2020年印度制藥行業展望 -印度品牌價值基金會（英文版）（35頁）.pdf

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1、For updated information, please visit www.ibef.org August 2020 PHARMACEUTICALS Table of Contents Executive Summary.3 Advantage India.4 Market Overview .6 Recent trends and Strategies.14 Growth Drivers.18 Opportunities.28 Useful Information.30 For updated information, please visit www.ibef.orgPharmac

2、euticals 3 EXECUTIVE SUMMARY Source: 1 FICCI - Trends domestic generic drug market is expected to reach US$ 27.9 billion in 2020 Due to their competence in generic drugs, growth in this market offers a great opportunity for Indian firms Based on moving annual turnover, Anti-Infectives (13.6%), Cardi

3、ac (12.4%), Gastro Intestinals (11.5%) had the biggest market share in the Indian pharma market in 2018. The highest growth in sales in 2018 were seen in hormones (14.2%), anti diabetic (12.9%), and respiratory (12%). During December 2019, on moving annual total (MAT) basis, industry growth was at 9

4、.8 per cent, with price growth at 5.3 per cent, new product growth at 2.7 per cent while volume growth at two per cent y-o-y. 0.41 0.91 0.31 0.34 0.35 0.95 1.14 1.27 1.29 1.43 1.61 1.78 2.17 2.34 2.58 Others Vaccines Hormones Ophthal Anti-Neoplastics Gynaecological Neuro / Cns Derma Pain / Analgesic

5、s Respiratory Vitamins / Minerals Anti Diabetic Gastro Intestinal Cardiac Anti-Infectives Segment Wise Moving Annual Turnover2 2018 (US$ billion) For updated information, please visit www.ibef.orgPharmaceuticals 11 PHARMA EXPORT TO CONTINUE WITNESSING POSITIVE GROWTH 32.1% 18.0% 15.7% 6.9% 6.8% 5.6%

6、 14.9% North America Africa EU ASEAN LAC Middle East Others Source: Department of Commerce India, Department of Pharmaceuticals, India Business News, Global Trade Atlas, KPMG US-India Dynamic June 2018, Pharmexcil India is the worlds largest provider of generic medicines; the countrys generic drugs

7、account for 20 per cent of global generic drug exports (in terms of volumes). Indian drugs are exported to more than 200 countries in the world, with the US as the key market. Indian pharma companies are capitalising on export opportunities in regulated and semi-regulated markets. Pharmaceutical exp

8、ort from India, which include bulk drugs, intermediates, drug formulations, biologicals, Ayush with expected worldwide revenue between US$ 80 to 250 billion. Patent Expiry Notes: CAGR - Compound Annual Growth Rate Indias generic drugs account for 20 per cent of global exports in terms of volume, mak

9、ing it the largest provider of generic medicines globally. The generics drug market accounts for around 70 per cent of the India pharmaceutical industry and it is expected to reach US$ 27.9 billion by 2020. Scope in generics market Indias OTC drugs market is estimated to have grown at a CAGR of 16.3

10、 per cent to US$ 6.6 billion over 200816 and is further expected to grow on the account of increased penetration of chemists, especially in rural regions. The India OTC market was accounted at US$ 4.61 billion in 2018 and is expected to reach US$ 10.22 billion by 2024. Over-The-Counter (OTC) drugs F

11、or updated information, please visit www.ibef.orgPharmaceuticals 22 DEMAND DRIVERS OF INDIAN PHARMA SECTOR Accessibility Over US$ 200 billion to be spent on medical infrastructure in the next decade. New business models expected to penetrate tier-2 and 3 cities. Over 160,000 hospital beds expected t

12、o be added each year in the next decade. Indias generic drugs account for 20 per cent of global exports in terms of volume, making the country the largest provider of generic medicines globally. Acceptability Rising levels of education to increase acceptability of pharmaceuticals. Patients to show g

13、reater propensity to self-medicate, boosting the OTC market. Acceptance of biologics and preventive medicines to rise. Surge in medical tourism due to increased patient inflow from other countries. Epidemiological factors Patient pool expected to increase over 20 per cent in the next 10 years, mainl

14、y due to rise in population. New diseases and lifestyle changes to boost demand. Increasing prevalence of lifestyle diseases. Pradhan Mantri Bhartiya Janaushadhi Kendras Rising income could drive 73 million households to the middle class over the next 10 years. Over 650 million people expected to be

15、 covered by health insurance by 2020. The Government plans to provide free generic medicines to half the population at an estimated cost of US$ 5.4 billion. AffordablemedicinesunderPradhanMantri Bhartiya Janaushdhi Kendras (PMBJKs) achieved an impressive sale of Rs 100.40 crore (US$ 14.24 million) i

16、n first two months of FY21. Demand drivers Source: ICRA Report on Indian Pharmaceutical Sector, Pharmaceutical Industry: Developments in India- Deloitte, Mckinsey Pharma Report 2020 Note: RSBY - Rashtriya Swasthya Bima Yojna For updated information, please visit www.ibef.orgPharmaceuticals 23 GROWIN

17、G HEALTH INSURANCE Source: IRDA, General Insurance Council Increasing penetration of non-life insurance including health insurance will drive the expansion of healthcare services and pharmaceutical market in India. Adoption of health insurance in the country has been increasing at a fast pace. Gross

18、 direct premium from health insurance reached Rs 516.37 billion (US$ 7.33 billion) in FY20 and contributed 27 per cent to the gross direct premiums of non-life insurance companies in India. Another boost to the sector will be the National Health Protection Scheme under Ayushman Bharat, announced in

19、Union Budget 2018-19. The scheme was launched in September 2018. Gross Direct Premiums of Non-Life Insurers (US$ billion)Visakhapatnam port traffic (million tonnes)Break-up of non-life insurance market in India (FY20) Note: CAGR is up to FY19 27% 73% HealthOthers Total size: US$ 27.09 billion 14.95

20、19.89 23.38 24.32 27.09 0.00 5.00 10.00 15.00 20.00 25.00 30.00 FY16 FY17 FY18 FY19 FY20 CAGR 16.01% For updated information, please visit www.ibef.orgPharmaceuticals 24 FAVOURABLE POLICY MEASURES SUPPORT GROWTH (1/2) Steps taken to reduce approval time for new facilities. NOC for export licence iss

21、ued in two weeks compared to 12 weeks earlier. Reduction in approval time for new facilities Government is planning to relax FDI norms in the pharmaceutical sector. In March 2017, the Government decided to create a digital platform to regulate and track the sale of quality drugs, and it can be used

22、by people living in the country as well as abroad. Support for technology upgrades and FDIs Pharma Vision 2020 by the Governments Department of Pharmaceuticals aims to make India a major hub for end-to-end drug discovery. Pharma Vision 2020 As per NBDS, a proposal has been made to set up the Nationa

23、l Biotechnology Regulatory Authority (NBRA) to provide a single-window clearance mechanism for all bio-safety products to create efficiencies & streamline the drug approval process. Single-window clearance Government of India is planning to set up mega bulk drug parks in order to reduce industrys de

24、pendency on raw material imports. As of October 2018, the Uttar Pradesh Government will set up six pharma parks in the state and has received investment commitments of more than Rs 5,000-6,000 crore (US$ 712-855 million) for the same. In October 2019, Telangana Government proposed Hyderabad Pharma C

25、ity with financial assistance from Central Government of Rs 3,418 crore (US$ 489 million). Pharmaceutical Parks In December 2018, the Government of India approved the National Commission for Homoeopathy, Bill, 2018 in order to have more transparency in the sector. National Commission for Homoeopathy

26、 (NCH) Bill, 2018 For updated information, please visit www.ibef.orgPharmaceuticals 25 FAVOURABLE POLICY MEASURES SUPPORT GROWTH (2/2) Source: Livemint, Union Budget The allocation to the Ministry of Health and Family Welfare has increased to Rs 65,012 crore (US$ 9.30 billion). The National Health M

27、ission Scheme is the largest Government funded healthcare programme, which is expected to benefit 7.31 million poor families in the country by providing a cover of up to Rs 5 lakh (US$ 7,314.22) per family per year on floater basis in the impaneled hospitals across India. The Government has allocate

28、d Rs 34,115 crore (US$ 4.88 billion) towards the National Health Mission under which rural and urban people will get benefited. Rs 6,400 crore (US$ 915.72 million) has been allocated to health insurance scheme Ayushman Bharat Pradhan Mantri Jan Arogya Yojana (AB-PMJAY). Union Budget 2020-21 BIRAC ha

29、s been established to promote research & innovation capabilities in Indias biotech industry. The council will provide funding to biotech companies for technology & product development. BIRAC under Small Business Innovation Research Initiative (SBIRI) scheme supports innovations in biotechnology. Bio

30、technology Industry Research Assistance Council Programme on application of biotechnology for women was done to provide employment, skill development, awareness generation, health improvement & socio-economic upliftment of the women population. Biotechnology Based Programme for Women The Industry Ac

31、ademia mission was launched in June 2017 to boost development of biopharmaceuticals in India. National Biopharma Mission For updated information, please visit www.ibef.orgPharmaceuticals 26 NATIONAL PHARMA POLICY TO BRING GREATER TRANSPARENCY In 2017, the Department of Pharmaceuticals released a dra

32、ft National Pharmaceutical Policy with the following objectives: Make all essential drugs accessible to masses through affordable prices. Provide the Indian pharmaceutical sector with a long term stable policy environment. Make India self sufficient in end to end domestic drug manufacturing. Maintai

33、n world class quality for domestic consumption and exports. Create a positive environment for research and development in the pharma sector. As per the new policy, the Department of Pharmaceuticals will have control over the National List of Essential Medicines (NLEM), which decides the drugs for wh

34、ich the Government of India can control the prices. In November 2019, Cabinet approved the extension/renewal of the extant Pharmaceuticals Purchase Policy (PPP) with the same terms and conditions while adding one additional product, namely, Alcoholic Hand Disinfectant (AHD) to the existing list of 1

35、03 medicines till the final closure/strategic disinvestment of the Pharma CPSUs. For updated information, please visit www.ibef.orgPharmaceuticals 27 GOVERNMENT EXPENDITURE IN THE PHARMA SECTOR ON AN UPTREND 23.58 35.07 34.91 41.42 45.96 0.00 5.00 10.00 15.00 20.00 25.00 30.00 35.00 40.00 45.00 50.0

36、0 FY16FY17FY18FY19FY20 Source: Business Monitor International, Economic Survey 2019-20 Note: CAGR - Compound Annual Growth Rate, Government expenditure on health increased to Rs 3.24 lakh crore (US$ 45.96 billion) in FY20, implying a CAGR of 18 per cent from FY16. Medical technology park in Vishakha

37、patnam, Andhra Pradesh has already been set up with an investment of US$ 183.31 million. States like Himachal Pradesh, Gujarat, Telangana and Maharashtra are showing interest for making investments in these parks. GermantechnicalservicesproviderTUVRheinlandsIndian subsidiary has partnered with Andhr

38、a Pradesh MedTech Zone (AMTZ) to create an infrastructure for Electro-Magnetic Interference (EMI/EMC) at an investment of US$ 12.64 million over a course of four to five years. As per Economic Survey 2019-20, Government expenditure (as a percentage of GDP) increased to 1.6 per cent in FY20 from 1.2

39、per cent in FY15 for health. Visakhapatnam port traffic (million tonnes)Government Expenditure on Health in India (US$ billion) For updated information, please visit www.ibef.orgPharmaceuticals 28 INVESTMENTS, JVs INFUSING SUPERIOR CAPABILITIES IN INDIAN FIRMS Source: BMI, Business Standard, EY, IQV

40、IA Winning the Indian Pharmaceutical Market Nov 2018, DPIIT Indian Drugs & Pharmaceuticals sector has received cumulative FDI worth US$ 16.39 billion between April 2000 and March 2020. Over the last three years, pharmaceuticals segment has accounted for more than 70 per cent of M&A deals. Indian pha

41、rmaceutical major Cipla Ltd has agreed to buy a 26 per cent stake in AMP Solar Power Systems Pvt Ltd for approximately Rs 12.90 crore (US$ 1.85 million). Healthcare sector witnessed private equity of total US$ 1.1 billion with 27 deals in first half of 2019. 10% 7% 10% 7% 14% 23% 20% 21% 24% 29% 29%

42、 15% 35% 39% 43% 50% 36% 46% 35%32%24%14%21%16% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 201320142015201620172018 Early Stage - AngelEarly Stage - VC Growth InvestmentsPipe Investments Visakhapatnam port traffic (million tonnes)PE Investments in Indian Pharma by Deal Type Pharmaceuticals OPPORTUN

43、ITIES For updated information, please visit www.ibef.orgPharmaceuticals 30 OPPORTUNITIES ABOUND IN CLINICAL TRIALS AND HIGH-END DRUGS India is among the leaders in the clinical trial market. Due to a genetically diverse population and availability of skilleddoctors,Indiahas the potential to attract

44、huge investments to its clinical trial market. As of February 2019, India was engaged in 3,618 trials in last one year. Clinical trials market Duetoincreasing populationandincome levels, demand for high-end drugs is expected to rise. Growingdemandcould openupthemarketfor productionofhigh-end drugs i

45、n India. High-end drugs With 70 per cent of Indias population residing in rural areas, pharma companies have immense opportunities to tap this market. Demandforgeneric medicines in rural markets has seen a sharp growth. Variouscompaniesare investing in the distribution network in rural areas. Penetr

46、ation in rural market The Contract Research and ManufacturingServices industry(CRAMS) estimatedatUS$17.27 billionin2017-18,is expected to reach US$ 20 billion by 2020. The market has more than 1,000 players. CRAMS Source: BMI, Drug Controller General of India Pharmaceuticals USEFUL INFORMATION For u

47、pdated information, please visit www.ibef.orgPharmaceuticals 32 INDUSTRY ORGANISATIONS Address: Kalina, Santacruz (E), Mumbai 400 098 Phone: 91-22-2667 1072 Fax: 91 22 2667 0744 E-mail: ipacentreipapharma.org www.ipapharma.org The Indian Pharmaceutical Association Address: 102-B, Poonam Chambers, Dr

48、 A.B. Road Worli, Mumbai 400 018 Phone: 91-22-2494 4624/2497 4308 Fax: 9122 24950723 E-mail: www.idma-assn.org Indian Drug Manufacturers Association Address: Peninsula Chambers, Ground Floor, Ganpatrao Kadam Marg, Lower Parel, Mumbai 400 013 Phone: 9122 24918123, 24912486, 66627007 Fax: 9122 2491516

49、8 E-mail: Organisation of Pharmaceutical Producers of India Address: C-25, Industrial Estate, Sanath Nagar Hyderabad 500018 Phone: 91 40 23703910/23706718 Fax: 91 40 23704804 E-mail: infobdmai.org www.bdmai.org Bulk Drug Manufacturers Association For updated information, please visit www.ibef.orgPharmaceuticals 33 GLOSSARY CRAMS: Contract Research and Manufacturing Services API: Active Pharmaceutical Ingredients FDI: Foreign Direct Investment GOI: Government of India INR: Indian Rupee US$ : US Dollar BPL: Below Poverty Lin