STW Report
STW Report
STW Report
2023-2025
SEMESTER: 2ND
SUBJECT CODE: SM6882
SEMINAR AND TECHNICAL WRITTING
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.
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
These include:
o Cipla
o Dr. Reddy's Laboratories
o Lupin
o Torrent Pharmaceuticals
o Divi's Laboratories
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 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....
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.
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
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.
Merck & Co. (US): Renowned for its research-driven approach, Merck develops innovative
drugs in areas like oncology, infectious diseases, and vaccines.
Europe
Roche (Switzerland): A global leader in pharmaceuticals and diagnostics, with a strong focus
on oncology, neuroscience, and ophthalmology.
Novartis (Switzerland): Another Swiss pharmaceutical giant, Novartis has a presence across
various therapeutic areas, including oncology, hematology, and ophthalmology.
Sanofi (France): A major pharmaceutical company in Europe, Sanofi excels in areas like
diabetes, vaccines, and rare diseases.
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.
Cipla (India): A leading Indian pharmaceutical company known for its affordable generic drugs
across various therapeutic areas.
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: