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Histamine Toxicity Market Size and Forecast, by Drug Type (Anti-histamines, Others); Route of Administration (Tropical, Oral, Nasal); Distribution Channel (Hospital Pharmacies, Online Pharmacies, OTC Drug Shops) - Growth Trends, Key Players, Regional Analysis 2026-2035

  • Report ID: 5462
  • Published Date: Nov 26, 2025
  • Report Format: PDF, PPT

Histamine Toxicity Market Outlook:

Histamine Toxicity Market size was valued at USD 440.18 million in 2025 and is set to exceed USD 737.76 million by 2035, expanding at over 5.3% CAGR during the forecast period i.e., between 2026-2035. In the year 2026, the industry size of histamine toxicity is estimated at USD 461.18 million.

Histamine Toxicity Market Size
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The growth in this market can be driven by an increase in consumption of seafood such as canned fish and the risk associated with its exposure to H.A.T. toxicity. According to estimates, 80% of fish consumed in the United States is imported from another country. It can also be said that the toxicity of histamine is intimately related to fish trade from all over the world.

The histamine toxicity market driven by a lack of internationally harmonized safety standards and awareness about the diseases associated with it. The development of the market for histamine toxicity is likely to be driven by a sufficient level of knowledge among food industry professionals regarding refrigeration and processing. In particular, people are not aware that expiry dates can be regarded as an important factor when buying food for cold storage. This is due to the lack of awareness, they occur more frequently in low-income countries.

Key Histamine Toxicity Market Insights Summary:

  • Regional Highlights:

    • North America is anticipated to capture a 33% revenue share by 2035, driven by high seafood consumption and growing awareness of histamine intolerance.
    • Europe is projected to hold a significant share by 2035, fueled by rising demand for frozen and canned fish and the development of novel diagnostics and treatments for histamine-related disorders.

  • Segment Insights:

    • By 2035, the anti-histamine segment is projected to achieve the highest CAGR of 90%, driven by its widespread use in managing allergies, gastrointestinal disorders, and related symptoms.
    • By 2035, the nasal segment is expected to secure a significant share, supported by its effectiveness in treating allergy-related symptoms with minimal side effects.

  • Key Growth Trends:

    • Growing Prevalence of Food Allergies
    • Lack of Safety Regulation on Fish Trade

  • Major Challenges:

    • Uncertainties in Histamine Levels
    • High Cost of Diagnostic Tests

  • Key Players: Travere Therapeutics, Inc., Alembic pharmaceuticals, Intas Pharmaceuticals Ltd, Sanofi Aventis Ltd, Cipla Limited, Actavis Inc.

Global Histamine Toxicity Market Forecast and Regional Outlook:

  • Market Size & Growth Projections:

    • 2025 Market Size: USD 440.18 million
    • 2026 Market Size: USD 461.18 million
    • Projected Market Size: USD 737.76 million by 2035
    • Growth Forecasts: 5.3%

  • Key Regional Dynamics:

    • Largest Region: North America (33% Share by 2035)
    • Fastest Growing Region: Europe
    • Dominating Countries: United States, China, Japan, Germany, United Kingdom
    • Emerging Countries: India, South Korea, Brazil, Singapore, United Arab Emirates

    • Last updated on : 26 November, 2025

Growth Drivers

  • Growing Prevalence of Food Allergies - The increasing prevalence of food allergies increases the risk of histamine intolerance, a condition where individuals experience adverse reactions to dietary histamine. This creates a larger target audience for histamine detection kits and treatment options boosting the histamine toxicity market expansion in the forthcoming period. Researchers anticipate that 33 million Americans have food allergies, consisting of 5.6 million children under the age of 18.
  • Lack of Safety Regulation on Fish Trade - Fish spoiling is caused by three main processes: oxidation, microbial growth, and enzymatic autolysis. The most widely used methods today for stopping oxidative, enzymatic, microbiological, and water activity deterioration are chemical methods and low-temperature preservation. Improper refrigeration during seafood shipment or seafood packaging may lead to histamine poisoning. As per a recent report, in 2022, the value of the world's seafood industry exceeded 257 billion US dollars. Therefore, for reasons related to the law, health, and environment, proper food labeling is crucial. Consumer interest in the precise ingredients of food that is sold has grown recently. Labels, along with other information that is frequently included, including energy values and nutritional information, are therefore crucial.

Challenges

  • Uncertainties in Histamine Levels - The varying histamine content in different foods and its dependence on various storage and processing factors pose challenges for accurate quantification and risk assessment. This uncertainty impedes the development of standardized regulatory measures. This is predicted to hamper the growth of the histamine toxicity market in the future.
  • High Cost of Diagnostic Tests are Predicted to Hamper the Market Growth in the Upcoming Period.
  • Limited Treatment Options Availability are Set to Pose Limitations on the Market Expansion in the Forecast Period.

Histamine Toxicity Market Size and Forecast:

Report Attribute Details

Base Year

2025

Forecast Year

2026-2035

CAGR

5.3%

Base Year Market Size (2025)

USD 440.18 million

Forecast Year Market Size (2035)

USD 737.76 million

Regional Scope

  • North America (U.S., and Canada)
  • Asia Pacific (Japan, China, India, Indonesia, Malaysia, Australia, South Korea, Rest of Asia Pacific)
  • Europe (UK, Germany, France, Italy, Spain, Russia, NORDIC, Rest of Europe)
  • Latin America (Mexico, Argentina, Brazil, Rest of Latin America)
  • Middle East and Africa (Israel, GCC North Africa, South Africa, Rest of the Middle East and Africa)
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Histamine Toxicity Market Segmentation:

Drug Type Segment Analysis

In terms of drug type, the anti-histamine segment in the histamine toxicity market is predicted to hold the highest CAGR of 90% by the end of 2035. Histamine can cause symptoms such as sneezing, coughing, and watery eyes when an individual reacts badly to allergens such as pollen, fish, and animal dander. Anti-histamines are medications used to treat allergies as well as nausea, colds, anxiety, and other symptoms. Anti-histamines mainly fall into two categories. H-1 blockers or H-1 receptor antagonists are the first category. This category of antihistamines is used to reduce allergy symptoms. H-2 blockers or H-2 receptor antagonists are the second subtype. They are used to treat gastrointestinal disorders such as motion sickness, vomiting, nausea, gastritis, stomach ulcers, and gastroesophageal reflux disease. Hence, the growing use of anti-histamine for the treatment of different symptoms, is anticipated to boost the segment’s growth.

Route of Administration Segment Analysis

Histamine toxicity market from the nasal segment is predicted to hold a significant share during the estimated period. It rarely causes side effects, apart from a possible runny nose and bitter aftertaste. If an individual’s nose becomes irritated after using the spray, they can try a moisturizing nasal gel or switch to a different nasal gel. Most allergy symptoms such as sneezing, runny nose, itching, and stuffy nose can be treated with steroid sprays. One study found that over 75% of patients with histamine intolerance reported nasal symptoms. These are very popular treatments for histamine toxicity because they work very well and have very few negative side effects. These, along with taking antihistamines, are often the doctor's first suggestion. Considering the increasing benefits of nasal sprays, this segment is expected to reach new heights during the forecast period.

Our in-depth analysis of the global histamine toxicity market includes the following segments:

          Drug Type

  • Anti-histamines
  • Others

          Route of Administration
  • Tropical
  • Oral
  • Nasal

          Distribution Channel
  • Hospital Pharmacies
  • Online Pharmacies
  • OTC drug shops
Vishnu Nair
Vishnu Nair
Head - Global Business Development

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Histamine Toxicity Market - Regional Analysis

North American Market Insights

 North America industry is poised to account for largest revenue share of 33% by 2035, due to rising substantial consumption of seafood and canned fish in the region. North American have a growing appetite for seafood with fish consumption levels exceeding the global average. This increased consumption, particularly of canned fish and certain fish species with naturally high histamine levels directly impacts the market. According to the recently published National Fisheries Institute's Top 10 List of Seafood Consumption in 2021, Americans consumed a record twenty-five pounds of fish per capita, up 1.5 pounds from 2020. Furthermore, public awareness about histamine intolerance a condition where people struggle to metabolize histamine efficiently is on the rise. This awareness creates a demand for diagnostic tests and treatments comprising digestive diamine oxidase enzyme supplements that aid in histamine breakdown.

European Market Insights

The market in the Europe region is set to hold a significant share by the end of 2035. Due to the increased demand for frozen foods, much-canned fish is exported from Europe. The histamine toxicity market growth is to blame for all of these factors. In order to set quality standards, collaboration with the fishing community and public health authorities will be required. Besides, the European pharmaceutical and research institutions are actively engaged in developing novel treatments and diagnostics for histamine intolerance and related disorders contributing to market innovation. The availability of anti-histamines as OTC drugs in the region is also significantly driving the growth of the histamine toxicity market in the European region during the anticipated time period.

Histamine Toxicity Market Share
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Histamine Toxicity Market Players:

    • Johnson and Johnson company
      • Company Overview
      • Business Strategy
      • Key Product Offerings
      • Financial Performance
      • Key Performance Indicators
      • Risk Analysis
      • Recent Development
      • Regional Presence
      • SWOT Analysis
    • Mylan Laboratories Ltd
    • Neogen Corporation
    • Pfizer Inc
    • Travere Therapeutics, Inc.
    • Alembic pharmaceuticals
    • Intas Pharmaceuticals Ltd
    • Sanofi Aventis Ltd
    • Cipla Limited
    • Actavis Inc.

Recent Developments

  • Two new tests to detect Histamine have been launched by Neogen, Reveal for histamine and Reveal Q+ for histamine. Reveal and Reveal Q+ assays are easy to use lateral flow tests using a simple water extraction method, providing results in a matter of minutes and eliminating the need to dispose of any chemicals, as is required by other commercially available histamine detection methods, which reduce the time needed to test.
  • Travere Therapeutics, Inc. reported that the US Food and Drug Administration granted accelerated approval for FILSPARRI to reduce proteinuria in adults with primary IgAN who are at risk of rapid disease progression, typically with a urine protein-to-creatinine ratio ≥1.5 g/g. This indication is given with accelerated approval based on reduction of proteinuria. It has not been established whether FILSPARI slows the decline in renal function in patients with IgAN. Continued approval of FILSPARI may require confirmation of clinical benefit in the ongoing Phase 3 PROTECT study, which is designed to show whether FILSPARI slows the decline in kidney function. Peak results from the two-year confirmatory endpoint of the PROTECT study are expected in the fourth quarter of 2023 and are intended to support traditional FILSPAR approval.
  • Report ID: 5462
  • Published Date: Nov 26, 2025
  • Report Format: PDF, PPT
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Frequently Asked Questions (FAQ)

In the year 2026, the industry size of histamine toxicity is estimated at USD 461.18 million.

The global histamine toxicity market size was around USD 440.18 million in 2025 and is likely to expand at a CAGR of more than 5.3%, surpassing USD 737.76 million revenue by 2035.

North America is anticipated to capture a 33% revenue share by 2035, driven by high seafood consumption and growing awareness of histamine intolerance.

Key players in the market include Travere Therapeutics, Inc., Alembic pharmaceuticals, Intas Pharmaceuticals Ltd, Sanofi Aventis Ltd, Cipla Limited, Actavis Inc.

Histamine Toxicity Market Report Scope

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