What is the global market size of the Regulatory Affairs Outsourcing Market?

Global Regulatory Affairs Outsourcing Market size was valued at USD 6.48 billion in 2021 and is poised to grow from USD 7 billion in 2022 to USD 13.99 billion by 2030, growing at a CAGR of 8% in the forecast period (2023-2030).

Who are the key vendors in the Global Regulatory Affairs Outsourcing Market?

Global regulatory affairs outsourcing market is highly competitive and somewhat fragmented. To maintain a competitive edge, the major industry participants are continually implementing various growth strategies. Innovations, mergers, and acquisitions, collaborations and partnerships are adopted by these players to thrive in the competitive market. In order to provide industries with the most effective and economical solutions, the major market players are also continually concentrating on R&D. 'IQVIA', 'PAREXEL International Corporation', 'Covance Inc.', 'Charles River Laboratories International Inc.', 'PRA Health Sciences Inc.', 'ICON plc', 'Syneos Health Inc.', 'Wuxi AppTec Inc.', 'FMD K&L Inc.', 'Clinilabs Drug Development Corporation', 'Premier Research', 'Medpace Holdings Inc.', 'Novotech Pty Ltd', 'Rho Inc.', 'Accell Clinical Research LLC', 'Genpact Limited', 'PharPoint Research Inc.', 'Catalyst Clinical Research LLC', 'MakroCare', 'Criterium Inc.'

What is the key driver of the Global Regulatory Affairs Outsourcing Market?

The increasing number of chronic illness cases, patent expirations of prescription biologics, brand extensions, immediate access to OTC drugs across various platforms, economic and social factors, increasing healthcare expenditures, and advancements in regulatory affairs outsourcing are the factors increasing the global demand for these services during the forecast period.

What is the key market trend for the Global Regulatory Affairs Outsourcing Market?

Increasing R&D investment to produce orphan, biosimilar, and generic drugs, as well as increased investment in clinical research, stringent government regulation, and an increased focus on product development to strengthen supply, are all making a significant contribution to the growth of the global regulatory affairs outsourcing market.

Which region accounted for the largest share in the Global Regulatory Affairs Outsourcing Market?

In 2021, the Asia Pacific region accounted for more than 38% of global revenue, and is further expected to have the significant market share during the forecast period due to an increase in clinical trials coupled with a spike in the proportion of companies trying to break into markets in emerging economies such as India and China. Furthermore, the availability of a qualified manpower in the region at lower costs than in the US is expected to drive regional market growth.

Regulatory Affairs Outsourcing Companies

Regulatory Affairs Outsourcing Market Competitive Landscape

Regulatory Affairs Outsourcing Market Top Player's Company Profiles

Accell Clinical Research, LLC
Genpact
CRITERIUM, INC
Promedica International
New WuXi Life Science Limited
Medpace
Bausch & Lomb
Freyr
SSI Strategy Holdings LLC
Pharmexon
Quanticate
PharmaLex
Cambridge Regulatory Services
APC Group
Real Regulatory Ltd
Ergomed Plc
Regulatory Pharma Net srl
Excelya Group SAS
BioMapas
REGENOLD GMBH

Regulatory Affairs Outsourcing Market

FAQs

Global Regulatory Affairs Outsourcing Market size was valued at USD 6.1 billion in 2022 and is poised to grow from USD 6.65 billion in 2023 to USD 12.62 billion by 2031, growing at a CAGR of 8.34% during the forecast period (2024-2031).

The regulatory affairs outsourcing market is characterized by intense competition, with key players leading the market such as Parexel International, IQVIA, PRA Health Sciences, ICON plc etc. Those companies provide comprehensive legal services, such as referrals, compliance monitoring and counselling. A notable example of strategic collaboration is the partnership between PAREXEL International and Oracle Health Sciences. This collaboration combines Oracle's advanced cloud-based clinical trial management technology with Parexel's regulatory expertise enabling customers to make regulatory submissions, ensure compliance, and accelerate drug development processes globally. Such alliances more efficient, enhance competitive advantage by providing tech-driven solutions. 'Accell Clinical Research, LLC ', 'Genpact ', 'CRITERIUM, INC ', 'Promedica International ', 'New WuXi Life Science Limited ', 'Medpace ', 'Bausch & Lomb ', 'Freyr ', 'SSI Strategy Holdings LLC ', 'Pharmexon ', 'Quanticate ', 'PharmaLex ', 'Cambridge Regulatory Services ', 'APC Group ', 'Real Regulatory Ltd ', 'Ergomed Plc ', 'Regulatory Pharma Net srl ', 'Excelya Group SAS ', 'BioMapas ', 'REGENOLD GMBH'

The regulatory landscape in various industries, particularly pharmaceutical, biotechnology and medical devices, is becoming increasingly complex because agencies such as the FDA (U.S.), EMA (Europe), and others frequently update regulations, guidelines, and compliance standards, it is difficult for companies to navigate these evolving systems. Regulation information outsourcing helps organizations meet these challenges by leveraging the expertise of specialized companies. These agencies have greater knowledge of local and global regulatory requirements, enabling companies to ensure compliance regardless of in-house groups. This need for awareness and flexibility is driving significant growth in regulatory issues.

Increasing the Use of Digital Solutions in Regulatory Matters: A key trend in the regulatory affairs outsourcing market is the increasing adoption of digital tools and platforms to streamline regulatory processes. Regulatory technology (RegTech) solutions are increasingly being used to manage how they comply with regulations, have automated shipments, follow approvals and follow regulatory changes. Legal outsourcing companies integrate digital systems to deliver fast, accurate and cost-effective solutions. Cloud-based solutions, AI, and automation increase productivity, reduce human error, and ensure real-time regulatory updates. This trend is changing how outsourcing of the regulatory functions is managed, making the process more transparent and scalable.

The Asia-Pacific region dominated the market and controlled the largest revenue share of over 39.9% in 2023. The region is also expected to witness the fastest CAGR during the forecast period this from increasing number of clinical trials. Apart from the reason that could be the availability of skilled labor in the region which is cheaper compared to the US. It is another driver for the regional market growth China is one of the attractive markets for the biopharmaceutical industry. The growing elderly population and the presence of a large middle-income population further increases the demand for new low-cost drugs, which are expected to attract major pharmaceutical companies of devices in this category for 12 to 24 months is needed while the approval process may need more than six years. In addition to receiving state approval, the new drug must be approved at the provincial and municipal levels, which could require an additional 4 to 5 years.

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What is the global market size of Regulatory Affairs Outsourcing Market?

Who are the key vendors in the Regulatory Affairs Outsourcing Market?

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Which region accounted for the largest share in Regulatory Affairs Outsourcing Market?

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