WHITE PAPER PHARMERGING MARKETS. Pharmerging markets. Picking a pathway to success

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1 WHITE PAPER PHARMERGING MARKETS Pharmerging markets Picking a pathway to success

2 PHARMERGING MARKETS 1 With slow growth for pharmaceutical sales in developed markets, multinational companies (MNCs) have placed substantial organic and inorganic investments into emerging markets in recent years. The revenue driver at almost all MNCs remains the innovative medicines portfolio, despite some companies diversification into generics, consumer medicines, diagnostics and other related healthcare markets. However, generics account for half the sales and more than half of the growth in emerging markets. The wide range of potential for generics and originals, and the differences in healthcare and business environments across the countries, make it a challenge to prioritize those investments and build the product portfolios to succeed. In this paper we characterize more precisely the areas of greatest opportunity for multinational companies in these markets and describe strategies for profitable growth. 1. Where is the future growth for pharmaceuticals? In 2010, IMS Health redefined the Pharmerging markets by identifying the 17 key geographies based on macroeconomic metrics and pharmaceutical market forecasts. In the latest IMS Health evaluation, we increased the count to 21 countries with the addition of Algeria, Colombia, Saudi Arabia and Nigeria. These 21 Pharmerging countries will together add $187bn in annual sales between 2012 and This is two thirds of global pharma growth and will increase the pharmerging markets global share from 23% in 2012 to 33% in 2017, with all 4 BRIC (Brazil, Russia, India, China) countries in the top 10 by sales value. FIGURE 1: GLOBAL PHARMA SALES $LC Bn 1,200 1, (F) CAGR (F) % Pharmerging markets Other developed markets 13% 7% 2% 2% Other emerging markets Top 8 Mature markets Source: IMS Health Global Market Prognosis, May 2013, at ex-manufacturer price levels, constant local currency (LC) $. Contains Audited + Unaudited data Between 2012 and 2017, Pharmerging markets have growth rates far higher than in mature markets: forecast 13% CAGR vs. 2% for the top 8 mature markets. Pharmerging definition: The study first divided the global economy into developed and emerging sectors, using a per capita GDP threshold of US$25,000. Countries classified as emerging were then sub-divided using market data forecasts from IMS Market Prognosis, which are based on a rigorous evaluation of the key events impacting the pharmaceutical and healthcare industries worldwide. The latest and refined definition ranked Pharmerging markets on the basis of their minimum anticipated added value to the total pharmaceutical market between 2012 and Latest evaluation was done in December 2012.

3 PHARMERGING MARKETS 2 Pharmerging markets will move from representing a fourth of the global pharma market in 2012 to a third by 2017, with growth mainly driven by government healthcare investment, private and out-of-pocket spend, and the increasing burden of chronic disease. Tier 1: China. Alone it will account for nearly half of Pharmerging market growth and is expected to become number two in the world pharma rankings in 2015 (including formulated traditional Chinese medicines). It is one of the world s fastest growing pharma markets with a CAGR of 16.7% forecast between 2012 and Despite the recent EDL (Essential Drug List) revision and associated policies, growth will be driven by the additional investment in healthcare from the Chinese government and the rising affluence of patients paying out-ofpocket for premium products. The government is implementing a four-year plan (2012 to 2015) for the prevention and control of chronic diseases which already account for the bulk of healthcare spending in the country. Tier 2: FIGURE 2: PHARMERGING MARKET SALES Tier 1 (China) Tier 3 Higher drug sales per capita Tier 2 (BR, RU, IN) Tier 3 Lower drug sales per capita Source: IMS Health Global Market Prognosis, May 2013, at ex-manufacturer price levels, constant local currency (LC) $. Contains Audited + Unaudited data. Brazil. Despite a slowdown in economic growth, price pressures and government cost containment measures, private healthcare, consumer medicines and the enhancement of current public healthcare provision will continue to drive forecast growth of a CAGR of 12.7% between 2012 and india. India is forecast to grow at a CAGR of 12.5% between 2012 and By 2016, health insurance is planned to reach half of the Indian population (630 million people), mainly by broadening basic healthcare provision to families living below the poverty line. Urban middle class private healthcare plans will also expand further. Both are helping to drive growth. russia. IMS forecasts 10.1% CAGR between 2012 and This is mainly due to a significant investment in healthcare by the government, which announced plans to increase healthcare spending from 5.6% of GDP in 2012 to 7.5% by 2020, including a national health insurance scheme covering drugs in the retail setting. Growth is, however, slowing due to price controls and a slowdown in the overall economy, which is heavily dependent on oil and gas export prices % 12% 9% 11% (F) CAGR (F) %

4 PHARMERGING MARKETS 3 Tier 3: These 17 markets represent a wide array of income levels, growth rates and healthcare sophistication. In this study, we classify Tier 3 countries into two groups based on average pharmaceutical spend per capita to highlight differences between them. Countries with 2012 pharma sales above $85 per capita: Poland, Argentina, Turkey, Mexico, Venezuela, Romania, Saudi Arabia and Colombia. IMS forecasts these eight countries will grow at 9% CAGR in reaching a combined market size of $82bn in Countries with 2012 pharma sales below $85 per capita: Vietnam, South Africa, Algeria, Thailand, Indonesia, Egypt, Pakistan, Nigeria and Ukraine. IMS forecasts these nine countries will grow at 11% CAGR reaching a combined market size of $45bn in FIGURE 3: 2012 PHARMA SALES PER CAPITA IN TIER 3 COUNTRIES 2012 Pharma sales >$85 per capita 2012 Pharma sales <$85 per capita PL AR TR MX VZ RO SA CO VN ZA AL TH ID EG PK NG UA Population (2012) 397Mn Population (2012) 982Mn GDP (PPP 2011) $6.4Tn GDP (PPP 2011) $4.3Tn GDP per pop (PPP 2011) $14.9k GDP per pop (PPP 2011) $5.9k Pharma CAGR % Pharma CAGR % 2017 Pharma Sales $82Bn 2017 Pharma Sales $45Bn Pharma sales per capita range $96-$222 Pharma sales per capita range $7-$81 Over half urban population Higher government healthcare spend Stricter cost containment measures Typically better intellectual tual property (IP) protection tion Over half rural population (except AL & ZA) Higher poverty rate Higher out of pocket healthcare spend More limited access to healthcare e IMS Health Global Market Prognosis, May 2013, at ex-manufacturer price levels, constant local currency (LC) $. Contains Audited + Unaudited data, CIA Factbook, IMF

5 PHARMERGING MARKETS 4 FIGURE 4: PHARMERGING MARKETS Tier 1 & 2 countries Tier 3 countries New Tier 3 countries FIGURE 5: GROWTH DRIVERS FOR NEW TIER 3 COUNTRIES Pharma sales (LC$) Growth drivers Algeria Saudi Arabia Colombia Nigeria 2012: $3.0Bn 2017 (F): $4.3Bn 2012: $4.6Bn 2017 (F): $7.0Bn 2012: $4.3Bn 2017 (F): $5.3Bn 2012: $1.4Bn 2017 (F): $2.6Bn Continued government investment in a sophisticated healthcare system (79% of spend is public) Private medical insurance Increased lifestyle diseases New 5 year healthcare plan Well-funded national tenders Social health insurance coverage increase Demand for quality healthcare from a growing wealthy middle class Economic growth driven by oil exports IMS Health Global Market Prognosis, May 2013, at ex-manufacturer price levels, LC$. Contains Audited + Unaudited data

6 PHARMERGING MARKETS 5 Frontier countries Further business opportunities can be seen in the Frontier markets. Frontier markets have the potential to become important markets as companies look for further growth opportunities. Combined, IMS forecasts these markets will add an additional $9.1bn in annual sales by With half of the Frontier markets in Africa and the Middle East, the potential of this region is becoming more evident. FIGURE 6: FRONTIER COUNTRIES FORECAST SALES $ $1.0BN INCREMENTAL IN THE NEXT 5 YEARS expected sales increase Asia Pacific $2.2Bn incremental Latin America $2.5Bn incremental east europe $0.8Bn incremental Middle east $1.7Bn incremental Africa $1.9Bn incremental Country Pharma Sales 2012 CAGr Philippines $3.0Bn 3.8% Malaysia $1.6Bn 8.3% Bangladesh $1.3Bn 10.4% Chile $2.3Bn 8.2% Peru $1.5Bn 7.8% Ecuador $1.3Bn 8.6% Kazakhstan $1.3Bn 10.3% Iran $2.6Bn 5.0% U.A.E $1.3Bn 8.9% Lebanon $0.8Bn 6.6% Morocco $1.2Bn 4.5% Tunisia $0.8Bn 10.0% Ghana $0.8Bn 12.4% Kenya $0.5Bn 16.9% Ethiopia $0.4Bn 10.0% Source: IMS Health Global Market Prognosis, May 2013, at ex-manufacturer price levels, LC$. Contains Audited + Unaudited data Africa s potential will reward commitment, engagement and a business model that strengthens the path to market and patient. Hurdles notwithstanding, there is a very real opportunity for the pharmaceutical industry in Africa. This will require long-term commitment and willingness to navigate the complexities and make difficult decisions to optimize margins, volumes and the investment required to build the path to market and patient. Engagement with this market now and in the long term will provide a robust platform for companies to shape the pharmaceutical industry dynamics alongside the broader healthcare environment in Africa. Source: IMS White paper Africa: a ripe opportunity, IMS Health, December 2012

7 PHARMERGING MARKETS 6 2. How are multinational companies performing in the originals and generics market segments? Sales growth in Pharmerging markets is attractive: the top 50 pharmacos grew at 9% across these countries in 2012 but shrank -2% in the top eight mature markets. While all promote their original brands, efforts behind other types of products vary. For example, Pfizer and Sanofi have invested in generics, Novo Nordisk and Roche stick predominantly to their innovative specialty portfolios, and Boehringer Ingelheim, Bayer, GSK and Teva (through its partnership with Procter & Gamble) have high consumer health sales. The product mix in Pharmerging markets is very different to that in mature markets, as shown in Figure 7. FIGURE 7: PRODUCT MIX IN PHARMERGING MARKETS Pharmerging Sales, LC$Bn Top 8 mature markets sales, LC$Bn CAGR Segment Pharmerging Mature Original brands 8.6% -0.7% Other 17.2% 2.7% Generic 15.0% 9.2% Source: IMS MIDAS, MAT 2012, LC$, Market Segmentation + LIC countries. LIC Countries are Argentina, China, Colombia, Egypt, Indonesia, Pakistan, Saudi Arabia, Thailand and Venezuela. Excludes Vietnam, Romania and Algeria. No data for Ukraine & Nigeria. Top 8 includes EU5, Japan, USCan. Non retail panel included for Brazil and Mexico CONSUMER MEDICINES The consumer medicines market represents approximately 30% of Pharmerging Markets sales (depending on definition). It does not face the same pricing threats as the Rx segment and benefits from high rates of self-medication and the power of brand equity. It is a highly competitive market with dynamics that vary by country and by product category and is growing faster than original prescription products. We will examine this market in an upcoming white paper on this topic to be published in 2013.

8 PHARMERGING MARKETS 7 A. Multinationals in the generics segment Generics delivered sales of $74bn at list price in 2012 in Pharmerging markets, accounting for more than half of sales growth. The explosive growth seen in recent years has slowed down. But at 15% in 2010 to 2012 generics still outpace originals and remain attractive for many companies. MACROECONOMIC FACTORS There are several reasons why generics will remain strong in these countries: Affordability is a substantial challenge for both governments and patients and the cheapest options are typically generics Weaker IP protection in some countries expands the playing field for generics companies Government policies and behaviors often favor local manufacturers, which are generally manufacturers of generic products rather than originals FIGURE 8: PHARMERGING MARKETS GENERIC SEGMENT GROWTH DYNAMICS CAGR Multinational companies Tier 3 - low spend Russia India Brazil China Tier 3 - high spend CAGR Local and regional companies Bubble size = 2012 total generic market sales Source: IMS Health, MIDAS, Full Year 2012, Corporation categorization. Excludes Vietnam, Romania, Algeria, Ukraine & Nigeria, Non retail panel included for Brazil and Mexico Importance to customers, tight control of costs, and rapid responses to changes in prices or competitive environment are all important levers for success when selling generics. Local and regional players outpace international players in this sector across pharmerging markets (Figure 8). They often have large portfolios, integrated distributors, strong stakeholder relationships, and quick decisionmaking processes to help out-compete foreign manufacturers. Local business practices can also act as a barrier for foreign companies. Several Pharmerging countries, including Algeria, Indonesia, Russia, Saudi Arabia and Turkey, have policies that provide price or access advantages to companies that manufacture locally. This creates a significant hurdle to foreign companies looking to import generics manufactured cheaply elsewhere.

9 PHARMERGING MARKETS 8 Despite the challenges, several MNCs remain attracted by the size and growth rates of generic market companies in Pharmerging countries. In almost all of these countries, physicians still write branded prescriptions that drive growth for unprotected originals and branded generics. MNCs that sell branded generics are often looking for synergies, market power and efficiencies of scale by promoting unprotected original brands alongside branded generics. The brand acts as a guarantee of quality to doctors and patients concerned about poorly manufactured or counterfeit drugs that may be ineffective or unsafe. Multinationals reputation for quality products counts in their favor. Local and regional players in the generic sector are growing faster than MNCs in all Pharmerging markets. Their large portfolios, integrated distributors, fast decision-making, and strong stakeholder relationships help them out-compete foreign manufacturers. There is significant merger and acquisition (M&A) activity, especially in China and India (Figure 9), as some companies consolidate to gain scale and others use acquired companies as a market entry strategy to expand across countries. Large multinationals represent a small share of overall M&A activity, with over 90% of deals in Brazil, India and China conducted by smaller foreign companies and local players. Local manufacturers in these countries, especially China, remain fragmented and consolidation will continue. FIGURE 9: DEALS IN KEY ASIAN AND LATIN AMERICAN MARKETS (JAN FEB 2013) No. Deals in key Asian & Latin American markets (Jan 2008-Feb 2013) Latin America Brazil Mexico Argentina Venezuela Asia China India Indonesia Vietnam Deals involving local companies Deals involving foreign companies only Source: Analysis based on deals contained in IMS PharmaDeals database; all deal types included

10 PHARMERGING MARKETS 9 To build generic business in Pharmerging markets, it takes many years to accumulate a large product portfolio organically, to have an effective infrastructure to manage complex supply chains, and to develop the necessary stakeholder relationships. As a result, companies (including local players with regional ambitions) typically acquire or partner with local players and invest to expand, rather than starting from scratch. For example, Teva is scaling up in Pharmerging by acquiring companies in China and other Pharmerging and Frontier countries. In a recent interview, Teva s Chief Financial Officer Eyal Desheh said: We ll have to go one by one, a lot of footwork, country by country. None of these will be huge acquisitions and this push may take a few years. (Bloomberg) Nevertheless, integrating an acquired company with an existing affiliate can be a challenge, with high transaction costs, loss of key talent and other problems. Rather than integrating operations, one strategy has been to transfer unprotected original drugs and other assets to the acquired company, with the expectation of better sales results. Joint ventures, out-licensing and other types of commercialization deals are more common as MNCs look to access cost-efficient and effective sales and marketing power without the risk of a major investment. Acquisitions of local players typically fulfill operational challenges in the generic segment and strategic objectives such as regional expansion or access to a product portfolio to sell globally. Joint ventures and other partnerships are more common, delivering less control and retained margin but also reduced risk. FUTURE TRENDS Looking ahead, several trends will change the face of generics in Pharmerging markets: Decline of branded generics Improved manufacturing standards Fewer players and business models 1. Branded generics business growth will slow down due to payer pressure to reduce costs via the commoditization of the generics market, with two important caveats: In many countries it will be years if not decades before the balance shifts from the branded model to a commodity model Brands will remain strong in the out-of-pocket and OTC market segments

11 PHARMERGING MARKETS improved manufacturing standards will reduce the power of the brand as a surrogate for product quality: With more consistent quality standards, branded generics will lose part of their value proposition, and the price differentials between branded and unbranded generics will narrow. Some unprotected original products will take large price cuts to compete, while others will see fast erosion of share Many local players will find GMP compliance difficult and may be bought or exit the market 3. A few dominant players and business models will emerge as generics markets commoditize, though many companies will pursue more than one: Some manufacturers have or will reach sufficient size to be one of a small number of players in each country with the economies of scale and market power to drive larger profits in a price competitive arena Companies can focus on more differentiated prescription products (e.g. reformulations, devices) and consumer medicines where brand power will remain strong. Non-original biologics will be an important niche within this business model Some companies will drive costs down low enough to win simply on price alone, though the margins will be low and the cost structures difficult to replicate for more diversified or sophisticated multinationals 4. Partnerships and acquisitions will remain an important mode of entry for MNCs that do not already have a substantial local presence in generics: Local players can act as the commercial arm of multinational companies, using their distribution, sales and marketing capabilities to deliver strong top-line results

12 PHARMERGING MARKETS 11 B. Multinationals in the original brands segment Despite the power and dominance of generics in Pharmerging markets, original products still hold a substantial share of sales and experience growth rates far higher than in developed countries. This is true for both products that have generic competition and those that are protected. Governments are pushing down prices in almost all Pharmerging markets, so growth is driven mostly by volume. Many of the sales and marketing activities to promote innovative products in Pharmerging markets are similar to those in mature markets. Two important differences are the continuing strength of original brands even after generic competition and the additional challenges to achieve desired prices and access funding, especially for niche products. MACROECONOMIC FACTORS Demand for quality medicines has always existed in these traditionally under-served markets. Two significant trends enable innovative companies to serve a growing number of patients: Economic growth increases the size of the affluent population that can afford out-of-pocket (OOP) payments or private insurance, and increasing tax revenues increase governments ability to reimburse drugs Governments are responding to citizens demands for healthcare by improving infrastructure, which in turn improves diagnosis rates and the supply of qualified personnel to administer the more complex treatment protocols associated with some innovative drugs China is often held up as the dominant Pharmerging market, but ranking countries on original brand sales instead of total sales reveals a different picture. While some of the large but less-developed countries, such as India and Indonesia, drop down the ranking, Brazil, Mexico, Russia and Turkey together have more than double the original products sales in China. Business practices in these countries are closer to the developed country norms that MNCs know best. FIGURE 10: MARKET VALUE COMPARISON LC$Bn China Brazil Russia India Mexico Turkey Venezuela Poland Argentina Indonesia S. Africa Thailand Egypt Saudi Arabia Colombia Pakistan 2012 Total Pharma Market Value 2012 Original Brand Market Value Large Pharma Other Players Sales ranked by pharma market value (MIDAS) Source: IMS Health, MIDAS, Full Year 2012, LC$ Note: MIDAS reports different figures from Market Prognosis. Excludes Vietnam, Romania and Algeria as no market segmentation available for these countries. No data for Ukraine & Nigeria. Non retail panel included for Brazil and Mexico

13 PHARMERGING MARKETS 12 Top 20 brands The top 20 brands in Pharmerging markets present an interesting mix of products: Most are for chronic conditions, such as hypertension and diabetes A larger number are older products (>20 years) than in mature markets, including Voltaren and Augmentin, launched over 30 years ago The top two brands, Plavix and Lipitor, are both still growing despite widespread generic competition Despite affordability challenges, several biologics make the list, with Herceptin, Mabthera, Lantus, Novomix and Lovenox all in the top 12 Despite only being available in China, three formulated traditional Chinese medicine (TCM) products make the list The top 20 brands still benefit from average growth of 15% versus 5% in mature markets FIGURE 11: TOP 20 BRANDS BY 2012 SALES Top 20 Drugs in Pharmerging markets Top 20 Drugs in top 8 mature markets Sales in $M FY 2012 Plavix Lipitor Lantus Nexium Voltaren Seretide Mabthera Augmentin Herceptin Crestor Novomix Lovenox Cialis Glivec Shen Jie Shu Xue Ning Diovan Xue Shuan Tong Betaloc Pantozol % 14% 20% 17% 13% 11% 30% 13% 29% 6% 12% 6% 8% -13% 43% 20% 3% 23% 15% 19% Average growth year on year = 15% Sales in $M FY 2012 Seretide Humira Crestor Abilify Enbrel Nexium Remicade Lantus Cymbalta Mabthera Avastin Plavix Spiriva Singulair Copaxone Neulasta Lyrica Januvia Herceptin Atripla 0 2,000 4, years ago years ago years ago 30+ years ago 6,000 8,000 7,462 7,268 6,972 6,613 6,608 6,429 6,380 5,536 5,443 4,827 4,590 4,303 4,279 4,149 4,126 3,934 3,853 3,790 3,757 3,741 1% 20% 3% 12% 10% -8% 11% 20% 24% 7% 3% -49% 11% -26% 11% 3% 14% 25% 7% 10% Average growth year on year = 5% Source: IMS MIDAS, Full Year-2012, LC$. No data for Ukraine & Nigeria Source: IMS MIDAS, Full Year-2012, LC$. Top 5EU, USCAN, Japan

14 PHARMERGING MARKETS 13 LAUNCHING NEW PRODUCTS In a recent study, Launch Excellence IV, IMS Health showed that BRICMT countries account for only 3.5% of first year sales of recently launched New Chemical Entities (NCE). This number should increase as the markets mature but it will be many years before widespread reimbursement and healthcare spend levels can support a substantially larger share of new launch value. Pharmerging markets represent approximately 10% of the global market for original drugs and new drugs face significant challenges in terms of affordability, IP protection and delays. For these reasons, Pharmerging countries are not a major contributor to global launch success. FIGURE 12: PHARMERGING MARKETS SHARE OF GLOBAL LAUNCH SALES Pharmerging Markets Sales 58.0% USA Six pharmerging markets contributed only 3.5% of global first year sales Brazil Turkey China Mexico Russia India 1.1% 0.6% 0.2% 0.4% 0.5% 0.6% n= % 6.5% 7.8% 4.6% 3.5% Japan France Germany Spain Italy Canada Australia UK South Korea 1 Year Six pharmerging markets contributed only 3.5% of global first year sales This is less than the cumulative contribution of any single European country This is less than the cumulative contribution of any single European country NOTE: NCE launches from 2004 to 2011, Country contribution is calculated based on the accumulative sales of these launches All launch years normalized for each country. The 16 selected countries are representing 80% of the total global pharmaceutical market Source: IMS Launch Excellence IV What does the market for original brands look like without NCE launches and how does it compare to the top eight mature markets? Excluding launches since 2008, Pharmerging markets CAGR for original brands in would have been 7.0%, instead of 9.8%. The impact of new launches in the top eight mature markets was similar, with a 3.5% difference. The importance of launch in Pharmerging markets is therefore nearly as big as in mature markets.

15 PHARMERGING MARKETS 14 FIGURE 13: CONTRIBUTION OF NEW LAUNCHES TO ORIGINAL BRAND SALES Pharmerging original brand sales, US$Bn Top 8 Mature original brand sales, US$Bn Products over 10 years old Products 5-10 years old Recent Launches CAGR Sales of original brands by launch year Pharmerging Top 8 Mature Only products >10 years old Only products >5 years old All products, including recent launches 5.3% 7.0% 9.8% -6.9% -2.0% 1.5% Source: IMS Health, MIDAS, Full Year Excludes Vietnam, Romania and Algeria. No data for Ukraine & Nigeria, launch categorisation recent launches between , drugs launched between and drugs launched before 2003 GROWTH FOR UNPROTECTED ORIGINAL DRUGS Original products in Pharmerging markets can enjoy success long after generics enter. In some countries it has been common for generic versions, legal or otherwise, to be present before the original even launches. Yet many older brands continue to thrive. In aggregate, original drugs launched more than five years ago are still growing despite widespread generic competition. However, unprotected original drugs are coming under increasing pressure from governments and payers, who want patients and their budgets to benefit from the cost savings from generics. This trend will continue as healthcare reforms increase reimbursement for retail-dispensed drugs. These can take several forms. For example: Steep price cuts, such as those enforced for reimbursed drugs in Turkey Competitive tenders, such as those run by states under Seguro Popular in Mexico Incentives that create price competition and lead to low reimbursed prices for listed drugs, such as those covered by Farmácia Popular do Brasil and likely to be emulated by the national health insurance plans announced in Russia and Indonesia

16 PHARMERGING MARKETS 15 Companies respond by cutting prices to compete with generics, as seen with Cozaar sold under Farmácia Popular do Brasil. Others keep prices high and compete in the smaller-volume private or out-of-pocket segments. The impact is greatest on primary care and widely-prescribed specialist care drug classes as these are priorities for governments expanding healthcare access. The importance of launching new innovative products in Pharmerging markets is nearly as great as it is in mature markets as we see unprotected original drugs coming under increasing payer pressure. ACCESS HURDLES IMS Consulting recently conducted a survey of 85 senior pharmaceutical executives in emerging markets to identify the key challenges they face. Pricing and market access issues dominated with about half of all mentions. FIGURE 14: CLIENT ISSUES SURVEY RESULTS Over the next 12 months Over the next 3 5 years Market issues category # of mentions Market issues category # of mentions Pricing & Market Access 70 Volatile business environment 28 Regulatory 25 Competition 18 Pricing & Market Access 86 Competition 29 Volatile business environment 15 Regulatory 8 Shift in demand (chronic therapy and older population) 3 The role of price cuts in driving access and volume growth is increasingly being recognized in Pharmerging markets. GSK created a Developing Countries Unit that, among other strategies, caps prices at no more than 25% of the UK price and reinvests 20% of any profits back into the healthcare infrastructure of the countries it covers (GSK website). Price reductions [in China] are in many ways very important in driving the access and take-up of healthcare coverage, GSK Chief Financial Officer Simon Dingemans said, adding we see very good volume response to that, which shows the strategy is working (Bloomberg).

17 PHARMERGING MARKETS 16 Historically, many companies tried to protect the price points of innovative treatments, leading to prices in Pharmerging markets that were out of reach for the majority of patients paying out-of-pocket. For governments to fund these products would have caused excessive stress on their budgets. Governments in Pharmerging markets have most often responded with severe restrictions on the funds available for these drugs. They have also purchased drugs through tenders to hide the true purchase price from public view and allow companies to sell at lower prices that are not referenced formally or informally by other payers. Despite the price flexibility shown to date, many governments are concerned about affordability and have responded with a variety of moves, ranging from complex outcomes-based deals to simple rejection of funding for specific drugs. Compulsory licensing is one of the most severe and visible responses. After the original actions targeting HIV drugs in Brazil and South Africa in 2001, the focus has shifted to include oncology drugs. The greatest threat is in India which has used compulsory licensing and patent revocations to allow generic versions of nine high-priced drugs to date. Governments are also looking to encourage local investments in innovative products. Many extend local manufacturing requirements to include innovative products while realizing that companies will not duplicate production lines for more complex products. The largest countries are taking actions in other parts of the value chain, such as Russia and China demanding local clinical trials prior to approval, and Brazil creating strong incentives to execute technology transfer deals to local companies. FIGURE 15: TIMELINE OF COMPULSORY LICENSING AND PATIENT REVOCATION IN EMERGING MARKETS Compulsory licensing provisions in WTO TRIPS authorizes a 3rd party to make, use or sell a patented ed drug without the patent owner s consent Timeline of compulsory licensing and patent revocation in emerging markets Tamiflu Compulsory Licensed Oncology therapies Compulsory in Taiwan, Korea and China Licensed in Thailand Mar Nexavar Compulsory Licensed in India Apr Nov Sept. Nov WTO Doha Declaration Agreement TRIPS Signed Signed Patent t Infringement ARVs Compulsory Licensed across of Pegasys, Sutent, Latin America, Africa, and SE Asia and Tarceva in India 2007 Oct Oncology HIV/AIDS Other TAs Plavix Compulsory Licensed in Thailand Compulsory Licensing of HIV and HBV Drugs in Indonesia Source: IMS Consulting Group white paper, Securing IP and Access to Medicine: Is Oncology the Next HIV

18 PHARMERGING MARKETS 17 Originators often address the affordability hurdle by lowering the net price using discounts and rebates that do not affect the list price, which can create price reference challenges in mature markets. Several are trying more innovative approaches with price-volume agreements, outcomes-based pricing models and risk sharing agreements. Issues of corporate social responsibility also come into play, with companies providing extensive patient access programs, gifts of free goods or at-cost sales. Companies aim to improve patient access and create a positive perception. For example: Genzyme, a unit of Sanofi, donates Cerezyme to Project HOPE, a humanitarian organization, which distributes the product to patients through its international infrastructure. It also has other free drug programs all over the world, particularly in the most needed geographies. Novartis has been running a worldwide patient assistance program for Glivec. For example, in Egypt, Glivec was priced so that for each bottle dispensed, patients receive three bottles free. The expected outcome is that it will strengthen partnerships with different stakeholders. Roche has found an innovative way to make cancer drugs affordable for millions in China by partnering with Swiss Re to create oncology-focused private insurance. Payers and R&D players are trying to find a trade-off between innovation and affordability. IMS recommends a collaborative approach with government and third party organizations to gain better access. FUTURE TRENDS In future, IMS expects original brand usage to evolve towards a more mature market model (Figure 16). In this journey, we expect Tier 3 higher-spend markets such as Russia and Brazil to evolve faster than India and Tier 3 lower-spend markets. The shift will proceed slower in the less developed countries because of their lower quality healthcare infrastructures and the large populations they have to cover. China s growth is partly a reflection of its increasing maturity as the government invests heavily in the healthcare system. FIGURE 16: TYPICAL USAGE CHARACTERISTICS FOR ORIGINAL DRUGS Developing market Restricted by healthcare access Innovative drugs considered a luxury good Out of pocket or via special funding Mainly for the affluent Preference for the brand (mark of quality) Costs controlled through price cuts and referencing Mature market Easy access to specialists for serious conditions Innovative drugs considered a right Reimbursed For everyone, regardless of income Receive generic where available (quality guaranteed by authorities) Costs controlled via sophisticated price evaluations and access rules Countries move towards a more mature market model

19 PHARMERGING MARKETS 18 Looking further ahead, we expect Pharmerging markets to continue towards a more sophisticated model: Decline of prescribed unprotected originals Greater sophistication of healthcare providers Higher affordability 1. The value of prescribed unprotected originals will decline due to: Greater direct competition with generics as governments use tenders and/or forced pharmacy substitution to reduce the cost of expanding retail drug reimbursement Rising generic manufacturing standards diminishing the quality perception that originals currently enjoy 2. High price specialty drugs will benefit from greater sophistication of healthcare providers Continued government investments in healthcare will improve standards Investment by drug and medical devices manufacturers in training programs and conference attendance to help up-skill specialists Appearance of new tertiary referral centers and private hospitals, often associated with famous Western hospitals, and expansion of existing ones 3. The expanding middle and upper classes in each country will increasingly be able to pay for innovative drugs, either out-of-pocket or via employer-provided coverage. According to the Economist Intelligence Unit, by 2020 three-fourths of urban Chinese households will be considered middle class. In India, the middle class population is expected to reach one billion by They will continue to be a strong driver of demand.

20 PHARMERGING MARKETS 19 Top 20 companies FIGURE 17: CORPORATION REVENUE PERFORMANCE ACROSS PHARMERGING MARKETS CAGR in pharmerging markets, % Daiichi Sankyo Pharmerging share of global sales (15%) Lilly Teva Merck & Co Roche Astellas Pharma Takeda AZ J & J BMS Novo Nordisk BI Abbott GSK Pfizer Novartis Sanofi Merck KGAA Share of pharmerging sales vs. mature markets sales for each corporation, % Bubble Size = 2012 Pharmerging Sales ($US) Bayer Pharmerging overall growth (14%) Source: IMS Health MIDAS, MAT Dec 2012.No data for Ukraine & Nigeria, non retail panel added for Brazil and Mexico Servier FIGURE 18: TOTAL OF DEALS BY LARGE PHARMA IN PHARMERGING MARKETS OVER THE LAST 5 YEARS Sanofi GSK Merck Bayer J&J Amgen AZ Daiichi Roche Novartis Takeda Abbott BI Lilly Pfizer M&A Joint Venture Manufacturing Source: IMS PharmaDeals BMS Novo Nordisk Teva Servier Merck KG MNCs have a wide range of contribution from pharmerging markets to their overall sales. The largest companies with over 20% contribuion are Sanofi and Bayer, which have both invested heavily over many years. Both companies have driven sales through large consumer health arms, and SANOFI also has a substantial generics business supported by some large acquisitions of local players such as Medley in Brazil and Kendrick in Mexico. Servier has a strong position thanks to its historic presence and long term vision with an adapted portfolio in fast growing therapy areas such as vascular, osteoporosis and diabetes.

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