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Last Updated: December 15, 2025

Barium sulfate - Generic Drug Details


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What are the generic sources for barium sulfate and what is the scope of patent protection?

Barium sulfate is the generic ingredient in fourteen branded drugs marketed by Bracco and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for barium sulfate
US Patents:0
Tradenames:14
Applicants:1
NDAs:4
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 104
Clinical Trials: 3
What excipients (inactive ingredients) are in barium sulfate?barium sulfate excipients list
DailyMed Link:barium sulfate at DailyMed
Recent Clinical Trials for barium sulfate

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

SponsorPhase
National Cheng-Kung University HospitalNA
General Electric
University of California, San Francisco

See all barium sulfate clinical trials

Pharmacology for barium sulfate
Medical Subject Heading (MeSH) Categories for barium sulfate

US Patents and Regulatory Information for barium sulfate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bracco VARIBAR THIN HONEY barium sulfate SUSPENSION;ORAL 208143-006 Jan 23, 2018 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bracco VARIBAR HONEY barium sulfate SUSPENSION;ORAL 208143-007 Mar 26, 2018 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bracco READI-CAT 2 barium sulfate SUSPENSION;ORAL 208143-001 Jan 15, 2016 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bracco E-Z-CAT DRY barium sulfate FOR SUSPENSION;ORAL 208036-003 Jan 3, 2017 DISCN Yes 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 Barium Sulfate

Last updated: July 27, 2025

Introduction

Barium sulfate (BaSO₄) is a widely used radiocontrast agent critical in diagnostic imaging, primarily for gastrointestinal examinations. Its unique physicochemical properties—high radiopacity, inertness, and insolubility—make it ideal for enhancing X-ray imaging without systemic absorption or toxicity. As the demand for advanced diagnostic imaging escalates globally, understanding the market dynamics and financial trajectory of barium sulfate becomes imperative for industry stakeholders, including pharmaceutical manufacturers, healthcare providers, and investors.

Market Overview

Global Demand and Usage

The global barium sulfate market has experienced consistent growth over the past decade, driven chiefly by increased utilization in diagnostic radiology, especially in gastrointestinal imaging. According to industry reports, the global market for barium sulfate was valued at approximately USD 1.2 billion in 2021 and is projected to grow at a Compound Annual Growth Rate (CAGR) of around 4% from 2022 to 2028 [1].

Key application segments include:

  • Medical Imaging: Primarily in upper and lower gastrointestinal (GI) series.
  • Industrial Applications: Such as in paints, plastics, and rubber, although these constitute a smaller share.
  • Other Uses: In oil and gas drilling fluids, particularly in certain regions.

Medical imaging remains the dominant segment, accounting for over 80% of total consumption, with growth correlating to rising healthcare infrastructure investment and diagnostic procedures.

Regional Market Dynamics

North America: The largest market, propelled by high healthcare spending, technological advancements in imaging, and extensive screening programs.

Europe: Steady growth supported by aging populations and increased adoption of minimally invasive imaging techniques.

Asia-Pacific: The fastest-growing region, driven by expanding healthcare infrastructure, rising GDP, and increasing awareness about early diagnosis.

Rest of World: Includes Latin America, Middle East, and Africa, where market growth correlates with healthcare development and access improvements.

Key Drivers

  • Rising Prevalence of Gastrointestinal Diseases: Increasing cases of gastrointestinal disorders, including Crohn’s disease, ulcerative colitis, and cancer, necessitate diagnostic imaging.

  • Advances in Imaging Technologies: Improvements in X-ray and fluoroscopy systems enhance the demand for effective contrast agents like barium sulfate.

  • Aging Population: Older demographics are more prone to GI ailments, fostering continued demand.

  • Regulatory Approvals and Clinical Adoption: Continuous approval and adoption of new formulations bolster market penetration.

Market Challenges

  • Toxicity and Safety Concerns: Although generally safe, adverse reactions such as allergic responses limit use in select patient populations.

  • Competition from Alternative Contrast Agents: Agents like iodinated contrast media and MRI-specific agents are emerging as alternatives.

  • Regulatory Hurdles: Variations in approval processes across regions affect market entry timing and product lifecycle.

  • Supply Chain Disruptions: Global logistics challenges impact raw material procurement and distribution.

Financial Trajectory

Pricing and Revenue Potential

Pricing strategies for barium sulfate are largely dictated by purity, formulation (e.g., powder vs. paste), and regulatory status. The cost per unit has remained relatively stable, with minor fluctuations due to raw material prices and manufacturing costs. Pre-pandemic, the average selling price (ASP) for a standard bulk dose hovered around USD 50-70 per unit, with regional variations.

Revenue projections anticipate consistent growth aligned with medical imaging demand, with larger hospitals and diagnostic centers representing substantial revenue streams. The introduction of high-purity, specialized formulations could command premium pricing, impacting overall revenue potential.

Market Entry and Investment Outlook

Manufacturers investing in scalable, cost-efficient production facilities could capitalize on the growing demand. The entry barrier is moderate, owing to established manufacturing processes rooted in mineral extraction and beneficiation.

Emerging markets present lucrative opportunities due to increasing healthcare access; however, regulatory complexities may influence time-to-market and profitability.

Profitability Factors

  • Operational Efficiency: Streamlining extraction and purification processes reduces costs.

  • Regulatory Compliance: Ensuring adherence minimizes risk and potential penalties.

  • Product Differentiation: Developing novel formulations with improved safety profiles sustains competitive advantage.

Risks and Uncertainties

  • Regulatory Changes: Stringent safety regulations could necessitate reformulation or additional testing, incurring costs.

  • Market Competition: Entry of synthetic or alternative contrast agents could compress margins.

  • Raw Material Availability: Dependence on mineral sources can cause supply chain vulnerabilities.

Regulatory Landscape

Global regulation of barium sulfate products revolves around safety and labeling standards. Agencies like the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) classify many formulations as medical devices or combination products. Approvals often require extensive safety data, especially for new formulations or delivery methods.

Standardized manufacturing practices (GMP) and quality controls are mandated to ensure consistent product quality. Regulatory pathways influence market timing, investment appetite, and potential revenue streams.

Conclusion

The market for barium sulfate remains robust, driven primarily by the expanding landscape of diagnostic imaging. While challenges exist—such as safety concerns, emerging alternatives, and regulatory hurdles—advances in formulation and manufacturing efficiencies, coupled with increasing global healthcare investments, suggest a positive financial trajectory.

Stakeholders should prioritize innovation in formulation, supply chain robustness, and compliance to capitalize on ongoing growth. A strategic focus on emerging markets and new imaging modalities might further enhance profitability in the evolving landscape.


Key Takeaways

  • Consistent Growth: The global barium sulfate market is projected to grow at approximately 4% CAGR, driven by rising diagnostic imaging demand.
  • Regional Opportunities: Asia-Pacific and emerging markets offer significant expansion potential, while North America remains the largest consumer.
  • Market Drivers: Prevalence of GI diseases, technological advancements, and aging populations underpin demand.
  • Challenges: Safety concerns, alternative contrast agents, and regulatory hurdles could impact growth trajectories.
  • Financial Outlook: Stable pricing, high demand, and operational efficiencies suggest favorable profitability prospects for manufacturers investing in quality and innovation.

FAQs

  1. What are the primary medical applications of barium sulfate?
    Barium sulfate is predominantly used as a radiocontrast agent in gastrointestinal imaging, such as barium swallow and barium enema procedures, to enhance X-ray visualization of the GI tract.

  2. How does regulatory approval impact the market for barium sulfate?
    Regulatory approvals determine product safety standards and manufacturing practices, influencing market entry timing, product formulation, and commercialization strategies. Variability across regions can pose challenges for global expansion.

  3. What are the main competitors to barium sulfate in medical imaging?
    Alternatives include iodinated contrast media and MRI contrast agents like gadolinium-based compounds. These substitutes are often considered for specific indications or in patients with contraindications to barium sulfate.

  4. What factors are expected to influence future profitability in this market?
    Innovation in formulation for improved safety and efficacy, supply chain optimization, regulatory compliance, and expanding into emerging markets will be key drivers.

  5. Are there any emerging trends disrupting the barium sulfate market?
    Advances in non-invasive imaging techniques, development of new contrast agents with enhanced safety profiles, and shifting preferences towards MRI contrast agents could impact the demand for traditional barium sulfate.


Sources:
[1] MarketWatch, "Global Barium Sulfate Market Size, Status and Forecast 2022-2028," 2022.

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