The healthcare regulatory affairs outsourcing market is projected to reach US$ 14,996.35 million by 2028 from US$ 7,274.73 million in 2021; it is expected to grow at a CAGR of 10.9% from 2021 to 2028. The market growth is attributed to factors such as the increasing regulatory pressure on healthcare companies and escalating demand for speedy approval of new products. However, dearth of skilled professionals is restraining the market growth.
Continuous upgrades and progress in traditional drug development approaches are creating significant challenges in the healthcare sector.There is tremendous pressure on the pharmaceutical companies and medical fraternity to reduce the cost of prescription drugs, while their operational costs are skyrocketing.
The complexity of regulatory requirements, declining revenues due to blockbuster drugs going off patent, and pressure from governments as well as health insurers for reduction in healthcare cost has presented additional challenges to healthcare industries.Given these difficulties, pharmaceutical companies have realized the need to leverage their resources along with the expertise provided by specialist external sources.
Many high-end regulatory consulting companies are offering their expertise across the complete product life cycle.The outsourcing of regulatory affairs may enable sponsors to gain experience, optimize cost, and enhance productivity.
Regulatory outsourcing companies are in better position to assess regulatory requirements, which allows them to select the best solutions. They are well versed with understanding associated with implementing, operating, and maintaining a regulatory publishing system. Most of the big pharmaceutical and biotechnology companies look out for consulting companies that can also offer supporting regulatory and pharmacovigilance services. The increased complexity of regulatory filings underlines the demand for specialist CRO expertise.Having planned product-specific regulatory advice and strategies, along with healthcare regulatory compliance measures, in an early stages of product development is extremely important for the regulatory approval of the products.
Failure to address the compliance in the early stage of development often leads to delay in the approval process due to inappropriately filed documentations, manufacturing oversights, omitted regulatory studies, and other failures to meet the regulatory requirements.Healthcare companies are now focusing on their core competencies and outsourcing the noncore functions to improve productivity and operational efficiency.
They generally outsource regulatory functions to CROs operational in emerging markets, such as Asia Pacific and the MEA, which also allows them to reduce their operational costs and strengthen their focus on core functions such as R&D activities, and existing products’ sales and distribution.
COVID-19 has presented the most significant global health emergency till date.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.
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, medical devices companies. The pharmaceutical companies segment would account for a larger market share in 2021, and same segment is estimated to grow at a higher CAGR from 2021 to 2028.
The Adverse Drug Reactions Committee, India Brand Equity Foundation, International Council for Harmonisation, National Medical Product Administration, Food and Drug Administration, WHO, and Centers for Disease Control and Prevention (CDC) are among the major primary and secondary sources referred to while preparing this report on the Healthcare Regulatory Affairs Outsourcing market.
Our reports have been used by over 10K customers, including:
The drug delivery devices market was valued at USD 258.81 billion in 2021, and it is expected to reach USD 394.03 billion by 2027, registering a CAGR of 7.40% during the forecast period of 2022-2027. At the outbreak of the COVID-19 pandemic, most pharmaceutical companies and governments are working toward offering efficient medical...
The Healthcare Facility Management Market-US Forecast is projected to reach USD 8.3 billion by 2026 from USD 6.0 billion in 2021, at a CAGR of 6.7% during the forecast period. Growth in the Healthcare Facility Management Market-US Forecast is primarily driven by theincreasing investments in healthcare infrastructure and the construction of...
Executive Summary The Global Orthotics Market was valued at USD 3.81 billion in the year 2021 with North American region leading the regional market share. The key factors driving the growth of this market include the rising prevalence of chronic diseases such as cardiovascular diseases and neurological disorders which...
The healthcare staffing market is expected to grow from US$ 34.76 billion in 2021 to US$ 51.28 billion by 2028; it is estimated to grow at a CAGR of 5.8% from 2021 to 2028. The market growth is mainly attributed to the increasing demand for physician extenders and the growing number of government initiatives. However, the shortage of...
The autotransfusion devices market is expected to grow from US$ 1,000.26 million in 2021 to US$ 1,331.99 million by 2028; it is estimated to grow at a CAGR of 4.2% from 2021 to 2028. Rapid increase in chronic diseases, rise in transplants, and difficulty in obtaining blood groups across the globe are driving the growth of the market....
The global depth of anesthesia monitoring market is projected to reach US$ 280.83 million by 2028 from US$ 203.32 million in 2021; it is expected to grow at a CAGR of 4.7% from 2021 to 2028. The rising number of surgical procedures drives the overall growth of the depth of anesthesia monitoring market. However, the high maintenance cost of...
This report considers the present scenario of the U.S. remote patient monitoring market and its market dynamics for 2022?2027. It covers a detailed overview of several market growth enablers, restraints, and trends. The study covers both the demand and supply sides of the market. It also profiles and analyses leading companies and several...
This study considers a detailed scenario of the present medical ventilators market and its market dynamics for 2022?2027. It covers a detailed overview of several market growth enablers, restraints, and trends. The report offers both the demand and supply aspects of the market. It profiles and examines leading companies and other prominent...
257 pages •
By Asia Market Information & Development Company
• May 2022
China’s demand for Health Care has grown at a fast pace in the past decade. In the next decade, both production and demand will continue to grow. The Chinese economy maintains a high speed growth which has been stimulated by the consecutive increases of industrial output, import & export, consumer consumption...
The organic peroxide market is projected to register a CAGR of more than 4% during the forecast period (2022-2027). Organic peroxide is a carbon-based molecule with two oxygen atoms joined together. Adhesives, coatings, textile, rubber, and paper industries are few applications of Organic Peroxide. Several end-use industries, such...
Gross Domestic Product
You can change your Cookie Settings at any time but parts of our site will not function correctly without them.