Nature Reviews Drug Discovery | AOP, published online 10 July 2015; doi:10.1038/nrd4656

BIOBUSINESS BRIEFS M A R K E T WAT C H

Therapeutic area ‘heat map’ for emerging markets Emerging markets represent a diverse biomedical innovation landscape (Nature Rev. Drug Discov. 13, 646–647; 2014; N. Engl. J. Med. 370, 3–6; 2014). Understanding the relative intensity of research in different therapeutic areas across these markets can help guide country-specific research strategies for companies and public-funding bodies. In this study, we collected and analysed data for key emerging markets and prominent therapeutic areas to develop a research intensity score. For each country and therapeutic area, three parameters — the number of publications, the number of clinical trials and the number of innovative biotech companies — were analysed, to design a ‘therapy area heat map’ (FIG. 1; see Supplementary information S1 (box) for details). Overall, China leads in all three parameters across all therapeutic areas within the emerging markets cohort. However, the research intensity is disproportionately focused in the oncology area, in alignment with local unmet needs around lung, liver and gastric cancers. Similarly, South Korea has a high portion of overall investment going into oncology. By contrast, South Africa has a greater focus on infectious diseases, and Brazil also has a substantial focus in this area (second only to oncology), reflecting their historical strengths in tropical diseases and viral infections. India has a diverse distribution of research intensity across therapeutic areas, with the greatest intensity for infectious diseases and oncology, but also substantial intensity in neuroscience, metabolic disorders and cardiovascular disease. Russia shows low levels of activity across the various parameters for a country with such a diverse scientific base and high public funding levels, and Turkey and Poland also rank low on overall research activity. China, South Korea, Brazil and Poland are leading locations for clinical trials, consistent with the local infrastructure and regulatory environment (in the case of South Korea and Poland), needs of global companies to access these markets (for example, China and Brazil) and patient pool. However, China has a disproportionately skewed number of trials in the area of oncology, with ~40% of all its clinical trials in the oncology area. Although India has a low number of clinical trials overall

owing to a challenging regulatory environment, it shows the most balanced distribution of trials across oncology, cardiovascular diseases, neuroscience and metabolic diseases (with each of these areas having more than 15% of the total number of trials). South Africa has a high proportion of trials in infectious diseases (~22%), whereas Brazil has a relatively high number of clinical trials in respiratory disorders, with ~15% of its trials in this therapeutic area. Autoimmune disease ranks low among all therapeutic areas, with less than 5% of the total clinical trials being conducted in this area across most markets, although ~10% of Russia and Poland’s clinical trials are in autoimmune disorders (see Supplementary information S1 (box) for details). China, India, South Korea and Brazil were the leading countries for publications, reflecting the strength of academic institutions in these countries. Oncology is the primary focus area for publications across all markets. Russia

N E W S & A N A LY S I S and Turkey score highly for cardiovascular publications (> 20% of all of their publications focused in this area); and South Africa ranks highest for infectious disease publications (~40%), with Brazil and India each also ranking proportionately highly in this area (~25%) (see Supplementary information S1 (box) for details). The number of autoimmune disease publications is low across all countries. With respect to the number of innovative biotech companies, China has the highest number (~35% of all the companies in our dataset), followed by India and South Korea, whereas Turkey and Brazil show low levels of biotech activity, consistent with other studies (Nature Biotech. 31, 195–201; 2013). Oncology is again the largest therapeutic focus (~45% of 105 biotech companies in our dataset), with infectious diseases (24%), metabolic disorders (13%) and autoimmune diseases (~10%) being the other therapeutic areas for biotech investments (see Supplementary information S1 (box) for details). An interesting anomaly that we observe is that although autoimmune and metabolic disease areas both show the lowest activity in clinical and academic parameters, the biotech activity in these therapeutic areas is relatively high, probably reflecting the fast-follower candidates that biotechs are developing for validated targets. By contrast, although respiratory disease shows moderate activity for academic

China India South Korea Brazil Russia Turkey South Africa Poland Oncology Neuroscience Infectious Cardiovascular Metabolic Autoimmune Respiratory disease disease disorders disease disorders High intensity

Medium intensity

Low intensity

Figure 1 | Heat map for therapeutic areas in selected emerging markets.  The number of publications, number of clinical trials and number of innovative biotech wereDiscovery used to Naturecompanies Reviews | Drug calculate a research intensity score for each therapeutic area for each country. The colour of the dots represents the relative intensity of therapeutic area research within a specific country across each row. The therapeutic area composite scores within the top third of the overall scores (2.1–3.0) for each specific country were classified as high-intensity (green). Medium intensity (blue) scores fall within the middle third of overall scores (1.1–2.0), and the low intensity (orange) scores fall within the bottom third of the overall scores (0.1–1.0). The size of the dots represents the relative intensity of research across different countries within a specific therapeutic area in each column. See Supplementary information S1 (box) for details.

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N E W S & A N A LY S I S BIOBUSINESS BRIEFS and clinical parameters, there are hardly any biotech companies developing novel candidates, reflecting the high hurdles for developing innovative molecules and the technological challenges in this therapeutic area. Furthermore, most of the companies have drug candidates in preclinical or early clinical stages, consistent with the early stage of development of the biotech industry overall in these markets. However, there are a few companies with launched products as well as drugs in the late-stage clinical pipeline, especially in oncology (see Supplementary information S1 (box) for details). Although oncology remains the dominant therapeutic area for industrial and academic research across these markets, we see some healthy signs of diversification across other diseases. For example, GlaxoSmithKline is conducting its global neuroscience research at its research and development centre in Shanghai, China. In the respiratory disease area, ZAI Lab, a new Shanghai-based start‑up, has partnered with Sanofi to develop molecules for asthma and chronic obstructive pulmonary disease in China, and Brazil has also demonstrated moderate research intensity in this therapeutic area. India is establishing expertise in metabolic disease, and South Africa and Brazil are leveraging their historical strengths to lead infectious-disease research. On the basis of this analysis, we envisage

China and South Korea to be key markets for oncology research; South Africa and Brazil, for infectious disease; and India, for metabolic diseases. Brazil also represents an attractive landscape for respiratory research. By contrast, Russia, Poland and Turkey are key markets that have yet to develop expertise in specific therapeutic areas, though there are early signs of investments in the oncology, infectious disease and cardiovascular disease areas. We hope this analysis provides an impetus for industry and public funding to diversify across therapeutic areas to address the future high unmet needs in the emerging markets, especially in areas such as neuroscience, metabolic disorders and respiratory diseases. Ajay Gautam and Lily Li are with Scientific Partnering and Alliances, Innovative Medicines and Early Development Biotech Unit, AstraZeneca, 199 Liangjing Road, Zhangjiang Hi-Tech Park, Shanghai 201203 China. Kumar Srinivasan is with Scientific Partnering and Alliances, Innovative Medicines and Early Development Biotech Unit, 5 Gatehouse Drive, Waltham, Massachusetts 02451, USA Correspondence to A.G. e-mail: [email protected] doi:10.1038/nrd4656 Published online 10 July 2015 The authors declare no competing interests.

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Market watch: Therapeutic area 'heat map' for emerging markets.

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