Global Regulatory Affairs Market Analysis, Drivers, Restraints, Opportunities, Threats, Trends, Applications, and Growth Forecast to 2029

Global Regulatory Affairs Market Overview:

"The Regulatory Affairs Market size is expected to be worth around US$ xx Billion by 2021 from US$ X.xx million in 2031, growing at a CAGR of X.x% during the forecast period 2021 to 2031."

Regulatory affairs, also known as government affairs, is a profession within regulated industries, whose main aim is to protect public health by controlling the efficacy and safety of products in areas such as pharmaceuticals, medical devices, agrochemicals, energy, banking, telecom, etc.

Dynamics:

The ongoing change in the regulatory landscape, the growing demand for faster approval processes, as well as the increasing prominence of emerging sector factions such as personalized medicines, specialty therapies, companion diagnostics, orphan drugs, etc., are some of the primary factors that are expected to continue to influence the revenue growth of the global regulatory affairs market over the next 10 years.

Increasing focus in the healthcare industry on the development of blockbuster therapies and on specialty drugs, targeted gene therapies. Precision medicine, as well as the use of these products in conjunction with medical devices to drastically improve patient and process outcomes, is another major factor that is slated to positively influence the future market growth of this global industry in the years to come.

In light of the recent COVID-19 outbreak, the operations of numerous industries have been either temporarily halted or are functioning with a minimal workforce due to enforced lockdowns and imposed restrictions by respective governing bodies. The global regulatory affairs industry is no different, and this factor is expected to negatively impact the revenue growth of this sector in the near future.

Nonetheless, numerous pharmaceutical/biotech are also looking to revamp their existing operational technologies in order to effectively cater to the growing healthcare needs of individuals across the world, as well as the anticipated launch of new products over the next decade are other factors that are expected to fuel the revenue growth of the global regulatory affairs market.

Segmentation of the global regulatory affairs market is as follows:

In terms of service, the regulatory writing & publishing segment accounted for the maximum number of revenue shares of the global regulatory affairs market in 2020, and is expected to index a high CAGR over the next decade. This can be attributed to the increase in the outsourcing of select regulatory affairs by key companies invested in life sciences, in order for them to focus on core affairs.  The legal representation segment is also slated to index considerable revenue growth in the coming years.

On the basis of categories, the medical devices segment accounted for the highest number of revenue shares of the global regulatory affairs market in 2020. However, the biologics sub-segment is slated to register the fastest rate of revenue growth over the next 10 years.

With regards to indication, the oncology segment accounted for the maximum number of revenue shares of the global regulatory affairs market in 2020. However, the immunology segment is anticipated to register the fastest rate of revenue growth over the forecast period.

Based on product stage, the clinical stage segment accounted for the maximum number of revenue shares in 2020. Although, the preclinical stage segment is slated to register the fastest rate of revenue growth in the coming years.

In terms of service provider, the outsourced segment accounted for the maximum number of revenue shares of the global regulatory affairs market in 2020, and is anticipated to index considerable revenue growth in the years to come.

With respect to company, medium-sized companies accounted for the majority revenue shares of the global regulatory affairs market I n2020, and is anticipated to continue doing so for the remainder of the forecast period.

On the basis of end-use, the pharmaceutical companies segment accounted for the maximum number of revenue shares of the global regulatory affairs market in 2020, and this segment is expected to continue to do so over the next 10 years.

Regional Segmentation and Analysis:

The markets in the Asia Pacific region accounted for the highest number of revenue shares of the global regulatory affairs market in 2020, and is anticipated to register the fastest rate of revenue growth in the years to come.

Segmentation of the Global Regulatory Affairs Market:

Segmentation by Service:

• Regulatory consulting
• Legal representation
• Regulatory writing & publishing
• Product registration & clinical trial applications
• Other services

Segmentation by Categories:

• Drugs
• Innovator
• Preclinical
• Clinical
• Post-market
• Generic
• Preclinical
• Clinical
• Post-market
• Biologics
• Biotech
• Preclinical
• Clinical
• Post-market
• ATMP
• Preclinical
• Clinical
• Post-market
• Biosimilars
• Preclinical
• Clinical
• Post-market
• Medical devices
• Diagnostics
• Preclinical
• Clinical
• Post-market
• Therapeutics
• Preclinical
• Clinical
• Post-market

Segmentation by Indication:

• Oncology
• Neurology
• Cardiology
• Immunology
• Others

Segmentation by Product Stage:

• Preclinical
• Clinical
• PMA

Segmentation by End-Use:

• Medical Device Companies
• Biotechnology Companies
• Pharmaceutical Companies

Segmentation by Service Provider:

• In-house
• Outsourced

Segmentation by Company Size:

• Small
• Medium
• Large

Segmentation by Regions:

• North America
• Europe
• APAC
• South America
• MEA