Medical Device Regulatory Affairs Market Expected to Reach $12.2 Billion by 2031—Allied Market Research

According to a new report published by Allied Market Research, titled, “Medical Device Regulatory Affairs Market," The medical device regulatory affairs market size was valued at $7.0 billion in 2021, and is estimated to reach $12.2 billion by 2031, growing at a CAGR of 5.8% from 2022 to 2031. Regulatory affairs arose from the desire of governments to protect public health by regulating the safety and efficacy of products in areas such as pharmaceuticals, veterinary medicines, medical devices, pesticides, agrochemicals, cosmetics, and complementary medicines.
The aim of companies is to be responsible for the discovery, testing, manufacture, and marketing of medical devices to ensure that the supplied products are safe and profitable. The various types of regulations followed in product life cycle of medical devices are regulatory strategy development, regulatory affairs consulting & support, regulatory outsourcing, and device classification determination. 
Some other regulations which are required for the approval of medical devices include - pre-market, post-approval & post-market support, appraisal & evaluation of technical documentation, preliminary assessments, gap analyses & desktop audits, technical files, design dossiers and quality system support, European authorized representation services and UK responsible person services. 

Ever changing law and regulation drive demand for regulatory affairs professionals who can help companies bring medical product to the market. The regulatory affairs for drugs, biologics, and medical devices require management of regulatory activities and to understand the current requirement for the development, design, and commercialization of new medical device.  
Increase in demand for the approval of new device in the market or to conduct post market surveillance are major drivers of the market growth. Furthermore, surge in demand for premarketing regulatory strategy and to meet the regulatory requirement of international regulatory affairs such as Europe and South-Korea to launch the products/medical devices such as auto-injectors or pen needles for insulin, nebulizer, pulse oximeter, ventilator and many such devices globally drives the growth of the market. Moreover, medical technological companies are focused on undertaking key strategies such as product launch and product approval to strengthen their product portfolio, thereby enhancing opportunities in the fast-growing clinical areas in various regions. For instance, in August 2021, EMERGO by UL launched its Regulatory Affairs Management Suite (RAMS) digital platform for more efficient & cost-effective medical device and IVD regulatory affairs & quality assurance (RA/QA) operations.

However, factors such as high cost of providing regulatory services and increase in number of cyber-attacks and concern related to cyber security are expected to hamper growth of the market up to some extent during the forecast period. 
 The global medical device regulatory affairs market is segmented based on services, service provider, types, indication and region. On the basis of services, the medical device regulatory affairs industry is divided into regulatory consulting /strategic services, regulatory writing and publishing, legal representation, product registration and clinical trials & others. By service provider, it is classified into in-house and outsourcing. The types segment includes diagnostics and therapeutics. Depending on indication, the market is fragmented into infectious diseases, oncology & hematology, gynecology & obstetric, musculoskeletal disorder, respiratory, cardiovascular and others. Region wise, it is analyzed across North America, Europe, Asia-Pacific, and LAMEA.

By services segment, the medical device regulatory affairs industry is divided into regulatory consulting /strategic services, regulatory writing & publishing, legal representation, product registration & clinical trials, and others. The legal representation segment was the highest revenue contributor to the market owing to increase in demand for traditional and special 510(k), pre-market approval (PMA) preparation & submission, design dossier preparation & FDA notified body, and ISO 13485 registrar audit preparation & participation accessibility are expected to drive the market growth. The product registration and clinical trials segment is estimated to register a significant CAGR of 6.8% during the forecast period. Owing to rising demand for faster approval processes.

By service provider, the outsourcing segment was the highest revenue contributor to the market with a CAGR of 6.0%. The increase in number of clinical studies conducted and providing regulatory guidance for the approval of medical device to the small-scale industries act as a driver to boost the growth of the market.
The in-house segment is estimated to reach at a significant CAGR of 5.5% during the forecast period due to the increasing complexity of medical devices and increase in demand for regulatory services required by small scale industries to get their product approval globally also because of the advantages such as cost and time saving.

By type, the therapeutics segment was the highest revenue contributor to the market, and is estimated to reach a CAGR of 5.6%. This is owing to increase in 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.
The diagnostic segment registered a high CAGR of 6.2% during the forecast period. 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.

On the basis of indication, the musculoskeletal disorders segment was the highest revenue contributor to the market with a CAGR of 4.6%. This is primarily due to increase in demand of advanced medical devices for oncology & hematology, the demand for the regulatory service required also increases which drives the growth of the medical device regulatory affairs market trends.
The cardiovascular segment is estimated to a high growth rate of 6.5% during the forecast period. Owing to rise in prevalence of heart related disease which increase the demand of regulatory services for the approval of new medical devices.

Region wise, the medical device regulatory affairs market size is analyzed across North America, Europe, Asia-Pacific, and LAMEA. North America was the largest shareholder in the medical device regulatory affairs market in 2021. Increase in geriatric population, R&D investments, and supportive government initiatives directed toward use of advanced medical devices for chronic diseases are the major factors that drive growth of the medical device regulatory affairs market share. 
Asia-Pacific is estimated to grow during the forecast period. Rise in number of product approval, increase in number of clinical trials procedures, surge in demand for regulatory services emphasis of prominent players in enhancing their presence and high demand for advanced medical devices in the region.

Some of the key players operating in the global medical device regulatory affairs market analysis include Amerisource Bergen, Charles River, Cliniexpert, Emergo, Icbio, Icon Plc, Iqvia, NKG, Parexel and Pepgra. 

KEY FINDINGS OF THE STUDY

• By services type, the regulatory consulting/strategic services segment was the highest contributor to the market in 2021.
• By service provider, the outsourcing was the highest contributor to the medical device regulatory affairs market forecast in 2021.
• By types, the diagnostic segment is projected to grow at a significant CAGR of 6.2% from 2022 to 2031.
• By indication, the oncology & hematology segment is projected to grow at a significant CAGR of 7.3% from 2022 to 2031.
• By region, North America garnered largest revenue share of 2056.1.in 2021, whereas Asia-Pacific is anticipated to grow at the highest CAGR of 6.9% during the review period.