INDIAN PHARMACEUTICAL INDUSTRY

India is known as the Pharmacy of the World.

India is the largest provider of Generic Drugs.

Currently third in pharmaceutical production by volume after evolving over time.

Major Segment of Indian Pharm Industry are Generic Drugs, OTC drugs, Bulk Drugs, Vaccines, Contract
Research and Manufacturing, Biosimilar and Biologics are some major segment.

500 API Producer 8%worldwide API Market.

India Supplies 50% of global demand for various Vaccines, 40% of Generic drugs in USA and 25% of all
medicines in UK.

India has approx. 3000 drug companies and almost 10500 Manufacturing units.

80% anti-retroviral drug (AIDS Therapy) used globally to combat AIDS are supplied by Indian Pharmaceutical
firms.

Indian pharmaceutical firms are Third largest in World in terms of volume and 14 th largest in Value.

IPM contributes around 1.72% of Country’s GDP.

IPM estimated to reach US$ 130 Billion by the end of 2030.

Global Market Size is US$ 1 Trillion in 2023.

2024 – 65 billion.

2047- US$ 450 Billion

20% of global export in Generic drugs are met by India.

India’s Hospital market is US$ 98.98 Billion in FY 23 and projected to grow 8% CAGR to reach US$193.59
Billion by FY 32.

India is top 12 in biotechnology area and 3rd largest destination in Asia pacific. India’s bioeconomy was valued
at US$ 137 billion, and aims to achieve US$ 300 billion mark by 2030.

During FY18 to FY23, the Indian pharmaceutical industry logged a compound annual growth rate (CAGR) of
6-8%, primarily driven by an 8% increase in exports and a 6% rise in the domestic market.

The Indian pharmaceutical industry has seen a massive expansion over the last few years and is expected to
reach about 13% of the size of the global pharma market while enhancing its quality, affordability, and
innovation.

India is the 3rd largest producer of API accounting for an 8% share of the Global API Industry. About 500+
different APIs are manufactured in India, and it contributes 57% of APIs to prequalified list of the WHO.
 The current market size of the medical devices sector in India is estimated to be US$ 11 billion and its share in
the global medical device market is estimated to be 1.5%. The government has set ambitious target to boost the
medical devices industry in India, aiming to elevate it from its current US$ 11 billion valuation to US$ 50
billion by 2030.

India has 20% share of global supply of generic medicines by volume.

The pharmaceutical exports from India reach more than 200 nations around the world, including highly
regulated markets of the USA, West Europe, Japan, and Australia. India supplied around 45 tonnes and 400
million tablets of hydroxychloroquine to around 114 countries globally.

India’s exports of Drugs & Pharmaceuticals stood at US$ 27.9 billion during FY24 and US$ 7.2 billion in FY25
(April-June).

Exports of Drugs & Pharmaceuticals were estimated to be at US$ 2.13 billion in January 2024, accounting for
5.8% of the total exports in the month.

India is the 12th largest exporter of medical goods in the world. Indian drugs are exported to more than 200
countries in the world, with US being the key market. Generic drugs account for 20% of the global export in
terms of volume, making the country the largest provider of generic medicines globally. Indian drug &
pharmaceutical exports stood at US$ 25.36 billion in FY23, US$ 24.60 billion in FY22 and US$ 24.44 billion in
FY21.

INVESTMENTS AND RECENT DEVELOPMENTS

 Sanofi announced its plans to invest US$ 435 million over the next six years to expand its global capability
center (GCC) in Hyderabad, India by increasing the headcount and further developing the facility.

 As of 30th June 2024, the Department for Promotion of Industry and Internal Trade (DPIIT) has
recognized a total of 1,40,803 entities as startups, of which 2,127 are from the pharmaceutical sector.

 In March 2024, Union Minister for Chemicals & Fertilizers and Health & Family Welfare Dr. Mansukh
Mandaviya inaugurated 27 greenfield bulk drug park projects and 13 greenfield manufacturing plants for
medical devices.

 Cipla received approval from the Central Drugs Standard Control Organization (CDSCO) to market the
novel antibiotic plazomicin in India for the treatment of complicated urinary tract infections (cUTI)
affecting approximately 150 million patients each year.

 In November 2023, Lupin Ltd. unveiled the world’s first fixed-dose triple combination drug for
managing chronic obstructive pulmonary disease (COPD).

 In October 2023, Glenmark Pharmaceuticals introduced Zita, a cost-effective triple combination drug for
Type 2 diabetes treatment, enhancing glycaemic control in diabetic patients.

 Prime Minister Mr. Narendra Modi during his Independence Day 2023 speech said that the government
has plans to increase the number of 'Jan Aushadhi Kendras' from 10,000 to 25,000.

 The Department of Pharmaceuticals will soon launch the Scheme for the Promotion of Research and
Innovation in Pharma (PRIP) MedTech Sector. The scheme has been approved by the Union Cabinet for
a period of five years starting from 2023-24 to 2027-28 with a total outlay of Rs. 5,000 crore (US$ 604.5
million).
  Emcure Pharmaceuticals Limited (EPL) becomes the first ever company to launch Orofer FCM 750, a
new extension of its parenteral iron brand containing Ferric carboxymaltose (FCM). The dose is suitable
for the majority of Indian patients with iron deficiency and iron deficiency anaemia.

 Glenmark Pharmaceuticals Ltd. (Glenmark), an innovation-driven, global pharmaceutical company, is

the first to launch a unique I.V. injection formulation, Akynzeo I.V., in India for the prevention of
chemotherapy-induced nausea and vomiting (CINV), under an exclusive licensing agreement with
Helsinn, a Swiss biopharma group company.

 BDR Pharmaceutical launched the first generic apalutamide (brand name Apatide) in India to treat both
metastatic castration sensitive prostate cancer as well as non-metastatic castration resistant prostate
cancer. The product will be available across India.

 Eli Lilly introduces Ramiven in India, for certain high-risk early breast cancer patients in November
2022.

TOP PHARMA COMPANIES IN INDIA

The Indian pharmaceutical industry supplies 50% of all pharmaceuticals used worldwide. India provides 25% of
all pharmaceuticals in the UK and over 40% of generic drugs in the US.

The domestic Indian market is served by more than 3000 pharmaceutical businesses and 11000 manufacturing
facilities.

The domestic pharmaceutical market in India is currently estimated to be worth $42 billion. The market size of
this industry will reach the $65 billion level by the end of 2024, and the $130 billion mark by 2030. After
Covid, the pharmaceutical export market will similarly have a 3 to 5 times increase in value over the next 5
years.

Sun Pharmaceutical Industries Ltd

Sun Pharmaceuticals is the largest pharmaceutical company from India and the fifth largest specialty generic
company in the world.

Its businesses include producing generics, branded generics, speciality, over the counter (OTC) products, anti-
retrovirals (ARVs), active pharmaceutical ingredients (APIs) and intermediates in the full range of dosage
forms. It also produces specialty APIs.

In January 2024, Sun Pharmaceuticals and Bayer inked a deal to market and distribute in India a second brand
of Finerenone, a patented medicine which aims to reduce the risk of various complications in adult patients with
chronic kidney disease linked to type 2 diabetes mellitus.

In January 2024, Sun Pharmaceuticals and Taro Pharmaceutical Industries Ltd. reached a definitive merger
agreement, with Sun Pharma set to acquire all outstanding ordinary shares.

Main therapeutic areas Anti-infectives; cardiology; dermatology; diabetology; gastroenterology; gynaecology;

nephrology; neurology; oncology; ophthalmology; orthopaedic; psychiatry; respiratory; urology

Sales presence** Sun Pharma reports sales in 49 countries in scope.

Sun Pharmaceutical Industries Inc. manufactures, markets and/or distributes more than 192 drugs in the United
States

Number of Countries present – Over 100 countries

Market Cap- 2.73 Trillion

Major Subsidiaries of Sun Pharmaceutical Industries Ltd.

Taro Pharmaceuticals
Taro Pharmaceuticals is a renowned subsidiary of Sun Pharmaceutical Industries Ltd., making a significant
mark in the industry. Founded in 1950, Taro is headquartered in Hawthorne, New York. Specialising in
prescription and over-the-counter pharmaceutical products, the company is prominent in the US, Canada, and
Israel. Its portfolio is rich with products addressing various dermatological conditions. A milestone in Taro’s
journey includes its successful development of high-barrier-to-entry generic medications, solidifying its position
in the pharmaceutical domain. This subsidiary’s product, Topicort (desoximetasone), is a trusted name for
treating a variety of skin conditions, reducing symptoms like swelling, itching, and redness.

Ranbaxy Laboratories
Ranbaxy Laboratories, now a part of Sun Pharma, is a key player in the Indian pharmaceutical arena. Founded
in 1961 and headquartered in Gurgaon, India, Ranbaxy has a strong global presence. Before its acquisition by
Sun Pharma in 2014, it was the largest pharmaceutical company in India. The merger marked a significant
expansion in Sun Pharma’s overall capacity and capabilities, enhancing its global footprint. Ranbaxy has
contributed substantially to the pharma industry with its vast range of generic medicines. Its most famed
product, Caverta (sildenafil citrate), has been a trusted solution for erectile dysfunction, offering effectiveness
and reliability to countless individuals

Major Acquisitions by Sun Pharmaceutical Industries Ltd.

Chattem Chemicals (2008)
Sun Pharmaceutical Industries Ltd. made a significant acquisition in 2008 by acquiring Chattem Chemicals,
Inc., a US-based company renowned for its proficiency in manufacturing and marketing bulk pharmaceuticals,
over-the-counter (OTC) drugs, and original prescription pharmaceuticals. This acquisition enhanced Sun
Pharma’s portfolio, as Chattem Chemicals held an essential place in the production of various active
pharmaceutical ingredients (APIs) and registered several notable milestones in drug manufacturing and
marketing. The company was well-regarded for its commitment to quality and innovation, and its integration
into Sun Pharmaceutical Industries Ltd. led to expansion of Sun Pharma’s global presence, particularly in the
United States.

Dusa Pharmaceuticals (2012)

2012 saw Sun Pharma advancing its strategic expansion with the acquisition of DUSA Pharmaceuticals. DUSA
Pharmaceuticals, a dermatology company, was headquartered in the United States. It was mainly involved in the
development and marketing of Levulan (aminolevulinic acid HCl), a product used in photodynamic therapy
(PDT), and its BLU-U brand phototherapy light source. This acquisition improved Sun Pharma’s already strong
position in dermatology, allowing them to add innovative and complementary products to their extensive
portfolio.

Pola Pharma (2019)

In 2019, Sun Pharmaceutical Industries Ltd. enhanced its dermatological footprint by acquiring Pola Pharma, a
Japanese pharmaceutical company. Pola Pharma was extensively involved in the development, manufacture,
and sale of dermatological products and over-the-counter (OTC) drugs, giving Sun Pharma a broader access to
the Japanese market, the third-largest pharmaceutical market globally. The company’s rich history in innovative
dermatological solutions, including treatments for skin conditions like acne and atopic dermatitis, and its range
of OTC and prescription pharmaceutical products, complemented Sun Pharma’s global dermatology franchise,
enabling the expansion of their portfolio and providing better healthcare solutions to a wider demographic.

26 Speciality products in Portfolio

380+ API Portfolio

Largest Pharmaceutical company in India

13th largest Generic pharmaceutical company in US.

6 Global Rand D Centre

6.7%Rand D spend of total sales in FY24.

Total Income- 498,510 billion INR

Total R&D Spent - 31,776 billion INR.

GLOBAL SPECIALITY BUSINESS

Global Specialty revenues recorded a strong 19.3% growth to reach US$ 1,039 Million. Ilumya sales continued
to do well globally and were up by 21.7% to US$ 580 Million.
The following products were key contributors to the Global Specialty business growth in FY24.

Ilumya/Ilumetri is an IL-23 inhibitor biologic used in the

treatment of adults with moderate-to-severe plaque
psoriasis and who are candidates for systemic therapy or
phototherapy. It is marketed by Sun Pharma directly in
several markets, including in the US, Canada, Australia,
Japan and in Western Europe and China through our
partners. Ilumetri was included in China’s National
Reimbursement Drug List from January 2024.
Winlevi is a first-in-class topical androgen receptor
inhibitor, approved by the US FDA for the topical
treatment of acne vulgaris in patients above the age of
12. Winlevi is the first US FDA-approved acne drug in
nearly 40 years with a first-in-class mechanism of action.
Besides the US, where it is already marketed, Winlevi was
launched in Canada during FY24 and is expected to be
available in Australia from June 2024.

Cequa, indicated for topical ophthalmic use, is the first

and only US FDA-approved cyclosporine treatment
delivered with NCELLTM technology. Cequa, which offers
the highest concentration of cyclosporine for ophthalmic
use approved by the US FDA, is indicated to increase
tear production in patients with dry eye, an inflammatory
disease that afflicts more than 16 Million people in the US.

Research & Development (R&D)

Our R&D investments stood at ₹ 32 Billion, or 6.7% of
overall sales. During the year, we filed approximately
250 formulation dossiers globally. In FY24, the Company
took steps to improve study enrollment for our Global
Specialty pipeline candidates, including creating a clinical
organisation within Sun and hiring key talent to lead the
same. Sun Pharma also continues to scout for external
R&D assets to strengthen the pipeline. R&D spending
is expected to increase as clinical trials for Specialty
products gain traction.

For FY25. We expect to see Sun’s Global Specialty business

continue on its growth path. Our R&D spending has been
on an upward trajectory due to increased clinical study
spending to advance our Global Specialty pipeline. For FY25,
we expect our R&D spend to be in the range of 8-10% of
sales, with an increasing share of spending expected on
Specialty products.

Key Trends and Drivers Shaping the Industry

Global Population Dynamics: Demographic shifts, including ageing populations

and evolving disease profiles, are contributing
to rising demand for pharmaceutical products.
Addressing this demand requires innovative
approaches to meet evolving healthcare needs.

Per Capita Consumption: Regional disparities in per capita consumption

persist, with higher-income countries like Japan
and Western Europe exhibiting double the usage
compared to lower-income regions. For instance,
in 2023, per capita consumption in Japan and
Western Europe was more than double that of
other regions. While consumption will likely rise
across most regions, Africa and the Middle East
face challenges in achieving comparable per capita
consumption. Improvements in per capita use
are slower in lower-income countries, hindering
efforts to improve healthcare access.

Budget Pressure and Cost Management: Payers in developed markets are facing
budget pressures, prompting efforts to curb
drug spending growth. The costs associated
with managing the COVID-19 pandemic and
increased expenditure on novel therapies have
demanded measures to moderate spending. To
this end, sectoral players use strategies such
as promoting generic and biosimilar drugs,
negotiating favourable pricing agreements with
pharmaceutical companies, and implementing
patient cost-sharing arrangements. Balancing cost
management with ensuring access to innovative
treatments remains a critical challenge for
healthcare systems globally.

Therapeutic Area Trends:- in medicine consumption across various

therapy areas, particularly in immunology,
endocrinology, and oncology. These advanced
therapy areas have witnessed significant
growth, driven by expanded patient access to
innovative treatments and advancements in
medical technology. The COVID-19 pandemic
disrupted consumption patterns, leading to
fluctuations in usage which rebounded in 2022
and 2023. This rebound reflects the resilience
of the pharmaceutical market and its ability to
adapt to changing circumstances.

Digital Health Solutions:- analytics has revolutionised the pharmaceutical

landscape, enabling more personalised and
efficient patient care. These technologies
provide valuable insights into patient
behaviour, facilitate clinical trial design, and
optimise supply chain management. Medical
and research professionals increasingly use
telemedicine and artificial intelligence (AI)
for remote diagnosis, personalised treatment
plans, and drug discovery, driving growth
and productivity across the pharmaceutical
value chain.

Impact of Innovative Therapies

Enhanced patient access to innovative
medicines is a crucial driver of increased
usage, particularly in advanced therapy
areas like immunology, endocrinology, and
oncology. Introducing biologic and small
molecule therapies has expanded patient
treatment options, driving up consumption
rates, particularly in developed markets.
These innovative therapies offer targeted
treatment approaches with improved efficacy
and fewer side effects, contributing to their
growing popularity among patients and
healthcare providers.

Speciality Products are those products which have special chemicals and drugs which are used to treat many
complex disease, rare disease.

ILUMETRI :- For treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic
therapy or phototherapy
• Long term clinical data shows that the significant response rate seen in 52 & 64 weeks were maintained over
five years1
• Ongoing Phase-3 trials for Psoriatic Arthritis
• Current Markets include US, Australia, Japan, Canada, Europe (by partner Almirall), China (by partner CMS
holdings)
• Out licensed to Hikma for Middle East & North Africa

WINLEVI:- Topical treatment of acne vulgaris in patients 12 years of age and older
• Results from two pivotal clinical trials showed favorable safety and efficacy data for WINLEVI in patients
with acne aged 12 years
and older2
• Current Markets: US and Canada

LEVULAN
KERASTICK
+ BLU-U:- For photodynamic therapy (treatment) of minimally to moderately thick actinic keratoses of the
face or scalp, or actinic keratoses of
the upper extremities
• First and only PDT approved to treat the face and scalp as well as the upper arms, forearms, and hands3
• Current Markets: US

Sun Pharma’s Global Specialty Pipeline

Deuruxolitinib, Ilumya (tildrakizumab), NidlegyTM, SCD-044

Business mix of Sun pharma:- India 32% and International 68%

INDIA’S BUSINESS

Sun Pharma is India’s largest pharmaceutical company,

holding an 8.5% market share and boasting a formidable
presence in the country’s chronic and acute segments.
With a comprehensive product portfolio spanning diverse
therapeutic segments such as neuropsychiatry, cardiology,
diabetes, gastroenterology, pain/analgesics, gynaecology,
ophthalmology, urology, dermatology, respiratory, antiinfectives,
and more, Sun Pharma addresses a broad
spectrum of healthcare needs.

Breakup Business: Cardiology 17%, Neurosciences 16%, Gastroenterology 12%, Anti-infectives 11%.

Indian Sales Growth:- FY24 = 149 Billion INR.

Sun pharma best product Cardiac Drug formulation Rosuvas, earning over 3.8 billion INR

Volini became the second largest a pain and analgesic formulation.

CIPLA LIMITED:- CIPLA best drug seller was from GIT Drugs and second largest is their Respiratory divison
and CNS divison drugs.

Revenue 25774 Crore INR

1571 CR INR in Research and Development centre.

46 manufacturing facilities in five countries.

FORACORT Ranked 1 In Indian pharmaceutical market.

Dr. Reddy’s Laboratories:- Omez and NISE are the top selling products.

Global generic product segment 254.1 billion indian rupees in fiscal year 2024.

60 active pharmaceutical ingredients.

Revenue 245,579 million INR

R and D investment – 19,381 million INR.

8 R & D facilities.

DIVI’s Laboratories: Revenue 797,431 Lakhs INR

Aurobindo Pharamceuticals

Lupin Pharmaceuticals

Abbott India

Torrent Pharmaceuticals

Zydus Cadilla

MARKET SHARE OF PHARMA COMPANIES

SUN 8.2

ABBOTT 6.2
 CIPLA 5 AUROBINDO 4.4

MACLEODS 3.1

ZYDUS 3.9

LUPIN 3.8

TORRENT 3.2 INTAS 3.1 ARISTO 3 DR REDDY 3, OTHERS 49.6

GLOBAL TOP COMPANIES

 Johnson & Johnson: $85.2 billion
 F. Hoffmann-La Roche Ltd: $66.4 billion
 Merck & Co: $60.1 billion
 Pfizer: $58.5 billion
 AbbVie: $54.3 billion
 Bayer: $51.9 billion
 Sanofi: $46.9 billion
 AstraZeneca: $45.8 billion
 Novartis: $45.4 billion
 Bristol Myers Squibb: $45.0 billion

Pfizer is considered the world's largest research-based pharmaceutical company. Johnson

& Johnson is one of the world's largest biotechnology and pharmaceutical companies, and
is also known for producing consumer health products and medical devices.

US $ 4.7 TRILLION GLOBALLY IS MARKETED BY 50 COMPANIES.

Ranking in second is Denmark’s Novo Nordisk, with a $453 billion market cap.

TOP SELLING DRUGS OF 2024

According to Statista, the top-selling drugs in 2024 are projected to be:

 Keytruda: A cancer drug from Merck & Co., with projected sales of $27.2 billion
 Ozempic: A type 2 diabetes drug from Novo Nordisk, with projected sales of $16.1 billion
 Dupixent: A drug from Sanofi, with projected sales of $13.5 billion
 Eliquis: A drug from BMS/Pfizer, with projected sales of $13.3 billion
 Biktarvy: A drug from Gilead, with projected sales of $12.6 billion
  Darzalex: A drug from Johnson & Johnson, with projected sales of $12 billion
 Opdivo: A drug from Bristol Myers Squibb/Ono Pharmaceutical, with projected sales of $11.3 billion
 Comimaty: A drug from Pfizer/BioNTech, with projected sales of $10.8 billion
 Gardasil: A drug from Merck/CSL, with projected sales of $10 billion
 Skyrizi: A drug from AbbVie, with projected sales of $9.9 billion

INDIA’S TOP SELLING DRUGS

Some of the top-selling drugs in India in 2024 include:

 Augmentin
An antibiotic drug from GSK that was a top-selling medicine brand in May and September 2024
 Glycomet GP
An anti-diabetic drug from USV that was a top-selling medicine brand in May 2024
 Monocef
An antibiotic drug from Aristo that was a top-selling medicine brand in September 2024

The United States is the world's largest pharmaceutical market, with a market share of
around 44% in 2023. China is the second largest market, with a market share of around
7%. Other major players include:
 Japan: The third largest market
 Germany: The fourth largest market
 France: The fifth largest market
 United Kingdom: The sixth largest market
 India: The seventh largest market
 Italy: The eighth largest market
 Spain: The ninth largest market
 Canada: The tenth largest market