Crisil Report On Pharmaceuticals

Crisil Report on Pharmaceuticals
Covid-19 vaccines to chart new growth story over medium term growth for
pharmaceuticals industry
Feb 1, 2022
Vaccine supply opportunity to aid growth in medium term. Further, base growth in the coming
years would be specific to players focusing on niche and limited competition products as well
as specialty drugs. Industry stands resilient despite Covid-19
Complex generics, specialty & biosimilars to drive growth; Covid vaccines
have significant growth potential
Players look to re-align their exports business models
Review and outlook for Indian pharmaceuticals industry sales by key segments
E: Estimated; P: Projected
Source: CRISIL Research, Directorate General of Commercial Intelligence and
Statistics
Covid-19 vaccine offers huge potential to both domestic and exports market growth;
however, only few players to benefit
CRISIL Research expects India's formulation exports to increase at 6-8% compound annual
growth rate (CAGR) from fiscals 2021-26, compared with ~8-9% CAGR over the previous five
years. Growth moderation is expected due to pricing pressure in the US. New product
launches, foray into specialty and complex generic products etc is likely to support growth in
the medium to long term. Covid vaccine exports can lead to significant upside albeit for few
players in the sector. Although, covid vaccine exports have resumed in October 2021, players
might find it difficult to gain meaningful market share in global vaccine trade which they lost
during the peiod of April-September when exports were banned. However, various contractual
agreements entered into by the manufacturers are in place and it would drive demand. As a
result, vaccine share in overall formulation exports is also likely to increase multi-fold in FY22.
For FY21, India’s exports were robust despite disruptions led by Covid-19. Formulation
exports registered ~19% on-year growth for the year on a constant currency basis.
Formulation exports growth is likely to be flat to negative at 0-(2)% in FY22 on account of
severe pricing pressure in the US. Additional upside of ~25-35% is possible on account of
exports of Covid vaccine.
Domestic growth slowed down in FY21 led by demand disruptions due to Covid-19,
growth on track in FY22
Domestic market growth moderated to ~3% in FY21. Covid-19 pandemic, which started
spreading across the world since early 2020, had necessitated lockdown all over the country.
As a result, the domestic pharma growth in first half of the fiscal fell by ~2.4% on-year. This
was because of OPD closures, deferment of elective surgeries, travel restrictions etc. which
lead to sharp de-growth in sale of drugs of acute segment The easing of lockdown restrictions
and seasonal demand supported industry growth in second half of FY21. Support was also
provided by sale of Covid related drugs and increase in sales of chronic therapies like Cardiac
and anti-diabetes. Moving ahead, domestic formulations are expected to grow by 16-18% in
FY22 with room for upside revision depending on severity and duration of third covid wave.
40-50% of additional upside is possible because of Covid vaccine.
China supply and quality disruption to offer opportunity for bulk drug exports;
transition to specialty segment to support growth over medium term
During fiscal 2016 to 2021, bulk drug exports growth moderated to ~4-5% CAGR on account
of competition from China and other Asian counterparts. This was preceded by patent cliffs
during 2012 to 2014 due to which, value of many key molecules supplied by Indian players to
global innovators dropped substantially during the period. Going forward, bulk drug exports
growth is expected to be in the similar range of 5-7% CAGR. Due to recurring quality and
supply disruptions from China, India had the opportunity to establish and grow its strong
footing on the global market as global customers (following Covid pandemic) adopted China+1
sourcing policy to secure their supply chains and reduce dependence on China. However, it
has been observed that post normalization, China has gained back market share in global
bulk drugs trade. So whether Indian players gain at the cost of China in the long term, remains
to be seen. Transition towards specialty segment and higher capabilities of Indian players viz
a viz Chinese players in high value API is expected to support growth.
On the domestic front, bulk drug production for captive consumption is likely to continue to
record strong growth. Domestic bulk drug manufacturers are expected to continue to register
double-digit growth, supported by strong domestic sales.
Further, the bulk drug promotion scheme (creation of bulk drug parks and production-linked
incentive) announced by the government would aid investment in the sector with a view to
reduce Chinese dependency on raw materials. The execution of the scheme will be gradual
and effect would be seen only in the medium term. However, how well can Indian
players match their Chinese counterparts in terms of pricing would be a key monitorable.
Profitability for most players remained supported in fiscal 2021; dip in margins likely
for few players in FY22
During fiscal 2018, the margins for large formulation players dropped by 350-400 bps on-year
on the back of pricing pressure and weak product launches. Players registered a marginal fall
of only ~20 bps on-year in fiscal 2019 as a better product mix with complex generics and
specialty products resisted a steep fall. Major players were faced with regulatory alerts that
increased remediation costs as well as delay product approvals for a few companies, resulting
in flattish margins for large players. In fiscal 2021, margins for most players improved on
account of lower travel and marketing spends amid the pandemic. Margins for most large
players are expected to remain supported with a slight negative bias in fiscal 22 whereas
margins of mid and small players is likely to fall in fiscal 2022.
Bulk drug players were able to pass on some of the rise in raw material costs in fiscal 2021,
thereby reporting a marginal growth in margins. Moving ahead, margins are expected to
remain flattish to negative. Foray into niche molecules is likely to improve realizations,
however, increase in raw material prices could offset effect of high realizations resulting in
slight contraction of margins.
Indian formulation exports to edge higher over next five years
Feb 1, 2022
India's formulation exports are projected to grow at relatively faster rate in next five years as
industry sees a potential upside from Covid-19 vaccines. Easing pricing pressure in the United
States will also support the growth. Growth in semi-regulated markets is also expected to pick
up.
New product launches, complex generics, specialty drugs to drive formulation exports
growth over next five years
CRISIL Research expects India's formulation exports to increase at 6-8% compound annual
growth rate (CAGR) from fiscals 2021-26, compared to ~8-9% CAGR over the previous five
years. The growth moderation is expected due to pricing pressure in the US which is likely to
persist in the near to medium term. However, new product launches in conventional generics,
complex generic products and specialty drugs is expected to drive exports growth. Covid-19
vaccine exports from India have the potential to further add to the formulation exports growth.
After the period of April-September 2021 when exports of Covid vaccines were disallowed,
vaccine exports resumed in October. However, Indian players could take some time to gain
market share in global covid vaccines trade as other global companies penetrated many
markets during aforesaid period. However, many Indian companies have entered into contract
manufacturing agreements with Russian Direct Investment Fund (RDIF) for manufacturing of
Sputnik V and other such agreements and alliances. Due to this, we believe that formulation
exports are likely to see a boost because of Covid vaccines in FY22 and FY23. Consequently,
vaccine share in overall formulation exports is also likely to increase multi-fold in FY22.
Manufacturers launching complex and specialty drugs and those receiving limited competition
drug approvals would also enjoy higher growth. Incremental revenue for formulation exporters
would be supported by new launches in the conventional generics segment. Even though
pricing pressure for generics persists, we expect it to reduce. However, the United States Food
and Drug Administration (USFDA) regulatory overhang from 2019 continues to be a
monitorable.
The exports growth in FY21 is estimated to be at ~19-20% (constant currency terms) on-year,
up from ~10% (constant currency terms) growth reported in FY20. The growth was led by
robust exports to semi-regulated markets and Europe along with other regulated markets.
However, high frequency data suggests flat growth of formulation exports in April-November
2021, albeit over high base of same period in the last year when there were additional one-
time export opportunities due to Covid. Additional upside of 25-35% is possible in FY22 due
to exports of Covid vaccines. However, the vaccine upside call hinges on various parameters
such as demand from other countries, pricing, regulatory approvals etc. and is subject to
revision based on change in regulatory/ market dynamics.
Formulation export trend
Note: All units are in US $ bn, P- Projected

Source: The Directorate General of Commercial Intelligence & Statistics (DGCIS),
CRISIL Research
Our forecast is based on:
 Thrust by developed countries to reduce overall spend on medicines
 Patent expiry generating significant opportunity for generic medicines
 Regulatory environment, including regulatory approval time for dossiers, for instance,
abbreviated new drug applications (ANDAs)
 Continent-specific factors:
o Consolidation among large buyers in the United States (US), impact of the Patient
Protection and Affordable Care Act (Obamacare) in the US, and continued
austerity measures in Europe
 Continued dependence of semi-regulated markets on low-cost generic medicines
Any significant change in these factors will impact our forecast.
(For more details, please refer to 'Formulation exports - Key growth drivers')
Below analysis on region-wise (regulated and semi-regulated) growth is sans the vaccine
upside
Exports to regulated markets
Focus on specialty and niche products to boost exports to the US in medium to long
term; US pricing pressure to hit formulation exports in the near term
The US market accounts for ~37-39% of Indian formulation exports. More than 50% of India’s
incremental exports over the past five fiscals was to the US.
Over fiscals 2013-16, exports growth was at a strong ~18% CAGR, driven by patent expiry of
blockbuster drugs over 2012-14. However, growth fell to ~2% CAGR over fiscals 2016-19 on
account of pricing pressures experienced during fiscals 2017 and 2018. Fiscal 2019 was a
year of recovery with abating pricing pressures and players moving away from conventional
generics to limited competition molecules. Exports growth remained at double digits in fiscal
2020 on back of new launches, especially limited competition and complex drugs. In FY21
exports registered a growth of ~14% on-year. However, formulation exports to the US have
de-grown by ~10% in April-November 2021 due to high pricing pressure.
We expect formulation exports to the country to moderate over the medium term due to pricing
pressure which is expected to affect growth in the near to medium term. Focus
of manufacturers at niche molecules, specialty drugs, complex generics, and biosimilars is
expected to drive growth in the long term.
Export momentum to European markets to continue
During the FY15 to FY20, pharma exports to European markets clocked a slow 6-7% CAGR
owing to stricter pricing regulations and adverse currency movements. Even the United
Kingdom (UK) and Germany, which traditionally had less stringent pricing mechanisms,
introduced regulations to control the government's healthcare expenditure.
Exports to Europe grew by a sharp 12% on-year in fiscal 2020 and 24% in FY21. Currency
depreciation has further aided Indian exporters. We expect healthy growth in formulation
exports to Europe over the next five years on rising generic penetration in the UK, France and
Germany, among others. Also, players are focussing towards Europe due to the ongoing
pricing pressure in the US. Easing of pricing pressure would also aid growth in these markets.
High incidence of chronic diseases, an ageing population, and adoption of specialty medicines
are set to drive growth in the European markets.
Players increasing focus on semi-regulated markets
India's pharma exports to semi-regulated markets are expected to post 6-7% CAGR over the
next five years to touch ~$12 billion in fiscal 2026, as players eye growth opportunities in
newer markets with low generic penetration. The semi-regulated markets are characterised
by lower penetration of healthcare facilities, low per capita consumption of medicines, high
population growth rates, a wide base of patients with acute and chronic diseases, and low
penetration of generics. Many markets also exhibit disease profiles similar to those in India. In
terms of medicine consumption, these markets are mainly driven by low-cost generics.
Region-wise, Africa and Asia (accounting for ~85% of the semi-regulated markets) will remain
key drivers. The African market is expected to continue to dominate because several Indian
companies have already established a large footprint in drug therapies such as anti-virals and
anti-malarial.
The demand for the treatment of chronic diseases will boost generics off-take due to limited
budgets and high out-of-pocket expenditure in the semi-regulated markets. Also, governments
in various countries are looking to strengthen their regulations to allow import of generic drugs
in order to reduce their healthcare expenditure.
Growth in these markets are expected to remain healthy in FY22 led by demand for antivirals
and antibiotics.
Formulation exports growth to moderate in fiscal 2022
Feb 1, 2022
Robust demand boosted sales in FY21. US pricing pressure to drag overall exports growth in
fiscal 2022.
India’s formulations exports continued on growth path in fiscal 2021 led by new launches and
opportunities in limited competition products, amid reducing pricing pressures in the US
market. Formulation exports increased by ~19% (constant currency terms) on-year during
fiscal 2021. This is despite the increased scrutiny by USFDA on the regulatory front in past
couple of years.
The exports had recovered to double-digit growth in fiscal 2019 following two years of weak
growth on account of easing pricing pressure and a better product pipeline. Fewer product
launches, regulatory hurdles and pricing pressure in regulated markets had resulted in
sluggish growth during fiscals 2017 and 2018. Adverse currency fluctuation and subdued
economic activity in Europe also affected growth.
Although, Covid-19 pandemic had caused logistic and demand disruption across the world,
formulation exports grew at a robust pace during fiscal 21. A spike in demand for pharma
products, induced by the Covid-19 pandemic, and hoarding of essential drugs by some nations
in the wake of anticipated production disruptions, boosted India's exports. However, in fiscal
22 so far (April-November 2021), exports growth has moderated and is flat, albeit, over high
base of fiscal 21. This is primarily due to pricing pressure in the US. Strong exports to Europe
and semi-regulated markets have helped somewhat offset the US decline.
Formulation exports from India
Note: Units are in US $ bn, E: Estimated, P: Projected

Source: CRISIL Research, Directorate General of Commercial Intelligence & Statistics
(DGCIS)
Note: The US, Canada, West Europe, South Korea, Japan and Australia are regulated marke
ts, which have robust regulatory frameworks. Semi-regulated export markets have less-devel
oped regulatory frameworks. These include Africa, Latin America, Asia, the Middle East and t
he rest of Europe, comprising Russia and Ukraine.
Covid-19 Vaccine supply opportunity in medium term
Covid-19 vaccine exports is expected to be a good opportunity for a few players present in the
vaccine manufacturing domain. Vaccine exports from India which had halted since April 2021
in order to ensure vaccine availability for the domestic population have resumed in
October. Although, Indian players like Serum Institute, Bharat Biotech and others have
entered into contractual agreements with various companies/ alliances which will have to be
fulfilled, they will have to compete with global covid vaccine manufacturers for market share
as those companies gained significant share during April to September 2021 when covid
vaccine exports from India were banned.
Exporters will find relatively better opportunities to supply in semi-regulated markets than
regulated ones because of stringent approval guidelines in the latter. However, price capping
by GAVI on vaccines may limit the upside potential in semi-regulated markets. We expect ~25-
35% additional upside in FY22 because of exports of Covid vaccine.
Regulated markets
Exports growth to moderate in FY22
As against a strong 12% CAGR from fiscals 2013 to 2016, exports to regulated markets
registered a de-growth of 1% between fiscals 2016 and 2018 on account of pricing pressures
and weak product launches. During fiscals 2014 to 2016, Indian companies were issued a
number of warning letters and import alerts, which impacted new product approvals of Indian
players. On the pricing front, wholesale consolidation and faster abbreviated new drug
application (ANDA) approvals led to price erosion in the US market in fiscal 2018, further
acting as a headwind to growth.
Following a dull performance in fiscal 2018, exports to the regulated markets improved in fiscal
2019, registering ~14% on-year growth. Rupee depreciation also aided growth in exports in
the year.
Fiscal 2020 registered good growth in exports (~11% on-year). In early fiscal 2020, the
coronavirus pandemic gripped the world and lockdown were initiated in far too many nations
including the US. However, pharma being an essential commodity stood resilient during the
tough times. The formulation exports during FY21 increased by ~19% on-year led by specific
opportunities and new product launches. Drug shortages in the US also augured well for Indian
exporters. Further, opportunities in supplying certain drugs to treat Covid also helped
exporters. Indian players continue to have a strong pipeline of product launches for fiscal 2022
as well. However, pricing pressure seen in the US has affected overall exports growth in fiscal
2022 so far. Although, exports to Europe and other regulated geographies have been better,
it is expected to only partly offset the US decline.
India's pharmaceutical exports: Share in regulated markets (FY21)
Source: CRISIL Research, DGCIS

Exports to regulated European markets have grown ~12% on-year in fiscal 2020 and ~24%
on-year in FY21 as players look at tapping into the under-penetrated European markets which
offer huge opportunities for uptake of generic drugs.
Indian players gain volume opportunities in the US as global players exit non-profitable
drugs
Due to Generic Drug User Fee Amendments (GDUFA) implementation from October 2012, a
large portion of the backlog was cleared by the USFDA by 2017 (calendar year). The number
of applications with no communication from the USFDA fell from ~1,700 in 2013 to 218 in April
2018. Competitive intensity peaked in 2017 with higher ANDA approvals and consolidation in
the customer base, leading to price erosions.
The number of approvals declined in 2018 but continued to remain at higher levels in 2019
and 2020. Despite the pandemic, ANDA approvals by US FDA in 2021 so far have been good
in number although India's share has dipped significantly.
Relatively strong niche product pipeline for players
With opportunities in conventional generics fading, companies are increasingly focusing on
building capabilities in complex and niche molecules. These products are relatively untapped
in comparison with conventional generics and offer huge realisation as they are difficult to
crack.
Note: A complex generic is a generic that could have a complex active ingredient, complex
formulation, complex route of delivery, or complex drug device combinations.
Specialty drugs are high-cost prescription medications used to treat complex, chronic
conditions such as cancer, rheumatoid arthritis, and multiple sclerosis. They can be used in
rare or orphan disease indications. It may have unique storage or shipment requirements and
might require additional patient education, adherence, and support beyond traditional
dispensing activities.
Thrust on R&D to discover niche drugs or to enter biosimilars market
Along with developing capabilities via the inorganic route, Indian companies are also looking
at strengthening their in-house product pipelines through increased research and
development (R&D) investment. R&D cost as a percentage of sales for Indian pharmaceutical
players increased from 5.5% in fiscal 2011 to ~9% in fiscal 2018. However, it has tapered off
in past 2-3 years. Players are expected to continue investing in R&D as they focus on
developing niche and complex products. There had been a slight fall in R&D as a percentage
of sales in fiscal 2020. However, it has improved in fiscal 2021. Moving ahead, we expect that
PLI scheme for formulations would be a good opportunity for approved companies to further
increase their R&D spends, come up with better products and gradually shift away from
commoditized generics.
That said, increasing focus on biosimilars would also increase R&D cost. The average cost of
developing a biosimilar is ~$150 million, compared with $1-5 million for developing a generic
drug. Players are also considering the inorganic route (M&As/JV with international companies)
to develop and manufacture biosimilars.
Despite the increasing focus on R&D over the last few years, Indian players still lag global
generic players in R&D efforts.
R&D (as a percentage of sales) investment trend
Note: E: Estimated, R&D numbers are for a set of eight large players
Source: Company filings, CRISIL Research
Semi-regulated markets
Players look to tap under-penetrated markets for growth
Overall growth in semi-regulated markets for fiscal 2020 improved by ~6% on-year, as players
looked at penetrating smaller markets. Growth in markets like Kenya and Brazil improved by
~11% and 9% on-year during the period. Fiscal 21 also, was a good year in terms of exports
to semi-regulated markets as the segment grew by a healthy 22%. The growth rate was high
in Africa, Asian semi-regulated and other semi-regulated markets. As pricing pressure
continues in the conventional generics segment in the regulated markets, albeit at a slower
rate now, more players are looking to enter semi-regulated markets, thereby boosting volume
growth and increasing market share.
This trend is projected to continue, with players expected to record healthy sales in these
markets. Also, low competition from many global generic players in the region and low
penetration of generics will aid growth for players. Further, governments in the region
are looking to streamline regulations to allow import of generics, which will help reduce
government expenditure. Increase in healthcare spending and rising demand for medicines to
treat chronic and lifestyle-related ailments would support growth in the semi-regulated
markets.
India's pharmaceutical exports: Share in semi-regulated markets (FY21)
Source: CRISIL Research, DGCIS

Note: The potential upside from Covid-19 Vaccine and its impact on market would be monitor
ed regularly on the backdrop of the changing dynamics and regulatory interventions
Indian pharma to see good growth in the medium to long term
Feb 1, 2022
Pricing pressure, wholesale consolidation in the US market and lower patent cliffs severely
impacted Indian players' growth in regulated markets during fiscals 2017 and 2018. However,
the sector bounced back to growth in fiscal 2019 and maintained pace in fiscal 2020. CRISIL
Research expects growth to be robust on-year in fiscal 2021 as well, led by demand. On the
other hand, vaccine exports, product diversification would support growth for players in
medium to long term. The increasing regulatory scrutiny by USFDA, however, remains a key
monitorable.
India - a preferred manufacturing hub
Indian pharmaceutical companies continue to enjoy a sizeable market share in the US
generics market. The number of firms seeking abbreviated new drug application (ANDA)
approvals and tentative approvals from the US Food and Drug Administration (FDA) is also
on the rise. Mid- and small-sized formulation manufacturers, who are traditionally engaged in
contract manufacturing, are also looking at tapping the generic drugs opportunity in regulated
markets.
India maintains lead in total ANDA approvals
The US market offers a huge opportunity for Indian generic drugs makers, given its size. They
maintain their lead in the US market by obtaining more ANDA approvals, which is mandatory
to enter the retail drugs market there.
India share in overall ANDA approvals drops sharply
Source: US FDA, CRISIL Research

With the highest ANDA approvals, India is better placed than most other exporting countries
to address the growing generic drugs market in the US. However, share of Indian players in
total ANDA approvals has declined sharply in CY2021. This would impede new launches and
thus existing products would continue to face pricing pressure. That said, India's share in
ANDA approvals is expected to pick up in the medium term considering strong product pipeline
of many leading players.
Country-wise share of ANDA approvals (2020)

Large manufacturing base of US-approved plants
India has the largest manufacturing base outside of the US for products sold in the US market.
India accounted for 12% of all drug manufacturing sites for the US market for fiscal 2019 (US
fiscal year Sep-October), followed by US at 42%. A large approved manufacturing base
provides Indian companies the opportunity to supply to lucrative regulated markets.
Increasing healthcare cost drives preference for generic drugs in regulated markets
Developed economies spend a major portion of their gross domestic product (GDP) on
healthcare. Going forward, demand for pharma products in developed markets is expected to
be driven by factors such as an ageing population and growing incidences of chronic diseases.
We believe that austerity measures adopted in Europe will continue to drive demand for
generic drugs, though pricing realisations may not be as favorable as in the past. On the other
hand, healthcare reforms in the US are driving higher insurance coverage and greater
usage of generic medicines.
India ranks among the lowest in healthcare expenditure globally. As of fiscal 2018, the
country's spend was only ~3.5% of its GDP, owing to lower healthcare penetration compared
with developed markets such as the US and Europe, which spend about 10-17% of their GDP
on healthcare. As per the World Health Organization (WHO) data, India's per-capita
expenditure on health is among the lowest in developing countries and, therefore, offers
significant potential.
Healthcare expenditure as percentage of GDP for global peers (2018)
Source: World Bank

US to lead growth in regulated markets
The US is the largest pharmaceuticals market for both innovator brands and generic drugs. It
has been at the forefront of medicine research and healthcare spending. Driven by the Hax-
Watchman Act, the generic drugs industry has grown tremendously over the years to
~$100 billion in fiscal 2019. The Act is a US federal law introduced in 1984 to regulate
procedures for approval and marketing of generic drugs in the country. Driven by greater
dependence on generic medicines and enactment of Patient Protection and Affordable Care
Act, growth in the market is expected to continue.
The Act, first enacted on March 23, 2010, was aimed at bringing a large section of the
population under public and private insurance coverage. The Affordable Care Act (2010)
included provisions to ensure that insurance companies do not refuse to cover patients
with pre-existing conditions, and expand Medicaid coverage to include more people from low-
income groups
Drop in uninsured population in the US market
Source: Centre for Medicare and Medicaid Services, CRISIL Research

The decline in uninsured population in the US will continue to drive demand for generic drugs
and aiding the growth of Indian manufacturers. However, continued pricing pressures on base
business in the US market.
Pricing pressure in the US market is on account of wholesale consolidation and increasing
pace of ANDA approvals due to implementation of generic drug user free amendment
(GDUFA). GDUFA had streamlined regulations which encouraged smaller players to enter the
market, leading to pricing pressure
Wholesale consolidation impacting bargaining power of Indian players
Source: Industry, CRISIL Research

On account of several mergers and acquisitions (M&A) over 2013-2015, the US wholesale
market is currently highly consolidated, with three players accounting for 85% of the market.
Therefore, the bargaining power of Indian players had substantially reduced.
ANDA approvals peaked in 2017 with GDUFA implementation picking up, gradual decline
since then

Due to the GDUFA implementation, the US FDA cleared a large portion of the backlog by
2017. The rate of approvals is stabilising. However, it continues to remain high as the regulator
aims to maintain competition in the market, in order to ensure lower drug prices for citizens.
Entry of smaller players added to pricing pressure
The lucrative generic drugs opportunity in the regulated markets, especially in the US and
Europe, had attracted players from various countries. Over the last few years, many Indian
companies -- mostly small and mid-sized players -- have set up operations in the US and
invested in the US FDA-approved facilities to capitalise on the generic drugs opportunity.
Indian companies, which traditionally used the contract manufacturing route to access
regulated markets, have simultaneously obtained ANDA approvals for direct entry into the
retail segment. The streamlining of regulations by the US FDA also facilitated the entry of mid
and small-sized players after 2012.
Consequently, the number of companies seeking ANDA approvals has increased substantially
over the last decade, intensifying competition and resulting in a sharp erosion in the price of
generic drugs, especially in the case of large molecules and blockbuster drugs.
Number of companies (global) receiving final ANDA approvals

Huge increase in ANDA withdrawals in the US market
Rate of ANDA withdrawals had increased two fold in 2018. The withdrawals remained high in
2019 as well. Thus competitive intensity in the US market reduced, which lead to easing of
pricing pressure in the subsequent years. However, pricing pressure is back in FY22 due to
increased competition.
ANDA withdrawals spike in 2018, continue to be higher in 2019, 2020

Specialty and complex generics – moving from ‘nice-to-have’ to a ‘must-have’ business
With declining opportunity in the conventional generics segment and pricing pressures on the
existing portfolios, it has become important for Indian players to look at high-value and high-
margin drugs. Players have been developing niche products in order to weather the impact of
pricing pressure. Number of niche product launches during fiscals 2019, 2020 and 2021 have
been high in comparison to previous three years.
Sun Pharma has a major pipeline of specialty drugs in order to mitigate the impact of base
erosion in the US. It had launched plaque psoriasis treatment drug Ilumya in October 2018. It
also launched Xelpros in the US, used for treatment of open-angle glaucoma. The company
launches two specialty products in fiscal 2018 and three in fiscal 2019. It recently launched
Cequa for dry eye disease in the US.
Other major players have also increased their portfolio of complex generics and specialty
products.
Biologics present huge opportunity during 2021-2025
Stupendous growth between fiscals 2012 and 2015 was characterised by patent cliffs for
blockbuster drugs and Para IV (180 days marketing exclusivity) opportunities for Indian
players. Biologics share in total patent expiries by value is expected to be higher in next five
years, signifying a tremendous opportunity for players. Seven of the top 10 drugs sold globally
in 2019 were biologics. The top 10 biologics had a combined global sales worth over $65
billion. The top players have already started moving towards biosimilar. However, they still lag
behind global peers. Also, companies are increasingly focusing on specialty and complex
molecules/drugs, which command higher returns.
Developing a biosimilar molecule needs 30-fold more investment than a plain vanilla generic.
The investment can go as high as $150 million for a biosimilar. Only three players from India
have received biosimilar approvals in regulated markets – Biocon (US), USV and Intas
Pharma (Europe).
European markets to grow at steady pace
The European generic drugs market (primarily Germany, the UK, France, Italy and Spain) is
the second-largest regulated market for generic drugs. Sensing opportunity, several Indian
companies strengthened their base in the region by making a series of acquisitions. However,
global slowdown and pricing uncertainties took a toll on the profitability of their European
operations, which prompted a change in strategy. Healthcare expenditure, as a percentage of
GDP, in Germany and France, respectively, is among the top ten globally. Consequently,
governmental steps to regulate prices adversely impacted the growth of Indian players in last
two years. However, the increasing penetration of generic drugs will continue to drive volume
growth in the region and offset the impact of pricing pressure. Further, lower generic
penetration in nations such as Belgium (16.6%), the UK (27%), France (19%) and Germany
(31.2%) indicates tremendous untapped potential for growth of Indian generics.
In recent times, Germany and other countries have turned to value-based pricing for new
drugs, which allows a price differential from existing offerings, including generic drugs, based
on a new product's demonstrated superiority. This exerts pricing pressure on generic drug
manufacturers. Moreover, the market has shifted towards a tender-based business, driven by
insurance companies and government-driven contracts such as that obtaining in the UK
(National Health Service). This poses a significant challenge to Indian pharma companies.
Thus, while the pro-generic stance of governments in Europe will boost demand for these
drugs, pricing environment and profitability could be subdued.
Demand for low-cost medicines -- key driver in semi-regulated markets
Low-cost generic medicines dominate semi-regulated markets. Further, these markets are
characterised by increasing healthcare awareness, rising consumer income and a large base
of patients in the acute and chronic disease segments, backed by a huge population. We
believe that a low-cost base, well-developed active pharmaceutical ingredient (API) industry
(and process chemistry skills), and similarity in disease profiles (between India and these
markets), will improve penetration of Indian drugs in these markets.
Wider product portfolio and penetration into smaller markets to aid exports to other
semi-regulated markets
Many semi-regulated markets, such as Brazil and Russia, with high out-of-pocket expenditure
on healthcare (unlike developed markets), are attractive for branded generic drugs. Therefore,
a strong distribution network is critical for success in these regions. Over the years, Indian
players have tackled these markets by setting up front-end marketing teams. Brazil is key for
Indian exports. Indian companies have been expanding their generic product portfolio since
the Brazilian government cut prices of branded generics and increased adoption of non-
branded generics. Players such as Torrent, Aurobindo, and Glenmark are concentrating on
increasing product filings, improving channel field force and marketing teams. However, timely
product approvals will be critical to drive exports to these markets.
A caveat remains, though -- currency exchange rate. For instance, a sharp depreciation of the
Russian ruble from the first to the third quarter of fiscal 2016 impacted India's exports to
Russia. A similarly steep depreciation of the Brazilian real impacted India's exports to the
country in the same fiscal. Hence, only traction in new approvals can offset such adverse
currency movements for Indian players.
They are also targeting newer markets in Asia and Africa with low generic penetration for
growth. For example, exports to Africa increased 21% on year during fiscal 2021. The top 10
markets here accounting for 67% of India’s exports grew by ~24%, while the exports to the
rest of the regions grew ~12% during the period.
Regulatory scrutiny mild in 2021
Having tightened its global regulatory scrutiny, the US FDA has increased its global
inspections since 2012. While GDUFA was implemented in 2012, its actual impact was visible
in 2015 when the number of inspections conducted saw a sudden increase. Indian plants
witnessed relatively higher inspections during 2015 and 2016. The US FDA had recruited more
hands in order to conduct inspections. It started collecting a GDUFA fee from generic drug
manufacturers to help the agency increase its staff and resources to cope with the backlog
caused by the rising number of ANDA applications and improve the quality of oversight on
generic drug manufacturers.
The players have taken special care to improve their regulatory compliance in the past two
years. However, USFDA scrutiny around plant operations- particularly towards cleanliness,
maintenance and laboratory controls increased in 2019.
US FDA inspections for Indian facilities

The Covid-19 led disruption led to USFDA delaying inspections for plants in 2020.
Inspections resumed in 2021 and US FDA has been clearing plants under scrutiny since last
few months. Trend in warning letters

Trend in import alerts
Note:2021*- (Jan-Nov), Large, mid and small players– revenues above Rs 50 billion, Rs
5-50 billion and below Rs 5 billion, respectively
Source: US FDA
2020 was a year of benign regulatory environment for Indian players with respect to USFDA.
The Covid-19 pandemic led to USFDA stopping foreign inspections for the year. Players urged
the regulator to conduct desktop reviews and virtual inspections. The timeline of resumption
of USFDA inspections and consequent scrutiny now remains a key monitorable.
Six major players – Cadila, Aurobindo, Jubilant Generics, Lupin, Glenmark and Torrent – had
received warning letters in 2019. Cipla is the only player to have received a warning letter in
2020 and Lupin in 2021 while Aurobindo pharma received a warning letter for its API facility.
While regulatory risk has remained overhang on the sector, players are better equipped now
compared with the 2014-2015 cycle. The players have taken steps such as site-transfers of
affected plants and dual product filings from different plants. Further, the resolution time is not
likely to be as prolonged as was the case in 2015 because of fewer data integrity observations.
The observations in recent alerts are more related to the cleanliness and maintenance of
facility, equipment and process and control records. Although, resolving these observations
may cost more, time for resolution is likely to come down now. Further, there are no import
alerts for large players since 2015. The scrutiny is, however, high on smaller players.
Although, we expect the resolutions to happen faster than in previous years, any further
escalation in scrutiny would impact the sector and thus this remains a key monitorable. Also,
a delay in site inspections by USFDA due to ongoing Covid-19 led travel restrictions continues
to be a risk.
Bulk drugs growth to moderate in the medium term
Feb 1, 2022
Bulk drug exports are likely to clock 8-10% CAGR over the next five years. Transition to the
specialty segment and strong capabilities in high-value active pharmaceutical ingredients
would support exports. Development of bulk drug industry in India would also aid growth.
After robust growth in FY21, growth moderation expected
Bulk drug exports, which rose ~7% CAGR during fiscals 2008 to 2013, decelerated sharply to
1.4% CAGR from fiscals 2014 to 2018 because of competition from China and other Asian
countries. Traditionally, the Indian pharmaceuticals market has been a major export hub for
bulk drugs owing to low manufacturing cost. However, with enhancing capability of Chinese
players, especially in the intermediates space, along with significantly lower production cost,
Indian bulk drug manufacturers have lost market share in recent years. Further, because of
the patent cliff (when many patents expired on innovator drugs) during 2012 to 2014
many Indian players who manufactured key patent molecules recorded a substantial decline
in revenue.
In fiscal 2019, bulk drug exports increased ~10% on-year on the back of a short-term
opportunity in the export market because of supply disruption from China. Chinese players
had been forced to shift their manufacturing facilities inland and outside the cities as the
government continues to crack down on polluting industries. With this, overall supply of bulk
drugs from China was impacted.
Covid-19 pandemic led disruptions subside; robust growth to return
In fiscal 2020, bulk drug exports de-grew by ~1% y-o-y in wake of Covid pandemic restricting
export growth in the last two months (February-March) of the fiscal.
The Indian government restricted the exports of 13 key API molecules during the month of
March in an executive order. These molecules constituted ~30-40% of overall bulk drug
exports. However, the restrictions were lifted in April, paving way for increased exports.
Exports grew by ~14% (constant currency terms) on-year in FY21 over low base of FY20.
Exports to Iran had increased in fiscal 2020 owing to a rupee payment mechanism agreed
between Indian and Iran. Bulk drug exports to China increased as well because of shortages
of some products owing to the supply disruption because of the relocation of industries.
Exports are likely to register 5-7% CAGR growth from fiscal 21 to fiscal 26 on the back of
various drivers. On the demand front, India now has the opportunity to establish and grow its
strong footing on the global market as customers now look at securing their supply chains and
reduce dependence on China. Following the coronavirus pandemic breakout, China was
unable to supply bulk drugs/API to its customers. Consequently, prices of these drugs
have increased. However, post return of normalcy, China has managed to gain back market
share in global trade while India's market share has dipped sequentially. Whether India
benefits in terms of market share gain at the cost of china in the long term, remains to be seen.
On the other hand, the government’s production linked incentive scheme and development of
bulk drug parks to promote Indian bulk drug industry, which includes providing incentives for
manufacturing is likely to aid growth in the long term.
Bulk drugs exports outlook
P: Projected
Source: DGCIS, CRISIL Research
Even though pricing pressure by formulation players will continue to impact the growth of
Indian bulk drug players, transition towards the specialty segment and higher capabilities of
Indian players versus Chinese players in high-value API will aid growth over the medium
term. Further, demand is expected to pick up in regulated as well as semi-regulated markets,
as customers source from India as part of de-risking value chain from China.
Consequently, overall export is projected to recover to 5-7% CAGR over the next five years
as players focus on niche molecules and specialty segments. However, in recent months,
China has come back in terms of market share in global bulk drugs trade. So whether Indian
players continue to gain market share at the cost of China in the long term, remains to be
seen. Players are also increasing capex across products and many have shown interest in the
PLI scheme as well. Growth will also be supported by increasing focus of Indian players in the
specialty products segment, where competition is comparatively low.
The pick-up in bulk drug exports could lead to somewhat gaining back the share of bulk drugs
in the export basket. However, addition of upside due to Covid vaccine in formulation exports
could lead to lesser share of bulk drugs over the next five years. The reason for the faster
growth in formulation exports is because of players climbing up the value chain (Please refer
to formulation exports chapter for details).
Trend in share of bulk drug exports in overall exports
Note: P: Projected
Source: Directorate General of Commercial Intelligence and Statistics
(DGCIS), CRISIL Research
Meanwhile, on the domestic front, bulk drug production for captive consumption is likely to
continue to record strong growth. In fact, domestic bulk drug manufacturers are expected to
continue to register double-digit growth, supported by strong domestic sales. The
government’s production-linked incentive scheme would also aid domestic manufacturing in
the medium term.
The geographic mix for bulk drug exports varies substantially compared with formulations. The
US accounted for ~9% of the bulk drug exports in fiscal 2021, compared with a ~37% share
in formulation exports. This is mainly because of China's large share in global bulk drug and
intermediates trade compared with India. Further, Japan, which constitutes negligible share in
formulation exports, accounts for ~3% share in bulk drug exports
Share of countries in bulk drug exports
Note: Values in $ bn
Bulk drug imports to India have been stagnant over the past 2-3 years. In fiscal 2019, imports
increased ~29% on-year (in Rs terms) mainly on from China. Imports during fiscal 2020
recorded de-growth of 4% on-year due to Covid-19 led disruptions from China during February
and March of 2020. Even then, China continued to account for ~68% share in India’s overall
bulk drug imports for FY20. Imports of bulk drugs increased by ~13% in FY21 with China
contributing a significant share.
Imports from China have been increasing over the years due to low-cost advantage enjoyed
by Chinese manufacturers. Government support in the form of infrastructure and low power
cost has helped lower overall production cost for bulk drugs and intermediates for Chinese
players. In fiscal 2021 as well, Indian players imported ~68% of the raw material requirement
from China.
Increasing dependency on imports from China
Note: Values in $ bn
Top 5 categories with largest import share from China

High dependence on Chinese imports is a concern for the domestic pharmaceuticals industry.
The covid outbreak has been detrimental in revealing the consequences of a supply disruption
from China and its potential impact.
Therefore, the central government has earmarked ~Rs 100 billion for the bulk drug industry,
including Rs 30 billion for promotion of bulk drug parks (for next five years) and Rs 69.4 billion
towards production-linked incentive scheme for promotion of domestic manufacturing of
critical KSMs/Drug Intermediates and APIs in the country (for next eight years).
The scheme has identified 53 critical APIs/intermediates where India’s reliance on China is
high and most of which are used to produce essential drugs. Most recently, the governement
has approved plants of Aurobindo, Karnataka Antibiotics and Kinvan as part of scheme for
manufacturing key fermentation-based intermediates.
Renewed regulatory interest a positive for the sector

Feb 1, 2022
The recent supply disruption in the wake of the coronavirus pandemic has resulted in the
government taking proactive steps to boost domestic manufacturing and bring down the costs.
A regulatory boost, along with strong process chemistry skills will continue to help the Indian
bulk drugs industry garner a big share of the global bulk drug exports pie. We expect growth
to pick up in the coming years on account of product diversification and increased global
demand.
Regulatory boost for domestic industry
The Union Cabinet, on March 21, 2020, approved the below schemes for the development of
the Indian bulk drug sector.
Source: PIB Delhi

The above mentioned schemes are aimed at providing regulatory boost to the sector by
reducing manufacturing cost of bulk drugs. One of the major factors for China’s dominance in
bulk drugs is the regulatory support it gets from its government, with common facilities across
plants and various subsidies being provided, which helps them bring down the cost
considerably. With the newly announced schemes, the Indian government is also looking at
creating common infrastructure facilities and reduce dependence on some critical drugs.
Scheme unlikely to significantly reduce Chinese dependence in medium term
This scheme may not quite offset the cost difference with China in the medium term. To be a
material offset, India will need to establish large-scale production to achieve economies of
scale and for sharing of common facilities (especially waste treatment plants). Whereas the
PLI scheme incentivises revenue from a six-year perspective and the set-up of plants is likely
to take next two-three years.
Further, eligibility criteria for the scheme works to the advantage of a few select players as for
each product under the fermentation-based and chemically synthesised categories, the
number of manufacturers has been capped at two and four, respectively. The scheme does
provide an impetus to the industry growth as more and more capacities come in.
India enjoys cost advantage over regulated markets
Bulk drug manufacturing costs are significantly lower in India than in the regulated markets of
the United States (US) and Europe, as illustrated in the chart below. China is a major exporter
of bulk drug intermediates globally as it enjoys competitive advantage due to government
support, coupled with low power and labour costs. On the other hand, India is a preferred
destination for the procurement of active pharmaceutical ingredients (APIs), especially in
regulated markets, compared with China. This is on account of its advanced process
chemistry skills, which aid the manufacture of bulk drugs and complex intermediaries.
Cost of manufacturing drugs in India, China, Europe and US
India has highest number of US FDA-approved facilities outside the US, leads US DMF
submissions
India has the highest number of US Food and Drug Administration (FDA) approved facilities
outside the US. The country also has skilled manpower and advanced process chemistry
skills. Some bulk drug manufacturers have forward-integrated into pre-formulations
(pelletisation / granularisation of bulk drugs before they are converted into finished dosages)
as well.
Though China is a major destination for bulk drug manufacturing, it has a major share primarily
in the manufacturing of bulk drug intermediates. India has consistently maintained its
leadership in drug master file (DMF) submissions. This proves the capability of Indian players
to meet required export quality standards for regulated markets. A DMF is an indicator of the
bulk drug manufacturing capabilities of players (in terms of quality standards maintained at
their facilities for processing, packaging, storage of drugs, etc.), which is used by global
pharmaceutical companies that are outsourcing production activities (innovators).
DMFs (global vs. India)
Source: USFDA, CRISIL Research

India is considerably ahead of its competitors in terms of the total number of DMFs.
Country-wise DMFs
Note: Active, Type II DMFs considered

Source: USFDA, CRISIL Research
Focus on niche and specialty products to aid growth
A focus on specialty products and niche molecules would aid the growth of bulk drug players.
Players have a healthy pipeline of complex generics and limited competition products, which
are difficult to manufacture but command a higher premium. The pricing pressure is also
expected to normalise in regulated markets in the coming years.
Further, the supply disruption from China is expected to aid business opportunities for bulk
drug players in the global market. Also, recent quality issues related to Chinese APIs have
slightly dented the country's image globally, which would in turn boost business for India, the
next largest and cost-effective API supplier after China. Some multinational corporations
(MNCs) are looking at alternative sources for bulk drug procurement following Chinese issues.
Outsourcing of bulk drugs from MNCs to continue
In view of high operating expenses, CRISIL Research believes MNCs will look at bulk drug
outsourcing to control cost and improve profitability. Margins of global innovator players
dipped substantially from 2015 to 2018. Going ahead as well, MNCs are likely to continue
outsourcing bulk drugs manufctruing to India
Major players look to improve capacities to reduce China dependence
Players such as Aurobindo, Divis Labs, and Aarti Industries are looking at expanding their API
capacities with an aim to reduce dependence on China.
Recent supply and quality issues in China have resulted in disruptions in the industry. Indian
players are now looking at capitalising the opportunity as even some global MNCs are
moving away from China as they consider alternate sourcing of APIs.
 Divis Laboratories has invested Rs 25 bilion in capex since FY18. the company has now
announced new capex at Kakinada, with an investment of Rs 6 billion to be spread over
2–3 years. Apart from this, the company has several other investments in line
 Aurobindo made Rs 150 million in local intermediate maker in FY20 to ensure continuous
supply of intermediates in event of Chinese disruption.
 Aarti Industries had announced a capex plan of Rs 23 billion over fiscal 2019 to fiscal
2021 in multiple chains to increase market share
 Aarti Drugs has guided for a capex in the range of Rs 10-12 billion annually for next
couple of years
The new production-linked incentive scheme announced by government will also see new
greenfield projects coming up which will boost bulk drug production in the country.
However, dependence on Chinese imports (key starting materials / intermediates) is likely to

continue because unless the government provides continued support in the form of
infrastructure and tax subsidies, it would be difficult for Indian players to match the
manufacturing costs of its Chinese counterparts.
Covid-19 vaccine to drive domestic market growth over medium term
Feb 1, 2022
The domestic formulations industry is facing regulatory changes and increased price controls,
which will put some pressure on revenue growth in the medium term. However, double digit
growth in the chronic segment and expansion of the Ayushman Bharat scheme in the coming
years are expected to lend support to demand. Further, Covid-19 vaccine would provide a
significant upside to the sector
Domestic growth to bounce back in FY22 led by chronic therapies and covid related
drugs and vaccines
Growth in the domestic formulations industry has historically been stable and strong apart
from certain exceptions. Drugs under the National List of Essential Medicines (NLEM)
comprised ~20% of the overall domestic market in fiscal 2020. Growth for NLEM drugs
improved during the fiscal, with both volume and value growth. Further, prices were revised
upwards for medicines under the NLEM, in line with the wholesale price index (WPI). On the
non-NLEM front, the industry expanded ~10% on-year, driven by increase in pricing.
The Covid-19 pandemic, which started spreading across the world in early 2020, had
necessitated lockdown all over the country in the first quarter of FY21. With this, the domestic
pharmaceutical sales were hit in the first quarter. As lockdown continued in April and May, the
domestic pharma market registered a 6% decline in growth for the quarter. Closure of smaller
clinics and hospital OPDs, postponement of elective surgeries resulted in slower sales of
drugs in domestic market. Acute therapies such as anti-infectives, gastro intestinal, pain etc.
were worst hit while some support was provided by increase in sales of chronic therapies like
Cardiac and anti-diabetes. The growth further deteriorated in the second quarter and the
market registered a de-growth of 2.4% in the first half of FY21. However, demand picked up
in the second half amid second covid wave led by chronic therapies and covid related drugs
and the overall industry growth moderated to ~3% in FY21.
Growth is expected to pick up as things return to normalcy gradually. The National
Pharmaceutical Pricing Authority (NPPA) has fixed retail prices of 866 scheduled formulations
under price control based on price revision as per annual wholesale price index (WPI) in the
month of March 2021.
FY22 revenue growth will be led by chronic therapies along with covid related drugs and
vaccines. Base domestic formulations is expected to grow by 16-18% in FY22. However,
additional upside of 40-50% in FY22 is possible in domestic market because of Covid
vaccines. Covid vaccine upside calculation is based on various assumptions relating to
demand, supply, pricing etc. and is subject to revision based on change in regulatory/ market
dynamics.
Domestic pharmaceutical revenue trend (excluding covid vaccine upside)
Note: E: Estimated, P: Projected

Source: CRISIL Research
CRISIL Research projects the industry to grow at a compounded annual growth rate (CAGR)
of 8-10% over the next five years, which is likely to take the market close to Rs 2.3 trillion by
fiscal 2026.
Covid-19 Vaccines to offer tremendous upside to industry over medium term
Domestic market potential
Covid vaccine upside to the tune of 40-50% in the domestic market is possible in FY22. It
would be important to note that the revenue would be concentrated towards few players
involved in manufacturing of Covid vaccine and not the large set of players in
the pharmaceutical industry. Hence, vaccine upside has been highlighted separately. Also,
the upside would depend on various factors such as demand, supply, prices, hesitancy etc. is
subject to change based on change in regulatory/ market dynamics.
Note: For determinig vaccine potential for FY23, it has been assumed that a booster shot wo
uld be required.
Source: Industry, CRISIL Research
Growth in chronic segment to continue to boost growth in medium term
New product launches in the chronic segment is likely to aid growth in the sector in medium
term. Further, the rise in the anti-diabetic, cardiac, and dermatology segments would support
growth of the domestic industry.
Chronic portfolios of major companies have seen a double digit growth in the past five years,
with anti-diabetes being the fastest growing segment. Further, prices have been revised
upwards by ~2% from April 2020 for medicines under the NLEM, in line with the wholesale
price index (WPI).
As per World Bank data, India's per capita expenditure on health is among the lowest among
developing countries, representing significant potential
Healthcare expenditure as a % of gross domestic product (GDP) for global peers (2018)
Source: World Bank

The sector is also expected to benefit from factors such as rising incidence of lifestyle-related
diseases, and better healthcare, diagnostic and hospital infrastructure, which has helped
improve the disease detection rate. CRISIL Research expects such factors to increase
healthcare expenditure, thereby aiding growth in the domestic market.
Ayushman Bharat to support long term growth
Rising lifestyle diseases and growth in insurance penetration (mainly because of Ayushman
Bharat) would aid demand for the sector in the long term.
Ayushman Bharat, a Government of India scheme launched in September 2018, is unlikely to
have a major impact in the short term. This is because the initial years will be spent in getting
majority of the population enrolled as well as private hospitals empaneled in the scheme,
which is very low currently. Nevertheless, the scheme can be a huge positive for the pharma
industry in the long run, as it will accelerate healthcare coverage in the country, which is
currently very low at 34%. Ayushman Bharat also aims to upgrade 1.5 lakh primary healthcare
centres (PHC) to provide diagnostic services and free medicines for preventive care. This
could be a huge spin-offs for the industry as well. Strengthening of PHCs is necessary to take
domestic industry growth to a higher trajectory.
However, proper implementation and continued government support are key to achieving
universal healthcare
Progress report
 Since implementation, 1.64 crore treatments have been made so far
 Over 28,000 hospitals have been empanelled, of which 50-55% are private hospitals
Domestic pharmaceuticals: Long-term potential
Note: P: Projected, E: Estimated

Chronic disease care drugs (meant to treat many non-communicable diseases) are seeing
high growth rates, primarily due to growth in the urban population, better awareness on
healthcare, and greater penetration of services. Disability-adjusted life years lost for the Indian
population reflect the shift in disease profile. The metric, published by the World Health
Organization, is the number of life years lost due to premature mortality plus the number of
years lived with disability.
Disability adjusted life years lost in India led by non-communicable diseases
Source: The Institute for Health Metrics and Evaluation (IHME) / Global Burden of
Disease Tool
The data indicates a rise in the number of life years lost due to non-communicable diseases
such as cancer, cardiovascular ailments, diabetes, and mental disorders between 2009 and
2019. Conversely, life years lost due to diarrhoea, tuberculosis, and respiratory infections have
dropped. CRISIL Research expects this shift in the disease profile to continue, with non-
communicable chronic ailments adding to disease woes.
Government push for schemes such as Jan Aushadhi Yojana, a step towards
increasing generic generics penetration
At 90-95%, branded generics (drugs that are off-patent and sold on brand names) comprise a
lion's share of the domestic pharmaceutical industry. Retailers as well as manufacturers earn
margins of over 20% on branded generics. As branded drugs account for much of the market
share, the government has undertaken steps to increase the uptake of unbranded generics. It
introduced the Jan Aushadhi Yojana in November 2008 to sell low-cost, unbranded, but
quality medicines to all citizens via stores called Jan Aushadhi Kendras.
The Jan Aushadhi scheme saw only about 100 stores till March 2014 since its inception.
However, it received a push post 2014 and about 7,000 stores are currently operational in the
country. Yet, of India's ~8.5 lakh pharmacies, Jan Aushadhi stores represent less than 1%.
Therefore, the share of sales through Jan Aushadhi stores is very low.
CRISIL Research does not foresee any significant impact of Jan Aushadhi Yojana on the
industry in the coming five years. Lack of awareness among consumers, non-prescription by
doctors, and low quality assurance for unbranded generics in comparison with branded
counterparts are some of the challenges faced. CRISIL Research estimates the sale of drugs
through Jan Aushadhi stores is thus likely to account for merely ~2% of total domestic
pharmaceutical sales by fiscal 2024. On the other hand, a significant increase in scale might
impact the volumes of chronic drugs in the market, thereby affecting the market share of
branded players.
Higher raw material and other costs to affect margins of players in FY22
Feb 1, 2022
Margins of large formulators is expected is remain supported in FY22 while that of mid and
small sized players is likely to fall due to raw material price increase amid lower realization
owing to pricing pressure etc.
Profitability of players expanded in fiscal 2021; to fall marginally in FY22
CRISIL Research has segregated Indian pharmaceutical companies into formulations or bulk
drugs, based on their key business segments, in order to assess their financial performance.
Formulation players have been further segregated into large (turnover more than Rs 50
billion), mid-sized (turnover more than Rs 5 billion and less than Rs 50 billion) and small
(turnover less than Rs 5 billion).
Indian pharmaceutical companies are present across the value chain, manufacturing active
pharmaceutical ingredients (APIs) to final formulations. These companies (selling both
formulations and APIs) operate in the domestic as well as export markets. While India largely
imports intermediates and chemicals, as per estimates, exports far outstrip imports by value,
making the country a net exporter of pharmaceutical goods. The structure of the industry thus
exposes players to several factors that can impact profitability, including:
 Raw material price movement
 Geographical factors impacting sales or realisations
 Rupee exchange rate
 Regulatory environment
 Company-specific factors
Based on the various macroeconomic factors at play, the profitability of different segments
has been analysed.
Profitability of Large-sized players improved in fiscal 2021; likely to remain flattish to
negative in FY22
After registering a fall of ~330 basis points (bps) on-year in fiscal 2018, large formulation
companies registered a ~20 bps increase in margin in fiscal 2019 on the back of easing price
erosion and ramp-up in specialty and complex generics. There were some major launches for
players during the year.
Margins remained flat in fiscal 2020 as major players were faced with regulatory alerts that
increased remediation costs as well as delayed product approvals for a few companies.
Further, players are likely to have seen increased promotion and marketing costs as they
promoted specialty products.
In fiscal 2021, margins improved by ~230 bps on account of lower travel and marketing
spend amid the pandemic to ~23%. Basis industry estimates, the discontinuation
of MEIS scheme is likely to have had a 50-100 bps impact on the margins of players in fiscal
21. Sustained increase in raw material prices is expected to affect margins of players in fiscal
22. Also, selling and other expenses which were less in fiscal 2021 are expected to be back
in fiscal 22 as everything opens up. At the same time, better product mix and ramp-up in
complex and specialty products are expected to provide support to margins of players into
niche segments.
Profitability of large formulation companies
Profitability of mid-sized players to fall in fiscal 2022
The impact on margin performance over the past few years (due to price erosion in regulated
markets) has been relatively less severe for mid-sized players compared with large players.
This is primarily because the larger players better leveraging the higher margins they enjoyed
from 2012 to 2014 due to patent cliffs, as compared with mid-sized players. However, fewer
first-to-file (FTF) opportunities post 2014, coupled with price erosion in the base business, has
led to margins converging for large players and mid-sized players.
Profitability of mid-sized players rose by ~70 bps in fiscal 2019. Players reported a ~300 bps
on-year increase in margin during fiscal 2020, led by limited competition launches and good
institutional sales in emerging markets for some players. Stabilisation in raw material cost
inflation as compared with fiscal 2019 provided support to margins.
In FY21, margins of mid and small formulation players expanded by 200-250 bps to 24-25%
owing to the benefit of lower operational expenses and high realization on one time institutional
sales due to covid. Margins are estimated to drop in FY22 to 21-22% on account of high raw
material prices and selling and other expenses along with lower institutional sales as
compared to last fiscal.
Profitability trend of mid-sized and small formulation companies
Margins of bulk drugs players to remain supported in fiscal 2022
In fiscal 2020, the operating margin of bulk drug players in the set improved by ~150 bps on-
year, led by stabilization in raw material costs following disruptions of fiscal 2019.
In fiscal 2021, margins improved by ~75 bps as players were able to pass on some of the rise
in raw material costs. Raw material costs increased in wake of the coronavirus pandemic. The
pandemic which started spreading in fiscal 21, originating in China, resulted in supply
disruptions and price rise for key APIs. Although, China gradually resumed operations and
raw materials started to flow in, the cost pressures remain. Margins of the set improved
significantly in fiscal 21 on account of foray by leading players into custom systhesis and niche
molecules. However, margins of players into conventional bulk drugs continued to remain low.
On the other hand, Indian bulk drug players also have opportunities to export key drugs like
Azithromycin which now command high margins. Further, a currency depreciation would also
aid revenue growth.
Further, players’ focus on high value and niche molecule APIs would support margin growth
in fiscal 22. Demand for such molecules would be high in the next five years as opportunities
in conventional generics fade. However, further increase in prices of KSMs/ DIs would
adversely affect margins as players would not be able to pass on the entire price rise due to
contractual obligations.
Trend in profitability of bulk drug manufacturers
Note: E: Estimated; P: Projected

Small players face lower profitability and liquidity concerns
Large and mid-sized players in the bulk drugs and formulation space command higher revenue
share and better profitability because of the large scale and depth of their business operations,
as well as the strength of their brands. These players have significant exposure to both the
Indian and lucrative export markets. On the other hand, small players operate in the more
price-competitive domestic market. They have limited exports, and that too mostly to semi-
regulated markets. Hence, these players face greater strain on their financials, especially in
situations involving price competition or external shocks such as domestic governmental
pricing interventions.
Company Profiles
1) Player Profile: Cadila Healthcare Ltd
Company overview/background
Cadila Healthcare Ltd was founded in 1952 by Mr. Ramanbhai B. Patel. The company has
its headquarters in Ahmedabad, Gujarat. The company is into research, development,
manufacturing, marketing and selling of finished dosage human formulations which includes
generics, branded generics and specialty formulations. Cadila has its presence in US,
Europe (France & Spain), Latin America and South Africa and offices across 25 emerging
markets apart from India. It has a major area of research in NCE research, Biologics and
Vaccines. The company employs around 24,412 on roll employees as of March 2021.
Manufacturing Facilities:
Cadila Healthcare Ltd has total 36 manufacturing facilities across India, US and Brazil which
includes 22 manufacturing facilities for formulation, 3 for Vaccines, 4 for APIs, 3 for
Biologics, 3 for consumer wellness and 1 for animal health. The company also has 8 R&D
sites across India, US and Italy.
Cadila Healthcare Ltd ranked 5th in the domestic pharma market, with a market share of
about 3.4% as of March 2021. The domestic sales accounted for 43% and
International sales accounted for 57% of overall revenue in FY21.
Content
 Key/recent developments
 Regulatory developments
 Operational Performance
Key/recent developments
 In August 2021, Zydus Cadila's ZyCoV-D – the world's first plasmid DNA vaccine got
Emergency Use Approval (EUA) from the Drugs Controller General of India. The
DCGI has given its permission for the vaccination to be given to children aged 12 to
17.
 In July 2021, received final approval for Fulvestrant Injection, first approval of a
complex product from Biologics site.
 The Company added 60 new customers in API segment across different countries
during the year
 In fiscal 2021, the company launched 30 new products in US market
Details of new initiatives
Equity infusion done/plan
Regulatory developments
 In FY20, Oral Solid Dosage (OSD) formulations manufacturing facility located in
Ahmedabad SEZ received the Establishment Inspection Report (EIR) from the
USFDA with Voluntary Action Indicated (VAI) classification of the facility. The EIR
followed the inspection conducted by the USFDA from 25th March to 3rd April, 2019
which concluded with one observation.
 In December 2020, USFDA provided a fast track designations to Zydus Cadila for its
drug Saroglitazar for the treatment of patients Primary Biliary Cholangitis (PBC).
 In November 2019, the company recieved warning letter from US FDA for its Moraiya
formulation facility in Ahmedabad. The plant contributes about 35% of the company's
US revenue. The Moraiya plant's case was escalated with the US regulator on
getting an official action indicated (OAI) after inspection between April 22 and May 3.
 In September 2019, Cadila received Establishment Inspection Report (EIR) from US
FDA for its manufacturing facility located at Ankleshwar in Gujarat.
 In May 2019, 44 states in the USA filed a lawsuit against seven Indian pharma
companies including Cadila Healthcare accusing them for inflating prices of generic
drugs.
Revenue split for FY21:

Therapy wise domestic revenue break-up in 2020-21:
2) Player Profile: Sun Pharmaceuticals Industries Ltd

Sun Pharmaceutical Industries Ltd is an international specialty pharmaceutical company
selling drugs in more than 150 countries including US, Europe, India and emerging markets.
It was formed as a partnership firm in 1982. In 1994, it was incorporated as a limited
company and subsequently renamed as Sun Pharmaceutical Industries Ltd (SPIL). The
company then built its first active pharmaceutical ingredient (API) manufacturing plant in
1995 in Panoli (Gujarat).
SPIL primarily manufactures generic formulations for the domestic and exports markets.
Oncology, Diabetes, Pain, Autoimmune and Respiratory have been the major therapy areas
for the company. Similarly, the company has gained a strong position in the chronic care
drugs segment in the domestic market.The company manufactures API largely for captive
consumption. Focus on manufacturing key API internally has led to lower raw material costs
for the company than its peers. Currently, the company manufactures approximately 300
APIs across 14 worldwide locations.
The company has a well-diversified manufacturing base amongst its peers with
44 manufacturing facilities across India, America, Asia, Africa, Australia and Europe. While
23 manufacturing plants are set up in India, the rest are spread across continents. The
company has 29 formulations and 14 API manufacturing sites. Sun Pharma also has several
research centres, spread across India, Israel, Canada and the US.
Content
 Equity infusion done/plan
 In May 2021, Sun Pharma entered into a licencing agreement with Eli Lilly to expand
access to Baricitinib, in helping alleviate the burden of COVID-19 in the country.
 In April 2021, the first generic for Absorica entered the US market.
 In FY21, the company launched 96 products in the domestic market, including the
anti-epileptic Brevipil (Brivaracetam) and FluGuard (Favipiravir)
 During the year, the Company supplied drugs like Remdesivir, Itolizumab,
Hydroxychloroquine (HCQS), Favipiravir and Liposomal Amphotericin B in the Indian
market for treatment of COVID-19 and associated ailments
 In August 2020, Sun pharma launched FluGuard (Favipiravir 200 mg), for the
treatment of mild to moderate cases of Covid-19 in India.
 In FY20, the company launched four specialty products in the US market viz., Cequa,
Absorica LD, Ezallor Sprinkle and Drizalma Sprinkle.
There was no equity infusion done during the year. In FY21 equity share capital was Rs.2.4
billion.
 In January 2020, the USFDA classified the inspection status of Halol facility as
Official Action Indicated (OAI).In December 2019, US FDA issued a form 483, with 8
observations for its Halol faclity. Earlier in June 2018, the had also
received Establishment Inspection Report (EIR) from US FDA for its Halol facility.
company including Sun pharma accusing them for inflating prices of generic drugs.
Operational Performance
As per AIOCD AWACS March 2021 data, the company witnessed an increase in our market
share to 8.2% on MAT basis compared to 8.1% in the previous year.
3) Player Profile: Pfizer India Ltd

Pfizer is an American pharmaceutical multinational company headquartered in New York.
The company's Indian arm is headquartered in Mumbai. Pfizer India sells mainly
pharmaceutical formulations.Pfizer India's operations include manufacturing and sale of
formulations in the domestic market. It operates in acute care segments such as pain
management, respiratory, anti-allergic, anti-histamines, anti-infectives, anti-parasitics,
gastrointestinals, dermatology and chronic care segments such as anti-diabetic,
cardiovasculars, neurologicals, etc., as well as vitamin/minerals. The company sells its
products through independent distributors in India. On the R&D front, the company only
spends on development of formulations, process improvements and clinical trials for
products it intends to market in India. Pfizer has a portfolio of 150 products across 15
therapeutic areas, its top brands include Prevenar 13, Lyrica, Eliquis, Enbrel, Becosules,
Gelusil and Corex range of products.
Pfizer India has one manufacturing facility at Goa (acquired due to Wyeth's amalgamation in
December, 2014). The company also depends on third party contract manufacturing and
imports for its pharmaceutical products.
Content
 In FY20, the company launched Zinforo, a novel cephalosporin indicated for
treatment of adult patients with community acquired Pneumonia
No equity infusion was done during the year. In FY21 equity share capital was Rs.458
million.
Pfizer India is the 16th largest player in the domestic formulations market, with a market
share of about 2.4% as of March, 2021.
Portfolio mix
Operational parameters
4) Player Profile: Wockhardt Ltd

Established in the early 1960s, Wockhardt Ltd has a product portfolio comprising
formulations, biotech, vaccines and active pharmaceutical ingredients (APIs). The company
mainly manufactures formulations. It has a significant presence in regulated markets such as
Europe and the US. The company generated 83% of total revenues from the international
businesses in 2020-21. The company also undertakes contract manufacturing at its
international plants. The company employ over 9,000 people and 27 nationalities. It has
600+ scientists, of whom 70+ are doctorates. USFDA has given Wockhardt QIDP status
(Qualified Infectious Diseases Programme) for 5 Anti-bacterial discovery programmes.
Wockhardt has formulation products in segments such as anti-infectives, cardiology,

dermatology, neurology, diabetology, pain management, respiratory, etc. The company's
bio-technology business focuses on developing biosimilars of insulin and its analogs. Over
the years, the company has been marketing insulin and analogs in India and globally. Some
of the company's marketed biological products are - Glaritus (long-acting insulin analog),
Wosulin (recombinant insulin), Wepox (erythropoietin) and Biovac-B (hepatitis B vaccine).
Its manufacturing plants located across India, US, UK, Dubai and Ireland. Within India, two
are in Waluj, one each in Chikalthana and Shendra (all in Maharashtra), two in Daman, and
one each in Ankleshwar (Gujarat) and Solan (Himachal Pradesh) in India. The company has
three multi-disciplinary research and development facilities in India, the US and the UK,
which deal with generic drugs, novel drug delivery systems and new chemical entities, with a
special focus on anti-infectives. As of 31st March 2021, the Company has 32 subsidiaries
(including step down) located in Switzerland, US, UK, Ireland, Germany, France, Belgium,
Mexico, Brazil, Nigeria, Russia, Australia, New Zealand and two in India.
Content
 Details of new initiatives
 Capital expenditure plans
Recent/Key Developments
 In FY21, the company launched 2 new antibiotics, EMROK (IV) and EMROK O
(Oral), for acute bacterial skin and skin structure Infections including diabetic foot
infections and concurrent bacteraemia.
 On 29th July 2018, Wockhardt Group set up its first manufacturing facility in Dubai for
manufacturing NCE (New chemical entities) which will be marketed in global market
through its subsidiary Wockhardt Bio AG.
Regulatory Developments
 In May 2020, the company received EIR from US FDA for the Active Pharmaceutical
Ingredients (API) manufacturing plant at Srikakulam, Andhra Pradesh (CTO VI),
indicating closure of the audit and the inspection classification of this facility is
determined as "Voluntary Action Indicated.
 In August 2016, the company received import alert 66-40 on its API facility at
Ankleshwar. This was followed by a warning letter for the same facility in January
2017.
 In July, 2016, the company received an establishment inspection report (EIR) from
the USFDA which had certain observations. The company stated that the receipt of
the EIR did not change the existing status of the plants in Maharashtra which are
under USFDA import alert.
 The company faced an import alert for 3 of its manufacturing facilities - Chikalthana
(in November 2013) and both the plants at Waluj (in May 2013) - from the US FDA
due to failure to comply with the manufacturing norm, is still under regulatory
scrutiny.
Wockhardt ranked 35th in the domestic formulations market, with a market share of ~0.3%
as of March 2021 (MAT basis). The company's top therapeutic categories include
vitamins/minerals/nutrients, gastro-intestinals, anti-infectives and respiratory drugs.
International business contributed 83% of total revenue of the company in FY21.
5) Player Profile: Lupin Limited

Lupin (erstwhile Lupin Chemicals) is an innovation led transnational pharmaceutical
company developing and delivering a wide range of branded & generic formulations,
biotechnology products and APIs globally. Lupin was incorporated in 1983 and is based in
Mumbai. Lupin Chemicals Limited merged with Lupin Laboratories Limited in June 2001.
Following this, the name of the merged entity was changed to Lupin Limited.
The company was founded by Dr. Desh Bandhu Gupta. He served as the Chairman of the
company until his demise in June 2017. Ms Vinita Gupta is the CEO of the company. Lupin
had 25 subsidiaries and a joint venture as of March 31, 2021.
The Company has significant presence in the Cardiovascular, Diabetology, Asthama,
Pediatrics, Central Nervous System, Gastro-Intestinal, Anti-Infectives and Nonsteroidal Anti
Inflammatory Drug therapy segments and is a global leader in the Anti-TB and
Cephalosporins segments. The Company along with its subsidiaries has manufacturing
locations spread across India, Japan, the United States, Mexico and Brazil. It has a pipeline
of biosimilars addressing therapies such as oncology, rheumatoid arthritis, ophthalmology,
and osteoporosis. The Company's products include Suprax, Methergine, Methylphenidate,
Antara and Gluconorm, among others.
The company has 15 manufacturing facilities in India, United States, Brazil and Mexico. Of
these, 8 are US FDA approved. Lupin has plant 1 in USA and 2 in Latin America. The
company also has 7 R&D facilities spread across globally. Lupin has maintained a strong
focus on building its R&D capabilities.
Content
 In December 2021, the company announced the launch of diagnostics arm
as Lupin Diagnostics, a wholly-owned subsidiary of the company.
 In fiscal 2021, the company launched 15 products, taking the cumulative launches to
168 products as of Mar’21.
 Lupin tied-up with Eli Lilly, Boehringer for anti-diabetics and with MSD for pneumonia
vaccines.
 In August 2020, the company launched Favipiravir drug under the brand name
'Covihalt' for the treatment of patients with mild to moderate COVID-19 symptoms.
Equity infusion of Rs 1.4 million was done by the company during the year. The equity share
capital was Rs. 907.4 million in FY21 as against Rs. 906 in FY20.
 In December 2021, USFDA issues Establishment Inspection Report (EIR) and
classified Goa facility as Voluntary Action Indicated.
 In September 2021, Goa plant got 7 form 483 observations from USFDA.
 In November 2020, Lupins Somerset facility in New Jersey recieved 13 observations
from USFDA
 In October 2019, the company received establishment inspection report (EIR) from
US FDA for its Nagpur facility in Maharashtra. The inspection was
concluded between August 5-8, 2019.
 In September 2019, the company received warning letter from US FDA for
its Mandideep unit-1 facility in Madhya Pradesh.
 In August 2019, the company received establishment inspection report (EIR) from
US FDA for its Aurangabad facility in Maharashtra. The facility is involved in the
manufacturing of oral solid dosage, oral liquid and powder for oral suspension
products for the US Market, WHO/Global Institution markets and Indian market.
 In May 2019, US FDA classified the inspection of the company's Goa facility as OAI
(Official action indicated).
company including Lupin accusing them for inflating prices of generic drugs.
Lupin is the 3rd largest player in the domestic market, with a 4% market share, as of March
2021. Sales from the chronic and semi-chronic segments accounted for 65.4% and Acute
sales constituted 34.6% of the overall revenues.

Portfolio mix
6) Player Profile: Cipla Ltd
Overview/Background
The late Dr. K A Hamied launched Cipla as Chemical, Industrial & Pharmaceutical
Laboratories in 1935. Its first set of products came out in 1937. It manufactures both active
pharmaceutical ingredients (API) and formulations. The key therapeutic categories include
respiratory, urology and cardiology, among others. Cipla is one of the largest manufacturers
of anti-retrovirals (Anti-HIV) in the world. Cipla is predominantly a formulations player
(formulations contributed about ~96% of the overall revenues in 2020-21) with presence in
over 80 countries in Africa, the Middle East, Europe, America, and Asia.
In the past, the company has largely focused on launching of generics drug products as both
single ingredient and fixed dose combinations as well as in new drug delivery systems and
devices. The company has achieved reasonable success in new drug delivery systems
(NDDS), especially in the anti-asthma segment. In order to boost the company's ability to
target research into new therapy areas, it had started an investment division called Cipla
New Ventures, which aims to invest in companies that may have promising products within
biologicals, regenerative medicine and consumer health space.
Cipla has 46 state-of the art manufacturing facilities as of March 2021, of which 7 are API
facilities, 35 are formulation facilities and 2 are pilot facilities. The facilities are located across
the states of Maharashtra, Goa, Madhya Pradesh, Karnataka, Himachal Pradesh and
Sikkim.
Content
 Recent/Key Developments
 Business Profile
 Capital market information
 Other Details
Recent/Key Developments
 In June 2020, Cipla introduced a generic medicine remedesivir under brand name
Cipremi
 In November 2020, Cipla entered a pact with Belgium-based Multi-G to distribute 10-
minute COVID-19 antibody test kit under the brand name COVI-G across countries.
 During the year, the company Signed exclusive marketing deal with Reliance Life
Sciences for Omalizumab for severe allergic asthma and urticaria.
Equity infusion done
The company witnessed Equity infusion of Rs 0.4 million during the year. In FY21, equity
share capital was Rs.16.13 billion.
Regulatory Developments
 In February 2020, the company received warning letter from US FDA for its Goa
facility.
 In May 2020, the company's manufacturing facility in Bommasandra,
Bangalore received the EIR from US FDA

Crisil Report On Pharmaceuticals

Uploaded by

Document Information

Original Description:

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Crisil Report On Pharmaceuticals

Uploaded by

Copyright:

Available Formats

Crisil Report on Pharmaceuticals

Note: All units are in US $ bn, P- Projected

Note: Units are in US $ bn, E: Estimated, P: Projected

India's pharmaceutical exports: Share in regulated markets (FY21)

Source: CRISIL Research, DGCIS

Source: CRISIL Research, DGCIS

Source: US FDA, CRISIL Research

Source: US FDA, CRISIL Research

Source: World Bank

Source: Centre for Medicare and Medicaid Services, CRISIL Research

Source: Industry, CRISIL Research

Source: US FDA, CRISIL Research

Source: US FDA, CRISIL Research

Source: US FDA, CRISIL Research

Source: US FDA, CRISIL Research

Source: US FDA, CRISIL Research

Share of countries in bulk drug exports

Source: DGCIS, CRISIL Research

Renewed regulatory interest a positive for the sector

Source: PIB Delhi

Source: USFDA, CRISIL Research

Note: Active, Type II DMFs considered

However, dependence on Chinese imports (key starting materials / intermediates) is likely to

Note: E: Estimated, P: Projected

Source: World Bank

Note: P: Projected, E: Estimated

Note: E: Estimated; P: Projected

Source: CRISIL Research

2) Player Profile: Sun Pharmaceuticals Industries Ltd

3) Player Profile: Pfizer India Ltd

4) Player Profile: Wockhardt Ltd

Wockhardt has formulation products in segments such as anti-infectives, cardiology,

5) Player Profile: Lupin Limited

Source: CRISIL Research

You might also like