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EC Reviews: An Executive Country Review on Turkey
Since 2001, the industry has grown in value from $3.7 billion to approximately $9 billion in 2007. Behind this transformation stand a steadily growing economy, a young workforce, and increased healthcare expenditures from both the government and consumers. As a "pharmerging" market operating within a population of more than 70 million people, Turkey could surpass pharmaceutical sales of $11 billion by 2010, likely putting it among the world's top 10 pharma countries.
The country stands to benefit from a growing national population with additional consumer spending on drugs and health improvements. Just as critical will be a surge in foreign investments, brought by economic consistency and recent government healthcare reforms that have improved public access to medicine and created a medical system that is closely aligned to the standards of European Union nations.
"As the Turkish market has become a lot more stable, a lot more predictable and with better transparency, the international purchasers can begin to understand the benefits of doing business in Turkey," says Zinta Krumins, managing director of Boehringer Ingelheim in Turkey. In the past decade, Turkey has unified its Social Security system, implemented critical patent legislation (1995), and created new laws for generics registration (1996), reference pricing (2004), and data exclusivity (2005).
Investors have noticed, beginning in 2000 when the Menarini Group, Italy's largest drugmaker, purchased I.E. Ulagay, Turkey's first pharmaceutical company. The deal was viewed with extreme skepticism until I.E. Ulagay increased its value by $200 million within seven years. A spate of strategic partnerships followed: Icelandic company Actavis's takeover of Fako (2004); EastPharma's (Istanbul) acquisition of Deva (2007); Citigroup (New York) and Pils' (Austria) co-purchase of Turkish player Biofarma (2006); and the highly touted deal between Zentiva (Prague) and Eczacibasi (2007). In the latter agreement, the Czech pharma giant took a 75% stake in the Turkish pioneer's generics division, a move that not only symbolized the attractiveness of the market but also the ease that multinationals have had in imposing themselves on a burgeoning sector. Six international companies rank among Turkey's top 10 pharmaceutical sellers, including market leader Novartis (Basel) ($800 million), Sanofi-Aventis (Paris) (nearly $600 million) and GlaxoSmithKline (London) (about $450 million). With broad product portfolios, deep prescription drug pipelines and economies of scale, multinationals have quickly asserted their dominance.
Turkish companies are prospering as well. Eighty-five local manufacturers, many with family roots and post-World War II origins, have built a branded market in Turkey where generics account for more than half of total volume. Antibiotics are market bestsellers, but the main growth-drivers are products in chronic disease sectors, especially cardiology, central nervous system, and gastro-intestinal.
But with intensifying generics competition and regulators committed to containing drug costs, several Turkish manufacturers are looking to high-tech, niche products, and overseas markets for future fortune. Mustafa Nevzat, Turkey's only FDA-approved company for finished products, is nearing completion on a production facility for oncologicals that could be exporting to the United States by 2009. Fresh off new capital investments, Biofarma plans to add 13 new export territories and begin construction on a production site for cancer drugs by the end of next year.
But for all the strides made, significant obstacles lie ahead for Turkey, chief among them government inconsistency and political instability. While health regulations are nearly harmonized with those of Europe, company executives complain about poor applications of current laws, including the 210-day product registration period and a reimbursement list that is seen as biased and incomplete.
"What we would like from the government is a more effective cooperation with the industry," says Murat Barlas, chairman of Liba Laboratories. "What we are waiting for is a centralized and independent drug authority like the FDA."
Some executives also worry Turkish manufacturers are not positioned to ward off an economic downturn, especially companies without global presence. Pharmaceutical exports were less than 4% of the industry's value–approximately $357 million–with about half coming from raw materials. Active pharmaceutical ingredient production in Turkey has been in severe decline, undercut by China and India's high-volume, low-price models. Worries about Chinese and Indian generics companies encroaching on the Turkish drug market have begun to materialize.
"We may have a Chinese or Indian invasion worldwide," says Dr. Cengiz Sezen, chairman of the Board of Mustafa Nevzat. "It is possible, economically."
Yet others see the branding strength of Turkish generics players, with domestic credibility and more acceptance from the global economy, holding an edge over China and India. "When you look at the record, the development of Indian and Chinese companies trying to get into the branded generics markets is very poor," says Clemens von Oswald, country head for Sandoz Turkey. "For the foreseeable future, Turkey will be a branded generics market. We have a strong growth and a clear positioning in terms of market dynamics."
A Nexus in Pharmaceuticals
Profile: Bell Holding
"One of the cornerstones of our strategy is to nurture relationships with pharmaceutical companies and stay close and attentive to their evolving needs," says Livio Manzini, Bell Holding's chairman and CEO.
Industrial packaging accounted for $75 million of Bell Holding's sales in 2007, and Manzini expects revenues to double within five years. The group leader, Perfektüp, Turkey's main supplier of collapsible aluminum tubes, is Bell Holding's most global player, exporting half of its production to Europe, North America, and the Middle East.
Since last March, Bell Holding also has offered contract-sales services to pharmaceutical manufacturers through a joint venture with Innovex, the world's largest commercial sales organization, based in the United Kingdom.
Applying the group's start-up expertise and its vast network in Turkish pharmaceuticals, Innovex already has acquired seven clients and 150 sales reps, and it aims to build a sales force of 1000 by 2010. The Innovex Turkey subsidiary provides drugmakers with product registration, human resources services, health management solutions, and the core activity, contract-sales.
"For any pharma company that may want to come to Turkey and establish its presence, this service is obviously precious," says Manzini.
The Local Multinational
Profile: Nobel Ilaç
"The first years are always years of learning, investing, and even losing money," says Nobel Chairman Hasan Ulusoy, of the company's long-term expansion strategy. "But, if you have the patience and are addicted to the target, you can manage it."
With 2007 revenues approaching $200 million, Nobel has historically been one of Turkey's top local players, bolstered by in-licensing agreements with multinationals such as Altana (Wesel, Germany) and Vitabiotics (London) and an extensive generics portfolio in major therapeutic areas, including cardiovascular, respiratory, and gastrointestinal. Its market leaders include the non-steroidal anti-inflammatory, "Etol," and "Tylol Hot," for cold relief.
Nobel also offers contract research services through its research and development (R&D) center, Fargem, Turkey's first independent R&D institute. The company wants to expand its R&D investments in Turkey and is conducting a Phase II study in cooperation with a US company.
"We are aware that the future lies in new developments," says Ulusoy. "Thus, we are also looking for partners with whom we can develop new projects."
Becoming a Global Brand
Profile: Bozlu Group
In July, Monrol sold 50% of its shares to Eczacibasi in an effort to hasten its expansion. It completed a fourth production site this year in Izmir that produces isotopes for PET scanners. In 2009, Bozlu Group plans to manufacture radiopharmaceuticals in Romania and Dubai. During the next five years, the company hopes to have a presence in North Africa, Central Asia, and throughout Europe.
"We find that when we go abroad from the Turkish business market, we are respected," says Bozlu Chairman and Founder Şükrü Bozluolçay. "American companies always contact us when they come to this region, sometimes bringing other companies with them."
The group continues to invest in new technologies for both radiotherapy and diagnosis, foreseeing a pivotal role in molecular imaging. At its research and development facility in Istanbul, Bozlu plans to develop radiopeptides that can simultaneously image and treat certain diseases specifically.
Bozluolçay envisions annual growth of at least 20% for nuclear medicine worldwide and predicts the group will reach annual sales of $100 million by 2012.
"We have more flexibility than big companies," says Bozluolçay. "We have strong technology and logistics and with that, we hope we can fight competition and meet our targets."
Building Bridges to Foreign Markets
Profile: Bilim Pharmaceuticals
The company has presence in more than 40 markets and exports to 24 countries worldwide. With a newly completed production site outside Istanbul, it hopes to soon export to European Union nations and the United States.
"We are trying to adapt ourselves for these markets," says Bülent Karaağaç, Bilim's president. "The new plant will be the key element in this development strategy."
Bilim also plans to use the new site's 125-million-unit yearly capacity to attract toll-manufacturing partners and to expand exports to Turkey's neighboring markets where it has formed marketing teams. Building upon a menu of 120 products, the marketing-oriented company plans to continue launching 10–20 drugs per year in the areas of diabetes and respiratory, cardiovascular, and central nervous systems. With ever-growing challenges brought by Turkey's intense generics competition and a more restrictive regulatory environment, Karaağaç says Bilim is positioned to sustain double-digit growth in the coming years.
"If you know how to play by the rules, you don't lose," he adds.
Ready for Any Challenge
Profile: Adeka Pharmaceuticals
Adeka produces its own line of generics and also represents 11 companies—from Europe and the United States—in exclusive licensing deals. Its product portfolio focuses on cardiology, gynecology, dermatology, pediatrics, and the central nervous system, a strategy that helps it rely on niche therapeutics and stay away from intensely competitive generics areas. The company's success derives from the diversity of its products, says Ali Cüneyt Arpacioglu, Adeka's CEO and president.
Looking forward, Adeka has created a mid-term vision that accepts industry realities and confronts all competitive threats, those within Turkey and from booming generics markets like India and China. Arpacioglu says the company is "going to be stronger in the current fields," by increasing the number of "value-added" products in dermatology, gynecology and pediatrics, and by launching as many as four new combinations in cardiology. Adeka has also recently penetrated the nutraceuticals and self-medication market with distinctive products, and Arpacioglu says there are more to follow.
Making Strides in Major Markets
Profile: Mustafa Nevzat Pharmaceuticals
Mustafa Nevzat is Turkey's only FDA-approved company for finished products and has been supplying the US since May 2007. By the end of 2008, the company will have completed construction on its fifth production site, a facility for oncological products that may export injectables to the US as early as 2009.
In addition, Mustafa Nevzat's sterile injectable manufacturing site has received approval from the United Kingdom's Medicines and Healthcare products Regulatory Agency.
With 15% of its current revenue based on exports, the company's goal is to have a $100 million in volume going to the US alone by 2012 and to create more balance between its domestic and foreign sales.
"The domestic pharma market is no longer enough for any company," says M. Levent Selamoglu, Mustafa Nevzat's CEO. "If you are a generics player, and you have a manufacturing base and if you want to stay in this business, you should be everywhere in the world."
From Local to Global
"We are like a multinational in that our top 10 products are group leaders and even sometimes we surpass the sales of multinational companies," says Ahmet Toksöz, a Sanovel board member.
In 2006, the company completed a new 430,000-ft2 production site, enabling expansion into Turkey's neighboring markets such as Georgia, Kazakhstan, Azerbaijan, and Uzbekistan. In January 2009, Toksöz says he expects to break ground on a new biotech facility that will symbolize the company's first entry into high-tech medicine.
Sanovel has agreements with companies to register products in Europe through its holding company in The Netherlands and subsidiaries in France and Germany. Toksöz says Sanovel plans to explore acquiring European companies. For now, however, the company's growth strategy is to establish a sales and marketing presence in emerging foreign markets worldwide.
"We prefer our own sales force because it's better to keep your concentration on your culture in your marketing strategies," says Toksöz. "We can compete with most local and even European companies production-wise, capacity-wise, and cost-wise."
Turkey's Triple Threat
Profile: The Birgi Group
Still producing tubular glass containers through its packaging company, Birgi, and making small- and medium-volume parenterals through Mefar, it has established relationships with nearly 50 companies, including Pfizer (New York), GlaxoSmithKline (London), and Turkish powerhouses Eczacibasi and Abdi Ibrahim. Since 2006, the Birgi Mefar Group has offered logistics and warehousing services through its third company, Defar.
"All of our companies are part of the production circle," says Group Chairman Mustafa Birgi. "They go very well with each other and we have a lot of synergies, having everything done in-house."
Birgi has had a presence in foreign markets such as Germany since 1969 and it currently exports nearly 35% of its primary packaging production. Mefar expects to increase exports as it continues shifting manufacturing operations into a new, EU-approved facility. "Our name is well known in the Western world," says Birgi.
By the end of next year, Mefar's new site should be running at a full annual capacity of 250-plus million units, providing a significant boost to the group, which earned $60 million in 2007.
Success in Small and Simple
Profile: Berko Ilaç
"In this market, I told myself I should do things small and simple, things that no one has thought of and that no one has done before," says Beran, the company's board chairman. Berko has 18 products registered in Romania and is creating a subsidiary in Lebanon. Going forward, Berko would like to open a new production site in three years with an annual capacity of 60 million bottles; form toll-manufacturing agreements with European companies; and establish sales and marketing franchises in seven foreign markets.
"I see Berko as a multinational company; this is my ideal," he says.
Gaining via Local Investments
Combining Sandoz's generics products and Novartis' original over-the-counter drugs and veterinary medicines, the company covers the entire life cycle of a drug. With 10,000 molecules currently under experimentation, Novartis plans to expand its portfolio in the areas of cardiovascular and respiratory treatments, oncology, and neuroscience. "Patients continue to want better medicines with better efficacy and fewer side effects," says Güldem Berkman, head of Novartis Turkey. "We have a broad healthcare portfolio addressing changing healthcare needs." With 2000 employees and four production sites, Novartis Turkey is the country's largest pharmaceutical exporter, to more than 120 countries. The company expects its facilities in Turkey's industrial zone to receive FDA approval by end-2009, in time to supplement its high-growth operations in the US. In June, Sandoz executives met with Turkey's Health Ministry about bringing biosimilars to market and introducing more quality, high-tech medicine.
Setting Global Benchmarks
Biofarma has a lofty set of benchmarks for the future: 15 product launches per year; 13 new export countries by the end of 2009; and a top-10 revenue ranking in Turkey by 2013. Within five years, it hopes to sell 100 million boxes of its products per year and earn $50 million in exports by establishing partnerships in North Africa, the Middle East, and the CIS countries. The company plans to introduce new products in niche sectors such as antidepressants and hormones and in 2009, will begin construction on a new production site for oncologicals.
"What we are trying to do is maintain a high-value product in the niche market," says Umur Südekan, Biofarma's general manager. "Because there is less competition, it is easier to become the number one or two player."
The Post-Generics Pioneer
With the sale, Zentiva gained access to a vast portfolio of products in cardiovascular, central nervous system, and anti-infective areas and to the massive Lüleburgaz production site, a facility with an annual capacity of 380 million packs that received FDA approval in 2007. Eczacibasi-Zentiva has "shifted our whole portfolio strategy toward chronic treatments" and this year has "created a significant franchise in diabetes," says Elif çelik, general manager of Eczacibasi-Zentiva.
In July, Eczacibasi Holding, a prominent industrial group of 42 companies with $3.2 billion revenue in 2007, reaffirmed its commitment to pharmaceuticals with a 50% acquisition of the Turkish radiopharmaceuticals maker, Monrol. Eczacibasi Holding continues to invest in its hospital-supplies joint venture, Eczacibasi-Baxter, and in Eczacibasi-Corridor, Turkey's first home healthcare services company. Yet, the group expects its biggest growth from Eczacibasi Pharmaceuticals Marketing, a division concentrating on niche therapeutics, including biotech products for oncology. Sales from this company could reach $135 million this year, up 35% from 2007, according to company forecasts.
"Importing and distributing gives us the opportunity to expand as much as we want into different areas," says Sedat Birol, executive vice-president of Eczacibasi Pharmaceuticals Division. "We have great expectations from this company."
The "Kitchen" of Big Pharma
Profile: Embil Pharmaceuticals
"We consider ourselves the kitchen of large pharmaceutical companies," says Koral Embil, vice-president of scientific affairs and business development. "We believe that if the product is innovative enough and if it can fill a need in the marketplace, the marketing partner will approach us and they will be committed to us."
Embil develops unique formulations and manufactures semi-solids in the areas of gynecology, dermatology and topical pain management. The company also has solid dosage form tablets produced through a contract-manufacturing partner. Embil reached global recognition in 1994 for its vaginitis treatment, "Neo-Penotran." In recent years, the company has focused on dermatological products to treat acne and local pain management products. It is also formulating generics molecules in emerging technologies such as microsponge drug delivery systems.
Approximately 40% of Embil's $25-million revenue in 2007 came from exports, and Koral Embil, who runs the company with his brother, Edis, says the ratio may soon reach 50% thanks to the addition of new export territories. By 2013, the company plans to move into new production facilities and expand its capacity 10-fold, to 40 million units. Embil says the complex, to be based in Istanbul, Turkey, is expected to receive approval from US and European Union regulators.
Hopes in High-Margin Drugs
Profile: Dr. F. Frik Pharmaceuticals
"The number one factor for us is a higher profit margin product," says Frik, the company's chairman. "It has to have a higher selling price per box because I'm tired of selling 1 million boxes, making €500,000 [about $706,000], and after marketing expenses and financial expenses, being left with absolutely nothing." The shakeup has resulted in epic growth—100% gains over each of the past three years—leaving Dr. F. Frik with 2007 revenues of about $65 million and a portfolio of more than a dozen products. The company anticipates 50% growth in 2008 but envisions larger increases during the next five years. The prediction is based on new licensing agreements with multinational firms and the introduction of 40 new products.
Taking Care of Turkey
Profile: Selçuk Ecza
This report was prepared by Executive Country Reviews, a press agency headquartered in Paris and Istanbul. Country editors
Ece Vatansever (firstname.lastname@example.org
Association of Research-Based Pharmaceutical Companies (AIFD)
Pharmaceutical Manufacturers Association of Turkey (IEIS)
Turkish Pharmaceutical Manufacturers Association (TISD)
International Society for Pharmaceutical Engineering–Turkey Affiliate (ISPE)