2016 will be a crucial for drug makers and consumers. During ?Make-in-India' week in Mumbai, Govt. highlighted many amendments or introduction of new policies with an aim to make India as a major hub for end to end drug discovery. To boost drug discovery, to promote manufacturing of certain drugs against life threatening diseases like AIDS, and to reduce our dependence on China, the Govt. has promised to offer many incentives (exemption from excise duty or tax) and also plans to setup venture capital funds, cluster developments to strengthen pharma infrastructure / business. Other developments or initiatives include, i) The voluntary Uniform code of Pharma marketing practice will be replaced with a mandatory code by June. This will stop the promotion of drug prior to receipt of the marketing approval and also the practice of drug makers offering gifts to doctors upon prescribing their products; ii) Concept of the ?Online pharmacies' is also expected to be implemented during this year; iii) Change in FDI rule where investor now invest thru Automatic route rather taking any prior regulatory approval; iv) Growth in Medical Infrastructure which will increase accessibility to drug market to improve in Tier-II towns and rural areas.
Declined growth in bulk drugs due to regulatory scrutiny and rising competition & market factors from other Asian competing nations will be compensated by geographies expansion (e.g., Lupin, Cipla, Sun pharma) and sustainable growth from Domestic formulation (e.g. Alkem, Cipla, Sun pharma, Dr Reddy), mainly from Chronic diseases' segment, due to growth in urban population, better awareness on healthcare, and greater penetration of services. India pharma has started expanding in other regulated markets (Japan, Germany, France, Canada) and Tier-II countries (Brazil, Mexico, Venezuela, Russia, etc.). To explore further opportunities of growth, Indian pharma companies have started developing complex generics/ biosimilars. Almost all companies, among Top-20 list, have robust pipeline in this value chain, targeting primarily emerging markets; however, they are also capitalizing on their competitiveness and capabilities to enter into the regulated market.
Aurobindo, Cadila Healthcare, Cipla, Dr. Reddy's, Lupin, Natco
Table of Contents
Aurobindo Pharma - US BUSINESS AND INJECTABLES KEYS TO GROWTH - Looking to STRENGTHEN IN OTHER GEOGRAPHY TOO Table 1 : Aurobindo Pharma : GLOBAL REGULATORY FILINGS Table 2 : Aurobindo Pharma KEY ANDAs APPROVAL IN 1H16 New Aeras to Watch For :
CADILA HEALTHCARE LTD : Future growth from NCE, Bio-Similars, Vaccines, Transdermal and Complex Generics - US REMAINS THE KEY GROWTH DRIVER FOR CDH - Table 1 Cadila Healthcare Ltd. KEY TRANSDERMAL PRODUCTS - ONGOING STUDIES OF LIPAGLYN IN NASH - Clinical Data in NASH so far - Clinical Data in NASH so far
Cipla Ltd : Consolidation of Recent Acquisitions + Geographic Expansion of the Inhaler Business -Figure 1 Cipla Ltd. GENERIC NEXIUM'S MARKET SHARE TREND - Table 1 Cipla Ltd. INVAGEN'S SELECT PARA IV OPPORTUNITIES - Table 2 Cipla Ltd. INVAGEN: HIGHEST MARKET SHARE PRODUCTS - TOP 5 - Annexure : Cipla Ltd. INVAGEN'S CURRENT PRODUCTS
DR REDDY'S LAB : Near-term Growth Muted: Strong Competition to Launched Products + No Significant Approvals + Remediation Costs related to FDA's WL - Figure 1 Dr. Reddy's Lab PENDING ANDAs(76) BY DOSAGE FORM& SELECT OPPORTUNITIES - Table 1 Dr Reddy's Ltd. FACING COMPETITION IN US: MARKET SHARE OF KEY INJECTABLES -Figure 2 Dr. Reddy's Lab AURIGENE: INTERNAL PIPELINE - ANNEXURE : Key highlights of the warning letter
LUPIN LIMITED :Potential of Complex Generics and Gavis Integration Yet to Unfold - Table 1 Lupin Limited NET SALES MIX: 2QFY16 - Figure 1 Lupin Limited COMBINED ENTITY: LUPIN + GAVIS - Figure 1 Lupin Limited COMBINED ENTITY: LUPIN + GAVIS - Figure 2 Lupin Limited INCREASED COMPETITION LED TO DECLINED MARKET SHARE IN US -Table 2 Lupin Limited US APPROVALS IN 9MFY16 - Table 3 Lupin Limited US: SELECT UPCOMING ANDAs OPPORTUNITIES - Annexure I Lupin Limited 2QFY16: SALES BREAKUP, GEOGRAPHY-WISE - Annexure III Lupin Limited COMBINED CAPABILITIES: GAVIS + LUPIN
NATCO PHARMA : Leading Oncology Company In India - Targeting US market with less competitive and high complex Drugs -Table 1 NATCO Pharma KEY ANDAs PIPELINE
List of Tables
Table 1 :Aurobindo Pharma GLOBAL REGULATORY FILINGS Table 2 :Aurobindo Pharma KEY ANDAs APPROVAL IN 1H16 Table 1 :Cadila Healthcare Ltd. KEY TRANSDERMAL PRODUCTS Table 1 :Cipla Ltd. INVAGEN'S SELECT PARA IV OPPORTUNITIES Table 2 :Cipla Ltd. INVAGEN: HIGHEST MARKET SHARE PRODUCTS - TOP 5 ANNEXURE I : Cipla Ltd. INVAGEN'S CURRENT PRODUCTS Table 1 :Dr Reddy's Ltd.FACING COMPETITION IN US: MARKET SHARE OF KEY INJECTABLES Table 1 :Lupin Limited NET SALES MIX: 2QFY16 Table 2 :Lupin Limited US APPROVALS IN 9MFY16 Table 3 :Lupin Limited US: SELECT UPCOMING ANDAs OPPORTUNITIES Annexure I : Lupin Limited 2QFY16: SALES BREAKUP, GEOGRAPHY-WISE Annexure II :Lupin Limited LPC'S ACQUISITIONS IN OTHER EMERGING MARKETS Annexure III :Lupin Limited COMBINED CAPABILITIES: GAVIS + LUPIN Annexure II Lupin Limited PORTFOLIO OF APPROVED DRUGS: GAVIS + NOVEL LAB Table 1 :NATCO Pharma KEY ANDAs PIPELINE
List of Figures
Figure 1 :Cipla Ltd. GENERIC NEXIUM'S MARKET SHARE TREND Figure 1:Dr. Reddy's Lab PENDING ANDAs(76) BY DOSAGE FORM& SELECT OPPORTUNITIESFigure 2 Dr. Reddy's Lab AURIGENE: INTERNAL PIPELINE Figure 1 :Lupin Limited COMBINED ENTITY: LUPIN + GAVIS Figure 2 :Lupin Limited INCREASED COMPETITION LED TO DECLINED MARKET SHARE IN US
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