Rapid increase of new drugs becoming available
A closer look at pharmaceutical research will reveal that the total number of drugs has been increasing rapidly. From just under 6,000 drug candidates in 2001, the figure has ballooned to 12,300 drug candidates 13 years later. On a year-on-year basis, the recorded increase has been incredible too, rising at 8.8% in 2015. In the same year, there were a total of 993 research and development projects. It is safe to assume that the industry will continue this stellar development trend, possibly at a faster pace. However, it is inevitable that R&D expenditure will be inflated proportionally, and may impact the eventual drug prices (1).
A significant proportion of the research projects were pre-clinical studies. In 2015, almost half of all pharmaceutical R&D projects fell under this category. However, data also showed the number of drugs undergoing any clinical research phases had gone up by 7.7%, signifying greater success of the industry to translate laboratory findings into useful clinical insights (1).
Anticancer research: The core of pharmaceutical R&D
In the same year, research in all therapeutic areas experienced decent growth, but the magnitude of such growth differed considerably according to therapeutic groups. Anticancer research remained at the centre of pharmaceutical R&D effort and experienced a significant 8.7% rise compared to the year before. It is challenging to comprehend the overall cancer burden at both the national and international level due to diverse cancer types, however, estimates from the International Agency for Research on Cancer (IARC) showed there were 14.1 million new cancer cases in 2012 worldwide. More than half of these cases occurred in economically developing countries. Malaysia also reported increasing cancer incidents and related mortality rates (2,3).
Research on neurological drugs ranked second with over 2,000 drug molecules in the pipeline (preclinical and clinical). However, the therapeutic group recorded an appalling growth rate of 4.5% compared to the 7.7% average growth. Thirdly, the number of drugs with anti-infective properties or as prophylactic vaccines also increased significantly, with more than 700 different products under development. This was followed by anti-diabetic therapies, and ophthalmological treatments (1).
Cardiovascular diseases: The leading cause of death in developed countries
It is worth mentioning that the pace of innovation and investment in cardiovascular disease treatment have been relatively stagnant, given cardiovascular diseases have been the leading cause of deaths in many developed countries. In addition, ischaemic heart disease was known as the leading cause of disability-adjusted-life-years (DALYs) in Malaysia (4). Studies showed that the number of new cardiovascular drugs entering clinical trials had fallen over time since 1990, and there have been fewer new cardiovascular investigational researches across all stages of clinical development. Most of the failures occurred in phase III clinical trials where inadequate efficacy or safety forced researchers to withdraw the drug candidates (5).
Similarly, research on neglected tropical diseases (NTDs) was also falling behind. NTDs are prevalent in many ASEAN countries even among upper-middle-income countries such as Malaysia and Thailand. Malaria was shown to have caused significant morbidity in the country, so was the increasing prevalence of dengue fever (6). Unfortunately, these infectious diseases attract very little attention, let alone research funding, from the pharmaceutical industry, partly because they are rare in developed countries with low financial returns. MIMS
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1. Citeline. Citeline Pharma R&D Annual Review 2015. 2015.
2. American Cancer Society. Global Cancer Facts & Figures 3rd Edition. Atlanta; 2015.
3. The Star. Rise in cancer deaths in M’sia. The Star Online: Community. 2014 Feb 14;
4. IHME. Malaysia [Internet]. Institute for Health Metrics and Evaluation. 2014 [cited 2016 Oct 4]. Available from: http://www.healthdata.org/malaysia
5. Hwang TJ, Lauffenburger JC, Franklin JM, Kesselheim AS. Temporal Trends and Factors Associated With Cardiovascular Drug Development, 1990 to 2012. JACC Basic to Transl Sci. 2016 Aug;1(5):301–8.
6. Hotez PJ, Bottazzi ME, Strych U, Chang L-Y, Lim YAL, Goodenow MM, et al. Neglected Tropical Diseases among the Association of Southeast Asian Nations (ASEAN): Overview and Update. Gray DJ, editor. PLoS Negl Trop Dis. 2015 Apr 16;9(4):e0003575.