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Market Overview

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The global regulatory affairs outsourcing market is projected to reach $16.8 billion by 2027, with a compound annual growth rate (CAGR) of 12.73%. Regulatory Affairs is a profession found in regulated industries such as pharmaceuticals, medical devices, energy, and banking. This field holds particular significance for the healthcare industry, including pharmaceuticals, medical devices, biologics, and functional foods. Whether it’s a large multinational pharmaceutical company or a small, innovative biotechnology firm, most companies have dedicated departments with regulatory expertise. The demand for regulatory affairs outsourcing services is rapidly increasing in the pharmaceutical, biotech, and medical device sectors. These companies face constant pressure to obtain timely marketing and clinical approvals from regulators in the regions where they operate due to the rise in drug pipelines, product registrations, clinical trials, and research and development activities.

Regulatory bodies and agencies play a crucial role in safeguarding public health by ensuring the safety, efficacy, and quality of human and veterinary drug products, biopharmaceuticals, medical devices, and food supply. They also accelerate innovations that enhance the effectiveness, safety, and affordability of healthcare products while providing accurate scientific information to the public for the maintenance and improvement of healthcare products and food safety.

Regulatory affairs (RA) serves as the interface between regulatory authorities and companies, facilitating communication during the approval process and ensuring effective execution of approvals. RA outsourcing companies assist biopharma and MedTech firms in managing regulatory approval workflows flexibly, productively, and efficiently. These service providers offer comprehensive support, ranging from strategic regulatory advice to regulatory maintenance and lifecycle management. RA outsourcing companies have the responsibility of staying up-to-date with current legislation, guidelines, and other regulatory intelligence.

Globally, there is a growing prevalence of chronic illnesses and infectious diseases, patent expirations of prescription biologics, advancements in biosimilars and orphan drugs, developments in cell and gene therapy products, brand extensions, accessible over-the-counter drugs through various platforms, economic and social factors, rising healthcare expenditures, and progress in regulatory affairs outsourcing. These factors are contributing to the increasing demand for regulatory affairs outsourcing services.

The healthcare industry is witnessing a trend where new compounds originate from sources outside the companies responsible for marketing them. Approximately one-third of approved drugs commercialized by big pharma and biotech companies were sourced externally a decade ago. Currently, 50% to 70% of pipeline molecules in large companies are acquired from external sources.

In recent years, both the pharmaceutical and medical device industries have experienced numerous mergers and acquisitions, with a particular focus on oncology, orthopedics, and cardiovascular diseases. For example, between 2014 and the first half of 2019, the pharmaceutical industry witnessed around 2,880 deals worth more than $1 trillion in gene therapy, immuno-oncology, microbiome, and orphan drugs.

The healthcare regulatory affairs outsourcing market is highly competitive, competing with traditional contract research organizations (CROs) and in-house regulatory affairs departments in pharmaceutical, biotech, and medical device companies.

Over the past two decades, there has been a transformation in the treatment of chronic and highly complex diseases such as autoimmune disorders, cancer, and diabetes, with the introduction of biopharmaceuticals. It is expected that over the next five years, there will be a significant increase in the number of biosimilars and their market authorizations as top-selling biologics, such as Herceptin, Enbrel, Humalog, MabThera, and Aranep, go off-patent. Companies like Pfizer, Biocon, Eli Lilly, AstraZeneca, and Boehringer Ingelheim have already made plans or established specialized businesses to produce biosimilars.

Another challenge for pharmaceutical and life sciences companies is anticipating the regulation of personalized medicine, including gene therapy and cell therapy. As research and development in these areas continue to advance rapidly, all stakeholders must remain aware of regulatory changes.

During the COVID-19 pandemic, regulatory authorities worldwide issued guidance documents to ensure the continuity of clinical trials. These included organizations such as the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Medicines and Healthcare Products Regulatory Agency (MHRA), and Singapore’s Health Science Authority. The pandemic has accelerated the adoption of virtual and decentralized clinical trials, enabling remote patient monitoring, electronic consent, telehealthcare, and electronic clinical outcome assessments (eCOAs). Even before the pandemic, a significant percentage of pharmaceutical and contract research organizations (CROs) had anticipated virtual trials becoming a major part of their portfolios.

In recent years, life sciences companies have faced increasing pressure due to regulatory requirements, technological advancements, and pricing pressures. The COVID-19 pandemic has further highlighted the need for compliance modernization, value improvement, and strong partnerships within and outside the organization.

A global survey of pharmaceutical company CEOs revealed that regulations are being closely scrutinized in various aspects of business, including sales and marketing practices, reporting drug prices to governments, privacy controls, and clinical practices. Regulatory changes were considered one of the top disruptive business trends facing pharmaceutical and life sciences companies. Consequently, pharmaceutical and medical device companies are increasingly outsourcing their activities to well-experienced contract research organizations (CROs) who stay up-to-date with all changes in regulatory affairs in the industry.

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Market Segmentation

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The market is segmented based on various factors, including product, company size, end-user, service type, geography.

Segmentation by Product
Small Molecule Drugs
Biologics
Medical Devices
Others

Segmentation by Company Size
Small & Mid-Sized Companies
Large-sized Companies

Segmentation by End-User
Pharma & Biotech Companies
Medical Device Companies
Other Companies

Segmentation by Service Type
Pre-Authorization
Marketing Authorization
Post-Authorization

Segmentation by Geography
North America – US, Canada
Europe – Germany, France, UK, Italy, Spain
APAC – China, Japan, India, South Korea, Australia
Latin America – Brazil, Mexico, Argentina
Middle East & Africa – South Africa, Saudi Arabia, Turkey, UAE

In 2022, the size of the small molecule drugs market is projected to exceed USD 3 billion. Small molecule drug compounds have been a cornerstone of the pharmaceutical industry for many decades and continue to play a crucial role in the development of new therapies worldwide. The demand for small molecule drugs remains strong, with approximately 97% of commercially available drugs classified as small molecules.

The biologics segment is expected to experience a higher growth rate, driven by the increasing demand for biopharmaceuticals such as monoclonal antibodies (mAbs), vaccines, cell and gene therapies, recombinant proteins, and others.

AbbVie, one of the key companies in the industry, witnessed a 3.5% increase in sales of their HUMIRA drugs, with sales amounting to around USD 19.8 billion in 2020 compared to USD 19.1 billion in 2019. Johnson & Johnson also reported a significant increase in sales of their STELARA drugs, reaching USD 7.7 billion in 2020 compared to USD 6.3 billion in 2019, representing a more than 21% growth. Merck & Co. experienced a remarkable sales increase of over 29% for their KEYTRUDA drugs, with sales amounting to around USD 14 billion in 2020 compared to USD 11 billion in 2019.

Small and mid-sized companies hold approximately 63.73% of the global regulatory affairs outsourcing market share. These companies, facing resource and technology limitations, often outsource around 90% and 75% of their regulatory requirements and collaborate with suppliers on a project basis.

The pharma and biotech companies market constitutes a significant share of around 65.19%. Many pharmaceutical and biotechnology companies choose to partner with contract research organizations (CROs) for regulatory services outsourcing. They rely on the expertise of regulatory outsourcing companies to achieve efficient results in terms of conceptual and technical aspects.

The pre-authorization market represents a significant share of around 55.48% of the overall market. US and EU health authorities now require regulatory applications in the ICH harmonized CTD format. Adopting a thorough submission approach and using standardized CTD document templates enable effective regulatory submissions and subsequent lifecycle management with shorter timelines and cost-effective measures.

The North American region dominates the market, accounting for approximately 33% of the market share. The United States is the primary revenue contributor in North America, representing around 91% in 2021. Factors such as the rising prevalence of chronic diseases, advancements in biologics and biosimilars, increased healthcare expenditures, and ongoing market innovation have contributed to the region’s growth and dominance.

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Competitive Landscape

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Key companies profiled in this report include Genpact, Labcorp Drug Development, Freyr, ICON, IQVIA, Medpace, Parexel International, PPD, Accenture, BlueReg, Intertek Group, Lachman Consultants, NDA Group, ProPharma Group, PharmaLex, Pharmexon, Promedica International, CRITERIUM, Dicentra, Nuventra Pharma Sciences, PharmaLeaf, MAVEN REGULATORY SOLUTIONS, Global Regulatory Partners, Sofpromed, Charles River Laboratories, Cambridge Regulatory Services, APC Group, Real Regulatory, Voisin Consulting Life Sciences (VCLS), Regulatory Pharma Net, Biomapas, REGENOLD.

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Key Questions Answered

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What is the expected market size of the Regulatory Affairs Outsourcing Market by 2028?

The market size of the regulatory affairs outsourcing industry is projected to reach USD 16.8 billion by 2028.

What factors are contributing to the growth of the market?

The growth of the regulatory affairs outsourcing market is driven by factors such as the changing regulatory landscape, increased utilization of digital platforms and solutions in regulatory affairs, and the impact of stringent government regulations.

Who are the major vendors in the regulatory affairs outsourcing industry?

Some key players in the regulatory affairs outsourcing industry include Genpact, Freyr, ICON, IQVIA, Medpace, and Parexel International.

Which region is experiencing the highest growth rate in the regulatory affairs outsourcing industry?

North America is witnessing the highest growth rate in the global regulatory affairs outsourcing market.