Healthcare Regulatory Affairs Outsourcing Market Report 2028

[Research Report] The healthcare regulatory affairs outsourcing market is projected to reach US$ 14,996.35 million by 2028 from US$ 7,274.73 million in 2021; it is expected to grow at a CAGR of 10.9 % from 2021 to 2028.

The increasing regulatory pressure on healthcare companies and escalating demand for speedy approval of new products. However, dearth of skilled professionals is restraining the healthcare regulatory affairs outsourcing market growth. Regulatory affairs outsourcing is the services offered to the pharmaceutical, biotech, and medical devices manufacturing industries. Regulatory affair outsourcing services help to achieve fast regulatory approvals. Regulatory affairs outsourcing industries are helping to get approval for new products, preparing protocols for conducting a clinical trial, publishing reports etc. An increase in demand for various services like regulatory consultation, medical writing and publishing of the regulatory documentation, clinical trial applications, and regulatory consulting and legal representations, patent application, product registration, and clinical trial applications has resulted in a surge in the adoption of healthcare regulatory affairs outsourcing business.

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Healthcare Regulatory Affairs Outsourcing Market: Strategic Insights

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Market Insights

Increasing Regulatory Pressure on Healthcare Companies Healthcare Regulatory Affairs Outsourcing Market Growth

Continuous upgrades and progress in traditional drug development approaches are creating significant challenges in the healthcare sector. There is tremendous pressure on the pharmaceutical companies and medical fraternity to reduce the cost of prescription drugs, while their operational costs are skyrocketing. The complexity of regulatory requirements, declining revenues due to blockbuster drugs going off patent, and pressure from governments as well as health insurers for reduction in healthcare cost has presented additional challenges to healthcare industries. Given these difficulties, pharmaceutical companies have realized the need to leverage their resources along with the expertise provided by specialist external sources. Many high-end regulatory consulting companies are offering their expertise across the complete product life cycle. The outsourcing of regulatory affairs may enable sponsors to gain experience, optimize cost, and enhance productivity. Regulatory outsourcing companies are in better position to assess regulatory requirements, which allows them to select the best solutions. They are well versed with understanding associated with implementing, operating, and maintaining a regulatory publishing system. Most of the big pharmaceutical and biotechnology companies look out for consulting companies that can also offer supporting regulatory and pharmacovigilance services.

The increased complexity of regulatory filings underlines the demand for specialist CRO expertise. Having planned product-specific regulatory advice and strategies, along with healthcare regulatory compliance measures, in an early stages of product development is extremely important for the regulatory approval of the products. Failure to address the compliance in the early stage of development often leads to delay in the approval process due to inappropriately filed documentations, manufacturing oversights, omitted regulatory studies, and other failures to meet the regulatory requirements. Healthcare companies are now focusing on their core competencies and outsourcing the noncore functions to improve productivity and operational efficiency. They generally outsource regulatory functions to CROs operational in emerging markets, such as Asia Pacific and the MEA, which also allows them to reduce their operational costs and strengthen their focus on core functions such as R&D activities, and existing products’ sales and distribution.

Service Type-Based Insights

Based on service type, the healthcare regulatory affairs outsourcing market is segmented into Regulatory & Scientific Strategy Development, Medical & Scientific Writing, eCTD & e-Submissions, Data Management Services, Life Cycle Management Services, Pharmacovigilance, Chemistry Manufacturing & Controls (CMC) Services, Regulatory Labelling, Regulatory Artwork Services. The Medical & Scientific Writing segment is expected to hold a larger market share in 2021, and Pharmacovigilance segment is further anticipated to register a higher CAGR during the forecast period.

End User-Based Insights

Based on end user, the healthcare regulatory affairs outsourcing market is segmented into Pharmaceutical Companies, Biotechnology Companies, and Medical Devices Companies. The Pharmaceutical Companies segment would account for a larger market share in 2021. The market for the Pharmaceutical Companies segment is estimated to grow at a higher CAGR from 2021 to 2028.

Companies operating in the healthcare regulatory affairs outsourcing market adopt the product innovations strategy to meet the evolving customer demands worldwide, which also permits them to maintain their brand name in the global market.

Healthcare Regulatory Affairs Outsourcing Market Regional Insights

The regional trends and factors influencing the Healthcare Regulatory Affairs Outsourcing Market throughout the forecast period have been thoroughly explained by the analysts at Insight Partners. This section also discusses Healthcare Regulatory Affairs Outsourcing Market segments and geography across North America, Europe, Asia Pacific, Middle East and Africa, and South and Central America.

Healthcare Regulatory Affairs Outsourcing Market Market Report Scope

Market Players Density: Understanding Its Impact on Business Dynamics

The Healthcare Regulatory Affairs Outsourcing Market market is growing rapidly, driven by increasing end-user demand due to factors such as evolving consumer preferences, technological advancements, and greater awareness of the product's benefits. As demand rises, businesses are expanding their offerings, innovating to meet consumer needs, and capitalizing on emerging trends, which further fuels market growth.

Market players density refers to the distribution of firms or companies operating within a particular market or industry. It indicates how many competitors (market players) are present in a given market space relative to its size or total market value.

Major Companies operating in the Healthcare Regulatory Affairs Outsourcing Market are:

1. KLIFO
2. ProPharma Group
3. Arriello Ireland Ltd.
4. DRA CONSULTING OY
5. Asphalion S.L.

Disclaimer: The companies listed above are not ranked in any particular order.

 

Healthcare Regulatory Affairs Outsourcing Market – by Service Type

• Regulatory & Scientific Strategy Development
• Medical & Scientific Writing
• eCTD & e-Submissions
• Data Management Services
• Life Cycle Management Services
• Pharmacovigilance
• Chemistry Manufacturing & Controls (CMC) Services
• Regulatory Labelling
• Regulatory Artwork Services

Healthcare Regulatory Affairs Outsourcing Market – by End User

• Pharmaceutical Companies
• Biotechnology Companies
• Medical Devices Companies
  • Medical Device Software (SaMD)
  • Medical Device Materials & Biomaterials
  • Medical Device Biomarkers and In vitro Diagnostics (IVD)
  • Medical Device Substance-based
  • Medical Device of Combination Product (DDC)

Healthcare Regulatory Affairs Outsourcing Market – by Geography

• North America
  • US
  • Canada
  • Mexico
• Europe
  • France
  • Germany
  • Italy
  • UK
  • Spain
  • Rest of Europe
• Asia Pacific (APAC)
  • China
  • India
  • South Korea
  • Japan
  • Australia
  • Rest of Asia Pacific
• Middle East & Africa (MEA)
  • South Africa
  • Saudi Arabia
  • UAE
  • Rest of Middle East & Africa
• South & Central America (SCAM)
  • Brazil
  • Argentina
  • Rest of South and Central America 

Company Profiles

• KLIFO
• ProPharma Group
• Arriello Ireland Ltd.
• DRA CONSULTING OY
• Asphalion S.L
• Parexel International Corporation
• IQVIA Inc.
• Pharmalex Gmbh
• ProductLife Group
• Voisin Consulting Life Sciences (VCLS)
• Azierta Contract Science Support Consulting