The E7 economies represent increasing opportunities for pharmaceutical companies constrained by maturing markets in the west.
Huge potential in E7 markets
The emerging E7 countries represent the best prospect for growth. The potential of these countries is huge: they have a combined population of over three billion people, and their economies are performing well. One consequence of this increasing wealth is a growing financial capacity to treat previously unmet health needs. Another is increasing incidence of 'affluence' diseases such as diabetes, as people live longer and have more sedentary lifestyles.
HIGHLIGHTS FROM THE REGION...
The government aims to encourage the development of biosimilar drugs. In 2012, ANVISA is expected to publish specific guidelines for the development of biosimilars of monoclonal antibodies. In October 2011, ANVISA published four guidelines for biosimilars. Along with these guidelines, ANVISA created a technical chamber for biologics and posted the main regulations, including those for the registration and post-registration, on its website in 2011. The Ministry of Health is very keen to encourage the local production of biosimilars. As part of these efforts, for instance, the Ministry of Health and the government of Sao Paulo signed an agreement with Instituto Butantan in December 2011. Local companies also consider the biosimilar sector very attractive, therefore a number of initiatives are in the pipeline. Foreign companies have also shown interest. Amgen, for example, acquired the local producer Bergamo in April 2011, and reacquired a number of products previously licensed to Mantercorp, which was acquired by Hypermarcas in January 2011. Novartis has confirmed its plans to build a plant for the production of vaccines against meningococcal B within three years.
The MoH has made lowering drug prices a top priority for health authorities in 2011. The National Development and Reform Commission (NDRC) implemented two rounds of drug price reductions in 2011, one in March and the other in September. Most of the drugs reduced were manufactured by multinationals, which had previously not been subject to pricing controls. In terms of regulatory developments, the SFDA started to inspect overseas manufacturing facilities in November 2011, as the agency seeks to align its practices with international standards. In July 2011, the MoH revealed that it may introduce mandatory licensing policy to secure cheaper drugs for HIV/AIDS patients, as part of the country’s universal health coverage programme. In January 2011, the MoH announced that the Essential Drugs List would be further expanded to cover nearly all government-sponsored grass-roots health institutions.
The need to maintain low prices for essential medicines has been addressed in the government’s draft National Pharmaceutical Pricing Policy (NPPP), released in 2011. The proposed NPPP focuses on the National List of Essential Medicines (NLEM), which is periodically revised. The headline major change is a move from the principle of cost-based pricing to a market-based pricing model. The Department of Pharmaceuticals argues that market-based pricing would result in more transparent and fair pricing, as well as increasing competition in the marketplace. Price regulation will encompass all drugs listed in the NLEM, as well as formulations containing combinations of drugs listed in the NLEM; this will include combinations comprising listed drugs and unlisted drugs. If the NPPP is implemented, around 60% of the drugs currently available in India will come under price control.
Due to the sheer size of the population, Indonesia cannot simply be dismissed. The Indonesian pharmaceutical market is projected to grow at a high single-digit CAGR in US dollar terms during the forecast period, and it will be the sixth largest pharmaceutical market in the Asia Pacific region by 2016. In 2010, there were around 250 pharmaceutical manufacturers, with the vast majority located in Java. However, despite the country possessing huge manufacturing capabilities, the complete lack of R&D in local companies could affect the market, especially if IPR regulations were tightened. Although multinationals will be unhappy at the legislation requiring all drugs in the Indonesian market to have been manufactured in Indonesia, it could potentially reduce costs in the long term for both the manufacturer and the consumer.
Mexico aims to become a global leader in the regulation of biologic and biosimilar medicines. A new decree that reformed and updated the Regulation of Health Supplies (RIS) in terms of biologic medicines was signed and published in the official bulletin (DOF) in October 2011. The new decree provides the legal requirements for any company interested in registering a biologic or “biocomparable” drug in Mexico; Mexico has opted for using the “biocomparable” term rather than the most commonly used “biosimilar” term to define off-patent biologics “comparable” with innovative biologics. The new decree will be enforced 180 days after its publication in the DOF; any registration requests for biologic medicines remaining on the enforcement date will be resolved according to the requirements valid when the original submission took place.
The Russian pharmaceutical market is the largest in Central & Eastern Europe (CEE) and accounts for two-fifths of the total CEE pharmaceutical market, due to its large economy and population. However, Russia has one of the smallest per capita pharmaceutical spending, comparable to Romania. The Russian pharmaceutical market is projected to expand at a double-digit CAGR in US dollar terms between 2011 and 2016. It will continue to be driven by import growth; imports registered a double-digit CAGR between 2006 and 2010. In fact, a heavy reliance on imports has resulted from the lack of locally-manufactured innovative pharmaceuticals. A strategy for encouraging growth in the Russian pharmaceutical industry for the period up to 2020 envisages the government helping local producers to cover the costs of the R&D that is required to boost production of innovative pharmaceuticals.
There have been a number of recent acquisitions by foreign pharmaceutical companies. In September 2011, Italy’s Recordati successfully concluded its acquisition of Dr F Frik Ilac, headquartered in Istanbul. This was Recordati’s second acquisition in Turkey, following the acquisition of Yeni Ilac in 2008. In September 2011, USA’s Eli Lilly began talks to invest in and form a partnership with Mustafa Nevzat (MN) Pharmaceuticals; it is also possible that MN could sell a stake to a Middle Eastern sovereign wealth fund. In May 2011, Poland's Polpharma acquired a majority of shares in Cenovapharma. In April 2011, Nycomed entered into several agreements with various local pharmaceutical companies to replace Biomeks Ilac as the marketing authorisation holder and distributor for the majority of the company's product portfolio in Turkey. Local companies are strengthening their position in the local market by expanding manufacturing capabilities. Additionally, some of them are focusing on external markets. In May 2011, for instance, MN began construction of what will become a major manufacturing facility at Yangzhou, between Shanghai and Beijing, China.
THESE REPORTS ANALYSE THE ISSUES
The E7: The Outlook for Pharmaceuticals is a unique collection of management reports from Espicom Business Intelligence. Each report provides individual and highly-detailed analysis of each market, looking at the key regulatory, political, economic and corporate developments in the wider context of market structure, service and access. The reports are available individually, or as a discounted collection, and prices include 4 completely updated reports sent quarterly, together with a comprehensive statistical appendix. There are over 60 markets covered in the worldwide series.
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