Betaine - Generic Drug Details

What are the generic drug sources for betaine and what is the scope of patent protection?

Betaine is the generic ingredient in two branded drugs marketed by Eton, Novitium Pharma, and Recordati Rare, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for betaine. Three suppliers are listed for this compound.

Summary for betaine

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	129
Clinical Trials:	25
Patent Applications:	6,354
What excipients (inactive ingredients) are in betaine?	betaine excipients list
DailyMed Link:	betaine at DailyMed

Recent Clinical Trials for betaine

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
University of Ioannina	Phase 4
Assistance Publique - Hôpitaux de Paris	Phase 2
University of North Carolina, Chapel Hill	Phase 1

See all betaine clinical trials

Pharmacology for betaine

Drug Class	Methylating Agent
Mechanism of Action	Methylating Activity

Anatomical Therapeutic Chemical (ATC) Classes for betaine

A16AA	Amino acids and derivatives
A16A	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A16	OTHER ALIMENTARY TRACT AND METABOLISM PRODUCTS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for betaine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novitium Pharma	BETAINE	betaine	FOR SOLUTION;ORAL	214864-001	Nov 23, 2021	AB	RX	No	No
Recordati Rare	CYSTADANE	betaine	FOR SOLUTION;ORAL	020576-001	Oct 25, 1996	AB	RX	Yes	Yes
Eton	BETAINE	betaine	FOR SOLUTION;ORAL	210508-001	Jan 28, 2022	AB	RX	No	No

Betaine Market Analysis and Financial Projection Experimental

Betaine Market Dynamics and Financial Trajectory

Market Size and Growth Projections

The betaine market is experiencing significant growth, driven by increasing demand across various industries. As of 2022, the market was valued at USD 3.4 billion and is projected to reach USD 5.5 billion by 2032, growing at a Compound Annual Growth Rate (CAGR) of 4.7% during the forecast period[1].

Another projection indicates that the market could reach USD 6,314.61 million by 2030, starting from USD 3,991.88 million in 2022, with a CAGR of 5.90% during the forecast period of 2023 to 2030[5].

Geographical Distribution

The betaine market is dominated by North America, which held the largest share in 2020, accounting for approximately 31% of the global market. This dominance is attributed to high demand from industries such as personal care, food, beverages, and dietary supplements in the region[2].

However, the Asia-Pacific region is expected to be the fastest-growing market, driven by expanding awareness of healthy lifestyles, rising per capita disposable income, and shifting consumer preferences for healthy ingredients in food, beverages, and personal care products. China and India are key players in this region, with China holding the largest market share and India being the fastest-growing market[3].

End-Use Industries

The betaine market is segmented across various end-use industries, including:

Food and Beverages

Betaine is used as a food additive to enhance the nutritional value of products. The growing demand for healthy and functional foods is a significant driver for this segment[5].

Animal Feed

Betaine is used in animal feed to improve the health and performance of livestock. The increasing awareness of nutritional benefits for animals is driving growth in this sector[2].

Personal Care

Betaine is widely used in personal care products due to its moisturizing and surfactant properties. The personal care industry, particularly in the United States, is a major contributor to the market growth, with significant investments in research and development for new products[4].

Detergents

Betaine is used in detergents for its surfactant properties, enhancing the cleaning efficiency of these products. The demand from the industrial sector, including deicers and detergents, is another key driver[5].

Dietary Supplements

The dietary supplements segment is growing rapidly due to the health benefits associated with betaine, such as improved metabolism, muscle strength, and endurance. The increasing obesity issues and the desire for weight loss among the population are driving the demand for betaine supplements[2].

Market Drivers

Several factors are driving the growth of the betaine market:

Health Benefits

Betaine offers various health benefits, including improved metabolism, muscle strength, and endurance. This has led to increased demand in the dietary supplements market[2].

Industrial Applications

The use of betaine as a surfactant in detergents and personal care products is a significant driver. Additionally, its application in the food and beverage industry as a food additive is on the rise[5].

Agricultural Demand

The demand for glycine betaine in agriculture, particularly for its role in stress relief for animals, is another key driver[2].

COVID-19 Impact

The COVID-19 pandemic had a detrimental effect on the betaine market in 2020, but the market has since recovered to pre-pandemic levels and is expected to grow steadily in the future. The pandemic also highlighted the importance of health and nutrition, further boosting the demand for betaine in dietary supplements and other health-related products[4].

Market Restraints

Despite the growth, there are some restraints to the betaine market:

Synthetic Cosmetics

The use of synthetic cosmetics, which can lead to skin and hair problems, acts as a restraint for the market. Consumers are increasingly seeking natural and organic products, which can impact the demand for synthetic betaine[4].

Opportunities

The betaine market presents several opportunities:

Growing Demand for Bio-Based Products

The increasing demand for bio-based products in home care and personal care applications is expected to boost market growth, particularly in North America[5].

Use as a Stress Reliever for Animals

The potential use of betaine as a stress reliever for animals in the agricultural sector offers new opportunities for market expansion[4].

Expansion in Emerging Markets

The growing middle-class disposable income and shifting consumer preferences in emerging markets, especially in the Asia-Pacific region, provide significant growth opportunities[3].

Key Players

The betaine market is characterized by the presence of several key players, including:

• BASF SE
• E. I. du Pont de Nemours
• Nutreco N.V.
• American Crystal Sugar Company
• Amino GmbH
• Associated British Foods PLC
• KAO Corp.
• Solvay
• Stepan Company
• Sunwin Company
• Lubrizol[1]

Financial Trajectory

The financial trajectory of the betaine market is positive, with steady growth projected over the next decade. Here are some key financial metrics:

• Market Size in 2022: USD 3.4 billion[1]
• Projected Market Size by 2032: USD 5.5 billion[1]
• CAGR (2022-2032): 4.7%[1]
• Projected Market Size by 2030: USD 6,314.61 million[5]
• CAGR (2023-2030): 5.90%[5]

Key Takeaways

• The betaine market is growing steadily, driven by increasing demand in various industries.
• North America dominates the market, but the Asia-Pacific region is expected to be the fastest-growing.
• Health benefits, industrial applications, and agricultural demand are key drivers.
• The market faces restraints from synthetic cosmetics but presents opportunities in bio-based products and emerging markets.
• Key players are investing heavily in research and development to capitalize on market growth.

FAQs

What is the current size of the betaine market?

The betaine market was valued at USD 3.4 billion in 2022[1].

What is the projected growth rate of the betaine market?

The market is projected to grow at a CAGR of 4.7% from 2022 to 2032 and 5.90% from 2023 to 2030[1][5].

Which region dominates the betaine market?

North America currently dominates the betaine market, but the Asia-Pacific region is expected to be the fastest-growing[2][3].

What are the primary end-use industries for betaine?

The primary end-use industries include food and beverages, animal feed, personal care, detergents, and dietary supplements[5].

How has COVID-19 impacted the betaine market?

COVID-19 had a detrimental effect in 2020, but the market has recovered and is expected to grow steadily, with increased demand for health-related products[4].

Cited Sources

1. Future Market Insights - Betaine Market Size, Share, Outlook & Trends | 2032 | FMI
2. IndustryARC - Betaine Market Size Report, 2024-2030
3. Cognitive Market Research - Betaine market size will be USD 5.37 Billion by 2030!
4. Mordor Intelligence - Betaine Market - Analysis, Size & Trends
5. Data Bridge Market Research - Global Betaine Market – Industry Trends and Forecast to 2030