Market Research and analysis of orlistat

Abstract: orlistat is a kind of gastrointestinal lipase inhibitor Through covalent bond with the active serine part of the lipase in the stomach, small intestine and pancreas, the lipase can't be inactivated to decompose the fat (mainly triglycerides) in the food into absorbable free fatty acids and monoacylglycerols, so as to reduce the heat intake, control the weight gain and control the body weight Objective: to make body weight, reduce blood sugar, reduce blood pressure and regulate fat Orlistat has been listed in major regions of the world, including 27 registered products in Europe, 2 registered products in the United States, 15 registered approvals in China, and orlistat capsule dosage form is the mainstream dosage form in the world, with specifications of 120mg and 60mg Due to the key driving factors such as the large population of obesity patients and the innovation of sales mode, which significantly expand the consumer interface, it is estimated that the global consumption of orlistat in 2019 will be about 180 tons, with the corresponding market value of about 600 million yuan (calculated at the average price of 19 years) It is estimated that the global consumption of orlistat in the next five years will reach 400 tons, with a compound growth rate of 22% in five years In recent years, the global market of orlistat has shown structural growth trend in different regions On the one hand, the market of orlistat API is declining in developed countries On the other hand, the main consumer markets of orlistat have been transferred to emerging markets, including Brazil, China, Russia, Mexico, South Korea, Egypt and other countries With the gradual opening of these market demands, the consumption of orlistat has increased The global API production is mainly concentrated in China, India and Europe On the one hand, the dependence of generic API in India on China has increased On the other hand, the new API projects in China have increased in recent two years, and the overall production capacity has increased significantly China has become the largest producer of orlistat API, bringing changes to the global competition pattern of API In 2019, the export amount of China's orlistat API reached 304 million yuan, with a total of 19 enterprises completing the export volume of about 82 tons, including 35 tons of Zhien export, accounting for 43% China's exports of orlistat APIs cover 31 countries, mainly in South America, Asia and Europe; CR3 reaches 78.8%, with high concentration of the top three enterprises in the industry, among which Zhien pharmaceutical ranks first, accounting for 43%, Shandong new era ranks second, accounting for 18.2%, and Haizheng pharmaceutical ranks third, accounting for 17.8% In 2019, the global market of orlistat preparation exceeded 3 billion yuan, and will reach 6 billion yuan in the next five years, with a compound growth rate of 18.9% In terms of the distribution of national share, it is relatively concentrated The top five countries account for 58.2% of the total, and Brazil ranks first, accounting for 20% The share of enterprises is also relatively concentrated, with 61% of the top five enterprises, including 26% of Roche In 2019, China's total sales volume of orlistat is expected to be 1.27 billion yuan According to the channel division, the online sales volume will reach 1 billion yuan, accounting for 79% of the total In terms of enterprise share, Zhien pharmaceutical industry ranks first in market share, accounting for 52% The Chinese market will continue to rise in the next few years, and it is estimated that the sales scale of orlistat preparation in the Chinese market will reach 2 billion yuan in 2021 Orlistat needs will be released in the future, thanks to the rapid development of obesity incidence rate in China in recent years The average obesity rate of 18-69-year-old adults has reached 12% The total number of obese people ranks first in the world, including 43.2 million obese men and 46.4 million obese women The overweight rate has reached 30% The number of overweight people has exceeded 200 million With the pursuit of body beauty and the recognition of the secondary diseases brought about by obesity, orlistat will gradually become the first choice of drugs for people who lose weight and are overweight Table of contents 1 Product definition 1 1 Basic chemical information 1 2 Basic pharmaceutical information 1 2 1 mechanism of action 1 2 2 indications 1 2 3 dosage forms and specifications 1 2 4 clinical application 1 3 orlistat safety 2 Listing and research at home and abroad 2 1 global Listing 2 1 EU listing 2.1.2 FDA listing in the United States 2.1.3 PMDA listing in Japan 2.2 domestic listing 2.2.1 domestic preparation listing 2.2.2 domestic API listing 2.3 Chinese preparation in research 2.3.1be test implementation 2.4 API registration 2.4.1 CEP certification in the European Union 2.4.2 DMF registration in the United States 2.4.3 GMP certification / filing in China 2.5 summary 3 Orlistat API Market Analysis 3.1 global API market demand analysis 3.1.1 global API Market Scale Analysis 3.1.2 global API countries demand analysis 3.2 China API market demand analysis 3.3 competition analysis 3.3.1 analysis of competition pattern of global API enterprises 3.3.2 analysis of competitiveness of Chinese api enterprises 3.3.3 production of Chinese enterprises 3.4 analysis of API export 3.4.1 product export volume / value and growth 3.4.2 export countries and regions 3.4.4 export price 3.5 demand forecast and development trend of API Market 3.6 summary of API Market Analysis 4 Analysis of orlistat pharmaceutical market 4.1 overview of global pharmaceutical market 4.1.1 market scale and growth 4.1.2 market share of major countries 4.1.3 market share of major enterprises 4.2 analysis of Chinese pharmaceutical market 4.2.1 market scale and growth 4.2.2 market share of major enterprises and brands 4.2.3 market share of subdivided channels 4.3 sales scale and development trend of Chinese market 4.4 summary of preparation market analysis 5 Market access of the product 5.1 basic medicine 5.2 medical insurance 5.3 bid winning 6 Market prospect analysis of target indications (obesity) 6.1 disease overview and epidemiological analysis 6.1.1 definition of obesity 6.1.2 classification of obesity 6.1.3 epidemiology of obesity 6.2 classification of therapeutic drugs 6.2.1 treatment of central nervous system 6.2.2 treatment of peripheral weight-loss drugs 6.2.3 hypoglycemic drugs with weight-loss effect 6.2.4 summary of therapeutic drugs of weight-loss drugs (chemical drugs) 6.3.1 market situation and trend analysis of global weight-loss drugs 6.3.2 market situation and trend analysis of Chinese weight-loss drugs 6.3.3 research status of Chinese weight-loss drugs reference disclaimer 1 Product definition 1.1 basic chemical information Orlistat is a gastrointestinal lipase inhibitor that reduces body fat content by blocking the body's absorption of fat from food Its chemical name is (3S, 4S) - 3-hexyl-4 - [(2S) - 2-hydroxytridecyl] - 2-oxobutyronone n-formyl-l-leucine ester, which is mainly used for the treatment of obese or overweight patients (BMI ≥ 24) Table 1.1 collation of basic information data of orlistat: Pharmaceutical intelligence consulting 1.2 basic pharmaceutical information 1.2.1 mechanism of action Orlistat is a semi synthetic lipostatin derivative, which has strong selective inhibition of lipase and pancreatic lipase It can be used for treatment by forming covalent bond with the active serine site of the stomach and small intestine cavity and pancreatic lipase to inactivate lipase Gastrointestinal lipase is an essential enzyme for the decomposition of fat in the gastrointestinal tract The inactivated enzyme can not decompose the fat (mainly triglycerides) in food into absorbable free fatty acids and monoacylglycerols; the undifferentiated triglycerides can not be absorbed and utilized by the body, so as to reduce calorie intake and control weight gain In order to control body weight, reduce blood sugar, reduce blood pressure, regulate fat and improve the state related to obesity The absorption of fat can be inhibited by 30% in the usual dosage At the same time, orlistat is a partial hydration derivative of endogenous iipstatin produced by Streptomyces toxyricini, so its pharmacological effect is dose-dependent 1.2.2 indications (1) the indications approved by European Union are used for weight loss of overweight adults (body mass index, BMI, ≥ 28KG / m2), which should be taken together with light low calorie and low fat diet Take one orlistat capsule or chewable tablet three times a day before, during or after each main meal If you miss a meal or eat a diet free of fat, you should not take orlistat Fat diet should be distributed in three meals, patients should pay attention to diet, about 30% of the calories from fat Patients taking orlistat should start eating and exercising before starting treatment and should not take it for more than six months If the patient does not achieve weight loss after 12 weeks, the doctor or pharmacist should be informed as soon as possible, or the treatment should be stopped (2) FDA approved indications are for weight loss in adults 18 years and older, combined with a reduced calorie and low-fat diet (3) Indications of orlistat prescription drugs approved in China: combined with micro low calorie diet, it is suitable for the long-term treatment of obese and overweight people, including those who have risk factors related to obesity Orlistat can reduce obesity related risk factors and incidence rate of obesity related diseases, including hypercholesterolemia, type 2 diabetes, impaired glucose tolerance, hyperinsulinemia, hypertension, and reduce fat content in viscera Over the counter indications of orlistat: This product is used for the treatment of obese or overweight patients (BMI ≥ 24) 1.2.3 for detailed report of dosage form and specification, please contact Mr Tian 17318481316 1.2.4 for detailed report of clinical application, and Mr Tian 17318481316 1.3 for detailed report of orlistat safety, please contact Mr Tian 17318481316 2 Listing and research at home and abroad 2.1 global listing Orlistat is a gastrointestinal lipase inhibitor that reduces body fat content by blocking the body's absorption of fat from food It was first listed in Argentina in 1997; in 1998, the European Drug Administration (EMA) approved orlistat to be listed as a prescription drug in Europe; in 1999, the U.S Food and Drug Administration (FDA) approved orlistat to be listed as a prescription drug in the United States; in 2000, the State Food and Drug Administration (SFDA) approved Roche to sell imported orlistat as a prescription drug in China In 2005, orlistat could be sold over-the-counter 2.1.1 EU listing needs to be reported in detail, please contact manager Tian 17318481316 2.1.2 US FDA listing needs to be reported in detail, please contact manager Tian 17318481316 2.1.3 Japan PMDA listing needs to be reported in detail, please contact manager Tian 17318481316 2.2 domestic listing needs to be reported in detail, please contact manager Tian 17318481316 2.2.2 at present, there are 6 enterprises in China, including Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd and Zhuhai United Pharmaceutical Co., Ltd., which have obtained approval documents for API production Table 2-5 data processing of domestic approval and listing of orlistat API: Pharmaceutical intelligence consulting 2.3 development of Chinese preparations 2.3.1be test needs a detailed report, please contact Tian manager 17318481316 2.4 API registration 2.4.1 EU CEP certification needs a detailed report, please contact Tian manager 17318481316 2.4.2 US DMF registration For detailed report, please contact manager Tian 17318481316 2.4.3 for detailed report of GMP certification / filing in China, please contact manager Tian 17318481316 2.5 summary (1) 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