eye
As appeared in March 2018
Tablets & Capsules
Copyright CSC Publishing
www.tabletscapsules.com
on
excipients
Kirti Vatsa
Beroe
This edition of the column discusses current
trends in the Indian pharmaceutical
excipient market, detailing factors that
make India a favorable alternative excipient
source for large pharmaceutical companies.
It also analyzes excipients currently being
exported to the US and Europe and the
leading Indian excipient exporters.
Large pharmaceutical companies
currently source less than 10 percent
of the excipients they use from India
and prefer to engage with suppliers
located in developed pharmaceutical
markets. However, the Indian
excipients market is growing at 10 to
12 percent annually compared to the
global annual growth rate of 5 to 7
percent. Companies are beginning to
consider India to be an attractive
alternative excipient source—at least
for commodity or non-functional
excipients.
Developed versus emerging
markets
The growth potential in the Indian
excipient market is largely due to the
availability of low-cost raw materials
and labor and the ability of suppliers
to quickly adapt to new technology
[1]. Indian excipient suppliers have the
advantage of offering conventional
excipients at a lower price than
suppliers from developed markets, yet
India contributes only 5 to 7 percent
of the global excipient supply.
Currently, suppliers from the US,
Europe, and Japan dominate the
market, contributing a combined 85
percent of the global excipient supply.
In 2013, while consumption of
solid oral dosage form (SODF)
excipients by volume was the same in
the US, Europe, China, and India—
approximately 100 kilotons per region
[2]—excipient consumption by value
was different for each region—39
percent in the US, 34 percent in
Europe, 14 percent in China, and 13
percent in India. This is because, in the
developed markets of the US and
Europe, consumption includes more
expensive, functional excipients,
while, in the emerging markets of
China and India, consumption is
limited primarily to less expensive,
traditional excipients [3]. Demand for
functional excipients is expected to
grow at a compound annual rate of 8
to 10 percent for the period from 2016
to 2020, compared to 3 to 4 percent
for traditional excipients. Because of
this relatively high demand for
functional excipients, the US and
Europe will lead in this segment [4, 5].
Major pharmaceutical companies
typically engage with one or two
qualified excipient suppliers. For
most excipients, these companies
prefer to work with top suppliers
from the developed market because
the suppliers not only provide highquality excipients but also offer their
large clients customized technical
services based on their specific
formulation needs. Table 1 shows
five common SODF excipients along
with the top two suppliers of each.
Large, multinational pharmaceutical
companies prefer excipient suppliers
such as Ashland, BASF, Colorcon, and
Lubrizol because they can provide
newer functional excipients that can
be used in applications that lower
manufacturing costs, such as
controlled-release modifications and
hot melt extrusion. These large
pharmaceutical companies primarily
use Indian and Chinese excipient
suppliers to leverage price against their
current, developed-market suppliers,
keeping them competitive. Companies
rarely switch suppliers unless there’s a
compelling reason, such as meeting
local demand from a regional source,
because the cost of switching and the
supply-chain risks associated with a
cheaper source dramatically outweigh
the savings.
Table 1
Top suppliers for common excipients
Excipient
Suppliers
Microcrystalline cellulose (MCC)
FMC, JRS Pharma
Hydroxypropyl methylcellulose (HPMC)
Ashland, Dow
Hydroxypropyl cellulose (HPC)
Ashland, Nisso
Empty hard gelatin capsules
Capsugel, Qualicap
Gelatin
Rousselot, Gelita AG
Copyright CSC Publishing
Major DMF-holding Indian excipient suppliers
11
Increasing number of Indian
DMF holders. To avoid regulatory
challenges for exports, global
excipient suppliers must invest in
local suppliers to upgrade their
manufacturing facilities. This
generally involves submitting a DMF
to the US FDA. The percentage of
Indian pharmaceutical companies that
are DMF holders for excipients has
increased from 7 percent in 2011 to
13 percent in 2017. Figure 1 shows
the major Indian excipient suppliers
and the number of DMFs held by
each. The top excipients supplied by
major suppliers such as Corel Pharma
Chem, Ideal Cures, Hindustan
Phosphates, and Crest Cellulose are
pharmaceutical coatings, phosphates,
and MCCs, respectively.
Between 2012 and the second
quarter of 2017, there were 119 new
DMF certifications in India for
pharmaceutical excipients, as shown
in Figure 2. The highest number of
certifications were for excipients
such as cellulose, capsules, coatings,
and calcium phosphate because of
their high market demand and wide
usage in co-processed excipients.
4
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Pho
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s
d
Supplier
Excipient manufacturing in India
While India is a dominant global
presence for API manufacturing, the
country is not a mature market for
excipient manufacturing. As with API
sourcing, the advantage of sourcing
excipients from India is the cost
benefit. India produces commodity
excipients such as starch, gelatin, and
capsules in adequate supply, but they
are primarily consumed by the
domestic Indian market. It’s estimated
that only 10 percent of excipients
manufactured in India are currently
being used in the US and Europe.
In the last 4 or 5 years, this has
begun to change. The Indian excipient
market has seen an increase in the
number of Indian Drug Master File
(DMF) holders, an increase in the
export growth rate of several major
excipients, and an increased interest
by Indian suppliers in expanding
export capacity to developed markets.
Because of these changes, which I will
discuss in more detail in the following
sections, the Indian excipient market is
expected to grow 10 to 12 percent
annually through 2020.
5
5
Th
erm
o
6
Vik
ram
6
Ide
al C
ure
s
10
Co
rel
Pha
rm
aC
hem
12
10
8
6
4
2
0
Dh
ara
Life
sci
enc
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Number of DMFs
Figure 1
Source: US DMF list
Increasing exports of major
excipients. Some excipients, including
MCC and croscarmellose sodium, are
currently being sourced from India to
developed markets, but Indian
pharmaceutical companies primarily
rely on imports from the US, Europe,
and Japan for more expensive
excipients such as povidone,
crospovidone, polyethylene glycol
(PEG), as well as a few cellulosederived excipients. However, as global
demand increases, global suppliers will
also increase production capacity in
emerging markets such as India, either
by establishing joint ventures or
acquiring local suppliers with smaller
product portfolios.
For example, a joint venture
between JRS Pharma and Gujarat
Microwax to manufacture MCC
products has been in place for nearly
10 years. In 2009, the companies also
commissioned a new disintegrant
plant, which has helped JRS Pharma
expand its disintegrant product line
and double its capacity.
In 2011, DFE Pharma acquired
Brahmar Cellulose, a Cuddalorebased excipient supplier, which has
Figure 2
New Indian pharmaceutical excipient DMF certifications (2012-2017*)
51
Number of DMFs
60
50
40
28
30
18
20
10
0
4
7
2012
2013
*through second quarter 2017
2014
2015
Year
11
2016
2017
Source: US DMF list
Copyright CSC Publishing
Table 2
Excipient
Indian export growth rate of common solid oral dosage excipients
Export growth rate (percentage)
Major Indian suppliers
US
Europe
6-8
20-25
MCC
5
Sodium starch glycolate
6
Calcium phosphate
(dibasic & tribasic)
(US DMF holders)
Price
Sudeep Pharma
Hindustan Phosphates
India Phosphate
Crest Cellulose
Not available
2
Sigachi
DFE Pharma
Gujarat Microwax
Developed market =
US $4-5 per kilogram
Emerging market =
US $2-3 per kilogram
2
Crest Cellulose
Not available
Source: Eximpulse, Beroe Analysis
allowed DFE to increase its global
market share in cellulosic excipients.
Table 2 shows the Indian export
growth rate from 2015 to 2016 along
with the major Indian DMF holders
for several common solid oral dosage
excipients. The market structure for
these excipients is mostly consolidated
between US and European suppliers,
while Indian suppliers occupy just 5 to
10 percent of the global market share.
Out of 62 total ExciPact manufacturing facilities, 19 percent are in India,
and that number is expected to increase
over the next several years. As more
Indian suppliers achieve ExciPact and
GMP certifications, the export of
• In 2016, ACG-Associated
Capsules received ExciPact certification
(indicating compliance with EU and
US FDA regulations) for its plant at
Dahanu, Maharastra, India [7].
• In 2014, the Controlled Release
Alliance between Dow and Colorcon
announced the launch of Methocel DC2
in Hyderabad, India. The HPMC
product allows pharmaceutical manufacturers to replace costly wet granulation
in matrix tablet production with costeffective dry granulation and direct
compression techniques, reducing
manufacturing costs by up to 60 percent
and shortening development time [8].
commodity excipients is expected to
increase. As shown in Table 3, ACGAssociated Capsules, a supplier of hard
gelatin capsule (HGC) hydroxypropyl
methylcellulose (HPMC) capsule
shells, and Ideal Cures, a supplier of
coatings, are the top Indian suppliers by
number of manufacturing facilities
certified by ExciPact.
Expanding export capacity.
Excipient suppliers have shown
increasing interest in expanding their
exports to developed markets. Recent
developments include the following:
• In 2016, Nitika Pharmaceutical
announced plans to build its fourth
excipient plant in Nagpur, India, primarily
to cater to the export market [6].
Table 3
ExciPact-certified Indian excipient suppliers
Supplier
ACG-Associated Capsules
Ideal Cures
Issue date
2017
2015
Location
Excipient
Khandala, Maharashtra
HGC shell
Pithampur, Madhya Pradesh
HGC and HPMC shell
Thane, Maharashtra
HGC and HPMC shell
District Anand, Gujarat
Methacrylic acid copolymers and dispersions,
ethyl acrylate copolymers
Jammu, Jammu, & Kashmir
Coating
Thane, Maharashtra
Coating
Asha Cellulose
2017
Valsad, Gujarat
Ethyl cellulose
Sigachi Industries
2017
Dahej, District Bharuch, Gujarat
Cellulose
Chemfield Cellulose
2016
Nagpur
MCC
Colorcon Asia
2016
Verna, Goa
Pigments, color
Sudeep Pharma
2016
Vadodara, Gujarat
Dicalcium phosphate, tribasic calcium
phosphate, calcium carbonate
Vikram Thermo
2015
District Gandhinager, Gujarat
Acrylate polymer
Source: ExciPact
Copyright CSC Publishing
• In 2014, Colorcon Asia invested
INR 70 crore to expand its Goa
facility dedicated to film coatings [9].
• In 2015, Sudeep Pharma entered
into a joint venture with JRS Pharma
to produce calcium-based phosphates.
As previously discussed, JRS Pharma
has already had a joint venture with
Gujarat Microwax for more than 10
years to produce MCC [10].
• In 2012, Roquette Pharma
acquired three corn-starch production
sites from Riddhi Siddhi Gluco Biols,
based in Ahmedabad [11].
Conclusions
Within 5 years, India is likely to
become a prominent region for
excipient manufacturing, and the
export market share to the US and
Europe should increase by at least 10
percent. Global pharmaceutical
companies will likely prefer to enter
into agreements with either global
suppliers that have a regional
presence (local manufacturing) or
domestic Indian GMP-qualified
suppliers with no regulatory risks.
The number of top excipient
suppliers entering into joint ventures
with Indian suppliers should increase
at a faster pace during the next five
years. These joint ventures will
continue to help global excipient
suppliers widen their geographical
reach and provide local Indian
suppliers with the means to upgrade
their facilities to meet the demands
of global pharmaceutical customers.
To be able to export to developed
markets, Indian suppliers must not
only produce excipients that comply
with pharmacopoeial specifications,
they must also manufacture their
products to GMP standards. Indian
suppliers wishing to access this
export market should embrace
quality-by-design and continuous
manufacturing and be prepared to
work with customers to provide the
necessary technical support required
by the developed excipient market.
With the regulatory and quality risks
removed, Indian excipient suppliers
will have a strong opportunity for
growth into the developed US and
European excipient markets.
T&C
References
1. http://www.business-standard.
com/content/b2b-pharma/novel
-drug-delivery-system-is-driving-the
-demand-for-innovative-excipients
-114081901422_1.html
2. http://www.klinegroup.com/
news/oral_solid_dosage_form_excipients.asp
3. https://www.in-pharmatechnologist.
com/Article/2014/04/30/Emerging
-excipient-markets-to-outpace-Western
-markets-report-says
4. http://www.gnaipr.com/
Articles/Gireesh%20Babu.pdf
5. http://ipec-europe.org/news
letter.asp?nlaid=776&nlid=56
6. http://www.in-pharmatechnologist.
com/Ingredients/Nitika-to-build-4th
-excipients-plant-near-emerging-Indian
-export-hub
7. https://www.europeanpharma
ceuticalreview.com/news/43490/acg
-acpl-asia-excipact-certification/
8. http://www.pharmabiz.com/
PrintArticle.aspx?aid=85629&sid=2
9. http://www.pharmabiz.com/
NewsDetails.aspx?aid=81645&sid
=2References
10. http://www.jrspharma.com/
pharma_en/india/local-manufacturing.
php
11. http://www.foodingredientsfirst.com/news/Roquette-Begins-JointVenture-With-Riddhi-Siddhi-toBecome-Leading-Starch-Company-InIndia.html?keepThis=true&TB_iframe
=true&height=425&width=800
Kirti Vatsa is lead procurement analyst,
specializing in contract manufacturing
-drug formulations and excipients at
Beroe (www.beroeinc.com). She is
responsible for end-to-end project
management and has been involved in
more than 150 successful project
deliveries. For more information,
contact: info@beroe-inc.com.