Bedaquiline Sales Market Forecast

Key Factors Driving Bedaquiline Growth

1. Rising Global Burden of Drug-Resistant Tuberculosis

A major factor fueling bedaquiline’s growth is the persistent and increasing incidence of multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB) — strains that do not respond to standard first-line therapies. New WHO treatment guidelines now recommend all-oral bedaquiline-based regimens (e.g., BPaL/M), replacing older injectable-containing regimens, which significantly increases bedaquiline use worldwide.

2. Expansion of National and Global TB Treatment Programs

• Organizations such as the World Health Organization (WHO) and Stop TB Partnership have strengthened guidelines and procurement support for bedaquiline, making it a recommended core drug for MDR-TB programs.
• Price reductions secured through global procurement initiatives (e.g., price cuts of up to ~55% via the Global Drug Facility) have expanded access in low- and middle-income countries, enhancing affordability and broadening patient access.

3. Market Growth and Economic Forecasts

Multiple independent market research reports project strong growth trajectories for the bedaquiline/bedaquiline fumarate market in coming years:

• One forecast estimates the bedaquiline market size could grow from ~USD 400 million in 2025 to ~USD 1.5 billion by 2035, at a CAGR of ~13.4% reflecting both broader use in MDR-TB regimens and enhanced global distribution infrastructure.
• Another analysis anticipates the overall bedaquiline market could expand from ~USD 773 million in 2024 to ~USD 1.53 billion by 2034, at a CAGR of ~7.1%, driven by growing demand in targeted therapies for MDR-TB and XDR-TB treatments across diverse regions.

4. Inclusion in Combination Regimens and Clinical Guidelines

• Bedaquiline is a key component of short-course, all-oral regimens (like bedaquiline + pretomanid + linezolid based on WHO recommendations) for MDR-TB, which shorten treatment durations, reduce side effects, and improve adherence compared with older multidrug regimens.
• Shifts in guideline recommendations toward these regimens drive greater bedaquiline utilization across national TB programs and private healthcare sectors alike.

5. Regional Growth Dynamics

Regional forecasts indicate diverse growth patterns:

• Asia-Pacific often the region with the highest TB burden is expected to register notably high growth in demand for bedaquiline and its APIs, reflecting both high disease prevalence and intensified TB control initiatives.
• North America & Europe with better healthcare infrastructure and early adoption are expected to contribute stable but smaller proportional growth, driven more by research, surveillance programs, and MDR-TB case management.

6. Expanded Access Through Generics and Supply Chain Investment

• The anticipated patent expirations for branded bedaquiline products have opened the door to generic manufacturing, which studies suggest will drive API (active pharmaceutical ingredient) market growth and reduce drug costs.
• Manufacturers in emerging markets (India, South Africa, Latin America) are scaling production and supply, increasing availability through public health programs and reducing reliance on imports.

Bedaquiline Recent Developments

In November 2025, New clinical trial results presented by TB Alliance at the Union World Conference on Lung Health show that the novel antibiotic candidate sorfequiline (TBAJ-876), a next-generation diarylquinoline, has the potential to improve tuberculosis (TB) treatment when combined with pretomanid and linezolid in a treatment regimen known as "SPaL."

“Bedaquiline Sales Forecast, and Market Size Analysis – 2034” report provides comprehensive insights of Bedaquiline for approved indication like Tuberculosis; as well as potential indications like Leprosy and Mycobacterium avium complex infections in the 7MM. A detailed picture of Bedaquiline’s existing usage in approved and anticipated entry and performance in potential indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 –2034 is provided in this report along with a detailed description of the Bedaquiline for approved and potential indications. The Bedaquiline market report provides insights about Bedaquiline’s sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current Bedaquiline performance, future market assessments inclusive of the Bedaquiline market forecast analysis for approved and potential indications in the 7MM, SWOT, analysts’ views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of Bedaquiline sales forecasts, along with factors driving its market.

Bedaquiline Drug Summary

Bedaquiline (Sirturo) is a diarylquinoline antimycobacterial drug that inhibits Mycobacterium tuberculosis by blocking ATP synthase, a proton pump essential for bacterial energy production, making it bactericidal against multi-drug resistant (MDR) and extensively drug-resistant (XDR) strains. Indicated as part of combination therapy with at least three other TB drugs for pulmonary TB due to M. tuberculosis resistant to rifampin and isoniazid in adults and pediatric patients (≥5 years weighing ≥15 kg in US; ≥2 years ≥7 kg in EU), dosing involves a 400 mg daily loading phase (weeks 1-2) followed by 200 mg three times weekly (weeks 3-24) orally with food, available as 20 mg or 100 mg tablets. The report provides Bedaquiline’s sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the Bedaquiline Market Report

The report provides insights into:

• A comprehensive product overview including the Bedaquiline MoA, description, dosage and administration, research and development activities in approved indications like Tuberculosis; as well as potential indications like Leprosy and Mycobacterium avium complex infections.
• Elaborated details on Bedaquiline regulatory milestones and other development activities have been provided in Bedaquiline market report.
• The report also highlights Bedaquiline‘s cost estimates and regional variations, reported and estimated sales performance, research and development activities in approved and potential indications across the United States, Europe, and Japan.
• The Bedaquiline market report also covers the patents information, generic entry and impact on cost cut.
• The Bedaquiline market report contains current and forecasted Bedaquiline sales for approved and potential indications till 2034.
• Comprehensive coverage of the late-stage emerging therapies for respective indications.
• The Bedaquiline market report also features the SWOT analysis with analyst views for Bedaquiline in approved and potential indications.

Methodology

The Bedaquiline market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight’s team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

Bedaquiline Analytical Perspective by DelveInsight

In-depth Bedaquiline Market Assessment

This Bedaquiline sales market forecast report provides a detailed market assessment of Bedaquiline for approved indication like Tuberculosis; as well as potential indications like Leprosy and Mycobacterium avium complex infections in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted Bedaquiline sales data uptil 2034.

Bedaquiline Clinical Assessment

The Bedaquiline market report provides the clinical trials information of Bedaquiline for approved and potential indications covering trial interventions, trial conditions, trial status, start and completion dates.

Bedaquiline Competitive Landscape

The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.

Bedaquiline Market Potential & Revenue Forecast

• Projected market size for the Bedaquiline and its key indications
• Estimated Bedaquiline sales potential (Bedaquiline peak sales forecasts)
• Bedaquiline Pricing strategies and reimbursement landscape

Bedaquiline Competitive Intelligence

• Number of competing drugs in development (pipeline analysis)
• Bedaquiline Market positioning compared to existing treatments
• Bedaquiline Strengths & weaknesses relative to competitors

Bedaquiline Regulatory & Commercial Milestones

• Bedaquiline Key regulatory approvals & expected launch timelines
• Commercial partnerships, licensing deals, and M&A activity

Bedaquiline Clinical Differentiation

• Bedaquiline Efficacy & safety advantages over existing drugs
• Bedaquiline Unique selling points
  

Bedaquiline Market Report Highlights

• In the coming years, the Bedaquiline market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
• The Bedaquiline companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence Bedaquiline’s dominance.
• Other emerging products for Tuberculosis; as well as potential indications like Leprosy and Mycobacterium avium complex infections are expected to give tough market competition to Bedaquiline and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of Bedaquiline in approved and potential indications.
• Analyse Bedaquiline cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted Bedaquiline sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of Bedaquiline in approved and potential indications.

Key Questions Answered in the Bedaquiline Market Report

• What is the class of therapy, route of administration and mechanism of action of Bedaquiline? How strong is Bedaquiline’s clinical and commercial performance?
• What is Bedaquiline’s clinical trial status in each individual indications such as Tuberculosis; as well as potential indications like Leprosy and Mycobacterium avium complex infections and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Bedaquiline Manufacturers?
• What are the key designations that have been granted to Bedaquiline for approved and potential indications? How are they going to impact Bedaquiline’s penetration in various geographies?
• What is the current and forecasted Bedaquiline market scenario for approved and potential indications? What are the key assumptions behind the forecast?
• What are the current and forecasted sales of Bedaquiline in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan? 
• What are the other emerging products available and how are these giving competition to Bedaquiline for approved and potential indications?
• Which are the late-stage emerging therapies under development for the treatment of approved and potential indications?
• How cost-effective is Bedaquiline? What is the duration of therapy and what are the geographical variations in cost per patient?