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© European Journal of Scientific Research, Vol. 93, No 1, 2012 ______________________________________________________________________________________ ______________________________________________________________________________________
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© FRDN Incorporated, 2012 Editor-In-Chief & Managing Editor: Adrian Marcus Steinberg, PhD 117, Orion Mall, Palm Street, P.O. Box 828, Victoria, Mahé, Seychelles Tel: +248 400138344 Fax: +248 400138345 European Journal of Scientific Research ISSN: 1450-216X / 1450-202X Vol. 93 (1): 234-249, December 2012 DOI: http://www.europeanjournalofscientificresearch.com/issues/EJSR_93_1.html
Pharmaceutical Industry Report - 2012 Pharmaceutical Industry: Key Issues in Growth in Pakistan &
International Market
Rizwan Raheem Ahmed Hamdard University, Karachi, PAKISTAN
1. Introduction
Pakistan has a very vibrant and forward-looking Pharma Industry. At the time of independence in 1947, there was hardly any pharma industry in the country. Today Pakistan has about 400 pharmaceutical manufacturing units including those operated by 25 multinationals present in the country. The Pakistan Pharmaceutical Industry meets around 70% of the country's demand of Finished Medicine. The domestic pharma market, in term of share market is almost evenly divided between the Nationals and the Multinationals (Ahmed & Saeed, 2012).
The National pharma industry has shown a progressive growth over the years, particularly over the last one decade. The industry has invested substantially to upgrade itself in the last few years and today the majority industry is following Good Manufacturing Practices (GMP), in accordance with the domestic as well as international Guidance. Currently the industry has the capacity to manufacture a variety of product ranging from simple pills to sophisticated Biotech, Oncology and Value Added Generic compounds (Aamir & Zaman, 2011).
Although Pakistan 's pharmaceutical and healthcare sectors are expanding and evolving rapidly, about half the population has no access to modern medicines. Clearly this presents an opportunity, but much more work needs to be done by the government and industry's stakeholders. The value of pharmaceuticals sold in 2007 exceeded US$1.4bn, which equates to per capita consumption of less than US$ 10 per year and value of medicines sold is expected to exceed US$2.3 B by 2012 (Ahmed et al., 2011).
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Pakistan is a developing pharmaceutical market, with a large population and economic progress evident, but per capita drug spending was rather low at around US$9.30 in 2007 (Ahmed & Jalees, 2008). Private spending accounts for 65% of total healthcare expenditure sourced through out-of pocket payments, international aid and religious or charitable institutions. Pharmaceutical spending accounts for less than 1% of the country's GDP, comparable to levels in some neighboring countries but above that in some of the South Asian countries (Federal Bureau of Statistics, 1997). The forecast period is likely to witness the marginal strengthening of the generics sector, albeit more in terms of volumes than values. The share of generics is also likely to increase further as major drugs come off patent in the near term, to the likely benefit of the generics-dominated local industry (Dr. Akhtar, 2006).
The Pakistan pharma industry is relatively young in the international markets with an export turnover of over US$ 100 Million as of 2007. Pakistan Pharma Industry boasts of quality producers and regulatory authorities all over the world approve many units. Like domestic market the sales in international market have gone almost double during last five years. The pharma industry is focusing to an Export Vision of USD 500 Million by 2013. In the meantime, exports are also likely to be boosted by new regional and global opportunities (Ahmed & Saeed, 2012).
The Pakistan Pharmaceutical Industry is a success story, providing high quality essential drugs at affordable prices to Millions. Technologically, strong and self reliant National Pharmaceutical Industry is not only playing a key role in promoting and sustaining development in the vital field of medicine within the country, but is also well set to take on the international markets (Kemal et al., 2002).
2. Pakistan overview The pharmaceutical industry is considered the backbone of public health services in Pakistan. This is strategically important both for the well being of the population in general and for the provision of good yet affordable healthcare in particular (Ahmed et al., 2012). The low cost of production and the huge potential of this sector has attracted major multinationals to establish their operations and production facilities in Pakistan (Trade Development Authority, 2000-02). Local (Pakistani) pharmaceutical companies started in the 1960s but their growth increased in the 1980s. During the last decade, they made substantial investments in production facilities and introduced the latest technology along with many new high quality products that were previously either unavailable or available on a limited scale at very expensive prices. By providing quality medicines at economical rates in this fashion, Pakistani pharmaceutical companies have contributed substantially towards public health (Kemal et al., 1997).
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The key to the success of Pakistani pharmaceutical companies is based on a simple formula, i.e. the production of high quality products at current Good Manufacturing Practices (cGMP)-compliant facilities and offering them at the most economical rates. Nearly all of Pakistan’s leading pharmaceutical companies has maintained high standards to ensure compliance of all operations of production and quality control under the cGMP guidelines. As a result, they are now successfully exporting their products to various international territories (TDAP, 2000). Top 25 national pharmaceutical companies are as follows: No. Company No. Company 1. Getz Pharma Pakistan (Pvt.) Ltd 14. Macter International (Pvt.) Ltd 2. Sami Pharmaceutical (Pvt.) Ltd 15. Brookes Pharmaceuticals Labs 3. Ali Gohar Pharmaceuticals 16. Himont Pharmaceuticals (Pvt.) Ltd 4. Werrick Pharmaceuticals 17. Ferozesons Laboratories Ltd 5. Hilton Pharma (Pvt.) Ltd 18. Indus Pharma (Pvt.) Ltd 6. Barrett and Hodgson Pakistan 19. Tabros Pharma 7. Wilsons Pharmaceuticals 20. Schazoo Laboratories (Pvt.) Ltd 8. Bosch Pharmaceuticals (Pvt.) Ltd 21. Highnoon Laboratories Ltd 9. Zafa Laboratories (Pvt.) Ltd 22. Atco Laboratories (Pvt.) Ltd 10. Global Pharmaceuticals 23. Remington Pharmaceutical 11. Platinum Pharmaceuticals 24. PharmEvo (Pvt.) Ltd 12. CCL Pharmaceuticals (Pvt.) Ltd 25. Amson Vaccines and Pharma 13. Nabiqasim Industries (Pvt.) Ltd * Included in IMS as a national company, although they have foreign shareholding and are a member of OCCI.
(Source: IMS, Q2, 2006) Top 10 multinational pharmaceutical companies No. Company No. Company 1. GSK 6. Novartis Pharma (Pakistan) Ltd 2. Sanofi Aventis 7. Bristol-Myers Squibb 3. Abbott Laboratories (Pakistan) 8. Pharmacia and Upjohn (Pvt.) Ltd 4. Merck Marker (Pvt.) Ltd 9. Parke-Davis 5. Roche Pharmaceuticals 10. Wyeth Pakistan Ltd Source: IMS, Q2, 2006
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3. Pakistani Pharmaceutical Sector: • $ 2.3 Billion Industry • 15.69% CAGR IN PKR, 9.98% IN US$ (IMSQ2, ‘12) • Total Domestic Investment of $ 500 Million • Foreign Direct Investment of $ 100 Million • The largest employer of University Graduates in Semi-urban and Rural Areas 4. Comparison with India Why Compare: 1. Part of tier 2 & 3 Pharmerging Countries 2. Similarities of market factors (Population, people behavior & economic conditions) 3. Medical Infrastructure 4. Prevalence, practices & treatment of diseases. 5. Growing markets with low cost of production like Pakistan 5. Industry Evolution –10 Years India vs. Pakistan 2002: • Indian Pharma’s Domestic Sales were $ 4 Billion • Pakistan Pharma’s Domestic Sales were $ 1.2 Billion
2012: • Indian Pharma Market croessed $ 16 Billion (300% Growth in a Decade or 18% per
annum) • Pakistan Pharma Market reached $ 2 Billion (66% Growth in a Decade or 4% per
annum)
6. History of Pharmaceutical Regulation in Pakistan: 1972: Drugs (Generics) Act passed prohibiting use of brand names/differentiation, instituting 100% controls on drug Pricing. 1976: Drugs Act 1976 Passed, allowing for use of Brand Names, but continuing with Draconian Price Controls on 100% of all Pharmaceutical Products. 2001: Last price increase Granted by the Ministry of Health to Manufacturers to allow for inflation, rise in cost of inputs
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2011: Devolution under the 18th Amendment led to dissolution of MoH, DRAP not Formed until Feb ’12, Shifted to new Division in April 12, Still not Fully Functional 7. Reasons for Stunted Growth of Pakistani Pharma Sector 1. Arbitrary Regulations: No price adjustments for inflation in a DECADE. 2. No Vitamin Policy, No policy for Over the Counter (OTC) Drugs. OTC drugs are a large segment for Big Pharma globally, adding to scale and profitability 3. Poor Domestic Regulation and weak government procurement policies that do not encourage investment in quality. 4. Energy Crisis Rendering Sector Uncompetitive. Electricity and Steam are the two Costliest Inputs. No R&D Grants or Tax Benefits to Pharma. No Support on Utilities 8. Global Pharmaceutical Industry and Trends 8.1 Global scenario The pharmaceutical industry in any country is considered as the mainstay of public health. Looking at the global scenario, the importance given by developing nations to the pharmaceutical sector can be clearly identified by including healthcare and pharmaceutical industry in their health and welfare strategy. The global pharmaceutical market is valued at no less than US$440 billon, with annual growth of 6% (Aday, 1996). Table 1: Major pharmaceutical companies.
Company HQ location
Revenue of pharmaceutical segment, mln USD
Total sales, mln USD
Share of pharmaceutical segment, %
Pfizer NY, U.S. 46,133 52,516 87.85% GlaxoSmithKline UK 31,434 37,324 84.22% Johnson & Johnson NJ, U.S. 22,190 47,348 46.87% Merck NJ, U.S. 21,494 22,939 93.70% AstraZeneca UK 21,426 21,426 100.00%
Novartis Switzerland 18,497 28,247 65.48%
Sanofi-Aventis France 17,861 18,711 95.46%
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Roche Switzerland 17,460 25,168 69.37%
Bristol-Myers Squibb NY, U.S. 15,482 19,380 79.89% Wyeth NJ, U.S. 13,964 17,358 80.45% Abbott IL, U.S. 13,600 19,680 69.11% Eli Lilly IN, U.S. 13,059 13,858 94.23% Takeda Japan 8,648 10,046 86.09% Schering-Plough NJ, U.S. 6,417 8,272 77.57% Bayer Germany 5,458 37,013 14.75% Source: 2004 Annual Reports of the companies
As Table above shows, the majority of the largest pharmaceutical companies are not diversified. They are either concentrated exclusively on pharmaceutical products (Eli Lilly and AstraZeneca are good examples with virtually 100% of their revenues coming from sales of pharmaceutical products). Table 2: Average 2004 exchange rates. Currency Exchange rate EUR / USD 1.2438 GBP / USD 1.8333 USD / JPY 108.1508 USD / CHF 1.2426 Source: calculated using Federal Reserve daily data
8.2 Industry Trends Several factors are worth mentioning. First, for almost all companies presented in the table, the pharmaceutical segment is the largest; and only for one of them, world giant Johnson & Johnson, sales of pharmaceutical segment are below 50% (Catlin et al, 2007). Table 3: Business segments of major U.S. pharmaceutical companies
Pfizer J&J Merck BMS Wyeth Lilly* Abbott Schering-Plough
Pharmaceutical 87.8% 46.9% 93.7% 80.0% 80.4% 94.2% 69.0% 77.6% Consumer Health & Nutritional products 6.7% 17.6% 10.0% 14.7% 13.1% Animal Health 3.7% 4.8% 5.8% 9.3% Medical Devices 35.5% 31.0%
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and Diagnostics Other Healthcare 10.0% Other 1.8% 6.3% Source: Annual Reports of the companies *In Financial statements Animal Health products are not stated as separate segment
Table 4: Top 5 pharmaceutical products for each company based on the sales in 2004
Sales, mln USD
% of total sales
Sales, mln USD
% of total sales
Pfizer Wyeth Lipitor $10,862 20.7% Effexor $3,347 19.3% Norvasc $4,463 8.5% Protonix $1,591 9.2% Zoloft $3,361 6.4% Prevnar $1,054 6.1%
Celebrex $3,302 6.3% Premarin family $880 5.1%
Neurontin $2,723 5.2% Zosyn / Tazocin $760 4.4%
J&J
Eli Lilly Procrit / Eprex $3,589 7.6% Zyprexa $4,420 31.9% Risperdal $3,050 6.4% Gemzar $1,214 8.8% Remicade $2,145 4.5% Humalog $1,102 8.0% Duragesic $2,083 4.4% Evista $1,013 7.3% Topamax $1,410 3.0% Humilin $998 7.2%
Merck
Schering-Plough Zocor $5,200 22.7% Remicade $746 9.0%
Fosamax $3,200 14.0% Clarinex / Aerius $692 8.4%
Cozaar $2,800 12.2% Nasonex $594 7.2% Singulair $2,600 11.3% Peg-intron $563 6.8% AZLP $1,500 6.5% Temodar $459 5.5%
BMS
Plavix $3,327 17.2% Pravachol $2,635 13.6% Taxol $991 5.1% Avapro / Avalide $930 4.8% Paraplatin $673 3.5%
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Chart 1: Liquidity analysis
Chart 2: Geographical distribution of sales, 2004
Source: Annual Reports of the companies
Liquidity ratios
0.00
0.20
0.40
0.60
0.80
1.00
1.20
1.40
1.60
1.80
2.00
Pfizer J&J Merck BMS Wyeth Eli Lilly Abbott Schering-Plough
Current Ratio CF from operations to Total Liabilities Debt-Equity Ratio
Geographical distribution of sales in 2004
58%68%
59% 55% 57% 55% 57%
39%
42%32%
41% 45% 43% 45% 43%
61%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
Pfizer J&J Merck* BMS Wyeth* Lilly Abbott* Schering-Plough*
USA International
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*No geographical distribution of pharmaceutical segment is available. Proportions calculated on geographical distribution of total sales.
Table 5: Sales dynamics of non-US pharmaceutical companies, 2002-2004
2002 2003 2004 GlaxoSmithKline 3.5% 1.1% -5.0% AstraZeneca 10.0% 5.6% 13.7% Novartis 11.3% 19.1% 13.6% Roche 1.0% 6.0% 0.2% Sanofi-Aventis 14.8% 8.1% 86.9% Takeda 4.3% 4.1% 3.9% Bayer -2.2% -3.6% 4.2% Source: calculations, data used from Annual Reports of the companies
Table 6: Total assets dynamics of non-US pharmaceutical companies, 2002-2004
2002 2003 2004 GlaxoSmithKline -0.1% -5.0% 6.5% AstraZeneca 16.7% 9.3% 8.7% Novartis 13.3% 9.5% 10.4% Roche -15.0% -7.0% -2.4% Sanofi-Aventis -5.1% 3.1% 687.3% Takeda 12.4% 4.8% 13.4% Bayer 12.6% -10.2% 1.0% Source: calculations, data used from Annual Reports of the companies
Bayer’s current acquisitions (seed treatment business and over-the-counter medicines) even further decreased its share of pharmaceutical segment. Major acquisitions of non-US pharmaceutical companies are summarized in Table 7. Table 7: Recent acquisitions by major non-US pharmaceutical companies
Company Company acquired*
Core business of target Purchase price
GlaxoSmithKline
Merger of Glaxo Wellcome and SmithKline Beecham
Megrer of two major pharmaceutical companies (registered in 2000)
-
Block Drug Oral care and over-the-counter medicines
843 mln GBP
AstraZeneca Merger of Astra and Zeneca
Megrer of two major -
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pharmaceutical companies (registered in 1999)
Novartis
Sabex
Generic manufacturer with a leading position in generic injectables
565 mln USD
Mead Johnson's adult nutrition business
Global adult medical nutrition 385 mln USD
Idenix Pharmaceuticals Inc
Biotechnology
255 mln USD + up to 357 mln USD in possible additional payments
Roche
Igen International Human in-vitro diagnostics 1,823 mln CHF
Disetronic
Insulin pumps and injection systems for the treatment of diabetes.
1,132 mln CHF
Sanofi-Aventis Merger of Sanofi-Synthelabo and Aventis
Merger of two major pharmaceutical companies (registered in 2004)
-
Bayer
Roche's over-the-counter business
Over-the-counter medicines 206 mln EUR
Gustafson Seed treatment 100 mln EUR
Source: Annual Reports of the companies *Acquisition of patents is not included in this table
Overall, as shown in Table 8, non-US pharmaceutical companies have approximately similar R&D costs as % of total sales to those of U.S. companies. Table 8: R&D costs as % of 2004 total sales 2001 2002 2003 2004 GlaxoSmithKline 12.5% 12.9% 12.9% 13.9% AstraZeneca 17.1% 17.2% 18.3% 17.7% Novartis 13.5% 13.6% 15.1% 14.9% Roche 13.3% 14.5% 15.3% 16.3% Sanofi-Aventis 15.9% 16.4% 16.4% 49.6% Takeda 9.3% 10.0% 11.9% 11.9% Bayer 8.5% 8.7% 8.4% 7.1%
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Source: Annual Reports of the companies To calculate this ratio R&D costs and revenues for all business segments of the company were used
Table 9: Top 5 pharmaceutical products based on the sales in 2004
GlaxoSmithKline
Sales, mln GBP
% of total sales
Sales, mln USD Roche
Sales, mln CHF
% of total sales
Sales, mln USD
Seretide / Advair
£2,461
12.1%
$4,512
MabThera / Rituxan
CHF 3,378
10.8%
$2,719
Avandial / Avandamet
£1,116 5.5%
$2,046
NeoRecormon, Epogin
CHF 2,082 6.7%
$1,676
Paxil £1,063 5.2%
$1,949
Pegasys + Copegus
CHF 1,562 5.0%
$1,257
Zofran £763 3.7% $1,399 Herceptin
CHF 1,435 4.6%
$1,155
Wellbutrin £751 3.7% $1,377 CellCept
CHF 1,403 4.5%
$1,129
AstraZeneca
Sales, mln USD
% of total sales
Sanofi-Aventis
Sales, mln EUR
% of total sales
Sales, mln USD
Nexium $3,883
18.1% Lovenox
€ 1,904
12.7%
$2,368
Seroquel $2,027 9.5% Plavix
€ 1,694
11.3%
$2,107
Losec / Prilosec
$1,947 9.1% Allegra
€ 1,502
10.0%
$1,868
Seloken $1,387 6.5% Taxotere
€ 1,436 9.5%
$1,786
Pulmicort $1,050 4.9% Stilnox
€ 1,423 9.5%
$1,770
Novartis
Sales, mln USD
% of total sales Bayer
Sales, mln EUR
% of total sales
Sales, mln USD
Diovan / Co-Diovan
$3,093
10.9%
Ciprobay / Cipro € 837 2.8%
$1,041
Gleevec/Glivec
$1,634 5.8% Adalat € 670 2.3% $833
Lamisil $1,16 4.1% Ascensia € 627 2.1% $780
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2
Zometa $1,078 3.8% Aspirin € 615 2.1% $765
Neoral / Sandimmun
$1,011 3.6% Kogenate € 563 1.9% $700
Source: Financial reports of the companies Sales are provided in the currency of financial reports; conversion of sales into USD was made for comparison purposes
Table 10: Profitability analysis
2002 2003 2004 GlaxoSmithKline ROA 17.6% 20.6% 19.7% Profit margin 18.5% 20.9% 21.1% Total Assets Turnover Ratio 0.95 0.99 0.93 AstraZeneca ROA 14.2% 13.4% 15.5% Profit margin 15.9% 16.1% 17.8% Total Assets Turnover Ratio 0.89 0.83 0.87 Novartis ROA 11.1% 10.6% 11.1% Profit margin 22.6% 20.2% 20.4% Total Assets Turnover Ratio 0.49 0.53 0.54 Roche ROA -5.8% 5.0% 11.3% Profit margin -13.7% 9.8% 21.2% Total Assets Turnover Ratio 0.42 0.51 0.53 Sanofi-Aventis ROA 18.1% 21.6% -8.3% Profit margin 23.6% 25.8% -24.0% Total Assets Turnover Ratio 0.77 0.84 0.35 Takeda ROA 12.5% 13.5% 13.0% Profit margin 23.1% 26.0% 26.3% Total Assets Turnover Ratio 0.54 0.52 0.49 Bayer ROA 2.7% -3.4% 1.6% Profit margin 3.6% -4.8% 2.0% Total Assets Turnover Ratio 0.75 0.72 0.79 Source: calculations, data used from Annual Reports of the companies
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It is also interesting to compare European and Asian business models: Takeda, the only Asian country in this group, showed the lowest debt-equity ratio (0.25) that is much lower than average 0.48 for the whole group (Lexchin, 1995). Chart 3: Liquidity analysis
Chart 4: Geographical distribution of sales, 2004
Source: Annual reports of the companies
0.00
0.50
1.00
1.50
2.00
2.50
3.00
3.50
4.00
4.50
GlaxoSmithKline
AstraZeneca
Novartis
Roche
Sanofi-Aventis
Takeda
Bayer
Current Ratio CF from operations to Total Liabilities Debt-Equity Ratio
49% 45% 40% 35% 31% 27%36%
30% 36%34% 38% 49%
14%
36%
21% 19%26% 26%
20%
59%
28%
0%
10%
20%
30%
40%
50%
60%
70%
80%
90%
100%
GlaxoSmithKline
AstraZeneca
Novartis
Roche*
Sanofi-Aventis
Takeda*
Bayer
USA Europe Other
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* No geographical distribution of pharmaceutical segment is available. Proportions calculated on the basis of geographical distribution of total sales (Agarwal, 2001). REFERENCES
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