Tuberculosis (TB) is a highly contagious disease caused by the bacterium known as Mycobacterium tuberculosis and is mostly spread through person to person contact. It causes multisystem infection and eventually might lead to death of the infected person. Two types of TB that are commonly observed include latent TB in which the infected person do not show symptoms and active TB in which the infected person shows clinical symptoms of TB. Clinical symptoms and signs of TB include fever, night sweats, cough, weight loss, hemoptysis (coughing up blood-stained sputum), fatigue, chest pain, and shortness of breath. Depending upon the symptoms, TB may be classified as pulmonary TB, subcutaneous TB or military TB. Depending on the resistance it shows, TB may be multidrug resistant TB or extended drug resistant TB. Diagnosis of tuberculosis can be carried out using skin test, polymerase chain reaction test or interferon-gamma release assays. Initial treatment regime for active TB includes drugs such as ethambutol, pyrazinamide, isoniazid, and rifampicin. Although currently no TB vaccine is approved commercially, children are vaccinated with BCG vaccine as a part of precautionary measure. However, BCG vaccine has limited utility and variable efficacy in both adults and children. Many TB vaccines are under the stage of clinical development, which are expected to reach the market in the near future.
Tuberculosis Vaccine Market Dynamics
Tuberculosis account for the highest amount of death caused due to infectious disease across the globe. According to the World Health Organization (WHO) factsheet 2018 on TB, 10.4 million people fell ill with TB in 2016 and 1.7 million people with TB died in the same year. More than 95% of TB deaths occur in low- and middle-income economies. Deaths caused due to TB also includes death of 0.4 million people infected with HIV. Such high number of patients across the world confirms the enormity of disease and urgent requirements for vaccines worldwide. Therefore, the launch of tuberculosis vaccine would gain significant revenue and in turn, would propel the market growth. According to a global report on tuberculosis vaccine in 2018, TB costs around US$ 21 billion annually to global economy. Another important impetus to tuberculosis vaccine market would be current complex drug regime and resistance TB has created to this drug regime. TB patient has to take more than 2-3 drugs for prolonged time period of 6 months in order to suppress the infection. Often this results in the poor patient compliance and eventually leads to drug resistance incidence which further deteriorate the TB. According to WHO, there were nearly 600,000 new cases with resistance to rifampicin antibiotic, which was the most effective first-line drug in 2017, of which around 490,000 had MDR-TB globally. If effective steps won’t be taken by 2050, MDR-TB alone could cost the world US$ 16.7 trillion as per global report on tuberculosis vaccine 2018. Drug toxicity due to high daily dose and prolonged treatment is another concern with current TB drugs. Although the cost of TB drug is not much of concern in developing economies due to government support and free medication, it is a matter of concern in developed countries such as the U.S. and Europe. Increased recognition of TB’s fatality by intergovernmental organization and national government would prosper funding for TB vaccine research. Increased research and development activities for development of vaccine against TB by companies and intergovernmental organizations is expected to boost growth of tuberculosis vaccine market. For instance, Aeras is an NGO, which supports TB vaccine development and has helped develop 9 TB vaccine candidates and conducted over 35 Phase 1-2b clinical trials.
Tuberculosis Vaccine Market - Regional Insights
TB is most prevalent in middle and low income economies in Asia Pacific and Africa and therefore, these regions would represent greatest opportunity for the potential TB vaccine. According to the World Health Organization factsheet 2018 on TB, countries such as India, China, Indonesia, Philippines, Pakistan, Nigeria, and South Africa account for around 64% of the total TB deaths. Another risk factor for these regions is the high number of HIV positive population living in this region. Around 40% of deaths among HIV-positive people were due to TB in 2016 as per WHO. Tuberculosis vaccine could prove most beneficial for these regions and in turn, would drive growth of tuberculosis vaccine market. Government initiatives and international support to curb TB incidence would speed up the vaccine development and also would support access for such vaccines. India, which accounts for half a million global TB deaths has launched National Strategic Plan (NSP) for TB Elimination 2017-2025 to combat TB. India also formed India TB Research Consortium to boost TB vaccine and medication research. Developed regions such as North America accounts for significant number of TB patients. According to the Centre for Disease Control, a total of 9,093 TB cases were reported in the U.S. in 2017. MDR-TB and XDR-TB accounted for approximately US$ 160,000 and US$ 513,000 respectively for treatment of each patient. Effective vaccine against TB would gain significant traction in countries such as the U.S.
Tuberculosis Vaccine Market - Competitive Landscape
Many companies and research institutes are taking efforts to develop tuberculosis vaccine to combat TB. There are fourteen TB vaccines under clinical trials, out of which one investigational candidate named Vaccae from China is in phase three whereas three are in late phase 2. Most of the researches are carried out in academic and research places, which eventually would be transferred to commercial companies for effective distribution and access. Companies are also improving current BCG vaccines, in order to target TB by bringing recombinant vaccine product.
Some of the key players in the tuberculosis vaccine market include GlaxoSmithKline, Sanofi Pasture, Longcom Enterprise Ltd, Biofabri, Valneva plc, and Archivel Farma S.L.
Tuberculosis Vaccine Market Taxonomy:
On the basis of type of vaccine, the global tuberculosis vaccine market is segmented into:
- Viral Vector Vaccine
- Recombinant Protein Vaccine
- Recombinant BCG Vaccine
- Attenuated Vaccine
- Others
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