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Emerging Clinical Research Opportunities in India

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Emerging Clinical Research Opportunities in India WHITEPAPER EMERGING CLINICAL RESEARCH OPPORTUNITIES IN INDIA: A NEW SOURCE OF PATIENTS FOR COMPETITIVE CLINICAL TRIALS EMERGING CLINICAL RESEARCH OPPORTUNITIES IN INDIA: WHITEPAPER A NEW SOURCE OF PATIENTS FOR COMPETITIVE CLINICAL TRIALS Given India’s past regulatory environment, biopharma The Emerging Clinical Research companies have been reticent to conduct clinical Opportunities in India trials in this country over the last few years. That is A vast population and growing economy changing, however. With its vast population, growing economy, major disease burdens, improved regulatory India’s population of more than 1.3 billion people, 2 environment, and strong research infrastructure, or 17.75% of the total world population, is growing. the Indian market is now emerging as an ideal According to UN estimates, it is expected to overtake destination for clinical research. An especially China’s by 2025 to become the world’s most populous 3 important fact for sponsors seeking a less competitive nation. According to the 2011 Census data, India landscape for study candidates is that only 1.4% is home to 104 million elderly people (aged 60 years of all global trials are currently conducted in India.1 and above), 53 million women and 51 million men. However, the opportunities do not come without It is also a well-educated population with a workforce challenges. A successful entree into this market is that has better English language skills than many best accomplished by using partners with extensive Eastern European markets. There are more university country, state and local experience. This includes graduates with degrees in India than there are people a provider dedicated to the recruitment of patients in South Africa or Poland. and sites for clinical trials in India. This significant population makes India the world’s third largest economy in purchasing power parity terms. The Search for Hard-to-Find Clinical Its recent economic growth (7.0% GDP) has been Trial Patients a significant achievement, driving rapid urbanization and an increasingly large new middle-class.4 For sponsors of clinical trials in highly competitive therapeutic areas, such as Inflammatory Bowel and Cardiovascular Disease, finding enough study subjects in the United States and Western Europe has become a major challenge. When multiple companies are researching similar compounds, + the number of patients in active research sites 1,300,000,000 PEOPLE is limited, there are not enough investigators, and/or existing research sites are full, the result is a backlog of trials and high costs for recruited patients. In order to accelerate research and 17.75% development in crowded therapeutic areas, sponsors OF TOTAL WORLD POPULATION need to find new sources of patients. 7.0% GDP 16.28% CAGR IN HEALTHCARE SECTOR 2 EMERGING CLINICAL RESEARCH OPPORTUNITIES IN INDIA: WHITEPAPER A NEW SOURCE OF PATIENTS FOR COMPETITIVE CLINICAL TRIALS A rapidly growing healthcare industry Once known as exporters of bulk Active Specifically, healthcare has become one of India’s Pharmaceutical Ingredients (APIs), Indian generic largest sectors, both in terms of revenue and drug makers have managed to gain a foothold in employment. During 2008-2022, the market is regulated markets such as the U.S. and Europe. expected to record a Compound Annual Growth Rate (CAGR) of 16.28%, with the total industry size Total Sales for Indian expected to reach $372 billion by 2022.5 Generic Drug Companies $30 $27 B Healthcare Sector Growth Trend (US$ billion) $25 $20 _________________________________________________________ 400 372 $15 350 _________________________________________________________ $10 $5 $4 B 300 _________________________________________________________280 $0 250 _________________________________________________________ 40% 16% 2004 2014 200 _________________________________________________________ 160 generic dosages by volume in annualized growth rate of total sales 150 _________________________________________________________ the U.S. that are manufactured for Indian generic drug companies 104 110 100 _________________________________________________________81 by Indian companies from 2004 to 2014 60 68 73 50 _________________________________________________________45 52 0 – – – – – – – – – – – – Source: www.nasdaq.com 2008 2008 2010 2011 2012 2014 2015 2016 2017F 2020F 2022F Notes: F - Forecast. CAGR - Compound Annual Growth Rate This augurs well for Indian companies, which are also Source: Frost and Sullivan, LSI Financial Services, Deloitte. Aranca Research experiencing growth momentum in their domestic market.7 It is opined that clinical research will follow This growth is being driven by several factors: this success, with India eventually becoming one • Dual disease burden (infectious and of the dominant research destinations. non-communicable) A significantly improved regulatory environment • Rising healthcare awareness In an effort to put India back on the global clinical • Increasing levels of disposable income research map, the Indian government has taken • Growing population and urbanisation great steps forward to speed up approvals, remove Another significant accomplishment for India intermediaries and provide more transparency. The has been the growth of its pharmaceutical Central Drugs Standard Control Organization manufacturing. Currently, India has the highest (CDSCO), whose main objective is to standardize number of FDA-approved manufacturing plants clinical research and bring safer drugs to the Indian 6 market, has made its vision clear: “To Protect and outside the U.S. It is also a leader in the field 8 of generic manufacturing, with products registered Promote Public Health in India”. and taken all over the world. Over the past decade, the regulatory climate in Sales Growth by Indian Generic Drug Companies India has fluctuated wildly, creating an uncertain research climate for biopharma companies. After 20,000 Total Sales CAGR (2004-2014): 15.79% 70% 18,000 Foreign Sales CAGR (2004-2014): 21.99% finally becoming fully TRIPS compliant in 2005, Share of Foreign Sales in Total Sales (2014): 70% 16,000 65% India emerged as a favourable destination for the 14,000 60% 12,000 conduct of clinical trials. With its timely completion 10,000 55% 8,000 of trials, large patient pool, highly skilled medical 50% 6,000 investigators and related professionals, India’s share 4,000 45% 2,000 of the global clinical trial market subsequently grew 0 40% 9 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 from 0.9% in 2008 to more than 5% in 2012. Total Sales (US$ Mn.) Foreign Sales (US$ Mn.) Foreign Sales as % of Total Sales (RHS) Source: PhramaBiz 3 EMERGING CLINICAL RESEARCH OPPORTUNITIES IN INDIA: WHITEPAPER A NEW SOURCE OF PATIENTS FOR COMPETITIVE CLINICAL TRIALS However, legacy infrastructure challenges and Since the introduction of the regulatory reforms, sometimes less efficient regulations resulted in India is well positioned for growth in the clinical many unfortunate complications on clinical trials. research arena. There has been a rapid increase in During late 2011 and early 2012, the existing the number of clinical research projects approved regulatory framework and patient safety guidelines in India: 84 in 2016 and 59 in the first six months were challenged. This led to sweeping changes, of 2017. Importantly, sponsors, CROs, sites and the introduction of an onerous and restrictive investigators all share a sense of optimism regarding 10 three-tier approval process, and new regulations. the changes and increased activity. Unfortunately, the unintended consequences were excessive timelines, as well as a significant increase A population in urgent need of medical treatment in cost and effort to adhere to the new regulations. Although India continues to struggle with the This led to many research institutions and burden of communicable diseases associated investigators discontinuing clinical trials in India. with a developing country, every state now has To reverse this situation, The Ministry of Health a higher burden from non-communicable diseases convened an Advisory Council in 2015 to formulate and injuries than from infectious diseases. The more practical policies related to the approval of contribution of non-communicable diseases clinical trials and new drugs. Following extensive to health loss — fueled by unhealthy diets, high input from various stakeholders – sponsors, CROs, blood pressure, and hyperglycemia — has doubled investigators and the pharmaceutical industry in India over the past two decades.11 – the committee recommended changes to the Cardiovascular diseases have now become the regulatory framework with an objective to revive leading cause of mortality in India, with a quarter the industry, while ensuring that trials are based of all mortality attributable to CVD. Ischemic heart on sound science and the highest ethical standards. disease and stroke are the predominant causes and Of significant importance for sponsors of clinical are responsible for >80% of CVD deaths.12 trials, they initiated: • The CTA review timeline of 180 days maximum, CVD mortality as a proportion of total mortality (%) as compared with unspecified timelines before. • A pre-trial checklist provided by the Regulatory High Income (GBD 2010) Authority to help sponsors ensure that their CTA Global dossier meets all the information requirements (GBD 2010) from the outset, avoiding potential delays. US (GBD 2010) • The ability to include an application for an India import and export “No
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