The United States infant formula market size is expected to expand from US$ 6,150.0 million in 2023 to US$ 8,456.0 million by 2033. Over the forecast period 2023 to 2033, United States infant formula sales are likely to soar at 3.3% CAGR.
In the United States, the infant formula market is dominated by three leading manufacturers, controlling over 90% of the market. The consolidation of these companies has raised concerns about shortages in the industry.
In 2021, a shortage of infant formula occurred. This was further exacerbated when Abbott Nutrition issued recalls for multiple products in mid-February 2022. The recall was prompted by the discovery of potentially dangerous bacteria at its plant.
During an investigation of the factory, FDA inspectors discovered unclean conditions and breaches of food safety laws. The facility was also related to an epidemic by Cronobacter sakazakii, a bacterium associated with baby formula.
Several newborns became sick as a result of the epidemic, and two died. However, no genetic relationship could be found between the germs at the facility with the infant milk drank by the sick infants.
In February 2021, a whistle-blower informed the FDA about suspected safety violations at the factory, but the information was delayed in reaching FDA executives. The whistleblower report raised concerns about inappropriate cleaning techniques and claimed record fabrication by personnel.
The result of recalls due to contamination concerns, and breaches of food safety regulations, resulted in a scarcity of baby formula on the market. This prompted investigations, recalls, and the need for improved safety measures and oversight within the infant formula manufacturing industry.
The Society for Paediatric Gastroenterology, Hepatology, and Nutrition recommends that the nutrient composition of all infant formulas must adhere to international requirements. All infant formulas must have sufficient levels of essential elements, making them all nutritionally equivalent and balanced for consumption.
Modern-day parents have become highly aware of the importance of infant formula and the nutrients required by the infant to stay healthy and fit in the early stages of growth. Manufacturers are responding by developing unique products with organic, natural, and non-GMO ingredients. Infant formulas with additional nutrients and better quality are readily accepted by parents at high prices.
There has recently been a lot of developments in production techniques of infant formula. This includes membrane filtration, wet mixing processes, hydrodynamic cavitation, and micro articulation. The supply of infant formula is expected to increase to cater to the growing demand during the forecast period.
A handful of infant formulas include specific nutrients such as iron, which can aid in the prevention of diseases like anemia. Generally, infant formulas are made from cow’s milk or soya beans. However, there are several infant formulas available, made from specific proteins.
A soy-based formula might be beneficial for an infant who has constipation issues or is sensitive to cow's milk. If the baby has digestive issues, infant formulas with all necessary nutrients are the ideal solution to all their health-related problems
Manufacturers are expanding their product portfolio and distribution network by collaborating with start-ups. They are focusing sustainable ideas and mergers and joint ventures with prominent players.
Collaboration helps in increased visibility and caters to the growing demand for infant formula across the globe. Most of the American manufacturers are investing greatly in research and development to develop products that cater to the changing demand of consumers.
Key Trends Listed by Future Market Insights (FMI):
Attributes | Key Insights |
---|---|
Estimated United States Infant Formula Market Size (2023E) | US$ 6,150.0 million |
Projected Market Value (2033F) | US$ 8,456.0 million |
Value-based CAGR (2023 to 2033) | 3.3% |
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The United States infant formula sales for the forecast period 2023 to 2033, is expected to progress at 3.3% CAGR. Infant formula is a convenient solution to working-women unable to feed their babies at regular intervals.
Women who are unable to pump enough breastmilk in a day can also feed infant formulas to their babies. It provides all the necessary ingredients required for healthy development of babies.
Infant formula is useful for working mothers who are unable to feed their babies due to multiple reasons. It provides convenient and nutritionally balanced alternative to breast milk.
With this formula mothers can ensure their babies receive essential nutrients when they are away at work. An infant formula-fed baby will require fewer rounds of meals as compared to the infant who is breastfed.
Several probiotics are present in the infant formula that can provide potential health benefits for infants. They are believed to support the development of a healthy gut microbiota, which can positively influence digestion and immune system.
Probiotics can also help in reducing the risk of gastrointestinal issues and support overall well-being. This is in turn further expected to boost the demand for infant formula in the United States.
Parents are increasingly concerned about the potential health risk associated with synthetic ingredients and additives found in conventional formulas. They opt for organic and natural alternatives to reduce exposure to potentially harmful substance. Choosing organic and natural options might support sustainable and eco-friendly practices.
There has been a rising interest in specialty infant formulas tailored to address specific needs. Often infants might have lactose intolerance, sensitive stomachs, or allergies to cow's milk proteins.
Infant formula is designed to address specific health conditions and nutritional requirement. It offers potential benefits for babies with allergies, digestion issues, and other health concerns.
Manufacturers have been responding to these demands by introducing a wide range of specialized formulas. Premature infants or those with specific medical conditions might require additional nutrients to support their growth and development. Human milk fortifiers are added to breast milk to enhance its nutritional content and mimic the composition of preterm infant formula.
Growth of E-commerce and Online Sales in the United States Pushing Infant Formula Sales
Modern parents have access to multiple data sources, which helps them to find the right infant formula. They often rely on reviews and ratings on third-party websites. The sources of information for the significant of parents are social media websites, forums, and events conducted on open sources. Online platforms are increasingly becoming a significant resource for information on nutrition and infant feeding that drive the choice of parents.
To assist parents in understanding the dietary requirements of their infants and making wise decisions, brands are often partnering with influencers. They are offering educational articles, videos, and guidelines on their websites.
Vendors are also placing an increased effort on the development of specialized formulas that cater to specific nutritional requirements of infants. The demand for infant formula is likely to rise in the near future.
Specialized Milk Formulas for Infants with Medical Issues to be Highly Popular
The rate of infant deficiencies and allergies has increased over the recent past. Special milk formulas are infant formulas that are formulated with the necessary nutrients that are required to cure specific deficiencies.
Colic, reflux, and lactose intolerance are just a handful of the digestive issues that infants might experience. Special milk formulas are designed to be easy to digest.
It is common in the United States that infants are generally born with intolerances and deficiencies. This can be attributed to multiple reasons such as the lack of proper nutrition to the baby during pregnancy and more. An effort to mitigate these issues is expected to accelerate the demand for special milk formula in the market over the forecast period.
Supermarkets & Hypermarkets Offer Several Infant Formula Options to Choose From
The sale of infant formula is projected to be heavily driven by supermarkets during the projection period. Parents generally shop for infant formula in hypermarkets and supermarkets.
These outlets offer easy availability, a variety of choices, and multiple brands to compare prices. In supermarkets, infant and baby products, including infant formula have their own designated aisles.
Parents can readily buy formula at supermarkets along with other commodities and household goods, giving them a one-stop shopping experience. These shops frequently provide well-known and reliable infant formula brands, ensuring that parents find it easy to buy the precise formula they require for their child.
Established distribution networks of supermarkets ensure an efficient supply of infant formula. The volume of sale of infant formula in hypermarkets is influenced by their wide consumer base and heavy footfall of consumers on a regular basis. Discount offers, coupons, loyalty programs, and customer service make the products affordable and attract a lot of buyers.
Key manufacturers in the infant formula market focused on continuous product innovation and differentiation to stand out from their competitors. They invested in research and development to create formulas that mimic breast milk and cater to specific nutritional needs of infants at different stages.
Key manufacturers are investing heavily in marketing campaigns to promote the benefits of their formulas and targeted both healthcare professionals and parents. They are using various channels such as social media, parenting websites, and medical conferences.
Recent developments:
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Attribute | Details |
---|---|
Market Size (2023) | US$ 6,150.0 million |
Market Value (2033) | US$ 8,456.0 million |
Anticipated Growth Rate (2023 to 2033) | 3.3% CAGR |
Forecast Period | 2023 to 2033 |
Historical Data Available for | 2018 to 2022 |
Market Analysis | Volume (MT) and Value (US$ Million) |
Key Regions Covered | North America |
Key Countries Covered | United States |
Key Market Segments Covered | Product Type, Distribution Channel and State |
Key Companies Profiled | Abbott Laboratories (Similac); Nestlé (Gerber Good Start); Mead Johnson Nutrition (Enfamil); The Honest Company (Honest Baby Formula); Perrigo Company plc (Store-brand formulas); Nature's One (Baby's Only Organic Formula); Happy Family Organics (Happy Baby Organic Formula); Earth's Best (Organic Infant Formula); Plum Organics (Plum Organics Infant Formula); Gerber (Gerber Formula) |
The overall market value could be near US$ 6,150 million in 2023.
The United States market is forecasted to exhibit a 3.3% growth rate up till 2033.
Specialized or infant formula segment leads the regional market.
Total sales through the supermarket segment may rise at a higher CAGR through 2033.
Abbott, Nestle, and Mead Johnson are the leading suppliers.
1. Executive Summary
1.1. Market Outlook
1.2. Demand Side Trends
1.3. Supply Side Trends
1.4. Technology Roadmap
1.5. Analysis and Recommendations
2. Market Overview
2.1. Market Coverage / Taxonomy
2.2. Market Definition
3. Market Dynamics
3.1. Drivers
3.1.1. Supply Side Drivers
3.1.2. Demand Side drivers
3.1.3. Economic Side Drivers
3.2. Restraints
3.3. Opportunity
3.4. Market trends By Region
3.5. Forecast Factors - Relevance & Impact
3.6. Key Regulations and Policies
4. Value Chain Analysis
4.1. Operating margins at each node of the supply chain
4.2. List of Active Market Participants
5. Pricing Analysis
5.1. Price Point Assessment by Region
5.1.1. Manufacturer-Level Pricing
5.1.2. Distributor Level Pricing
5.2. Price Point Assessment By Product
5.3. Price Forecast till 2033
6. Market Size (in Value (US$ billion) and Volume (MT) Analysis 2018 to 2022 and Forecast, 2023 to 2033
6.1. Historical Market Size (in Value (US$ billion) and Volume (MT) Analysis, 2018 to 2022
6.2. Current and Future Market Size (in Value (US$ billion) and Volume (MT) Analysis, 2023 to 2033
6.2.1. Y-o-Y Growth Trend Analysis
6.2.2. Absolute $ Opportunity Analysis
7. Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Product Type
7.1. Introduction / Key Findings
7.2. Historical Market Size (in Value (US$ billion) and Volume (MT) Analysis By Product Type, 2018 to 2022
7.3. Current and Future Market Size (in Value (US$ billion) and Volume (MT) Analysis and Forecast By Product Type, 2023 to 2033
7.3.1. Starting Milk Formula
7.3.2. Follow-on Milk Formula
7.3.3. Follow-on Milk Formula
7.3.4. Special Milk Formula
7.4. Market Attractiveness Analysis By Product Type
8. Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Distribution Channel
8.1. Introduction / Key Findings
8.2. Historical Market Size (in Value (US$ billion) and Volume (MT) Analysis By Distribution Channel, 2018 to 2022
8.3. Current and Future Market Size (in Value (US$ billion) and Volume (MT) Analysis and Forecast By Distribution Channel, 2023 to 2033
8.3.1. Specialty Outlets
8.3.2. Supermarkets
8.3.3. Online Stores
8.3.4. Pharmacy Stores
8.3.5. Others
8.4. Market Attractiveness Analysis By Distribution Channel
9. Market Analysis 2018 to 2022 and Forecast 2023 to 2033, by Country
9.1. Introduction
9.2. Historical Market Size (in Value (US$ billion) and Volume (MT) Analysis By Region, 2018 to 2022
9.3. Current Market Size (in Value (US$ billion) and Volume (MT) Analysis and Forecast By Region, 2023 to 2033
9.3.1. California
9.3.2. Texas
9.3.3. Florida
9.3.4. New York
9.3.5. Illinois
9.3.6. Ohio
9.3.7. North Carolina
9.3.8. Michigan
9.3.9. Colorado
9.3.10. Wisconsin
9.3.11. Washington
9.4. Market Attractiveness Analysis By Region
10. California Market Analysis 2018 to 2022 and Forecast 2023 to 2033
10.1. Introduction
10.2. Historical Market Size (US$ billion) and Volume Trend Analysis By Market Taxonomy, 2018 to 2022
10.3. Market Size (US$ billion) and Volume Forecast By Market Taxonomy, 2023 to 2033
10.3.1. By Product Type
10.3.2. By Distribution Channel
10.4. Market Attractiveness Analysis
10.4.1. By Product Type
10.4.2. By Distribution Channel
10.5. Key Takeaways
11. Texas Market Analysis 2018 to 2022 and Forecast 2023 to 2033
11.1. Introduction
11.2. Historical Market Size (US$ billion) and Volume Trend Analysis By Market Taxonomy, 2018 to 2022
11.3. Market Size (US$ billion) and Volume Forecast By Market Taxonomy, 2023 to 2033
11.3.1. By Product Type
11.3.2. By Distribution Channel
11.4. Market Attractiveness Analysis
11.4.1. By Product Type
11.4.2. By Distribution Channel
11.5. Key Takeaways
12. Florida Market Analysis 2018 to 2022 and Forecast 2023 to 2033
12.1. Introduction
12.2. Historical Market Size (US$ billion) and Volume Trend Analysis By Market Taxonomy, 2018 to 2022
12.3. Market Size (US$ billion) and Volume Forecast By Market Taxonomy, 2023 to 2033
12.3.1. By Product Type
12.3.2. By Distribution Channel
12.4. Market Attractiveness Analysis
12.4.1. By Product Type
12.4.2. By Distribution Channel
12.5. Key Takeaways
13. New York Market Analysis 2018 to 2022 and Forecast 2023 to 2033
13.1. Introduction
13.2. Historical Market Size (US$ billion) and Volume Trend Analysis By Market Taxonomy, 2018 to 2022
13.3. Market Size (US$ billion) and Volume Forecast By Market Taxonomy, 2023 to 2033
13.3.1. By Product Type
13.3.2. By Distribution Channel
13.4. Market Attractiveness Analysis
13.4.1. By Product Type
13.4.2. By Distribution Channel
13.5. Key Takeaways
14. Illinois Market Analysis 2018 to 2022 and Forecast 2023 to 2033
14.1. Introduction
14.2. Historical Market Size (US$ billion) and Volume Trend Analysis By Market Taxonomy, 2018 to 2022
14.3. Market Size (US$ billion) and Volume Forecast By Market Taxonomy, 2023 to 2033
14.3.1. By Product Type
14.3.2. By Distribution Channel
14.4. Market Attractiveness Analysis
14.4.1. By Product Type
14.4.2. By Distribution Channel
14.5. Key Takeaways
15. Ohio Market Analysis 2018 to 2022 and Forecast 2023 to 2033
15.1. Introduction
15.2. Historical Market Size (US$ billion) and Volume Trend Analysis By Market Taxonomy, 2018 to 2022
15.3. Market Size (US$ billion) and Volume Forecast By Market Taxonomy, 2023 to 2033
15.3.1. By Product Type
15.3.2. By Distribution Channel
15.4. Market Attractiveness Analysis
15.4.1. By Product Type
15.4.2. By Distribution Channel
15.5. Key Takeaways
16. North Carolina Market Analysis 2018 to 2022 and Forecast 2023 to 2033
16.1. Introduction
16.2. Historical Market Size (US$ billion) and Volume Trend Analysis By Market Taxonomy, 2018 to 2022
16.3. Market Size (US$ billion) and Volume Forecast By Market Taxonomy, 2023 to 2033
16.3.1. By Product Type
16.3.2. By Distribution Channel
16.4. Market Attractiveness Analysis
16.4.1. By Product Type
16.4.2. By Distribution Channel
16.5. Key Takeaways
17. Michigan Market Analysis 2018 to 2022 and Forecast 2023 to 2033
17.1. Introduction
17.2. Historical Market Size (US$ billion) and Volume Trend Analysis By Market Taxonomy, 2018 to 2022
17.3. Market Size (US$ billion) and Volume Forecast By Market Taxonomy, 2023 to 2033
17.3.1. By Product Type
17.3.2. By Distribution Channel
17.4. Market Attractiveness Analysis
17.4.1. By Product Type
17.4.2. By Distribution Channel
17.5. Key Takeaways
18. Colorado Market Analysis 2018 to 2022 and Forecast 2023 to 2033
18.1. Introduction
18.2. Historical Market Size (US$ billion) and Volume Trend Analysis By Market Taxonomy, 2018 to 2022
18.3. Market Size (US$ billion) and Volume Forecast By Market Taxonomy, 2023 to 2033
18.3.1. By Product Type
18.3.2. By Distribution Channel
18.4. Market Attractiveness Analysis
18.4.1. By Product Type
18.4.2. By Distribution Channel
18.5. Key Takeaways
19. Wisconsin Market Analysis 2018 to 2022 and Forecast 2023 to 2033
19.1. Introduction
19.2. Historical Market Size (US$ billion) and Volume Trend Analysis By Market Taxonomy, 2018 to 2022
19.3. Market Size (US$ billion) and Volume Forecast By Market Taxonomy, 2023 to 2033
19.3.1. By Product Type
19.3.2. By Distribution Channel
19.4. Market Attractiveness Analysis
19.4.1. By Product Type
19.4.2. By Distribution Channel
19.5. Key Takeaways
20. Washington Market Analysis 2018 to 2022 and Forecast 2023 to 2033
20.1. Introduction
20.2. Historical Market Size (US$ billion) and Volume Trend Analysis By Market Taxonomy, 2018 to 2022
20.3. Market Size (US$ billion) and Volume Forecast By Market Taxonomy, 2023 to 2033
20.3.1. By Product Type
20.3.2. By Distribution Channel
20.4. Market Attractiveness Analysis
20.4.1. By Product Type
20.4.2. By Distribution Channel
20.5. Key Takeaways
21. Market Structure Analysis
21.1. Competition - a Dashboard View
21.2. Industry Structure Analysis
21.2.1. % tier 1 market players
21.2.2. % tier 2 market players
21.2.3. % tier 3 market players
21.3. Market Company Share Analysis
21.3.1. For Tier 1 Market Players, 2023
21.3.2. Company Market Share Analysis of Top 5 Players, By Region
21.4. Key Participants Market Presence (Intensity Mapping) by Region
22. Competition Analysis
22.1. Competition Dashboard
22.2. Competition Benchmarking
22.3. Competition Deep Dive
22.3.1. Abbott Laboratories
22.3.1.1. Product Portfolio
22.3.1.2. Product Claim
22.3.1.3. Revenue by Market Segments (Product/ channel/Region)
22.3.1.4. Sales Footprint
22.3.1.5. Strategy Overview
22.3.1.5.1. Marketing Strategy
22.3.1.5.2. Product Strategy
22.3.1.5.3. Channel Strategy
22.3.1.6. SWOT Analysis
22.3.2. Arla Foods Amba
22.3.2.1. Product Portfolio
22.3.2.2. Product Claim
22.3.2.3. Revenue by Market Segments (Product/ channel/Region)
22.3.2.4. Sales Footprint
22.3.2.5. Strategy Overview
22.3.2.5.1. Marketing Strategy
22.3.2.5.2. Product Strategy
22.3.2.5.3. Channel Strategy
22.3.2.6. SWOT Analysis
22.3.3. Campbell Soups
22.3.3.1. Product Portfolio
22.3.3.2. Product Claim
22.3.3.3. Revenue by Market Segments (Product/ channel/Region)
22.3.3.4. Sales Footprint
22.3.3.5. Strategy Overview
22.3.3.5.1. Marketing Strategy
22.3.3.5.2. Product Strategy
22.3.3.5.3. Channel Strategy
22.3.3.6. SWOT Analysis
22.3.4. Dana Dairy Group Ltd.
22.3.4.1. Product Portfolio
22.3.4.2. Product Claim
22.3.4.3. Revenue by Market Segments (Product/ channel/Region)
22.3.4.4. Sales Footprint
22.3.4.5. Strategy Overview
22.3.4.5.1. Marketing Strategy
22.3.4.5.2. Product Strategy
22.3.4.5.3. Channel Strategy
22.3.4.6. SWOT Analysis
22.3.5. Danone
22.3.5.1. Product Portfolio
22.3.5.2. Product Claim
22.3.5.3. Revenue by Market Segments (Product/ channel/Region)
22.3.5.4. Sales Footprint
22.3.5.5. Strategy Overview
22.3.5.5.1. Marketing Strategy
22.3.5.5.2. Product Strategy
22.3.5.5.3. Channel Strategy
22.3.5.6. SWOT Analysis
22.3.6. Gujarat Co-operative Milk Marketing Federation Ltd. (GCMMF)
22.3.6.1. Product Portfolio
22.3.6.2. Product Claim
22.3.6.3. Revenue by Market Segments (Product/ channel/Region)
22.3.6.4. Sales Footprint
22.3.6.5. Strategy Overview
22.3.6.5.1. Marketing Strategy
22.3.6.5.2. Product Strategy
22.3.6.5.3. Channel Strategy
22.3.6.6. SWOT Analysis
22.3.7. Nestle S.A.
22.3.7.1. Product Portfolio
22.3.7.2. Product Claim
22.3.7.3. Revenue by Market Segments (Product/ channel/Region)
22.3.7.4. Sales Footprint
22.3.7.5. Strategy Overview
22.3.7.5.1. Marketing Strategy
22.3.7.5.2. Product Strategy
22.3.7.5.3. Channel Strategy
22.3.7.6. SWOT Analysis
22.3.8. Perrigo Company PLC
22.3.8.1. Product Portfolio
22.3.8.2. Product Claim
22.3.8.3. Revenue by Market Segments (Product/ channel/Region)
22.3.8.4. Sales Footprint
22.3.8.5. Strategy Overview
22.3.8.5.1. Marketing Strategy
22.3.8.5.2. Product Strategy
22.3.8.5.3. Channel Strategy
22.3.8.6. SWOT Analysis
22.3.9. Reckitt Benckiser Group PLC
22.3.9.1. Product Portfolio
22.3.9.2. Product Claim
22.3.9.3. Revenue by Market Segments (Product/ channel/Region)
22.3.9.4. Sales Footprint
22.3.9.5. Strategy Overview
22.3.9.5.1. Marketing Strategy
22.3.9.5.2. Product Strategy
22.3.9.5.3. Channel Strategy
22.3.9.6. SWOT Analysis
22.3.10. The Kraft Heinz Company
22.3.10.1. Product Portfolio
22.3.10.2. Product Claim
22.3.10.3. Revenue by Market Segments (Product/ channel/Region)
22.3.10.4. Sales Footprint
22.3.10.5. Strategy Overview
22.3.10.5.1. Marketing Strategy
22.3.10.5.2. Product Strategy
22.3.10.5.3. Channel Strategy
22.3.10.6. SWOT Analysis
22.3.11. Bobbie
22.3.11.1. Product Portfolio
22.3.11.2. Product Claim
22.3.11.3. Revenue by Market Segments (Product/ channel/Region)
22.3.11.4. Sales Footprint
22.3.11.5. Strategy Overview
22.3.11.5.1. Marketing Strategy
22.3.11.5.2. Product Strategy
22.3.11.5.3. Channel Strategy
22.3.11.6. SWOT Analysis
22.3.12. D-Signstore
22.3.12.1. Product Portfolio
22.3.12.2. Product Claim
22.3.12.3. Revenue by Market Segments (Product/ channel/Region)
22.3.12.4. Sales Footprint
22.3.12.5. Strategy Overview
22.3.12.5.1. Marketing Strategy
22.3.12.5.2. Product Strategy
22.3.12.5.3. Channel Strategy
22.3.12.6. SWOT Analysis
22.3.13. Else Nutrition Holdings, Inc.
22.3.13.1. Product Portfolio
22.3.13.2. Product Claim
22.3.13.3. Revenue by Market Segments (Product/ channel/Region)
22.3.13.4. Sales Footprint
22.3.13.5. Strategy Overview
22.3.13.5.1. Marketing Strategy
22.3.13.5.2. Product Strategy
22.3.13.5.3. Channel Strategy
22.3.13.6. SWOT Analysis
22.3.14. Hipp GmbH & Co.
22.3.14.1. Product Portfolio
22.3.14.2. Product Claim
22.3.14.3. Revenue by Market Segments (Product/ channel/Region)
22.3.14.4. Sales Footprint
22.3.14.5. Strategy Overview
22.3.14.5.1. Marketing Strategy
22.3.14.5.2. Product Strategy
22.3.14.5.3. Channel Strategy
22.3.14.6. SWOT Analysis
22.3.15. Other Players (On Additional Requests)
22.3.15.1. Product Portfolio
22.3.15.2. Product Claim
22.3.15.3. Revenue by Market Segments (Product/ channel/Region)
22.3.15.4. Sales Footprint
22.3.15.5. Strategy Overview
22.3.15.5.1. Marketing Strategy
22.3.15.5.2. Product Strategy
22.3.15.5.3. Channel Strategy
22.3.15.6. SWOT Analysis
23. Assumptions and Acronyms Used
24. Research Methodology
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