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1332567100research Report On Pharmaceutical Sector of BD-Initiation, June 28, 2011 PDF
1332567100research Report On Pharmaceutical Sector of BD-Initiation, June 28, 2011 PDF
Management Trainee
Salim@idlc.Com
Research Report
Date : 28 June 2011
Abstract
Pharmaceutical is the core of Bangladeshs Healthcare sector, and serves as one of the most important
manufacturing industry. With a history since 1950s, the industry has now turned one of the most
successful pharmaceuticals manufacturing industry among the developing countries. Presently, the
industry meets 97% of local demand and exports to more than 80 countries.
The industry has been experiencing robust growth over the last few years. A local industry supporting
drug policy and effective regulatory framework, along with TRIPS relaxations are the key reasons for
success of the industry.
While the industry is achieving self sufficiency, it yet procures 70% of raw materials from abroad. But
developments are already taking place, with a number of firms now manufacturing raw materials locally.
In addition, an API project has already been undertaken to accelerate the vertical integration within the
industry.
The industry has been expanding locally and internationally. Local market grew at 23% in 2010, while
import reached USD 50 Million landmark. A number of firms got accreditations from USA, UK, Australia
etc. developed markets, and are underway toward expansion into the developed markets. Locally, firms
are preparing themselves for post 2016 scenario, when TRIPS will be implemented. Almost all the firms
are upgrading their facilities and taking up precautions for post 2016 scenario, while aggressively
expanding in both local and export markets.
While TRIPS and import dependence on raw materials put challenges to the growing sector, prospect of
the sector depends largely on the interactions among the players, regulatory bodies and the govt.,
whether they can meet up the requisites to continue growth of the sector while facing the challenges
List of Abbreviations
API
TRIPS -
IMS
WTO
MNC
R&D
cGMP -
BP
British Pharmacology
USP
BAPI
LDC
VAT
OTC
ETP
IV
Intra Vascular
1.0 PREFACE
3.50%
3.00%
2.50%
2.00%
1.50%
1.00%
0.50%
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
0.00%
Indicator Name
GDP growth (annual %)
2005
2006
2007
2008
2009
5.96%
6.63%
6.43%
6.19%
5.74%
6.7%
3.21%
3.40%
3.46%
3.32%
3.35%
3.21%
35.42
37
40
54.93
68
26.96
37.74
46.54
45.71
BDT Bn
Unit
$ Mn
3
2010
18.18
50
2010, top 5 MNCs have approximately 9.05% of the market share and
97% of total local demand is met through local production.
Mainly Finished
Formulation products
Degree of concentration
Being Branded-generic product oriented business, manufacturers
usually are able to charge a premium for established brands, and enjoy
a relatively stable market share. As a result, the list of top performing
firms have been quite consistent over the years, with the leader, Square
pharmaceuticals topping since 1985.
High concentration of
business
Market share
46.40%
67.60%
77.70%
97%
0%
50%
100%
Top 5
Top 10
Top 20
Local Production
Competitive structure
Over the last three years, the top 4 players are consistent, with 5th to
10th position interchanged among 6 market players. As a total, top 5
firms capture on average 45% of the aggregate market. Adding 5 more
to the list brings on average 66% of total market to Top 10. Thus the
market is very much concentrated. (Source:IDLC Research)
Market Dominance
Prior to formulation of National Drug Policy and Drug control ordinance,
the market was chiefly controled by MNCs, holding about 75% of total
market (1985). Since then, market structure has changed, and now local
firms dominate the industry. At present, 97% of local demand is met
from local production, and the top 10 MNCs possess only 9.05% of
market share, compared to 67.6% held by local top 10 firms. (Source:IDLC
Research)
Market share of the top 10 firms over last two years are presented
Market
Market Share
3.88%
3.79%
4.48%
4.21%
5%
4.07%
3.97%
46%
10%
2010
4.54%
3.23%
Top 5
15%
4.76%
4.94%
68%
20%
4.81%
4.53%
Top 10
7.72%
8.35%
84%
2009
8.24%
8.98%
25%
19.48%
19.19%
Top 20
4.59%
4.92%
100%
0%
below-
Market
Structure
2010
Layer
3: Manufacture
of Formulation
2.2.2 Segmentation
The overall business activities of pharmaceuticals can be classifeid in
three layers. The primary layer is R&D Activities where reasearch and
development of new drugs are done, and this business concerns Drug
Discovery, and development. This is often a very costly and hish risk
business, and for many of global Pharmaceutical firms, represent the
majority of costs. However, in Bangladesh, this activity is nil, and all the
firms are producers of known and established drugs.
The second layer is manufacture of ingredients for finished
formulations. These activities cover production of Active
Pharmaceuticals Ingredients (API), Excipients, Solvents etc. that are
Source: IMS
2. Ampicillin Trihydrate
5. Ferrous Suplhate
8. Ciprofloxacin Hcl
11. Oxytetracycline
14. Celecoxib
17. Ranitidine
20. Diclofenac Potassium
23. Zinc Sulphate Monohydrate
3. Aspirin
6. Fluconazole
9. Loratadine
12. Paracetamol
15. Ceterizine
18. Diclofenac Sodium
21. Diclofenac Diethylamine
Source: Presentation by Square Pharmaceuticals in International Conference on Local Pharmaceutical Production in Africa, Cape Town, 2011.
Formulations
Formulations represent the mainstream business in pharmaceuticals
industry of Bangladesh. Presently, the market consists of approximately
8000 generic products and 258 firms with manufacturing capability,
along with some imported patented products. (Source:IDLC Research)
High End
Branded Generics
FORMULATIONS
MARKET
Contract
Manufacturing
Low End
Branded Generics
Largest % of Market
Local firms dominate
Stable Margin
Branding strategy
Low End
Smallsegment
Price based competition
Contract Manufacturing
Significant Growth
oportunity exists in export
Requires cGMP compliant
plants
Contract manufacturing:
Locally, this segment is small as almost every firm manufactures its own
products. The business usually comes from Health organizations like
SMC (Social Marketing Company), UNICEF etc. to provide products such
as saline, contraceptives etc. However, there is a good market for
foreign contract manufacturing. As per observation of Bangladesh
Pharmaeuticals Society, our industry can earn approximately BDT 200
billion (USD 2.9 Billion) each year.
Presently, a number of top firms engage in contract manufacturing.
Competition is very low, as each firm engage based on foreign
counterpart relations. Manufacturing technologies and accreditations
play a vital rolein developing contract manufacturing capability.
Pricing:
Under the present regulatory structure, government fixes the maximum
retail prices (MRP) of 209 essential drug chemical substances. Other
drugs, listed as non-essential, are priced through an indicative price
system. For imported finished products, whether they fall in the
category of vital or non-vital drugs, a fixed percentage of markup is
applied to the C&F price to obtain the MRP. For local distribution, all
drugs must be registered with DRA. However, for export purpose, such
registration is not mandatory. (SOURCE: National Drug policy 2004)
Key registration areas:
1. Combination drugs (other than vitamins, nutritional preparations or
therapeutically useful) are not allowed
2. For imported drugs, GMP validation, bioavailability and bioequivalency are important registration criteria
Stimulates Export of
products
Direct marketing is
prohibited
Withdrawal of VAT (15%) and Import duty (5%) from leucocyte filter
import by pharmaceutical companies.
pharmaceutical companies.
Extending eligibility for tax holiday from June 2011 to June 2013.
Reduced duty will lower product cost for certain product classes
(Anticancer drugs, Analgesics, Antipyretics, and Injectables)
providing potentials for local pharmaceuticals manufacturers.
100%
100%
50%
50%
25%
25%
3.2 TRIPS
In 2001, under the trade-related aspects of intellectual property rights
Due to TRIPS relaxation,
LDCs can produce drugs
without patent or license
cost up to 2016
And as 2005 passed, developing countries like India and China had to
Growth in exports to LDCs
till TRIPS implementation
benefits of TRIPS relaxation. In addition, WTO still could not finalize the
list of patented products. If such an extension is provided, Bangladeshi
pharmaceutical industry is most likely to enjoy a good growth from
exports to LDCs. (Source:IDLC Research)
The project would include common ETP and adequate utility services.
The costs would be borne by Plot Owners, on a 60% Allotment and 40%
Installments basis. The Projected impact of this project is to save 90% of
pharma ingredient (API) import. At present, land filling of the park is to
be completed by June 2011. (Source:IDLC Research)
Change in regional
business growth
areas like Chittagong and Rajshahi. Whereas Dhaka region had a growth
of 18% in 2010, Chittagong and Rajshahi showed a growth of 24% and
33% respectively.
Declining Wholesalers
contribution
5.00%
15.70%
10.00%
6.70%
15.00%
24.58%
20.00%
0.00%
Market Growth Rate
Global Market
Afro Asian Market
Bangladesh Market
20
18
16
14
12
10
8
6
4
2
-
160
155
150
145
140
135
2009
2007
2005
2003
2001
130
Population, total
Health expenditure per
capita (current US$)
are increasing product lines each year. Thus growth is likely to continue
for the coming future.
4.2 Export
The export market has shown significant growth over the years. Since
Export Destinations
(No. of countries)
62
68
72
80
37
2011
2010
2009
2007
2006
2004
huge opportunities from exports. This is because for API (also known as
Bulk Drugs), there is no stringent registration requirement and the
operational as well as promotional costs are also nominal. The only
decisive factor in this regard is the cost competitiveness. API can be
exported to several countries if cost effectiveness is ensured.
But Being confined to synthesis stage only, Bangladesh has to rely on
import of core compound, solvent and other intermediates. Thus cost
effectiveness of local production can be a bit dependent on import
costs. Alongside, these productions often also entail effluent treatment
plans, requiring a high investment. Further, economy of scale is yet to
be achieved, and high investment requirement has troubled achieving
entrepreneurs attention.
Formulation
Finished formulations (finished products) have a global market with
varying rules and regulations. In terms of regulatory structure, overseas
markets can be categorized in three ways.
First one is the Highly Regulated Markets like USA, UK etc. that require
various certifications like USEDA, UKMCA etc. and need huge
investment in facilities and documentation.
with more growth coming from exports. However, total growth will be
lower than 2011-2016, due to indsutry size effect, saturation in many
GDP, and a stable life expectancy level, 10.1% growth can be expected.
And If not extended, export growth would certainly fall (assumed
growth to be 2%), while domestic industry would reach saturation and
will depend on demographic variables. In that case, a growth rate of
8.5% can be expected.
Pharmaceuticals Export
Pharmaceuticals Import
Year
Value
2000
2119652
USD Mn (current
prices)
2.12
2001
3957480
3.96
2002
6995071
7.00
2003
6423924
6.42
2004
19534611
19.53
2005
18177105
18.18
2006
26960916
26.96
2007
37740790
37.74
2008
46541954
46.54
2009
45714931
45.71
2000
139700056
139.70
2001
124578340
124.58
2002
137591660
137.59
2003
145064519
145.06
2004
149661640
149.66
2005
147419132
147.42
2006
171527526
171.53
2007
229142923
229.14
2008
293733231
293.73
2009
269029761
269.03
Indicator
Name
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
5.94
5.27
4.42
5.26
6.27
5.96
6.63
6.43
6.19
5.74
334.77
327.92
326.28
350.10
375.25
393.66
398.17
433.69
497.21
550.85
334.77
346.23
355.29
367.70
384.42
400.94
421.08
441.65
462.40
482.25
4.04
3.42
2.62
3.49
4.55
4.30
5.02
4.88
4.70
4.29
GDP growth
(annual %)
Poverty
headcount ratio
at national
poverty line (%
of population)
Poverty
headcount ratio
at rural poverty
line (% of rural
population)
Poverty
headcount ratio
at urban poverty
line (% of urban
population)
Population, total
2010
48.90
40.00
31.5
52.30
43.80
35.2
35.20
28.40
21.3
143288578.0
145797298.0
148281341.0
150726249.0
153122039.0
155463091.0
157752512.0
160000128.0
162220762.0
Life expectancy
at birth, total
(years)
62.00
62.68
63.34
63.98
64.59
65.16
65.68
66.15
66.56
26.39
25.66
24.90
24.13
23.37
22.65
22.00
21.43
20.95
Health
expenditure per
capita (current
US$)
9.45
10.01
10.58
11.59
12.07
13.18
15.04
16.52
18.43
Health
expenditure per
capita, PPP
(constant 2005
international $)
24.54
26.58
27.57
30.99
34.31
39.40
43.25
44.42
47.67
Health
expenditure,
private (% of
GDP)
1.79%
1.87%
1.89%
1.91%
2.09%
2.16%
2.27%
2.28%
2.29%
Health
expenditure,
public (% of
GDP)
1.19%
1.23%
1.14%
1.21%
1.12%
1.24%
1.19%
1.04%
1.06%
Health
expenditure,
total (% of GDP)
Population
growth (annual
%)
2.98
3.09
3.04
3.12
3.21
3.40
3.46
3.32
3.35
1.78
1.74
1.69
1.64
1.58
1.52
1.46
1.41
1.38
GDP (current
US$ mn)
47,124.93
46,987.84
47,571.13
51,913.66
56,560.74
60,277.56
61,901.12
68,415.42
79,554.35
89,359.77
GDP (constant
2000 US$ mn)
47,124.93
49,610.30
51,800.80
54,523.45
57,942.34
61,393.08
65,463.04
69,670.90
73,983.83
78,231.38
6.70%
North America
5.50%
Europe
4.90%
Africo-Asia
15.70%
Latin America
12.50%
Bangladesh
24.58%
Japan
5.90%
Source: IMS
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