International:

Pharma regulatory bodies

In India:

The Drugs and Cosmetics Act, 1940: The import, manufacture, distribution and sale of drugs in India are regulated by this act.

• Schedule M of the Drugs and Cosmetics Act specifies the requirements for factory premises and materials, plant and equipment and basic installations for certain categories of drugs.
• Schedule T of the Drugs and Cosmetics Act prescribes GMP specifications for the manufacture of Ayurvedic, Siddha and Unani medicines.
• Schedule Y of the Drugs and Cosmetics Act governs the clinical trials.

The Pharmacy Act, 1948: This legislation regulates the Pharmacy Profession in India. Central Government constitutes a Central Pharmacy Council of India and the State Governments constitute State Pharmacy Councils.

The Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954: This Act controls the advertisements regarding drugs and prohibits the advertising of remedies alleged to possess magic qualities.

The Narcotic Drugs and Psychotropic Substances Act, 1985: This act concerns with the control and regulation of operations relating to Narcotic Drugs and Psychotropic Substances.

The Medicinal and Toilet Preparations (Excise Duties) Act, 1956: Provides the levy and collection of duties of excise on medicinal and toilet preparations.

The Drugs Price Control Order (DPCO), 1995: Issued under the Essential Commodities Act, 1955 to regulate the prices of drugs. Provides the list of price controlled drugs, procedures for fixation of prices of drugs, method of implementation of prices fixed by Government and penalties for contravention of provisions among other things.

National Pharmaceutical Pricing Authority (NPPA) is empowered to implement provisions of DPCO.

Good Clinical Practice (GCP) Guidelines: Based on Declaration of Helsinki, World Health Organization (WHO) guidelines and International Conference on Harmonization (ICH) requirements for good clinical practice the Ministry of Health, along with Drugs Controller General of India (DCGI) and Indian Council for Medical Research (ICMR) has come out with draft guidelines for research in human subjects.

The following laws also govern the manufacture, distribution and sale of pharmaceutical products in India:

• The Industries (Development and Regulation) Act, 1951
• The Trade and Merchandise Marks Act, 1958
• The Indian Patent and Design Act, 1970
• Factories Act

Regulatory Bodies:

The Ministry of Health & Family Welfare (MoHFW) and the Ministry of Chemicals and Fertilizers (MoC&F) of the Government of India regulate the pharmaceutical sector in the country.

Ministry of Health & Family Welfare (MoHFW):

Department of Health: The following are the main agencies of the department which deal with key issues including drug approvals:

Central Drugs Standard Control Organisation (CDSCO): Works at both Central and State levels and responsible for ensuring safety, efficacy and quality of drugs supplied to the public. Functions with the Drugs Controller General of India (DCGI) as the executive head.

Drugs Controller General of India (DCGI): The DCGI governs issues such as product approval and standards, clinical trials, introduction of new drugs, import licenses for new drugs and enforcing new drug legislation.

Department of Health administers the following major acts:

• The Drugs & Cosmetics Act, 1940
• The Prevention of Food Adulteration Act
• The IMA Act
• The Tobacco Control Act

Ministry of Chemicals and Fertilizers (MoC&F): Constitutes bodies such as the Department of Chemicals & Petrochemicals and the National Pharmaceutical Pricing Authority (NPPA). These departments are responsible for policy making, planning, development and regulations relating to Chemicals, Petrochemicals and Pharmaceuticals.

Department of Chemicals & Petro-Chemicals: Formulates and implements policies and programmes to achieve growth and development of pharmaceuticals in the country. The Department has undertaken several initiatives to attract investment into the sector, the major being the Pharmaceutical Policy with the objective of strengthening production, export & R&D.

The first comprehensive pharmaceutical policy formulated in 1978 has been revised through new policy guidelines issued in 1986, 1994 and recently in 2002.

Pharmaceutical Policy 2002 – The main objectives of the policy are:

• To ensure availability of quality essential pharmaceuticals at reasonable prices for mass consumption.
• To strengthen the indigenous capability for cost effective quality production and export of pharmaceuticals by reducing trade barriers in the pharmaceutical sector.
• To implement quality control systems for pharmaceutical production and distribution in the domestic industry.
• To encourage pharmaceutical R&D compatible with the country’s needs.
• To encourage new investment in the pharmaceutical industry and the introduction of new technologies and new drugs.

Draft Pharmaceutical Policy 2006 – The Department of Chemicals has released the draft of the New Pharmaceutical Policy 2006 which is waiting for approval by the Indian Government.

The draft National Pharmaceutical Policy, 2006 aims at strengthening the Drug Regulatory System and Patent offices in the country. Focuses on research and drug development with clinical trials. Aims at providing a better access to anti-cancer and anti-HIV/AIDS drugs to the patients. Seeks to rationalize the excise duty on pharmaceuticals and to streamline the system of bulk

procurement of drugs by the Government besides promoting the generic medicines.

National Pharmaceutical Pricing Authority (NPPA): Entrusted with the fixation / revision of prices of bulk drugs and formulations, enforcement of provisions of the Drugs (Prices Control) Order and monitoring the prices of controlled and decontrolled drugs in the country.

Drugs Price Control Order (DPCO), 1995: Issued by the Government of India under the Essential Commodities Act, 1955 to regulate the prices of drugs. DPCO controls the domestic prices of major bulk drugs and their formulations with an aim to provide patients with medicines at affordable prices. DPCO ascertains, as per Drug Policy guidelines, the bulk drugs (and their formulations) to be kept under price control.

At the State level, the State Food and Drug Administration’s (FDAs) monitor the drug manufacture, sale, and testing by companies in their jurisdiction. There are also two main statutory bodies formed by Parliament:

• the Drugs Technical Advisory Board, advises the Central and State Governments on special technical matters involving drug regulation, and
• the Drugs Consultative Committee, ensures that drug control measures are enforced uniformly in all states.

The domestic pharmaceutical industry is represented by the following three main pharmaceutical associations:

Organization of Pharmaceutical Producers of India (OPPI): Premier association of research based international and large pharmaceutical companies in India and a scientific and professional body.

Indian Drug Manufacturers’ Association (IDMA): Represents domestic manufacturers and plays a vital role in the growth and development of the pharmaceutical industry, by taking up with the Government major issues such as Price Control, Patents and Trade Marks Laws, Quality & GMP, R&D, Exports and so on.

Indian Pharmaceutical Association (IPA): This is the premier professional association of pharmacists in India.

(Adapted from: http://www.indialawoffices.com/pdf/pharmaceuticalmarket.pdf)

(Source: Indian Pharma 2015: Unlocking the potential of the Indian Pharmaceutical Market –McKinsey&Company. http://www.mckinsey.com/locations/india/mckinseyonindia/pdf/India_Pharma_2015.pdf)

Global Pharma’s evolving business models and options in India

Varieties of options are available for Global Pharma players who can maximize their investment in India. Indian companies too are willing to play increasingly partnership roles.

Following are the examples of evolving business models in India.

Export-oriented business: CRAMS

Low costs, availability of skilled talent and a large patient pool are the driving factors for MNCs increasing interest in India not only for manufacturing but also for research and clinical trials

Licensing

Multinationals are increasingly entering into licensing agreements to get a share of the  Indian Pharma market. For example, Elder Pharmaceuticals has entered into an exclusive in-licensing deal with Israel’s Enzymotec to sell the latter’s cholesterol-reducing dietary supplement, CardiaBeat, in India.

Franchising

The master franchisee of US-based Medicine Shoppe International has already forayed the market and plans to expand 1,000 stores by 2010. Fortis Healthcare plans to open a chain of 1,000 stores by 2012, of which the US$200 million has been committed.

Joint Ventures Joint ventures (JVs)

are becoming a more prevalent option for companies looking to capitalise on the opportunities presented in India. Foreign companies are increasingly looking at local partners to work with in order to increase their presence in India. R&D joint ventures are also growing in popularity. Some Indian companies are collaborating with overseas players to enhance their vaccine development capabilities. Requirements of a JVForeign companies forming a JV in India can invest directly via the automatic route i.e. no prior approval of the Government is required. Foreign direct investment up to 100% is permitted in pharmaceutical sector under the automatic route. In cases where the foreign investor has an existing venture or tie-up in India in the same field as on 12 January 2005, prior Foreign Investment Promotion Board (FIPB) approval is required. The FIPB generally grants its approval on the basis of a no objection certificate (NOC) from the existing JV partner.

Partnerships

Some multinational companies have also increased their stake in their Indian subsidiaries to take advantage of the India opportunity. Pfizer has been able to increase its stake in its Indian arm, Pfizer India, from 41.2% to around 72%.128 Similarly, Novartis AG has hiked its stake to 76.42% in its Indian subsidiary Novartis India from 50.9%.

Infrastructure

Insufficient energy infrastructure and inadequate transport infrastructure has historically posed challenges for companies operating in India. The situation is definitely improving, as the Government focuses attention on infrastructure needs.

Tax environment India is expected to implement a new Direct Tax Code, pending approval, by April 2011, which should simplify the existing tax structure. The new tax code proposes a reduction in the corporate tax rate from the current 30% to 25% and an unlimited carry forward of business losses. India offers some attractive tax benefits for Pharma companies and reductions in customs duties should also help global manufacturers compete in the price-sensitive Indian market.

Counterfeiting

Counterfeit drugs have been a serious issue in India. The Organization of Pharmaceutical Producers of India (OPPI) has spearheaded various initiatives to combat the problem. It found the prevalence of spurious drugs at 0.046% of all medicines sold to customers, in contrast to results of an earlier survey funded by the WHO and undertaken by the International Pharmaceutical Federation, which concluded that 3.1% of drugs in India were counterfeit.

Intellectual Property Rights

The federal Government introduced product patents for all industrial sectors under the Patents (Amendment) Act, 2005 – in line with the commitment India made when it signed up to the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Accord in 1995. This regulation aims to balance the interests of domestic and multinational drug makers. It represents a major improvement on the previous rules, but some issues remain. Firstly, it does not apply to drugs patented before 1995.137 Copies of drugs patented between 1995 and the introduction of the law will probably not be withdrawn.

(Source: “Global Pharma looks to India: Prospects for growth” – PriceWaterHouseCooper

http://www.pwc.com/gx/en/pharma-life-sciences/publications/india-growth.jhtml)

Growing Research & Development

India’s top 10 largest drug firms spent US$480 million on R&D in 2008 and is expected to reach around US$1 billion in 2010.

Clinical trials in India offer 50% of cost savings:

Even though insufficient regulatory oversight is currently a barrier, yet India’s overall costs which are only 50% of the US-based programs should spur dramatic growth in clinical testing in the next 2-5 years. Indian clinical trials market could reach US$2 billion by 2012, up from just US$300 million in 2008.

Biotech and biosimilars on track for growth

In 2008-09, Biotech and Biosimilar products  generated sales of US$2.64 billion with a CAGR of 26 and expected to achieve revenues of US$5 billion by 2010 -11. India’s developing biotech industry and cost advantages should drive significant growth in local development of biosimilars for the global market.

India’s top 10 biotech firms:

Bioinformatics in India:

India’s existing IT knowledge capital provides a natural base for the development of bioinformatics research and operations. As of March 2009, revenues for the Indian bioinformatics industry were around US$48 million out of which US$37 million from overseas and the remaining US$11 million from domestic market.

Stem cell research:

In India 40 institutions and hospitals are involved in stem cell research progressing from a few institutions. India’s considerable progress in stem cell research has positioned it to take leverage of growing capabilities in this area.

Medical devices

India’s medical devices market is new and estimated to be US$2.75 billion in 2008 and is expected to double by 2012 to US$5 billion. Global Medical Devices market is around US$220 billion in 2008 and India’s market share is just 1.25%.

Indian Pharma Market

Definition:

Indian Pharma Market is the total value of Pharmaceutical Formulations in India sold at the retail level to the final consumers.

Why we should know?

To know the pharmaceutical market potential, therapeutic category wise, products, major competitors, so that we can make appropriate choices and decisions to achieve company objectives.

Main features of Indian Pharma Market

India is the potential market for MNCs. This is because India’s population is growing rapidly and its economy – creating a large middle class with the resources to afford Western medicines. Moreover the changing epidemiological profile of India shall increase the demand for drugs used to treat cardio-vascular problems, disorders of the central nervous system and other chronic diseases.

India’s growing pharmaceutical industry is likely could be a competitor and potential partner in many key areas of global Pharma.  India has considerable manufacturing expertise and as such Indian producers are likely to partner with global Pharma companies to market their wares outside of India.

India will be the most populous country in the world by 2050, will make its mark as a growing market, potential competitor or partner in manufacturing and R&D, as a location for clinical trials and partner with MNCs.

India is a fast growing economy.  The Indian economy is rapidly getting bigger. The real GDP growth reached 9% in March 2008. In the year to March 2009, growth eased to 6.7%. Reserve Bank of India (RBI) anticipates growth improving to 6% in the year ending March 2010, and expects robust growth of 7.8% p.a for the next ten years. Forecasts such as those of Goldman Sachs suggest that India will be the only emerging economy to maintain such an outstanding pace over the longer term, i.e. to 2050.

Government-provided healthcare is improving, but private healthcare dominates. The Indian Government is currently in the throes of a much needed programme to reform the health care system.

The factors that propel growth in sales volumes are increased buying power and epidemiological changes yet India remains a price-sensitive market. While India’s healthcare system is struggling to meet the needs of its vast population, government programmes and reforms in the health insurance industry should improve the situation.

India’s Pharma domestic market was worth around US$11 billion in March 2009 and expected to reach US$30 billion by 2020.

Indian Pharmaceutical manufacturers produce more than 20% of the world’s generic products. As  US$70 billion worth of drugs are expected to go off patent in the US over the next three years, Indian manufacturers are positioned to take a substantial share of the resulting new generics market.

Till February 2009, Indian companies account for 35% of the Abbreviated New Drug Application (ANDA) approvals granted by the US Food and Drug Administration (FDA). Indian Pharma manufacturers are entering into strategic alliances globally to jointly market the generics in the world resulting in major market share of generics by Indian companies.

In spite of global recession in 2008, Mergers & Acquisitions  in the Pharma sector  in India more than doubled compared to the previous year. There were 57 M&A, a 128% increase. Investment in Pharmaceutical, healthcare and biotech was of US$5.57 billion, the second among industry.

In 2009, India’s pharmaceutical exports reached US$8 billion and by 2020, it is estimated to attain approximately US$20 billion.

The reverse engineering manufacturing experience of generics helped Indian Pharma companies to stream line the costs to two-fifths of the cost in the west. This also widened the scope of contract manufacturing facilities with enhanced scrutiny of quality issues resulting in significant improvement in quality standards.

The US FDA has already approved over 100 manufacturing sites – more than  in any country except the US. The Indian contract manufacturing segment worth US$605 million in 2008 is expected to reach US$916 million in 2010.

India has more US FDA-approved manufacturing plants than any country except the US

India is one of the largest vaccine producers in the world, with many new vaccines set to be launched in the next five years. In March 2008, vaccines market is estimated to be US$780 million, growing at a compounded annual growth rate (CAGR) of 15%. India not only exports vaccines to about 150 countries but also meets 40-70% of the World Health Organization (WHO) demand.

The OTC market in India valued at US$1.8 billion in 2009, is expected to grow at 18% a year to reach about US$3 billion in 2012 as the Government is now considering to expand the list of OTC drugs which can be sold outside pharmacies, since many common household remedies are more difficult to obtain in India than in other developing countries. Hence OTC sales are on the increase, offering opportunities to achieve high volumes of OTC Pharma brands in India.

Though urban markets remain in focus for short term goals, getting treatment to the remaining 70% of the rural population shall be the next volume driver.

The US market – growth improves to 6%

The US pharmaceutical market, which constitutes around 45% of the global market, Grew by 6% — from US$206.4bn to US$218.8bn (Rs9, 310bn-Rs9, 870bn). The growth Rate for Nov’09 was 5%, indicating a steady improvement of the US Pharma market. Moreover, the US Pharma market is growing at 6% in line with the global markets indicating steady and sustainable growth.

The Canadian pharmaceutical market, much smaller in size as compared to the US market, grew by 7% — from US$16.3bn to US$17.4bn (Rs735bn to Rs785bn).

European markets – signs of sluggishness

The five major European pharmaceutical markets (Germany, France, Italy, UK and

Spain) grew by 2% — from US$108.1bn to US$110.3bn (Rs4,880bn to Rs4,980bn).

The growth rate of 3% in November’09 fell to 2% indicating that the European market is showing signs of sluggishness.

Details of key country drug purchases in these markets are shown in the table below:

Particulars 12 months ending

12 months ending

Jan’09 % Growth Economic downturn affects markets

Growth has slowed in countries where with high out-of-pocket spending on drugs and steep decline in macroeconomic activity especially in Russia, Mexico and S. Korea. Growth has been less affected in countries where drugs are largely funded publicly, such as Germany, Japan and Spain.

Chinese market – likely to grow over 20%

China’s pharma market is expected to grow at over 20% per annum and contribute 21% of overall global growth through 2013.

Global events

According to IMS data (for 12 months ending January 2010):

The top five global pharmaceutical companies were Pfizer, Merck, Astra Zeneca, Novartis and Glaxo Smith Kline (GSK).

The five largest-selling drugs were Lipitor (Pfizer), Plavix (Bristol Meyer Squibb, Sanofi Aventis), Nexium (Astra Zeneca), Seretide/Advair (Glaxo Smith Kline) and Crestor (Astra Zeneca).

The top five therapeutic classes were: cholesterol and triglyceride regulators, anti-ulcerants, anti-depressants, anti-psychotics and Angioten-II antagonists.

Global news

• Clinical trials carried out by MNC pharma companies in India has seen a 30% drop from 229 trials in 2008 to 158 trials in 2009. This is due to sharp reduction in R & D budgets in 2009 due to global recession and shrinking R & D pipeline of MNC pharma companies.
• Astra Zeneca has signed an agreement with Torrent Pharma to market 18 of its products in 9 emerging markets.
• Glenmark Pharma has been issued a warning letter by US FDA for marketing unapproved Nitroglycerin tablets in the US.
• Novo Nordisk has launched its new diabetes drug Victoza in the US.
• The US FDA has approved Astra Zeneca’s statin Crestor for additional indications.
• Roche and Biogen’s Rituxan were cleared by US FDA for the treatment of chronic leukemia.
• The US FDA approved Pfizer’s Prevenar 13 pneumococcal vaccine.
• Daiichi Sankyo is forming a new subsidiary in April’10 for the sale of generics in Japan.
• US FDA has warned Eli Lilly about manufacturing problems at its Puerto Rican plant that manufactures Humalog Insulin.

US Healthcare Bill

• Legislation to overhaul US Healthcare system would cost $940bn over next 10 years.
• The Bill will extend coverage to 32m uninsured Americans. This will include aged people or those deprived of insurance based on pre-conditions. The drug requirement for them will be high.
• With this 95% of the US population will be covered by healthcare.
• It will cut the federal budget deficit by $138bn in the first decade.
• Insurers such as Cigna Corporation would get millions of new policyholders and are required to accept all customers.
• Big pharma companies including Pfizer and Amgen will be major beneficiaries.
• The new regulations are likely to generate direct new business of $115bn over the next 10 years ($11bn per annum).
• The branded biologics will have exclusive period of 12 years instead of 7 years earlier, leading to prolonged protection. This is positive for US biotech companies.

Global Pharmaceutical Market Estimated to Double to $1.3 Trillion by 2020

The global pharmaceutical market shall more than double in value and  reach $1.3 trillion by 2020, driven by soaring worldwide demand for medicines as the population grows, ages and becomes more obese and as chronic conditions and infectious diseases tied to global warming increase. It is warned that the current pharmaceutical business model is unsustainable and the industry must fundamentally change the way it operates if it is to capitalize on future growth opportunities.

The E7 countries – Brazil, China, India, Indonesia, Mexico, Russia and Turkey – could account for as much as one-fifth of global pharmaceutical sales by 2020, an increase of 60 percent since 2004. Further, as these countries become more prosperous,  the chronic conditions in the developing world will increasingly resemble those of the developed world, with a significant rise in hypertension and diabetes. Many scientists also predict that global warming and rise in greenhouse gases will have a major effect on the world’s health, with the spreading of diseases such as malaria, cholera and higher prevalence of respiratory illnesses such as asthma and bronchitis.

The pharma industry will not be able to meet the challenge unless R&D productivity improves. The Pharma Industry lacks innovation. The industry is investing twice as much in R&D as it was a decade ago to produce two-fifths of the new medicines it then produced. It is simply an unsustainable business model. The current pharmaceutical industry business model is both economically unsustainable and operationally incapable of acting quickly enough to produce the types of innovative treatments that will be demanded by global markets. Pharmaceutical companies are facing a dearth of new compounds in the pipeline, poor share value performance, rising sales and marketing expenditures, increased legal and regulatory constraints and tarnished reputations.

In the next decade, the industry must invest in research and focus less on sales and marketing. Pharma’s traditional strategy of placing big bets on a few small molecules, marketing them heavily into primary care with the aspiration of achieving blockbuster sales, will no longer be viable. The Industry  must focus on the development of medicines that prevent, treat or cure. These must demonstrate tangible benefits and tackle unmet medical needs. Governments and payers must play their part and ensure the industry is rewarded for these efforts.”

Some of the major changes expected are:

The blockbuster sales model shall be replaced by a smaller, smarter and more effective sales force, led by key account managers who will negotiate contracts based

on therapeutic benefit and outcomes. The quality of value shall prevail over the quantity. Integrated packages of medicines and services, and some services, such as personalized

patient monitoring and disease management, shall be more valuable than the medicines themselves.

Emphasis on outcomes to increase. Successful companies will prove that their products really work and add value. Companies also will be financially rewarded for developing new therapies versus me-too medicines. Risk-sharing agreements will become more mainstream with drug manufacturers adjusting prices according to the results of outcomes analysis data that demonstrates drug efficacy.

Compliance monitoring becomes win-win for patients, payers and providers. Solutions to monitor and ensure that patients are fully compliant with their medications could generate more revenue a year in new sales, and would improve outcome and patient safety. Pharmaceutical companies will revise their proposition, employ new technologies and develop personalized compliance monitoring techniques as a value-added service to patients, payers and providers.

Prevention shall come first than treatment. Pharma companies health management, with wellness programs, compliance monitoring and a significant increase in the production of vaccinations. Vaccines market is estimated to grow to $42 billion by 2015.

New technologies will drive R&D. Technological transformations such as genetic-based diagnostics, human genome etc., shall reshape the business strategies.

The current linear R&D process will give way to in-life testing and live licensing. Phase I, II III and IV clinical trials will be replaced by collaborative in-life testing and ‘live license’ issued contingent on the ongoing performance.

Greater international regulatory cooperation. There may well be one global regulatory system by 2020. Such a system would help to reduce the spiraling costs of regulatory compliance and reduce time to market.

The supply chain functions will become revenue generating. The future supply chain will be revenue generating rather than a cost center. 2020 will likely give rise to ‘made to order’ therapies.

More sophisticated direct-to-consumer distribution channels shall diminish the role of wholesalers. Growing self medication sector, automated dispensing direct to consumers, automated prescriptions etc., will supplant reliance on wholesalers.

The entire global health care system is being subjected to a seismic shift  or upheaval that will force the pharmaceutical companies to change the way they operate. The challenges are steep, but the rewards could be significant.

(Adapted from http://www.PharmaManufacturing.com)

WHAT TO ANALYZE AND WHY?

Economic indicators: The following economic indicators are important to evaluate and formulate entry strategies for each country.

GDP (purchasing power parity): A nation’s GDP at purchasing power parity (PPP) exchange rates is the sum value of all goods and services produced in the country valued at prices prevailing in the United States. This is the measure most economists prefer when looking at per-capita welfare and when comparing living conditions or use of resources across countries.

GDP (official exchange rate): A nation’s GDP at official exchange rates (OER) is the home-currency-denominated annual GDP figure divided by the bilateral average US exchange rate with that country in that year. The measure is simple to compute and gives a precise measure of the value of output.

GDP – real growth rate: This entry gives GDP growth on an annual basis adjusted for inflation and expressed as a percent.

GDP – per capita (PPP): This entry shows GDP on a purchasing power parity basis divided by population as of 1 July for the same year.

Population: The total population presents one overall measure of the potential impact of the country on the world and within its region.

Budget: This entry includes revenues, expenditures, and capital expenditures.

Inflation rate (consumer prices): This entry furnishes the annual percent change in consumer prices compared with the previous year’s consumer prices.

Exports: This entry provides the total US dollar amount of merchandise exports on an f.o.b. (free on board) basis. These figures are calculated on an exchange rate basis, i.e., not in purchasing power parity (PPP) terms.

Imports: This entry provides the total US dollar amount of merchandise imports on a c.i.f. (cost, insurance, and freight) or f.o.b. (free on board) basis. These figures are calculated on an exchange rate basis, i.e., not in purchasing power parity (PPP) terms.

Reserves of foreign exchange and gold: This entry gives the dollar value for the stock of all financial assets that are available to the central monetary authority for use in meeting a country’s balance of payments needs as of the end-date of the period specified. This category includes not only foreign currency and gold, but also a country’s holdings of Special Drawing Rights in the International Monetary Fund, and its reserve position in the Fund.

Debt – external: This entry gives the total public and private debt owed to nonresidents repayable in foreign currency, goods, or services. These figures are calculated on an exchange rate basis, i.e., not in purchasing power parity (PPP) terms.

Exchange rates: This entry provides the official value of a country’s monetary unit at a given date or over a given period of time, as expressed in units of local currency per US dollar and as determined by international market forces or official fiat. The International Organization for Standardization (ISO) 4217 alphabetic currency code for the national medium of exchange is presented in parenthesis.

(Source: https://www.cia.gov/library/publications/the-world factbook/docs/notesanddefs.html)

Global Pharma Market

Global Pharma Market maintains growth expectations of 4-6% in 2010. Forecast: 5-8% annually through 2014. To reach $1.1 trillion by 2014 growing nearly $300 billion in the next 5 years. The growth in 2008 was 4.8 percent but where as in 2009, the market growth was 7% reaching $837 billion.

Leading products loose patent protection in developed markets and strong growth in emerging markets tilt growth towards generics

Pressure from the payers to curb drug spending on the publicly funded healthcare plans in developed markets will only intensify growth, which will be more than offset by the ongoing, rapid expansion of demand in the Pharmerging markets. The net result  over the next five years will be a strong growth — in spite of  industry facing  the peak years of patent expiries and  entry of lower-cost generic alternatives.

Pharmerging countries continue to tilt the geographic balance of Global pharmaceutical market. While developed markets will grow only 3-6%, Pharmerging markets will record a growth of 14 – 17% through 2014 which will be around $120-$140 billion from $69 billion over the past 5 years, similar to the growth of developed markets. The U.S. shall continue to remain the single largest market, reaching $360 – $390 billion in 2014, up from $300 billion in 2009, with 3 – 6 percent growth expected annually in the next five years.

Therapy area growth dynamics driven by innovation cycle and areas of unmet need. Higher growth will occur in the therapy areas where there is significant unmet clinical need, high cost burden of disease and new treatment options through innovative science. As the new drugs are brought to market, patient access is expanded and funding is redirected from other areas where lower-cost generics will be available, annual growth is expected to exceed 10 percent through 2014 in the areas of oncology, diabetes, multiple sclerosis and HIV.

Drug budgets growth reduced due to cuts in spending applied by public payers. Due to global economic down turn, publicly funded health systems are under increased pressure to reduce growth in drug budgets. Countries such as Turkey, Spain, Germany and France already have         announced restrictions on access or reductions in reimbursements to reduce drug spending growth. Other countries under pressure to restore fiscal balance may take similar actions, or shift more costs to patients.

Generic dominance shall increase as patents expire. In the next five years, as the patents of products with sales of more than $142 billion expire  and face generic competition in major developed markets,  the patients shift to lower-cost generics in major therapy areas such as cholesterol regulators, antipsychotics and anti-ulcerants reducing the total drug spending by about $80 – $100 billion worldwide through 2014. This will impact the U.S., where nearly two-thirds of the total value of patent expiries will occur. Patents of 6 products out of 10 will face generic competition in the U.S. and will peak in 2011 and 2012.

Payers spend less initially while new products await scrutiny. 30 -35 new molecular entities will be launched annually over the next five years. But before being accepted into clinical practice and reimbursed, these will be subject to more rigorous and complex assessments by payers. In many countries such as China, Spain, Italy and Canada, funding and implementation of healthcare at regional or local levels is becoming more significant which will  extend the time it takes for new medicines to become available to patients, and therefore contribute to lower initial spending by payers.

Global Pharma Market

Definition:

Global Pharma Market is the total value of Pharmaceutical Formulations in the world sold at the retail level to the final consumers.

Why we should know?

To know the pharmaceutical market potential country wise, therapeutic category wise, product wise etc., so that we can make appropriate choices and decisions to achieve company objectives.

Sources of data:

Various data such as Health care, Disease pattern, regulatory data, etc., can be obtained from

Respective Ministries of Health portals given below (Click on hyperlink):

On-line reports:

On line reports on each country’s health and pharmaceuticals can also be obtained from the following websites:

http://www.who.int/whr/en/index.html

http://www.who.int/publications/en/

https://apps.who.int/infobase/report.aspx

http://apps.who.int/globalatlas/

http://www.imshealth.com/portal/site/imshealth

http://www.imsglobal.org/

http://www.fda.gov/

http://www.hhs.gov/

http://www.nih.gov/

http://www.pharmaceutical-business-review.com/

http://www.pharmiweb.com/

Pharma research portals:

Detailed research into various aspects of Pharma markets can also be obtained from the following research portals. Most of these need subscription or charge for each of the reports.

http://www.datamonitor.com/

http://www.globalbusinessinsights.com/hc/hc_portfolio.htm

http://www.businessmonitor.com/

http://www.frost.com/

http://www.marketlineinfo.com/

http://www.marketresearch.com/

Journal /Magazine publications etc.:

Some of the secondary data can also be obtained from the following journals and magazines.

European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)

European Federation of Pharmaceutical Industries and Associations (EFPIA)

European Pharmaceutical Market Research Association (EphMRA)

International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)

Japan Pharmaceutical Manufacturers Association (JPMA)

New York Health Products Council (NYHPC)

Pharmaceutical Research and Manufacturers of America (PhRMA)

Irish Pharmaceutical Healthcare Association (IPHA)

Types of data:

Data such as basic statistics, overview, disease outbreaks & crises, mortality and burden of disease, health services, risk factors, health systems etc., could be obtained from each country profiles (Please click on each country’s link)

Country profiles

Country wise healthcare data can also be obtained from the following:

http://www.who.int/whosis/en/

http://www.nationmaster.com/

Http://www.pwc.com/us/en/healthcare/…/secondary-health-data.jhtml

http://www.imf.org/external/pubs/ft/survey/so/…/BOK051C.htm

http://www.thehealthcareblog.com/…health_care…/medical-data-in-the-internet-cloud-part-3-data-privacy.html

Country wise Economic indicators could be obtained from the following links:

https://www.cia.gov/library/publications/the-world-factbook/

http://www.economywatch.com/economic-statistics/country/

http://www.imf.org/external/data.htm

http://www.oecd.org/…/0,3343,en_2649_34265_2367750_1_1_1_1,00.html

http://www.forextradinghq.com/forex-information/economic-indicators

http://unfccc.int/ghg_data/ghg_data_non_unfccc/items/3170.php

http://www.library.mcgill.ca/edrs/links/country/country.html

http://www.imf.org/external/pubs/ft/weo/2009/01/weodata/index.aspx

Country wise Pharmaceutical sales data could also be obtained from:

http://apps.who.int/medicinedocs/en/d/Js6160e/6.html

http://en.wikipedia.org/wiki/Pharmaceutical_industry

http://www.piribo.com/publications/general_industry/pharmaceutical_market_trends_2008_2012.html

http://www.marketresearch.com/map/prod/2539915.html

http://www.researchandmarkets.com/reports/481962