Despite significant annual variation in research funding and global funding totals that fall far short of the field’s reported needs, the global market in tuberculosis (TB) diagnostics and treatments is expected to grow at a compound annual growth rate (CAGR) of 4.2% by 2025. That’s good news as we acknowledge another World TB Day—and another year dedicated to “Uniting to End TB”.
Some of this anticipated growth can be attributed to the increase in funding partnerships enabling smoother international collaboration and cohesive approaches to research. By uniting to set goals for drug and diagnostics development—and redirecting efforts when certain avenues of research do not provide the desired results—these partnerships are forging a clearer path forward. Another explanation for the expected growth in the global TB market includes the development of new technologies, for both diagnosis and treatment. Although the pipeline falls short of many TB organizations’ ideals, it offers a fairly robust platform for future advances and could be improved further with additional investment.
The importance of TB diagnostics development
According to the World Health Organization’s (WHO) 2016 TB report, TB is dramatically underdiagnosed. This results in part from a lack of sufficient health system resources, but it also reflects the inadequacy of current TB diagnostics to reach global areas where the diagnostic tools are needed most.
Point-of-care testing options for the bedside and the clinic are urgently needed. Current rapid tests vary substantially in sensitivity and price. Furthermore, most are limited—they often cannot distinguish between active and latent TB or drug susceptible and multi-drug resistant TB (MDR-TB) strains. One of the simplest and most regarded diagnostic modalities determines only rifampicin mono-resistance. This leaves treatment decisions being made without the pertinent information required for effective treatment, resulting in only 1 in 5 people infected with multi-drug resistant TB receiving treatment in 2015.
Thankfully, there is an active pipeline in TB diagnostics that is holds great promise in replacing smear microscopy as the golden standard first line TB diagnostic strategy plus is also serving as a surrogate marker for MDR-TB detection. One well know technology is GeneXpert's MTB/RIF test. The manufacturer is also developing an additional test to specifically call out extensively drug-resistant (XDR) tuberculosis which would provide more conclusive drug resistance patterns for better patient management. In 2016, four diagnostic tests were reviewed and recommended by the WHO: the loop-mediated isothermal amplification test for TB (known as TB-LAMP), two line probe assays (LPAs) for the detection of resistance to the first-line anti-TB drugs isoniazid and rifampicin, and an LPA for the detection of resistance to second-line anti-TB drugs. A next-generation cartridge called Xpert Ultra and a new diagnostic platform called GeneXpert Omni are in development; assessment of both by the WHO is expected in 2017.
TB treatment, vaccines and clinical research
Basic research is advancing scientists’ understanding of TB, its genetics, and appropriate animal models, which will in turn aid efforts at prevention, diagnosis, and treatment. Although new drug candidates are sorely lacking, promising work in new combinations of therapies are already reducing treatment duration and helping address drug-resistant TB infections. However, ongoing trials and new investigations will be required to build on this progress. There are nine drugs in advanced phases of clinical trials for the treatment of drug-susceptible TB, drug-resistant TB or LTBI. These are bedaquiline, delamanid, linezolid, PBTZ169, pretomanid, Q203, rifampicin (high-dose), rifapentine and sutezolid.
TB vaccine development has also fallen short of expectations due to scientific roadblocks as well as funding limitations, according to the Stop TB Partnership’s Treatment Action Group, but research has still produced 14 candidates entering phase I trials, 7 entering phase II trials, and 2 entering phase IIb as of 2015.
To conduct research that meets regulatory standards and clinical needs with the accuracy required for true scientific advancement, there is a tool that all trials should employ: central laboratories.
The role of central laboratories in global TB market growth
Central laboratories are an essential tool in TB research and diagnostics because they can provide:
- A one-stop lab: all testing is conducted under one roof, eliminating standardization concerns
- Development of trial-specific customized assays
- Audit and management of local labs required for in-country studies
- Excellent data management: complex, lengthy trials benefit from standardized data collection and monitoring
- Scientific expertise and commitment to the project’s success.
In many TB studies, laboratory data and analysis informs the primary outcome and objective of the study. If the testing and data are managed in a harmonized fashion by a qualified central laboratory, it allows seamless comparison across all sites and treatment arms for the trial. Q2 Solutions can function as a local laboratory servicing country specific local sites providing standard assays as well as have the capability to act as a central laboratory for specialized TB assays.
Q2 Solutions’ South Africa Central Laboratory, for example, offers all of the services described above. Because of its focus on TB, it also offers capabilities suited specially to the challenges of research in this field, including a dedicated biosafety Level 3 TB lab set-up, safety analytical testing services, standard TB microbiology/molecular biology capabilities, immunological assays, early bactericidal activity (EBA) assays and client-specific assay development and testing for drug susceptibility research. The standard TB assays include culture, identification, first- and second-line susceptibility testing, and MIC determination with the option to employ BD MGIT™ systems as well as LJ medium, HAINs assays (including genotypic drug resistance and speciation), and the GeneXpert system.
Specialty centralized laboratories are poised to help drive growth in the global TB biopharmaceutical space through improved methodology, processing, and harmonized data management, paving the way for smoother regulatory submissions. Knowing the importance of such advances in diagnosis and care for millions of people worldwide, this is a field Q2 Solutions is proud to be a part of—especially on World TB Day.
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