<div class="Insight_area"><!--전문가인사이트 헤더--> <div class="article_head"><!--제목--> <div class="titarea"><!--메인타이틀--> <p class="mtit mt30" style="font-size: 28px;"><strong>Thailand: A Hidden Gem for Clinical Research</strong></p> <!--서브타이틀--></div> <!--//제목--> <!--전문가 소개영역--> <div class="photozone "><!--전문가사진--><span class="pz_photo"><img style="width: 110px;" src="/fileDownload2?fileGubun=phm&fileId=00000000000000330195" alt="전문가" /></span> <!--//전문가사진--> <!--전문가정보--><dl class="pz_cont line3"><dt><strong>글</strong> <!--이름--> <span class="nm"> Siri Leksuwat </span></dt><!--소속명/직위--><dd class="ex">GPKOL위원</dd></dl><!--//전문가정보--></div> <!--//전문가 소개영역--></div> <!--//전문가인사이트 헤더--> <div class="docarea"> <div class="doctorinfo"><strong>컨설팅 분야</strong> <ul class="wp100"> <li>PM, 임상</li> </ul> </div> <div class="doctorinfo mt20"><strong>컨설팅 내용</strong> <ul class="wp100"> <li>Clinical Research : Product registration, Marketing Launch, and Market Access in Asia Pacific, EU and USA</li> <li>Project Management : Portfolio management in the Clinical trial, Looking for new business potential and extend product lifecycle in APAC region, and Marketing strategic planning and execution</li> </ul> </div> </div> <!--전문가인사이트 내용--> <div class="article_body"><!--내용style1--> <div class="cont mt30"> <p class="cotit mt20">Thailand: A Hidden Gem for Clinical Research</p> <p>Siri Leksuwat, MPH. MBA</p> </div> <div class="cont mt30"> <p class="cotit mt20">Introduction:</p> <p>In 2009, South Korean had their passion for being one of the global leaders in Biosimilar market, targeting for capturing 22% of the global biosimilar market by 2020. The Korea Pharmaceutical Manufacturers Association reported that Korea’s biosimilar value would rise from 80 Billion won in 2013 to 150 Billion won by 2019,. This good result attributable to the government’s support; major companies’ Changes in price calculation methods for biosimilars may expand the market even further. The industry is currently demanding a price increase for biosimilars, which now sell for between 70 and 80 percent of the prices of the original medications. However, Korea is also facing a price cut problem from the Indian and Chinese pharmaceutical companies. To sustain the sales growth yet remain competitive, Korean Pharmaceutical/Biotech should look to expand their products to the global scales network. Together with Korea Vision 2020, it is understandable that Korea is anticipate the following:<br /><br /></p> <ul class="ullist01"> <li>Become a top seven global Pharma powerhouse by 2020</li> <li>KRW 10 Trillian ( USD 8.9 billion) between 2013-2017 allocate by Korean government R&D</li> <li>20 new drugs to be produced by 2020</li> <li>Two Korean company in the global top 20</li> <li>Global Market share to increase from 2 to 2.5 percent</li> <li>Pharma exports from 12.5 percent to 46 percent of Total Production</li> </ul> <p><br /><br /> The objective of this trend report has two objectives, firstly is to respond to my conversation with pharmaceuticals and biotech company during my conversation at BioKorea on the direction to optimize your research funding and maximise the result. Secondly, this report will provide the audience with an alternated solutions to assist Korea in achieving the Korea vision 2020 by expanding the Koren’s Pharmaceutical/Biotech internationally to boost the export rate, increase global market share. In addition to Korea Pharma vison 2020, Thailand can be one of a potential country to conducts the clinical trial, especially to Biosimilar. The report will provide you with the overview of ASEAN, the location of Thailand, updating on relevant country infrastructure upgrading, Disease burden and Government’s policy to support Thailand to be a country of choice for your next investment. <br /><br /> <strong>Thailand: Heart of ASEAN</strong><br /><br /></p> <div style="text-align: center;"><img style="text-aling: center;" src="/fileDownload2?fileGubun=phm&fileId=00000000000000330196" alt="Figure" width="auto" height="auto" /><br /><br /></div> <p>Geographical: <br /><br /> Thailand is a country located in the heart of ASEAN ( The Association of Southeast Asian Nations), ASEAN was established on 8 August 1967 in Bangkok, Thailand. The ASEAN Charter entered into force on 15 December 2008, to date ASEAN comprises of 10 countries; Indonesia, Thailand, Phillippines, Malaysia, Singapore, Vietnam, Myanmar, Cambodia, Laos, and Brunei. ASEAN aims to strengthen the economic, promote peace which is in line with United Nation Charter. <br /><br /> As of Oct 2017, ASEAN has approx. 645 Million of the population with a GDP = 2,719,884 Million and will be increased to 4,058,427 million USD in 2022 whereby South Korea will have = 1,878,237 million USD. <br /><br /> List of ASEAN countries GDP, International Monetary Fund 2022 (estimates)<br /><br /> <img style="text-aling: center;" src="/fileDownload2?fileGubun=phm&fileId=00000000000000330198" alt="Figure" width="100%" height="auto" /><br /><br /> Thus, ASEAN population and its GDP will make ASEAN be an attractive place for investment. In 2015, EU ranked the 1st investment in ASEAN whereby Korean is 6th after USA and China.<br /><br /> In 2003, ASEAN members established an ASEAN Economic Blueprint. In response to an agreement, The Thai Government has established THAILAND 4.0 which is an economic model that is focusing on becoming a value-based and innovation-driven economy by moving from producing commodities to innovative products; emphasizing on promoting technology, creativity, and innovation in focused industries; and from a production based to a service-based economy. Major investments in infrastructure are underway including railway and airport upgrades, highspeed rail, roadways . Thailand also allocates three provinces at the east of Thailand to establish a project calls “Eastern Economic Corridor (EEC), this considers the government’s efforts to make Thailand one of the most preferred investment destinations in Asia., Likes “killing many birds with one stone”- effects; the government also plan to build the road from the northern part of Thailand to EEC to respond to One-Belt-One-Road project that is initiated by China’s President. With all of the efforts made, to be made, it is believed to make ASEAN and Thailand one of the most preferred investment destinations in Asia.<br /><br /></p> <div style="text-align: center;"><img style="text-aling: center;" src="/fileDownload2?fileGubun=phm&fileId=00000000000000330201" alt="Figure" width="auto" height="auto" /><br /> <img style="text-aling: center;" src="/fileDownload2?fileGubun=phm&fileId=00000000000000330197" alt="Figure" width="auto" height="auto" /><br /><br /></div> <p>Focusing more on the Eastern Economic Corridor (EEC) the Thai Government together with Thailand Board of Investment Incentive (BOI), has prepared many benefits favorable to overseas investors such as:<br /><br /></p> <ul class="ullist01"> <li>Corporate income tax exemption up to 15 years</li> <li>Exemption of import duty on machinery, raw and essential material used for export products and products used for R&D</li> <li>Financial incentives for investment in R&D, innovation or human resources development in targeted industries</li> <li>Permit to own land used for BOI promoted projects</li> <li>Facilitation for visas and work permits</li> </ul> <p><br /><br /> The distribution of the 1.5 trillion baht over the 5 years <br /><br /></p> <div style="text-align: center;"><img style="text-aling: center;" src="/fileDownload2?fileGubun=phm&fileId=00000000000000330200" alt="Figure" width="auto" height="auto" /><br /><br /></div> <p>From the chart above, the government has allocated 11.5 Billion USD to build the healthcare infrastructure within EEC areas to support the growth of foreign workers. The normal growth rate of the foreign patients who visit Thailand via health-travel is 10.9 % ( compound growth rate from, 2009-2014) and expected to be more once EEC launch.</p> </div> <div class="cont mt30"> <p class="cotit mt20">Thailand: Burden of the Disease:</p> <p>By now, you would see the infrastructure the government promised to deliver, understanding the cause of death would help in strategical response to the situation and maximise your potential.<br /><br /> In 2014, the WHO report shows that Non-communicable Disease is attributable to 71% a major total cause of death in both male and female in Thailand.<br /><br /> In 2016, Ischemic Heart Disease, Cerebrovascular Disease, and Alzheimer Disease rank top 5 cause of death. Despite the lower number, the cause of death from communicable diseases also remain the challenge especially Artemisinin-resistant malaria as well as TB and road traffic accidents. Though the country has their universal healthcare scheme to bring equitable healthcare access to the general public, however, the budget is rather low, therefore utilize generic drug could help reduce the country’s financial burden, and this will allow the country to narrow the gaps of health access when compare to Korea<br /><br /> <img style="text-aling: center;" src="/fileDownload2?fileGubun=phm&fileId=00000000000000330199" alt="Figure" width="100%" height="auto" /></p> </div> <div class="cont mt30"> <p class="cotit mt20">Thailand and Clinical Research</p> <p>With the population of 70 million, Thailand has 2,232 studies conducting in Thailand;only four studies are biosimilar(www.clinicaltrials.gov,17Nov2017). Tilleke & Gibbins commented that:<br /><br /> “…Biosimilar in Thailand has grown at a fast pace. There is more widespread use of off-patent biologicals, particularly erythropoietin and insulin. It is likely that the future expanded use of biological products in Thailand will come in the form of biosimilars (follow-on biologics) after the patents on originator products expire…”<br /><br /> Thailand has few companies who are focused on Biosimilar study. Therefore Thailand will be a potential market awaits for investment.<br /><br /> An estimated timeline for a clinical trial startup is approx. 5- 6 months ( Ethics Committee approval and Import license processing).<br /><br /> The informed consent requires a Thai translation.<br /><br /> The Ministry of Health, Thailand reported that; 6,524 clinical trials are being conducted in the South East Asia, of these 2,161(33%) are being conducted in Thailand. The MOPH also conduct A Retrospective Analysis of Research Protocols by Ethical Review Committee for Research in Human Subjects. The full reports (or can be accessed via https://drive.google.com/file/d/0B9SSU61lnB-RYXV3RVplUnNKR1k/view) After the clinical trial completion, The time to progress through regulatory and subsidized patient access systems in Thailand (minimum) is 104 weeks whereby Korea takes 92 weeks this because the process can perform in parallel while the trial is conducted.</p> </div> <div class="cont mt30"> <p class="cotit mt20">Pricing Strategies:</p> <p>Price setting would be one of the factors for country selection. Research conducted nearly 500 patients noted about the patient’s willingness to pay for the life-saving medicine in Thailand is THB 160,000 per QALY ( 5.3 million won) and willing pay at 1,250,000 ( 41.6 million won) yearly to get their life back to the normal stage.</p> </div> <div class="cont mt30"> <p class="cotit mt20">Conclusion</p> <p>The pharmaceutical market is one of the most aggressive markets; both of originator and generic company play both equally important role to improve quality of patient's life with affordable price. Thailand is one of the countries that could be value added to drug discovery especially the current situations whereby the government is fully supporting the policy and infrastructure.</p> </div> <div class="cont mt30"> <p class="cotit mt20">About the author:</p> <p>Siri Leksuwat, is a freelancer who has more than 25 years of cross-cultural Clinical Research Project Management. She has helped small to large Pharmaceutical and Biotech companies to bring new treatments to improve quality of life. To discuss further on your clinical development strategies, Siri can be contacted via sleksuwat@gmail.com</p> </div> <div class="cont mt30"> <p class="tit03 mt20">References :</p> <ul class="ullist01"> <li>to capture 22% of the global biosimilar market by 2020.</li> <li>https://www.bigmoleculewatch.com/2016/06/16/south-koreas-biosimilars-industry-poised-to-grow/</li> <li>Kim, Daejung, McGuire, Alistair and Kyle, Margaret (2015) Korean pharmaceutical industry policy: lessons for Korea. Research Reports, 2015-37. Korea Institute for Health and Social Affairs, Sejong, South Korea. ISBN 9788968272905</li> <li>http://koreabizwire.com/koreas-biosimilar-market-on-the-rise/55297</li> <li>http://www.imf.org/external/datamapper/NGDPDPC@WEO/OEMDC/ADVEC/WEOWORLD</li> <li>http://asean.org/?static_post=foreign-direct-investment-statistics</li> <li>ASEAN Econimic Blueprint access via http://asean.org/wp-content/uploads/archive/5187-10.pdf</li> <li>http://www.boi.go.th/upload/content/TIR_Jan_32824.pdf</li> <li>http://thaiembdc.org/2017/11/01/eastern-economic-corridor/</li> <li>https://www.set.or.th/thbigmove/files/Kanit_EEC.pdf</li> <li>http://thaiembdc.org/2017/11/01/eastern-economic-corridor/</li> <li>BOI’s Incentives in the EEC via https://www.bangkokpost.com/business/news/1202317/bois-incentives-in-the-eec</li> <li>Presentation Slide “Eastern Economic Corridor Development project” Driving Forward 17 Feb 2017 access via http://www.boi.go.th/upload/EEC%20pack%20for%20BOI%20fair_Rev4%203%201.pdf</li> <li>http://apps.who.int/iris/bitstream/10665/136889/1/ccsbrief_tha_en.pdf?ua=1</li> <li>http://www.wpro.who.int/asia_pacific_observatory/hits/series/thailand_health_systems_review.pdf</li> <li>http://www.tilleke.com/resources/biosimilars-thailand 3 October 2016</li> <li>From Regulatory Approval to Subsidized Patient Access in the Asia-Pacific Region: A Comparison of Systems Across Australia, China, Japan, Korea, New Zealand, Taiwan, and Thailand Greg Cook, PhD*, Hansoo Kim, MSc Bristol Myers Squibb Australia, Mulgrave, Victoria, Australia</li> <li>1.1.1.1. Willingness-To-Pay For Life-Saving Treatments In Thailand: A Discrete Choice Experiment <br /> Nimdet, K et al.Value in Health , Volume 20 , Issue 9 , A682</li> </ul> </div> </div> </div>
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