This PPT contains complete analysis of Pharmaceutical Industry including worldwide and nationwide picture, leading organizations, SWOT analysis, Government policies and regulations, challenges and solutions.

1. BUSINESS ENVIRONMENT
INDUSTRY ANALYSIS
PHARMACEUTICAL INDUSTRY
DEPARTMENT OF COMMERCE
MASTER OF BUSINESS ADMINISTRATION
UNIVERSITY COLLEGE OF COMMERCE AND BUSINESS MANAGEMENT
KAKATIYA UNIVERSITY ( 2020-2022)

2. S.no. Hall ticket no. Name of the student
1. 21564C1022 A. Hindu
2. 21564C1106 Abhishek
3. 21564C1154 S. Vinay
4. 21564C1148 B. Preethi
5. 21564C1023 B. Ramya Sree
6. 21564C1105 S. Chidvilas Pavan
7. 21564C1143 Meharaj
8. 21564C1002 K. Sagar
9. 21564C1109 P. Deepika Reddy
10. 21564C1016 Ajith
11. 21564C1107 T. Akhil Kumar

3. Table of contents
1. Introduction
2. Meaning and definition
3. Origin and growth
4. Worldwide picture and nationwide picture
5. Leading organizations – Strategies
6. SWOT Analysis
7. Government Policy and regulations
8. Challenges and solutions
9. Conclusion

4. Introduction
• India is called the Pharmacy of the world.
• In India there are 3000 drug companies and 10500 manufacturing
units.
• The word pharmacy comes from the Greek word ‘pharmakeia’.
• Father of Pharmaceutical Industry is William Procter Jr.

5. • The pharmaceutical industry discovers, develops, produces and markets drugs or
pharmaceutical drugs for use as medications. Pharmaceutical companies may deal in generic
or brand medications and medical devices. They are subject to a variety of laws and
regulations that govern the patenting, testing, safety, efficacy and marketing of drugs.
• Pharmaceutical industry is engaged with manufacturing of API ( Active Pharmaceutical
Ingredients) Drug i.e. pharmaceutical dosage form (tablet, capsule, suspension, emulsion,
parenteral preparation etc.) as well as medical devices.
Definitions:

6. Types of Drugs
Branded drugs Generic drugs
Prescription drugs
Over the counter
(OTC) drugs
2. Based on the nature of disposal
1. Based on the nature of development

7. Origin :
• The roots of the pharmaceutical industry lie back with the apothecaries and pharmacies that
offered traditional remedies as far back as the middle ages.
• Originating as a pharmacy founded in Darmstadt in 1668.
• Merck in Germany was possibly the earliest company to move in the
direction of rationalism and experimentation.
• It was only in the middle of the 19th century that Beecham became
involved in the industrial production of medicine, producing
patented medicine from 1842, and the world’s first factory for
producing only medicines in 1859.
• Pfizer an American(USA) company was founded in 1849
• Pfizer was initially into the chemicals business.
• Their business expanded rapidly during the American civil war as
demand for painkillers and antiseptics rocketed.

8. • It wasn’t just Swiss companies that had their roots in the dye trade.
• Bayer was founded in 1863 as a dye maker.
• It later moved into medicines, commercialising aspirin around the turn of the 20th century,
one of the most successful pharmaceuticals ever at that point.
Origin of pharmaceutical industry in India
• The evolution of pharmaceutical sector in India may be set into four stages.
A. First stage : before 1970
B. Second stage : 1970-1990
C. Third stage : 1990-2010
D. Fourth stage : 2010-now
• In 1930, in Calcutta the first pharmaceutical company named Bengal chemical and
pharmaceutical works was established. It is the government owned company.
• Today, India has gained immense importance in the pharmaceutical domain.

9. GROWTH OF PHARMACEUTICAL INDUSTRY
 The factors that affect the pharmaceutical
market size include disease prevalence, drug
affordability, consumer attitudes, government
policies and some supply-side factors:
 The global pharmaceuticals market was worth
$935 billion in 2017 and will reach $1170
billion in 2021, growing at 5.16%, according to
a recent pharma market research report by
The Business Research Company.

10. GROWTH IN INDIA
 In 1969, Indian pharmaceuticals had a 5% share in the domestic market and global pharma
had a 95% share. By 2020, Indian pharma has almost 85% share.
 India's pharmaceutical industry, which is currently valued at $41 billion, is expected to grow
to $65 billion by 2024 and $120-130 billion by 2030.
 Innovation-led research and development, healthcare delivery (R&D), manufacturing and
supply chain, and market access are the opportunities.
 India ranks 3rd worldwide for pharmaceutical production by volume and 14th by value. The
country has an established domestic pharmaceutical industry, with a strong network of 3,000
drug companies and 10,500 manufacturing units.

11.  Indian pharmaceutical sector supplies over 50% of the global demand for various vaccines,
40% of the generic demand for US and 25% of all medicines for UK.
 India contributes the second largest share of pharmaceutical and biotech workforce in the
world.
 India’s domestic pharmaceutical market turnover reached Rs. 1.4 lakh crore (US$ 20.03
billion) in 2019, up 9.8% y-o-y from Rs. 1.29 lakh crore (US$ 18.12 billion) in 2018.
 In May 2020, pharmaceutical sales grew 9% y-o-y to Rs. 10,342 crore (US$ 1.47 billion.
 Though the pharma industry has grown at a compounded annual growth rate (CAGR) of
approximately 13% over the two decades, in the last decade it was 8.5% and has been lower
at 6.2% over the past five years.
 Medical devices industry in India has been growing 15.2% annually and is expected to reach
US$ 8.16 billion by 2020 and US$ 25 billion by 2025.

12. PRESENT PANDEMIC SITUATION
 Covid-19 has presented both an opportunity and a challenge for India to emerge as the
‘pharmacy of the world.
 During April-October, 2020, India’s pharmaceutical exports totaling $11.1 billion witnessed an
impressive growth of 18%, as against $ 9.4 billion during the corresponding period a year ago.
This has led to an increase in the share of pharmaceuticals exports in India’s total exports from
5.1% in April-October, 2019 to 7.3% in April-October, 2020, making it the third largest
exported commodity.
 The commitment of provision of Covid-19 vaccine to other countries has made India the
epicenter for its manufacturing.
 Healthcare and well-being has received top priority in this 2021-2022 budget, with more than
doubling of the outlay to Rs 223,846 crore, including the allocation of Rs 35,400 crore towards
COVID-19 vaccination and Rs 64,184 Cr for a new scheme to strengthen the country’s primary,
secondary and tertiary health infrastructure.

13. World Wide Picture of Pharmaceutical Industries
 Global Pharmaceutical Market is expected to grow in the upcoming years
despite the recent slowdown in key markets across the globe.
The reasons are
a. Aging and Growing population
b. Rising income levels
c. Emerging medical conditions
d. Emergence of new diseases
Global pharmaceutical market is expected to be worth USD 1.57 trillion by 2023.
 The growth in this market is predicted on the basis of various factors like
market drivers, current and upcoming trends, current growth pattern, and
market challenges

14. Growth Drivers and Inhibitors

15.  The global pharmaceutical industry is expected to witness positive growth as
the top pharma companies are at forefront of the fight against COVID-19.
 The world’s biggest pharmaceutical companies: Top ten by revenue
1. Johnson & Johnson – $82.584bn
2. Roche – $63.751bn
3. Novartis – $48.66bn
4. Merck – $47.94bn
5. Pfizer– $47.64bn
6. Bayer – $46.8bn
7. GlaxoSmithKline – $43.26bn
8. Sanofi – $40.69bn
9. AbbVie – $33.266bn
10. Abbott – $31.9bn
Globally Top Leading Pharmaceutical Industries

16.  The top pharmaceutical products sold globally include Humira, Eliquis and
Revlimid.
 Globally, the United states has emerged as the leading market for
pharmaceuticals followed by group emerging markets.
 Emerging markets may include middle and low income countries.
 Despite increasing revenues globally , the Latin America region accounts for the
low share of the global pharmaceutical markets revenues.
 The pharmaceutical industry comprises companies that engage in research and
development, manufacturing, marketing, and distribution of chemical and
biological drugs for human and veterinary use.

17. • India ranks 3rd worldwide for pharmaceutical production by volume and 14th by value.
The country has an established domestic pharmaceutical industry, with a strong network
of 3000 drug companies and 10500 manufacturing units.
Market Size: Indian Pharmaceutical sector is expected to grow to US$100 million, while
medical device market is expected to grow U$ 25 billion by 2025. Pharmaceuticals
export from India stood at U$ 16.3 billion in FY 2020.(Bulk Drugs, Intermediates, Drug
Formulations, Biologicals, and Surgicals.)
National Wide Picture of Pharmaceutical Industry
ADVANTAGE OF OUR NATION
 Cost efficiency
 Economic Drivers
 Policy Support
 Increasing Investment

18. Net profits of leading Pharmaceutical companies
in India as of 2020(in billion Indian rupees)

19. LEADING ORANIZATIONS OF PHARMACEUTICAL INDUSTRY
 World Wide Leading Organizations
 Nation Wide Leading Organizations

20. WORLDWIDE LEADINGORGANIZATIONS
Particulars Johnson&Johnson Hoffman-La Roche Novartis
Founders :
Headquarters :
Robertwood Johnson
New Jersey , US. (1886)
Fritz Hoffman-La Roche
Basel , Switzerland.(1896)
John Rudolf , Clavel
Basel , Switzerland.(1996)
Revenue :
No of employees:
USD 82.58 billions.
1,32,200.
USD 63.751 billions.
1,01,200.
USD 48.66 billions.
1,10,000.
Subsidiaries : Janssen Pharma, Mc Neil,
Ethicon Inc etc--
Genentech, Ventenna,
Syntex, Genmark etc--
Sandoz, Ciba Geigy, Alcon,
Delmark, Wasabrod etc--
Vision : Be yourself change the world. We inspire people to transform
healthcare in the world.
Trusted leader in changing the practice
of medicine.
Mission : Make diversity and inclusion how we
work every day.
Identifies the purpose of
organization’s operational goals and
existence.
To discover new ways to improve and
extend people’s lives.
Strategies : Diversification.
Growth & Innovation.
Management for long term goals.
Focus on human healthcare.
People & Values.
Finding new medicines.
Fitting treatment to patients.
Excellence in science.
Delivering value for all stake holders.
Unleash the power of people
Transformative innovation.
Embrace operational excellence.
Go big on data & digital.
Build trust with society.
Tagline : For all you love. We innovate healthcare. Caring and Curing.

21. Nation wideleading organizations
Particulars Sun Pharma Cipla Dr Reddy’s Lab
Founders :
Headquarters :
Dilip Shanghvi (1983).
Goregoan, Mumbai.
Khawaja Abdul Hamied.
Mumbai. (1935).
Kallam Anji Reddy.
Hyderabad. (1984).
Revenue :
No of employees:
INR 33,473.4 Cr
36,000.
INR 17,476.19 Cr
22,036.
INR 17,460 Cr
21,650.
Subsidiaries : Ranbaxy , GSK ltd ,
Pharmaleucence Inc etc--
Invagen, Medpro, Sitech Lab, Medialab
pvt ltd.
Hetero Biopharma, BMS
Laboratories, Glaxo ltd.
Vision : Reaching people , touching
lives as a leading provider of valued
medicines.
Make India self - reliant in
healthcare.
To improve quality of life and life
expectancy itself.
Mission : To provide good health and
happiness for all.
To be a leading global health
care company.
To provide affordable and innovative
medicines for healthier lives.
Strategies : Sustainable revenue streams.
Seek cost leadership.
Balance profitability and
investments for future.
Low cost strategy.
Business scope & expanding
to other countries.
More strategic partnerships.
More R&D spending.
Rationalization of costs.
Improving corporate relationship.
Discovery of new chemical
entities.
Importance to research &
innovation.
Tagline : Leadership through focused research. Caring for life. Good health Can’t wait.

22. STRENGTHS
• Strong Manufacturing Base
• Low cost of Innovation , Manufacturing and operations.
• Effective purchasing and good relationships with suppliers.
• Skilled financial management , good credit control and few bad debts.
• A strong product range. Effective Research and Development.
• Growing turnover and profitability.
• Healthy domestic market with rising per capita expenditure is another significant
strength enabling achievement of economies of scale.
SWOT Analysis of Pharmaceutical Industry

23. WEAKNESSES
• Less investment in Research and development .
• Negligible expenditure on healthcare in the country.
• Sales and Marketing knowledge is inadequate due to lack of knowledge of
international pharmaceutical marketing /pricing practises and market environment
in various countries.
• Ability to evaluate contracts /alliances etc., is available only in top countries.
• Process and product patents procedure is different in different countries.

24. OPPORTUNITIES
• India has significant export opportunities
• Licensing deals with MNCs for NCE (New Chemical Entities), New drug
substance and NDDS (New Drug Delivery Systems) offer new opportunities for
Indian manufacturers
• India has a very high potential for developing as a centre for international clinical
trials due to its rich diversity.
• India can become a niche player in global pharmaceutical R&D and possibilities
exist for expansion of biotechnology generics (also known as bio-similars) and
biopharmaceuticals.

25. THREATS
• Product patent regime poses serious challenge to domestic industry unless it
invests in research and development.
• R&D efforts of Indian pharmaceutical companies are hampered by lack of
enabling regulatory requirement.
• Drug Price Control Order puts unrealistic ceilings on product prices and
profitability
• Export effort is hampered by procedural hurdles in India as well as non-tariff
barriers imposed abroad.
• Lowering of tariff protection has increased competition in domestic markets
resulting in erosion of profitability.

26. Government Policy and Regulations
Regulations
Pharmaceutical industries in India are mainly under the surveillance of CDSCO and NPPA
1. CDSCO : Central drug standard control organization
2. NPPA : National pharmaceutical pricing authority
3. FDI : Foreign Direct Investment
Objectives of the CDSCO & NPPA
• To collect /maintain data on production ,export and imports.
• To deal with all legal matters arising out of the decision of the authority.

27. Licenses and Documents Required to Start a Pharma industry
1. Drug License Number
2. GST(Goods and service Tax ) Registration
3. Food Safety & Standard Authority of India(FSSAI)
4. Trade Mark & Name for The Product
5. Company Registration
Licenses Required for Export and Import of drugs:
1. NOC (No Objection Certificate)
2. Controller and CDSCO

28. Permissions & Licenses Required to Start a Pharma Industry in Some Foreign Countries
• USA – FDA(Food and Drug Administration)
• European Countries –EMA(European Medical Agency)
• Brazil- ANVISA (Angencia Nacional de Vigilancia Sanitaria)
• China –SPAC(State Pharmaceutical Administration of China)

29. Challenges in Pharmaceutical Industry
• Demand forecasting
• Price fluctuation assessment
• Risk management
• Drug quality
• Patent issues
• Lack of Research
• Low earning/ Less profits
• Skilled manpower, raw materials
• Equipment, modification of operational facility

30. Solutions to overcome challenges
• Predictive Analytics solution to help in better demand forecasting.
• Analyzing shifting customers interests and fluctuating prices.
• Big data analytics solution to devise robust risk management strategies.
• Using of latest laboratory equipment and technology for production of pharma products using
raw materials.
• Prevention of mixing pollutants which as produced as byproducts in nearby water bodies and
natural air which effects severely nearby people.
example : Divis laboratories
• Encouragement of researches for development of R&D.
• Recruitment of skilled people to achieve great results.

31. Conclusion
• Pharmaceutical Industry plays an important role in implementing the
welfare state of the people.
• Economic growth of the industry along with the availability of generic
goods and healthy competition is the need of the hour for India.
• After analyzing the impact of the FDI in the Indian pharmaceutical Industry,
it is established that India needs adequate FDI and its spillovers for the
growth of the industry.