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Biologics Regulatory Affairs Outsourcing Market Size, Share & Trends Analysis Report By Service (Regulatory Consulting), By Phase, By Modality, Phase by Service, Phase by Modality, Modality by Service, By Region, And Segment Forecasts, 2025 - 2030
»óǰÄÚµå : 1632594
¸®¼­Ä¡»ç : Grand View Research, Inc.
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Biologics Regulatory Affairs Outsourcing Market Growth & Trends:

The global biologics regulatory affairs outsourcing market size is expected to reach USD 3.69 billion by 2030, registering a CAGR of 9.06% from 2025 to 2030, according to a new report by Grand View Research, Inc. Globalization of biopharmaceutical companies is one of the major growth drivers boosting overall market demand. Emerging markets of Asia Pacific, Latin America, and MEA regions offer low product development & manufacturing costs, tax benefits, and availability of skilled labor at relatively low costs with supportive regulations. The abovementioned factors have made the regional markets attractive prospects in terms of outsourcing and expansion for biopharmaceutical companies, thereby stimulating the demand for regulatory services. Furthermore, the presence of EMA- and/or FDA-approved facilities in emerging economies is anticipated to increase foreign investments in the country and the demand for regulatory services, such as legal representation and regulatory consulting services.

A significant increase has been witnessed in the number of clinical trials conducted in emerging economies. This can be attributed to the availability of skilled labor, advanced technologies, and infrastructure facilities at relatively lower costs than developed economies such as the U.S., which is expected to stimulate the demand for regulatory services such as clinical trial applications & product registrations in these regions. Emerging economies contribute to more than 30.0% of total clinical trial applications submitted across the globe, and the share is expected to increase over the coming years, contributing to market growth.

Several biopharmaceutical companies are focusing on their core competencies and outsourcing noncore functions to increase their productivity & operational efficiency. These companies face several challenges with regard to complying with global regulations, which can be a lengthy and tedious process. Thus, the race to launch a novel molecule in the market in a feasible timeline and at a reasonable cost will likely propel the demand for service providers. Furthermore, many small- and medium-scale biopharma companies lacking in-house capabilities are inclined towards outsourcing regulatory affairs, which is estimated to positively influence the industry's progression.

Growth in markets for biosimilars, orphan drugs, personalized medicines, adaptive trial designs, and others is projected to boost the demand for regulatory specialization in these areas. As several companies expand into new avenues, the increasing need for skilled service providers with experience in regulations leads to the necessity to comply with regulations. Government support, especially in developed economies, has significantly increased the development of orphan drugs. Patent expiration of biologics, such as Simulect, Vectibix, Mircera, and Kineret, is increasing the demand and development of biosimilars, thereby contributing to the demand for regulatory services in this segment.

Biologics Regulatory Affairs Outsourcing Market Report Highlights:

Table of Contents

Chapter 1. Methodology and Scope

Chapter 2. Executive Summary

Chapter 3. Biologics Regulatory Affairs Outsourcing Market Variables, Trends & Scope

Chapter 4. Biologics Regulatory Affairs Outsourcing Market: Service Estimates & Trend Analysis

Chapter 5. Biologics Regulatory Affairs Outsourcing Market: Phase Estimates & Trend Analysis

Chapter 6. Biologics Regulatory Affairs Outsourcing Market: Modality Estimates & Trend Analysis

Chapter 7. Biologics Regulatory Affairs Outsourcing Market: Phase by Service Estimates & Trend Analysis

Chapter 8. Biologics Regulatory Affairs Outsourcing Market: Phase by Modality Estimates & Trend Analysis

Chapter 9. Biologics Regulatory Affairs Outsourcing Market: Modality by Service Estimates & Trend Analysis

Chapter 10. Biologics Regulatory Affairs Outsourcing Market: Regional Estimates & Trend Analysis

Chapter 11. Competitive Landscape

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