Thiamine Hydrochloride Injection Market Size
| Study Period | 2019 - 2029 |
| Market Size (2024) | USD 174.17 Million |
| Market Size (2029) | USD 226.81 Million |
| CAGR (2024 - 2029) | 4.50 % |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | Medium |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Thiamine Hydrochloride Injection Market Analysis
The Thiamine Hydrochloride Injection Market size is estimated at USD 174.17 million in 2024, and is expected to reach USD 226.81 million by 2029, at a CAGR of 4.5% during the forecast period (2024-2029).
Thiamine Hydrochloride Injection is a medical formulation designed to address thiamine (Vitamin B1) deficiency, a condition associated with severe neurological and cardiovascular complications. Thiamine, a vital water-soluble B vitamin, plays a pivotal role in energy metabolism and brain neurotransmitter function. While it's predominantly sourced from foods like whole grains, fortified cereals, legumes, liver, and salmon, Thiamine Hydrochloride Injections serve as a crucial supplement for individuals struggling to meet their thiamine requirements through diet alone.
These injections offer a swift and direct route to rectify thiamine deficiencies, crucial in averting complications like Wernicke's encephalopathy and Korsakoff's psychosis. They are especially beneficial for patients with severe deficiencies or those with absorption challenges, such as chronic alcoholics or individuals with specific gastrointestinal conditions.
Furthermore, as thiamin deficiency rises, so does the demand for thiamin injections. Increasing thiamin deficiency is likely to enhance the demand for thiamin injections. For instance, a February 2023 article from the National Institute of Health highlighted that 20% to 30% of older adults exhibit laboratory indicators of thiamin deficiency. Contributing factors may include insufficient dietary intake, a mix of chronic diseases, the simultaneous use of various medications, and reduced thiamin absorption, a natural consequence of aging.
The demand for Thiamine Hydrochloride Injections is bolstered by a growing awareness of thiamine deficiency and an uptick in chronic diseases such as chronic diarrhea and liver disease. Recent studies, like one from the BMJ in February 2024, highlight how thiamine deficiency can hamper cognitive function by limiting energy to brain neurons and reducing acetylcholine signaling. This mounting evidence underscores the significance of thiamine, spurring a surge in demand for supplements and injections.
Furthermore, a significant market driver is the limited availability of alternative products. For instance, in April 2024, the Department of Health and Social Care, along with NHS England, established a clinical reference group to address the looming shortage of Pabrinex, a potent solution of vitamins B and C. The article also underscored that regulatory bodies are collaborating with importers and suppliers to source alternative products, including unlicensed thiamine injections, to satisfy the rising demand.
The Thiamine Hydrochloride Injection market is set for significant growth with heightened awareness of thiamine's health implications and current product shortages. This momentum, coupled with proactive regulatory measures, paints a promising future for the market. As demand and awareness continue to climb, manufacturers and healthcare providers are poised for ample opportunities in this space.
However, a limited supply of raw materials is preventing the company from producing injections at optimal levels, thereby restraining market growth.
Thiamine Hydrochloride Injection Market Trends
The Wernicke Syndrome Segment is Expected to Hold a Significant Market Share Over the Forecast Period
Wernicke syndrome and its associated condition, Korsakoff syndrome (WKS), represent serious neurological disorders stemming from thiamine (vitamin B1) deficiency. Wernicke syndrome, formally known as Wernicke encephalopathy, manifests through a triad of symptoms, including confusion, ataxia (loss of coordination), and ocular abnormalities. If left untreated, this condition can lead to severe consequences, highlighting the critical need for prompt intervention with thiamine supplementation.
In the United States, Wernicke syndrome primarily arises in individuals with chronic alcoholism due to poor nutritional intake and impaired thiamine absorption. However, it can also affect those with malnutrition, eating disorders, or other conditions leading to thiamine deficiency. Recent studies suggest there may even be genetic predispositions that contribute to susceptibility.
Recent research published in May 2024 underscores the importance of early thiamine administration in managing Wernicke syndrome. A multicenter study involving the Germans Trias i Pujol University Hospital highlighted variability in vitamin B1 treatment protocols. The study revealed that 84% of patients received thiamine within 48 hours of diagnosis, with varying administration routes: 52% intramuscularly, 39% intravenously, and a minority orally. This highlights the growing demand for thiamine injections in clinical settings.
Thiamine Hydrochloride Injection plays a pivotal role in treating Wernicke syndrome. As emphasized by a recent article published by WebMD LLC in March 2024, rapid correction of brain thiamine deficiency is crucial to improving patient outcomes. Oral thiamine absorption can be unreliable in high-risk patients, necessitating parenteral routes for effective and timely treatment.
With an increasing recognition of Wernicke syndrome and its debilitating effects, the demand for thiamine Hydrochloride Injection is expected to rise. The growing incidence rates of Wernicke syndrome and the need for immediate and effective thiamine supplementation will likely drive market growth for injectable thiamine formulations. Healthcare providers are increasingly aware of the necessity to administer thiamine promptly, underscoring the importance of having reliable access to injectable formulations in clinical settings.
North America is Expected to Hold a Significant Market Share Over the Forecast Period
Thiamine Hydrochloride Injection, a vital therapeutic for addressing thiamine deficiency, has seen a notable rise in demand across North America in recent years. This surge is driven by several factors including increased awareness of thiamine deficiency disorders, advancements in generic drug approvals, and the expanding portfolio of pharmaceutical companies catering to this niche market.
Thiamine deficiency, often associated with conditions like beriberi and Wernicke-Korsakoff Syndrome, stems primarily from malnutrition, particularly in cases of chronic alcoholism or gastrointestinal illnesses. Deficiency manifests in various forms, impacting the nervous, cardiovascular, and digestive systems.
Although it is less common in the United States, its clinical implications underscore the importance of prompt diagnosis and treatment, as highlighted in recent medical literature. For instance, in April 2024, the HCA Healthcare Journal of Medicine emphasized the critical role of thiamine in preventing and managing these disorders, reinforcing the need for accessible treatment options like Thiamine Hydrochloride Injection.
The regulatory landscape has significantly influenced the market dynamics of Thiamine Hydrochloride Injection. In March 2023, Caplin Steriles Limited, a Caplin Point Laboratories Limited subsidiary, received final approval from the United States FDA for its generic version, marking a milestone in providing cost-effective alternatives to the existing brand-name products.
Further contributing to the competitive market environment, the FDA's June 2024 publication listed several approved manufacturers of Thiamine Hydrochloride Injection in the United States. Companies such as Dr. Reddy's Laboratories Ltd., Eugia Pharma Specialties Ltd., Fresenius Kabi USA LLC, and Mylan Institutional LLC are among the prominent players, each contributing to the injection's accessibility and availability.
In Canada, Omega Laboratories Limited stands out as a regional provider of Thiamine Hydrochloride Injection, demonstrating a localized response to regional healthcare needs.
The increasing demand for Thiamine Hydrochloride Injection in North America reflects a growing recognition of its therapeutic importance in managing nutritional deficiencies. With regulatory approvals paving the way for expanded market participation, the future holds promise for continued advancements in meeting healthcare challenges related to thiamine deficiency disorders.
Thiamine Hydrochloride Injection Industry Overview
The thiamine hydrochloride injection market is semi-consolidated and consists of major players. Both regional and global players in the healthcare sector are increasingly turning to vertical collaboration as a key strategy to bolster their market positions. Healthcare providers recognize and diagnose thiamine deficiency disorders more effectively, and introducing generic alternatives enhances affordability and widens patient access; addressing medical and economic considerations, the intense competition increases. Some market players in the thiamine hydrochloride injection market are Lupin, Hikma Pharmaceuticals, and Fresenius Kabi USA
Thiamine Hydrochloride Injection Market Leaders
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Viatris Inc.
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Lupin
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Fresenius Kabi USA
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Sagent Pharmaceuticals
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Hikma Pharmaceuticals
*Disclaimer: Major Players sorted in no particular order
Thiamine Hydrochloride Injection Market News
- June 2023: Lupin Limited introduced its Thiamine Hydrochloride Injection USP, 200 mg/2 mL (100 mg/mL) Multiple-dose Vials. This launch followed the approval of an ANDA by Lupin's partner, Caplin Steriles Limited, from the United States FDA.
- March 2023: Dr. Reddy's Laboratories Inc. marked its entry into the United States market with its FDA-approved thiamine hydrochloride injection under the ANDA marketing category.
Thiamine Hydrochloride Injection Market Report - Table of Contents
1. INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study
2. RESEARCH METHODOLOGY
3. EXECUTIVE SUMMARY
4. MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Surging Demand for Vitamin B1 as a Dietary Supplement
4.2.2 Rising Incidence of Diseases Linked to Vitamin B1 Deficiency
4.3 Market Restraints
4.3.1 Challenges Arise from Limited Raw Material Supply and Escalating Costs
4.4 Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry
5. MARKET SEGMENTATION (Market Size by Value - USD)
5.1 By Indication
5.1.1 Wernicke's Disease
5.1.2 Dietary Supplement
5.1.3 Pregnancy
5.1.4 Other Indications
5.2 By End User
5.2.1 Hospitals/Clinics
5.2.2 Home Care Setting
5.2.3 Other End Users
5.3 Geography
5.3.1 North America
5.3.1.1 United States
5.3.1.2 Canada
5.3.1.3 Mexico
5.3.2 Europe
5.3.2.1 Germany
5.3.2.2 United Kingdom
5.3.2.3 France
5.3.2.4 Italy
5.3.2.5 Spain
5.3.2.6 Rest of Europe
5.3.3 Asia-Pacific
5.3.3.1 China
5.3.3.2 Japan
5.3.3.3 India
5.3.3.4 Australia
5.3.3.5 South Korea
5.3.3.6 Rest of Asia-Pacific
5.3.4 Middle East and Africa
5.3.4.1 GCC
5.3.4.2 South Africa
5.3.4.3 Rest of Middle East and Africa
5.3.5 South America
5.3.5.1 Brazil
5.3.5.2 Argentina
5.3.5.3 Rest of South America
6. COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Viatris Inc.
6.1.2 Lupin
6.1.3 Hikma Pharmaceuticals
6.1.4 Baxter
6.1.5 Pfizer Inc.
6.1.6 Caplin Steriles Limited
6.1.7 Fresenius Kabi USA
6.1.8 Aurobindo Pharma
6.1.9 Sagent Pharmaceuticals
6.1.10 Dr. Reddy’s Laboratories Ltd.
- *List Not Exhaustive
7. MARKET OPPORTUNITIES AND FUTURE TRENDS
Thiamine Hydrochloride Injection Industry Segmentation
Thiamine hydrochloride injection consists of a sterile solution of thiamine hydrochloride. It is designed for intramuscular (IM) or slow intravenous (IV) administration. Thiamine hydrochloride, or vitamin B1, presents as white crystals or crystalline powder, typically with a faint odor. It is highly soluble in water, soluble in glycerin, slightly soluble in alcohol, and remains insoluble in ether and benzene.
The thiamine hydrochloride injection market is segmented by indication, end-user, and geography. By indication, the market is segmented into Wernicke's disease, dietary supplements, pregnancy, and other indications. By end-user, the market is segmented into hospitals/clinics, home care settings, and other end-users. By geography, the market is segmented into North America, Europe, Asia Pacific, the Middle East and Africa, and South America. For each segment, the market sizing and forecasts have been done on the basis of revenue (USD).
| By Indication | |
| Wernicke's Disease | |
| Dietary Supplement | |
| Pregnancy | |
| Other Indications |
| By End User | |
| Hospitals/Clinics | |
| Home Care Setting | |
| Other End Users |
| Geography | ||||||||
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Thiamine Hydrochloride Injection Market Research FAQs
How big is the Thiamine Hydrochloride Injection Market?
The Thiamine Hydrochloride Injection Market size is expected to reach USD 174.17 million in 2024 and grow at a CAGR of 4.5% to reach USD 226.81 million by 2029.
What is the current Thiamine Hydrochloride Injection Market size?
In 2024, the Thiamine Hydrochloride Injection Market size is expected to reach USD 174.17 million.
Who are the key players in Thiamine Hydrochloride Injection Market?
Viatris Inc., Lupin, Fresenius Kabi USA, Sagent Pharmaceuticals and Hikma Pharmaceuticals are the major companies operating in the Thiamine Hydrochloride Injection Market.
Which is the fastest growing region in Thiamine Hydrochloride Injection Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2024-2029).
Which region has the biggest share in Thiamine Hydrochloride Injection Market?
In 2024, the North America accounts for the largest market share in Thiamine Hydrochloride Injection Market.
What years does this Thiamine Hydrochloride Injection Market cover, and what was the market size in 2023?
In 2023, the Thiamine Hydrochloride Injection Market size was estimated at USD 166.33 million. The report covers the Thiamine Hydrochloride Injection Market historical market size for years: 2019, 2020, 2021, 2022 and 2023. The report also forecasts the Thiamine Hydrochloride Injection Market size for years: 2024, 2025, 2026, 2027, 2028 and 2029.
Thiamine Hydrochloride Injection Industry Report
Statistics for the 2024 Thiamine Hydrochloride Injection market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Thiamine Hydrochloride Injection analysis includes a market forecast outlook for 2024 to 2029 and historical overview. Get a sample of this industry analysis as a free report PDF download.
