TB Drugs Market $700 Million by 2010

November 22, 2001

The Global Alliance for TB Drug Development has published a report it believes will revive he interest of the pharmaceutical industry and public research organisations in R&D for new tuberculosis medicines.

“The Economics of TB Drug Development” reveals that the market for drugs to treat TB is larger and more accessible than expected, and while not of “blockbuster” proportions, does warrant interest. The report shows that the market is worth around $450 million today, and will approach $700 million by 2010. The market was previously thought to be worth around $150 million. New TB drugs would also bring substantial social benefits.

The market will be fuelled by the growing TB epidemic -- TB infects a third of the world’s population (1.9 billion people), takes two million lives each year, and is increasingly resistant to existing drugs. By 2010, 11.6 million will become sick with TB each year, a 45% increase. Only 23% of TB patients are currently treated properly.

The study recognises the low likelihood of a single industry player pursuing the development of an anti-TB drug, and advocates partnerships to link investors and laboratories in the public and private sectors for the development of new drugs.

The market promises to become more accessible over time because of a series of recent global efforts to improve access, says Dr Giorgio Roscigno, director of strategic development and chair of the economics report committee. Trends that are improving access to the market include the strength of the private market, which accounts for 67% of TB drug sales, rising accessibility of the public market, and worldwide mobilisation to expand the World Health Organisation’s DOTS (directly observed treatment, short course) programme.

In an interview with Scrip, the Alliance’s CEO Dr Maria Freire and Dr Roscigno said the report confirmed there was a space in the market for public/private partnerships. They also pointed to the increasing global awareness of the need to balance public health with markets, as was recently demonstrated in the TRIPS declaration at the World Trade Organisation meeting in Doha, Qatar (Scrip No 2696, p 16). In addition, they believe there may be a general move towards more research into anti-infectives.

. . . “must haves”

The report points out that, although TB is treatable, current drugs have limitations that are contributing to the spread of the disease. A treatment duration of at least six months is required, and the most effective treatment strategy, DOTS is cumbersome, labourintensive and expensive. Also, multidrugresistant TB (MDR-TB) has become more prevalent, and the standard treatment for latent TB infection (LTBI) lasts from two months to 12 months.

New drugs that would shorten treatment for both active and latent forms as well as multidrug resistant strains are “must-haves”, says Dr Freire. New compounds should shorten treatment duration to two months or less, and/or significantly reduce the number of doses to be taken under DOTS supervision. Despite the need for new TB drugs, no new class has been introduced in more than 30 years, and TB has remained a neglected disease, according to the report.

A single, new anti-TB drug that reduces the treatment course from six months to less than two months will capture about $325 million of the TB market, a figure which could expand to more than $400 million because of the premium some markets may be willing to pay for a shortened treatment course, the report finds.

. . . costs and returns

The estimated costs of developing an NCE to treat TB are $76 million to $115 million, including the costs of failure, while the estimated costs of discovering and developing a new anti-TB drug, including the costs of failure, are between $115 million and $240 million.

Clinical trials for a new anti-TB agent were estimated to cost $26.6 million in an established economy, and $9.9 million in a developing economy, excluding costs related to the probability of failure.

However, it is generally accepted that the discovery and development of a new TB drug will require an international collaborative effort among governments, academic institutions, foundations, NGOs and pharmaceutical companies. In this way, costs are shared by multiple organisations, ultimately lowering the investment burden borne by a single body. The “internal rate of return” for bringing a lead compound to market is estimated at between 15% and 32%, in the report.

New TB drug development would also bring significant public health and socioeconomic benefits worldwide, the report says. The potentially profound reduction in disease burden would result in improved treatment success rates, reduced overall treatment costs, possible reduction in the number of MDR-TB cases, decreased morbidity and TB
transmission in the long term, and lower medical and non-medical costs for long-term TB treatment.

A new drug that reduced treatment duration could lower non-drug costs such as sputum smears, X-rays and hospital stays by up to 65%, the report finds. The costs of treating a single TB case vary widely around the world, ranging from $51 in Indonesia, to often more than $25,000 per patient in the US. The majority of these costs are for healthcare services, with drug costs making up a small fraction of the total -- from $7 in India to $800 in the US.

Scientific advances such as the sequencing of the Mycobacterium tuberculosis genome and the use of combinatorial chemistry, can bring forward TB R&D, the report says.

. . . alliance in negotiations

The report comes as the Global Alliance completes its first year of operations as a not-for-profit public-private partnership organisation to accelerate the discovery and development of new drugs to fight TB. The Alliance aims to function as a lean, virtual R&D organisation that outsources R&D projects to public or private partners. It has also published a companion strategic research study, “The Scientific Blueprint for TB Drug Development”, which identifies issues from research to registration and approval.

The Alliance says it has been reviewing promising drug research in public and private sector laboratories worldwide to identify potential partners for the development of new drugs. It is in negotiations with public and academic research centres as well as biotech and pharmaceutical firms for five separate compounds at the lead optimisation phase and the preclinical stage. Dr Freire said that concrete agreements could start to be announced within the next few months.

The report was developed in co-operation with the Research Triangle Institute, with the support of the Rockefeller Foundation and the National Institute of Allergy and Infectious Diseases of the US National Institutes of Health.