Regulatory Information Management Market Forecast, Trend Analysis & Competition Tracking: Global Market Insights 2019 to 2029

Published on : Jun-2019 | List of Tables : 82 | List of Figures : 101 | No. of Pages : 170 | Report Code : FACT3741MR |

Regulatory Information Management Market in Numbers 

  • The regulatory information management market registered a CAGR of nearly 8% during the period 2014 to 2018. This industry remains influenced by rapid transformations in regulation paradigms, from pharmaceuticals to medical devices verticals, thereby, witnessing an increased demand for software, such as regulatory information management.
  • The regulatory information management market has been envisaged to surpass revenues worth US$ 893 Mn in 2019, and record a Y-o-Y growth at nearly 9% in 2020.
  • North America will remain the leading market for regulatory information management, upheld by the availability of pharmaceutical stalwarts in the countries, such as US and Canada.
  • East Asia is expected to be the high-growth market for regulatory information management, with gains mainly driven by rising number of clinical trials taking place in the region, coupled with immense untapped opportunities in China.
  • Regulatory information services remain the leading solution in regulatory information management market due to a significant rise in number of regulatory solution providers that help companies implement regulatory processes seamlessly, and with high precision.
regulatory information management market snapshot

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Regulatory Information Management – Competitive Landscape 

The market for regulatory information management is highly fragmented with a wide pool of small scale companies operating in this industry. Companies, including

  • Veeva/ Sparta Systems
  • DXC Technology
  • Parexel
  • Aris Global

are leading the market owing to their broader and best-in-industry portfolios, in addition to their robust geographical reach.

While the attractiveness of RIM remains high for health authority management, the rapidly changing portfolios of drug manufacturers are compelling RIM service providers to align their regulatory training and management offerings with product specifications and regulations in the region of deployment. 

Promising product launches hold a competitive advantage in regulation information management market. For instance, IQVIA™ has recently launched IQVIA RIM Smart, the first fully integrated, cloud-based, complete regulatory information management solution for life sciences. Companies are increasingly leveraging artificial intelligence (AI) and machine learning (ML) to enable intelligent management of the complete regulatory lifecycle of a product portfolio. 

Leading players in the RIM market are eying IDMP (Identification of Medicinal Products) regulatory changes as an opportunity for business improvement. Increased focus of market forerunners on establishing a data model and supporting system that allows seamless data sharing across manufacturing, registration, labeling, and submission domains, is likely to heighten the scope of sales.

Additionally, growing number of regulatory information management providers are entering partnerships with pharmaceutical giants to gain a stronghold in the market. For instance, Boehringer Ingelheim has chosen the Ennov regulatory information management platform for their global RIM needs across human and veterinary sectors.

regulatory information management market competitive analysis

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Key Growth Drivers of Regulatory Information Management Market 

  • Growing regulatory reporting requirements and business financial imperatives are driving a regulatory shift from a mainly document-based model to data-based paradigm. Managing structured as well as unstructured content and a large amount of metadata demands a new level of precision in executing regulatory responsibilities, which is provided by regulatory information management software.
  • Rapidly transforming regulatory compliance of life sciences with no loss of momentum has made the regulatory approval more complex, thereby, increasing the burden - both direct costs and indirect costs, of compliance for most organizations. With no alternative to compliance, and for the fact that companies’ approach to compliance holds a direct impact on their competitive stature, installation of regulatory information management software has increased considerably.
  • The world is driven by ever-increasing demand for speed to market, which continues to make it difficult for brands to maintain pharmaceutical regulatory compliance. Unification of information enabled by an efficient regulatory information management software coupled with benefits such as improved consistency and reduced wasted efforts is favoring its deployment across verticals.
  • Organizations are increasingly taking efforts to gain additional value from their product data, as they realize strategically important role data could play in driving new productivity, competence and competitive differentiation. This, coupled with the growing importance to make product as well as regulatory information more shareable among and beyond specific functions, are driving the deployment of regulatory information management software.
  • The implementation of new European requirements, and the fact that other regions are considering adoption of similar requirements, companies will need to submit higher volumes of structured product information across demographics. A unified regulatory information management capability is vital to sourcing and linking data and submission, reinforcing the broader supply chain with authentic and accessible product data.
regulatory information management market regional opportunity assessment

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Key Challenges Faced by Stakeholders in Regulatory Information Management Market 

  • Rapidly evolving regulatory framework and changing product approval requisites continue to propel developers to stay abreast of latest regulations, and connected with market players to ensure software efficiency for error-free regulation compliance processes. This constant hassle is making the regulatory information management software less attractive to many companies.
  • The level of training required to operate regulatory information management software has been impeding its adoption, particularly in the small-scale enterprises that remain wary of additional costs associated with training employees. 

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Regulatory Information Management Market – Additional Insight 

End User Demand for Regulatory Information Management Services Remains High 

In light of the growing enforcement of different regulations and standards across various countries, regulatory information management has emerged as a key challenge for regulatory submissions in life sciences companies. Companies are facing challenges resultant of high confusion and accumulation of massive documentation due to market-specific and highly dissimilar regulations, which is necessitating consulting with professional trainers, thereby, creating further demand for regulatory information management services. 

Research Methodology

regulatory information management market taxonomy

A realistic methodology along with a holistic approach forms the base for the incisive insights offered in the regulatory information management market for the foreseeable period. The Fact.MR report presents detailed information on the growth prospects of regulatory information management industry along with riveting insights into the projection analysis of the market. 

Extensive primary as well as secondary research has been performed to garner valuable insights into the forecast analysis of regulatory information management market. The report on regulatory information management has further gone through cross-validation by in-house analysts to make the report one-of-its-kind with the utmost credibility.

Request Methodology of this Report.

A recently compiled report of Fact.MR, titled “Global Regulatory Information Management Market Forecast, Trend Analysis & Competition Tracking – Global Market Insights 2019-2029,” presents a comprehensive study on the regulatory information management market worldwide. Size of the regulatory information management market has been studied in detail and enumerated in terms of (US$ Mn). The report also offers a detailed analysis and forecast on different segments of the market, in tandem with crystal clear view of the competitive landscape of the regulatory information management market. 

Chapter 1 - Regulatory Information Management Market Executive Summary 

A concise summary of the regulatory information management market has been provided in the first chapter of the report, which provides a synopsis of the key findings in the market, and information on the market structure. Opportunity assessment for various companies functional in the regulatory information management market has been detailed with the aid of Wheel of Fortune. Key trends that are shaping the growth of the regulatory information management market are also offered in the report. 

Chapter 2- Regulatory Information Management Market Overview 

The report provides a succinct overview of the regulatory information management market, which covers the introduction and definition of the key offering– regulatory information management. A systematic breakdown of the regulatory information management market has also been detailed in the report. 

Chapter 3- Regulatory Information Management Key Success Factors 

This chapter of the report offers information about the primary factors that are shaping the growth and success of the market. It also provides information about the investment feasibility matrix along with product life cycle assessment. 

Chapter 4 - Regulatory Information Management Market Background 

This section of the report on regulatory information management market offers an exhaustive outlook of the market background, wherein myriad factors impacting the sales of regulatory information management are offered in detail. This chapter also provides information about the applications of the key product to aid the market enthusiasts evaluate the growth of regulatory information management market in a better way. 

Chapter 5 - Regulatory Information Management Market Dynamics 

This chapter of the report provides information about the key drivers, restrains and the trends that are impacting the growth of the regulatory information management market. 

Chapter 6 - Global Regulatory Information Management Market Analysis (2014–2018) and Forecast (2019-2029) 

In this chapter of the report, information about the historical, current and future performance of the regulatory information management market has been provides in terms of value, and Y-o-Y analysis. This chapter provides an incisive viewpoint about how the historical and current market performance is expected to impact growth of the regulatory information management market in the coming years.

The chapter also sheds light on the performance of different segments of the regulatory information management market. The market has been segmented on the basis of solution, category, company size, verticals, and region. 

Chapter 7 - North America Regulatory Information Management Market Analysis (2014–2018) and Forecast (2019-2029) 

This chapter of the regulatory information management market report provides key insights related to North America regulatory information management industry and also mentions the regional trends that are influencing the growth of the market in this region. 

Chapter 8 – Latin America Regulatory Information Management Market Analysis (2014–2018) and Forecast (2019-2029) 

This section of the regulatory information management market report offers key insights pertaining to Latin America regulatory information management industry and also provides the regional trends that are impacting the growth of the market in the region. 

Chapter 9 – Europe Regulatory Information Management Market Analysis (2014–2018) and Forecast (2019-2029) 

This chapter provides a concise introduction to the regulatory information management market in Europe, and exhaustive analysis and forecast on regional trends that are impacting the market growth. Key countries assessed in the Europe regulatory information management market are the Germany, France, Italy, Spain, U.K., BENELUX, Russia, and Rest of Europe. Value & volume forecast on the regulatory information management market in these countries have also been delivered in this chapter. 

Chapter 10 – South Asia Regulatory Information Management Market Analysis (2014–2018) and Forecast (2019-2029) 

This chapter offers a succinct introduction to the regulatory information management market in South Asia, along with exhaustive analysis and forecast on regional trends that are shaping the growth of the market. Value & volume forecast on the regulatory information management market in different countries of South Asia have also been delivered in this chapter. 

Chapter 11 – East Asia Regulatory Information Management Market Analysis (2014–2018) and Forecast (2019-2029) 

This part of the report provides concise introduction to the regulatory information management market in East Asia, in tandem with comprehensive analysis and forecast on regional trends that are impacting the growth of the market. Value & volume projection on the regulatory information management market in various countries of East Asia have also been offered in this chapter. 

Chapter 12 – Oceania Regulatory Information Management Market Analysis (2014–2018) and Forecast (2019-2029) 

This section of the report offers succinct introduction to the regulatory information management market in Oceania, along with the in-depth analysis and forecast on regional trends shaping the growth of the market. 

Chapter 13 – Middle East & Africa Regulatory Information Management Market Analysis (2014–2018) and Forecast (2019-2029) 

This part of the report provides concise introduction to the regulatory information management market in Middle East & Africa, along with detailed analysis and forecast on regional trends that are impacting the growth of the market in this region. 

Chapter 14 – Competition Analysis 

This critical chapter of the report provides in-depth assessment on the regulatory information management market’s structure, and a dashboard view of all vital companies profiled in the report. A company share analysis on the regulatory information management market players has also been provided in this chapter. In addition, a footprint matrix on the market players has been provided and the presence of these companies is depicted with the aid of an intensity map. 

Chapter 15- Competition Deep Dive 

Key companies profiled in the regulatory information management market report include

  • Instem Information Solutions
  • IQVIA Holdings Inc.
  • Synchrogenix Information Strategies Inc.
  • DXC Technology
  • PAREXEL International
  • AMPLEXOR
  • Sparta Systems Inc.
  • Ennov SA
  • Extedo GmbH
  • Veeva Systems Inc.
  • NIT A/S
  • Instem Information Solutions
  • Dovel Technologies, Inc. 

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Regulatory Information Management Market Forecast, Trend Analysis & Competition Tracking: Global Market Insights 2019 to 2029