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Emtricitabine and Tenofovir Market Size, Share, Industry, Forecast and outlook (2024-2031)

Published: January 2024 || SKU: MD3458
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Emtricitabine and Tenofovir Market is segmented By Type (Outsourcing of API, Self-production API), By Application (Hospitals, Clinics, Others), and By Region (North America, Europe, South America, Asia Pacific, Middle East, and Africa) – Share, Size, Outlook, and Opportunity Analysis, 2023-2030

 

Emtricitabine and Tenofovir Market Overview

[180 Pages Report] The Emtricitabine/Tenofovir Market is estimated to reach at a CAGR of 5% during the forecast period (2023-2030). 

Emtricitabine/tenofovir, sold under the brand name Truvada, is a fixed-dose combination antiretroviral medication used to treat and prevent HIV/AIDS. It contains the antiretroviral medications emtricitabine and tenofovir disoproxil. For treatment, it must be used in combination with other antiretroviral medications.

Emtricitabine and Tenofovir Market - Strategic Insights

Metrics

Details

Market CAGR

5%

Segments Covered

By Type, By Application, and By Region

Report Insights Covered

Competitive Landscape Analysis, Company Profile Analysis, Market Size, Share, Growth, Demand, Recent Developments, Mergers and acquisitions, New Product Launches, Growth Strategies, Revenue Analysis, and Other key insights.

Fastest Growing Region

Asia Pacific

Largest Market Share 

North America

 

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Emtricitabine and Tenofovir Market Growth and Trends

An increase in the number of HIV/AIDS patients will drive the market

The human immunodeficiency virus (HIV) targets the immune system and weakens people's defence against many infections and some types of cancer that people with healthy immune systems can fight off. Emtricitabine and tenofovir combination (Descovy, Truvada) is used along with other medications to treat HIV in adults and children who weigh at least 37 pounds (17 kg). Emtricitabine and tenofovir (Truvada) are also used along with practising safer sex (e.g., condom use) to reduce the risk of HIV infection in high-risk adults and teenagers who weigh at least 77 pounds (35 kg). Emtricitabine and tenofovir are a class of nucleoside and nucleotide reverse transcriptase inhibitors (NRTIs). They work by slowing the spread of HIV in the body.

HIV continues to be a major global public health issue, having claimed 34.7 million [26.0–45.8 million] lives so far.

Increasing drug approvals will drive the market in the forecast period

The available antiretroviral (ARV) drugs for the treatment of HIV have expanded. Novel types of ARVs with new mechanisms of action have been approved. There have been approvals of combination tablets of previously available drugs, such as emtricitabine/tenofovir.

On May 15, 2018- Gilead Sciences, Inc. (Nasdaq: GILD) announced that the U.S. Food and Drug Administration (FDA) had approved once-daily oral Truvada® (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)—in combination with safer sex practices—to reduce the risk of sexually acquired HIV-1 in at-risk adolescents. 

Strides Pharma Global of Singapore has received approval for Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg from the United States Food & Drug Administration (USFDA). The product is bioequivalent, therapeutically equivalent to the Reference Listed Drug (RLD), Truvada Tablets, 200 mg/300 mg, of Gilead Sciences.

Side-effects related to the use of emtricitabine/tenofovir will hamper the market

Rarely, this medication can cause severe (sometimes fatal) liver and blood problems (lactic acidosis). The patient should contact a doctor if they develop symptoms of liver problems (such as persistent nausea, light-colored stools, stomach/abdominal pain, dark urine, yellowing eyes/skin) or lactic acidosis (such as rapid breathing, drowsiness, fast/irregular heartbeat, unusual weakness, feeling cold especially in the arms/legs).

Truvada (emtricitabine/tenofovir) may cause severe and life-threatening side effects. These generally include a buildup of lactic acid in the blood (lactic acidosis), liver problems, and new or worse kidney problems, including kidney failure. Truvada is not approved for the treatment of chronic hepatitis B virus infection (HBV). If a patient has both HIV and HBV infection and takes Truvada,  then HBV infection may worsen (flare-up) if the patient stops taking Truvada. Before starting Truvada, the patient should talk to a health care provider about getting tested for HBV.

COVID-19 Impact Analysis

Emtricitabine/Tenofovir market saw a decline due to COVID-19, as all the diagnosis and treatments in hospitals were affected. Antiretrovirals are also being explored for COVID-19 prevention. There were reports of fewer cases of severe COVID-19 amongst HIV-positive people in Spain. This prompted the design of a large randomized study involving healthcare workers in Spain, exploring the safety and efficacy of tenofovir/emtricitabine with low-dose hydroxychloroquine as COVID-19 prophylaxis.

Emtricitabine and Tenofovir Market Segment Analysis

Outsourcing of API will dominate the market in the forecast period 

Concerned with rising R&D costs, U.S. bio/pharma companies are considering Asian countries, such as India and China, to develop their Active Pharmaceutical Ingredients (APIs) and pharma products, often because manufacturers there can provide low-cost production facilities and cheap labor.

From a cost perspective, Asian manufacturers may be able to save companies 30-to-60 to per cents of the costs of manufacturing in the U.S. Yet. At the same time, offshoring may make sense for some industries and specific biotech projects. There are pitfalls and caveats that U.S. companies should closely consider before committing to working with a team-based outside the country.

Many U.S. companies have come to realize those challenges since several years ago, it was predicted that eventually, all chemical manufacturing would take place in China. Yet, API manufacturing still takes place domestically, and the U.S. business is continuing to grow, outpacing that of Asia Pacific. The main advantage of outsourcing highly potent API (HPAPI) manufacture is that it helps to eliminate the need to invest in expensive containment infrastructure, which can also be complex to engineer, install and maintain. Unless the pharma companies have a broad portfolio of HPAPIs in their pipeline, such an infrastructure may not be fully utilized. They can often be more cost-effective to outsource activities that involve the use of HPAPIs.

The hospital segment has dominated the market

All directions on the prescription label should be followed. The medicine should not be taken in larger or smaller amounts or for longer than recommended. While using the medicine, patients may need frequent blood tests. Kidney and liver function may also need to be checked. HIV/AIDS is usually treated with a combination of drugs. Use all medications as directed by a doctor. One should not change their doses or medication schedule without the doctor's advice. Every person with HIV or AIDS should remain under the care of a doctor.

The complications in using emtricitabine/tenofovir without doctors' assistance and the increase in the number of admissions in hospitals due to HIV will drive the market of hospital segment.

As of the end of 2019, about 25.4 million people with HIV (67%) were accessing antiretroviral therapy (ART) globally. That means 12.6 million people are still waiting. HIV treatment access is key to the global effort to end AIDS as a public health threat. People with HIV who are aware of their status, take ART daily as prescribed, and get and keep an undetectable viral load can live long, healthy lives and have effectively no risk of sexually transmitting HIV to their HIV-negative partners.

Emtricitabine and Tenofovir Market Geographical Share

North America will dominate the market

Approximately 1.2 million people in the U.S. have HIV and about 13 per cent of them don't know it and need testing. In 2019, an estimated 34,800 new HIV infections occurred in the United States. 36,801 people received an HIV diagnosis in the U.S. in 2019 and six dependent areas an overall 9% decrease compared to previous years. With over 143,000 cases of AIDS reported to the World Health Organization from 145 countries and with an estimated 5 to 10 million people worldwide infected with HIV, AIDS has become firmly established as a global pandemic. In the Americas, over 100,862 cases of AIDS have been reported, with indigenous transmission documented in 45 to 46 countries. While North America has the highest annual number of AIDS cases per population, with 72 cases/million, the Caribbean subregion has a disproportionately high number of cases, with annual rates as high as 200 to 300 cases/million population for some countries. Despite differences in the absolute number of cases, there has been a remarkable similarity in the temporal rate of increase of AIDS in the countries of the Americas, reflecting the delayed introduction of the virus to some areas with an early exponential increase similar to that observed initially in the United States.

Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd.(NYSE and TASE: TEVA), announced the availability of the first Food and Drug Administration (FDA)-approved generic versions of TRUVADA®i and ATRIPLA®i tablets.

Emtricitabine and Tenofovir Market Companies

Some prominent key players in this market are Gilead Sciences, Cipla, Mylan Pharmaceuticals, Emcure Pharmaceuticals, Hetero Drugs, Sun Pharmaceutical Industries, Alkem Laboratories, Teva, Hengrui Medicine, SYSVAX and Hisun Pharmaceutical

Key Companies to Watch

Gilead Sciences

Overview: Gilead Sciences, Inc. is an American biopharmaceutical company headquartered in Foster City, California, that focuses on researching and developing antiviral drugs used to treat HIV, hepatitis B, hepatitis C, and influenza including Harvoni and Sovaldi. Gilead as a company is dedicated to developing innovative medicines for life-threatening illnesses. Gilead's management approach is designed to create a sustainable future that reflects our integrity and commitment to excellence.

Product Portfolio: The Company offers antiviral drugs used to treat HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi. 

Key Development: On November 18, 2020, Gilead Sciences, Inc. (Nasdaq: GILD) announced topline results from the Phase 2/3 CAPELLA trial evaluating the company's investigational, long-acting HIV-1 capsid inhibitor, lenacapavir, in heavily treatment-experienced people with multidrug-resistant HIV-1 infection. 

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FAQ’s

  • The emtricitabine and tenofovir market is expected to grow at a 5% CAGR between 2023 and 2030, driven by factors like rising HIV prevalence, expanding PrEP programs, and increased access to generic versions of the drug.

  • Gilead Sciences is the leading player in the market, followed by companies like Cipla, Mylan Pharmaceuticals, Emcure Pharmaceuticals, Hetero Drugs, Sun Pharmaceutical Industries, Alkem Laboratories, Teva, Hengrui Medicine, SYSVAX, and Hisun Pharmaceutical.

  • North America is currently the largest market and is expected to remain dominant due to factors like high HIV prevalence and well-developed healthcare infrastructure.

  • The market faces challenges such as side effects associated with the drug, patent expiry of key drugs, and competition from other antiretroviral drugs.
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