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Regulatory Affairs Outsourcing Market - Global Outlook and Forecast 2022-2027

Regulatory Affairs Outsourcing Market - Global Outlook and Forecast 2022-2027

  • June 2022
  • 345 pages
  • ID: 6288148
  • Format: PDF
  • Arizton


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The Global Regulatory Affairs Outsourcing Market is expected to grow at a CAGR of 12.73%.

The following factors will drive the global regulatory affairs outsourcing market growth during the forecast period:

• Increasing Use of Digital Platforms/Solutions in Regulatory Affairs
• Changing Regulatory Landscape
• Rising Demand For Fast Drug & Medical Device Approvals
• Impact of Strict Government Regulations


RA serves as the interface between the regulatory authorities and companies, acts as the channel of communication with the regulatory authorities as to the approval process proceeds, and ensures that the approval will be executed effectively. RA outsourcing companies help biopharma and MedTech companies handle regulatory approval workflows flexibly, productively, and efficiently. Regulatory affairs service providers offer comprehensive services to companies, from strategic regulatory advice to regulatory maintenance and lifecycle support. It is the responsibility of RA outsourcing companies to keep abreast of current legislation, guidelines, and other regulatory intelligence.
• Across the world, there have been growing cases of chronic illness or infectious diseases, patent expirations of prescription biologics, developments of biosimilars/orphan drugs and cell and gene therapy products, brand extensions, easy accessibility of OTC drugs across various platforms, economic and social factors, increasing healthcare expenditures, and advancements in regulatory affairs outsourcing, which are increasing the demand for regulatory affairs outsourcing services.
• The healthcare industry is witnessing new compounds originating outside the companies ultimately responsible for marketing them. For instance, around one-third of approved drugs commercialized by big pharma/biotech companies were sourced from outside a decade ago. Approximately 50% to 70% of large companies’ pipeline molecules are currently sourced outside.
• In recent years, both pharma and medical device industries have witnessed many M&As, with oncology, orthopedic, and cardiovascular diseases being a particular area of interest. For instance, the pharma industry saw around 2,880 deals worth more than $1 trillion between 2014 and the first half of 2019 in gene therapy, immuno-oncology, microbiome, and orphan drugs.
• The healthcare regulatory affairs outsourcing market is highly competitive and competes with traditional CROs and in-house regulatory affairs departments in pharma/biotech and medical device companies.
Increasing Development of Biosimilars, Orphan Drugs, and Personalized Medicines
• Over the last two decades, a transformation has occurred in treating many chronic and highly complex diseases like autoimmune disorders, cancer, and diabetes, introducing biopharmaceuticals.
• Over the next five years, it is expected that the number of biosimilars and their market authorization will increase significantly as top-selling biologics such as Herceptin (Trastuzumab; Roche/Genentech), Enbrel (Etanercept; Amgen), Humalog (Insulin Lispro;), MabThera (Ritziximab; Roche, Basel), and Aranep (Darbepoetin Alpha; Amgen) go off patent.
• Pfizer has agreed with Biocon (India) to produce biosimilar insulin. Eli Lilly and AstraZeneca have announced plans to produce biosimilars, and Boehringer Ingelheim has established a specialized business to develop and sell biosimilars.
• Another challenge for pharmaceutical companies and other life sciences companies is anticipating the regulation of personalized medicine such as gene therapy and cell therapy. As R&D related to human cell and gene therapy grows rapidly, all stakeholders need to be aware of regulatory changes quickly.

The emergence of Virtual Trials and Virtual Communication

• Many regulatory authorities around the globe issued guidance documents containing information on how trials could continue during the pandemic, which includes 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 COVID-19 pandemic has energized the ascent of clinical trials without clinical sites and made way for proceeding with these inventive models after the general well-being emergency has blurred.
• A constellation of emerging technology and services has permitted the relocation of clinical-trial activities closer to patients. Without in-person visits, investigators can maintain relationships with study participants using electronic consent, telehealthcare, remote patient monitoring, and electronic clinical outcome assessments (eCOAs).
• Before the pandemic, an Industry Standard Research survey in December 2019 found that 38% of pharma and contract research organizations (CROs) expected virtual trials to be a major part of their portfolios, and 48% expected to run a trial with most activities taking place in participants’ homes.
• Sponsors and service providers attempting to execute decentralized trials must manage technological and approach uncertainties while balancing the demands of each stakeholder group and providing a good, distinctive experience.

Changing Regulatory Landscape

• In recent years, life sciences companies have faced increasing pressure, including regulatory requirements, technological advances, and pricing pressure. COVID-19 has only provided more reasons for modernizing compliance and improving values and partnerships within the organization and with external stakeholders.
• A recent global survey of pharmaceutical company CEOs reveals that regulations are being scrutinized for many aspects of business, including sales and marketing practices, government reporting of drug prices, privacy controls, and clinical practice.
• Changes in the regulation viewed it as one of the top three disruptive business trends facing pharmaceutical and life sciences companies. Large pharmaceutical companies recognize these changes as the greatest threat to their potential future growth.
• Contract research organizations (CROs) are well experienced and have updated on all changes in regulatory affairs in the pharmaceutical or the medical device industry. Thus, the pharmaceutical and medical devices companies are increasingly outsourcing the regulatory affairs activities to CROs.


The small molecules drugs market size will cross USD 3 billion in 2022. For many decades, small molecule drug compounds have been the mainstay of the pharmaceutical industry. Small molecule drugs continue to play an essential role in developing new therapies globally. The demand for small molecule drugs remains high, with around 97% of the commercial drugs available in the market classified as small molecules.

The biologics segment will likely witness a faster growth rate due to a surge in demand for biopharmaceuticals like mAbs, vaccines, cell & gene therapies, recombinant proteins, etc.

Major Biologics & Their Revenue in 2019 & 2020

• In 2020, one of the key companies, AbbVie, has sold around USD 19.8 billion worth of HUMIRA drugs compared to USD 19.1 billion in 2019, which shows an increment of almost 3.5% in sales.
• Johnson & Johnson sold approximately USD 7.7 billion worth of STELARA drugs in 2020, compared to USD 6.3 billion in 2019, representing a more than 21% increase in sales.
• In 2020, Merck & Co. sold around USD 14 billion worth of KEYTRUDA drugs, up from USD 11 billion in 2019. This is a more than 29% increase in sales.

The small & mid-sized companies reported a major share of around 63.73% of the global regulatory affairs outsourcing market. Small and Medium-sized companies are leading because small and Medium-sized pharmaceutical companies outsource about 90% and 75% of their regulatory requirements. These companies often face resource and technology shortages and partner with suppliers on a project basis.

The pharma & biotech companies market reported a major share of around 65.19%. Pharmaceutical and biotechnology companies have partnered with contract research organizations (CROs) for outsourcing needs, including regulatory services. Most companies choose CROs for outsourcing regulatory services. They believe that regulatory outsourcing companies have the conceptual and technical expertise to achieve efficient results.

The pre-authorization market reported a major share of around 55.48% of the global regulatory affairs outsourcing market. US and EU health authorities require most regulatory applications to be received in ICH harmonized CTD format in the current regulatory era. A thorough submission approach and standardized CTD document templates enable effective regulatory submissions and subsequent lifecycle management with shorter and cost-effective parameters.

The North American region dominates the regulatory affairs outsourcing market with around 33% of the market share. The US is the major revenue contributor to the North American regulatory affairs outsourcing market and accounted for around 91% in 2021. The region’s growth is primarily attributed to the increasing number of chronic diseases, development of biologics & biosimilars, increasing healthcare expenditures, and increasing innovation & advancements in regulatory affairs outsourcing.

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 Region
• North America
o US
o Canada
• Europe
o Germany
o France
o UK
o Italy
o Spain
o China
o Japan
o Australia
o South Korea
o India
• Latin America
o Brazil
o Mexico
o Argentina
• Middle East & Africa
o Turkey
o Saudi Arabia
o South Africa

Key Vendors
• Genpact
• Labcorp Drug Development
• Freyr
• Medpace
• Parexel International

Other Prominent Vendors
• Accenture
• BlueReg
• Intertek Group
• Lachman Consultants
• NDA Group
• ProPharma Group
• PharmaLex
• Pharmexon
• Promedica International
• Dicentra
• Nuventra Pharma Sciences
• PharmaLeaf
• Global Regulatory Partners
• Sofpromed
• Charles River Laboratories
• Cambridge Regulatory Services
• APC Group
• Real Regulatory
• Voisin Consulting Life Sciences (VCLS)
• Regulatory Pharma Net
• Biomapas

1. What will be the size of the Regulatory Affairs Outsourcing Market by 2028?
2. What are the factors driving the market growth?
3. Who are the key vendors in the regulatory affairs outsourcing industry?
4. Which region holds the highest growth rate in the regulatory affairs outsourcing industry?

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