Medical Device Regulatory Affairs Market Size to Hit US$ 11.6 BN by 2030

According to Vision Research Reports, the Medical Device Regulatory Affairs market size is expected to hit around US$ 11.6 billion by 2030 and is predicted to grow at a CAGR of 10.6% from 2021 to 2030.

Growth Factors

Technological advancements in medical devices such as AI/Machine learning, increasing trends of portable and smaller devices, and government regulations are driving the market.

Medical equipment regulation is a vast and rapidly changing field that is often complicated by legal challenges. Even within one regulatory framework, legal terms and their definitions are not always consistent. As technology expands, software, machine learning, and algorithms become an essential component of an increasing number of digital health resources. This presents new challenges as an increasing number of instruments fall under the regulatory framework.

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Also, due to COVID-19, the global regulatory landscape is changing for all medical device companies. Exemptions have been granted by countries ranging from China to Australia and beyond. China has intensified the registration of medical protective clothing. Respirators, protective gear, thermometers, and surgical masks are exempt from registration requirements in Singapore.

Scope of the Report

Service Insights

The regulatory writing and publishing segment dominated the market for medical device regulatory affairs with 36.4% of revenue share in 2020. This is largely attributed to the fact that these services are provided from the early stages of product development to premarket approval, as high-quality documentation is essential for regulatory affairs in order to escape delays in the approval process. Hence, with the increasing number of products in development, the demand for these services is likely to increase, thereby contributing to the growth of the market for medical device regulatory affairs.

The segment of product registration and clinical trial services is anticipated to witness the fastest growth rate of 25.1% over the forecast period. The clinical trial for a medical device and regulations to manage the studies are very different. The medical device studies are complex that span across regulatory challenges, product types, and unique statistical analyses and study designs. Hence, this creates more demand for the services supporting market growth.

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Service Provider Insights

The outsourcing segment dominated the market for medical device regulatory affairs with the largest revenue share of 60.0% in 2020. This is largely attributed to the lack of an in-house regulatory team. Besides, the advantages such as cost and time saving associated with the outsourcing of these services are contributing to the market growth.

Besides, new regulatory challenges, such as medical device regulation and in vitro diagnostic device regulation in Europe, as well as regulatory cybersecurity scrutiny, make market launch and recertification timelines difficult. It is incredibly challenging for businesses to manage regulatory hurdles with unskilled personnel which drives the demand of outsourcing these services.

Type Insights

The therapeutics segment led the market for medical device regulatory affairs and accounted for the largest revenue share of more than 55.0% in 2020. The segment is also projected to witness the fastest CAGR of 8.9% during the forecast period. This may be attributed to the increasing prevalence of various chronic diseases such as cancer, diabetes, cardiovascular diseases, and respiratory disorders that create demand for advanced therapeutic products.

For instance, increasing demand for technologically advanced products such as auto-injectors or pen needles for effective and efficient delivery of insulin in diabetic patients is driving the segment. As there are multiple modalities involve in the combination product, more than one regulatory agency office reviews the submission. Due to the complexity of combination products, it is difficult to understand which regulatory requirements apply to combination products. Hence, this creates demand for these services.

Besides, with the increasing cases of COVID-19 around the world, there is a growing need for respiratory devices such as oxygen tanks, nebulizers, pulse oximeters, and spirometers, and ventilators for patients with severe COVID-19 infection, which is contributing to market growth. Furthermore, the pandemic has increased the demand for regulatory services. Due to a lack of supply, temporary approvals for expired therapeutic equipment such as respirators/ventilators and certification of similar equipment such as positive pressure breathing devices and anesthesia gas machines are permitted.

Regional Insights

Asia Pacific dominated the medical device regulatory affairs market and accounted for the largest revenue share of 37.1% in 2020. The region is also expected to grow at a significant rate during the forecast period. This is due to the highly evolved regulatory systems in countries like Australia and Japan. For instance, in 2018, Australia’s Therapeutic Goods Administration took a significant step toward broadening recognition of international approvals and embracing the Medical Device Single Audit Program, giving manufacturers significantly more options for entering the market for medical device regulatory affairs. Furthermore, government efforts to simplify the regulatory system for foreign investors, expedited approval for innovative products, and procurement control relaxation are some of the key factors driving the market for medical device regulatory affairs.

Regional regulatory initiatives in Africa, Asia, and the Americas are evolving to promote the harmonization of regulatory requirements across countries, lowering market entry barriers for manufacturers that can lead to lower product prices, encourage manufacturers to register their products in more countries, and contribute to a more sustainable total market for health products.

North America and Europe are also expected to be key markets for medical device regulatory affairs owing to the presence of two major international regulatory agencies — the European Medicines Agency (EMA) and the U.S. FDA respectively, which regulate more than half of medical devices worldwide. The U.S. FDA issues various guidelines for medical device manufacturers to help in the process.

Key Players

• ICON Plc
• Emergo
• Covance
• Freyr
• Promedica International
• Medpace
• IQVIA Holdings
• Intertek Plc
• SGS SA
• Integer Holdings

Market Segmentation

• Services Outlook
  • Regulatory Consulting
  • Legal Representation
  • Regulatory Writing & Publishing
  • Product Registration & Clinical Trial Applications
  • Other Services
• Type Outlook
  • Diagnostic
  • Therapeutic
• Service Provider Outlook
  • Outsource
  • In-house
• Regional Outlook
  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa

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