The growing complexity and rise in fixed in-house cost of conducting regulatory affairs are the key propositions that drive businesses in life science industries to seek outsourcing model.
The growing complexity and rise in fixed in-house cost of conducting regulatory affairs are the key propositions that drive businesses in life science industries to seek outsourcing model. The volumes of data generated particularly in clinical trials is bewildering.
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Further, the dynamic nature of compliance in life science industries makes regulatory writing and publishing a resource-intensive task, thereby burdening their core expertise. The cost efficiencies and hassle-free compliance are thus the key anchors for spiralling interest in end-to-end regulatory affairs outsourcing. The regulatory writing and publishing alone is expected to spawn revenues worth of US$ 2,406.6 million by 2023.
All these factors underpin the vast end-to-end regulatory affairs outsourcing market potential. Clocking 10.1% CAGR from 2017 to 2023 (forecast period), the valuation of the market is projected to touch the mark of US$ 5,746.5 million by the period-end. Rise in incidence of chronic and infectious diseases from viral and bacterial pathogens are expected to favorably impact the prospects in the market.
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Bulging Numbers of Clinical Trial Applications to Lead to Spurt in Opportunities
The past few decades have been marked by a spurt in clinical trial applications. A great deal of this can be ascribed to rise in patent expiries of crucial drugs and the rise in incidence of chronic diseases. Both large and small life sciences companies have grown their product registrations tremendously. They are thus hard-pressed to not just cut costs but also improve their time-to-market. This has led to gush of opportunities for service providers in the market. Big players have their eye on exploiting revenues from new, untapped markets. These trends are expected to fuel the lucrativeness of the overall regulatory affairs outsourcing market. Of note, clinical trial application and product registration services are expected to remain promising segments for companies specializing on regulatory affairs and operations.
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Latin America and Asia Pacific Becomes Cynosure of Attention
The globalization of healthcare has led to groundswell of interest in outsourcing models on numerous non-core activities especially for the pharmaceutical and biopharmaceutical industries. This is a key driver for the spurt in demand in specific regions where cost are easily managed. The emergence of low-cost clinical trials is another factor fueling the growth of the market. Thus, biopharmaceuticals in North America and Europe have been increasingly eyeing opportunities in the developing world with cost-effective centers, most notably in Asia and Latin America. Thus, these economies are expected to become attractive centers in product development and commercialization.
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Strides in the medical sector in Asia Pacific are expected to propel prospects in the regional market for providers in the regulatory affairs services. The Asia Pacific market is expected to clock 14.1% CAGR during the forecast period. Countries in India and China are emerging as new cost centers and companies there are offering new cost-management approaches to gain foothold in the market.
The competitive dynamics in the market is characterized by fair degree of fragmentation. Few players exercise dominance over the forces of demand and supply in the market. Some of the key companies profiled in the regulatory affairs outsourcing market are WuXi App Tec, Quintiles Transnational Corporation, Promedica International, Pharmaceutical Product Development, (PPD) LLC, PAREXEL International Corporation, Charles River Laboratories International, Inc., Medpace, Inc., ICON plc., Criterium, Inc., Covance, Inc., and Clinilabs, Inc.
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Strict Regulatory Framework Bolstering Prospects
The intensifying level of competition among life-science industries has led regulators to make regulatory framework stricter. Development of medical devices and drug candidates have become increasingly competitive. The need for identifying novel drug targets has also risen over the past few years. All these activities have become more cost-intensive for conducting in-house, given the constant updates in the regulatory frameworks. These aspects have turned in favor of the regulatory affairs outsourcing market.
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