Tuberculosis (TB) Drugs Market

Market Overview

The global tuberculosis (TB) drugs market was estimated to be valued at USD 1.41 billion in 2023. It is estimated to reach USD 2.41 billion by 2032, growing at a CAGR of 6.10% during the forecast period (2024–2032). The global tuberculosis (TB) drugs market is driven by the surging prevalence of tuberculosis cases worldwide, especially in low- and middle-income countries. Due to these rising cases, international organizations like WHO are introducing novel guidelines and support for the use of TB drugs, boosting the tuberculosis (TB) drugs market growth. Moreover, there has been a rise in the research and development activities of tuberculosis (TB) drugs, which are expected to create expansion opportunities for the global market.

Highlights

• Active TB dominates the disease type segment
• First-line drugs dominate the drug type segment
• North America is the largest shareholder in the market

Tuberculosis is an infectious bacterial disease that mostly targets the lungs but can also impact other body areas. The pathogen responsible for tuberculosis is Mycobacterium tuberculosis. TB is transmitted via airborne transmission when an individual afflicted with the disease coughs, sneezes, or speaks, generating respiratory droplets that contain the infectious agent. Tuberculosis symptoms can appear as coughing (sometimes accompanied by bleeding), chest discomfort, weariness, loss of body mass, elevated body temperature, and nocturnal perspiration. However, certain individuals afflicted with tuberculosis may exhibit no symptoms, particularly during the initial phases.

Tuberculosis drugs are medicines employed for the treatment and prevention of tuberculosis infection. Various categories of tuberculosis medications exist, including first-line, second-line, and newer medications. The primary medications used to treat tuberculosis that are susceptible to pharmaceuticals are isoniazid, rifampicin, ethambutol, and pyrazinamide, collectively known as first-line treatments. Second-line medications are employed to treat tuberculosis that is resistant to standard medicines. These medications encompass fluoroquinolones, aminoglycosides, cycloserine, and other similar agents.

Market Dynamics

Global Tuberculosis (TB) Drugs Market Drivers:

Increasing Prevalence of TB

The prevalence of tuberculosis (TB) is high on a global scale, with around 25% of the world's population being infected with TB bacteria. It is further predicted that 5-10% of these individuals may eventually develop active TB disease over their lifetime. According to the World Health Organization (WHO), the number of individuals worldwide who contracted tuberculosis (TB) in 2021 is predicted to be 10.6 million, marking a 4.5% rise from the 10.1 million cases reported in 2020. Moreover, the TB incidence rate, which represents the number of new cases per 100,000 individuals in a given population per year, is projected to have risen by 3.6% from 2020 to 2021.

Moreover, the same source claims that in 2022, only Covid-19 was more lethal than tuberculosis. Tuberculosis is more widespread in low- and middle-income nations, where the majority of cases and fatalities are concentrated. Several variables that contribute to the high prevalence of tuberculosis (TB) are poverty, malnutrition, overcrowding, inadequate sanitation, HIV/AIDS, smoking, diabetes, and other co-morbidities. The rising incidence of tuberculosis necessitates a substantial need for tuberculosis medications, as they are crucial for the treatment and prevention of the disease, as well as for mitigating its spread.

Rising Support from International Organizations

Government and non-government organizations are implementing programs to raise awareness about the medications utilized in tuberculosis therapy to improve the effectiveness of treatment. In 2022, the World Health Organization (WHO) published revised unified guidelines for the management of drug-resistant tuberculosis (DR-TB), which included significant enhancements in the available treatment choices for individuals with multidrug-resistant or rifampicin-resistant tuberculosis (MDR/RR-TB).

The guidelines propose a new suggestion for treating individuals with MDR/RR-TB or MDR/RR-TB with added resistance to fluoroquinolones (pre-XDR-TB). This suggestion involves using a novel all-oral 6-month regimen of bedaquiline, pretomanid, linezolid, and moxifloxacin (BPaLM). The recently suggested BPaLM regimen provides superior results, notably reducing the treatment duration and thus enhancing the quality of life for those with MDR/RR-TB. These factors contribute to the tuberculosis (TB) drugs market growth.

Global Tuberculosis (TB) Drugs Market Restraint:

Emergence and Spread of Drug-Resistant TB Strains

Drug-resistant tuberculosis (TB) is a kind of TB that does not exhibit a positive response to conventional first-line drugs. Instead, it necessitates the use of more complex and expensive second-line treatments. Drug-resistant tuberculosis (TB) can be categorized into two types: multidrug-resistant TB (MDR-TB), which is immune to at least isoniazid and rifampicin, and extensively drug-resistant TB (XDR-TB), which is resistant to at least isoniazid, rifampicin, any fluoroquinolone, and any injectable second-line medication.

Moreover, the rise and spread of drug-resistant tuberculosis strains primarily result from the inappropriate or inaccurate utilization of tuberculosis drugs, including insufficient dosing, substandard quality, non-compliance, or discontinuation of therapy. The presence of drug-resistant tuberculosis presents a significant obstacle for the tuberculosis pharmaceutical industry. It diminishes the efficacy of existing medications, amplifies the expenses and adverse reactions associated with these drugs, and restricts the possibilities for developing new drugs.

Global Tuberculosis (TB) Drugs Market Opportunities:

Growing Research and Development Activities

The market for tuberculosis drugs has substantial opportunities for research and development initiatives, given the demand for novel and enhanced drugs for tuberculosis, particularly for drug-resistant tuberculosis and latent tuberculosis infection. The research and development activities receive support from diverse stakeholders, including pharmaceutical companies, academic institutions, non-governmental organizations, and public-private partnerships such as the TB Alliance, the Global Alliance for TB Drug Development, and the Innovative Medicines Initiative.

Furthermore, the research and development activities primarily concentrate on multiple facets, including the exploration of novel drug candidates, enhancement of current pharmaceuticals, formulation of new drug combinations, evaluation of innovative drug delivery systems, and execution of clinical trials. For instance, in November 2023, UNITE4TB, an international public-private partnership (PPP) focused on accelerating the development of advanced Tuberculosis (TB) treatments, initiated its phase 2B/C clinical trial program. The first participant was enrolled at the Cape Town, South Africa trial site. The development represents a significant achievement for the project and the tuberculosis (TB) community in general, as it contributes to the progress of TB research and improves the effectiveness of delivering novel therapies. These factors present opportunities for market expansion.

Regional Analysis

Based on region, the global tuberculosis (TB) drugs market share is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global tuberculosis (TB) drugs market shareholder and is expected to expand substantially during the forecast period. The regional market is primarily influenced by the significant incidence of tuberculosis, particularly among vulnerable populations such as immigrants, refugees, homeless individuals, criminals, and individuals with HIV/AIDS. The market is bolstered by the advanced healthcare infrastructure, prominent market participants, the widespread awareness and utilization of tuberculosis medications, and the favorable policies implemented by the government. According to the CDC, in 2022, the United States recorded 8,331 tuberculosis cases, with an incidence rate of 2.5 cases per 100,000 individuals. This indicates a 5.9% rise in cases and a 5.5% increase in the incidence rate compared to 2021. In 2022, there was a second consecutive increase in TB incidence following a record-low incidence rate of 2.2 cases per 100,000 people in 2020, which coincided with the onset of the COVID-19 pandemic.

Furthermore, there has been increased funding from government and non-government groups to carry out innovative research and development trials for tuberculosis medications. For instance, in December 2023, researchers from Weill Cornell Medicine and the TB Drug Accelerator were awarded two grants amounting to USD 6.8 million by the Bill & Melinda Gates Foundation. The amount is intended to further study the development of tuberculosis (TB) drugs. This endeavor will accelerate the discovery of novel therapeutic targets within bacteria and identify new primary chemicals, two major obstacles in the development of tuberculosis drugs. As a result, these variables are projected to enhance the expansion of the regional market.

The European market is primarily influenced by the rising prevalence of tuberculosis, particularly in Eastern European nations, where the rates of multidrug-resistant tuberculosis (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB) are elevated. Robust research and development initiatives bolster the market, the accessibility of innovative and efficacious medications, and the collaboration and coordination among the European Union and other key participants. Researchers at University Hospital Cologne have discovered new antibiotic molecules specifically targeting Mycobacterium tuberculosis, decreasing its pathogenicity in humans. They have done this in collaboration with colleagues from the German Center for Infection Research (DZIF) and the Institute Pasteur in Lille, France. Moreover, certain discovered chemicals have the potential to facilitate the re-administration of existing tuberculosis therapies, even for strains of the bacterium that have previously developed resistance to drugs. These elements enhance the growth of the regional market.

The Asia-Pacific market is primarily influenced by the substantial prevalence of tuberculosis (TB), as this region is responsible for over 60% of the worldwide TB cases and fatalities. Notably, India, China, and Indonesia are the countries most severely impacted by this disease. The escalating demand for tuberculosis drugs propels the market, the mounting investment and initiatives from governments and international organizations, and the growing awareness and availability of diagnosis and treatment options. In March 2023, Prime Minister Narendra Modi unveiled the TB-Mukt Panchayat effort to eradicate tuberculosis from India by 2025. This plan involves implementing a nationwide program that provides a shorter preventive treatment and focuses on providing care to families affected by tuberculosis.

Segmental Analysis

The global tuberculosis (TB) drugs market is segmented by disease type and drug type.

Based on disease type, the global tuberculosis (TB) drugs industry is segmented into active and latent TB. 

The active TB segment dominates the global market. Active tuberculosis (TB) refers to a state where the bacteria responsible for the disease are actively reproducing, leading to noticeable symptoms in the affected individual. Immediate medical intervention is crucial for anyone suspected of harboring active TB. Not all individuals infected with the bacteria that cause TB develop active tuberculosis. Under certain circumstances, the immune system can regulate the infection, resulting in the bacteria entering a dormant (latent) phase where they do not produce any symptoms. However, latent tuberculosis has the potential to transition into an active state at a later time, particularly if the immune system becomes weakened.

Tuberculosis (TB) is a disease that may be treated and cured using suitable antibiotic treatments. However, it necessitates a well-coordinated and consistent strategy to guarantee effective treatment and prevent illness transmission to other individuals.

Based on drug type, the global market for tuberculosis (TB) drugs is divided into first-line drugs and second-line drugs. 

The first-line drugs segment owns the highest market share. The segment of first-line drugs dominated the market, as they represent the standard and most extensively utilized treatment for drug-susceptible tuberculosis. The primary first-line drugs for tuberculosis (TB) are Isoniazid (INH), Rifampin (RIF), Pyrazinamide (PZA), and Ethambutol (EMB). Isoniazid is a crucial medication that exhibits high efficacy against both actively dividing and latent forms of Mycobacterium TB.

Rifampin, a vital medication, effectively targets bacteria that are actively dividing, even those resistant to isoniazid. Pyrazinamide exhibits high efficacy against bacteria thriving in acidic conditions, specifically within macrophages. On the other hand, ethambutol functions by impeding the synthesis of the bacterial cell wall and is frequently administered in conjunction with other primary medications.

Recent Developments

• August 2023- The PAN-TB (Project to Accelerate New Treatments for Tuberculosis) partnership commenced a phase 2b/c clinical trial, which is being funded by the Bill & Melinda Gates Medical Research Institute (Gates MRI). The trial aims to assess the efficacy of innovative treatment regimens that combine approved drugs and new chemical compounds in treating drug-sensitive tuberculosis (DS-TB).
• April 2023- Natco Pharma and MacLeods Pharmaceuticals are ready to introduce their versions of Johnson & Johnson's pioneering Tuberculosis (TB) drugs, Bedaquiline, in India.