The "Biologics Regulatory Affairs Outsourcing Market Size, Share & Trends Analysis Report By Service, By Phase, By Modality, Phase by Service, Phase by Modality, Modality by Service, By Region, And Segment Forecasts, 2025 - 2030" report has been added to ResearchAndMarkets.com's offering.
The biologics regulatory affairs outsourcing market is set for significant expansion, predicted to reach USD 3.69 billion by 2030, with a compound annual growth rate (CAGR) of 9.06% from 2025 to 2030
This growth trajectory can be largely attributed to the globalization of biopharmaceutical companies coupled with the allure of emerging markets. Regions such as Asia Pacific, Latin America, and MEA present attractively low costs for product development and manufacturing, tax benefits, and skilled yet affordable labor. The complementing regulations in these areas enhance their appeal for biopharmaceutical operations, subsequently fueling the surge in demand for regulatory services.
Clinical Trials and Operational Efficiencies Catalyze Market Dynamics
A notable uptick in clinical trials within burgeoning economies is apparent, propelled by the procurement of talent, modern technologies, and infrastructural facilities at a more economic rate than those found in western counterparts such as the U.S. This scenario is anticipated to escalate the need for regulatory services including clinical trial applications and product registrations. The outsourcing trend is being spurred on by biopharmaceutical enterprises aiming to concentrate on core competencies while enhancing productivity, and by an intricate and often protracted compliance landscape that necessitates specialized assistance.
Specialization and Patent Expirations Enrich the Sector
Emergent markets for biosimilars, orphan drugs, and personalized medicines are foreseen to inject vigor into the demand for regulatory specialization. As organizations navigate new territories, the prerequisite for adept service providers familiar with regulations becomes increasingly critical. Legislative support, specifically within developed nations, has substantially elevated the production of orphan drugs. Moreover, with biologic patents reaching their terminus, the burgeoning biosimilars market is also invigorating the need for regulatory affairs services.
Regional Spotlight and Market Insights
Dominating the sector, the Asia Pacific region commanded a significant revenue share in 2024 and is forecast to ascend at a record CAGR throughout the projection period. This underscores the pivotal role this area plays in shaping the global biologics regulatory affairs outsourcing market. The market is characterized by several dynamic trends and driving factors that end-users and stakeholders in the biopharmaceutical industry must navigate to secure a competitive edge and ensure compliance with multifaceted global regulations amidst the rapid innovation in biologics.
Future-Focused and Informed Decision-Making
Access to comprehensive market analyses, competitive landscapes, and emergent trend forecasts is essential for forward-thinking organizations poised to attain new revenue opportunities and to formulate strategic business decisions. The evolving market conditions, particularly in light of the COVID-19 pandemic, necessitate a nuanced understanding of the market dynamics at play to maintain resilience and foster growth in these rapidly changing environments.
The indicated growth and trends highlight the dynamic and increasingly pivotal role that the biologics regulatory affairs outsourcing market is expected to play in the global biopharmaceutical sector by 2030.
Key Attributes:
| Report Attribute | Details |
| No. of Pages | 120 |
| Forecast Period | 2024 - 2030 |
| Estimated Market Value (USD) in 2024 | $2.22 billion |
| Forecasted Market Value (USD) by 2030 | $3.69 billion |
| Compound Annual Growth Rate | 9.0% |
| Regions Covered | Global |
Companies Featured
- Lonza AG
- Wuxi AppTec Inc.
- Thermo Fisher Scientific Inc.
- Eurofins Scientific SE
- Freyr solutions
- Catalent Inc.
- Piramal Group
- AGC Biologics
- ICON Plc.
- Charles River Laboratories International, Inc.
- Labcorp
- Parexel International
- Medpace Holdings, Inc.
- IQVIA
- Syneos Health
- SGS SA (SGS)
For more information about this report visit https://www.researchandmarkets.com/r/9ug9i
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View source version on businesswire.com: https://www.businesswire.com/news/home/20250115829994/en/
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