Surge in Research and Development Activities by Medical Devices Companies will drive the Demand for Medical Device Regulatory Affairs Outsourcing Market

 

The healthcare environment is undergoing a transformation due to various factors including changing purchasing trends in the medical device industry, a strong emphasis on digitalization, a diverse talent footprint and a focus on ecosystem alliances which include collaborations with Tech companies, start-ups and service providers. The top five R&D spenders account for 38% of global R&D spending with investments centered mostly on sub-verticals such as non-imaging diagnostics, surgical procedures and prosthetics. This increased research and development by medical devices companies had increased its product development leading to increased requirement for the regulatory affairs services such as medical writing among others.

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Data Bridge Market Research analyses that the medical device regulatory affairs outsourcing market is expected to grow at a CAGR of 12.81% in the forecast period of 2021 to 2028 and is expected to reach USD 11,935.77 million by 2028. The rising healthcare expenditure is positively associated with the product development, product registration and product launch. Thus, the rising healthcare expenditure and government support are further expected to drive the global medical device regulatory affairs outsourcing market in coming years.

Medical Device Regulatory Affairs Outsourcing Market

Surging amount of the Clinical Trials is expected to drive the market's growth rate

The increasing number of clinical trials across the globe is being driven by increasing demand for new medical equipment and therapies among end users and rising investment in R&D activities for developing effective medicines. The current pandemic is altering the way clinical trials are being conducted now and in the future. Regulatory agencies including the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), the National Institutes of Health (NIH) and China's National Medical Products Administration among others have provided guidelines for conducting trials during the coronavirus outbreak. The increasing number of clinical trials further enhances the demand of regulatory affair services in order to provide the medical devices and pharmaceutical companies with the desired approval. Thus, the rising number of clinical trials acts as driver for the growth of the global medical device regulatory affairs outsourcing market.

Report Scope and Market Segmentation

Report Metric

Details

Forecast Period

2021 to 2028

Base Year

2020

Historic Years

2019(Customizable to 2018 - 2013)

Quantitative Units

Revenue in USD Million, Volumes in Units, Pricing in USD

Segments Covered

Services (Regulatory Affairs Services, Quality Consulting and Medical Writing), Product (Finished Goods, Electronics and Raw Material), Device Type (Class I, Class II and Class III), Application (Cardiology, Diagnostic Imaging, Orthopedic, IVD, Ophthalmic, General and Plastic Surgery, Drug Delivery, Dental, Endoscopy, Diabetes Care and Others), End User (Small Medical Device Company, Medium Medical Device Company and Large Medical Device Company)

Countries Covered

U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

Market Players Covered

BD (U.S.), Thermo Fisher Scientific Inc. (U.S.), Merck KGaA (Germany), Organogenesis Inc. (U.S.), Vericel Corporation (U.S.), ANTEROGEN. CO., LTD. (South Korea), VistaGen Therapeutics, Inc. (U.S.), American Cryostem Corporation (U.S.), PromoCell GmbH (Germany), Sartorius AG (Germany), ViaCyte, Inc. (U.S.), STEM CELL Technologies, Inc. (Canada), Takeda Pharmaceutical Company Limited (Japan), DAIICHI SANKYO COMPANY, LIMITED (Japan), Bio-Techne (U.S.), REPROCELL Inc. (India), Catalent, Inc. (U.S.), Mesoblast Ltd (Australia), Astellas Pharma Inc. (Japan), FUJIFILM Holdings Corporation (Japan)

Data Points Covered in Report

In addition to the market insights such as market value, growth rate, market segments, geographical coverage, market players, and market scenario, the market report curated by the Data Bridge Market Research team also includes in-depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

Segment Analysis:

Global medical device regulatory affairs outsourcing market is categorized into five notable segments which are based on the services, product, device type, application and end user.

  • On the basis of services, global medical device regulatory affairs outsourcing market is segmented into regulatory affairs services, quality consulting and medical writing. In 2021, the regulatory affairs services segment is expected to dominate the market, growing with the highest CAGR of 13.69%

The regulatory affairs services segment is expected to dominate the market

In 2021, the regulatory affairs services segment is expected to dominate the market, growing with the highest CAGR of 13.69% in the forecast period of 2021 to 2028 because of the increased adoption of regulatory affairs outsourcing by key medical device companies.

  • On the basis of product, global medical device regulatory affairs outsourcing market is segmented into finished goods, electronics and raw material. In 2021, finished goods segment is expected to dominate the market, growing with the highest CAGR of 15.01% in the forecast period of 2021 to 2028 due to the increased adoption of regulatory affairs outsourcing for the finished goods by major medical device companies.
  • On the basis of device type, global medical device regulatory affairs outsourcing market is segmented into class I, class II and class III. In 2021, the class I segment is expected to dominate the market, growing with the highest CAGR of 15.29% in the forecast period of 2021 to 2028 because of the rising demand for medical devices worldwide to treat patients with chronic diseases.
  • On the basis of application, global medical device regulatory affairs outsourcing market is segmented into cardiology, diagnostic imaging, orthopedic, IVD, ophthalmic, general and plastic surgery, drug delivery, dental, endoscopy, diabetes care and others. In 2021, the cardiology segment is expected to dominate the market, growing with the highest CAGR of 17.5% in the forecast period of 2021 to 2028 because of the increased adoption of regulatory affairs outsourcing for the class III medical devices by key medical device companies.
  • On the basis of end user, global medical device regulatory affairs outsourcing market is segmented into small medical device company, medium medical device company and large medical device company. In 2021, the medium medical device company segment is expected to dominate the market, growing with the highest CAGR of 14.75% from 2021 to 2028 due to the rising demand for medical devices worldwide.

Major Players

Data Bridge Market Research recognizes the following companies as the major medical device regulatory affairs outsourcing market players in medical device regulatory affairs outsourcing market are Parexel International Corporation (U.S.), North American Science Associates, Inc. (U.S.), SGS SA (Switzerland), Pace Analytical Services, LLC (U.S.), Trilogy Writing & Consulting GmbH (Germany), Creganna (Galway), American Preclinical Services, LLC (U.S.), Intertek Group plc (U.K.), WuXi AppTec (China), Charles River Laboratories (U.S.),, Celestica Inc. (Canada), Freyr (U.S.), Cactus Communications (India), Cekindo Business International (Indonesia), Eurofins Scientific (Luxembourg), Covance (U.S.), Plexus Corp. (U.S.), Sanmina Corporation (U.S.), Omron Corporation (Japan).

Medical Device Regulatory Affairs Outsourcing Market

Market Development

  • In January 2021, ProTom International signed a strategic distribution agreement with the Guohong Guokang Health Technology Development Co., LTDGHGK in China for the Radiance 330 Proton Therapy system. This agreement is totally based on the distribution of the product in China Mainland. This agreement signifies the company's international expansion as the worldwide provider of the product.
  • In October 2020, Mevion Medical Systems signed partnership with Hermes Advanced Therapy Systems Corp. (HATS) for the distribution of Mevion S250iproton therapy system in the Taiwan and South East Asia including Malaysia, Thailand and Singapore. This will expand the business for the company in these regions, add up to profit of the company, and help in further business expansion.
  • In January 2021, Pace Analytical Services, LLC announced that the company's environmental manager has received the service award by the ASTM International. This recognition received by the company's employee has increased its credibility in the market.
  • In December 2020, Parexel International Corporation announced that it has been named as the "Best Contract Research Organization" in the Full-Service Provider category to the Digital 16th Annual Scrip Awards. This recognition received by the company has increased its sales and demand in the market.
  • In October 2020, Cactus Communications announced that it had received two bronze Stevie Awards at the 17th annual Stevie Awards for Women in Business. This recognition received by the company has increased its credibility in the market leading to increased sales and revenue in future.

Regional Analysis

Geographically, the countries covered in the medical device regulatory affairs outsourcing market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E, South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

As per Data Bridge Market Research analysis:

North America is the dominant region in medical device regulatory affairs outsourcing market during the forecast period

North America dominated the medical device regulatory affairs outsourcing market due to major key players. North America will continue to dominate the medical device regulatory affairs outsourcing market in terms of market share and market revenue and will continue to flourish its dominance during the forecast period due to increasing adoption of outsourcing models for the regulatory affairs services segment.

Asia-Pacific is estimated to be the fastest growing region in medical device regulatory affairs outsourcing market

Asia-Pacific is expected to grow during the forecast period due to the growing research and development activities for this region's regulatory affairs services segment. In addition, increasing adoption of advanced technology is also expected to propel the market's growth rate in this region.

COVID-19 Impact Analysis

The COVID-19 pandemic epidemic has had a negative effect on the market. Clinical trial sites and related operations had been shut down as a result of the initial shutdown. Additionally, regulatory entities temporarily suspended their operations in order to track supply chain activity. Nearly every factor that was important for drug development to stop the virus' spread at the start of the pandemic had a negative impact on the market.

However, the pandemic had made it urgently necessary to treat COVID-19 infection, which is why regulatory bodies, like the U.S. FDA and the European Union (EU), had authorized several COVID-19 testing tools and medications for emergency use. Following the pandemic, it is anticipated that these regulatory agency actions will increase market demand for regulatory affairs outsourcing. As various businesses concentrated on the creation of cutting-edge therapies for the treatment of COVID-19 infection, the market saw a rise in revenue in 2021. Additionally, the market expansion after 2020 has been further fueled by the development in R&D activities for new treatments, vaccines, and medical devices.

Frequently Asked Questions (FAQs)

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