Tag Archives: Regulatory Affairs Outsourcing Market

Regulatory Affairs Outsourcing Market Outlook and Forecast up to 2023

Due to the highly fragmented nature of the global regulatory affairs outsourcing market, only a handful of large players have been able to gain significant share in this market over the past couple of years, says a new report by Transparency Market Research (TMR). This, however, has intensified the competitive rivalry in the market with players contending to deliver top-notch services. The top seven players in the market including Quintiles Transnational Holdings Inc., ICON plc, Pharmaceutical Product Development LLC, and PAREXEL International Corporation collectively held a share of 55% in the global market in 2014. The presence of a large number of small and medium-sized companies in the market has been advantageous to the bargaining power of clients.

The scenario demands regulatory affairs outsourcing service providers to top in terms of timeliness and quality. With increasing acceptance of electronics submissions from health governing bodies and compliance agencies, technological advancements will favor regulatory affairs outsourcing service providers to gain competitive edge, says the TMR report.

This 76 page report gives readers a comprehensive overview of the regulatory affairs outsourcing market. Browse through 10 data tables and 18 figures to unlock the hidden opportunities in this market: http://www.transparencymarketresearch.com/global-regulatory-affairs-outsourcing-market.html

The global market for regulatory affairs outsourcing was worth US$1.9 bn in 2014 and is projected to rise at a CAGR of 11.5% between 2015 and 2023. As such, the market will reach a valuation of US$5.7 bn by 2023.

Cost-effective Outsource Activities Befit over In-house Regulatory Maintenance

With the medical industry witnessing an increased rate of product innovations from companies vying to make a mark in the highly competitive market, investments on research and development are on the rise. In this regard, cost pressures and intense competition are pushing companies to discover new ways to contain costs incurred at the time of regulatory operations and practices principal to the life sciences industry. Outsourcing is increasingly being preferred over in-house data management as it is considered to be cost-effective and resource-efficient way of managing vast amounts of data generated during clinical trials, approvals, and patent approvals.

Moreover, strict regulatory framework in place that governs every facet of development and marketing of medical drugs and device mandate that regulatory documents to be in sync with pre-defined writing guidelines. This is further boosting the need for professional service providers that specialize in data handling related to regulatory affairs thereby further augmenting the need of dependable service providers for regulatory affairs outsourcing.

Varied Regulations Encourages Global Companies to Seek On-the-ground Expertise Help

With life sciences companies continually striving to spread their wings across the globe, the challenges of keeping up with varied and constantly changing regional, local, and national regulations can be overwhelming without expert help. In this scenario, outsourcing regulatory affairs to service providers that have a successful global footprint will be most suitable.

Request a sample of this report to know what opportunities will emerge in the rapidly evolving regulatory affairs outsourcing market during 2015 – 2023: http://www.transparencymarketresearch.com/sample/sample.php?flag=S&rep_id=3528

On a regional consideration, regulatory affairs service providers in the emerging economies of Asia Pacific and Latin America are expected to account for the leading number of outsourcing projects worldwide. An increasing number of biopharmaceutical companies are taking off from emerging economies to venture into large markets of North America and Europe.

Product improvement and setting up research and commercialization units is the focus of emerging economies due to cheap resources and cheap cost of raw materials. The large population of Asia Pacific makes for a lucrative regional market for the medical industry. These factors are benefitting the regulatory affairs outsourcing markets in these regions and will help them gain a strong foothold in the next few years.

The review presented is based on the findings of Transparency Market Research report, titled “Regulatory Affairs Outsourcing Market (Services – Regulatory Submissions, Clinical Trial Applications and Product Registrations, Regulatory Writing and Publishing, Regulatory Consulting and Legal Representation) – Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2015 – 2023.”

Regulatory Affairs Outsourcing Market is witness the highest gains from the clinical trial applications and product registration segment

In the highly fragmented market for regulatory affairs outsourcing, a very small number of large players have been able to acquire dominant share in the past few years. The top seven companies in the market, including Quintiles Transnational Holdings, Inc., Pharmaceutical Product Development (PPD), LLC, ICON plc, and PAREXEL International Corporation had a combined share of 55% in the global market in 2014. The presence of a large number of small- and medium-size companies in the market grants high bargaining power to buyers/clients. The intense competitive rivalry in the market has increased the number of options to choose from for clients in terms of product differentiation and price.

The scenario calls for regulatory affairs service providers to excel on the metrics of timeliness and quality. As health authorities and compliance agencies now accept electronic submissions, technological advancements will also play a crucial role for regulatory affairs service providers in gaining a competitive edge, states a recent report by TMR.

This 76 page report gives readers a comprehensive overview of the regulatory affairs outsourcing market. Browse through 10 data tables and 18 figures to unlock the hidden opportunities in this market: http://www.transparencymarketresearch.com/global-regulatory-affairs-outsourcing-market.html

Cost-efficient Outsource Activities Appeal Companies to Shift from Expensive In-house Regulatory Maintenance

As the medical industry witnesses an increased rate of product innovations from companies wanting to make a mark in the intensely competitive market, investments on R&D activities are skyrocketing. Cost pressures and intense competition in the global market are pushing companies in finding ways of containing costs incurred during the process of undertaking a variety of regulatory operations and practices central to the life sciences industry. Outsourcing, being a cost- and resource-efficient way of cutting costs incurred during the management of the vast data generated during activities such as clinical trials, approvals, and patent approvals, is being increasingly preferred by companies in comparison to in-house data management.

Diverse Regulations Encourage Global Companies to Prefer On-the-ground Expertise

In addition, the presence of strict regulatory framework governing every aspect of development and marketing of medical drugs and devices require that the regulatory documents be in line with defined writing guidelines. This factor has also led to the increased preference for professional service providers focused primarily on handling data related to regulatory affairs, driving the increased need for reliable regulatory affairs outsourcing service providers.

Request a sample of this report to know what opportunities will emerge in the rapidly evolving regulatory affairs outsourcing market during 2015 – 2023: http://www.transparencymarketresearch.com/sample/sample.php?flag=S&rep_id=3528

As life sciences companies look forward to spread their business network across the globe, the implications and challenges of managing the diverse and constantly changing local, regional, and national regulations can be overwhelming without on the ground expertise. In this situation, outsourcing regulatory affairs to service providers with a successful global footprint will be the most preferred solution.

The global regulatory affairs outsourcing market had a valuation of US$1.9 bn in 2014. The market is expected to expand at a substantial 11.5% CAGR from 2015 to 2023 and rise to a valuation of US$5.7 bn by 2023. Rising numbers of low-cost clinical trial centers in emerging economies such as Asia Pacific and Latin America will provide the most lucrative growth opportunities for the market during 2015 to 2023. The market is expected to expand at the highest, 15.8% CAGR, in Asia Pacific during the period. Latin America will follow, exhibiting 11.1% CAGR.

The review is based on a recent market research report published by Transparency Market Research, titled “Regulatory Affairs Outsourcing Market – Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2015 – 2023.”

 

Rising Investments in R&D to Encourage Increased Demand for Effective Regulatory Affairs Outsourcing Services

Life sciences companies can end-up spending nearly one-third of their regulatory resources for the maintenance of products that are already approved and are in the market. These maintenance activities, which provide almost no competitive advantage but are critical to maintain sales, may restrict a company from putting its best regulatory resources for core competencies and innovations.

Today’s evolving healthcare landscape already poses many challenges to life science companies in terms of restructuring, consolidation, globalization, and budget cuts. Add to this the vast product portfolios of today’s life science companies covering numerous verticals and we get an operational landscape that is ripe with unprecedented challenges for survival. To compete effectively in such a scenario, life science companies are presented with the dire necessity to put more focus on core competencies.

Browse Market Research Report of Regulatory Affairs Outsourcing Market: http://www.transparencymarketresearch.com/global-regulatory-affairs-outsourcing-market.html

Companies are thus considering outsourcing of a number of non-core but highly critical processes, such as regulatory maintenance, as a way to address the numerous challenges and benefit from a variable cost model for regulatory maintenance abilities via an agile workforce. Regulatory outsourcing allows companies to apply a multidisciplinary expertise to their regulatory affairs and operations, thereby leading to reduced costs, improved processes, and accelerated approvals.

Increasingly Stringent Regulatory Requirements Lead to Rising Adoption of Regulatory Outsourcing

The stringent regulatory framework ruling the manufacturing, testing, and distribution landscape of drugs and medical devices across the globe is impelling life science companies to outsource regulatory affairs as a cost-competent and much effective tool for satisfying the diverse requirements of different regions. Currently, more than 70% of the world’s major pharmaceutical companies are outsourcing their regulatory affairs. This represents a huge growth over the past decade as regulatory burdens have increased. Companies may have a variety of reasons for regulatory outsourcing, such as more product launches than can be handled by internal teams. With the help of a regulatory outsourcing partner, companies can benefit from additional expertise that can be brought in as the need arises.

A research report published by market research company Transparency Market Research states that the global market for regulatory outsourcing had a valuation of US$1.56 billion in 2013. Developing at a 14.6% CAGR between 2014 and 2020, the market is expected to rise to a valuation of US$4.49 billion by 2020. The services of regulatory writing and publishing held a nearly 40% of the global regulatory outsourcing market in 2013, adds the report.

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Life Science Companies Need On-the-Ground Expertise to Survive in Regional Territories

The growth and profits of life sciences companies depend on their business in the international market. With the rising globalization, a need for a broader level of on-the-ground, local expertise has risen before the life sciences industry. Lucrative regional markets such as Brazil, India, China, and Russia come with their own individual set of rules. Even in the European Union, there can be 28 different sets of regulations according to each of its member states.

For efficient operations in such varying sets of regulations, companies need to appreciate the difference in cultures and bureaucracies, which can be a huge challenge for growing life science companies. This presents the need for regulatory expertise on local, regional as well as national levels. Outsourcing regulatory affairs to a trusted partner having a global footprint can make the task easy and add to the competitive advantage of the company.

 

Global Regulatory Affairs Outsourcing Market will exhibit a healthy 11.5% CAGR from 2015 to 2023

In the highly fragmented market for regulatory affairs outsourcing, a very small number of large players have been able to acquire dominant share in the past few years. The top seven companies in the market, including Quintiles Transnational Holdings, Inc., Pharmaceutical Product Development (PPD), LLC, ICON plc, and PAREXEL International Corporation had a combined share of 55% in the global market in 2014. The presence of a large number of small- and medium-size companies in the market grants high bargaining power to buyers/clients. The intense competitive rivalry in the market has increased the number of options to choose from for clients in terms of product differentiation and price.

The scenario calls for regulatory affairs service providers to excel on the metrics of timeliness and quality. As health authorities and compliance agencies now accept electronic submissions, technological advancements will also play a crucial role for regulatory affairs service providers in gaining a competitive edge, states a recent report by TMR.

Cost-efficient Outsource Activities Appeal Companies to Shift from Expensive In-house Regulatory Maintenance

As the medical industry witnesses an increased rate of product innovations from companies wanting to make a mark in the intensely competitive market, investments on R&D activities are skyrocketing. Cost pressures and intense competition in the global market are pushing companies in finding ways of containing costs incurred during the process of undertaking a variety of regulatory operations and practices central to the life sciences industry. Outsourcing, being a cost- and resource-efficient way of cutting costs incurred during the management of the vast data generated during activities such as clinical trials, approvals, and patent approvals, is being increasingly preferred by companies in comparison to in-house data management.

Diverse Regulations Encourage Global Companies to Prefer On-the-ground Expertise

In addition, the presence of strict regulatory framework governing every aspect of development and marketing of medical drugs and devices require that the regulatory documents be in line with defined writing guidelines. This factor has also led to the increased preference for professional service providers focused primarily on handling data related to regulatory affairs, driving the increased need for reliable regulatory affairs outsourcing service providers.

As life sciences companies look forward to spread their business network across the globe, the implications and challenges of managing the diverse and constantly changing local, regional, and national regulations can be overwhelming without on the ground expertise. In this situation, outsourcing regulatory affairs to service providers with a successful global footprint will be the most preferred solution.

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The global regulatory affairs outsourcing market had a valuation of US$1.9 bn in 2014. The market is expected to expand at a substantial 11.5% CAGR from 2015 to 2023 and rise to a valuation of US$5.7 bn by 2023. Rising numbers of low-cost clinical trial centers in emerging economies such as Asia Pacific and Latin America will provide the most lucrative growth opportunities for the market during 2015 to 2023. The market is expected to expand at the highest, 15.8% CAGR, in Asia Pacific during the period. Latin America will follow, exhibiting 11.1% CAGR.

The review is based on a recent market research report published by Transparency Market Research, titled “Regulatory Affairs Outsourcing Market – Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2015 – 2023.”

The Current Trends and Future Growth in Regulatory Affairs Outsourcing

According to a new market report published by Transparency Market Research “Regulatory Affairs Outsourcing Market – Global Industry Analysis, Size, Share, Growth, Trends and Forecast 2014 – 2020,” the global regulatory affairs outsourcing market was valued at USD 1.56 billion in 2013 and is expected to grow at a CAGR of 14.6% from 2014 to 2020, to reach an estimated value of USD 4.49 billion in 2020

At present, biopharmaceutical industries are highly synchronized by various regulatory authorities across the globe. For the protection of public health, medical devices and pharmaceutical products are subject to strict regulations. Most of the pharmaceutical companies are opting to outsource their regulatory affairs operations to various competent contract research organizations (CROs) and contract manufacturing organizations (CMOs) in order to acquire timely approval from regulatory bodies. Furthermore, cost efficiencies, process improvement and utilization of the expertise available with the CROs are some of the primary factors which are responsible for the growth of regulatory affairs outsourcing market. Due to higher costs associated with the clinical trial and development procedures and the rising need for cost containment among manufacturing companies and rapid product commercialization, the regulatory affairs outsourcing market is expected to propel during the forecast period of 2014 to 2020.

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The regulatory writing and publishing services segment accounted for the largest share, i.e., more than 40% of the total regulatory affairs outsourcing market in 2013. Factors that have contributed towards the growth of the segment are growing need for rapid approval and submission of drug applications. Moreover, regulatory writers have appropriate understanding of the global and domestic regulatory requirements, thereby driving the growth of the regulatory writing and publishing services market. Similarly, in terms of growth rate, the regulatory consulting and legal representation services segment is estimated to grow at the fastest growth rate of over 13% from 2014 to 2020 of the regulatory affairs outsourcing market. Growing pressure for regulatory consulting and increasing need of client interaction with various regulatory agencies has attributed towards the growth of the regulatory consulting and legal representation services segment.

Geographically, North America accounted for the largest share (more than 30%) of the total regulatory affairs outsourcing market in 2013. However, Asia Pacific countries such as Japan, South Korea, Malaysia, Australia, Thailand, India and China are witnessing remarkable growth and are anticipated to grow at a CAGR of over 15% during the forecast period of 2014 to 2020 due to extensive presence of skilled workforce and easy market penetration in developing economies. Moreover, favorable support from governments for healthcare infrastructure would further boost the growth of the regulatory affairs outsourcing market in Asia Pacific.

The impressive growth of the regulatory affairs outsourcing market is likely to attract various market entrants. Major players operating in the regulatory affairs outsourcing market are Charles River Laboratories International, Inc., Covance Group Ltd., Parexel International Corporation, Quintiles Transnational Holdings, Inc., Medpace, Inc., Promedica International, Clinilabs, Inc., Accell Clinical Research, LLC, Criterium, Inc., ICON plc and Pharmaceutical Product Development.

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The global regulatory affairs outsourcing market is segmented as follows:

Regulatory Affairs Outsourcing Market, by Services

Regulatory Affairs
Clinical Trial Applications and Product Registrations
Regulatory Writing and Publishing
Regulatory Consulting and Legal Representation
Others (Post Approval Maintenance, Reimbursement Consulting etc.)

Regulatory Affairs Outsourcing Market, by Geography
North America
Europe
Asia Pacific
Rest of the World (RoW)

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