USD 6.48 billion
Regulatory Affairs Outsourcing Market Size, Share, Growth Analysis, By Services(Regulatory Consulting (Strategy & Development Planning, QA Consulting, Others), Legal Representation), By Company Size(Small, Medium, Large), By Category(Pharmaceuticals (Regulatory Consulting (Strategy & Development Planning, QA Consulting, Others), Legal Representation), By Indication(Oncology, Neurology, Cardiology, Immunology), By Product Stage(Preclinical, Clinical, PMA (Post Market Authorization)), By End Use(Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies), By Region - Industry Forecast 2024-2031
Report ID:
SQMIG35D2051 |
Region:
Global |
Published Date: September, 2024
Pages:
157
|Tables:
174
|Figures:
79
Regulatory Affairs Outsourcing Market Insights
Global Regulatory Affairs Outsourcing Market size was valued at USD 6.1 billion in 2022 and is poised to grow from USD 6.65 billion in 2023 to USD 12.62 billion by 2031, growing at a CAGR of 8.34% during the forecast period (2024-2031).
Healthcare companies are under constant pressure to obtain timely clinical approvals from regulators in various countries. Such activities further increase the demand for legal information services, thereby contributing to the of the regulatory affairs outsourcing market growth. Furthermore, increased demand for new product approvals while maintaining regulatory compliance, drives market growth. According to a survey sponsored by Genpact, 72.0% of life sciences agency executives consider compliance to be one of the top three challenges facing life sciences companies and legal departments are often burdened with dealing with multiple tasks role simultaneously and must ensure compliance with strict regulatory standards. Increased efforts by companies to gain faster approvals in the regulatory affairs outsourcing market to expand their geographical reach is expected to further help adopt outsourcing strategies for legal services. Increased use of pharmaceutical products and demand for cheaper drugs and medical devices are expected to drive down healthcare costs, increasing the preference for legal outsourcing.
Increasing out-of-pocket debt in developed and developing countries, uneven economic growth and measures taken by many governments to reduce drug costs are some of the factors exerting economic and competitive pressures comes into being, which in turn is expected to drive demand for the outsourcing of regulatory functions in life sciences companies. Drug-specific medical advice & compliance with policies and regulations in the early stages of drug development can be critical to drug approval.
US Regulatory Affairs Outsourcing Market is poised to grow at a sustainable CAGR for the next forecast year.
Market snapshot - 2024-2031
Global Market Size
Largest Segment
large
Fastest Growth
large
Growth Rate
8% CAGR
Global Regulatory Affairs Outsourcing Market ($ Bn)
Country Share for Asia Pacific Region (%)
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Regulatory Affairs Outsourcing Market Segmental Analysis
Global Regulatory Affairs Outsourcing Market is segmented by Services, Company Size, Category, Indication, Product Stage, End Use, and Region. Based on Services, the market is segmented into Regulatory Consulting (Strategy & Development Planning, QA Consulting, Others), Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Product Stages, Regulatory Submission, Regulatory Operations, Other Services. Based on Company Size, the market is segmented into Small, Medium, Large. Based on Category, the market is segmented into Pharmaceuticals (Regulatory Consulting (Strategy & Development Planning, QA Consulting, Others), Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Product Stages, Regulatory Submissions, Regulatory Operations, Other Services), Medical Device (Regulatory Consulting (Strategy & Development Planning, QA Consulting, Others), Legal Representation, Regulatory Writing & Publishing, Product Registration & Clinical Trial Product Stages, Regulatory Submissions, Regulatory Operations, Other Services). Based on Indication, the market is segmented into Oncology, Neurology, Cardiology, Immunology, Others. Based on Product Stage, the market is segmented into Preclinical, Clinical, PMA (Post Market Authorization). Based on End Use, the market is segmented into Medical Device Companies, Pharmaceutical Companies, Biotechnology Companies. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.
Regulatory Affairs Outsourcing Market Analysis by Indication
The oncology segment dominated the regulatory affairs outsourcing market share of over 33.3% in 2023. Recent advances in cancer biology and the advent of new tools for genome analysis have opened clinical perspectives in oncology, and it offers personalized medicine. Scientific advances are increasing the number of personalized medicines and services, subject to regulatory review, so other factors that determine the extent of research contributing to regulatory affairs outsourcing market growth are neuroscience, cardiology, physiology immunity, and among others. The oncology segment driven via the growing range of cancer healing procedures and remedies under development. As oncology capsules regularly require stringent regulatory approvals because of their complexity and life-saving ability, pharmaceutical and biotech organizations to ensure compliance with evolving worldwide requirements.
The immunology segment is expected to expand at the fastest CAGR of 9.8% during the forecast period. This is due to its sensitivity in the treatment of cardiovascular, neurological, cancer and various inflammatory diseases. Positive policies by market players for the immune system are expected to facilitate the growth of the segment. For example, in September 2021, Boehringer Ingelheim acquired Abexa Biologics. This expands the company’s cancer immunotherapy and immunotherapy segment markets. In addition, the COVID-19 pandemic created an urgent need for vaccines. Therefore, the development of COVID-19 vaccines is likely to have a positive impact on the growth of the segment.
Regulatory Affairs Outsourcing Market Analysis by Product Stage
The clinical studies segment dominated the regulatory affairs outsourcing market share, accounting for 46.8% in 2023. This is probably due to the clinical trials registered in the last few years. Apart from the registration of about 32,540 new trials put aside, this number increased of biologics, huge demand for advanced technologies, need for orphan drugs & personalized medicines are other factors which are likely to fuel the growth of the segment during the forecast period. The clinical research phase is essential for outsourcing regulatory functions, as it involves the development, implementation, and monitoring of trials to ensure drug efficacy and patient safety. Key responsibilities include monitoring clinical trial design, data collection, and compliance. The outsourcing of these processes helps companies manage the high cost and complex compliance standards in developing new therapies. Regulatory agencies also help streamline submissions and they ensure compliance with FDA, EMA, and other global standards.
The preclinical segment is expected to expand at the fastest CAGR of 9.0% during the forecast period 2024-2031. Growing demand for new treatments for diseases such as COVID-19, Zika virus, Ebola and existing diseases such as CVD, cancer and vascular diseases. Also, strict preclinical research regulations, enforced by global regulatory bodies such as the International Conference on Compounding (ICH), WHO, FDA, EMEA (Europe), PMDA (Japan), ANVISA (Brazil). The MHRA (UK), & ROEB (Canada), are increasingly raising the requirement for companies to outsource regulatory functions for pre-clinical investigations. Preclinical studies focus on evaluating the safety and biological effects of drugs before human trials. This phase ensures that the initial safety, toxicity, and pharmacokinetics of the product meet regulatory guidelines. By outsourcing preclinical work, organizations gain access to strong regulatory frameworks and specialized laboratories for testing and expertise. This category helps pharmaceutical companies mitigate risks early in their development process and comply with regulatory guidelines for future clinical trial approval.
Global Regulatory Affairs Outsourcing Market By Indication (%)
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Regulatory Affairs Outsourcing Market Regional Insights
The Asia-Pacific region dominated the regulatory affairs outsourcing market and controlled the largest revenue share of over 39.9% in 2023. The region is also expected to witness the fastest CAGR during the forecast period this from increasing number of clinical trials. Apart from the reason that could be the availability of skilled labor in the region which is cheaper compared to the US. It is another driver for the regional regulatory affairs outsourcing market growth. China is one of the attractive markets for the biopharmaceutical industry. The growing elderly population and the presence of a large middle-income population further increases the demand for new low-cost drugs, which are expected to attract major pharmaceutical companies of devices in this category for 12 to 24 months is needed while the approval process may need more than six years. In addition to receiving state approval, the new drug must be approved at the provincial and municipal levels, which could require an additional 4 to 5 years.
North America is the dominant region in the market. The North America region in the market also reported a significant share of the regulatory affairs outsourcing industry. Presence of large pharmaceutical and medical device companies and high R&D expenditure in the region are some of the key factors driving the regulatory affairs outsourcing market in North America. Along with patented products, cost-effective generic biosimilars are also in high demand in this segment. For example, as of January 2022, there were approximately FDA-approved biosimilars in the US. Thus, the increasing development and approval of new biosimilars is expected to drive demand for regulatory services in the US, driving the market.
Global Regulatory Affairs Outsourcing Market By Geography
- Largest
- Fastest
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Regulatory Affairs Outsourcing Market Dynamics
Regulatory Affairs Outsourcing Market Driver
Legal Requirements becoming Increasingly Complex
- The regulatory landscape in various industries, particularly pharmaceutical, biotechnology and medical devices, is becoming increasingly complex because agencies such as the FDA (U.S.), EMA (Europe), and others frequently update regulations, guidelines, and compliance standards, it is difficult for companies to navigate these evolving systems. Regulation information outsourcing helps organizations meet these challenges by leveraging the expertise of specialized companies. These agencies have greater knowledge of local and global regulatory requirements, enabling companies to ensure compliance regardless of in-house groups. This need for awareness and flexibility is driving significant growth in regulatory issues.
Cost Effectiveness and Focus on Core Competencies
- Another key driver of the regulatory affairs outsourcing market is cost efficiency. Maintaining an internal compliance team can be important, especially for small and medium-sized companies that may not have the resources to set up large compliance departments. These outsourcing functions provide businesses with the expertise they need to handle submissions, documentation and approvals. This shift towards efficiencies that can focus more, such as product development and innovation, and reliability the elevation of third parties to ensure that their products meet stringent regulations is a key driver of the increasing demand for outsourcing.
Restraints
Data Security and Privacy Concerns
- One of the major limitations in the regulatory affairs outsourcing market is data security and privacy concerns. The outsourcing of critical regulatory services often requires the sharing of sensitive information, such as clinical trial data, intellectual property, and proprietary business processes and this carries the risk of a data breach and compliance with data protection regulations such as the GDPR. Many organizations are reluctant to rely entirely on third-party providers due to concerns about protecting privacy, especially in highly regulated industries such as pharmaceuticals and biotechnology, where data security is very important. These concerns may slow the uptake of outsourcing and restrict market growth.
Quality Control Issues Involving Third Party Suppliers
- Another key mandate is the potential loss of productivity when outsourcing legal action. Companies can face challenges in ensuring that their suppliers adhere to the same standards of quality and accuracy as their in-house teams. Any misuse of legal procedures, late paperwork, or paperwork errors can have costly consequences, including fines, penalties, or even returning products. Besides, outsourcing partners do not always align well with the client’s specific business model and company culture, creating negotiations for differences or quality issues. This lack of direct oversight remains a major concern for organizations when considering outsourcing their legal functions.
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Regulatory Affairs Outsourcing Market Competitive Landscape
The regulatory affairs outsourcing market is characterized by intense competition, with key players leading the market such as Parexel International, IQVIA, PRA Health Sciences, ICON plc etc. Those companies provide comprehensive legal services, such as referrals, compliance monitoring and counselling. A notable example of strategic collaboration is the partnership between PAREXEL International and Oracle Health Sciences. This collaboration combines Oracle's advanced cloud-based clinical trial management technology with Parexel's regulatory expertise enabling customers to make regulatory submissions, ensure compliance, and accelerate drug development processes globally. Such alliances more efficient, enhance competitive advantage by providing tech-driven solutions.
Regulatory Affairs Outsourcing Market Top Player's Company Profiles
- Accell Clinical Research, LLC
- Genpact
- CRITERIUM, INC
- Promedica International
- New WuXi Life Science Limited
- Medpace
- Bausch & Lomb
- Freyr
- SSI Strategy Holdings LLC
- Pharmexon
- Quanticate
- PharmaLex
- Cambridge Regulatory Services
- APC Group
- Real Regulatory Ltd
- Ergomed Plc
- Regulatory Pharma Net srl
- Excelya Group SAS
- BioMapas
- REGENOLD GMBH
Regulatory Affairs Outsourcing Market Recent Developments
- In February 2023, AmerisourceBergen Corporation acquired PharmaLex Holding GmbH, a leading business, including regulatory, in the life science industry. This expands the company’s service reach in important markets.
- In April 2022, VCLS entered a partnership with EC Innovations, a Chinese company that provides translation services worldwide and has extensive experience in the translation of highly regulated life science and medical products. The Strategy helped form the partnership production and operating capacity intensity.
- In January 2021, ICON plc acquired PRA Health Sciences, Inc. This strategic acquisition has significantly enhanced the company’s medical information and business strategy.
Regulatory Affairs Outsourcing Key Market Trends
- Increasing the Use of Digital Solutions in Regulatory Matters: A key trend in the regulatory affairs outsourcing market is the increasing adoption of digital tools and platforms to streamline regulatory processes. Regulatory technology (RegTech) solutions are increasingly being used to manage how they comply with regulations, have automated shipments, follow approvals and follow regulatory changes. Legal outsourcing companies integrate digital systems to deliver fast, accurate and cost-effective solutions. Cloud-based solutions, AI, and automation increase productivity, reduce human error, and ensure real-time regulatory updates. This trend is changing how outsourcing of the regulatory functions is managed, making the process more transparent and scalable.
- Growing Demand for Regulatory Outsourcing in Emerging Markets: Another key trend is the growing demand for outsourcing of regulatory information in emerging markets, especially areas such as Asia-Pacific and Latin America. As pharmaceutical and medical device companies expand their activities, these markets are faced with the challenge of navigating the complex regulatory environments. Outsourcing allows companies to accelerate market movement and ensure compliance with local authorities. Emerging markets are also becoming an outsourcing destination due to the availability of skilled labor and low labor costs. This trend is contributing to the global expansion of the regulatory affairs outsourcing market.
Regulatory Affairs Outsourcing Market SkyQuest Analysis
SkyQuest’s ABIRAW (Advanced Business Intelligence, Research & Analysis Wing) is our Business Information Services team that Collects, Collates, Correlates, and Analyses the Data collected by means of Primary Exploratory Research backed by robust Secondary Desk research.
According to SkyQuest analysis, the regulatory affairs outsourcing market is driven by the growing complexity of regulatory necessities and the value performance gained with the aid of outsourcing regulatory features. While the market faces demanding situations together with concerns over records security and manage problems, it maintains to grow because of the growing adoption of digital tools and expanding demand in emerging markets. Increased geographic expansion activities for firms targeting early approval in local markets are expected to contribute to the adoption of outsourcing arrangements for legal services. The market is expanding rapidly due to increasing R&D activities, clinical trial implementation and increasing number of product registrations. Companies inside the pharmaceutical, biotechnology, and the scientific device sectors are leveraging expertise to navigate the regulatory panorama, reduce charges, and recognition on centre abilities. As a result, the market is anticipated to amplify similarly as the need for specialized regulatory aid grows throughout diverse industries.
| Report Metric | Details |
|---|---|
| Market size value in 2022 | USD 6.1 billion |
| Market size value in 2031 | USD 12.62 billion |
| Growth Rate | 8.34% |
| Base year | 2023 |
| Forecast period | 2024-2031 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
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| Regions covered | North America (US, Canada), Europe (Germany, France, United Kingdom, Italy, Spain, Rest of Europe), Asia Pacific (China, India, Japan, Rest of Asia-Pacific), Latin America (Brazil, Rest of Latin America), Middle East & Africa (South Africa, GCC Countries, Rest of MEA) |
| Companies covered |
|
| Customization scope | Free report customization with purchase. Customization includes:-
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Table Of Content
Executive Summary
Market overview
- Exhibit: Executive Summary – Chart on Market Overview
- Exhibit: Executive Summary – Data Table on Market Overview
- Exhibit: Executive Summary – Chart on Regulatory Affairs Outsourcing Market Characteristics
- Exhibit: Executive Summary – Chart on Market by Geography
- Exhibit: Executive Summary – Chart on Market Segmentation
- Exhibit: Executive Summary – Chart on Incremental Growth
- Exhibit: Executive Summary – Data Table on Incremental Growth
- Exhibit: Executive Summary – Chart on Vendor Market Positioning
Parent Market Analysis
Market overview
Market size
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- SWOT Analysis
KEY MARKET INSIGHTS
- Technology Analysis
- (Exhibit: Data Table: Name of technology and details)
- Pricing Analysis
- (Exhibit: Data Table: Name of technology and pricing details)
- Supply Chain Analysis
- (Exhibit: Detailed Supply Chain Presentation)
- Value Chain Analysis
- (Exhibit: Detailed Value Chain Presentation)
- Ecosystem Of the Market
- Exhibit: Parent Market Ecosystem Market Analysis
- Exhibit: Market Characteristics of Parent Market
- IP Analysis
- (Exhibit: Data Table: Name of product/technology, patents filed, inventor/company name, acquiring firm)
- Trade Analysis
- (Exhibit: Data Table: Import and Export data details)
- Startup Analysis
- (Exhibit: Data Table: Emerging startups details)
- Raw Material Analysis
- (Exhibit: Data Table: Mapping of key raw materials)
- Innovation Matrix
- (Exhibit: Positioning Matrix: Mapping of new and existing technologies)
- Pipeline product Analysis
- (Exhibit: Data Table: Name of companies and pipeline products, regional mapping)
- Macroeconomic Indicators
COVID IMPACT
- Introduction
- Impact On Economy—scenario Assessment
- Exhibit: Data on GDP - Year-over-year growth 2016-2022 (%)
- Revised Market Size
- Exhibit: Data Table on Regulatory Affairs Outsourcing Market size and forecast 2021-2027 ($ million)
- Impact Of COVID On Key Segments
- Exhibit: Data Table on Segment Market size and forecast 2021-2027 ($ million)
- COVID Strategies By Company
- Exhibit: Analysis on key strategies adopted by companies
MARKET DYNAMICS & OUTLOOK
- Market Dynamics
- Exhibit: Impact analysis of DROC, 2021
- Drivers
- Opportunities
- Restraints
- Challenges
- Exhibit: Impact analysis of DROC, 2021
- Regulatory Landscape
- Exhibit: Data Table on regulation from different region
- SWOT Analysis
- Porters Analysis
- Competitive rivalry
- Exhibit: Competitive rivalry Impact of key factors, 2021
- Threat of substitute products
- Exhibit: Threat of Substitute Products Impact of key factors, 2021
- Bargaining power of buyers
- Exhibit: buyers bargaining power Impact of key factors, 2021
- Threat of new entrants
- Exhibit: Threat of new entrants Impact of key factors, 2021
- Bargaining power of suppliers
- Exhibit: Threat of suppliers bargaining power Impact of key factors, 2021
- Competitive rivalry
- Skyquest special insights on future disruptions
- Political Impact
- Economic impact
- Social Impact
- Technical Impact
- Environmental Impact
- Legal Impact
Market Size by Region
- Chart on Market share by geography 2021-2027 (%)
- Data Table on Market share by geography 2021-2027(%)
- North America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- USA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Canada
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Europe
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Germany
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Spain
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- France
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- UK
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Europe
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Asia Pacific
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- China
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- India
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Japan
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Korea
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of Asia Pacific
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Latin America
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- Brazil
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of South America
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Middle East & Africa (MEA)
- Chart on Market share by country 2021-2027 (%)
- Data Table on Market share by country 2021-2027(%)
- GCC Countries
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- South Africa
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
- Rest of MEA
- Exhibit: Chart on Market share 2021-2027 (%)
- Exhibit: Market size and forecast 2021-2027 ($ million)
KEY COMPANY PROFILES
- Competitive Landscape
- Total number of companies covered
- Exhibit: companies covered in the report, 2021
- Top companies market positioning
- Exhibit: company positioning matrix, 2021
- Top companies market Share
- Exhibit: Pie chart analysis on company market share, 2021(%)
- Total number of companies covered
Methodology
For the Regulatory Affairs Outsourcing Market, our research methodology involved a mixture of primary and secondary data sources. Key steps involved in the research process are listed below:
1. Information Procurement: This stage involved the procurement of Market data or related information via primary and secondary sources. The various secondary sources used included various company websites, annual reports, trade databases, and paid databases such as Hoover's, Bloomberg Business, Factiva, and Avention. Our team did 45 primary interactions Globally which included several stakeholders such as manufacturers, customers, key opinion leaders, etc. Overall, information procurement was one of the most extensive stages in our research process.
2. Information Analysis: This step involved triangulation of data through bottom-up and top-down approaches to estimate and validate the total size and future estimate of the Regulatory Affairs Outsourcing Market.
3. Report Formulation: The final step entailed the placement of data points in appropriate Market spaces in an attempt to deduce viable conclusions.
4. Validation & Publishing: Validation is the most important step in the process. Validation & re-validation via an intricately designed process helped us finalize data points to be used for final calculations. The final Market estimates and forecasts were then aligned and sent to our panel of industry experts for validation of data. Once the validation was done the report was sent to our Quality Assurance team to ensure adherence to style guides, consistency & design.
Analyst Support
Customization Options
With the given market data, our dedicated team of analysts can offer you the following customization options are available for the Regulatory Affairs Outsourcing Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Regulatory Affairs Outsourcing Market for additional countries.
Competitive Analysis: Detailed analysis and profiling of additional Market players & comparative analysis of competitive products.
Go to Market Strategy: Find the high-growth channels to invest your marketing efforts and increase your customer base.
Innovation Mapping: Identify racial solutions and innovation, connected to deep ecosystems of innovators, start-ups, academics, and strategic partners.
Category Intelligence: Customized intelligence that is relevant to their supply Markets will enable them to make smarter sourcing decisions and improve their category management.
Public Company Transcript Analysis: To improve the investment performance by generating new alpha and making better-informed decisions.
Social Media Listening: To analyze the conversations and trends happening not just around your brand, but around your industry as a whole, and use those insights to make better Marketing decisions.
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