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SUB HEzcAD
SUB HEzcAD
twenty-first
century
offers
challenging
opportunities
for
the
in
US$
billion,
Growth
over
previous
year
in
US$
billion,
Growth
over
previous
year
Exports
Imports - Composition
INTRODUCTION:
1981
1991
2000
685
844
967
Urban Population
137
169
193
Rural Population
548
765
774
50.50 Yr.
59.0Yr.
64.0Yr.
80
60
15
9.6
8.2
37.2
29.9
23.1
INDUSTRY SENARIO
Capital
Investment
Production :
Formulations
Bulk Drugs
Import
Export
R&D
1965-66
140
1980-81
500
1997-98
1840
150
18
8.20
3.05
3
1200
240
112.54
46.38
14.75
12068
2623
2868.00
5353.00
220.00
1998-99
2150
13878
3148
3128.00
5959.00
260.00
1999-2000
2500.00
15960.00
3777.00
3441.00
6631.00
320.00
Expenditure
Source: OPPI
India is one of top five manufacturers of bulk drugs in the world and is among the
top 20 pharmaceutical exporters in the world. The industry manufactures almost
the entire range of therapeutic products and is capable of producing raw
materials for manufacturing a wide range of bulk drugs from the basic stage.
Attain cumulative dollar exports growth rate of 20 per cent per annum.
In the field of pharmaceutical R&D, the committee has set the following targets:
EXPORTS
10
Exports (Rs.Crores)
YEAR
Finished
% of Total
Formulations
Bulk
Drugs % of Total
Total
including
Quinine Salts
1997-98
3180
59
2173
41
5353
1998-99
3194
54
2764
46
5959
6631
1999-2000
Source : OPPI
While overall pharmaceutical exports have grown in 1999-2000, Indias exports to a few
of its leading markets have declined. For instance, according to a CHEMEXCIL report,
Indias pharmaceutical exports to USA have declined to Rs.671.8 crores in 1999-2000
from Rs.724.5 crores in 1998-99; Germany to Rs.325 crores from Rs.375 crores; Hong
11
1999-2000 (Rs.)
USA
672
RUSSIA
493
GERMANY
325
HONG KONG
356
U.K.
257
SINGAPORE
245
NETHERLANDS
219
IRAN
180
BRAZIL
163
VIETNAM
141
CHINA
137
ITALY
151
SPAIN
129
NEPAL
123
12
SRI LANKA
124
JAPAN
120
Source: CHEMIXCI
MARKET SEGMENTATION
13
14
15
Improved literacy rates and access to medical information will lead people to use
more medicines, being the least costly component of total healthcare. The per
capita expenditure on medicines, currently at U.S.$ 5.6, is likely to increase
substantially.
Ageing population, focus on preventive aspects such as vaccination and
immunization and shifting disease patterns will create new opportunities and
drive robust growth of pharmaceutical companies. People are naturally looking
forward to lead longer, healthier and more productive lives. This opens up new
vistas of research into newer and better medicines.
Year
Status
1950s
Formulations
1960s
Formulations
1970s
Formulations
Bulk drugs
1980s
Formulations
Marginal
imports
(<5%)
Bulk drugs
1990s
Table 2.
Formulations
Significant
exports,
minimal
Bulk drugs
imports
(<
2%)
INDICATORS
1965-66
1994-95
1997-98
growth over
17
94-95 (%)
Investment
1,400
12,000
18,400
53.3
30
1,400
2,200
57.0
1,500
79,350
1,20,680
52.0
180
15,180
26,230
72.8
30
9,240
28,050
32.9
30
12,607
21,730
58.0
2,000
8,250
R&D Expenditure
Formulations
Turnover
Bulk Drugs
Exports
Formulations
Bulk Drugs
No. of manufacturers
18
Investment in R&D by industry as a whole in India has been low, only around
0.6% of the turnover. In the Indian pharmaceutical industry the average R&D
expenditure is around 2% of the turnover contributed by around 150 companies.
The low investment in R&D is due to the low levels of profitability and
comparatively small size of the companies. However, the scenario is now
changing. Some pharma companies now spend nearly 5% of their turnover on
R&D. In addition to R&D in industry, substantial pharma related R&D is carried
out in publicly funded research organizations, mainly by the laboratories of
Council of Scientific & Industrial Research (CSIR), Indian Council of Medical
Research (ICMR), around 25 universities and a few pharmacy colleges. Some of
the new R&D units in industry and a few of the publicly funded laboratories are
equipped with sophisticated laboratory equipment, instruments and pilot plant
facilities. The R&D manpower is generally highly qualified and proficient in
conventional techniques of pharmaceutical R&D.
Hitherto, R&D was largely concentrated on process development for known bulk
drugs albeit through novel and innovative process routes, invariably substituting
for expensive imported raw materials enhancing the productivity and efficiency of
the processes, besides research on formulations and known drug delivery
19
STRATEGIES
FOR
SMALLER
INDIAN
PHARMACEUTICAL COMPANIES
Many leading Indian Pharmaceutical companies relied heavily on the domestic market
until the mid-1990s. Most recently, many Indian Pharmaceutical companies have taken
advantage of the lucrative global generics market. The anticipated $ 80 billion worth of
blockbuster products set to lose patent protection by 2008 will drive growth of the U.S.
generics market between 2002 and 2008. Within this market, one of the stronger forces is
the economically competitive generic drugs companies from China and India. India
especially is well positioned in the industry with their product development skills through
advanced chemistry and low cost manufacturing.
According to SSKI report, Ranbaxy was the first Indian Pharmaceutical company
to recognize and take advantage of the generics market. Ranbaxy declared a
revenue of USD 1 Billion I 2004, with-65% of the revenues being generated in
Regulated markets and USA accounting for 50% of the total revenues. As one of
20
Lupins export turnover (32% of sales in F.Y 2003) is also growing rapidly, most of it
coming from APIs. Also, it has made inroads into regulated markets like US and Europe.
Orchid has already make a mark in area of injectables, and its strengths include
international standard facilities. It has already entered into a tie up with Apotex of US to
supply injectables.
21
IPCA is a fast growing generics company, which is now planning to enter the US market.
It is already a significant player in the EU market with a significant part of exports going
to UK.
Shasun is a generic bulk suppler to both generic companies and innovators. It is now
diversifying its product portfolio to reduce dependence on three drugs. It is also planning
to get into contract research.
Indian firms are arguably the world best in drug development (of both APIs and finished
dosages.) With their superiority established in process development they are refining their
legal skills to fight the innovator companies in patent challenges. While the smaller
companies are devising strategies, the large ones have already established their own
networks. By 2005, Indian companies are expected to file 60 ANDAs almost 20 % of
total filling. The scenario in bulk drug supply is even better. Indian pharma companies
had a 25% share in the total Drug Master Files (DMFs) filed with the US FDA in the
quarter March June03. Indian companies have also shown their excellence in
developing non-infringing processes. For instance, Ranbaxys non-infringing process for
generic version of cefuroxime axetil enabled it to be the sole seller of this generic for
almost 17 months, product. However, Few firms apart from Ranbaxy and DRL have the
legal skills to make the most of the generics opportunity.
In order for the smaller Indian Pharmaceutical companies to take advantage of this giant
market, there are various ways of entering and capturing the market share. This market is
highly competitive as these Indian companies are not only fighting with the domestic
giants who are currently active in the generic drugs industry, but also with the
multinational corporations and many American and European specialty pharmaceutical
companies and generics drugs industry, but also with the multinational corporations and
many American and European specialty pharmaceutical companies and generics drug
companies in the space. In order for the smaller Indian Pharmaceutical companies to
22
With large intellectual capabilities and existing cost advantage at all levels, India
has become the outsourcing capital to the U.S and European companies in many
23
RECENT TRENDS
The major players of the Indian pharma industry are aggressively increasing their
overseas business, which will help the domestic pharma industry to grow from
the present US$ 6 billion to US$ 25 billion by 2010, says a report by McKinsey.
24
25
include
pharmacogenomis
(personalised
medicine),
bio-
26
27
RATIO ANALYSIS
Structure Ratio:
Composition
16%
32%
28%
Net worth
Borrowings
24%
The above chart shows the composition of the total liability, it includes networth,
free reserves total borrowings. The chart shows the average percentage data for
the years 1999-2003.Thew composition shows 32.62% of Net worth, 25.39% of
Reserve & surplus, 25.02% of Borrowings, 16.96% of current liabilities &
provisions.
28
Industry Growth:
This chart indicates that there ia an upward trend for total income, pbdit and pat.
There is a very huge difference between total income and pbdit, which indicates
that the proportion of raw materials, operating and administrative expenses are
INDUST RY GROWT H
RUPEES
350000
300000
250000
Total Income
200000
PBDIT
PAT
150000
100000
50000
0
1999 2000 2001 2002 2003
YEAR
very high. high Difference between pbdit and pat arises because of high rate of
depreciation, interest rate and tax rate. Industry maintains PAT below 10% of
total income.
PAT as a % of Net Sales:
8.57
8
6
4
6.28
3.67
3.35
1999
2000
4.03
2
0
2001
2002
2003
year
This ratio determines the overall profitability of the industry due to various factors
such as operational efficiency, trading on equity, etc. The ratio of the firm has
increased from 3.87% to 8.57% in the period of 1999-2003, which shows that the
industry has greater capacity to withstand adverse conditions like decline in sales
& increase in the cost of production.
29
61%
Dividend
Retained Profit
99.61
100
90
80
70
60
50
40
30
20
10
0
99.61
69.8
63.09
43.44
1999
2000
2001
2002
2003
Year
This ratio reflects the dividend distributed from the profit after tax of
the industry. Dividend distributed to the investors was highest 99.81%
in the year of 2000 and 2003. It implies that these both the years are
30
1.538
1.519
TIMES
1.5
1
0.56
1.494
0.62
0.54
1.551
1.435
0.68
0.54
0.5
0
1999
2000
2001
2002
2003
YEAR
quick Ratio
Current Ratio
19.01
10.04
3.65
3.14
0.03
1999
2000
2001
2002
2003
Year
31
11.9
6.99
2.67
2.29
0.02
1999
2000
2001
2002
2003
Year
Debt-Equity Ratio:
TIMES
0.955
0.991
1999
2000
0.817
0.839
2001
2002
0.649
0.5
0
2003
YEAR
TIMES
3.54
1.76
1.67
2.05
1999
2000
2001
2.57
2002
2003
YEAR
32
The interest coverage ratio shows the number of times the interest charges
are covered by funds. The ratio is increased from 1.76% to 3.54% from the
year 1999-2003.It indicates that craze to utilize debt amount is decreasing
and the industry rely more on owners fund.
Statistics
Foreign Trade of Pharmaceuticals from India
Year
Exports*
% growth
(in crores)
1996-97
4341.8
n.a.
1997-98
5419.32
24.82
1998-99
6256.06
15.44
1999-2000
7230.16
15.57
2000-01
8729.89
20.74
#
of
medicinal
and
*
of
Drugs,
Pharmaceuticals
Import#
% growth
(in crores)
1039.18
n.a.
1447.12
39.26
1625.19
12.31
1616.21
-0.55
1701.46
5.27
Pharmaceutical
and
fine
products
chemicals
33
2623
3148
3777
in
Rs
12,068
13,878
15,960
crore;
14,691
17,026
19,737
Over
15.86%
15.89%
15.92%
previous
year
Amount
29
40
48
50
125
140
160
185
220
260
320
Crore
Overview
RANBAXY
34
35
INDIA
DR REDDY'S LABORATORIES
EXECUTIVE SUMMARY
36
DRL has transformed itself from process engineering and research driven
pharmaceutical company in the past 5 years. The company achieved several
landmarks in 2001 with its ADR issue, launch of generic fluoxetine in the US and
license of anti diabetic molecule to Novartis.
The US$300bn global pharmaceutical industry is research driven. New drug
R&D cost being prohibitive, MNCs in developed nations where product patents
are enforced, are more active. High prices of under-patent drugs are causing a
shift to generics, especially in USA and European markets. So, to spread their
R&D costs over a larger base, pharma MNCs are consolidating through mergers/
alliances. Historically, India has recognized only process patents. Under WTO, as
per TRIPs agreement India too has to enforce product patents latest by year
2005 AD.
In the Rs160bn Indian pharma sector, prices of over 60% of the drugs/
formulations are Government controlled (through DPCO). In the domestic bulk
drugs market, low entry barriers have resulted in overcapacity and price wars.
So, major players are focussing on formulations, where brand image and
distribution network act as entry barriers. Most players are increasing their
overseas marketing/-manufacturing network in order to enhance exports (under
patent drugs to third world countries and generics to developed nations). In
anticipation of WTO, MNCs are strengthening their ranks in India - either setting
up new 100% subsidiaries or marketing tie-ups with major domestic players.
Large local players are consolidating through brand acquisitions, co-marketing/
contract manufacturing tie-ups with MNCs etc.
DRL has formulated new chemical entities (NCE) with two licensed to Novo
Nordisk and one to Novartis. After the merger with sister company Cheminor
Drugs, DRL has gained entry into the lucrative US generics market. The
company created headlines in August 2001 when it was the first company to
launch generic version of Fluoxetine 40 mg dosage form and enjoyed six month
37
Indian pharma industry dominated by Indian owners has done well during 80s 90s due
to encouragement given by the government and apathy of MNC in India. The
opportunities helped many companies to prosper. Good opportunity created a boom in
pharma industry leading India to produce bulk drugs, formulation at economical price
compared to our neighboring countries and European countries. Success leads to
complacency and lethargic attitude. Market has grown due to mushrooming of
manufacturing companies. High degree of competition has also checked over
profiteering. However, Indian parka companies did not show much interest in :
R&D
Improving productivity
38
Developing brands
Many owners were stockiest. The mindset did not change. This mental block did not
allow them to become more professional. Therefore, a big question is emerging Will
Indian pharma companies survive or they have to become trader again?
Recently during journey to Vasai, on outskirts of Mumbai, a group of Indian owners
expressed that it will be difficult to complete if they do not change their mindset. Infact,
one of the entrepreneurs reported that it will be better to become a trader again!! What a
change in scenario? Will it happen? How can they overcome such situation? What
strategies should be adopted?
Indian companies can survive post 2005 provided they make effort to become more
professional and not just trading activities. If they initiate action today, it can sure help
them to face the competition better.
Do Swot analysis:
How many times they have done swot for the company? A regular analysis will help the
company to accelerate growth. Can they compare the same with GROWING COMPANY
IN THE INDUSTRY? The bench marking approach using swot analysis can definitely be
beneficial. Analysis of top 20 reveals that many may not figure after 2005. Some of the
weakness may be:
Lack of professionalism
39
40
41
42
Therefore, companies should strive to retain not only "external customers" but also
internal customers. Thus, loyalty can lead to better stability.
How many companies are doing such activities? Failure to do has led to downfall and
degrowth of many companies. Analysis of 400 companies by the author on these
parameters revealed the following.
*From existing 250 top listed companies of India 50% will vanish and will be replaced
by in progressive companies hopefully.
Thus, very few companies will remain active companies. Rest will close down, merge,
sold or become stockiest. The authors earlier prediction in Pharma Pulse, India, 4 years
back was 450. India has 700 companies. There is upward trend due to greater awareness
among Indian owners. It is possible some of them will become contract manufacturers.
43
44
45
46