The Indian economy grew at an average rate of 9% during the period, 2006-08. Following signs of slowdown in late-2008 because of the global financial crisis, the Indian Government introduced stimulatory fiscal measures at the beginning of 2009 along with sizeable increase in public outlays. With a subsequent recovery, the real GDP increased 7.4% in 2009-2010. In 2010-11, the expected real GDP growth is slightly over 8%. As exports have started to grow once again, business investment is expected to rebound by September 2011. Concerns include increase in long-term interest rates, widening fiscal gap, and inflationary pressure affecting investments adversely.
Source: IMaCS Research
Industrial GDP recovered sharply from 0.6% in fourth quarter of 2008-09 to 13.8% in the third quarter of 2009- 2010, because of substantially higher growth in manufacturing. Global figures on industrial production, trade and employment also indicate that the rate of contraction may now be starting to moderate and point towards faster trade growth in 2010. The Indian index of industrial production (IIP) increased 10.4% in 2009-2010, compared with 2.7% in 2008-09.
Investment flows in India have increased rapidly because of portfolio equity inflows from foreign institutional investors. Gross capital inflows increased from US$ 59.37 billion in the fourth quarter of 2008-09 to US$ 90.23 billion in the corresponding period of 2009-2010.
Exports increased 2.7% (year-on-year) in October 2009, representing the first increase in twelve months. Trade growth has rapidly accelerated since November 2009. Imports growth has been higher than exports reflecting increased crude oil and other commodity import prices.
Global Pharmaceuticals Industry
The global pharmaceuticals market reached US$ 837 billion in 2009, up 7% from the 2008 sales of about US$ 781 billion. According to IMS Health forecast, world-wide pharmaceuticals sales growth of 4% to 6% percent is expected in 2010. It is likely to reach US$ 1.1 trillion by 2014 at a 5% to 8% compound annual growth rate (CAGR).
Source: IMaCS Research
In the 12-month period to May 2008, retail sales through pharmacies increased about 2% in North America, the largest market. In the other markets, Europe had a 4% growth; Japan (5%); Brazil, Mexico and Argentina (9%); and Australia and New Zealand (13%).
In terms of new innovation versus established product categories, a Pfizer report indicates that sales of established pharmaceutical products, which accounted for 40% of the total market in 2008, are expected to have a CAGR of 9.7% by 2013 with a 51% market share. The innovative products that accounted for 60% of the total market in 2008 are expected to have a flat growth and account for 49% of the market by 2013. While the innovative products markets would be driven by direct payer and pharmacy channels, the branded emerging markets would be driven by physicians and pharmacists, and the branded traditional markets would be driven by direct payer and pharmacy channels, but influenced by physicians and pharmacists. In such a scenario, established international companies have the tasks of protecting their base, expanding product portfolio, reducing cost of goods to improve margins, and enhancing performance of products that have lost their exclusivity.
Global trends and growth drivers
The key trends in the global pharmaceuticals industry in today's scenario include the following: Table 1: Emerging global trends
Strong growth prospect in the emerging markets of India, China, Brazil, other Latin America, some countries in Africa and Russia.
Innovative products in therapeutic segments with unmet demand such as oncology, diabetes, multiple sclerosis and HIV to provide margin growth.
Annual growth expected to exceed 10% through 2014 as new drugs reach market, patient access expands and funding is redirected from lower-cost generics to high value products.
Rationalised drug and health care costs because of an expectation of cut in public spending and greater burden of drug cost borne by the patients.
Products sales of estimated US$ 145 million to face generic competition by 2014.
Patent expiries in the US expected to peak in 2011-12 when six of today's 10 largest products are likely to face generic competition.
Patent expiries, particularly, in the US to generate demand for lower-cost generics in major therapies such as cholesterol regulators, antipsychotics and anti-ulcer.
A decrease in total drug spending by about US$ 80-100 billion worldwide is expected as a result of the patent expiries.
With publicly-funded healthcare plans, the pressure to curb drug spending is expected to intensify in the developed markets. However, demand from other markets is likely to more than offset curb on drug spending.
Source: IMaCS Research
Markets in the Asia-Pacific, Latin America, Central Asia and some African countries are expected to grow many times over because of some or all of the following reasons:
- Their economies are growing more rapidly than the rest of the world
- The governments are undertaking healthcare reforms
- A gradually ageing demographic profile
- Greater access to healthcare and drugs
- Shifting disease profiles from basic malnutrition concerns and vaccine-based epidemic management to lifestyle diseases and new threats.
Growth possibilities in the US are expected to arise from the following reasons:
- Sustained price increases by drug makers
- Greater use of discounts, rebates and insurance incentives
- Changing inventory stocking patterns by pharmacies
- Prescription drugs that benefit from the US healthcare system
- Greater sourcing from low-cost generic manufacturing bases overseas
Opportunities in the emerging markets
Asia-Pacific region is emerging as the fastest growing pharmaceuticals industry in the world. The reasons include good quality but lower-cost production base and favourable regulatory environment. The region has had significant growth in terms of contract manufacturing, especially, in the generics segment. Increased research and development (R&D) activities have helped the regional industry achieve an estimated market size of around US$ 187 billion in 2009. It is expected to grow at a CAGR of around 12.6% during the period 2010-12. There is rapid market growth in India, China, Malaysia, South Korea and Indonesia because of reasons including increasing disposable incomes, growing health insurance market (ensures sales of branded drugs), better healthcare delivery and infrastructure, and intense industry competition leading to competitively-priced drugs.
Infrastructure development and rapidly changing regulations in the Middle East and African regions are viewed as drivers of future growth. Also, with high prevalence of diseases and huge population base, there is growth potential in overall pharmaceutical sales in this part of the world. Presently, South Africa, Saudi Arabia and Israel dominate the region's pharmaceuticals industry due to their better infrastructure and regulatory environment. The Middle East market depends on imports of pharmaceuticals and therapeutics. The governments of countries in this region are taking measures to raise their domestic production through heavy investments in the pharmaceuticals industry.
Table 2: Growth trends in emerging markets
Emerging Market Market Value Expected Market in 2009 Value by 2014
China 31 over 86
India, Brazil, Russia 10-20 18-38
Venezuela, South Korea, Argentina, Turkey, Poland, 1-10 2-18 Indonesia, Vietnam, South Africa, Saudi Arabia, Thailand, Ukraine, Egypt, Algeria, Romania, Czech Republic, Pakistan
Source: IMaCS Research
The increasing value of Asia-Pacific region (excluding Japan) comes from rapid market expansion, contributing to 43% of growth during the period 2009-2014 with 22% coming from China alone. The region is expected to be a key contributor to the next billion consumers because of a growing middle-class in China, India, Indonesia and Vietnam. However, international companies perceive challenges in terms of intra-regional heterogeneity, low-cost competition from local players, widely accepted and growing alternative medicine markets, a constant need for flexible business models, and management of local talent pool.
The Indian Pharmaceuticals Industry
The Indian pharmaceuticals industry is significantly developed in terms of infrastructure, technology and product range. It meets most of the country's pharmaceuticals requirements. Approximately 80% of domestic industry production consists of formulations, with the remainder consisting of bulk drugs.
Overall, the country now ranks among the top four, worldwide, accounting for 8% to 10% of world's production by volume and 1.5% to 2% by value. India exports pharmaceutical products to more than 200 countries around the globe including the highly regulated markets of US, Europe, Japan and Australia as well as the unregulated markets of Africa and the Middle-East. According to the Department of Pharmaceuticals, the domestic market was valued at about Rs. 554.5 billion (US$ 11.8 billion) in 2008-09. Imports were about Rs. 85.5 billion (US$ 1.8 billion).
Source: IMaCS Research
India joined the WTO in 1995. Since then, the Indian pharmaceutical sector has emerged as a major contributor to the country's exports with earnings increasing from a negligible amount in early 1990s to Rs. 395.4 billion (US$ 8.4 billion) in 2008-09. Exports of drugs, pharmaceuticals and fine chemicals have grown at an average annual rate of 10.6% over the period FY2007-09 and are estimated to account for about 60% of industry's turnover and 43% of the total pharmaceuticals and alternative medicine exports. The country also produces 20% to 22% of the world's generic drugs by value.
In January 2005, India amended its patent laws to conform to the WTO TRIPs agreement. Under the new patent law, Indian drug makers can no longer manufacture and market reverse-engineered versions of drugs patented by foreign drug producers. However, as a benefit of TRIPs compliance, many of India's leading pharmaceutical producers have not only diversified into international markets, but also increased their exports of generic drugs, particularly, to the US and Western Europe.
On the domestic front, India's private final consumption expenditure (PFCE) on medical care and health services increased 10% (year-on-year) in 2008-09 to Rs. 1,406 billion (US$ 29.9 billion). At current prices, the PFCE on medical care and health services increased 2.6 times between 1999-2000 and 2008-09. Estimates indicate that every Rs. 1,000 (US$ 22) increase in per capita health expenditure results in a 1.3% increase in life expectancy.
Source: IMaCS Research
The industry contributes to the Government exchequer in terms of sales tax; excise duty and import duty; and corporate tax on profit and dividends. It is estimated to provide direct and indirect employment to around 3 million people. By improving indicators such as life expectancy, reduction in disease burden and child mortality, the sector can drive macroeconomic growth, which in turn will result in greater income, consumption and investment.
As the demand for pharmaceutical products is directly related to medical care, the pharmaceuticals industry, globally, is relatively less impacted by economic cycles and the industry maintains a minimum growth rate. India's pharmaceutical industry has been one among the fastest growing segments of the Indian economy and has not been significantly affected by economic cycles. The industry is not recession-proof, but it is more insulated than other industries with discretionary spending patterns.
India's drugs and pharmaceuticals exports
Internationally, India is well recognised as a high-quality, low-cost, skilled producer of pharmaceuticals. The top twenty destinations for Indian Pharmaceuticals are the US, Russia, Germany, Austria, the UK, South Africa, Canada, Brazil, Nigeria, Ukraine, Israel, Netherlands, Spain, Turkey, China, Kenya, Vietnam, Belgium, Italy and Mexico.
India exports a full basket of pharmaceutical products comprising intermediates, APIs, finished dosage combinations, biopharmaceuticals, vaccines and clinical services to several parts of the world. The country is among the top-10 pharmaceutical exporters world-wide. The Government of India has set up joint working groups on pharmaceuticals and biotechnology with the European Union, Tunisia and Russia under the respective trade cooperation initiatives.
India's exports of drugs and pharmaceuticals have registered strong growth during the last few years. Exports have increased at a three-year average growth rate of 10.6% to Rs. 395.4 billion (US$ 8.4 billion) in 2008-09.
Source: IMaCS Research
In terms of global trade, India ranked sixth in the list of top-pharmaceuticals exporters according to the World Trade Organisation statistics, 2008. While total exports have increased from US$ 2.8 billion in 2005 to US$ 5.8 billion in 2008, the share of exports has steadily increased from 1% to 1.4% during this period. The growth in exports during 2000-08 was 22%. However, the bulk exporters are the European Union, Switzerland and the US. China and Canada are also ahead of India in terms of exports.
Table 3: World exports - top 15 exporters of pharmaceuticals
US$ billion Growth (%) Share (%)
2005 2006 2007 2008 2008 2000 2000 2008 -08
European Union 190.9 214.5 255.4 293.3 14.0 19.0 65.1 68.7
Switzerland 25.1 31.2 36.2 44.2 22.0 20.0 9.6 10.4
United States 26.0 29.1 33.5 38.3 14.0 14.0 12.1 9.0
China 3.8 4.5 6.0 8.1 34.0 21.0 1.6 1.9
Canada 3.5 4.7 6.2 6.2 0.0 22.0 1.1 1.4
India 2.8 3.5 4.4 5.8 27.0 22.0 1.0 1.4
Singapore 2.9 5.3 6.3 5.0 -21.0 22.0 0.9 1.2
Israel 2.0 3.0 3.5 4.8 38.0 35.0 0.4 1.1
Japan 3.3 3.2 3.2 3.7 15.0 4.0 2.5 0.9
Australia 2.5 2.6 3.3 3.3 3.0 14.0 1.1 0.8
Hong Kong, China 0.7 1.0 1.2 1.5 26.0 10.0 0.1 0.1
Mexico 1.4 1.3 1.5 1.5 0.0 7.0 0.8 0.3
Brazil 0.5 0.7 0.8 1.1 29.0 19.0 0.2 0.2
Korea Republic 0.5 0.6 0.8 1.0 25.0 15.0 0.3 0.2
Norway 0.5 0.5 0.7 0.7 7.0 15.0 0.2 0.2
Total 265.9 304.8 361.9 417.2 15.3 - - -
Share of World 97.8% 98.0% 98.2% 97.8% - - 97.2% 97.8%
Source: IMaCS Research
Policy and government initiatives
Nearly four decades of protection has enabled the Indian pharmaceutical industry to perfect its scientific and manufacturing capabilities, allowing many of its leading companies to move up the value-addition chain. India's pharmaceutical industry consists of large, medium, and small companies and is one of the most price- competitive, globally. Because many of these companies focus on producing similar generic drugs, with possibly hundreds of companies producing the same drug, the industry is characterised by fierce competition and high volumes, competitive profit margins and overcapacity.
The Indian pharmaceuticals industry is governed by the Patent (Amendment) Act, 2005 which was brought into effect to comply with the TRIPS Agreement concluded during the Uruguay Round of WTO negotiations. In addition to this, the Drug Price Control Order (DPCO) caps prices on 74 bulk drugs and 260 formulations that account for approximately 25% of India's retail pharmaceuticals market. Trade margins for these drugs were capped at 8% for retailers and 16% for wholesalers.
Recent initiatives of the government include the following:
- In the Union Budget 2010-11, the government has increased the weighted deduction on expenditure incurred on in-house R&D enhanced from 150% to 200% to encourage research and development.
- Under the Jan Aushadhi Kendras programme initiated in August 2008 for procurement of drugs, the Union Government's Department of Pharmaceuticals has decided to procure medicines from small and medium enterprises in the pharmaceuticals industry, which is likely to benefit 6,000 small enterprises in the private sector.
Formulations market in India
Formulations broadly fall under two categories:
- Patented drugs - An innovative formulation that is patented for a period of time (usually 20 years) from the date of its approval
- Generic drugs - A copy of an expired patented drug that is similar in dosage, safety, strength, method of consumption, performance and intended use.
There are two sub classes in generics: branded generics and unbranded generics. Branded generics are primarily patented drugs sold by the patent-holder but with more emphasis on the generic name. They may also be copies of drugs whose patents have expired and are sold under brand names of the local manufacturers. Unbranded generics are normally those that are sold without any brand name with more emphasis on the basic salts included.
During the period 2004-2010, formulations exports increased consistently, at an average annual rate of 24.2%, from Rs 70.9 billion to 205.4 billion.
Source: IMaCS Research
India's competitive advantage arises from the following factors:
- Complex synthesis capabilities
- Increasing endorsement of good manufacturing practices (GMP)
- Lower-cost production.
These factors enable exports of drugs and formulations to countries with relatively weaker patent laws, while gaining preference in the developed world as well. In the developed markets, the presence of select Indian players is restricted to the generics market. Introduction of price ceilings in the domestic market has had a positive impact on India's exports. They have generally made exports more profitable, and thus, provided an incentive for overseas market development. However, companies that manufacture new medicines on the basis of indigenous technologies are eligible for price control exemption for a period of 15 years from the date of commencement of commercial production in the country.
Figure 8: Indian pharmaceuticals - market segmentation
The Indian formulations market is dominated by branded generic generics with an estimated market of US$ 9 billion in 2009. It is expected to grow to US$ 23.5 billion by 2015. While branded generics are expected to contribute 85% of the market, unbranded-generics and patented molecules are expected to contribute the remaining.
Contract Research and Manufacturing Services (CRAMS)
Companies worldwide are increasingly outsourcing their research and manufacturing services to improve R&D productivity and profit margins. Outsourcing manufacturing is primarily a cost function, while outsourcing research allows a company to focus more on core products and drug discovery.
The key reasons why India has emerged as a significant destination for contract manufacturing are as follows:
- Increase in technically skilled personnel, particularly in basic sciences.
- The number of trained chemists in is over six times those in the US.
- Introduction of product patents in 2005, which has led to greater interest from multinational companies.
- The industry has invested recently in upgrading manufacturing facilities
- Greater number of plants with WHO and multiple-country accreditations and certifications.
- India has the highest number of US FDA approved plants outside the US.
- Compliance of intellectual property rights (IPR).
- Comparatively lower manufacturing costs.
The key drivers of the contract research industry in India include the following:
- Specialised scientific and technical knowledge.
- Greater chemical synthesis capabilities.
- Laboratory capabilities such as instruments and equipment needed in laboratory for tests, investigations, research, analysis, experimentations, evaluations, and developments.
- Considerable savings in initial set up and maintenance costs for the outsourcer.
- Use of new research tools
- Comparatively lower R&D costs.
- Greater use of IT and telecommunications.
- Product patent regime, which has stimulated Indian companies to undertake research.
Some of the large companies that are likely to drive the contract research outsourcing business in the coming years include AstraZeneca, Merck, Glaxo SmithKline, Dr. Reddy's Laboratories and Cipla. India is among the preferred destinations for outsourced contract research and manufacturing also because a large patient pool with varied ethnicities, which is significant for clinical trials.
Growth potential and outlook
Indian domestic pharmaceutical market has had an average growth of about 12% in the last five years. However, it is still small as compared to the Western market in terms of per capita spending on drugs, which is about US$ 4.50 per person as compared with US$ 820 in the US and US$ 13 in China in 2006.
The long term potential for growth is strong given that a larger proportion of the population will have aged by 2016. The national commission on population estimates that about 8.94% of the total population will have aged beyond 60 years by 2016 as compared to 8.14% in 2011. With India's population of over 1 billion, that translates into a 60 plus years population of 87 million. People of this age group spend around three to four times more on drugs than people in younger age groups. This indicates substantial growth potential for the domestic pharmaceutical industry.
Incomes levels are increasing and the country's young but developing medical insurance sector is likely to change the future demand for medicines and healthcare. Private sector has entered the organised healthcare sector and is setting up multi-specialty hospitals with international healthcare facilities, thereby increasing the growing importance of health care and insurance.
The positive approach towards product patent product has encouraged the Indian pharmaceutical companies to invest more in R&D. Patented drugs are expected to have a 6% share of the formulations market in 2015.
The pharmaceuticals industry has the following strengths:
- Self-reliance displayed by the production of 70% of bulk drugs required and almost the entire formulations requirement within the country.
- Thrust on improving healthcare delivery as well as pharmaceuticals manufacturing infrastructure by many state governments.
- Growth in opportunities for medical tourism
- Low-cost production and R&D
- Highly skilled workforce with significant expertise in chemical synthesis
- World-class facilities at national laboratories specialising in process and cost-effective technology development
- Increasing international trade in the pharmaceuticals sector
- Cost-effective source for generic drugs, especially, for those going off patent
- Emerging centre for clinical trials in view of diverse population and significantly low cost
Although the middle class represents only a small fraction of the total population, it is expected to grow significantly provided economic growth is sustained in the mid-to-short term. With the growing disposable income, the prevalence of lifestyles diseases is increasing.
With the introduction of product patents, many Indian companies plan to move up the product value chain and increase exports to regulated markets such as the US and Europe. Leveraging their comparative cost advantages, these firms plan to target plain vanilla generics sales to regulated markets in the near-term and to develop more value-added generics, lower-risk new drugs, and follow-on biologics in the medium term. Growth in exports is expected to continue, driven by India's cost advantage, regulatory filing skills, and a large number of USFDA- approved manufacturing plants. Indian companies are also targeting some European markets, with acquisitions there. The three markets that are under-penetrated with respect to generics (France, Italy and Spain) are expected to be especially important targets for Indian companies in the medium-term.
The US market is expected to continue to be the growth driver as its economy improves. The changing combination of innovative and mature products apart from the rising influence of healthcare access and funding is also likely to have a bearing on growth prospects.
However, significant market shifts are expected, with the Asia-Pacific region emerging as the fastest growing. Important drivers in these markets would be low cost, better regulatory environment, growth of contract manufacturing and higher R&D activities. The region's pharmaceutical industry is expected to grow at a CAGR of around 12.6% during 2010-12.
Trends also indicate that pharmaceutical sales are growing in India, China, Malaysia, South Korea and Indonesia due to the rising disposable income, several health insurance schemes that ensure the sales of branded drugs, and intense competition among top pharmaceutical companies in the region that has increased the availability of low cost drugs. The average annual growth of the Indian market is expected to be 14% to 15% up to 2014.The Asia-Pacific pharmaceuticals industry could gain from the Middle East and African markets, which together, are expected to grow at a CAGR of around 11% during 2010-12.
Global sales growth of pharmaceutical companies is driven mainly by product innovation. Since the price of a patented brand is significantly higher than its generic product. With the prospect of loss of patent protection of several brands in the Western markets, India companies have a significant opportunity in the coming five to ten years. Several established multinational players are tying up with manufacturers in the Asia-Pacific to continue producing their branded drugs at a much cheaper cost even after they lose the patents.
Key challenges in the pharmaceuticals and formulations markets
- The key success factors as well as barriers to entry include R&D investments, adoption of good manufacturing practices (GMP), strong branding requirements, and access to marketing and distribution network.
- A vast majority of Indian companies are not invention-based (i.e., aiming at the production of new chemical entities) but are innovation-based (i.e., aiming at producing incremental modifications of existing drugs).
- With the globalisation of the industry and markets, the requirement multiple plant certifications from several importing countries adds to cost. The Indian Government is trying to forge a pact in which at least the countries that have mutual recognition for such certifications should allow products, if a manufacturing unit has certification from a member of such group.
- Shortage of trained personnel to carry out research and development, despite facilities that match global standards is a growing concern in the industry. Even reverse engineering requires a deep understanding of chemical processes and products in the pharmaceutical industry.
- Lately, Indian manufacturers have increased their cost of research and development in the overall expenditure. However, new product pipelines need to be strengthened and sustained.
- New drug launches result from long duration and costly R&D conducted by pharmaceutical companies. Meeting these costs has resulted in ever-increasing investment efforts, which the pharmaceutical industry almost entirely finances from its own resources.
- High failure rates, the significant cost of clinical trials and the amount of resources needed to get approval by regulatory authorities are the primary reasons for this exponential increase of R&D costs.
Until recently, Indian companies spent only 2% to 4% of revenue on R&D, and drug discovery research was undertaken in public sector research institutes only. However, in the last decade there has been a steady rise in private sector R&D. The new IPR regime has induced a strategic reorientation towards increasing technological capacity of the top Indian firms and in domestic policies. In an attempt to improve the rewards for R&D, the has stipulated that innovative drugs and processes developed and produced in India would be exempt from price control for up to 15years. Some companies are spending over 6% of sales on R&D. Further, R&D spend of the leading companies has increased at a high rate in the recent past.
- The vast majority of India's pharmaceutical firms are small by global standards with annual revenues of less than US$4 million. Approximately 80% of them are engaged in some type of contract manufacturing or outsourcing.
- A highly fragmented market with the top-250 players accounting for about 70% of the market share has resulted in high level of competition and lower margins in the predominantly branded generics market.
- Price controls in key product segments add to margin pressures. This makes exports markets potentially attractive. However, the cost of marketing and selling overseas can be high. Also, multiple certifications for facilities become necessary.
- Although India is the world's leading producer of generic drugs, its annual per capita consumption of pharmaceuticals is among the lowest in the world.
- There has been a significant growth in exports during 2000-08. However, bulk exporters are the European Union, Switzerland and the US. fsfsChina and Canada are also ahead of India in terms of exports.
Source:Brooks Laboratories Ltd. - 16/08/2011
Disclaimer: Pursuant to the requirements of the SEBI (ICDR) Regulations, 2009, the discussion on the business of Our Company in this Red Herring Prospectus consists of disclosures pertaining to industry grouping and classification. The industry grouping and classification is based on our Company's own understanding and perception and such understanding and perception could be substantially different or at variance from the views and understanding of third parties. Our Company acknowledges that certain products described in this Red Herring Prospectus could be trademarks, brand names and/ or generic names of products owned by third parties and the reference to such trademarks, brand names and/or generic names in this Red Herring Prospectus is only for the purpose of describing the products. The industry data has been collated from various industry and/or research publications and from information available from the World Wide Web.
The entire content of this section has been extracted from the Industry Report of IMaCS titled "Indian Pharmaceutical Formulations Industry" dated November 2010 and addendum to the said report titled "India's Formulations exports by country"dated February 2011.
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