Regulatory Affairs Outsourcing Market is Expected to Cross USD 11.81 Billion at a CAGR of 8.9% from 2022-2028; Rapid Globalization of Clinical Trials to Propel Demand for Regulatory Affairs Outsourcing Services
The regulatory affairs outsourcing market is a rapidly expanding industry that is attracting the attention of investors and market participants worldwide. SkyQuest’s research report provides an invaluable resource for those seeking a comprehensive and trustworthy market understanding. In addition to offering insights into the industry’s products and services, the report includes regional market analysis, which is essential for identifying potential growth opportunities and making informed investment decisions. With the market’s performance varying across different regions worldwide, understanding these nuances is crucial for success in this industry.
Westford USA, March 15, 2023 (GLOBE NEWSWIRE) — The Asia Pacific region has become a prominent player in the regulatory affairs outsourcing market, with strong competition from North America and Europe. This growth can be attributed to the surge in research and development activities, which have increased the volume of clinical trial applications and product registration. Furthermore, expanding companies into new geographical locations has led to adopting outsourcing models for regulatory services. This trend is driven by the need for speedy approvals in local markets, and outsourcing can provide the necessary expertise and resources to achieve this goal. Furthermore, with a robust regulatory framework and a talented workforce, outsourcing regulatory services can offer a cost-effective and efficient solution to meet the demands of this growing market.
According to SkyQuest’s recent global research report, the clinical trials industry is poised to grow at a CAGR of 5.9%, reaching a value of US$ 80.53 billion by 2028. This forecasted growth is expected to surge demand for regulatory affairs outsourcing services. Outsourcing regulatory affairs can help pharmaceutical and biotech companies reduce costs, increase efficiency, and accelerate time-to-market for their products. It also allows them to access a wider talent pool and stay up-to-date with the latest regulatory developments.
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- Pages – 275
- Tables – 174
- Figures – 71
Regulatory affairs outsourcing refers to delegating regulatory compliance and documentation tasks to a third-party service provider. This outsourcing can take many forms, such as specific tasks or entire projects. Regulatory Affairs Outsourcing has become increasingly popular in recent years due to regulatory compliance requirements’ complex and time-consuming nature.
Prominent Players in Regulatory Affairs Outsourcing Market
- GenPack Ltd.
- Accell Clinical Research, LLC
- PRA Health Sciences
- Criterium Inc.
- Promedica International
- Zeincro Group
- ICON Plc.
- Parexel International Corp.
- Freyr
- Dr. Renengold GmbH
- Charles River Lab. International, Inc.
- Covance
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Regulatory Writing and Publishing Segment to Exhibit High Growth due to the Essential Nature of These Services and Complexity of the Regulatory Landscape
According to a recent market analysis, the regulatory affairs outsourcing market in 2021 was largely dominated by the regulatory writing and publishing segment. This segment is expected to maintain its dominance in the market from 2022 to 2028. The dominance of the regulatory writing and publishing segment can be attributed to the increasing complexity of regulatory requirements and the need for expertise in navigating regulatory frameworks. Outsourcing these tasks to specialized service providers can save time and resources for pharmaceutical companies while ensuring compliance with regulatory guidelines.
The regulatory affairs outsourcing market in the Asia Pacific region saw remarkable growth potential in 2021, with a positive future outlook. The region is expected to lead the way in outsourcing regulatory affairs services by 2028, fueled by increasing demand for cost-effective regulatory compliance solutions and the growing need for global regulatory harmonization. In addition, the Asia Pacific region is particularly attractive for outsourcing due to its lower labor costs and availability of skilled professionals.
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Large Company Segment to Generate Higher Revenues as Such Organizations Mostly Outsource their Regulatory Affairs Needs
The regulatory affairs outsourcing market witnessed significant growth in 2021, and the large company segment emerged as a promising contributor. As per segment analysis, this trend is expected to continue, and the large company segment will remain a key contributor to the market between 2022 and 2028. Regulatory affairs outsourcing has become increasingly popular among large companies, enabling them to streamline their regulatory processes and focus on their core competencies. In addition, by leveraging the expertise of regulatory consulting firms, companies can ensure compliance with regulations and minimize the risk of non-compliance.
The regulatory affairs outsourcing market witnessed remarkable growth in North America and Europe in 2021, expected to continue into 2022-2028. As companies face increasing regulatory requirements, they are outsourcing as a solution. The rapid growth of the regulatory affairs outsourcing market in North America and Europe can be attributed to several factors, including increasing regulatory complexity, cost pressures, and the need for specialized expertise. In addition, outsourcing regulatory affairs allows companies to tap into the expertise of third-party providers who are well-versed in the nuances of regulatory compliance and can help ensure that companies remain in good standing with regulatory bodies.
The regulatory affairs outsourcing market is highly competitive, and companies that operate in this market must differentiate themselves from their competitors in order to succeed. By utilizing the insights gained from SkyQuest’s industry analysis, companies can develop strategies to improve their competitive position and expand their businesses in this challenging and dynamic market.
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Key Developments in Regulatory Affairs Outsourcing Market
- Clariant, a leading specialty chemicals company, has significantly enhanced its regulatory affairs by transforming its product portfolio. The move aims to improve the company’s compliance with global regulations and standards, which are becoming increasingly stringent. Clariant’s product portfolio transforms by thoroughly reviewing each product’s formulation, composition, and manufacturing process.
- Celegence, a leading provider of regulatory consultancy services and solutions for the pharmaceutical industry, has acquired Qdossier to bolster its offerings. The acquisition will bring together two leading firms in the pharmaceutical industry, creating a stronger and more comprehensive service for clients. Celegence has long been known for its expertise in regulatory affairs, including regulatory strategy, submissions, and compliance.
- Merck, a leading pharmaceutical company, has recently renewed its regulatory compliance strategy to ensure that all its operations comply with the latest regulatory guidelines. Regulatory compliance is essential for pharmaceutical companies as it ensures they meet all the standards and regulations set forth by regulatory bodies. This strategy is a proactive approach that involves the implementation of policies, procedures, and processes designed to prevent and detect any violations of regulatory requirements.
Key Questions Answered in Regulatory Affairs Outsourcing Market Report
- What specific factors have positively impacted market growth in different regions?
- What strategies can businesses employ to capitalize on major global events for future growth?
- What are some notable case studies of major players driving innovation and adoption of new technologies in the target market?
- How have organizations in different regions specifically adapted to regulatory shifts within the target market?
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