INTEGRASE INHIBITORS MARKET ANALYSIS

The global integrase inhibitors market size was valued at US$ 14.7 billion in 2023 and is expected US$ 21.7 billion by 2030 is expected to grow at a compound annual growth rate (CAGR) of 5.7% from 2023 to 2030. The increasing adoption of integrase inhibitors as first-line therapy for HIV, the rising prevalence of HIV/AIDS, and the growing government initiatives to improve HIV treatment and prevention programs are the major factors driving the growth of the market.

The integrase inhibitors market is segmented By Drug (Raltegravir, Dolutegravir, Elvitegravir, Bictegravir, and Others (Cabotegravir, etc.)), By Route of Administration (Oral, Intravenous, and Others), and By Distribution Channel (Hospital Pharmacies, Retail Pharmacies, Online Pharmacies).

Among by Drug segment, the raltegravir segment is expected to dominate the market during the forecast period. This is due to the high efficacy and safety profile of raltegravir. Dolutegravir is the fastest-growing segment in the integrase inhibitors market. This is due to the increasing adoption of dolutegravir as first-line therapy for HIV.

Integrase Inhibitors Market Regional Insights

• North America (33.5%): North America is the largest market for integrase inhibitors due to the presence of a large patient pool, well-developed healthcare infrastructure, and increasing government support for HIV/AIDS treatment. For instance, in May 2022, Oracle, a multinational computer technology company, and HIV Vaccine Trials Network, funded by the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health (NIH), launched a new HIV awareness campaign and the Red Ribbon Registry with the goal of helping end HIV.
• Asia Pacific (26.1%): Asia Pacific is the second largest market for integrase inhibitors, due to the increasing patient pool, rising investment in the healthcare sector, and growing government support. For instance, in November 2021, according to a report published by the National Center for Biotechnology Information (NCBI), 045 million HIV/AIDS cases were reported in China.
• Europe (20.3%): Europe is the third-largest market for integrase inhibitors, due to the well-developed healthcare infrastructure and increasing awareness about HIV/AIDS. For instance, on April 25 2023, according to the Ministry for Europe and Foreign Affairs, HIV kills 650,000 people a year. France was mobilized at a very early stage in the fight against HIV/AIDS and has conducted an international policy based on solidarity, fair and universal access to treatments, and to that end its approach takes discrimination into account.

Figure 1. Global Integrase Inhibitors Market Share (%), by Region, 2023

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Integrase Inhibitors Market Drivers

• Increasing prevalence of HIV: The increasing prevalence of HIV globally is a major factor driving the growth of the Integrase Inhibitors market. As per recent data from UNAIDS, there were approximately 38 million people living with HIV across the world in 2020. While antiretroviral treatment has helped in reducing HIV-related illnesses and deaths over the years, the need for more effective and durable treatment options remains high. Integrase inhibitors work by blocking the integrase enzyme that the HIV virus uses to insert its genetic material into a human cell's DNA, which is essential for the virus to multiply and infect other cells. This class of antiretroviral drugs leads to durable viral suppression and has fewer side effects when compared to older drug classes like non-nucleoside reverse transcriptase inhibitors (NNRTIs) and protease inhibitors (PIs). For these reasons, integrase inhibitors are gradually becoming the preferred first line treatment regimen for HIV globally according to recent guidelines issued by the World Health Organization (WHO).
• Development of Long-Acting Formulations: The development of long-acting formulations of integrase inhibitors is another driver in the market. These formulations allow for less frequent dosing, such as monthly or quarterly injections, which can improve patient convenience and adherence. Long-acting integrase inhibitors are being investigated as potential options for both treatment-naive and treatment-experienced patients. For instance, in January 2021, according to a report published by Elsevier B.V., an academic publishing company, long-acting injectable nanoformulations of the integrase inhibitor cabotegravir and the non-nucleoside reverse transcriptase inhibitor rilpivirine were safe, well tolerated and efficacious in large randomized phase 3 studies.

Integrase Inhibitors Market Opportunities

• Increasing research and development for pediatric population: Pediatric formulations in integrase inhibitors market can be a huge opportunity going forward. Integrase inhibitor drugs are critical for children living with HIV as they need antiviral treatment. However, most integrase inhibitor drugs are currently only available in formulations suitable for adults like tablets or capsules which kids may find difficult to swallow or get confused with dosages. Developing pediatric-friendly formulations like suspension, oral solution or even flavored tablets for integrase inhibitors can help improve medication adherence among children significantly. In June 2023, according to UNAIDS data, every hour 11 children die of AIDS and 1.7 million children are living with HIV
• Combination Therapies: Integrase inhibitors are often used in combination with other antiretroviral drugs as part of highly active antiretroviral therapy (HAART). There is an opportunity to develop and optimize combination therapies that include integrase inhibitors, particularly those with novel mechanisms of action. Combination therapies can enhance treatment effectiveness, overcome resistance, and improve patient outcomes. For instance, in December 2022, a report published by the National Center for Biotechnology Information (NCBI), stated a study regarding Cabotegravir which is a novel HIV integrase inhibitor combined with rilpivirine as the first long-acting injectable program for the treatment of HIV infection

Integrase Inhibitors Market Trends

• New Product Launches: Pharmaceutical companies continue to introduce new integrase inhibitors with improved properties, such as enhanced efficacy, safety, and resistance profiles. These innovations contribute to the expansion of the market and provide healthcare providers with a wider range of treatment options. For instance, in June 2020, ViiV Healthcare group, a multinational pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) had approved Tivicay PD (dolutegravir) tablets for oral suspension, which are used in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric patients
• Resistance Monitoring and Management: The emergence of drug-resistant strains of HIV poses a challenge in HIV/AIDS treatment. As a result, there is a growing emphasis on resistance monitoring and management strategies, including the use of integrase resistance testing. This trend drives the development of new integrase inhibitors that are effective against resistant strains and the incorporation of resistance testing into treatment guidelines.

Integrase Inhibitors Market Restraints

• High Treatment Costs: The cost of integrase inhibitors and other antiretroviral drugs can be a significant barrier to access, particularly in low- and middle-income countries. The high prices of these medications can limit their availability and affordability, hindering market growth and impacting patient care. The high cost of HIV treatment is proving to be a major restraint on the growth potential of the integrase inhibitors market. While integrase inhibitors have revolutionized HIV management over the past decade and allowed for more effective single pill once daily treatment options, their expense puts them out of reach for many patients globally. Integrase inhibitors require lifelong daily usage to keep the virus suppressed. However, the annual cost of treatment with these drugs can range from US$ 20,000 to US$ 40,000 per patient in the U.S. alone according to 2020 figures from the UNAIDS Gap Report. The prohibitive cost is even more unsustainable for low and middle-income countries accounting for the majority of new HIV cases worldwide.
• Side Effects and Safety Concerns: While integrase inhibitors are generally well-tolerated, they can still cause side effects. Some individuals may experience adverse reactions such as gastrointestinal issues, metabolic changes, or allergic reactions. Safety concerns associated with long-term use and potential drug interactions may impact patient acceptance and utilization of integrase inhibitors. For instance, in September 2022, according to information provided by NIH’s Office of AIDS Research, the adverse effects of integrase inhibitors include weight gain, nausea, diarrhea, headache, insomnia; depression and suicidality.

Hence, key players in the market are focused on developing drugs with less side effects and more cost effective.

Recent Developments

New product approvals

• On September 5 2023, Viatris Inc., a global healthcare company, announced the U.S. Food and Drug Administration (FDA) tentative approval for a New Drug Application for abacavir 60 mg/dolutegravir 5 mg/lamivudine 30 mg tablets for oral suspension for the treatment of HIV-1 infection in pediatric patients.
• In March 2022, Johnson & Johnson Services, Inc., a multinational, pharmaceutical and medical technologies corporation, announced the U.S. Food and Drug Administration (FDA) had approved CABENUVA (cabotegravir and rilpivirine) for the treatment of HIV-1 in virologically suppressed adolescents.
• In February 2022, ViiV Healthcare group, a multinational pharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) had approved Cabenuva (cabotegravir, rilpivirine) for every-two-month dosing for the treatment of HIV-1 in virologically suppressed adults

Collaborations and agreements

• In September 2021, ViiV Healthcare group, a multinational pharmaceutical company, announced an exclusive collaboration and license agreement with Shionogi & Co. Ltd., a pharmaceutical company, for S-365598, a third-generation investigational integrase strand transfer inhibitor (INSTI) with potential for use in ultra long-acting HIV regimens (regimens with dosing intervals of three months or longer).
• In March 2021, Gilead Sciences, Inc., a research-based biopharmaceutical company, and Merck KGaA, a pharmaceutical and chemicals company, announced that they have entered into an agreement to co-develop and co-commercialize long-acting treatments in HIV that combine Gilead’s investigational capsid inhibitor, lenacapavir, and Merck’s investigational nucleoside reverse transcriptase translocation inhibitor, islatravir, into a two-drug regimen with the potential to provide new, meaningful treatment options for people living with HIV.

Figure 2. Global Integrase Inhibitors Market Share (%), By Drug, 2023

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Top companies in Integrase Inhibitors Market

• Gilead Sciences
• ViiV Healthcare group
• Merck & Co., Inc.
• GlaxoSmithKline PLC
• Bristol-Myers Squibb Company
• Johnson & Johnson
• AbbVie Inc.
• Janssen Pharmaceuticals, Inc.
• Theratechnologies Inc.
• Shionogi & Co., Ltd.
• Viatris Inc.

Definition: The Integrase Inhibitors market refers to the pharmaceutical market segment focused on the development, production, and sale of drugs that belong to the class of antiretroviral medications known as Integrase Inhibitors. These drugs are primarily used in the treatment of HIV/AIDS by inhibiting the activity of the viral enzyme called integrase, thereby preventing the integration of the viral DNA into the host cell's DNA.