According to our new research study on Healthcare Regulatory Affairs Outsourcing Market Size Analysis and Forecast to 2028 - COVID-19 Impact and Global Analysis By Service Type
According to our new research study on Healthcare Regulatory Affairs Outsourcing Market Size Analysis and Forecast to 2028 - COVID-19 Impact and Global Analysis 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); End User (Pharmaceutical Companies, Biotechnology Companies, Medical Devices Companies) and Geography.
| Report Coverage | Details |
| Market Size Value in | US$ 7,274.73 million in 2021 |
| Market Size Value by | US$ 14,996.35 million by 2028 |
| Growth Rate | CAGR of 10.9% from 2021 to 2028 |
| Forecast Period | 2021-2028 |
| Base Year | 2021 |
| No. of Pages | 192 |
| No. Tables | 84 |
| No. of Charts & Figures | 80 |
| Historical Data Available | Yes |
| Segments Covered | Service Type, End User and Geography |
| Regional Scope | North America; Europe; Asia Pacific; Latin America; MEA |
| Country Scope | US, UK, Canada, Germany, France, Italy, Australia, Russia, China, Japan, South Korea, Saudi Arabia, Brazil, Argentina |
| Report Coverage | Revenue forecast, company ranking, competitive landscape, growth factors, and trends |
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Healthcare Regulatory Affairs Outsourcing Market: Competition Landscape and Key Developments
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) and Azierta Contract Science Support Consulting are among the key companies operating in the healthcare regulatory affairs outsourcing market. Leading players focus on expanding and diversifying their market presence and acquiring a new customer base, thereby tapping prevailing business opportunities.
In August 2021, ProPharma Group had announced the acquisition of India based iSafety Systems. This acquisition pursue to strengthen ProPharma Group’s position as the prime global provider of regulatory and compliance consulting, pharmacovigilance, clinical research services, and medical information..
In May 2021, Propharma Group announced that the company has entered into a definitive agreement to merge with “The Planet Group”. The merger will accelerate growth opportunities as well as support ProPharma Group’s higher purpose of enhancing patient health and safety and Planet’s mission.
In April 2021, Parexel and Veeva Systems announced a strategic partnership to accelerate clinical trials through technology and process innovation. Both the companies will mutually benefits from each others regulatory consulting business.
In February 2020, Asphalion S.L announced that the company has entered into a new collaboration with Maria Molist for the providing pharmacovigilance/regulatory services in the UK
In March 2019, Asphalion S.L announced that the company has entered into a definite partnership agreement with Agatha Inc, a global provider of Quality and Content Management cloud service. The company further added that partnership with Agatha Inc, has helped to bring market foremost cloud solutions to pharma, biotech and medical devices organizations in Spain.
North America is largest market for regulatory affairs, with the US holding the largest market share followed by Canada. The growth in North America is characterized by robust research activities carried out by healthcare industries, increasing funding for the pharmaceuticals, and rising regulatory pressure on pharmaceutical sector. In North America, the US is the largest market for healthcare regulatory affairs outsourcing. The market’s growth is attributed to the enormous number of R&D activities in the field of drug discovery carried out in the country. The U.S. healthcare industry’s effort to minimize costs without compromising on quality of services is the major factor for the outsourcing of healthcare and medical services to other countries. The rigorous regulations imposed by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 towards the establishment of national standards for electronic health care transactions and national identifiers for providers, health insurance plans, and employers has boosted the market growth. The market’s growth is attributed to the enormous number of R&D activities in the field of drug discovery carried out in the country.
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The U.S. healthcare industry’s effort to minimize costs without compromising on quality of services is the major factor for the outsourcing of healthcare and medical services to other countries. The rigorous regulations imposed by the Health Insurance Portability and Accountability Act (HIPAA) of 1996 towards the establishment of national standards for electronic health care transactions and national identifiers for providers, health insurance plans, and employers has boosted the market growth. The increasing regulatory pressure on healthcare companies and escalating demand for speedy approval of new products are driving the market. Further, the advancements in specialty therapies, orphan drugs, and personalized medicines is expected to offer significant growth opportunities to the market players to expand their customer base in the region. However, dearth of skilled professionals is restraining the market growth.
Advancements in Specialty Therapies, Orphan Drugs, and Personalized Medicines to Provide Significant Growth Opportunities to Market Players:
The development of blockbuster therapies such as targeted gene therapies, specialty drugs, and precision medicine that help treat specific diseases and disorders has been a major focus in the healthcare sector for a long period. A few of these therapies are also being combined with medical devices to enhance the quality of drug delivery, dose, and patient monitoring or adherence, which is expected to add to the complexity of the related regulatory strategies and difficulties in their way to market. For instance, Alexion’s Ultomiris, AbbVie’s JAK1 inhibitor, Boehringer Ingelheim/AbbVie’s Skyrizi, Novartis/Avexis’ Zolgensma, Aimmune’s Palforzia, and bluebird bio’s Zynteglo are among the blockbusters products that are expected to be commercialized by 2023. Such large blockbuster product pipeline indicates huge opportunities in areas such as regulatory affairs, commercialization strategies, and post-marketing strategies. For instance, in 2018, Otsuka Pharmaceutical has outsourced it’s in house regulatory affairs business to Parexel international to oversees all strategic regulatory affairs including the CNS, oncology, cardio/renal, and digital medicine therapeutic areas. Thus, developments in emerging segments in healthcare sectors such as specialty therapies, orphan drugs, and personalized medicines are expected to offer significant growth opportunities to healthcare regulatory affairs outsourcing market players during the forecast period.
Healthcare Regulatory Affairs Outsourcing Market: Segmental Overview
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. Based on end user, the healthcare regulatory affairs outsourcing market is segmented into Pharmaceutical Companies, Biotechnology Companies, and Medical Devices Companies. The institutional 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
The COVID-19 outbreak was first detected in Wuhan (China) in December 2019. It has since spread to over 100 countries, prompting the World Health Organization (WHO) to declare it a public health emergency. The global impacts of COVID-19 are being felt across several markets. The North American economy is severely affected due to the exponential growth of COVID-19 cases in the region. North America is one of the most important regions for the adoption and growth of new technologies due to flattering government policies to boost innovation, the presence of a huge industrial base, and high purchasing power, mainly in developed countries such as the US and Canada. Hence, any impact on the growth of industries is expected to affect the region’s economic growth negatively. However, COVID-19 has placed many regulatory and outsourcing teams under pressure but, it also has had a positive impact on the bio/pharmaceutical outsourcing industry, wherein the demand for R&D activity is increasing leading to a rise in regulatory affairs assistance. This rising demand has caused various CROs to focus on their outsourcing and other operations. Due to the COVID-19 (coronavirus) pandemic, healthcare companies find it challenging to keep up with regulatory standards. Several regulatory experts are analyzing the impact of pandemic-related delays seen in implementing the European regulations. Countries like France, Spain, and the Netherlands are under scrutiny due to a spike in COVID-19 cases. This has further triggered business activities in the medical device & IVD regulatory affairs outsourcing market. The impact of COVID-19 has resulted in delay in onsite inspection due to travel bars and delay in approval for several products. This has caused around 65% of pharmaceutical activities to be outsourced to CROs, a number that is expected to reach 75% in the future. Along with this, the demand for innovative pharmaceutical products has put pharma companies under pressure to increase R&D spending to deliver these new products, while at the same time containing costs.
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The current pharmaceutical markets in the MENA region differ considerably between the various nations. For example, high purchasing power and a cultural predilection for expensive foreign brands in Saudi Arabia have resulted in 85% of pharmaceuticals being imported. South Africa has increasingly turned to generics in recent years, which is an excellent opportunity for domestic and foreign manufacturers. Additionally, due to COVID-19, various healthcare companies are likely to opt for more regulatory advice during the recovery phase - on remote monitoring, telemedicine, data protection, and more. Also, as companies push to accelerate product development and approvals of therapies, vaccines, and devices for COVID-19, they are likely to work even more closely with regulators. While regulatory outsourcing methods in clinical trials are not new to this region, the pandemic has accelerated their adoption. As physicians and patients have become more accepting of digital technologies and teleconferencing, more opportunities for remote monitoring have arisen. Drug developers are challenged to rapidly assess the effectiveness of existing vaccines against evolving SARS-CoV-2 strains due to the virus’s constant mutations.
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Key Questions to Request for Healthcare Regulatory Affairs Outsourcing Market:
- What are healthcare regulatory affairs outsourcing?
- What are the driving factors for the healthcare regulatory affairs outsourcing market across the globe?
- Which service type segment led the healthcare regulatory affairs outsourcing market?
- What are the restraining factors for the healthcare regulatory affairs outsourcing market across the globe?
- Which end user held the largest share in the healthcare regulatory affairs outsourcing market?
- Who are the key players in the healthcare regulatory affairs outsourcing market?
- What is the regional market scenario of healthcare regulatory affairs outsourcing?
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