USD 458.2 billion
Montelukast Sodium Market Size, Share, and Growth Analysis
Montelukast Sodium Market By Dosage Form (Tablets, Oral Solution), By Application (Asthma, Allergic Rhinitis and Urticaria), By Region -Industry Forecast 2025-2032
Report ID:
SQMIG35I2394 |
Region:
Global |
Published Date: July, 2025
Pages:
196
|Tables:
62
|Figures:
70
Format -
Montelukast Sodium Market Insights
Global Montelukast Sodium Market size was valued at USD 458.2 billion in 2023 and is poised to grow from USD 527.39 billion in 2024 to USD 1624.55 billion by 2032, growing at a CAGR of 15.1% during the forecast period (2025-2032).
The global montelukast sodium market growth is being fueled by the increasing prevalence of diseases like asthma, allergic rhinitis, etc. and a rise in geriatric population. As air pollution is rising worldwide and the AQI of urban areas is rapidly decreasing, the cases of asthma and allergies are increasing which increases the demand for montelukast sodium market. Healthcare infrastructure improvements and the inclusion of montelukast in treatment guidelines by regulatory authorities have also contributed to market growth. Furthermore, ongoing research into new formulations and combination therapies is expected to enhance the drug’s application scope, supporting its continued demand in the coming years.
For instance, In April 2024, the United Nations Department of Economic and Social Affairs published demographic data showing a 12% increase in the global population aged 65 and above, especially in Japan, Germany, and Italy. This age group is more susceptible to chronic respiratory issues, leading to higher monthly sodium usage.
The global montelukast sodium market is transforming through integration of AI, machine learning, IoT, augmented reality and virtual reality, and reshaping the pharma sector. Artificial intelligence is being utilized in drug discovery and development processes where companies analyze vast chemical databases to identify novel formulations and less side effects. IoT devices are used to monitor drug storage and transportation. Montelukast sodium is sensitive to light and moisture and when it is exposed to them, IoT sensors raise alarms. Block kill technology is used to ensure transparency and source of montelukast sodium in the global supply chain. Overall, these technologies are helping companies to remain competitive while ensuring the medicines are safe, effective, and accessible in the global market.
What Makes AI Crucial for Montelukast sodium market?
Artificial intelligence plays a crucial role in transforming the montelukast sodium market, particularly in areas such as drug development, process optimization, patient centric approach and regulatory compliance. All AI algorithms are used to predict optimal drug formulations by analyzing patient demographics, response data, and side effect profiles. For example, Atom Weiss Pharma uses artificial intelligence and deep learning to identify molecular structures with higher efficiency and fewer side effects based on patients’ clinical data. AI is also used by manufacturers to monitor production, detect anomalies, and predict equipment failure. AI is empowering the stakeholders and driving sustainable growth in the highly competitive montelukast sodium market.
Market snapshot - 2025-2032
Global Market Size
Largest Segment
Tablets
Fastest Growth
Oral Solution
Growth Rate
15.1% CAGR
Montelukast Sodium Market ($ Bn)
Montelukast Sodium Market for North America (%)
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Montelukast Sodium Market Segments Analysis
Global Montelukast Sodium Market is segmented by Product Type, Dosage Form, Drug Class, Application, Distribution Channel and region. Based on Product Type, the market is segmented into Inhalers and Nebulizers. Based on Dosage Form, the market is segmented into Tablets, Oral solutions and Others. Based on Drug Class, the market is segmented into Anti-inflammatory, Bronchodilators and Combination Therapy. Based on Application, the market is segmented into Asthma, Allergic rhinitis, Urticaria and Other applications. Based on Distribution Channel, the market is segmented into Hospital pharmacies, Retail pharmacies and Online pharmacies. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.
What Makes Tablets a Preferred Choice for Montelukast Sodium Market?
Based on the 2024 global Street furniture industry outlook, tables are preferred due to factors such as convenience, stability, cost effectiveness, and patient compliance. Tablets are easy to handle, store, and consume, making them highly preferred by patients of various age groups. Physicians are familiar with tablet prescriptions and often consider them a first-line option. Moreover, tablet formulations have evolved to include chewable and dispersible tablets addressing the needs of pediatric and geriatric populations.
The demand for oral solutions in montelukast sodium market is driven by evolving patient needs, pediatric and geriatric applications and innovations in formulation technology. Oral solutions allow for flexibility and ease of swallowing, increasing adherence among younger patients, and enhancing therapeutic outcomes. With increased stability, shelf life and packaging innovation the demand for oral solutions is expanding in the montelukast sodium market.
What Makes Asthma Application More Dominant in Montelukast Sodium Market?
As per the 2024 global montelukast sodium market analysis, the predominance of asthma application is attributed to factors such as global prevalence, chronic nature and established clinical use of Montelukast sodium as a long-term controller medication. Urban areas are experiencing decreasing air quality, increased pollen, and climate related changes that increase respiratory conditions like asthma. Asthma is a chronic disease and often requires add-on therapy which further increases its demand in the montelukast sodium market.
The demand for montelukast sodium in treatment of allergic rhinitis is increasing rapidly, due to surge in environmental allergens, urban pollution, seasonal changes, and growing awareness about allergic conditions. Montelukast Sodium has been incorporated into several national and international allergy treatment guidelines for patients unresponsive to antihistamines, which further increases its application. However non chronic and seasonal nature of allergic rhinitis limits its application in the montelukast sodium market.
Montelukast Sodium Market By Dosage Form
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Montelukast Sodium Market Regional Insights
Why Does North America Lead the Montelukast sodium market?
As per the 2024 montelukast sodium market regional forecast, factors such as the presence of key players, the high prevalence of asthma and other respiratory diseases and the established healthcare infrastructure. The region's growing patient base, and rising disposable income support the region's market expansion. Moreover, the rise in geriatric population in the region further increases the demand in north America.
U.S. Montelukast Sodium Market
The US montelukast sodium market remains a healthy sector, with growth, supported by Increasing respiratory diseases, advanced health care system and government initiatives. The growing aging population and rising chronic allergies among children accelerate the demand for montelukast sodium. The market is also benefiting from rising awareness among people in government initiatives like easy approvals of generic variations, which leads to market expansion. Strict regulatory measures regarding chemical formulations and side effects are also reshaping the market.
Canada Montelukast Sodium Market
As per 2024, specimen validity testing industry analysis, Canada's montelukast sodium market is expanding rapidly due to factors such as Increasing cases of asthma, allergic rhinitis and respiratory complications. Market in Canada is flooded with several generic variations which are effective and economic, preferred by patients and hospitals and clinics. Government initiatives such as spreading awareness and investing in research and development for safer formulations is also reshaping the market.
Why Europe Is the Fastest Growing Region in Montelukast Sodium Market?
As per 2024, the street furniture regional outlook, Europe is emerging as the fastest growing region in montelukast sodium market, due to factors such as rising prevalence of respiratory diseases, presence of major generic pharmaceutical manufacturers and strict regulations by European Medicines Agency. Governments in Europe are spreading awareness, and early diagnosis through well-developed healthcare systems and montelukast sodium-based treatment, which accelerates the growth in the market. Moreover, EU funded research projects and collaborations between academics and industry are fostering the development of new montelukast sodium formulations, contributing to innovation and market expansion.
Germany Montelukast Sodium Market
As per 2024, regional montelukast sodium industry forecast, the demand for montelukast sodium market in Germany is driven advanced healthcare infrastructure, and high prevalence of respiratory diseases. Germany’s emphasis on research and development gave rise to innovations in drug delivery systems, in therapeutic outcomes, which propels the market expansion. Moreover, Germany is a hub for pharmaceuticals making it a key player in montelukast sodium market.
UK Montelukast Sodium Market
The market for montelukast sodium in UK is driven by, increasing cases of respiratory diseases, clinical expertise and regulatory measures. The UK’s health care system emphasizes on preventive care, promoting the use of Monterey Lucas sodium specially for asthma and allergic rhinitis. The market is also witnessing increased competition, from generic manufacturers leading to more affordable options for patients. Strict regulatory measures regarding safety and efficacy standards are reshaping Montelukast sodium market, in the UK.
France Montelukast Sodium Market
As per 2024, montelukast sodium industrial analysis the growth of montelukast sodium market in France is driven by factors such as, government initiatives and steady pharmaceuticals market. Consumers in France, prefer established brands and proven therapies over cheap generic variations. The health care system is proactive and incorporates montelukast sodium into treatment protocols for asthma and allergic rhinitis. The market is also benefiting from increased awareness campaigns, and educational initiatives aimed at early diagnosis and effective management of respiratory conditions.
How Is Asia-Pacific Balancing Innovation in the Montelukast Sodium Market?
As per 2024, street furniture regional forecast, Asia Pacific region is emerging market for montelukast sodium market due to factors such as Rising prevalence of respiratory diseases, increasing pollution levels and changing climate conditions. Government support in universal health care programs, inclusion of montelukast sodium in essential drug list and cost regulation initiatives ensuring affordable access for treatment accelerates the demand in the region. Additionally, strategic partnerships between domestic companies and global pharmaceutical giants are enabling the introduction of innovative formulations, and expand regional access, ensuring growth of Asia Pacific region.
India Montelukast Sodium Market
As per 2024 montelukast sodium market forecast, the market in India is driven by factors such as rising respiratory health concerns, rapid urbanization and supportive government policies. Montelukast sodium is widely used in India for managing asthma, and allergies that are increasing due to rising pollution and rapid urbanization. Government initiatives have made montelukast sodium-based drugs more affordable and accessible by including them in public healthcare initiatives. Moreover, India is a major exporter of pharmaceuticals strengthening its position in the region.
China Montelukast Sodium Market
China’s montelukast sodium market is driven by increasing respiratory disease burden, government healthcare reforms and a strong emphasis on self-sufficiency in pharmacy. Regulatory authorities have streamlined regulatory processes and encouraging faster approval of generic drugs especially in case of emergency. The government and companies are investing in research and development to innovate montelukast chemical formulation and new delivery systems, which further accelerates growth in the market.
Montelukast Sodium Markett By Geography
- Largest
- Fastest
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Montelukast Sodium Market Dynamics
Montelukast Sodium Market Drivers
Rising Prevalence of Respiratory Diseases
- The increasing prevalence of respiratory diseases such as asthma and allergic rhinitis and factors such as air pollution, smoking, genetic predisposition, and changing lifestyles requires medication made from montelukast sodium. As more individuals are diagnosed with chronic conditions due to factors like increasing air pollution, urbanization, climate change, and genetic predisposition, there is a corresponding surge in montelukast sodium market.
Growing Awareness and Adoption of Asthma Management Therapies
- As awareness about asthma and rhinitis allergies increases, healthcare providers are adopting pharmacological therapies. These therapies use montelukast sodium as the main preventive drug, increasing its demand for the market. Additionally, montelukast sodium is also used in maintenance therapies which reduces the frequency of asthma attacks, and allergy reactions further driving the demand.
Montelukast Sodium Market Restraints
Generic Competition
- Montelukast sodium does not have patent protection leading to intense competition among companies that manufacture montelukast sodium. Generic variation of montelukast sodium is often sold at very cheap prices, which is impacting the branded variation of montelukast sodium. Moreover, countries are also importing cheap montelukast sodium, which is restricting the expansion of the domestic market.
Regulatory Scrutiny and Safety Concerns
- Regulatory agencies have issued warnings and required updated labeling to reflect these safety concerns. Addressing these safety issues, conducting further research to understand the risks better, and implementing risk mitigation strategies, present challenges for manufacturers in maintaining consumer confidence, and regulatory compliance. While ensuring the continued availability of montelukast sodium in the market.
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Montelukast Sodium Market Competitive Landscape
Global and regional players interested in innovation and growth are locked in fierce competition in the global Montelukast sodium market. The competition among the companies is driven by enhanced product quality, investments in research and development, and effective marketing strategies. The market faces intense competition due to montelukast sodium being a non-patent drug. The government easily approves different variations of montelukast sodium, which further intensifies the competition. As different generic and non-generic variations of montelukast sodium continue to grow the competition becomes more and more intense in montelukast sodium market.
- Orcosa Inc. (2020): Orcosa has developed a rapidly infusing platform and compositions for therapeutic treatment including montelukast sodium. This technology focuses on enhancing the delivery and absorption of medications.
- Manus Aktteva Biopharma LLP (2015): Manus Aktteva Biopharma LLP have developed new innovative process to manufacture montelukast sodium through affordable raw materials and intermediaries, particularly for research and development and commercial requirements.
Top Player’s Company Profiles
- Teva Pharmaceuticals USA Inc. (U.S.)
- Merck & Co. Inc. (U.S.)
- Cipla Limited (India)
- Morepen Laboratories (India)
- Sanofi Aventis SA (France)
- SUN PHARMA (India)
- Intas Pharmaceuticals Ltd (India)
- Delmar Chemicals Inc. (Canada)
- SK Capital (Apotex Inc) (Canada)
- Sanyo Chemical Industries Ltd (Japan)
Recent Developments in Montelukast Sodium Market
- December 2024: Sun Pharmacy released counterfeit version of montelukast sodium and levocetirizine hydrochloride combination drug, Montek-LC was seized in Telangana, India.
- November 2024: FDA researchers found evidence linking Merck & Co. former asthma drug montelukast to adverse neuropsychiatric effects.
- December 2024: Teva Pharmaceuticals inc. recalled its montelukast oral granules as a safety precaution because several samples were found defective.
Montelukast Sodium Key Market Trends
- Patent Expirations and Rise of Generic: The original patent for montelukast sodium expired several years ago, due to several chemical and pharmaceutical companies manufacturing montelukast sodium. The generic variation of montelukast sodium offers the same efficacy at lower cost making it a preferred choice for patients, healthcare providers and government health systems. Stricter regulatory measures are taken by governments for the approval of generic versions to ensure safe and effective drug use.
- Advancements in Drug Delivery Systems: The market is experiencing a shift from traditional drug delivery to novel delivery systems. The drug is available in different forms, based on consumer preferences and dosage requirements. For pediatric and geriatric patients' drug is available in chewable tablets, oral granules and sachets. For heavy dose patients the drug is available with other active ingredients, to reduce pill burden and increase the effectiveness of the drug.
Montelukast Sodium 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.
As per SkyQuest analysis, global montelukast sodium market is driven by factors such as rising cases of asthma and allergies, growing awareness and government initiatives. Companies and governments are investing in chemical formulation and research and development to find innovative drug delivery systems and more efficient compounds. However, market growth is restricted by intense generic competition and stricter regulatory measures. In North America, the market is driven by robust healthcare infrastructure and latest pharmaceutical advancements. In Europe the market is driven by pharmaceutical expertise and an efficient public health system. The demand in Asia Pacific is growing due to factors such as rapid urbanization, large pharmaceutical manufacturing units and increase in awareness for asthma and allergies.
| Report Metric | Details |
|---|---|
| Market size value in 2023 | USD 458.2 billion |
| Market size value in 2032 | USD 1624.55 billion |
| Growth Rate | 15.1% |
| Base year | 2024 |
| Forecast period | 2025-2032 |
| Forecast Unit (Value) | USD Billion |
| Segments covered |
|
| 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 Montelukast Sodium 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 Montelukast Sodium 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 Montelukast Sodium 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 Montelukast Sodium 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 Montelukast Sodium Market:
Product Analysis: Product matrix, which offers a detailed comparison of the product portfolio of companies.
Regional Analysis: Further analysis of the Montelukast Sodium 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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