The global Medical Device Regulatory Affairs Market was valued at $6,969.7 million in 2021, and is projected to reach $12,247.7 million by 2031, registering a CAGR of 5.8% from 2022 to 2031.
Medical Device Regulatory Affairs are Regulatory affairs (RA), commonly known as government affairs, is a specialty in regulated industries such as pharmaceuticals, medical devices, and agrochemicals. Within the healthcare industry, regulatory affairs have a very specific connotation. The regulatory function in the healthcare industry is critical in ensuring the availability of safe and effective healthcare products around the world. Regulatory professionals include individuals who ensure regulatory compliance and prepare submissions, as well as those whose primary job function is clinical affairs or quality assurance. Medical Device Regulatory Affairs experts serve as a link between the medical device industry and regulatory bodies around the world, including the United States, the United Kingdom, Canada, the European Union, India, Japan, and Australia. As one of the most highly regulated industries, the healthcare industry needs more experts than ever before who are capable of resolving regulatory issues in a proficient way. Regulatory affairs experts are critical in ensuring that all medical devices comply with industry regulations. Industry regulatory specialists are involved with a wide range of medical devices manufactured in various nations. As regulatory processes become more sophisticated and broader, and as the area becomes more globalized, there will be a continued demand for personnel with a strong background in medical device regulatory affairs.
The advantages of medical device regulatory affairs are that it ensure that all GCP and ICH guidelines, as well as EU CTD and other applicable laws and regulations, are followed when conducting clinical trials for medical devices, it help in establishing, maintaining, and obtaining senior management approval for the Quality Management project and strategic audit programmed and also it help in setting up and maintaining clinical quality assurance papers, protocol deviations, investigations, and change management systems and tools wherever required for the approval of new medical device. With the rapid changes taking place in medical technologies the regulations and quality requirements also need to keep pace and address the specific needs across different geographies. For Medical Devices, the Quality and Regulatory affairs requirements kick in and play a crucial role from the product design phase and provide guidelines across the product lifecycle.
The market is expected to witness a moderate growth during the forecast period, owing to rise in adoption and development of advanced medical devices for the treatment of various disease such as cardiovascular, cancer, and other infectious diseases, along with various technological advancements and their increasing applications in the healthcare sector. Furthermore, surge in geriatric population along with various technological advancements in the market to meet the unmet needs of patients provides significant opportunities for existing players and new entrants.
However, factors such as high cost of providing regulatory services and increase in number of cyber-attacks & concern related to cyber security are expected to hamper growth of the market up to some extent during the forecast period.
Impact of COVID-19 pandemic is expected to remain negative for the medical device regulatory affairs market, as the COVID-19 pandemic continues to unfold, medical device companies are finding it difficult to make informed decisions about their products, supply chains, and regulatory obligations in the midst of uncertainty.
For instance, the impact of COVID-19 on clinical trials has been immediate, due to challenges posed by travel bans, hospital/clinic visitation restrictions, and social distancing precautions, just to name a few. These factors have translated into multiple issues that pose challenges related to corporate milestones, budgets, and data integrity. IRB meetings and processes are not impacted by any restrictions on travel. As a standard practice, the IRB meets remotely via video conference technology. IRB has been prioritizing the review of the numerous COVID-19 protocols received as well as amendments relating to changes in research conduct because of unforeseen circumstances. Clinical trial protocols are required to be changed to eliminate apparent immediate hazards to participants such as changing in-person visits to virtual visits, elimination of study visits/procedures that do not impact the integrity of the study or participant safety, incorporation of screening questions to identify potential COVID-19 exposure.
The global medical device regulatory affairs market is segmented on the basis of services, service provider, types, indication and region. On the basis of services, the market is divided into regulatory consulting /strategic services, regulatory writing and publishing, legal representation, product registration and clinical trials and others. By service provider, it is classified into in-house and out-sourcing. By types it includes diagnostics and therapeutics. By indication the segment includes infectious diseases oncology & hematology, gynecology & obstetrics, musculoskeletal disorders, respiratory, cardiovascular and others. Region wise, it is analyzed across North America, Europe, Asia-Pacific, and LAMEA.
Some of the key players operating in the global medical device regulatory affairs market include Amerisource Bergen, Charles River, Cliniexpert, Emergo, Icbio, Icon PLC, IQVIA, NKG, Parexel and Pepgra.
Medical Device Regulatory Affairs are Regulatory affairs (RA), commonly known as government affairs, is a specialty in regulated industries such as pharmaceuticals, medical devices, and agrochemicals. Within the healthcare industry, regulatory affairs have a very specific connotation. The regulatory function in the healthcare industry is critical in ensuring the availability of safe and effective healthcare products around the world. Regulatory professionals include individuals who ensure regulatory compliance and prepare submissions, as well as those whose primary job function is clinical affairs or quality assurance. Medical Device Regulatory Affairs experts serve as a link between the medical device industry and regulatory bodies around the world, including the United States, the United Kingdom, Canada, the European Union, India, Japan, and Australia. As one of the most highly regulated industries, the healthcare industry needs more experts than ever before who are capable of resolving regulatory issues in a proficient way. Regulatory affairs experts are critical in ensuring that all medical devices comply with industry regulations. Industry regulatory specialists are involved with a wide range of medical devices manufactured in various nations. As regulatory processes become more sophisticated and broader, and as the area becomes more globalized, there will be a continued demand for personnel with a strong background in medical device regulatory affairs.
The advantages of medical device regulatory affairs are that it ensure that all GCP and ICH guidelines, as well as EU CTD and other applicable laws and regulations, are followed when conducting clinical trials for medical devices, it help in establishing, maintaining, and obtaining senior management approval for the Quality Management project and strategic audit programmed and also it help in setting up and maintaining clinical quality assurance papers, protocol deviations, investigations, and change management systems and tools wherever required for the approval of new medical device. With the rapid changes taking place in medical technologies the regulations and quality requirements also need to keep pace and address the specific needs across different geographies. For Medical Devices, the Quality and Regulatory affairs requirements kick in and play a crucial role from the product design phase and provide guidelines across the product lifecycle.
The market is expected to witness a moderate growth during the forecast period, owing to rise in adoption and development of advanced medical devices for the treatment of various disease such as cardiovascular, cancer, and other infectious diseases, along with various technological advancements and their increasing applications in the healthcare sector. Furthermore, surge in geriatric population along with various technological advancements in the market to meet the unmet needs of patients provides significant opportunities for existing players and new entrants.
However, factors such as high cost of providing regulatory services and increase in number of cyber-attacks & concern related to cyber security are expected to hamper growth of the market up to some extent during the forecast period.
Impact of COVID-19 pandemic is expected to remain negative for the medical device regulatory affairs market, as the COVID-19 pandemic continues to unfold, medical device companies are finding it difficult to make informed decisions about their products, supply chains, and regulatory obligations in the midst of uncertainty.
For instance, the impact of COVID-19 on clinical trials has been immediate, due to challenges posed by travel bans, hospital/clinic visitation restrictions, and social distancing precautions, just to name a few. These factors have translated into multiple issues that pose challenges related to corporate milestones, budgets, and data integrity. IRB meetings and processes are not impacted by any restrictions on travel. As a standard practice, the IRB meets remotely via video conference technology. IRB has been prioritizing the review of the numerous COVID-19 protocols received as well as amendments relating to changes in research conduct because of unforeseen circumstances. Clinical trial protocols are required to be changed to eliminate apparent immediate hazards to participants such as changing in-person visits to virtual visits, elimination of study visits/procedures that do not impact the integrity of the study or participant safety, incorporation of screening questions to identify potential COVID-19 exposure.
The global medical device regulatory affairs market is segmented on the basis of services, service provider, types, indication and region. On the basis of services, the market is divided into regulatory consulting /strategic services, regulatory writing and publishing, legal representation, product registration and clinical trials and others. By service provider, it is classified into in-house and out-sourcing. By types it includes diagnostics and therapeutics. By indication the segment includes infectious diseases oncology & hematology, gynecology & obstetrics, musculoskeletal disorders, respiratory, cardiovascular and others. Region wise, it is analyzed across North America, Europe, Asia-Pacific, and LAMEA.
Some of the key players operating in the global medical device regulatory affairs market include Amerisource Bergen, Charles River, Cliniexpert, Emergo, Icbio, Icon PLC, IQVIA, NKG, Parexel and Pepgra.
Key Benefits For Stakeholders
- This report provides a quantitative analysis of the market segments, current trends, estimations, and dynamics of the medical device regulatory affairs market analysis from 2021 to 2031 to identify the prevailing medical device regulatory affairs market opportunity.
- The market research is offered along with information related to key drivers, restraints, and opportunities.
- Porter's five forces analysis highlights the potency of buyers and suppliers to enable stakeholders make profit-oriented business decisions and strengthen their supplier-buyer network.
- In-depth analysis of the medical device regulatory affairs market segmentation assists to determine the prevailing market opportunities.
- Major countries in each region are mapped according to their revenue contribution to the global market.
- Market player positioning facilitates benchmarking and provides a clear understanding of the present position of the market players.
- The report includes the analysis of the regional as well as global medical device regulatory affairs market trends, key players, market segments, application areas, and medical device regulatory affairs market growth strategies.
Key Market Segments
By Services
- Regulatory consulting /Strategic Services
- Regulatory writing and publishing
- Legal representation
- Product Registration and Clinical trials
- Others
By Service Provider
- In-House
- Out sourcing
By Types
- Diagnostic
- Therapeutics
By Indication
- Infectious Diseases
- Oncology and Hematology
- Gynaecology and Obstetrics
- Muscusloskeletal Disorders
- Respiratory
- Cardiovascular
- Others
By Region
- North America
- U.S.
- Canada
- Mexico
- Europe
- Germany
- France
- United Kingdom
- Italy
- Spain
- Rest of Europe
- Asia-Pacific
- Japan
- China
- India
- South Korea
- Malaysia
- Rest of Asia-Pacific
- LAMEA
- Brazil
- Israel
- Saudi Arabia
- South Africa
- Rest of LAMEA
Key Market Players
- Amerisource Bergen
- Charles river
- Clini expert
- Emergo
- icbio cro
- icon plc
- IQVIA Holdings Inc.
- NKG
- parexel
- Pepgra
Table of Contents
CHAPTER 1: INTRODUCTION
CHAPTER 2: EXECUTIVE SUMMARY
CHAPTER 3: MARKET OVERVIEW
CHAPTER 4: MEDICAL DEVICE REGULATORY AFFAIRS MARKET, BY SERVICES
CHAPTER 5: MEDICAL DEVICE REGULATORY AFFAIRS MARKET, BY SERVICE PROVIDER
CHAPTER 6: MEDICAL DEVICE REGULATORY AFFAIRS MARKET, BY TYPES
CHAPTER 7: MEDICAL DEVICE REGULATORY AFFAIRS MARKET, BY INDICATION
CHAPTER 8: MEDICAL DEVICE REGULATORY AFFAIRS MARKET, BY REGION
CHAPTER 9: COMPANY LANDSCAPE
CHAPTER 10: COMPANY PROFILES
LIST OF TABLES
LIST OF FIGURES
Executive Summary
According to this report 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.
Companies Mentioned
- Amerisource Bergen
- Charles river
- Clini expert
- Emergo
- icbio cro
- icon plc
- IQVIA Holdings Inc.
- NKG
- parexel
- Pepgra
Methodology
The analyst offers exhaustive research and analysis based on a wide variety of factual inputs, which largely include interviews with industry participants, reliable statistics, and regional intelligence. The in-house industry experts play an instrumental role in designing analytic tools and models, tailored to the requirements of a particular industry segment. The primary research efforts include reaching out participants through mail, tele-conversations, referrals, professional networks, and face-to-face interactions.
They are also in professional corporate relations with various companies that allow them greater flexibility for reaching out to industry participants and commentators for interviews and discussions.
They also refer to a broad array of industry sources for their secondary research, which typically include; however, not limited to:
- Company SEC filings, annual reports, company websites, broker & financial reports, and investor presentations for competitive scenario and shape of the industry
- Scientific and technical writings for product information and related preemptions
- Regional government and statistical databases for macro analysis
- Authentic news articles and other related releases for market evaluation
- Internal and external proprietary databases, key market indicators, and relevant press releases for market estimates and forecast
Furthermore, the accuracy of the data will be analyzed and validated by conducting additional primaries with various industry experts and KOLs. They also provide robust post-sales support to clients.
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Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 356 |
| Published | May 2022 |
| Forecast Period | 2021 - 2031 |
| Estimated Market Value ( USD | $ 6969.7 million |
| Forecasted Market Value ( USD | $ 12247.7 million |
| Compound Annual Growth Rate | 5.8% |
| Regions Covered | Global |
| No. of Companies Mentioned | 10 |
