全球生物製剂监管事务外包市场受到生物药物监管要求日益复杂、更快市场准入需求不断增长以及内部监管营运成本上升的推动。随着生物製剂在癌症和自体免疫疾病等各种疾病的治疗中变得越来越普遍，公司越来越多地将监管事务外包给擅长应对全球监管环境的专业公司。这使得公司能够专注于核心竞争力，同时确保遵守美国、欧盟和亚洲等地区的不同法规。对处理生物製剂相关文件、临床试验和上市后监测的专业知识的需求进一步刺激了外包需求。成本效益、节省时间和获得专业知识是推动该市场成长的关键因素。

市场概况
预测期	2026-2030
2024 年市场规模	25.4 亿美元
2030 年市场规模	41.7 亿美元
2025-2030 年复合年增长率	8.56%
成长最快的领域	监理咨询
最大的市场	北美洲

主要市场驱动因素

生物製品监管要求日益复杂

对更快市场准入的需求不断增加

缺乏内部监管专业知识

重点关注快速审批途径

监管协调和全球标准

新兴市场对生物製剂的采用日益增多

主要市场挑战

不同地区监管的复杂性与差异性

沟通不良和延误的风险

资料安全和保密问题

主要市场趋势

更加重视成本效率与资源最佳化

生物製剂市场日益全球化

分段洞察

服务洞察

阶段洞察

区域洞察

目录

第 1 章：产品概述

第 2 章：研究方法

第 3 章：执行摘要

第 4 章：顾客之声

第五章：全球生物製剂监理事务外包市场展望

• 市场规模和预测
  • 按价值
• 市场占有率和预测
  • 按服务分类（监管咨询、法律代表、监管写作和出版、产品註册和临床、试验申请、监管提交、监管运营及其他）
  • 按阶段（临床前和临床）
  • 按方式（单株抗体、重组蛋白、疫苗、细胞及基因疗法、生物相似药等）
  • 按地区
  • 按公司分类（2024）
• 市场地图

第六章：北美生物製剂监理事务外包市场展望

• 市场规模和预测
  • 按价值
• 市场占有率和预测
  • 按服务
  • 按阶段
  • 按方式
  • 按国家
• 北美：国家分析
  • 美国
  • 加拿大
  • 墨西哥

第七章：欧洲生物製剂监理事务外包市场展望

• 市场规模和预测
  • 按价值
• 市场占有率和预测
  • 按服务
  • 按阶段
  • 按方式
  • 按国家
• 欧洲：国家分析
  • 德国
  • 英国
  • 义大利
  • 法国
  • 西班牙

第 8 章：亚太地区生物製剂监理事务外包市场展望

• 市场规模和预测
  • 按价值
• 市场占有率和预测
  • 按服务
  • 按阶段
  • 按方式
  • 按国家
• 亚太地区：国家分析
  • 中国
  • 印度
  • 日本
  • 韩国
  • 澳洲

第九章：南美洲生物製品监理事务外包市场展望

• 市场规模和预测
  • 按价值
• 市场占有率和预测
  • 按服务
  • 按阶段
  • 按方式
  • 按国家
• 南美洲：国家分析
  • 巴西
  • 阿根廷
  • 哥伦比亚

第 10 章：中东和非洲生物製剂监管事务外包市场展望

• 市场规模和预测
  • 按价值
• 市场占有率和预测
  • 按服务
  • 按阶段
  • 按方式
  • 按国家
• MEA：国家分析
  • 南非
  • 沙乌地阿拉伯
  • 阿联酋

第 11 章：市场动态

• 驱动程式
• 挑战

第 12 章：市场趋势与发展

• 合併与收购（如有）
• 产品发布（如果有）
• 最新动态

第 13 章：波特五力分析

• 产业竞争
• 新进入者的潜力
• 供应商的力量
• 顾客的力量
• 替代产品的威胁

第 14 章：竞争格局

• Lonza Group AG Ltd
• WuXi AppTec Co., Ltd.
• Freyr solutions
• Catalent Inc.
• ICON Plc
• Charles River Laboratories International, Inc.
• Laboratory Corporation of America Holdings
• Medpace, Inc.
• Iqvia Holdings Inc.
• Syneos Health

第 15 章：策略建议

第16章 调査会社について・免责事项

Global Biologics Regulatory Affairs Outsourcing Market was valued at USD 2.54 Billion in 2024 and is expected to reach USD 4.17 Billion by 2030 with a CAGR of 8.56% during the forecast period. The global biologics regulatory affairs outsourcing market is driven by the increasing complexity of regulatory requirements for biologic drugs, the growing demand for faster market access, and the rising costs of in-house regulatory operations. As biologics become more prevalent in the treatment of various diseases, including cancer and autoimmune disorders, companies are increasingly outsourcing regulatory affairs to specialized firms with expertise in navigating global regulatory landscapes. This allows companies to focus on core competencies while ensuring compliance with diverse regulations across regions like the US, EU, and Asia. The need for expertise in handling biologics-related documentation, clinical trials, and post-market surveillance further fuels outsourcing demand. Cost-efficiency, time savings, and access to specialized knowledge are key factors driving the growth of this market.

Market Overview
Forecast Period	2026-2030
Market Size 2024	USD 2.54 Billion
Market Size 2030	USD 4.17 Billion
CAGR 2025-2030	8.56%
Fastest Growing Segment	Regulatory Consulting
Largest Market	North America

Key Market Drivers

Increasing Complexity of Regulatory Requirements for Biologics

The increasing complexity of regulatory requirements for biologics is one of the most significant drivers of the global biologics regulatory affairs outsourcing market. As biologics become more advanced and diverse, they are subject to highly specific and detailed regulations. Biologics, which include products like monoclonal antibodies, gene therapies, and recombinant proteins, often involve complex production processes that must meet stringent quality standards. Each biologic drug has its own set of regulatory hurdles, ranging from manufacturing controls to clinical trial data and long-term safety monitoring, all of which must be tailored to specific regional guidelines. According to Cardinal Health's 2023 biosimilars report, approximately 40 FDA-approved biosimilars were available in the U.S. in 2023, with 25 of them commercially available. As a result, the growing development and approval of novel biosimilars is anticipated to boost the demand for regulatory services in the U.S., driving further market growth.

Navigating these regulations can be a significant challenge for companies, particularly when they are aiming for global distribution. Different regions have varying approval processes, requirements for preclinical and clinical data, and specific regulatory documentation that must be submitted for review. In the United States, for instance, the FDA's regulations are focused on product safety, efficacy, and manufacturing quality. Meanwhile, the European Medicines Agency (EMA) has its own set of criteria and guidelines. In emerging markets, countries such as China, India, and Brazil are developing their own biologics regulations. Staying compliant with all of these regulations requires deep knowledge of each market's rules, regulations, and submission processes, which can be both time-consuming and costly.

This is where outsourcing regulatory affairs functions to specialized service providers becomes invaluable. These outsourcing firms have established expertise in regulatory affairs, with dedicated teams that stay up-to-date on the latest guidelines and regulatory changes worldwide. By outsourcing, pharmaceutical companies can mitigate the risk of non-compliance and avoid costly delays. Regulatory affairs outsourcing providers can also ensure that product submissions and documentation are of the highest quality, meeting the specific requirements for each region, which improves the likelihood of approval. This expertise is crucial for the successful development and commercialization of biologic products, which is why many companies in the biologics space are increasingly turning to outsourcing to navigate these complex regulatory landscapes.

Increasing Demand for Faster Market Access

Another key driver of the biologics regulatory affairs outsourcing market is the growing demand for faster market access. The global pharmaceutical industry is under immense pressure to accelerate the launch of new drugs, especially biologics, which are among the most innovative and high-demand therapies available today. Biologics, such as gene therapies and monoclonal antibodies, are increasingly being used to treat a variety of complex diseases like cancer, autoimmune disorders, and rare genetic conditions. Due to the high unmet need for these treatments, there is a significant focus on reducing the time it takes for new biologic therapies to reach the market. In October 2023, Samsung Biologics formed a partnership with Kurma Partners to develop and manufacture novel biologics for Kurma Partners. This collaboration provided Kurma Partners with access to Samsung Biologics' CDMO services, including regulatory support during the development of advanced therapeutics. These partnerships have expanded the company's opportunities for revenue growth in the market.

Outsourcing regulatory affairs is a strategic approach for companies looking to expedite the approval and launch process. Regulatory affairs experts specialize in understanding the intricacies of regulatory submission and approval processes across different regions, and they are skilled at ensuring that submissions are accurate, comprehensive, and submitted on time. Outsourcing regulatory affairs functions allows companies to tap into this expertise and speed up their interactions with regulatory agencies. A streamlined and efficient regulatory process can reduce delays in clinical trial approvals, shorten the time to market, and enable faster commercialization of biologic drugs.

This demand for faster market access is particularly critical in highly competitive therapeutic areas, where companies are racing to bring their biologic treatments to patients before their competitors. The ability to leverage external expertise and gain insights into regulatory pathways for various markets can provide a significant competitive edge. Regulatory affairs outsourcing firms can also offer solutions to navigate expedited approval pathways, such as breakthrough therapy designations, priority review processes, or accelerated approval routes, which are available in markets like the US and EU. By utilizing outsourcing, companies can significantly enhance their chances of faster approval and market entry, meeting the growing demand for biologic therapies while maximizing their return on investment.

Shortage of In-House Regulatory Expertise

A shortage of in-house regulatory expertise is another factor driving the biologics regulatory affairs outsourcing market. As the biologics industry grows, the need for specialized regulatory professionals who can navigate the increasingly complex regulations governing biologic drugs has intensified. However, finding and retaining top regulatory talent, especially those with deep expertise in biologics, can be a challenge. Regulatory professionals must stay up-to-date on rapidly evolving regulations, compliance requirements, and approval pathways for biologics, which requires significant expertise and ongoing training.

Given the complexity of biologics and the highly specialized nature of regulatory affairs, many pharmaceutical companies, particularly small- and mid-sized biotech firms, find it challenging to maintain an in-house team with the necessary expertise. This has created a demand for outsourcing solutions, where specialized regulatory affairs firms can provide the required knowledge and support without the need to recruit, train, and retain a large internal team. Outsourcing partners often have teams with extensive experience across multiple therapeutic areas and regulatory jurisdictions, offering companies access to the high-level expertise they need for a fraction of the cost of building an in-house team.

In addition to the shortage of expertise, regulatory affairs can be time-consuming, and companies may lack the bandwidth to manage the regulatory aspects of drug development while also focusing on R&D and clinical trials. By outsourcing, companies can leverage the expertise of external specialists who are equipped to handle regulatory submissions, manage clinical trial approvals, and navigate the regulatory hurdles involved in bringing biologic drugs to market.

Focus on Expedited Approval Pathways

Another significant driver of the biologics regulatory affairs outsourcing market is the increasing focus on expedited approval pathways. Given the growing demand for biologic therapies, especially in areas such as oncology, immunology, and rare diseases, there is an increasing emphasis on fast-tracking the approval process for life-saving treatments. Regulatory agencies around the world, including the FDA, EMA, and others, have introduced various expedited approval pathways, such as Breakthrough Therapy Designation, Priority Review, and Fast Track Designation in the U.S., to accelerate the time to market for promising biologic drugs. In February 2022, Ergomed acquired ADAMAS Consulting Group Ltd., a leading consulting firm in the biopharmaceutical industry. This acquisition expanded the company's service portfolio and extended its geographical reach across the U.S., Europe, and the APAC regions.

These expedited approval routes can significantly reduce the time it takes for companies to get their biologic drugs to market, which is crucial in competitive therapeutic areas. However, these pathways often come with additional regulatory requirements and more stringent data expectations, making it even more important for companies to have experienced regulatory affairs teams to navigate the approval process efficiently. Outsourcing regulatory affairs to firms with expertise in expedited approval pathways allows companies to leverage specialized knowledge in submitting for faster approvals, increasing the chances of securing these designations and getting their biologic drugs to patients sooner.

Regulatory Harmonization and Global Standards

Regulatory harmonization efforts aimed at creating global standards for biologics are also driving the outsourcing market. Over the past decade, international regulatory organizations have worked toward creating more standardized regulations to facilitate the approval of biologic drugs across borders. Bodies such as the International Council for Harmonisation (ICH) and the World Health Organization (WHO) have made efforts to align regulatory processes to simplify the approval of biologics in multiple regions.

However, despite these efforts, regional differences still persist, and companies often struggle with varying requirements across countries. Outsourcing regulatory affairs functions allows companies to tap into the knowledge of experts who are well-versed in both global standards and region-specific regulations, enabling them to navigate this complex environment more effectively.

Increasing Adoption of Biologics in Emerging Markets

The adoption of biologics in emerging markets is a growing driver of the biologics regulatory affairs outsourcing market. As the healthcare infrastructure in countries such as China, India, and Brazil improves, there is an increasing demand for biologic drugs to address a variety of health conditions. These regions offer significant growth opportunities for biologics manufacturers, but they also present unique regulatory challenges due to their evolving regulatory environments. Outsourcing regulatory affairs allows companies to ensure that their products meet local requirements, paving the way for successful market entry and growth in these high-potential regions. In October 2024, Biocon Biologics Limited, a fully integrated global biosimilars company, has released the findings of an in-depth study aimed at fostering a more supportive environment for biosimilars in low- and middle-income countries (LMICs). The goal of the study is to enhance the uptake of biosimilars and expand access to affordable healthcare solutions in these regions. Commissioned by Biocon Biologics, the study's methodology was defined by the company in collaboration with Clarivate to develop the final report. The results of the study were published as a peer-reviewed article in the prestigious Generics and Biosimilars Initiative (GaBI) Journal.

By partnering with regulatory affairs outsourcing firms, companies can tap into the growing demand for biologics in emerging markets and navigate the regulatory complexities associated with these regions.

Key Market Challenges

Regulatory Complexity & Variability Across Regions

One of the primary challenges in the biologics regulatory affairs outsourcing market is the significant variability in regulatory requirements across different regions. While global harmonization efforts have made strides, countries still have unique requirements for biologic drug approvals, clinical trials, labeling, and post-market surveillance. For example, the U.S. FDA, European Medicines Agency (EMA), and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) all have different submission requirements, review timelines, and approval processes. These differences create a complex landscape that companies must navigate to ensure global market access. Outsourcing regulatory affairs can mitigate this challenge, but it still requires outsourcing partners to have deep knowledge of region-specific regulations to ensure compliance. Managing such complex regulatory frameworks, particularly when expanding into emerging markets with evolving regulations, requires constant attention and resources.

Risk of Miscommunication and Delays

Another challenge with outsourcing regulatory affairs is the potential risk of miscommunication and delays. When regulatory affairs are handled by an external partner, the communication between the pharmaceutical company and the outsourcing firm must be clear and timely to avoid setbacks. The regulatory submission process can be lengthy and complicated, involving multiple stages of documentation and approval. Delays or mistakes in communication-whether it's related to data submission, regulatory feedback, or required adjustments-can lead to extended timelines and missed market opportunities. It is essential that pharmaceutical companies and outsourcing partners maintain constant communication and work in close collaboration to ensure that timelines are adhered to and submissions are accurate.

Data Security and Confidentiality Concerns

Given the highly sensitive nature of regulatory affairs data, including clinical trial results, patent filings, and drug development plans, data security and confidentiality are critical concerns when outsourcing regulatory functions. With a growing reliance on digital communication and cloud-based systems, there is always the risk of cyberattacks, data breaches, or unauthorized access to confidential information. Pharmaceutical companies are under strict legal obligations to protect sensitive data, and any lapses in security could result in regulatory penalties or damage to the company's reputation. Choosing outsourcing firms with robust cybersecurity practices and ensuring that they comply with data protection regulations, such as GDPR (General Data Protection Regulation) in Europe, is essential to mitigating these risks.

Key Market Trends

Increasing Focus on Cost Efficiency and Resource Optimization

Cost-efficiency is another significant driver of the biologics regulatory affairs outsourcing market. Developing and bringing biologic drugs to market is an expensive and resource-intensive process. Pharmaceutical companies must invest significant time and money in research and development, clinical trials, regulatory submissions, and marketing. The complexity and length of regulatory approval processes add to these costs. As a result, many companies, especially small- and mid-sized biotech firms, seek ways to optimize their resources and reduce overhead costs.

Outsourcing regulatory affairs functions allows companies to focus their internal resources on core activities like R&D, clinical development, and commercialization, while leaving the regulatory compliance aspects to experts who are specifically trained and experienced in this area. Regulatory outsourcing firms typically have access to the latest regulatory intelligence, tools, and technologies, enabling them to execute regulatory tasks more efficiently and accurately than in-house teams might be able to. This can significantly reduce the overall cost of regulatory affairs by eliminating the need for large, in-house regulatory teams, training costs, and the overhead associated with maintaining regulatory operations in-house. By outsourcing, companies can avoid delays and additional costs due to mistakes or inefficiencies in the regulatory submission process. With specialized knowledge of regulatory requirements and experience with multiple international markets, outsourcing firms can help pharmaceutical companies avoid costly errors that could lead to rejections or extended approval timelines. Outsourcing firms can often scale their services based on a client's needs, allowing companies to avoid unnecessary costs during quieter periods of product development while ensuring they have the support needed during peak submission times. In this way, outsourcing regulatory affairs provides both cost savings and operational flexibility, which is especially important for companies looking to maintain a lean and efficient operation.

Increasing Globalization of the Biologics Market

The globalization of the biologics market is another important driver for the growth of the biologics regulatory affairs outsourcing market. As pharmaceutical companies increasingly look to expand into international markets, they are faced with the challenge of understanding and complying with regulatory requirements in diverse regions. Biologics are subject to unique and highly detailed regulations in each market, from manufacturing and clinical trial requirements to packaging, labeling, and post-market surveillance. The regulatory requirements can vary significantly between regions, such as the United States, European Union, Japan, China, and other emerging markets.

The complexity of managing multiple regulatory environments, each with its own set of standards, presents a significant challenge for companies looking to expand their biologic products globally. Navigating the regulatory landscapes of diverse regions requires expertise and resources that many companies may not have in-house. This is where outsourcing regulatory affairs becomes a valuable solution. Outsourcing providers, especially those with global reach, offer deep knowledge of regulatory requirements in multiple markets and can help companies streamline the process of gaining approval in various regions. Regulatory affairs outsourcing firms typically have local teams or partnerships in key markets around the world, ensuring that they understand the specific regulatory nuances of each region and can effectively manage submissions for companies looking to launch their biologics in multiple markets.

By outsourcing regulatory affairs to global specialists, companies can enter new markets more efficiently, reducing the time and cost associated with regulatory approval processes. This gives them a competitive advantage as they expand their footprint globally and tap into high-growth markets, particularly in emerging economies where the demand for biologics is rapidly increasing. The ability to navigate multiple regulatory environments quickly and effectively is a significant driver of the biologics regulatory affairs outsourcing market, particularly as companies expand their reach across borders.

Segmental Insights

Service Insights

Based on the Service, regulatory consulting is emerging as the most dominant. This can be attributed to the increasing complexity of biologic drug development and the diverse regulatory requirements across global markets. As biologics-such as monoclonal antibodies, gene therapies, and cell-based therapies-become more advanced, pharmaceutical companies require expert guidance to navigate the ever-changing regulatory landscape. Regulatory consultants bring essential expertise in interpreting and applying regulatory guidelines, ensuring that companies comply with the stringent and diverse requirements set by different regulatory bodies around the world.

Biologics are subject to a wide range of regulations, including preclinical requirements, clinical trial protocols, product labeling, and post-market surveillance. Each region-whether it's the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), or other regulatory authorities in Asia, South America, or emerging markets-has distinct rules and approval processes. The need to meet these regional standards while also adhering to international best practices creates a considerable demand for regulatory consulting services. Consultants with specialized knowledge in biologics can help companies develop regulatory strategies that align with the requirements of each market and guide them through the approval process, minimizing delays and reducing the risk of non-compliance.

Another reason why regulatory consulting dominates the biologics regulatory affairs outsourcing market is the demand for expedited market access. As biologics are increasingly used to treat complex and life-threatening conditions, companies are under pressure to bring these treatments to market as quickly as possible. Regulatory consultants are essential in identifying and navigating expedited approval pathways, such as the FDA's Breakthrough Therapy Designation or the EMA's Conditional Marketing Authorisation. These pathways offer the potential for faster approval but require a high level of expertise to navigate effectively. Consultants can assist in preparing and submitting applications for these accelerated processes, ensuring that companies capitalize on available opportunities to speed up market access.

Phase Insights

Based on the Phase segment, the preclinical stage is emerging as the dominant phase. The increasing complexity of biologic drug development and the need for regulatory oversight from the very beginning of the product's lifecycle make preclinical regulatory affairs a key area of focus for many pharmaceutical companies. Preclinical activities lay the foundation for clinical trials, making the regulatory process during this stage crucial for the success of any biologic product. The preclinical stage typically involves rigorous testing for pharmacology, toxicology, and safety, as well as the development of a robust regulatory strategy that will guide the subsequent clinical trial and commercialization phases.

As biologics become more intricate-encompassing gene therapies, monoclonal antibodies, and recombinant proteins-the regulatory requirements for preclinical studies have become more stringent. Regulatory agencies, such as the U.S. FDA and the European Medicines Agency (EMA), require comprehensive data on the safety, pharmacokinetics, and pharmacodynamics of biologic candidates before they can be approved for clinical trials. During this phase, regulatory affairs outsourcing firms play a pivotal role in helping companies navigate complex guidelines, prepare submissions, and ensure compliance with Good Laboratory Practice (GLP) and other international standards.

The preclinical phase also involves extensive documentation, including Investigational New Drug (IND) applications, which must be submitted to regulatory authorities before a company can progress to clinical trials. Regulatory consultants and outsourcing partners who specialize in biologics can help guide pharmaceutical companies through these requirements, ensuring that all the necessary documentation is in place and complies with regional regulations. Outsourcing partners provide valuable expertise in drafting preclinical study protocols, designing preclinical trials, and interpreting data to meet regulatory expectations. This specialized expertise significantly reduces the risk of delays caused by errors or non-compliance during the preclinical phase, which can cost companies time and resources in the long term.

Regional Insights

In the global biologics regulatory affairs outsourcing market, North America was the dominant region. The U.S. and Canada lead the market due to their well-established pharmaceutical and biotech industries, the advanced regulatory environment, and the significant investment in research and development (R&D). North America, particularly the United States, is home to many of the world's largest pharmaceutical and biotechnology companies, which have a major impact on the global biologics landscape. These companies frequently seek outsourcing partners with specialized knowledge in regulatory affairs to navigate complex approval processes, accelerate time-to-market, and ensure compliance with stringent regulatory requirements.

One of the primary reasons North America holds a dominant position in the biologics regulatory affairs outsourcing market is the presence of leading regulatory bodies such as the U.S. Food and Drug Administration (FDA) and Health Canada. The FDA is one of the most influential regulatory agencies globally, setting high standards for biologics approval and enforcement. As a result, U.S.-based pharmaceutical companies, as well as international companies targeting the U.S. market, frequently turn to regulatory affairs outsourcing providers with expertise in FDA regulations to ensure they meet the agency's complex requirements. The FDA's rigorous approval process for biologics, including the need for comprehensive clinical trial data, safety assessments, and quality control, drives the demand for specialized regulatory consulting and submission services. Regulatory affairs outsourcing providers in North America are well-versed in these requirements and provide services that help companies navigate the FDA's procedures, minimizing risks and delays in the approval process.

North America benefits from a highly developed infrastructure for biologic drug development and commercialization. This includes a vast network of research institutions, universities, and biotech companies that constantly push the boundaries of innovation in biologics. As the development of cutting-edge biologics, such as gene therapies, monoclonal antibodies, and cell-based therapies, becomes more prevalent, the need for regulatory expertise to manage the increasingly complex regulatory requirements has escalated. North American outsourcing firms have built a reputation for offering specialized services in preclinical and clinical trials, product registration, regulatory submissions, and ongoing compliance management, making them highly sought after by companies in the biologics space.

Key Market Players

• Lonza Group AG Ltd
• WuXi AppTec Co., Ltd.
• Freyr solutions
• Catalent Inc.
• ICON Plc
• Charles River Laboratories International, Inc.
• Laboratory Corporation of America Holdings
• Medpace, Inc.
• Iqvia Holdings Inc.
• Syneos Health

Report Scope:

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

Biologics Regulatory Affairs Outsourcing Market, By Service:

• Regulatory Consulting
• Legal Representation
• Regulatory Writing & Publishing
• Product Registration & Clinical
• Trial Applications
• Regulatory Submissions
• Regulatory Operations
• Others

Biologics Regulatory Affairs Outsourcing Market, By Phase:

• Preclinical
• Clinical

Biologics Regulatory Affairs Outsourcing Market, By Modality:

• Monoclonal Antibodies
• Recombinant Proteins
• Vaccines
• Cell & Gene Therapies
• Biosimilars
• Others

Biologics Regulatory Affairs 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 present in the Global Biologics Regulatory Affairs Outsourcing Market.

Available Customizations:

Global Biologics Regulatory Affairs 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 & Validations
• 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 Biologics Regulatory Affairs Outsourcing Market Outlook

• 5.1. Market Size & Forecast
  • 5.1.1. By Value
• 5.2. Market Share & Forecast
  • 5.2.1. By Service (Regulatory Consulting, Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical, Trial Applications, Regulatory Submissions, Regulatory Operations, and Others)
  • 5.2.2. By Phase (Preclinical and Clinical)
  • 5.2.3. By Modality (Monoclonal Antibodies, Recombinant Proteins, Vaccines, Cell & Gene Therapies, Biosimilars, and Others)
  • 5.2.4. By Region
  • 5.2.5. By Company (2024)
• 5.3. Market Map

6. North America Biologics Regulatory Affairs 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 Phase
  • 6.2.3. By Modality
  • 6.2.4. By Country
• 6.3. North America: Country Analysis
  • 6.3.1. United States Biologics Regulatory Affairs 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 Phase
      • 6.3.1.2.3. By Modality
  • 6.3.2. Canada Biologics Regulatory Affairs 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 Phase
      • 6.3.2.2.3. By Modality
  • 6.3.3. Mexico Biologics Regulatory Affairs 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 Phase
      • 6.3.3.2.3. By Modality

7. Europe Biologics Regulatory Affairs 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 Phase
  • 7.2.3. By Modality
  • 7.2.4. By Country
• 7.3. Europe: Country Analysis
  • 7.3.1. Germany Biologics Regulatory Affairs 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 Phase
      • 7.3.1.2.3. By Modality
  • 7.3.2. United Kingdom Biologics Regulatory Affairs 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 Phase
      • 7.3.2.2.3. By Modality
  • 7.3.3. Italy Biologics Regulatory Affairs 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 Phase
      • 7.3.3.2.3. By Modality
  • 7.3.4. France Biologics Regulatory Affairs 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 Phase
      • 7.3.4.2.3. By Modality
  • 7.3.5. Spain Biologics Regulatory Affairs 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 Phase
      • 7.3.5.2.3. By Modality

8. Asia-Pacific Biologics Regulatory Affairs 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 Phase
  • 8.2.3. By Modality
  • 8.2.4. By Country
• 8.3. Asia-Pacific: Country Analysis
  • 8.3.1. China Biologics Regulatory Affairs 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 Phase
      • 8.3.1.2.3. By Modality
  • 8.3.2. India Biologics Regulatory Affairs 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 Phase
      • 8.3.2.2.3. By Modality
  • 8.3.3. Japan Biologics Regulatory Affairs 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 Phase
      • 8.3.3.2.3. By Modality
  • 8.3.4. South Korea Biologics Regulatory Affairs 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 Phase
      • 8.3.4.2.3. By Modality
  • 8.3.5. Australia Biologics Regulatory Affairs 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 Phase
      • 8.3.5.2.3. By Modality

9. South America Biologics Regulatory Affairs 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 Phase
  • 9.2.3. By Modality
  • 9.2.4. By Country
• 9.3. South America: Country Analysis
  • 9.3.1. Brazil Biologics Regulatory Affairs 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 Phase
      • 9.3.1.2.3. By Modality
  • 9.3.2. Argentina Biologics Regulatory Affairs 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 Phase
      • 9.3.2.2.3. By Modality
  • 9.3.3. Colombia Biologics Regulatory Affairs 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 Phase
      • 9.3.3.2.3. By Modality

10. Middle East and Africa Biologics Regulatory Affairs 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 Phase
  • 10.2.3. By Modality
  • 10.2.4. By Country
• 10.3. MEA: Country Analysis
  • 10.3.1. South Africa Biologics Regulatory Affairs 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 Phase
      • 10.3.1.2.3. By Modality
  • 10.3.2. Saudi Arabia Biologics Regulatory Affairs 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 Phase
      • 10.3.2.2.3. By Modality
  • 10.3.3. UAE Biologics Regulatory Affairs 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 Phase
      • 10.3.3.2.3. By Modality

11. Market Dynamics

• 11.1. Drivers
• 11.2. Challenges

12. Market Trends & Developments

• 12.1. Merger & Acquisition (If Any)
• 12.2. Product Launches (If Any)
• 12.3. Recent Developments

13. Porter's Five Forces Analysis

• 13.1. Competition in the Industry
• 13.2. Potential of New Entrants
• 13.3. Power of Suppliers
• 13.4. Power of Customers
• 13.5. Threat of Substitute Products

14. Competitive Landscape

• 14.1. Lonza Group AG Ltd
  • 14.1.1. Business Overview
  • 14.1.2. Company Snapshot
  • 14.1.3. Products & Services
  • 14.1.4. Financials (As Reported)
  • 14.1.5. Recent Developments
  • 14.1.6. Key Personnel Details
  • 14.1.7. SWOT Analysis
• 14.2. WuXi AppTec Co., Ltd.
• 14.3. Freyr solutions
• 14.4. Catalent Inc.
• 14.5. ICON Plc
• 14.6. Charles River Laboratories International, Inc.
• 14.7. Laboratory Corporation of America Holdings
• 14.8. Medpace, Inc.
• 14.9. Iqvia Holdings Inc.
• 14.10. Syneos Health

15. Strategic Recommendations

16. About Us & Disclaimer