Tuberculosis Disease

Published Date : Jan 2024
Category : Infectious Diseases
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Fighting Tuberculosis: Revealing Innovations, Obstacles, and International Projects in the Battle Against TB

Tuberculosis (TB) is a persistent and formidable peak standing tall in the vast landscape of human health, where the terrain of medical research continually evolves." TB has had a lasting impact on society for ages, pushing the limits of medical knowledge and healthcare systems around the globe like a shadow on the landscape of global well-being.

TB is the second most common infectious killer globally, behind COVID-19 (thus it is higher than HIV and AIDS), according to the WHO.

Furthermore, approximately 10.6 million cases of tuberculosis (TB) are predicted to occur globally in 2022, affecting 5.8 million men, 3.5 million women, and 1.3 million children. In 2022, TB claimed the lives of 1.3 million people, including 167,000 HIV-positive individuals.

However, the Centers for Disease Control and Prevention (CDC) received reports of 7,882 cases in 2021 in the United States; this represents an increase in the rate from 2.2 cases per 100,000 cases in 2020 to 2.4 cases per 100,000 persons. 71% of tuberculosis infections in 2020 and 2021 happened in non-US citizens. Of all TB cases reported in the United States, four states—California, Texas, New York, and Florida—account for over half (49.9%). California reported the greatest number of tuberculosis cases in 2020 and 2021, whereas Alaska reported the highest incidence of infections per population.

According to WHO, TB-related deaths have also decreased by 18% worldwide and in India over the same time frame. The World Health Organization revised tuberculosis death rates lower, from 4.94 lakhs in 2021 to 3.31 lakhs in 2022—a decrease of more than 34%.

The pathogen that causes tuberculosis (TB) in humans is Mycobacterium tuberculosis. Since pulmonary illness primarily affects the lungs, it is the most common manifestation.

Two forms of tuberculosis exist:

Latent Tuberculosis Infection (LTBI) occurs when a person has a tuberculosis infection but can fight it off with the help of their immune system.

Active Tuberculosis Infection (ATI): When the TB germs proliferate and the immune system is unable to contain them, the condition is known as active tuberculosis. Active TB produces symptoms.

About 1 in 10 people with latent TB will go on to acquire active TB, although the majority never get sick from it. This occurs years after infection or only a few years afterward. Individuals with low immune systems, elderly individuals, and young children are more susceptible to illness.

When a person with active tuberculosis in their lungs or throat coughs, sneezes, speaks, laughs, or sings, the disease is dispersed via the air. Other close individuals get tuberculosis (TB) if they inhale the pathogenic bacteria.


A latent, or inactive, tuberculosis patient won't show any symptoms. Although the patient still has a tuberculosis infection, the bacteria are not yet posing a threat to health.

Active tuberculosis symptoms include:

  • a prolonged cough lasting longer than three weeks.
  • appetite loss and inadvertent weight loss
  • Chills with a fever
  • Sweats at night

Additional symptoms about the operation of a particular afflicted organ or system manifest. Sputum or blood in the cough is a symptom of tuberculosis (TB) of the lungs. The bones are infected with bacteria if the patient experiences bone pain.

Since these symptoms also be found in other illnesses, it's critical to visit a doctor and let them determine whether have tuberculosis.

Diagnostic Analysis

History And Physical Examination

To find out if the patient has been exposed, the doctor begins by getting a patient’s history. They will listen to the lungs with a stethoscope and feel swelling in the neck lymph nodes during a physical examination. A skin or blood test is ordered by a physician who suspects tuberculosis.

Mantoux Skin Testing for Tuberculin

The classic screening test for tuberculosis exposure is the Mantoux reaction after a dose of PPD (Purified Protein Derivative). The patient's overall risk of exposure is considered while interpreting the outcome. Based on the risk of exposure, patients are divided into three categories, each having three matching cut-off thresholds. These are the three main groupings that were used.

Low Risk: Only extremely substantial induration following intradermal injection of PPD is deemed a positive Mantoux test result for individuals with a small probability of exposure. For this subset of individuals (who have a low chance of exposure), 15 mm is considered the cut-off mark.

Intermediate Risk: If an individual's induration measures more than 10 mm, they are classified as positive with mild probability.

High Risk: If the induration measures more than 5 mm, the person is deemed positive if they have a high possibility of exposure.

Interferon Release Assays (IGRA, Quantiferon Assays)

This is a more sensitive and specific test for tuberculosis screening than the Mantoux test. This test measures the inflammatory cytokine levels, particularly those of interferon-gamma.

One benefit of antigen-specific stimulation of IFN-γ release is that it only takes a single blood sample, which eliminates the need for follow-up appointments to interpret results. This is especially true for those who have already received the BCG vaccine. Furthermore, the same blood draw was used for further studies, including HIV screening, with patient agreement.

The expense of Quantiferon and the level of technical proficiency needed to conduct the test are its drawbacks.

Confirmatory Tests

  • Chest X-ray: For all screening test-positive cases, a chest x-ray is recommended to rule out or rule in the presence of active illness.
  • Nuclear Amplification and Gene-Based Tests: This new generation of tuberculosis diagnostic methods includes nuclear amplification and gene-based tests. These tests employ DNA-based molecular methods to identify bacteria or bacteria-related particles.
  • Blood test & Urine test: Tests on the patient's blood and urine are done to determine whether they have active or latent tuberculosis. Determining whether a patient has an active disease is aided by further blood testing.

Diagnostic Market Players

Diagnostic Market Players

Diagnostic Products

Abbott Laboratories


Becton, Dickinson, and Company

Accuquik™ Test Kits

Advacare Pharma Usa


JHP Pharmaceuticals, LLC

Tuberculosis Antibody Test Kit (Colloidal Gold)

Par Pharmaceutical, Inc.

JOYSBIO (Tianjin) Biotechnology Co., Ltd

Medcaptain Medical Technology


bioMérieux SA

QuantiFERON-TB Gold Plus (QFT-Plus)



SSI Diagnostica A/S

Geno Sen’s®

Genome Dia gnostics Pvt. Ltd.

Daan's MTB DNA PCR test kit

DaAn Gene Co., Ltd




Thermo Fisher Scientific Inc.



Treatment Analysis for Tuberculosis

Antibiotics are used to treat both latent tuberculosis infection and tuberculosis illness. It's critical to take medication as prescribed to ensure the complete elimination of tuberculosis germs from the body. Antibiotic-resistant TB germs develop in the body if treatment procedures are not followed. As a result, the medication stops working and TB becomes more difficult to treat.

For Latent Tuberculosis: Latent tuberculosis infections are treated by taking medication for 3 to 9 months. Treatment helps ensure that do not get tuberculosis disease again.

For Active Tuberculosis: Patients with active tuberculosis typically require medication for 6 to 12 months.

In the US, there are various approved treatment plans for latent tuberculosis infection. The following drugs are used to treat latent tuberculosis infection:

  • Rifapentine (RPT)
  • Isoniazid (INH)
  • Rifampin (RIF)

The CDC and the National Tuberculosis Controllers Association (NTCA) prefer short-course, rifamycin-based, 3- or 4-month latent TB infection treatment regimens over 6- or 9-month isoniazid monotherapy. These drugs are used alone or in combination.

However, like other medicines anti-tuberculosis also causes some side effects. It includes vomiting or nausea; jaundice, or yellowish skin or eyes; dark urine (orange/red urine is a normal side effect and is not harmful); unexplained fever or fatigue; joint pains; tingling (pins and needles) or numbness of hands or feet; skin rash; itchy skin or bruises; and visual abnormalities, like blurred or reddish-green vision.

Treatment Market Players

Treatment Market Players

Treatment Product

Teva Pharmaceutical Industries Ltd.




Arene Lifesciences




Macleods Pharmaceuticals Ltd.




AdvaCare Pharma USA




Biowin Healthcare Ltd


Azista Industries Private Limited.


Healthy Inc.


Novartis AG


Johnson & Johnson


Otsuka Pharmaceutical Co., Ltd.


AFT Pharmaceuticals Pty Ltd



Vaccination for Tuberculosis

"Armoring the Future, One Shot at a Time – Vaccinate Against Tuberculosis, Since Prevention is the Ultimate Protection!"

Mycobacterium bovis live-attenuated vaccine, known as Bacillus Calmette-Guerin (BCG), is used to prevent tuberculosis and other mycobacterial illnesses. Calmette and Guerin developed the vaccine, which was first administered to people in 1921. The only approved TB vaccine is BCG, which protects infants and young children from mild to moderately effective forms of the disease, preventing thousands of pediatric deaths each year. However, adolescents and adults, who bear most of the burden of TB infection and disease, are not sufficiently protected by BCG. According to the WHO End TB Strategy, significant technical advancements must be made by 2025 to stop the pandemic by 2030. The WHO End TB Strategy targets of 90% global reduction in TB incidence and a 95% reduction in TB death by 2035 will necessitate the development of a new vaccine that is safe for use in all age groups, especially adults and adolescents. Additionally, vaccinations present the best opportunity to slow the rapidly spreading multidrug-resistant tuberculosis.

Trends & Dynamics

The market is anticipated to rise because of the rising demand for these medications brought on by the increased prevalence of TB, MDR-TB, and TB-HIV co-infection, as well as the rising costs associated with research and development, the expansion of studies, and the introduction of innovative products. Novel anti-tuberculosis medications are the subject of studies to evaluate their effectiveness, safety, and other aspects. In March 2022, Qurient Co. revealed the findings of its phase 2 clinical trial, an open-label experiment demonstrating Telacebec, a novel human anti-tuberculosis medication concept published in the New England Journal of Medicine. In this experiment, which included 61 newly diagnosed patients with pulmonary tuberculosis receiving combination therapy, it was found that a significant reduction in the time it took for the collected samples to test positive was associated with higher telacebec doses.

The increasing number of new, innovative product launches, creative technology developments, and various funding sources are contributing to the high demand for these tuberculosis medications. For example, in January 2022, the non-profit TB Alliance announced that the US Agency for International Development has provided funding to begin investigating new medicines for tuberculosis.

Regulatory Framework

Growing businesses are likely to benefit from the revised regulatory requirements provided by DiseaseLandscape Insights (DLI). These upgrades ensure companies keep up to speed with the constantly changing industry standards, steer clear of any potential legal errors, and improve their marketing and development processes.

  • In July 2023, TGA approved HYDROCORTISONE-AFT (hydrocortisone sodium succinate) of AFT Pharmaceuticals Pty Ltd for the treatment of TB, in cases where oral medication is not practical and the drug's strength, form, and mode of administration reasonably contribute to the condition's treatment, Hydrocortisone-AFT powder for injection is recommended for intravenous or intramuscular administration.

Clinical Trial Assessment

The DiseaseLandscape Insights consultancy firm provides valuable support in future market trends on the development of new pharmaceutical products. This support helps to streamline the planning and execution of clinical trials of novel medications and treatments, implement effective patient recruitment strategies, ensure regulatory compliance, and increase the likelihood of successful trial outcomes.

The below table gives information about some currently ongoing clinical trials, including their study titles and respective stages:

Phase 1

Phase 2

Phase 3

Phase 4

Phase I Clinical Protocol for Pre-evaluation of the Safety of BCG-PPD in Tuberculosis Patients

Evaluation of the Early Bactericidal Activity of Tedizolid and Linezolide Against Mycobacterium Tuberculosis (TEDITUB)

Study of the Safety and Efficacy of the Subunit Recombinant Tuberculosis Vaccine GamTBvac

Phase IV Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein

Safety and Immune Responses After Vaccination with Two Investigational RNA-based Vaccines Against Tuberculosis in Healthy Volunteers

Preventing Acquired Resistance: Strengthen TB Treatment by Adding Amikacin in the First Treatment Week of Multidrug-resistant Tuberculosis

Protecting Households on Exposure to Newly Diagnosed Index Multidrug-Resistant Tuberculosis Patients

A Study of an Oral Short-course Regimen Including Bedaquiline for the Treatment of Participants with Multidrug-resistant Tuberculosis in China

Study of a Single Dose of Pretomanid Added to an Optimized Background Regimen in Children with Rifampicin-Resistant Tuberculosis

Efficacy and Safety Evaluation of Two to Four Months of Treatment with the Combination Regimens of DBOS and PBOS in Adults with Pulmonary Tuberculosis

Immunization With BCG Vaccine to Prevent Tuberculosis Infection

An Exploratory Study of Vγ2Vδ2 T Lymphocyte-based Immunotherapy for MDR-TB

Safety and Immune Responses After Vaccination with Two Investigational RNA-based Vaccines Against Tuberculosis in BCG Vaccinated Volunteers

Early Bactericidal Activity, Safety & Tolerability of Oral GSK3036656 in a Dual Combination with Novel and Established Antitubercular Agents, or Standard of Care in Adults with Rifampicin Susceptible Pulmonary Tuberculosis

Clinical Study of Recombinant Mycobacterium Tuberculosis Fusion Protein for 65-year-olds and above

The Safety, Completion Rate and Prevention Effect by Rifamycin-containing Regimens for Latent Tuberculosis Infection in Patients with Kidney Transplantation: a Prospective Intervention Pilot Study

Safety and Tolerability of Chlorquine in Addition to Anti-tuberculosis Therapy

Safety and Efficacy of RUTI® With the Standard of Treatment for Tuberculosis


Testing New Strategies for Patients Hospitalised With HIV-associated Disseminated Tuberculosis

Pharmacokinetics of Twice or Once Daily DTG (50mg) in Children with HIV and TB



DiseaseLandscape Insights (DLI) helps companies build and run effective strategies to prevent and control ACC epidemics. Furthermore, as awareness and anticipated epidemics grow, there is a growing demand for diagnostic tools, clinical evaluations, and novel therapeutics.

Major players involved in the production of medicinal items benefit from the information and experience provided by DiseaseLandscape Insights. The assistance provided by DLI facilitates patient recruitment strategies, regulatory compliance, and the planning and execution of clinical trials for novel medications and pharmaceuticals.

This ultimately motivates the leaders to conduct qualitative research, investigate manufacturing companies, and find out about raw material sources. All industry participants gain a stronger foothold in TB and keep one step ahead with the help of DiseaseLandscape Insights.

Vishal SawantBusiness Development

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