Global Trifluridine API Market 2024-2031

Trifluridine API Market Size, Share & Trends Analysis Report by Product Type (Trifluridine API Powder and Trifluridine API Solutions), by Application (Antiviral Drugs, Oncology Drugs, and Others), and by End-User (Pharmaceutical Companies, Contract Manufacturing Organizations (CMOs) and Academic and Research Institutes) Forecast Period (2024-2031)

Trifluridine API market is anticipated to grow at a considerable CAGR of 8.7% during the forecast period (2024-2031). The market growth is attributed to pivotal factors increasing rates of Herpes Simplex Virus (HSV) infection, rising antiviral drug demand, and developments in drug delivery technology. Millions of people globally are affected by herpetic keratitis and other HSV infections every year. Trifluridine and other antiviral medications are used to treat HSV infections. Moreover, the need for drugs such as trifluridine API is being driven by the growing awareness of eye health and the accessibility of efficient treatments. According to the World Health Organization (WHO), in April 2023, an estimated 3.7 billion people under age 50 (67.0%) globally had HSV type 1 (HSV-1) infection, the main cause of oral herpes. An estimated 491 million people aged 15-49 (13.0%) globally had HSV type 2 (HSV-2) infection, the main cause of genital herpes.

Market Dynamics

Increasing Ongoing Research and Development in Trifluridine API

The market benefits from ongoing R&D efforts aimed at improving drug delivery systems for trifluridine API ophthalmic medications, offering opportunities for manufacturers to develop new formulations and dosage forms of trifluridine. Market players are increasingly focusing on product innovation and development such as ophthalmic solutions, ointment, and gel, to meet evolving consumer demands and preferences. Expansion into emerging markets and strategic partnerships or collaborations are also pivotal strategies for market growth. Additionally, investments in R&D to enhance technological advancements and improve product quality play a vital role.

Growing Adoption of Advanced Technologies for Trifluridine API Manufacturing

The introduction of new and advanced technologies for trifluridine API manufacturing is one of the major factors supporting the growth of this market. Continuous manufacturing technology, which includes continuous flow chemistry, offers the potential for improved safety and environmental profiles. This technology has recently been adopted by companies such as Vertex Pharmaceuticals (UK), GlaxoSmithKline (UK), and Novartis (Switzerland) for API manufacturing. By ensuring continual processing and output, and consistent production, this technology offers several potential advantages over traditional batch manufacturing of pharmaceuticals, such as greater optimization and control of the process and a reduced manufacturing footprint. In addition, the micro-structured devices used for this type of Trifluridine API manufacturing provide controlled process conditions, high flow rates, and high mass throughput.

Market Segmentation

• Based on the product type, the market is segmented into trifluridine API powder and trifluridine API solution.
• Based on the application, the market is segmented into antiviral drugs, oncology drugs, and other (scientific research).
• Based on the end-user, the market is segmented into pharmaceutical companies, Contract Manufacturing Organizations (CMOs), and academic and research institutes.

The Trifluridine API Powder Segment is Projected to Hold the Largest Market Share

The primary factors supporting the growth include trifluridine API powder, a nucleoside metabolic inhibitor that is used as part of chemotherapy for some forms of metastatic gastrointestinal cancers as well as for the treatment of simplex virus-induced keratoconjunctivitis and epithelial keratitis. Utilizing Trifluridine API powder in a bottle or capsule to have the benefit of speed. A few hundred bottles or capsules can be swiftly prepared, to cover the supplies for clinical Phase I and the required stability tests. For instance, Merck KGaA offers trifluridine powder for pharmaceutical applications. Manufacturer by British Pharmacopoeia (BP) with grade pharmaceutical primary standard.

Antiviral Drugs to Hold a Considerable Market Share

The factors supporting segment growth include increasing demand for trifluridine antiviral drugs as an ophthalmic solution and is effective in treating conditions such as herpetic keratitis, a serious eye infection caused by HSV. According to the Government Accountability Office, in September 2023, estimates of the cost of development of new antiviral drugs range from $800.0 million to more than $2.5 billion. Approximately nine out of 10 drug candidates that enter clinical trials will fail during clinical trials. The key players offer trifluridine API-based antiviral drugs for effective treatment against the herpes virus. For instance, Santiago lab offers Trifluridine triphosphate, an anti-herpesvirus antiviral drug, used primarily on the eye. The company offers Trifluridine triphosphate in the form of Et3NH+ salt as a powder or water solution.

Regional Outlook

The global trifluridine API market is further segmented based on geography including North America (the US, and Canada), Europe (the UK, Italy, Spain, Germany, France, and the Rest of Europe), Asia-Pacific (India, China, Japan, South Korea, and Rest of Asia-Pacific), and the Rest of the World (the Middle East & Africa, and Latin America).

Growing Demand for Trifluridine API in Asia-Pacific

The regional growth is attributed to increasing demand to treat keratoconjunctivitis and epithelial keratitis and the rising prevalence of HSV drives the growth of the trifluridine API market in the region. According to the National Center for Biotechnology Information, HSV-1 epidemiology is transitioning in Asia with lower seroprevalence in youth. Yet, 50.0% of children and 75.0% of adults are infected. HSV-1 explained one-fifth of genital herpes and 6.0% of genital ulcer disease cases.

North America Holds Major Market Share

North America holds a significant share owing to the presence of trifluridine API offering companies such as Cayman Chemical, MedKoo Biosciences, Inc. Pfizer Inc., and others. The market growth is attributed to the increasing prevalence of eye infections, rising awareness about the medication, and growing demand for effective antiviral drugs. Trifluridine (trifluorothymidine) is an antiviral agent for topical use in the eye and is structurally related to idoxuridine. In vitro studies have shown that it effectively inhibits the replication of HSV-1, which causes primary keratoconjunctivitis and recurrent epithelial keratitis in men.

According to the National Center for Biotechnology Information, in March 2024, HSV-2 continues to be a common infection, affecting approximately 22.0% of adults ages 12 and older, representing 45 million adults in the US alone. The key players offering antiviral medicine used to treat eye infections caused by a virus, such as herpes infection. For instance, Pfizer Inc. offering VIROPTIC is the brand name for trifluridine (also known as trifluorothymidine, F3TdR, F3T), an antiviral drug for topical treatment of epithelial keratitis caused by herpes simplex virus. VIROPTIC is also effective in treating epithelial keratitis that has not responded clinically to the topical administration of idoxuridine or when ocular toxicity or hypersensitivity to idoxuridine has occurred.

Market Players Outlook

The major companies serving the trifluridine API market include Merck KGaA, NATCO PHARMA LTD., Pfizer Inc., Sandoz Group AG, and Taiho Pharmaceutical Co., Ltd. among others. The market players are increasingly focusing on business expansion and product development by applying strategies such as collaborations, mergers and acquisitions to stay competitive in the market.