You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 30, 2025

BETA CAROTENE - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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

Beta carotene is the generic ingredient in one branded drug marketed by Roche and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for beta carotene.

Summary for BETA CAROTENE
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Raw Ingredient (Bulk) Api Vendors: 111
Clinical Trials: 35
DailyMed Link:BETA CAROTENE at DailyMed
Recent Clinical Trials for BETA CAROTENE

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

SponsorPhase
Universidad de GranadaEARLY_PHASE1
Duta Wacana Christian UniversityPhase 4
Dexa Medica GroupPhase 4

See all BETA CAROTENE clinical trials

Medical Subject Heading (MeSH) Categories for BETA CAROTENE

US Patents and Regulatory Information for BETA CAROTENE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Roche SOLATENE beta carotene CAPSULE;ORAL 017589-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for Beta Carotene

Last updated: August 2, 2025

Introduction

Beta carotene, a naturally occurring pigment classified as a carotenoid, commands a significant niche within the global dietary supplement and functional food markets. Known for its antioxidant properties and as a precursor to vitamin A, beta carotene’s broad application spectrum—including nutraceuticals, pharmaceuticals, cosmetics, and food fortification—positions it at a lucrative intersection of health trends and consumer preferences. This report examines current market dynamics, underlying growth drivers, challenges, and the evolving financial trajectory of beta carotene.

Market Overview and Key Trends

The global beta carotene market is experiencing steady expansion, projected to grow at a Compound Annual Growth Rate (CAGR) of approximately 6% between 2022 and 2030 (source: Reports and Industry Insights). This resilience reflects increasing consumer awareness of health and wellness, rising geriatric populations prone to nutritional deficiencies, and expanding research indicating beta carotene’s antioxidant benefits.

Regionally, Asia-Pacific dominates the market with over 50% market share, driven by burgeoning health supplement usage, dietary fortification initiatives, and the region’s significant production capacity of natural carotenoids. North America and Europe follow, propelled by sophisticated healthcare infrastructures, regulatory acceptance, and a focus on preventive health.

Market Drivers

Health and Wellness Trends:
The global shift toward preventative healthcare has boosted demand for natural antioxidants. Beta carotene’s role in reducing oxidative stress and supporting immune health aligns with consumer trends favoring natural, plant-based health solutions.

Aging Population:
Global demographic shifts show an increasing elderly demographic susceptible to age-related macular degeneration, immune decline, and skin aging. As a result, demand for beta carotene as an ingredient in supplements targeting ocular health, skin health, and immune function has surged.

Food Fortification and Functional Foods:
Stringent regulations and consumer preference are driving the integration of beta carotene into functional foods, beverages, and dairy products. Governments in countries like India and China are actively promoting fortification programs, bolstering demand.

Natural and Plant-based Products Preference:
Consumers favor naturally derived beta carotene over synthetic variants, influencing manufacturers to invest in natural extraction methods, such as from Dunaliella salina algae, carrots, and sweet potatoes.

Market Challenges

Regulatory Hurdles:
Regulatory frameworks differ globally, with some regions like the EU imposing strict standards on health claims for beta carotene, impacting marketing strategies.

Supply Chain Constraints:
Natural extraction of beta carotene is susceptible to climatic variability affecting raw material availability and yields. Volatility in raw material prices can impact profit margins.

Synthetic vs. Natural Debate:
While synthetic beta carotene is cost-effective, increasing consumer and regulatory preference for natural sources pressures manufacturers to adopt more expensive extraction techniques, affecting product pricing.

Market Saturation in Certain Segments:
The high penetration of beta carotene in existing supplement markets poses a risk of saturation, necessitating innovation and diversification in product formulations.

Financial Trajectory and Investment Outlook

Revenue Growth and Revenue Streams:
The pharmaceutical and nutraceutical sectors represent the core revenue streams, with the global market expected to reach ~$600 million by 2030 (source: Market Research Future). The increasing integration into functional foods and cosmetics expands revenue opportunities further.

Pricing Dynamics:
Raw material costs and extraction methods directly influence product prices. Natural sources generally command higher prices, but technological advancements in cultivation and extraction could mitigate costs over time.

Investment and M&A Activities:
Major players like DSM, BASF, and Lycored have expanded their natural betacarotene portfolios through strategic acquisitions, signaling confidence in long-term growth prospects. Increased venture capital funding targets startups innovating in natural extraction, formulation technologies, and bioavailability enhancement.

R&D and Product Innovation:
Investment in R&D is crucial for optimizing bioavailability, stability, and targeted delivery of beta carotene. Innovations in nanoencapsulation and lipid-based formulations could unlock new premium markets.

Emergent Markets:
In emerging economies, rising disposable incomes and health awareness are translating into increased beta carotene consumption, forecasted to accelerate market expansion.

Future Outlook and Strategic Considerations

The forecast indicates a resilient growth trajectory driven by natural product demand and health-conscious consumer behavior. Strategic differentiation—such as sourcing from sustainable natural sources, developing proprietary extraction techniques, and securing regulatory approvals—will remain critical.

Key areas for growth include:

  • Expansion into cosmeceuticals with skin health benefits.
  • Development of stable, bioavailable formulations for capsules, liquids, and topical applications.
  • Addressing supply chain vulnerabilities through vertical integration and R&D in cultivation technologies.

Key Takeaways

  • The beta carotene market is expanding consistently, driven by health and wellness trends, aging demographics, and natural product consumption.
  • Asia-Pacific remains the dominant market but developed regions present lucrative opportunities through innovation and functional food fortification.
  • Challenges include regulatory variability, supply chain constraints, and consumer preference for natural over synthetic sources.
  • Financial growth is buoyed by increased R&D activity, product innovation, and strategic acquisitions within the industry.
  • Long-term success hinges on sustainable sourcing, technological advancements, and effective market segmentation.

FAQs

1. What are the primary applications of beta carotene in the pharmaceutical industry?
Beta carotene is mainly used as a dietary supplement to prevent vitamin A deficiency, support immune health, and act as an antioxidant. It is also incorporated into skin health products and functional foods targeting age-related ailments.

2. How does natural beta carotene differ from synthetic variants in terms of market appeal?
Natural beta carotene, derived from sources like algae and vegetables, is preferred for its perceived health benefits, cleaner labels, and sustainability credentials. Synthetic beta carotene, though cost-effective, faces consumer skepticism and regulatory scrutiny, impacting marketability.

3. What are the major raw materials used in beta carotene extraction?
Key raw materials include Dunaliella salina algae, carrots, sweet potatoes, and other orange/yellow vegetables. Algae-based extraction is gaining prominence due to scalability and sustainability.

4. How are technological advancements impacting beta carotene’s bioavailability?
Innovations like nanoencapsulation and liposomal delivery systems enhance beta carotene's stability and absorption, opening avenues for high-value, targeted health supplements and functional foods.

5. What regulatory considerations influence beta carotene markets globally?
Regulations vary, with agencies like the FDA and EFSA setting guidelines on permissible health claims, maximum intake levels, and labeling standards. Navigating these frameworks is vital for market access and branding strategies.


References
[1] Market Research Future, "Beta Carotene Market Analysis," 2022.
[2] Industry Reports, "Global Nutraceuticals and Dietary Supplements Market," 2022.
[3] Dietary Supplement and Labeling Regulations, U.S. FDA, 2022.
[4] European Food Safety Authority (EFSA) Scientific Opinions on Carotenoids, 2021.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.