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SCHOOL OF MANAGEMENT ACADEMIC SESSION:

2023-2025
SEMESTER: 2ND
SUBJECT CODE: SM6882
SEMINAR AND TECHNICAL WRITTING

NAME – PARITOSH MISHRA

ROLL NO: 323SM1072


EMAIL: paritosh.mishra26@gmail.com

INDUSTRY: PHARMACEUTICALS INDUSTRIES

SUBMITTED TO: DR. TANUJ NEGI


Introduction:
The pharmaceutical industry stands as a cornerstone of global healthcare, playing a vital role in
improving human health. This introduction shows the workings of this industry, exploring its
multifaceted nature, its profound impact on human well-being, its key components, and the
broader landscape in which it operates.

The pharmaceutical industry serves the human health, relentlessly pushing the boundaries of
medicine through research, development, manufacturing, and distribution of life-saving drugs
and treatments. It is a constantly evolving force, dedicated to combating diseases, minimising
suffering, and improving the quality of life for people across the globe.

The pharmaceutical industry encompasses a diverse range of activities. From research in


laboratories to meticulous quality control in manufacturing plants, this industry works tirelessly
to bring forth medications that address a vast array of medical needs. Whether it's developing
vaccines to prevent infectious diseases or creating life-changing therapies for chronic conditions,
the pharmaceutical industry is at the forefront of medical advancement.

Challenges and Opportunities:


The pharmaceutical industry operates in a complex and ever-changing environment. Challenges
such as drug discovery costs, regulatory hurdles, and counterfeit medications demand constant
innovation and adaptation. However, advancements in biotechnology, personalized medicine,
and digital health technologies offer exciting opportunities for the future of healthcare.

This introduction provides a foundational understanding of the pharmaceutical industry, its


significance in the global healthcare landscape, and the multifaceted nature of its operations. We
will delve deeper into the various aspects of this industry, exploring its challenges and
opportunities, its key players, and its enduring impact on human well-being.

Dominant Players in the Pharmaceutical Industry


The pharmaceutical industry is a global marketplace with a complex web of dominant players.
Here's a breakdown of the landscape:

Globally:

 Big Pharma: This term refers to the established multinational pharmaceutical companies with a
significant market share. Some of the leading names include:
o Pfizer (US)
o Johnson & Johnson (US)
o Roche (Switzerland)
o Novartis (Switzerland)
o Merck & Co. (US)
o AbbVie (US)
o AstraZeneca (UK/Sweden)
o Sanofi (France)

Nationally (India):

Sun Pharma (India): As your company, Sun Pharma is a major force in the Indian
pharmaceutical industry. It's the largest by market capitalization and a prominent player globally
in generic drugs. Having cap size of 3.90 trillion INR

 Current share price is about 1625 INR


 Other Indian Pharmaceutical Companies: Alongside Sun Pharma, several other Indian
companies are making their mark nationally and internationally.
 Sun Pharma is one of the top players in Indian as well as global markets. The pharma market is
fragmented. And according to media reports, the company holds about 8.2% market share in
India. This is one of the largest (pharma) players in the country.

 These include:
o Cipla
o Dr. Reddy's Laboratories
o Lupin
o Torrent Pharmaceuticals
o Divi's Laboratories

The Competitive Landscape:

While the landscape is dominated by established players, there are interesting dynamics at play:

 Emerging Markets: Companies from emerging markets like India are gaining ground in
generics production, making medications more affordable globally.
 Biotechnology and Specialty Drugs: Innovation in areas like biotechnology and specialty drugs
is leading to the rise of new players focused on niche markets.

Sun Pharma's Position:


Sun Pharma holds a strong position in the Indian market and is a well-established player in the
global generics market. Here are some areas where Sun Pharma can leverage its strengths:

 Cost-Effectiveness: Maintaining its edge in producing affordable generic drugs.


 Product Portfolio: Expanding its product portfolio to cover a wider range of therapeutic areas.
 Research & Development: Investing in R&D to develop innovative new drugs and stay ahead
of the curve.
By focusing on these areas, Sun Pharma can solidify its position as a dominant player in the
global pharmaceutical industry.

Sun Pharma's News by MONEYCONTROL.COM in the


2024

Buy Sun Pharmaceuticals; target of Rs 1827: KR Choksey


KR Choksey is bullish on Sun Pharmaceuticals has recommended buy rating on the stock with a
target price of Rs 1827 in its research report dated March2024.

Sun Pharma gets regulatory nod in Australia for acne treatment cream

Sun Pharma hits 52- week high on USFDA all-clear to Ankleshwar unit

Strong India growth, benign price erosion in the US drive Q3 earnings for Indian pharma
Indian generic companies have benefited from the continuing shortages and approval slowdown
in the US....

Diabetes, BP drugs to cost less as NPPA fixes retail prices of 69 formulations


Various drugs manufactured by listed players like Sun Pharmaceuticals, Alkem Laboratories,
Cipla Ltd, Mankind Pharma,

Sun Pharma, Lupin, Alkem recall products from US market


Sun Pharma is recalling 54,960 bottles of Mesalamine Extended-Release Capsules, an anti-
inflammatory medicine used to treat a type of bowel disease ..
Pharmaceutical Regulations by Indian Government ;
The Indian government implements a comprehensive set of regulations to ensure the safety,
efficacy, affordability, and quality of pharmaceuticals within the healthcare system. Here's a
breakdown of the key regulatory bodies and aspects covered:

 Central Drugs Standard Control Organization (CDSCO): The primary national regulatory
body for pharmaceuticals in India. The CDSCO is responsible for:
o Drug approvals and registrations
o Clinical trial regulations
o Good Manufacturing Practices (GMP) compliance
o Pharmacovigilance (drug safety monitoring)
 Department of Pharmaceuticals (DoP): Formulates policies and promotes the growth of the
pharmaceutical industry in India. The DoP is involved in:
o Pricing policies for essential drugs
o National Pharmaceutical Policy (NPP) development
o Promoting research and development (R&D)
Key Regulatory Aspects:
 Drugs and Cosmetics Act, 1940 (DCA): The foundation for drug regulation in India, covering
aspects like:
o Drug licensing and manufacturing
o Import and export controls
o Quality standards
o Drug labeling and advertising
 National Pharmaceutical Pricing Authority (NPPA): Regulates the prices of essential drugs to
ensure affordability. The NPPA sets:
o Ceiling prices for essential drugs
o Trade margins for retailers and wholesalers
 Clinical Trial Regulations: Govern the conduct of clinical trials for new drugs in India. These
regulations ensure:
o Protection of research participants
o Ethical conduct of clinical research
o Data integrity and transparency
Recent Developments:
 National Pharmaceuticals Policy 2023 (Draft): A draft policy outlining the government's
vision for the pharmaceutical industry. It focuses on:
o Fostering R&D and innovation
o Promoting self-reliance in API (Active Pharmaceutical Ingredient) manufacturing
o Strengthening regulatory efficiency and transparency
Impact on Sun Pharma:

These regulations significantly impact Sun Pharma's operations. Here are some examples:
 Compliance with CDSCO regulations is essential for Sun Pharma to manufacture and
market drugs in India.
 NPPA price controls can affect Sun Pharma's profit margins on essential drugs.
 Changes in clinical trial regulations can impact the timelines and costs associated with
developing new drugs.

By staying updated on the latest regulations and actively engaging with regulatory bodies, Sun
Pharma can navigate the Indian pharmaceutical landscape effectively.

Sun Pharma reports full year and Q4 results for FY23

Full Year FY23 Gross Sales up 12.6% YoY, EBITDA up 12% & Adjusted Net Profit up 12.8%
Q4 Gross Sales up 14.3% YoY, EBITDA up 19.7% & Adjusted Net Profit up 36.3%
Highlights of FY23 consolidated financials

• Gross sales at Rs. 432,789 million, growth of 12.6% over same period last year
• India formulation sales at Rs. 136,031 million, up 6.6% over same period last year • US
formulation sales at US$ 1,684 million, up 10.3% over same period last year
• Global specialty sales at US$ 871 million, up 29% over same period last year • Emerging
Markets formulation sales at US$ 983 million, up 8.6% over same period last year
• Rest of World formulation sales at US$ 752 million, up 2.7% over same period last year •
R&D investments at Rs. 23,676 million compared to Rs. 22,194 million for FY22
• EBITDA at Rs. 116,468 million up 12% over same period last year. EBITDA margin for FY23
at 26.5% vs 26.9% for same period last year.
• Reported net profit for FY23 was Rs. 84,736 million compared to Rs. 32,727 million for FY22
• Excluding the exceptional items, adjusted net profit for FY23 was Rs. 86,450 million, up
12.8% over same period last year

Highlights of Q4FY23 consolidated financials

• Gross sales at Rs. 107,256 million, growth of 14.3% vs Q4 last year


• India formulation sales at Rs. 33,641 million, up 8.7% vs Q4 last year
• US formulation sales at US$ 430 million, up 10.5% vs Q4 last year
• Global specialty sales at US$ 244 million, including US$6.8 million milestone received in Q4.
Ex-milestone, up 28% vs Q4 last year
• Global specialty sales, ex-milestone, accounted for 18.2% of Q4FY23 overall sales
• Emerging Markets formulation sales at US$ 221 million, up 7.5% vs Q4 last year
• Rest of World formulation sales at US$ 191 million, up 7.4% vs Q4 last year
• R&D investments at Rs. 6,657 million compared to Rs. 5,433 million for Q4 last year
• EBITDA at Rs. 28,021 million, up 19.7% vs Q4 last year. EBITDA margin for Q4 at 25.6% vs
24.8% for Q4 last year. • Reported net profit for Q4FY23 was Rs. 19,845 million compared to
net loss Rs. 22,773 mn for Q4 last year.
• Excluding the exceptional items, adjusted net profit for Q4FY23 was Rs. 21,559 million, up
36.3% over Q4 last year. These results were taken on record by the Board of Directors at a
meeting held today. The Board has proposed a final dividend of Rs. 4.00 per share for the year
FY23. This is in addition to the interim dividend of Rs. 7.5 per share paid in FY23, taking the
total dividend for FY23 to Rs. 11.5 per share compared to Rs. 10 per share for FY22.
Dilip Shanghvi, Managing Director of the Company said, “I am pleased with well-rounded
growth demonstrated in FY23 by the company. Several of our businesses including Specialty,
India and Emerging markets have continued to progress well. Our Specialty business remains on
growth path and we are committed to continue scaling it up. Acquisition of Concert helps further
strengthen our portfolio in dermatology. I believe deuruxolitinib can become a leading product to
address highly unmet need in alopecia areata patients.”

DOMINANT PLAYERS
The pharmaceutical industry is a global marketplace with a complex web of dominant players.
Here's a breakdown of the landscape, categorized by major regions:

North America

 Johnson & Johnson (US): A diversified healthcare company with a significant pharmaceutical
segment, focusing on areas like immunology, oncology, and neuroscience.

Johnson & Johnson company logo

 Merck & Co. (US): Renowned for its research-driven approach, Merck develops innovative
drugs in areas like oncology, infectious diseases, and vaccines.

Merck & Co. company logo

Europe
 Roche (Switzerland): A global leader in pharmaceuticals and diagnostics, with a strong focus
on oncology, neuroscience, and ophthalmology.

Roche company logo

 Novartis (Switzerland): Another Swiss pharmaceutical giant, Novartis has a presence across
various therapeutic areas, including oncology, hematology, and ophthalmology.

Novartis company logo

 Sanofi (France): A major pharmaceutical company in Europe, Sanofi excels in areas like
diabetes, vaccines, and rare diseases.

Sanofi company logo

 AstraZeneca (UK/Sweden): This multinational pharmaceutical company focuses on areas like


oncology, cardiovascular disease, and respiratory diseases.
AstraZeneca company logo

Asia

 Sun Pharmaceutical Industries Ltd. (India): The top pharmaceutical company in India by
market capitalization, Sun Pharma is a major player in the global generics market.

Sun Pharmaceutical Industries Ltd. company logo

 Cipla (India): A leading Indian pharmaceutical company known for its affordable generic drugs
across various therapeutic areas.

Cipla company logo

Other Notable Players


 Several other companies play a significant role in the global pharmaceutical industry, including:
o Eli Lilly and Company (US)
o Bristol Myers Squibb (US)
o Gilead Sciences (US)
o Takeda Pharmaceutical Company (Japan)

Competitive Landscape Dynamics


The pharmaceutical industry is characterized by:

 Mergers and Acquisitions: Companies often merge or acquire rivals to expand their market
reach, product portfolio, and R&D capabilities.
 Focus on Innovation: High investments in research and development to bring forth new drugs
and therapies for unmet medical needs.
 Patent Expirations: When patents on brand-name drugs expire, generic manufacturers can
create lower-cost versions, impacting revenue for brand-name companies.
 Regulation: Stringent government regulations regarding drug development, testing, approval,
and pricing significantly impact the industry.

Future Outlook

The pharmaceutical industry is expected to experience continued growth, driven by factors like:

 Aging population: As the global population ages, the demand for medications to treat chronic
diseases is likely to increase.
 Emerging markets: Growing economies in Asia and other regions will fuel the demand for
affordable healthcare solutions.
 Technological advancements: Advancements in biotechnology, personalized medicine, and
artificial intelligence (AI) hold immense potential for developing new drugs and improving
healthcare delivery.

Staying updated on the latest trends, challenges, and opportunities will be crucial for
pharmaceutical companies to maintain their dominant positions in the ever-evolving global
marketplace.

ECONOMIC TREND

o Growth: The pharmaceutical industry is expected to see continued growth, driven by factors like
an aging population and rising demand for affordable healthcare solutions. However, factors like
inflation and rising interest rates could impact investment and consumer spending.
o Pricing Pressures: Governments around the world are increasingly looking to control healthcare
costs, which can put pressure on pharmaceutical companies' pricing strategies for both branded
and generic drugs.
o Emerging Markets: Growth in emerging markets like India and China presents a significant
opportunity for pharmaceutical companies, particularly in generics.
o Supply Chain Disruptions: Global supply chain disruptions can affect the availability and cost
of raw materials needed for drug manufacturing.
 Legal and Regulatory Environment: The pharmaceutical industry is heavily regulated to
ensure the safety and efficacy of drugs. Here are some key areas to consider:
o Patent Laws: Changes in patent laws can impact a company's ability to protect its intellectual
property and revenue streams from branded drugs.
o Drug Approval Processes: Streamlining or tightening drug approval processes can affect the
speed and cost of bringing new drugs to market.
o Antitrust Regulations: Regulations are in place to prevent anti-competitive practices within the
pharmaceutical industry.
 Technological Advancements: The pharmaceutical industry is constantly evolving with new
technologies. Here are some areas of interest:
o Biotechnology: Advancements in biotechnology are leading to the development of new drugs
and therapies, such as personalized medicine.
o Artificial Intelligence (AI): AI is being used in drug discovery, clinical trials, and healthcare
delivery, with the potential to improve efficiency and accuracy.
 Sun Pharma's Specific Situation: As a leading Indian pharmaceutical company, Sun Pharma is
impacted by the trends mentioned above. Here are some additional points to consider:
o Sun Pharma's Generics Focus: Sun Pharma's strength lies in generic drugs. The growth of the
generics market, particularly in emerging economies, is a positive factor.
o Investment in R&D: Sun Pharma's investment in research and development for new drugs and
its ability to adapt to changing regulations will be crucial for its future success.

SUMMARY
Sun Pharmaceutical Businesses Ltd. (Sun Pharma), the best Indian pharmaceutical company by
showcase capitalization, may be a unmistakable player within the worldwide generics showcase.
This report gives a preview of Sun Pharma's commerce, its working environment, and future
prospects.

Key Discoveries:

Strong Budgetary Execution:


Sun Pharma enjoys a driving position within the Indian pharmaceutical advertise and
encompasses a noteworthy worldwide nearness. Analyze monetary information from yearly
reports to get it benefit, income development, and showcase capitalization.
Legitimate and Administrative Scene:
Exacting directions by Indian government bodies like CDSCO, DoP, and NPPA affect Sun
Pharma's operations. Remain overhauled on changes in medicate estimating approaches, clinical
trial controls, and obvious laws (allude to "Pharmaceuticals wellbeing care control by Indian
government" segment for subtle elements).
Diverse Product Portfolio:
Sun Pharma offers a wide run of nonexclusive drugs over different helpful zones. Their center on
claim to fame drugs may be a potential driver for future development. Analyze yearly reports and
news articles to get it their item portfolio and R&D speculations.
Development Methodologies:
Sun Pharma's methodologies for growing it’s advertise share locally and globally are vital for its
proceeded victory. Inquire about their plans for geological extension, item advancement, and
advertise entrance.
Future Viewpoint:
The generics market in rising economies presents a critical opportunity for Sun Pharma. Be that
as it may, challenges like competition, estimating weights, and innovative progressions require
vital route.
Sources of Information:
 Sun Pharma Annual Reports: https://sunpharma.com/investors-annual-reports-presentations/
 Investor Presentations: https://sunpharma.com/investors-annual-reports-presentations/
 Government of India Websites (Ministry of Finance, Department of Pharmaceuticals)
(https://finmin.nic.in/)
 Industry News Articles https://www.moneycontrol.com/company-article/sunpharma/news/SPI
 Legal Databases (https://pharmaceuticals.gov.in/)

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