Global Tranexamic Acid Market Size, Share, and Trends Analysis Report – Industry Overview and Forecast to 2031

Tranexamic Acid Market Analysis

The tranexamic acid market is experiencing significant growth, driven by the increasing recognition of its efficacy in managing bleeding disorders and its application in various surgical procedures. As highlighted in a systematic review published on PMC, tranexamic acid has been shown to reduce mortality in trauma patients by one-third compared to placebo, underscoring its vital role in emergency medicine. The CRASH-2 trial further confirmed the drug's effectiveness when administered within three hours of the inciting event, solidifying its status as a critical intervention in traumatic bleeding. Additionally, tranexamic acid's applications extend beyond trauma care; it is increasingly used in elective surgeries, including orthopedic and dental procedures, where it helps minimize blood loss and reduces the need for blood transfusions. This growing body of evidence, combined with a rising global incidence of trauma cases and surgical interventions, is propelling demand for tranexamic acid across healthcare settings. Furthermore, innovations such as the development of topical formulations are expanding its use, presenting lucrative opportunities for market players. As healthcare providers continue to prioritize patient safety and outcome optimization, the tranexamic acid market is poised for sustained growth in the coming years.

Tranexamic Acid Market Size

The global tranexamic acid market size was valued at USD 81.85 million in 2023 and is projected to reach USD 128.50 million by 2031, with a CAGR of 5.80% during the forecast period of 2024 to 2031. In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

Tranexamic Acid Market Trends

“Increasing Introduction of Topical Formulations”

The tranexamic acid market is witnessing a notable trend toward the development of innovative formulations that enhance its usability and application across various medical fields. One significant advancement is the introduction of topical formulations, such as tranexamic acid sprays, which provide an easy-to-apply, non-invasive option for managing localized bleeding. For instance, Shilpa Medicare Limited's recent launch of the world’s first topical hemostatic spray containing tranexamic acid has been approved by the Central Drugs Standard Control Organization (CDSCO) in India. This formulation is designed for emergency use, making it a lifesaving tool for trauma patients and surgical procedures. Such innovations broaden the scope of tranexamic acid’s applications and improve patient outcomes by facilitating timely intervention. As healthcare providers increasingly adopt these advanced formulations, the tranexamic acid market is set to expand, driven by the demand for effective and user-friendly solutions in bleeding management.

Report Scope and Tranexamic Acid Market Segmentation    

Tranexamic Acid Market Definition

Tranexamic acid is a synthetic derivative of the amino acid lysine, primarily used as an antifibrinolytic agent. It works by inhibiting the activation of plasminogen to plasmin, a process that breaks down fibrin, the protein that helps form blood clots. By preventing this breakdown, tranexamic acid effectively reduces excessive bleeding in various medical situations, including surgical procedures, trauma, and certain bleeding disorders.

Tranexamic Acid Market Dynamics

Drivers

• Increasing Prevalence of Bleeding Disorders

The increasing prevalence of bleeding disorders significantly drives the demand for tranexamic acid as an effective treatment option. According to the World Federation of Hemophilia, approximately 1 in 5,000 to 10,000 male live births are affected by hemophilia A, with an estimated global population of over 400,000 people living with this condition. Additionally, menorrhagia, or heavy menstrual bleeding, affects around 10-30% of women in their reproductive years, highlighting a substantial patient population seeking effective management solutions. Tranexamic acid has emerged as a first-line therapy for treating these conditions due to its proven efficacy in reducing blood loss. Clinical studies have shown that tranexamic acid can reduce menstrual bleeding by up to 60% in women with menorrhagia, enhancing patient quality of life and offering a non-invasive alternative to more aggressive treatments. As awareness of these bleeding disorders grows and healthcare providers increasingly adopt tranexamic acid in their treatment protocols, the market for this drug is poised for continued expansion, making it a critical driver in the healthcare landscape.

• Increasing Number of Surgical Procedures

The increasing number of surgical procedures performed worldwide is a crucial driver of the tranexamic acid market, as effective hemostatic agents are essential in minimizing blood loss and enhancing patient safety. According to a report by the World Health Organization, surgical procedures are projected to rise by 25% by 2030, highlighting the growing demand for reliable patient blood management solutions. Tranexamic acid is particularly valuable in high-risk surgeries, such as orthopedic and cardiac operations, where excessive bleeding can lead to complications and increased healthcare costs. For instance, in orthopedic surgeries, National Institute of Health U.S., studies have shown that the use of tranexamic acid can reduce blood loss, significantly decreasing the necessity for blood transfusions. Furthermore, in cardiac surgery, the administration of tranexamic acid has been associated with reduced rates of postoperative bleeding and improved recovery times. This growing trend towards more surgical interventions, coupled with the proven efficacy of tranexamic acid, underscores its critical role in modern surgical practices and propels its market growth as a vital hemostatic agent.

Opportunities

• Rising Awareness of Trauma Management

Rising awareness of trauma management has created a significant market opportunity for tranexamic acid, especially given its critical role in emergency medicine. Increased recognition of the importance of timely intervention in trauma cases has led to the incorporation of tranexamic acid in treatment protocols for traumatic hemorrhage, which is a leading cause of preventable death. For instance, findings from the CRASH-2 trial demonstrated that administering tranexamic acid within three hours of injury can reduce mortality from bleeding by approximately 15%, making it a vital therapeutic option in trauma care. The growing emphasis on early and effective hemorrhage control has prompted emergency medical services and hospitals to prioritize the use of tranexamic acid in their protocols, enhancing its adoption in critical situations. Furthermore, training initiatives and awareness campaigns aimed at improving trauma care practices continue to advocate for the use of tranexamic acid, further expanding its market potential as a key intervention in saving lives during emergencies.

• Growing Investments in Healthcare Infrastructure

Growing investments in healthcare infrastructure, particularly in emerging markets, present a substantial market opportunity for tranexamic acid, as these improvements enhance access to essential medications. For instance, countries such as India and Brazil are significantly increasing their healthcare expenditures to modernize hospitals and expand access to quality care. As healthcare facilities upgrade and expand their capabilities, the demand for effective treatment options for bleeding control is likely to rise, particularly in surgical and trauma settings where tranexamic acid plays a critical role. Furthermore, initiatives aimed at improving emergency care and surgical outcomes will lead to higher utilization rates of this hemostatic agent. This trend towards enhanced healthcare infrastructure improves patient outcomes and creates a conducive environment for the increased adoption of tranexamic acid, driving its market growth in these regions.

Restraints/Challenges

• Lengthy and Complex Regulatory Processes

Regulatory hurdles represent a significant challenge in the tranexamic acid market, as obtaining approval for new indications often involves a lengthy and complex process that can vary widely across different countries. For instance, while tranexamic acid is already established for use in managing bleeding during surgery, its approval for newer indications, such as preventing blood loss in trauma patients or treating heavy menstrual bleeding, requires extensive clinical trials and comprehensive documentation to satisfy varying regulatory standards. In the U.S., the FDA mandates rigorous premarket evaluation, including randomized controlled trials, to assess safety and efficacy for any new indication, which can take years and incur substantial costs. Similarly, in Europe, the European Medicines Agency (EMA) requires a detailed assessment under the European Medicines Agency's regulatory framework, including compliance with the Medical Device Regulation (MDR) when applicable. These differing regulatory requirements can lead to significant delays in bringing tranexamic acid to market for new uses, hindering the market growth in diverse clinical settings.

• Adverse Effects and Safety Concerns

Adverse effects and safety concerns pose a significant challenge in the tranexamic acid market, as, despite its general safety profile, the drug is associated with potential adverse events that can deter its use in certain populations. One of the most notable concerns is the increased risk of thromboembolic events, such as deep vein thrombosis and pulmonary embolism, particularly among patients with pre-existing risk factors, including obesity or a history of vascular disorders. Such hesitancy can result in underutilization of tranexamic acid, especially in settings where alternative hemostatic agents are available and perceived as safer. Consequently, the safety profile of tranexamic acid can significantly influence clinicians' decision-making processes, potentially limiting its adoption in critical surgical and trauma care settings, which ultimately impacts its market growth.

This market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Tranexamic Acid Market Scope

The market is segmented on the basis of type, form, application, end users, and distribution channel. The growth amongst these segments will help you analyse meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Type

• USP25
• BP2000
• Other

Form

• Tablets
• Injections
• Oral Liquid

Application

• Trauma
• Craniocerebral Trauma
• Menorrhagia
• Postpartum Hemorrhage
• Surgery
• Whitening Cosmetics
• Others

End Users

• Clinics
• Hospitals
• Diagnostic Centers
• Others

Distribution Channel

• Hospital Pharmacy
• Retail Pharmacy
• Online Pharmacy

Tranexamic Acid Market Regional Analysis

The market is analysed and market size insights and trends are provided by country, type, form, application, end users, and distribution channel as referenced above.

The countries covered in the market report are U.S., Canada and Mexico in North America, Germany, France, U.K., Netherlands, Switzerland, Belgium, Russia, Italy, Spain, Turkey, Rest of Europe in Europe, China, Japan, India, South Korea, Singapore, Malaysia, Australia, Thailand, Indonesia, Philippines, Rest of Asia-Pacific (APAC) in the Asia-Pacific (APAC), Saudi Arabia, U.A.E., South Africa, Egypt, Israel, Rest of Middle East and Africa (MEA) as a part of Middle East and Africa (MEA), Brazil, Argentina and Rest of South America as part of South America.

North America is anticipated to lead the global Tranexamic Acid market, primarily driven by significant investments in the healthcare sector that are projected to stimulate market expansion. Within this region, the United States is expected to take the lead, largely due to its rapid technological advancements in healthcare solutions and innovative treatment options. Additionally, the growing emphasis on early disease detection and personalized medicine in the U.S. further enhances the demand for Tranexamic Acid, contributing to the region's dominance in this market.

The Asia-Pacific region is projected to experience significant growth from 2024 to 2031, largely fueled by the availability of azithromycin in both generic and branded forms, making it more accessible to patients. The rapid advancements in the biopharmaceutical sector contribute to the development of innovative therapies, further driving market expansion. Increased research and development activities in the region are fostering a dynamic environment for drug discovery and improvement. Additionally, ongoing developments in the healthcare sector, along with strong government support and initiatives aimed at enhancing healthcare access and affordability, are set to bolster the overall growth of the Tranexamic Acid market in Asia-Pacific.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.  

Tranexamic Acid Market Share

The market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to market.

Tranexamic Acid Market Leaders Operating in the Market Are:

• Venkatasai Life Sciences (India)
• Shanghai Shengxin Pharmaceutical & Chemical Co., Ltd. (China)
• VBShilpa (India)
• Hunan Dongting Pharmaceutical Co., Ltd. (China)
• Hainan Huluwa Pharmaceutical Co., Ltd. (China)
• GSK Inc. (U.K.)
• Aurobindo Pharma (India)
• Dr. Reddy’s Laboratories Ltd. (India)
• Lupin (India)
• Sun Pharmaceutical Industries Ltd. (India)
• Viatris Inc. (U.S.)
• Teva Pharmaceutical Industries Ltd. (Israel)
• Hikma Pharmaceuticals PLC (U.K.)
• Baxter (U.S.)
• Sandoz Group AG (Switzerland)
• Pfizer Inc. (U.S.)
• Novartis AG (Switzerland)
• Amgen Inc. (U.S.)
• Zydus Cadila (India)

Latest Developments in Tranexamic Acid Market

• In May 2024, Maxwellia, a champion of women’s health, announced the availability of Evana Heavy Period Relief 500mg tablets (containing tranexamic acid) and Ultravana Period Pain Relief 250mg gastro-resistant tablets (containing naproxen) to assist women in managing heavy and painful periods. Evana is an anti-fibrinolytic indicated for reducing heavy menstrual bleeding (HMB), with the potential to decrease flow by up to 60%. It is the only pharmacy brand available specifically for the relief of heavy menstrual bleeding
• In January 2024, Avenacy, a specialty pharmaceutical company focused on providing essential injectable medications, announced the launch of Tranexamic Acid Injection, USP in the United States as a therapeutic generic equivalent to Cyklokapron, as approved by the U.S. Food and Drug Administration. This injection is indicated for short-term use (2 to 8 days) in patients with hemophilia to reduce or prevent bleeding and minimize the need for replacement therapy during and after tooth extraction
• In September 2022, Shilpa Medicare Limited announced the successful innovation of the world’s first topical hemostatic spray containing Tranexamic Acid, which has received approval from the Central Drugs Standard Control Organization (CDSCO). This groundbreaking spray formulation is user-friendly, portable, easy to apply, and serves as a lifesaving tool. It has been clinically validated in humans and through a robust swine trauma model

SKU-63748