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1、Q2 2012 pharmaceuticals +15.9% in local currency terms and +11.5% in US dollar terms. Our forecast has been revised upwards moderately since Q112 due to analyst intervention. ? Healthcare: INR3,353bn (US$71.8bn) in 2011 to INR3,748bn (US$77.3bn) in 2012; +11.8% in local currency terms and +7.6% in
2、US dollar terms. Our forecast has been revised downwards moderately since Q112 due to analyst intervention. ? Medical devices: INR139bn (US$3.0bn) in 2011 to INR156bn (US$3.2bn) in 2012; +12.2% in local currency terms and +8.0% in US dollar terms. Our forecast has been revised downwards significantl
3、y since Q112 due to analyst intervention. Risk/Reward Rating: Indias Q212 Pharmaceuticals Risk/Reward Rating (RRR) rating of 56.0 out of 100 is unchanged from Q112. However, the countrys ranking has increased from 10th out of 18 countries in the Asia Pacific region to ninth due to a decrease in New
4、Zealands score from 56.3 to 53.9. India scores highly for the absolute size of its pharmaceutical market, as well as projected growth, but it is let down by low annual per capita spending on medicines. Key Trends And Developments ? In December 2012, the Ministry of Commerce and Industry extended the
5、 deadline for compulsory barcodes on pharmaceutical products for foreign markets till January 2013. The deadline was previously July 1 2012, set by the Directorate General of Foreign Trade (DGFT), but it has been extended after the Pharmaceuticals Export Promotion Council (Pharmexcil) asked for more
6、 time as smaller companies lack the infrastructure to meet the original deadline. The deadline on primary packaging has been extended to early 2013 and for secondary packaging it has been extended to July 1 2012. India Pharmaceuticals however, these types of interventions are not included in our pha
7、rmaceutical market calculation. Alimentary tract, antibiotics and respiratory drugs are some of the most prominent prescription segments, as are cardiovascular and nervous system remedies, with vitamins leading the OTC sector. India accounts for almost 10% of global drug production by volume and is
8、increasingly focusing on indigenous research and development (R boost biomedical research activities; develop infrastructure; engender public-private partnerships; and oversee five state-owned drugmakers. However, we are disappointed that a framework to facilitate dialogue with the approvals agency
9、and pricing body has not been put in place. Unless all three have harmonised objectives, the Department of Pharmaceuticals may well become another layer of bureaucracy. Table: Department Of Pharmaceuticalss Reponsibilities 1. Drugs and pharmaceuticals, excluding those specifically allotted to other
10、departments. 2. Promotion and coordination of basic, applied and other research in areas related to the pharmaceutical sector. 3. Development of infrastructure, manpower and skills for the pharmaceutical sector and management of related information. 4. Education and training including high-end resea
11、rch and granting of fellowships in India and abroad, exchange of information and technical guidance on all matters relating to pharmaceutical sector. 6 .International co-operation in pharmaceutical research, including work related to international conferences in related areas in India and abroad. 7.
12、 Inter-sectoral coordination including co-ordination between organisations and institutes under the central and state governments in areas related to the subjects entrusted to the department. 8. Technical support for dealing with national hazards in the pharmaceutical sector. 9. All matters relating
13、 to the National Pharmaceutical Pricing Authority, including related functions of price control/monitoring. 10. All matters relating to the National Institutes for Pharmacy Education and Research. 11. Planning, development and control of, and assistance to, all industries dealt with by the departmen
14、t. 12. Bengal Chemicals and Pharmaceuticals Limited. 13. Hindustan Antibiotics Limited. 14. Indian Drugs and Pharmaceuticals Limited. 15. Karnataka Antibiotics and Pharmaceuticals Limited. 16. Rajasthan Drugs and Pharmaceuticals Limited. Source: Ministry of Chemicals and Fertilisers Although regulat
15、ory conditions have improved, other problems remain, especially with patent protection, a marked lack of pricing transparency and strict price controls. The legality of a vast amount of generic medicines is questionable and a sizeable counterfeit market exists. According to recent reports, India is
16、the source of about one-third of total counterfeit drug trade in Asia, with state and national governments increasingly being urged to address the issue as a public health problem. In April 2008, the World Health Organization (WHO) criticised Indias pharmaceutical regulatory system for lacking indep
17、endence, being understaffed and insufficiently rigorous. The global body has India Pharmaceuticals patent monopolies called exclusive privileges (making, selling and using inventions in India and authorising others to do so for 14 years from date of filing specification). 1872 The Patents Teva Pharm
18、aceuticals Industries Copaxone (glatiramer acetate), which is used in the treatment of multiple sclerosis; and the alpha crystalline form of Novartiss cancer drug Glivec (imatinib mesylate). During April 2009, an Indian court dismissed a plea by Roche and allowed Indian pharmaceutical company Cipla
19、to continue with the production and marketing of a generic version of the lung cancer drug Tarceva (erlotinib). The Swiss company had earlier approached the court to stop Cipla from producing and marketing its generic version of the drug till the matter of patent rights is resolved. Cipla introduced
20、 its Erlocip, a generic version of Roches patented drug, in India in January 2008. It was revealed in April 2010 that three multinational pharmaceutical companies Pfizer, Novartis and Eli Lilly had won almost a third of 81 contentious drug patents for drugs otherwise considered non- patentable in In
21、dia. The contentious patents were awarded as two important rules contained in Indias modified patents regime were allegedly violated. In May 2010, the Indian Patent Office announced that it would not grant a patent to Roches valganciclovir drug, as it did not comply with the requirement of higher th
22、erapeutic efficacy as mentioned under Clause 3(d) of the patent law. In August 2011, India-based pharmaceutical company Natco Pharma sought a compulsory licence for the commercialisation of a generic version of German drugmaker Bayers patented medicine Nexavar (sorafenib) in the Indian market. The f
23、iling was the countrys first compulsory licence application. Natco made the application as the drug was unaffordable for Indian patients. Counterfeit Medicines In January 2008, Indias Ministry of Health and Family Welfare launched a nationwide survey to establish the true scale of counterfeit medici
24、nes in the country. The results will be used to identify perpetrators and to improve measures against the practice, which has expanded despite the counterfeit- targeting Drugs and Cosmetics (Amendment) Bill 2005. A smaller investigation funded by the WHO and conducted by SEARPharm Forum (a group of
25、South East Asian regulatory agencies) in late 2007 found that just 3.1% of pharmaceuticals in India were fake or substandard, with the figure viewed as inaccurately low. Indian exports are, in particular, susceptible to counterfeiting activities. India Pharmaceuticals and Goa for formulations. Strat
26、egy BMI expects robust performance from Sanofi India as it was among the first multinational pharmaceutical companies to announce a specific strategy for penetrating Indias rural areas. The companys main competitive advantage is that it commercialises products that address chronic disease endemic in
27、 India, specifically Lantus (insulin glargine) for diabetes and Cardace (ramipril) India Pharmaceuticals or by private entities such as non-profit institutions, commercial insurances and households acting as complementary funders to the previously cited institutions or unilaterally disbursing health
28、 commodities. The revenue base of these entities varies by country and comprises multiple sources. The inclusion of this in BMI India Pharmaceuticals pharmaceutical trade associations; company press releases and annual reports; subscription information providers; local news sources; information from
29、 market research firms that is in the public domain. ? Data that has been validated by BMIs pharmaceutical and healthcare analysts using a composite approach, which scores data sources by reliability in order to ensure accuracy and consistency of historic data. ? Five key macroeconomic and demograph
30、ic variables, which have been demonstrated, through regression analysis, to have the greatest influence on the pharmaceutical market. These have been forecast by BMIs Country Risk analysts using an in-house econometric model. ? The burden of disease in a country. This is forecast in DALYs using BMIs
31、 BoDD, which is based on the WOs burden of disease projections and incorporates World Bank and IMF data. ? Subjective input and validation by BMIs pharmaceutical and healthcare analysts to take into account key events that have affected the pharmaceutical market in the recent past or that are expect
32、ed to have an impact on the countrys pharmaceutical market over the next five years. These may include policy/reimbursement decisions, new product launches or increased competition from generic drugs. India Pharmaceuticals & Healthcare Report Q2 2012 Business Monitor International Ltd Page 90 Pharma
33、ceuticals Risk/Reward Ratings Methodology BMIs approach in assessing the risk/reward balance for Pharmaceutical & Healthcare Industry investors globally is fourfold. First, we identify factors (in terms of current industry/country trends and forecast industry/country growth) representing opportuniti
34、es to would-be investors. Second, we identify country and industry-specific traits which pose or could pose operational risks to would-be investors. Third, we attempt, where possible, to identify objective indicators that may serve as proxies for issues/trends to avoid subjectivity. Finally, we use
35、BMIs proprietary Country Risk Ratings (CRR), ensuring that only the aspects most relevant to the Pharmaceutical & Healthcare Industry are incorporated. Overall, the system offers an industry-leading, comparative insight into the opportunities and risks for companies across the globe. Ratings Overvie
36、w Ratings System Conceptually, the ratings system divides into two distinct areas: Rewards: Evaluation of the sectors size and growth potential in each state, as well as broader industry/state characteristics that may inhibit its development. Risks: Evaluation of industry-specific dangers and those
37、emanating from a states political/economic profile that call into question the likelihood of anticipated returns being realised over the assessed time period. Indicators The following indicators have been used. Overall, the ratings use three subjectively measured indicators and 41 separate indicator
38、s/datasets. India Pharmaceuticals & Healthcare Report Q2 2012 Business Monitor International Ltd Page 91 Table: Pharmaceutical Business Environment Indicators Indicator Rationale Rewards Industry Rewards Market expenditure, US$bn Denotes breadth of pharmaceutical market. Large markets score higher t
39、han smaller ones Market expenditure per capita, US$ Denotes depth of pharmaceutical market. High value markets score better than low value ones Sector value growth, % y-o-y Denotes sector dynamism. Scores based on annual average growth over five-year forecast period Country Rewards Urban-rural split
40、 Urbanisation is used as a proxy for development of medical facilities. Predominantly rural states score lower Pensionable population, % of total Proportion of the population over 65. States with ageing populations tend to have higher per capita expenditure Population growth, 2003-2016 Fast-growing
41、states suggest better long-term trend growth for all industries Overall score for Country Structure is also affected by the coverage of the power transmission network across the state Risks Industry Risks Intellectual property (IP) laws Markets with fair and enforced IP regulations score higher than
42、 those with endemic counterfeiting Policy/reimbursements Markets with full and equitable access to modern medicines score higher than those with minimal state support Approvals process High scores awarded to markets with a swift appraisal system. Those that are weighted in favour of local industry o
43、r are corrupt score lower Country Risks Economic structure Rating from CRR evaluates the structural balance of the economy, noting issues such as reliance on single sectors for exports/growth, and past economic volatility Policy continuity Rating from CRR evaluates the risk of a sharp change in the
44、broad direction of government policy Bureaucracy Rating from CRR denotes ease of conducting business in the state Legal framework Rating from CRR denotes the strength of legal institutions in each state. Security of investment can be a key risk in some emerging markets Corruption Rating from CRR den
45、otes the risk of additional illegal costs/possibility of opacity in tendering/business operations affecting companies ability to compete Source: BMI India Pharmaceuticals & Healthcare Report Q2 2012 Business Monitor International Ltd Page 92 Weighting Given the number of indicators/datasets used, it
46、 would be inappropriate to give all sub-components equal weight. Consequently, the following weight has been adopted. Table: Weighting Of Components Component Weighting Rewards 60% Industry Rewards 75% Country Rewards 25% Risks 40% Industry Risks 60% Country Risks 40% Source: BMI Sources Sources used include national industry associations, government ministries, global health organisations, officially released pharmaceutical company results and international and national news agencies.