Document3

Project 11. Introduction

1.1 Company Overview

The AIOCD is a very powerful organization representing nearly seven and half lakh chemists

both the retail and the wholesaler in every nook and corner of the country. This organization is

now recognized as the only true representative body of the pharmaceutical trade in India.

AIOCD Pharma softtech AWACS Pvt. Ltd. is a pharmaceutical market research company

formed by All Indian Origin Chemists & Distributors Ltd. (AIOCD Ltd) in a joint venture with

Trikala Medi InfoTech Pvt. Ltd.

AIOCD AWACS is a pharmaceutical market research organization that has evolved into an IT

infrastructure player in Pharma Distribution & Retail. With 7 different product offerings and

several in the offing our aim is to cut time and improve accuracy. AWACS in military parlance

stands for Airborne Warning and Control System – where it cuts time and improves accuracy of

information. AWACS in AIOCD AWACS stands for Advanced Working, Action & Correction

System – giving our clients early & accurate information to plan strategies & win over

competition. The underlying philosophy behind each of our product is to reduce time to

information by 50% or more and to significantly improve on accuracy of information.

AIOCD Ltd. is a corporate Pharma retail chain set up by 5.5 Lac members of AIOCD

1.2 OBJECTIVE OF THR PROJECT

To provide sound market intelligence so as to help clients grow top line & bottom-line by

accurate & faster information flows from the market.

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2. Review of Literature

2.1 Description of Business

A brief snapshot of some of our leading products & services.

Data Exchange

For the first time ever get Electronic Data of Secondary Sales. Used for variety of purpose

including moving field to secondary targets, replenishment based supplies to stockists,

streamlining production planning & CFA stock allocation as well as reviews and early

information throughout the sales, marketing & distribution. Satisfies the Basic Need of the

Pharma Industry that’s unmet for decades.

PharmaTrac

The preferred Sales Data Audit. Having multiple advantages like early information, additional

parameters like stock levels & bonus details, excellence in client servicing, accurate pricing &

immediate new product reporting – more than 3 dozen clients have shifted to PharmaTrac in 2

years. We have clients as diverse as Pharma Companies, Equity Analysts and Consultants.

DrugInfo

Mobile drug database. Useful for Doctors & Retailers – enjoy the latest prices updated monthly

and the most comprehensive drug database that updates new products on weekly basis. For top

100 companies – guaranteed 100% products, including latest launches, are updated. Available

through SMS, GPRS & Internet – its instant and affordable access to quality information.

Retail Reach

Powered by DrugInfo – but is used as a one way communication medium to Retailers. In terms

of identifying brand to generic / company relationship the Retailer has the same, and perhaps

bigger, problem than Doctors. Once Retailer is registered by a company, instead of sending post

card sized prints on bonus, an SMS can be sent which cuts costs and cuts time. This is ideal to

announce bonus offers as well as to make retailers aware of new product launches.

Zero Bounce

Whenever a registered retailer does a new product query – an alert is sent to linked field staff –

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to ensure availability and to find out the Doctors that have started writing the new product.

Solution to the challenging problem of availability of new products. With 170,000 packs in

industry for top companies and average retailer carrying just 2000 packs, its virtually impossible

to create stocking for new products on retailer shelf. Drug Info with Zero Bounce can overcome

this challenge.

2.2 Classification of AIOCD Data Base

1. Classification

Any new product launched in the Indian Pharma market is captured from various

sources for the AWACS database and classified according to the EphMRA guidelines

based on the formulation of the product.

1.1. EPhMRA

EPhMRA stands for the European Pharmaceutical Market Research Association. It

develops and improves the standards and techniques for market research in Europe in

the field of health and healthcare, creating excellence in professional standards and

practices enabling healthcare market researchers to become highly valued business

partners.

1.1.1. Objective

To provide the opportunity for members to add value to their international marketing

research and business intelligence activities by improving their skills and knowledge.

1.1.2. EphMRA Classification (ATC and NFC)

Anatomical Classification of Pharmaceutical Products has been developed and

maintained by the European Pharmaceutical Marketing Research Association

(EphMRA) and is therefore the intellectual property of this Association.

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EphMRA Classification Committee prepares the guidelines for this classification

system and takes care for new entries, changes and improvements in consultation with

the product's manufacturer. The contents of the Anatomical Classification of

Pharmaceutical Products remain the copyright to EphMRA.

New Form Code Classification is to maintain an international uniformity of the

coding structure for the audits and the databases, it is important that the classification

remains simple and easy to understand.

1.1.3. Classification at AWACS

At AWACS, we maintain our own Master Classification based on the EPhMRA

classification which contains the following descriptions:

i. Therapy – Target of therapeutic action

ii. Class – Mode of action on target

iii. Group – Specific mechanism of action based on Route of administration.

iv. Sub group – Molecules/Active ingredients

v. Super-group – Broader categorization based on target

vi. Acute / chronic – Nature of treatment

vii. Schedule / non-schedule – Prescription or Over-The-Counter (OTC) drugs

1.2. Classifying an SKU based on EPhMRA

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1.2.1. Therapy

Therapy refers to the target organ system for the drug. As per EPhMRA,

Therapy is classified under 17 heads including unclassified and diagnostic

tools. Therapy is coded with a single alphabet which will remain as standard

as shown below:

Code Therapy

A ALIMENTARY TRACT AND METABOLISM

B BLOOD AND BLOOD FORMING ORGANS

C CARDIOVASCULAR SYSTEM

D DERMATOLOGICALS

G GENITO URINARY SYSTEM AND SEX HORMONES

H SYSTEMIC HORMONAL PREPARATIONS (EXLUDING SEX

HORMONES)

J GENERAL ANTI-INFECTIVES SYSTEMIC

K HOSPITAL SOLUTIONS

L ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS

M MUSCULO-SKELETAL SYSTEM

N CENTRAL NERVOUS SYSTEM

P PARASITOLOGY

R RESPIRATORY SYSTEM

S SENSORY ORGANS

T DIAGNOSTIC AGENTS

U UNCLASSIFIED

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1.2.1 Different Therapy Segments

V VARIOUS

1.2.2. Class

Class represents the specific mode of targeted action under each Therapy and

is coded as Therapy code followed by a numeral code.

For Example: Therapy code for Musculo-Skeletal System is “M”. Hence

the Classes under this are coded as follows:

Code Class

M1 ANTI-INFLAMMATORY AND ANTI-RHEUMATIC PRODUCTS

M2 TOPICAL ANTI-RHEUMATICS

M3 MUSCLE RELAXANTS

M4 ANTI-GOUT PREPARATIONS

M5 OTHER DRUGS FOR DISORDERS OF THE MUSCULO-SKELETAL

SYSTEM

1.2.3. Group

The group represents the mode of action based on route of administration and

is coded as Class code followed by an alphabetic code.

For e.g. from the above Classes, if we take M2 – Topical Anti-Rheumatics,

we will find the following groups under it as shown:

Code Group

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1.2.2 Different Class Segments

1.2.3 Different Group Segments

M2A TOPICAL ANTI-RHEUMATIC, NON-

STEROIDAL

M2B RUBEFACIENTS

M2C OTHER TOPICAL ANTI-RHEUMATICS

1.2.4. Subgroup

Subgroup is the final classification which represents the active ingredients or

molecules or combination of various drugs which constitute the SKU. It is

coded as the Group code followed by a numeric code.

For e.g. considering generics under Group M2B – Rubefacients, we can find

the following Subgroups:

Code Sub-Group

M2B1 MENTHOL BASED RUBEFACIENTS

M2B2 METHYL SALICYLATE RUBEFACIENTS

M2B3 CAPSAICIN BASED RUBEFACIENTS

M2B4 CINNAMON BASED RUBEFACIENTS

2. UPC

2.1. Introduction

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1.2.4 Different Subgroup

UPC stands for Uniform Product Code. AIOCD has opened this new concept of

standardized coded identification of drugs in India called – UNIFORM PRODUCT

CODE (UPC).

Objective: To improvise a uniform National Drug Database in India by providing a

standard coding system (UPC).

Concept

A UPC identifies the Manufacturer, the drug type, formulation, the strength and a

unique code to prevent duplication. The syntax being: CCCBBBBBFFSSSSPP

CCC- Represents the ‘Company’ of the drug.

BBBB- Represents the ‘Brand name’ of the drug.

FF- Represents the ‘Formulation type’ of the drug.

SSSS- Represents the ‘strength’ of the drug.

PP- Represents the numeric code to avert duplication.

Whenever a new product is launched by an EDE company, it generates a UPC and

mail is received at Awacs HO for the same having the following details:

• Brand name

• Strength

• Drug type

• Pack

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• Manufacturer name

• Division name

Significance

It is designed to help to identify, and to do electronic data transfer across the

distribution chain, which saves huge amount of manpower in data entry, expiry

returns, claims processing, etc., between manufacturers and stockiest, stockiest and

retailers.

3. Master Correction

Since our database is mostly based on Stockiest reporting, all details may not

necessarily be correct in the first go. That is why, to strengthen the Master, we

welcome all client feedbacks and update regularly after verifying the same. We accept

the same till a defined timeline every month and verify. Any clarifications are sent

back to company and once cleared, they are incorporated in our Masters.

Post Audit launch, the clients review their own and peer data and send us their reviews

regarding the following fields:

1. Classification

2. Manufacturer Division

3. Price

4. Discontinued products/ New product launches

5. Miscellaneous corrections like Drug type, pack size, Alteration of existing brand

name etc.

3.1. Principles

• Professional: Any client feedback should be addressed to corresponding

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Awacs Marketing team manager. HO team coordinates only with Awacs

Marketing team and not directly with Client Company.

• Classification: Any classification change request needs to be verified with

other sources like UPC website, MSCDA or web-search and then updated

similar to new classification. Any contradiction in the sources need to be re-

confirmed with the Manufacturing Company and then updated.

• Manufacturer Division: Divisions are generally updated from Company

product list or Stockiest reporting. However, the second one being a major

source for us, it is not always possible to capture the correct division. In such

cases, we need to update the division as the Company short name. For e.g.

Ranbaxy for RANBAXY LABORATORIES LTD. The same can later be

updated based on client feedback.

• Price: Price of each product is captured from stockiest reporting. However the

criteria is, at least 10 stockiest should be reporting the price.

• Miscellaneous: Any change in the SKU regarding pack, brand name, drug-

type etc. can be done directly based on Client feedback.

• Discontinued Brands: If the client suggests certain brands have been

discontinued, it is flagged as discontinued in the status option and not deleted.

It does not appear in transaction anymore but continues to exist in the database.

2.3 Types of Error

The brand name in the data base is represented in a particular format to avoid confusion and

assure uniformity across the pan India level for all the stockiest providing with the data. Thus it

helps in avoiding duplicity and minimizing the errors for the market research carried with this

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data. Further, there are multiple strength available for a particular brand and thus it is very

important to categorize all the strength for the purpose of market research and so the brands in

the data base are divided at an S.K.U (Stock Keeping Unit) level. Hence all the strengths of same

brand and different brands with same strength are found in the data base. The format for writing

an SKU name undertaken by AIOCD AWACS is the brand name followed by the strength of the

drug, units used to describe strength, its form and pack size.

For e.g. if crocin advance tablet has to be written in the prescribed format of AIOCD it would be

as follows: Crocin 500 Mg tablet 15.

Thus there are multiple columns which provide the information of the brand as follows:

Item Code: Unique identification code given to individual SKU.

SKU: It contains all the details of the brands s explained above.

Manufacturer name: Name of the company manufacturing the brand.

Subgroup code: Code of the subgroup according to EPHMRA under which it is

categorized in the database.

Subgroup Name : Contain the generic name of the brand

Web search Result: Information related to the contents found on the web.

Subgroup found in EPHMRA: Subgroup as mentioned in EPHMRA.

Generic representation: Generic name found in EPHMRA.

Strength: Available strength of the contents.

Source: the web link from which the information is sourced.

Remarks: Corrections to be mentioned if any.

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These following types of errors were observed in the AIOCD data base:

1. Error in the brand name

Brand name is different for the given generic drug, the spelling of the brand name is

wrong or the brand name is incomplete.

For e.g. if a brand name of the product is Demoxin CV then it is written as Demoxin CB.

2. Error in the strength of the brand

Strength of the SKU is wrongly written

For e.g. The strength of the brand is 400mg but it is written as 200mg.

3. Error in the dosage form:

The form in which the brand is available is wrong.

For e.g. a brand is available in the tablet form but it is represented in liquid form.

4. Error in the pack size:

For e.g. A brand is available in a pack size of 10 tablet but it is written as it is available in

pack size of 15 tablets.

5. Error in the name of the manufacturer:

The name of the manufacturer is misrepresented.

For e.g. a brand like Megaclav is manufactured and sold by alembic but it would be

misrepresented as it is sold by sun pharma.

6. Error in the name and number of subgroup:

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The name and number under which the brand falls in EPHMRA is different.

For e.g. a brand like Megaclav falls under the group of AMOXYCILLIN +

CLAVULANIC ACID but it will be represented under the group of Paracetamol.

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3. Methodology

3.1 Research Methodology

Survey instrument

The type of method used was secondary research for data collection. This involved mainly

AIOCD- AWACS data base and information available on the public domain related to the

category of drug which was corrected.

Data correction from external data gathered by looking at secondary information sources, usually

through desk research. This means sourcing and analyzing published information to build a

picture of a market and to try and answer some specific commercial questions.

3.2 Method of study

Secondary method of research.

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4. Data Analysis

4.1 Data Correction files

Following are the subgroups corrected for the AIOCD in summer internship:

1. Subgroup name: Ibuprofen + Paracetamol

Number of SKU: 409

Number of errors reported: 92

Errors related to brand names: 24

Errors related to strength of SKU: 32

Errors related to manufacturers name: 29

Miscellaneous Errors: 7

2. Subgroup name: Alprazolam

Number of SKU: 854






3. Subgroup name: Ciprofloxacin + Dexamethasone

Number of SKU: 45






4. Subgroup name: Glucosamine + Diacerein + MSM

Number of SKU: 45



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5. Subgroup name: Ranitidine

Number of SKU: 336






6. Subgroup name: Fexofenadine

Number of SKU: 170






7. Subgroup name: Aspirin + Clopidogrel

Number of SKU: 119






8. Subgroup name: Ceftriaxone

Number of SKU: 572





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9. Subgroup name: Cefixime

Number of SKU: 1000






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5. Conclusion & Recommendation

Data correction is a continuous project to improve the efficiency and accuracy of the

company’s data base.

Company has a team of people who are related to the collection and validation of the

information to improve the data base.

Company should also prefer primary data collection as a source of gathering information

rather than only secondary sources.

Secondary data search should be conducted only pertaining to the company’s website

rather than gathering information from third party websites, in this way they can improve

the accuracy of the data collection

Instead of updating the data base and keeping it a continues project, company should

come up with a software which can be in sync with the manufacture and marketing

pharma companies and which can provide all the updated information as it is released.

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REFERENCES

1 Source : www.medplusmart.com

2 Source : www.genericpedia.com

3 Source : www.shabirmedicalhall.in

4 Source : www.1mg.com

5 Source : www.medclick.com

6 Website of various pharmaceutical companies

7 AIOCD master brand report

8 Maharashtra state chemist and druggist association database

9 Indian pharmaceutical market molecule and brands data base

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http://www.medclick.com/

http://www.1mg.com/

http://www.shabirmedicalhall.in/

http://www.genericpedia.com/

http://www.medplusmart.com/

PROJECT – 2

1. Introduction

1.1 Objective of the Study

The main objective of this market intelligence report is to describe the set of activities that

provide a company with a view of a market using existing sources of information to understand

what is happening in a market place, what the issues are, what competitors are doing, what

customers or consumers are doing and what the likely market potential is for new products or

services based on previous activities and responses.

This report helps the market leaders to understand the investment levels, marketing activities,

timing and structure needed to successfully steer products and pipeline molecules through the

complex oncology marketplace.

This report helps the company to forecast the future trends of the market and get an idea on how

will the molecules and brands pertaining to those molecules will behave in the near future.

The research finding in the report will help the company take leadership decisions of budgeting

and strategic planning like when to enter the segment, understand the trend in the oncology

market, portfolio management and the competition company will face in the market

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2. Review of Literature

2.1 What Is Cancer?

An abnormal growth of cells which tend to proliferate in an uncontrolled way and, in some cases,

to metastasize (spread).

Cancer is not one disease. It is a group of more than 100 different and distinctive diseases.

Cancer can involve any tissue of the body and have many different forms in each body area.

Most cancers are named for the type of cell or organ in which they start. If a cancer spreads

(metastasizes), the new tumour bears the same name as the original (primary) tumour.

The frequency of a particular cancer may depend on gender. While skin cancer is the most

common type of malignancy for both men and women, the second most common type in men

is prostate cancer and in women, breast cancer.

Cancer frequency does not equate to cancer mortality. Skin cancers are often curable. Lung

cancer is the leading cause of death from cancer for both men and women in the United States

today.

Benign tumours are NOT cancer; malignant tumours are cancer. Cancer is NOT contagious.

Types of Cancer

Lung cancer

Breast cancer

Colon and rectal cancer

Endometrial cancer

Pancreatic cancer

Kidney cancer

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Prostate cancer

Thyroid cancer

Leukemia

Signs and Symptoms

Thickening or lump in the breast or any other part of the body

Obvious change in a wart or mole

A sore that does not heal

Nagging cough or hoarseness

Change in bowel or bladder habits

Indigestion or difficulty swallowing

Unexplained changes in weight – without any apparent cause

Unusual bleeding or discharge

Different Types of Treatment

Since there are numerous types of cancer affecting several organs, treatment also differs. Some

of the treatment modalities like surgery, radiation therapy, chemotherapy with anticancer drugs

are common for nearly all types of cancers.

Some of the types of therapy for cancers include:

Surgery: Surgery is used for diagnosis of cancer as well. Sometimes a solid lump or

tumour is removed surgically and tissues are examined under the microscope for cancer.

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Chemotherapy: Chemotherapy is the use of drugs to kill cancer cells. However, when

most people use the word chemotherapy they are referring specifically to drug treatments

for cancer that destroy cancer cells by stopping their ability to grow and divide. These

anticancer drugs are cyto-toxic.

Radiation Therapy: After surgery, sometimes radiation therapy is advised. In this

therapy high energy radiation beams are projected on cancerous regions. This kills the

cancer cells. Radiation may be external when the patient needs to visit the hospital for

radiation sessions that may last from 10 to 30 minutes. Radiation therapy may also be

given internally when small pellets of seeds that emit radiation are implanted in the body

of the patient. The seeds emit small amounts of radiation.

Targeted Therapy: Some types of cancers have specific targeted therapy that affects

only the cancer cells and spares the healthy cells. These have significantly lower side

effects compared to generalized anti-cancer drugs.

Immunotherapy: This includes therapy with molecules called monoclonal antibodies

that target the cancer specifically and spare healthy cells.

Hormonal therapy: Some cancers like breast cancer and prostate cancer are responsive

to certain female hormones like estrogen and male hormones like testosterone. Drugs that

modulate levels of these hormones are used in therapy of these cancers.

Biological therapy: This includes monoclonal antibodies as well as use of gene therapy

and certain vaccines in treatment of cancers.

Stem Cell Transplant: There are several methods of bone marrow transplants that may

benefit patients with leukemia and lymphomas.

Photodynamic Therapy: This therapy involves use of special drugs that are called

photosensitizing agents and these are used along with laser light to kill cancer cells. The

drugs only work after they have been activated with light.

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2.2 Oncology Market

Current Market Scenario

There are 28 lakh prevalent cases of all types of cancer, while at least 8 lakh new cases

are being witnessed every year.

India contributes 20 percent of the disease burden globally.

India has less than one oncologist for every 100000 people.

Studies have revealed that incidence of cancer is higher amongst women than men.

Across India there are 84 dedicated cancer hospitals.

Cancers of oral cavity and lungs in males, and cervix and breast in females, account for

over 50 percent of all cancer-related deaths in India for 2013.

According to bright insights, the global cancer market in 2010 was valued at $54bn, an

increase of 5.1% over the previous year‘s sales of $51.3bn, and is forecasted to grow at a

CAGR of 6.9% from 2010–16, reaching $81bn in 2016.

Collectively, the seven major markets (US, 5EU, and Japan) represented 79.1% (or

$43bn) of in the global cancer market in 2010. In terms of size, the US dominated the

global cancer market, with 2010 sales of $21bn and a market share of 38.5%.

The global cancer market is becoming increasingly competitive, with two therapeutic

classes, namely antineoplastics and cytostatic hormonal treatments, dominating this

sector. Collectively, the leading 10 brands accounted for almost 58.2% (or $31.4bn) of

the global cancer market in 2010.

In 2010 antineoplastics was the leading drug class in the global cancer market. The global

antineoplastics market was valued at $46bn in 2010 at a year-on-year (Y-o-Y) growth of

7.3%. The major drugs that contributed to the 2010 sales in the antineoplastics category

were Roche‘s Avastin (bevacizumab) at $6.2bn, Herceptin (trastuzumab) at $5.2bn, and

MabThera (rituximab) at $5.1bn, with Y-o-Y sales growth of 3.8%, 3.1%, and 3.3%

respectively.

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The cytostatic hormonal market registered 2010 sales of $8bn at a Y-o-Y decline of

6.5%. AstraZeneca‘s Arimidex (anastrozole) and Novartis‘s Femara (letrozole) led this

class, reaching sales of $1.5bn and $1.3bn respectively in 2010.

According to Frost & Sullivan, The anti-cancer drug market in India was estimated to be

around Rs 2,000 crore in 2013.

The Oncology market in India is presently growing at 23% percent year-on-year.

According to the report on oncology market in India, the market is estimated to grow to

INR 3831 crore by 2017at a CAGR of 15.46 percent.

Chemotherapy, biologics, targeted therapy, hormonal therapy, and supportive care are the

different types of available cancer treatment in India.

Among this chemotherapy recorded the highest market value of approximately Rs 700

crore in 2012.

There is likely to be a sharp rise in the market share percentage of biologics and targeted

therapy, which are poised to overtake chemotherapy as the preferred treatment option.

In 2013, estimated chemotherapy market was around $112.5 in India and estimated anti-

cancer market was around $321 million.

Oncology has become one of the major focus areas for pharmaceutical and biotechnology

companies because of the high unmet need for improved treatments for multiple types of

cancer.

Due to the high incidence and subsequent potential for market success, breast cancer and

NSCLC continue to drive high levels of R&D (along with indications such as NHL,

RCC, CML, and prostate cancer).

Another factor that plays a major role in the growth of the cancer therapy market is the

expansion of target indications. Most of the blockbuster drugs were launched for a

narrow indication, and were later approved for other indications. A classic example is

imatinib, which was first approved by the FDA in 2001 for the treatment of CML, and

later expanded to nine different indications.

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Although a large number of cancer vaccines are in development, Dendreon‘s Provenge

(sipuleucel-T) is the first therapeutic cancer vaccine approved in the US (April 2010) for

the treatment of prostate cancer.

In 2013, government allocated $2.5 billion for cancer diagnosis and treatment.

With increase in emphasis on health coverage both by Central and State Governments,

spending on coverage of medicines for Oncology will see substantial rise in coming 3-5

years thus making oncology as the key are of growth in Indian pharmaceutical market.

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Incidence, Prevalence and Mortality

Cancer is the leading cause of disease worldwide with approximately 14.1 million new cases in 2012.

Cancer is the leading cause of death worldwide, with an estimated 8.2 million death in 2012.

Among men, the five most common sites of cancer diagnosed in 2012 were the lung (16.7% of the total), prostate (15.0%), colon-rectum (10.0%), stomach (8.5%), and liver (7.5%).

Among women, the five most common incident sites of cancer were the breast (25.2% of the total), colon- rectum (9.2%), lung (8.7%), cervix (7.9%), and stomach (4.8%).

Among men, lung cancer had the highest incidence (34.2 per 100 000) and prostate cancer had the second highest incidence (31.1 per 100 000). Among women, breast cancer had a substantially higher incidence (43.3 per 100 000) than any other cancer; the next highest incidence was of rectal cancer (14.3 per 100 000).

P reva l e nce e s t im a te s fo r 2012 ind i c a t e t ha t t he r e w e re 8 .7 m i l l i on peop le (o lde r t han 15 yea r s ) alive who had a cancer diagnosed in the previous year, 22.0 million with a diagnosis in the previous 3 years, and 32.6 million with a diagnosis in the previous 5 years.

The w or ldw ide e s t im a te fo r t he number o f canc e r s d i agnos ed in ch i ldhood ( age s 0–14 yea r s ) i n 2012 is 165 000 (95 000 in boys and 70 000 in girls).

F or a l l c ance r s c ombine d the h ighes t i nc i dence r a t e s a r e associated with the high-income countries of North America and Western Europe

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INCEDENCE

PREVELANCE

MORTALITY

More than 60% of the world’s cancer cases occur in Africa, Asia, and Central and South America, and these regions account for about 70% of the cancer deaths.

Growth Drivers for Oncology Market

Increase in the cancer cases across the globe in the past few years due to lifestyle changes

like overweight, harmful alcohol use, sedentary lifestyle

Decreased mortality rates and increased life span due to development in healthcare.

Earlier diagnosis, longer treatment duration, and increased effectiveness of drug therapies

are contributing to rising levels of spending on medicines for cancer care.

Government schemes for cancer insurance.

Increase in the research activities for new drug development.

India being the export hub for many companies the manufacturing of the drugs for

exports add up to the total oncology drug market.

Changes in the treatment scenario and shifting of targeted drug therapy treatment instead

of surgery and radiation.

Increase in the number of patient and early diagnosis leading to faster growth of anti-

cancer drug market. In 2014, the anti-neoplastic market showed the highest growth of

approx. 30%.

Affordable treatment from Indian companies further helped the market to grow. Thus, the

top oncology companies are Indian MNC’s. Companies like Dr. Reddy’s labs and Emure

pharma which are the leading players in the oncology market grew at a rate of

approximately20%.

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Patent expiry of leading drugs and thus marketing of affordable generic/biosimilar drugs

from Indian company further acts as a driving force for the market.

Indian patent laws of compulsory licensing and prevention of ever greening helps Indian

companies to provide treatment at affordable cost thus large demands for drugs are meet

at affordable prices which helps growing the market.

Market Leaders

0

50

100

150

200

250206 205

133

88 78 77 71 68 6752 49 43 39 29 27

173 178

9774 62

85

5230 43 38 41 31 29 26 28

2.2.1 Revenue of Leading Players in indian oncology Market

In 2015, the leading 15 companies of the Indian cancer market represented 83.94% (or

988 cr) of the total market. The Indian oncology market grew at 23.44% from 1177 cr₹ ₹

in 2014 to 1453 cr in 2015.₹

Dr. Reddy’s led the Indian cancer market with market share of 14.18% for 2015 and sales

of 206 cr which grew at 20% from 173 cr in 2014; this was mainly based on sales₹ ₹

from Reditux, Grafeel and Mitotax which contributed to 50% of the total oncology

portfolio of the company.

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Sale

s (

cro

res)

₹

Emcure pharmaceuticals stood second with 2015 sales of 206 cr which grew from 178₹ ₹

cr from 2014. The company captured the market share of 14.07 % with a growth of 14.77

compared to previous year.

Zydus cadila captured 9.16% of the total oncology market in 2015 with the sales value of

133 cr compared to 2014 sales value of just 97 cr. The company’s oncology portfolio₹ ₹

grew at 37.40%. Thus, Zydus showed the highest growth in the top 5 oncology

companies in India.

At number forth position Intas Pharmaceuticals showed a growth rate of 19.93% and

market share of 6.06%. Company’s oncology sales of 2015 grew at 88 cr from 74 cr in₹ ₹

2014.

17%

17%

11%

7%6%6%

6%

6%

5%

4%4%

4%3% 2% 2%

2.2.2 Market Share (2015)DR. REDDYS LABORATORIES LTDEMCURE PHARMACEUTICALS LTDZYDUS CADILAINTAS PHARMACEUTICALS LTDPANACEA BIOTEC LTDROCHENATCO PHARMA LTDFRESENIUS KABI INDIA PVT LTDBIOCON LTDBIOCHEM PHARMACEUTICAL INDSCIPLA LTD.IPCA LABORATORIES PVT LTD.PFIZER LTDRPG LIFE SCIENCES LTD.SUN PHARMA LABORATORIES LTD.

Panacea Biotech which ranked fifth in the list of oncology drug market showed a growth

of 25.56% for 2015 with a sales revenue of ₹78 cr compared to ₹62 cr for

2014.Company captured a market share of 5.35% in the Indian oncology drug market.

Roche which stood first in the global oncology market scored sixth position in india.

Company sales declined to ₹77cr in 2015 compared to ₹85 cr in 2014 thus, showing a

declining growth of 9.72%. This might be because of the reduction in the prices of the top

products in the company’s portfolio to sustain itself in the competitive market.

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Natco Pharma captured a market share of 4.86% with revenues of ₹71 cr in 2015

compared to 2014 value of ₹52 cr. Natco showed a growth of 35.43% for 2014-2015.

Fresenius Kabi India ltd showed a tremendous growth of 126% for the year 2014- 2015

and ranked seventh in the oncology Indian market. The ompany captured a market share

of 4.71% with sales value of ₹68 cr in 2015 compared to ₹30 cr in 2014.Fresenius kabi

showed the highest growth rate and the only company which showed three digit growths

in the segment.

Biocon ltd with a market share of 4.63% and market growth of 58.06% ranked ninth in

the top oncology pharma market. The revenues of 2015 clocked at ₹67 cr compared to

₹43 cr in 2014.

Biochem Pharma which ranked tenth in the Indian oncology market achieved a market

share of 3.61% at ₹52 cr in 2015 compared to ₹38 cr in 2014.

Major players like Cipla, Pfizer and Sun Pharma who dominate the Indian

Pharmaceutical Market did not score reasonable position in oncology segment and ranked

eleventh, thirteenth and fifteenth respectively. Thus, it can be concluded that this players

did not focus on this segment in India.

Biceltis– Emcure Pharmaceuticals

Biceltis is a humanized version of the anti-HER2/neumAb 4D5 directed against the cell-

surface signaling molecule HER2. Biceltis has become the standard of care in treating all

patients with HER2-overexpressing breast cancer. The generic name of the brand is

Trastuzumab which is innovated by F. Hoffmann-La Roche and marketed by the brand

name Herceptin.

Biceltis topped the chart of top oncology drugs with the sales value of ₹73 cr but a

declining growth of -12%. Thus, the market captured by the brand was mere 5%.

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Avastin – Roche

Avastin is a humanized IgG1 monoclonal antibody targeting the signaling of vascular

endothelial growth factor (VEGF), a protein normally made by tumor cells to attract new

blood vessels and facilitate growth of the tumor.

Avastin was the first anti-angiogenic oncology therapy to be approved and this has given

avastin a strong first mover advantage in all tumor types

Avastin accrued the sales of ₹69 cr in 2015 at a Y-o-Y growth of 33% compared with the

previous year sales of ₹52 cr in 2014.

Avastin is indicated as a first- or second-line therapy for metastatic colorectal cancer

(MCC) in combination with intravenous (IV) 5-fluorouracil (5-FU)-based chemotherapy,

and in combination with carboplatin and paclitaxel for the first-line treatment of patients

with unresectable, locally advanced, recurrent or metastatic non-squamous non-small-cell

lung cancer.

Reditux– Dr. Reddy’s

Rituxan is a murine/human chimeric antibody that targets CD20, a protein that is present

on more than 90% of B-cell lymphomas.

It is primarily indicated for the treatment of non-Hodgkin‘s lymphoma (NHL) and for

several specific indications within this overall diagnosis.Rituxan was the first

commercially successful oncology mAb to reach the market.

With 2015 sales of ₹45 cr and a Y-o-Y growth of 6.56%, Reditux remained the third

largest selling cancer brand in the Indian pharmaceutical market.

Grafeel – Dr. Reddy’s

Grafeel is a brand of Filgrastim, which is a granulocyte colony-stimulating factor (G-

CSF) analog used to stimulate the proliferation and differentiation ofgranulocytes. It is

produced by recombinant DNA technology

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In 2015, Grafeel ranked fourth with revenue of ₹32 cr compared to ₹16 cr in

2014.Grafeel showed the second highest growth rate of 105.12% for 2015 Y-O-Y sales

and a market share of 2.21%.

Erlonat– Natco Pharma

Erlotinib hydrochloride is a drug used to treat non-small cell lung

cancer (NSCLC), pancreatic cancer and several other types of cancer. It is a

reversible tyrosine kinase inhibitor, which acts on the epidermal growth factor receptor.

With 2015 sales of ₹31 cr and a market share of 147.83%, Erlonat is the sixth largest

selling cancer brand in the Indian pharmaceutical market.

Erlonat showed the highest growth rate of 147.83% in the Indian oncology market.

Folitrax– IPCA labs

Folitax is a brand of methotrexate and acts by inhibiting the production of folic acid in

the body. Methotrexate is used in the treatment of various diseases including cancer,

autoimmune disease, and ectopic pregnancy and for induction of medical abortions.

Methotrexate was originally developed and continues to be used for chemotherapy, either

alone or in combination with other agents. It is effective for the treatment of a number

of cancers including: breast, head and neck, leukemia, lymphoma, lung, osteosarcoma,

bladder, and trophoblastic neoplasms.

In 2015, with the sales of ₹29cr folitrax captures the market share of approximately 2%

and grew at 21.94% from ₹24cr in 2014.

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2.3 SWOT Analysis for Oncology Market

Oncology market is one of the fastest growing market in Indian pharmaceutical industry

mainly because of the increased incidence of cancer cases in the population. Moreover

there are more than 200 types of cancer are detected thus there is a huge market

opportunity for Research based company to enter the market.

Lack of infrastructure and research activities are the major factors which has to be

improved by the company in the segment.

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Many blockbuster molecules are about to get off patent till 2020 and thus generic form of

the molecules can be launched at a reasonable price by the companies thus providing

affordable treatment for the life threatening disease.

Oncology drug market is dominated by the top players in the segment thus a company

can sustain in the segment only if it has patented products in the basket or if the products

are at affordable prices.

2.4 Patent Scenario in Oncology Market

What is intellectual property right

Intellectual Property Rights are legal rights, which result from intellectual activity in

industrial, scientific, literary & artistic fields. These rights Safeguard creators and other

producers of intellectual goods & services by granting them certain time-limited rights to

control their use.

Protected IP rights like other property can be a matter of trade, which can be owned, sold

or bought. These are intangible and non-exhausted consumption.

A patent is an exclusive right granted for an invention, which is a product or a process

that provides a new way of doing something, or offers a new technical solution to a

problem.

It provides protection for the invention to the owner of the patent. The protection is

granted for a limited period, i.e 20 years. Patent protection means that the invention

cannot be commercially made, used, distributed or sold without the patent owner's

consent.

Types of Intellectual Property Rights:

Patents.

Trademarks.

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Copyrights and related rights.

Geographical Indications.

Industrial Designs.

Trade Secrets.

Layout Design for Integrated Circuits.

Protection of New Plant Variety.

Indian Patent Act, 1970

The Patents Act, 1970 is a landmark in the industrial development of India. The basic philosophy

of the Act is that patents are granted to encourage inventions and to secure that these inventions

are worked on a commercial scale without undue delay; and patents are granted not merely to

enable patentee to enjoy a monopoly for the importation of the patented article into the country.

The said philosophy is being implemented through compulsory licensing, registration of only

process patents for food, medicine or drug, pesticides and substances produced by chemical

processes which, apart from chemical substances normally understood, also include items such

as alloys, optical glass, semi-conductors, intermetallic compounds etc. It may, however, be noted

that products vital for our economy such as agriculture & horticulture products, atomic energy

inventions and all living things are not patentable. Thus, the Patents Act 1970was expected to

provide a reasonable balance between adequate and effective protection of patents on the one

hand and the technology development, public interest and specific needs of the country on the

other hand.

Uruguay round of GATT negotiations paved the way for WTO. Therefore India was put under

the contractual obligation to amend its patents act in compliance with the provisions of TRIPS.

India had to meet the first set of requirements on 1-1-1995. This was to give a pipeline protection

till the country starts giving product patent. It came to force on 26th March 1999 retrospective

from 1-1-1995. It lays down the provisions for filing of application for product patent in the field

of drugs or medicines with effect from 01.01.1995 and grant of Exclusive Marketing Rights on

those products.

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India amended its Patents Act again in 2002 to meet with the second set of obligations, which

had to be effected from 1-1-2000. This amendment, which provides for 20 years term for the

patent, Reversal of burden of proof etc. came into force on 20th May, 2003. The Third

Amendment of the Patents Act 1970, by way of the Patents (Amendment) Ordinance 2004 came

into force on 1st January, 2005 incorporating the provisions for granting product patent in all

fields of Technology including chemicals, food, drugs &agrochemicals and this Ordinance is

replaced by the Patents (Amendment) Act2005 which is in force now having effect from 1-

1-2005.

Under the Patents Act, the Government of India is empowered to make rules for implementing

the Act and regulating the Patent Administration. Accordingly, the Government brought into

force Patents Rules, 1972 w.e.f. 20.4.1972. These Rules were amended on 2.6.99 and replaced

by the Patents Rules 2003 w.e.f. 20.5.2003 and further it is amended by the Patents

(Amendment) Rules 2005, which is in force now; this includes provisions relating to time-lines

with a view to introducing flexibility and reducing processing time gradually for patent

applications, and simplifying and rationalizing procedure for grant of the patent.

There are four Schedules to the Patents (Amendment) Rules 2005; the First Schedule prescribes

the fees to be paid; the Second Schedule specifies the list of forms and the texts of various forms

required in connection with various activities under the Patents Act are set out in this schedule.

These forms are to be used wherever required and if needed, they can be modified with the

consent of the Controller. The Third Schedule prescribes form of Patent to be issued on Grant of

the Patent. The Fourth Schedule prescribes costs to be awarded in various proceedings before the

Controller under the Act.

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PCT Timeline

Different phases of PCT Timeline

Filing: you file an international application, complying with the PCT formality

requirements, in one language, and you pay one set of fees.

International Search: an “International Searching Authority (ISA)” (one of the

world’smajor patent Offices) identifies the published documents which may have an

influence on whether your invention is patentable and establishes an opinion on your

invention’s potential patentability.

International Publication: as soon as possible after the expiration of 18 months from

the earliest filing date, the content of your international application is disclosed to the

world.

Supplementary International Search (optional): an ISA which is willing to carry out

supplementary searches and which did not carry out the main search, identifies published

documents which may not have been searched by the ISA which carried out the main

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search because of the diversity of prior art in different languages and different technical

fields.

International Preliminary Examination (optional): one of the ISAs, at your request,

carries out an additional patentability analysis, after international publication, usually on

an amended version of your application.

National Phase: after the end of the PCT procedure, you start to pursue the grant of your

patents directly before the national (or regional) patent Offices of the countries in which

you want to obtain them.

IPR Sections for Pharmaceutical Industry

Section 47 (Grant of Patent)

Where an application for a patent has been found to be in order for grant of the patent and either

—

1. the application has not been refused by the Controller by virtue of any power vested in

him by this Act; or

2. the application has not been found to be in contravention of any of the provisions of this

Act, the patent shall be granted as expeditiously as possible to the applicant or, in the case

of a joint application, to the applicants jointly, with the seal of the patent office and the

date on which the patent is granted shall be entered in the register.

3. On the grant of patent, the Controller shall publish the fact that the patent has been

granted and thereupon the application, specification and other documents related thereto

shall be open for public inspection.

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Section 64 (Revocation of Patent)

Any Interested person including the government can file a petition on any of the grounds

specified for revocation of a patent under Section 64 of the Patents Act. Section 64 dealing with

revocation of patents stipulates that a patent, whether granted before or after the commencement

of this Act, may, be revoked on a petition of any person interested or of the Central Government

by this Appellate Board or on a counterclaim in a suit for infringement of the patent by the High

Court on any of the following grounds namely:

1. that the invention, so far as claimed in any claim of the complete specification, was

claimed in a valid claim of earlier priority date contained in the complete specification of

another patent granted in India;

2. that the patent was granted on the application of a person not entitled under the

provisions of this Act to apply therefore;

3. that the patent was granted on the application of a person not rights of the petitioner or

any person under or through whom he claims;

4. that the subject of any claim of the complete specification is not an invention within the

meaning of this Act;

5. that the invention so far as claimed in any claim of the complete specification is not new,

having regard to what was publicly known or publicly used in India before the priority

date of the claim or to what was published in India or elsewhere in any of the documents

referred to in section 13:

6. that the invention so far as claimed in any claim of the complete specification is obvious

or does not involve any inventive step having regard to what was publicly known or

publicly used in India or what was published in India or elsewhere before the priority

date of the claim:

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7. that the invention, so far as claimed in any claim of the complete specification, is not

useful;

8. that the complete specification does not sufficiently and fairly describe the invention and

the method by which it is to be performed, that is to say, that the description of the

method or the instructions for the working of the invention as contained in the complete

specification are not by themselves sufficient to enable a person in India possessing

average skill in, and average knowledge of, the art to which the invention relates, to work

the invention, or that it does not disclose the best method of performing it which was

known to the applicant for the patent and for which he was entitled to claim protection;

9. that the scope of any claim of the complete specification is not sufficiently and clearly

defined or that any claim of the complete specification is not fairly based on the matter

disclosed in the specification;

10. that the patent was obtained on a false suggestion or representation;

11. that the subject of any claim of the complete specification is not patentable under this

Act;

12. that the invention so far as claimed in any claim of the complete specification was

secretly used in India, otherwise than as mentioned in sub-section (3), before the priority

date of the claim;

13. that the applicant for the patent has failed to disclose to the Controller the information

required by section 8 or has furnished information which in any material particular was

false to his knowledge;

14. that the applicant contravened any direction for secrecy passed under Section 35 or made

or caused to be made an application for the grant of a patent outside India in

contravention of Section 39

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15. that leave to amend the complete specification under section 57 or section 58 was

obtained byfraud;

16. that the complete specification does not disclose or wrongly mentions the source and

geographicalorigin of biological material used for the invention;

17. that the invention so far as claimed in any claim of the complete specification was

anticipatedhaving regard to the knowledge, oral or otherwise, available within any local

or indigenouscommunity in India or elsewhere.

Section 92 (Compulsory Licensing)

1. Section 92 provides that if the Central Government is satisfied, in respect of any patent in

force incircumstances of national emergency or in circumstances of extreme urgency or

in case of public noncommercial use, that it is necessary that compulsory licences should

be granted at any time after the sealingthereof to work the invention, it may make a

declaration to that effect, by notification in the Official Gazette,and thereupon the

Controller shall on application made at any time, after the notification, by any

personinterested, grant to the applicant a license under the patent on such terms and

conditions as he thinks fit.

2. In settling the terms and conditions of a license the Controller shall endeavor to secure

that the articles manufactured under the patent shall be available to the public at the

lowest prices consistent with the patentees deriving a reasonable advantage from their

patent rights.

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Section 92A (Patents Relating to the Manufacture of Pharmaceutical Products)

1. Section 92A of the Patents Act, 1970 inserted by The Patents (Amendment) Act, 2005

postulates compulsory license for export of patented pharmaceutical products in certain

exceptional circumstances.

2. It states that compulsory license shall be available for manufacture and export of patented

pharmaceutical products to any country having insufficient or no manufacturing capacity

in the pharmaceutical sector for the concerned product to address public health problems,

provided compulsory license has been granted by such country or such country has, by

notification or otherwise, allowed importation of the patented pharmaceutical products

from India.

3. Sub-section (2) authorizes the Controller, on receipt of an application in the prescribed

manner, to grant, on such terms and conditions as he may specify, a compulsory licence

solely for manufacture and export of the concerned pharmaceutical product to such

country under such terms and conditions as may be specified and published by him.

4. Explanation to Section 92A defines the pharmaceutical products as to mean any patented

product, or product manufactured through a patented process, of the pharmaceutical

sector needed to address public health problems and shall be inclusive of ingredients

necessary for their manufacture and diagnostic kits required for their use.

Section 3(d) (What Are Not Inventions)

1. The mere discovery of a new form of a known substance which does not result in the

enhancement of the known efficacy of that substance or the mere discovery of any new

property or new use for a known substance or of the mere use of a known process,

machine or apparatus unless such known process results in a new product or employs at

least one new reactant.

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2. Explanation – for the purpose of this clause , salts, esters, polymorphs, metabolites, pure

form, particle size, isomers, mixtures of isomerers, complex, combinations and other

derivatives of known substance shall be considered to be the same substance, unless they

differ significantly in properties with regards to efficacy.

Top global drugs loosing patents

1. Drug name : Avastin

Molecule name:Bevacizumab

Innovator: Roche

Patent expiration: United States – 2019

Europe – 2022

2. Drug name : Herceptin

Molecule name : Trastuzumab

Innovator : Roche

Patent expiration : United States – 2023

Europe – 2014

India – 2013

3. Drug name : MabThera

Molecule name: Rituximab

Innovator: Roche


Europe – 2013

India – 2013

4. Drug name : Gleevec

Molecule name : Imatinib

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Innovator: Novartis


Europe –2016

India – 2015

5. Drug name : Taxotere

Molecule name: Docetaxel

Innovator: Sanofi


Europe – 2010

6. Drug name : Alimta

Molecule name: Pemetrexed

Innovator: Eli lilly


Europe – 2015

7. Drug name : Alimta

Molecule name: Pemetrexed

Innovator: Eli lilly


Europe – 2015

8. Drug name : Femara

Molecule name: Letrozole

Innovator: Novartis


Europe – 2011

9. Drug name : Xeloda

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Molecule name: Capecitabine

Innovator: Roche


Europe – 2011

10. Drug name :Xeloda

Molecule name: Capecitabine

Innovator: Roche


Europe – 2011

2.5 Gleevec case study

The patent application at the center of the case was filed by Novartis in India in 1998,

after India had agreed to enter the World Trade Organization and to abide by worldwide

intellectual property standards under the TRIPS agreement.

As part of this agreement, India made changes to its patent law; the biggest of which was

that prior to these changes, patents on products were not allowed, while afterwards they

were, albeit with restrictions. These changes came into effect in 2005, so Novartis' patent

application waited in a "mailbox".

India also passed certain amendments to its patent law in 2005, just before the laws came

into effect.

The patent application claimed the final form of Gleevec (the beta crystalline form of

imatinib mesylate). In 1993, during the time India did not allow patents on products,

Novartis had patented imatinib, with salts vaguely specified, in many countries but could

not patent it in India.

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The key differences between the two patent applications, were that the 1998 patent

application specified the counterion (Gleevec is a specific salt - imatinib mesylate) while

the 1993 patent application did not claim any specific salts nor did it mention mesylate,

and the 1998 patent application specified the solid form of Gleevec

As provided under the TRIPS agreement, Novartis applied for Exclusive Marketing

Rights (EMR) for Gleevec from the Indian Patent Office and the EMR were granted in

November 2003

When examination of Novartis' patent application began in 2005, the application was

rejected by the patent office and by an appeal board.

The key basis for the rejection was the part of Indian patent law that was created by

amendment in 2005, describing the patentability of new uses for known drugs and

modifications of known drugs. That section, Paragraph 3d, specified that such inventions

are patentable only if "they differ significantly in properties with regard to efficacy."

The Supreme Court case hinged on the interpretation of Paragraph 3d. The Supreme

Court decided that the substance that Novartis sought to patent was indeed a modification

of a known drug (the raw form of imatinib, which was publicly disclosed in the 1993

patent application and in scientific articles), that Novartis did not present evidence of a

difference in therapeutic efficacy between the final form of Gleevec and the raw form of

imatinib, and that therefore the patent application was properly rejected by the patent

office and lower courts.

In January 2006, the Indian patent office ruled that the drug was not substantially

different from one for which patents had already been given in the US and Europe. Thus,

it did not pass the novelty test. While moving to the new patent regime, Indian lawmakers

had inserted a provision — section 3(d) in the Patents Act — to check against 'ever

greening'.

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This is the term used to describe a practice under which firms slightly tweak an existing

process or product to seek a fresh patent once the original protection expires. This helps

them retain monopoly rights for a longer period.

Had Novartis won and gotten its patent issued, it could not have prevented generics

companies in India from continuing to sell generic Gleevec, but it could have obligated

them to pay a reasonable royalty under a grandfather clause included in India's patent

law.

How will the SC judgment impact consumers?

If Novartis had won the case, it would have been granted a monopoly on Glivec, and

denied Indian companies the right to make the drug. This would obviously have allowed

Novartis to sell the medicine at a much higher price.

Already, there is a huge differential with generic versions by Indian companies costing

Rs 5,000-9,000 for a month's treatment, compared to Glivec's cost of around Rs 1.2 lakh

a month.

The order is also likely to encourage existing Indian manufacturers to step up production

and perhaps new players to enter the market. This should lead to a further fall in prices.

What will be the impact on the drug industry?

The multinational drug companies are worried that this could be a trendsetter and are

even threatening to block supplies of new patented medicines to India. But this is

unlikely to deter Indian industry from developing "copycat" versions that would sell at a

lower price.

This can also discourage Big Pharma companies to spend on their R&D and that can led

to reduction in the pipeline of companies who are driven by innovation.

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In short, while this is bad news for Big Pharma, it is as much good news for domestic

manufacturers as it is for consumers. Big Pharma could also be worried that the Indian

example may be emulated by others.

2.6 India’s compulsory licensing case

Bayer holds the patent to the pharmaceutical compound sorafenib tosylate. Marketed

under the brand name Nexavar, sorafenib is used to treat advanced stages of kidney and

liver cancer. Nexavar is not a life-saving treatment. Its use, however, can extend the lives

of patients with advanced kidney and liver cancer.

Bayer obtained a patent covering Nexavar in India in 2008. A month’s supply of Nexavar

costs Indian patients approximately $5,600.

Natco Pharma Ltd. is a well-known generic drug manufacturer in India. Natco developed

the process needed to manufacture generic sorafenib, sought and obtained government

permission for bulk manufacture, and then approached Bayer for a voluntary license.

Bayer was unwilling to grant the license.

Natco then brought its application for a compulsory license under Section 84 of the

applicable Indian Patent Act.Section 84 outlines the circumstances whereby a

compulsory license may be granted. Under Section 84, grounds for compulsory license

include a patentee’s failure to:

1. Meet the public’s “reasonable requirements” for the patented product

2. Make the patented item available at reasonably affordable price

3. Work the patented item within the territory of India

Natco argued that data on Nexavar’s use and need proved that Bayer was not meeting the

Indian public’s reasonable requirement for the drug, especially given its high price. The

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controller agreed. Noting evidence of strong sales of the drug outside of India and

Bayer’s well-established Indian sales force, the controller found Bayer could not justify

its failure to make Nexavar more available to the Indian public.

Natco also claimed that the drug was not sold at the affordable price in India and thus

large number of India’spopulation could not afford the treatment. Ultimately, the

controller found that a reasonable affordable price has to be construed with reference to

the public. Bayer could not overcome the evidence that the cost of Nexavar put it out of

reach for the vast majority of potential Indian cancer patients—justifying the award of the

compulsory license.

Concluding that Natco had made the necessary showing under Section 84, the controller

granted it a compulsory license. Under the terms of that license, Natco must sell the drug

for about $160 per month, as well as give the drug for free to 600 needy patients per year.

Natco must pay Bayer a 6 percent royalty and may not sell the drug outside of India or

sublicense any of its rights.

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3. Methodology

3.1 Research Methodology

Survey instrument

The type of method used was secondary research for data collection. This involved mainly

AIOCD- AWACS data base and information available on the public domain related to the

category of drug which was corrected.

Data correction from external data gathered by looking at secondary information sources, usually

through desk research. This means sourcing and analyzing published information to build a

picture of a market and to try and answer some specific commercial questions.

3.2 Method of study

Secondary method of research.

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4. Data Analysis

4.1 Data Analysis and Findings

Market Analysis by Drug Type

Drug class Sales 2010($ millions)

Growth 2009- 10(%)

Market share2010 (%)

Antineoplastics 45990 7.3 85.3

Cytostatic hormone therapy

7952 -6.5 14.7

Total 53942 5.1 10.5

Anti-neoplastics, with 2010 sales of $46bn and a Y-o-Y growth of 7.3%, formed the

leading drug class for cancer treatment. The major drugs that contributed to the 2010

sales in the antineoplastics category were Avastin ($6.2bn), Herceptin ($5.2bn), and

MabThera ($5.1bn), with Y-o-Y sales growth of 3.8%, 3.1%, and 3.3% respectively.

Cytostatic hormone therapies formed the other drug class, registering 2010 sales of $8bn

at a Y-o-Y decline of 6.5%. Arimidex and Femara, with 2010 sales of $1.5bn and $1.3bn

at a Y-o-Y decline of 21.3% and growth of 8.7% respectively, remained the leading drugs

in this class.

In 2014, Antineoplastic drug category ranked 13th in the Indian pharmaceutical market

and was valued at ₹1103 Crs and showed an incremental value of ₹258Cr over previous

year.

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4.1.1 Global Market Drug Type Analysis

Antineoplastic market showed the highest growth rate of 30.5% across all the drug

category in IPM.

North zone contributed the highest value of ₹214 Crs from the total ₹1103 Crs followed

by south, west and east zones at ₹162 Cr, ₹139 Cr and ₹126 Cr respectively.

In May 2014, Antineoplastic market was valued at ₹1453 Crs with a growth rate of

23.5% and an incremental value of ₹124 Crs for IPM.

Drug Class Mat May-14

(in₹ crores)

Mat May-15

(in₹ crores)

Total-ANTI-NEOPLASTIC Market 1177.07 1453.42

Anti- Neoplastic 797.91 981.48

Cytostatic Hormone Therapy 83.27 91.70

Immuno stimulating Agents 165.95 211.20

Immunosuppressive Agents 129.94 169.04

The anti neoplastic market is supported by four major class contribution for the growth of

the drug Treatment.

Anti neoplastic drug market which has 10 class in it is the highest performing segment

clocked at ₹981.48 cr with a growth rate of 23%

Thus, accounts for almost 68% of the total anti neoplastic drug market.

Immunostimulating and Immunosuppressants are the two other class of drug which are

gaining importance for treatment of oncology market.

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4.1.2 Indian Market Drug Type Analysis

Immunostimulating Drugs cover a market share of 15% with a growth rate of 27%.

And, immunosuppressive agents cover a market share of 12% and a growth rate of 24%.

Market Analysis Based On Mechanism of Action

GROUP NAME Mat May-14 Mat May-15

VINCA ALKALOIDS AND OTHER PLANT PRODUCTS

129.10 178.64

ANTIMETABOLITES 146.97 166.43

IMMUNOSUPPRESSIVE AGENTS 129.94 164.70

IMMUNOSTIMULATING AGENTS EXCLUDING INTERFERONS

92.04 138.70

CYTOSTATIC HORMONE ANTAGONISTS 75.84 81.68

INTERFERONS 73.91 72.50

ALKYLATING AGENTS 59.16 65.98

ANTINEOPLASTIC ANTIBIOTICS 40.74 47.62

CYTOSTATIC HORMONES 7.43 10.02

ANTI-TNF PRODUCTS 0.00 4.35

ALL OTHER ANTINEOPLASTICS 421.94 522.80

Anti neoplastic market continues to grow at 23% with all the subgroups included.

The most prominent class for the treatment is that of vinca alkaloids with the total

turnover of ₹178.64 cr. Thus, the class comes on the number one postiton with gain of

three positions compared to last year.

Anti metabolites have lost the number one position and now ranks second in the lsit of

class which clocked at ₹166.43 cr.

Immunosuppressents also lost a rank from number two position to number three position.

- 54

4.1.3 Market Analysis Based On Mechanism of Action

Anti – TNF drugs have started getting recognition in the market and shows some growth

compared to previous year.

Top Anti- Neoplastic Molecules in IPM

Rank Molecules MAT May- 2015

( crores)₹

Total Anti- Neoplastic Drug Market 1453

1 Paclitaxel 123

2 Filgrastim 92

3 Trastuzumab 87

4 Rituximab 85

5 Bevacizumab 69

6 Mycophenolate Mofetil 61

7 Pegylated Interferon Alpha 2B 58

8 Bortezomib 47

9 Methotrexate 46

10 Pegfilgrastim 43

Pcalitaxel stood number one in the list of top molecules ranking in the anti neoplastic

drug market. It is the only molecule crossing the ₹100cr mark.

Filgrastim captured the market of ₹92cr ranking second in the list of the top molecules.

The molecule is the major part of the company’s portfolio and thus there are two brands

belonging to this molecule in the top brands in India.

- 55

4.1.4 Top Anti – Neoplastic Molecules

Trastuzumab stays at the third position with the turnover of ₹87cr and ranks third in the

list. Biceltis which is the leading brand in the Indian oncology market belongs to this

class of drug.

Company Wise Top Brands

Rank COMPANY NAME RANK BRAND MAT May-2015

(in ₹ crores)

1 DR. REDDYS LABORATORIES LTD

206

1 REDITUX 45

2 GRAFEEL 32

3 MITOTAX 24

4 CYTOGEM 15

5 PEMGEM 10

2 EMCURE PHARMACEUTICALS LTD

205

1 BICELTIS 73

2 BIOCURE 24

3 IKGDAR 24

4 GROS 15

5 PEGEX 13

3 ZYDUS CADILA 133

1 PEGIHEP 32

2 COLSTIM 22

3 PEGSTIM 15

4 TAXONAB 7

5 NUDOXA 7

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4.1.5 Company Wise Top Brands

4 INTAS PHARMACEUTICALS LTD

88

1 NEUKINE 24

2 MABTAS 14

3 IMANIB 8

4 PEGASTA 4

5 STIMUFOL 3

5 PANACEA BIOTEC LTD 78

1 PANGRAF 25

2 MYCEPT 18

3 PANIMUN BIORAL

12

4 MYCEPT S 8

5 PACLITRUST 7

6 ROCHE 77

1 AVASTIN 69

2 XELODA 7

3 NEUPOGEN 1

4 NEULASTIM 0

5 TARCEVA 0

7 NATCO PHARMA LTD 71

1 ERLONAT 31

2 GEFTINAT 12

3 VEENAT 12

4 BORTENAT 6

5 CANTRET 2

8 FRESENIUS KABI INDIA PVT LTD

68

1 KEMOCARB 13

2 GEMITA 11

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3 NANOXEL 7

4 ADRIM 5

5 OXITAN 5

9 BIOCON LTD 67

1 ABRAXANE 21

2 CANMAB 14

3 BIOMAB EGFR 8

4 ABSTET 5

5 TACROGRAF 4

10 BIOCHEM PHARMACEUTICAL IND

52

1 PETAXEL 11

2 IMAT 6

3 CACIT 4

4 CHEMORESSA 4

5 GLIOZOLAMIDE

4

The top 3 brands contribute to approximately 50% of the oncology portfolio for the

company.

Avastin alone contributes to almost 90% of the oncology segment for Roche. Thus, the

company should focus on the other products to strengthen their oncology portfolio.

Several companies like Panacea, Fresenius Kabi which does not show any prominent

growth in other markets should try to increase their revenue from oncology market by

capturing bigger market share as this is the most prominent growing segment for the

company.

- 58

Leading Brand Dynamics

Brand Generic name Company Sales 2015

( crores)₹Growth

(%)

Market share

(%)

Biceltis Trastuzumab Emcure 73 -12.00 5.03

Avastin Bevacizumab Roche 69 33.00 4.74

Reditux Rituximab Dr. Reddy’s 45 6.56 3.10

Grafeel Filgrastim Dr. Reddy’s 32 105.12 2.21

Pegihep Peginaterferon Zydus 32 -10.95 2.19

Erlonat Erlotinib Natco 31 147.83 2.16

Folitrax Methotrexate IPCA 29 21.94 2.01

Pangraf Tacrolimus Panacea 25 51.47 1.72

Neukine Filgrastim Intas 24 -3.35 1.66

Biocure Bortezomib Emcure 24 51.64 1.62

Total 385 23.44 26.50

In 2015, the cancer market clocked at ₹1453 cr and grew at 24% compared to ₹1177 cr

in 2014.

The Indian cancer market is highly competitive with two classes (antineoplastics and

cytostatic hormone therapies) dominating the sector. Collectively, the leading 10 brands

accounted for almost 27% of the cancer market (or ₹385) in 2015.

- 59

4.1.6 Sales of leading brands in Indian oncology market 2015

5. CONCLUSION & RECOMMENDATION

As there are more than 200 types of cancer identified by the American cancer society and

the cancer incidences are on rise, there is a huge opportunity for the pharmaceutical

companies to discover new target specific drugs for the treatment.

Many companies have huge R&D spending and number of products in the pipeline to be

launched for oncology market as it is a research driven market and huge untapped

potential.

The oncology drug market is the highest growing market in the Indian pharmaceutical

industry and is not saturated compared to other markets thus the entry barrier for the

segment is less for a reputed pharmaceutical company.

95% of the market share is captured by the top 25 players in the industry thus there is a

tight competition between the companies for market share.

The molecule trend in Indian pharmaceutical industry is completely different compared

to that of the global level, as the global oncology market is driven by innovation and that

of the Indian oncology market is driven by generic drugs.

The top brands in the market are mostly generic or bio similar brands of that of the

molecule which have lost patent and very less innovator brands are listed in the list of top

10 brands. Thus, India lacks in innovation.

On the other hand, the Indian patent laws which were amended in 2005 are different

compared to rest of the world. The major difference lies in the compulsory licensing law

and prevention of ever greening.

While this law allows the Indian companies to make generic or bio similar copies of the

patented molecules to be sold in India at affordable prices to meet the demands of the

- 60

large population, it forces MNC to reduce their research budgets and thus does not

encourage innovation which is very important for pharmaceutical industry.

Many research companies do not launch their products in the Indian market and thus the

treatment system in the country lacks compared to that of the developed countries.

As cancer is a life threatening disease in the country which shares 20% of the global

disease burden, it can be concluded that there should be more research activities for better

treatment at an affordable price. Hence government should make special provisions

related to this segment.

- 61

REFERENCES

1. AIOCD AWACS Data Base

2. Source : http://www.cancer.gov/about-cancer/treatment/types/

3. Source : http://www.slideshare.net/RenukaShankar1/oncology-intelligence-2013

4. Source : http://articles.economictimes.indiatimes.com/2013-05-09/news/39143930_1_oncology-market-cancer-cases-targeted-therapy

5. Source : http://www.pharmabiz.com/NewsDetails.aspx?aid=75263&sid=1

6. Source : http://www.slideshare.net/krea/10-things-about-oncology-in-india?qid=52b57fad-afae-4d75-9055-ff08bf0f984c&v=qf1&b=&from_search=12

7. Source : http://www.who.int/mediacentre/factsheets/fs297/en/

8. Source : http://www.who.int/cancer/en/

9. Source : http://icmr.nic.in/cancer.pdf

10. Source : http://www.who.int/cancer/country-profiles/ind_en.pdf?ua=1

11. Source : http://articles.economictimes.indiatimes.com/keyword/oncology

12. Source : https://en.wikipedia.org/wiki/Novartis_v._Union_of_India_%26_Others

13. Source : http://archivepharma.financialexpress.com/20091215/expressbiotech23.shtml

14. Source : http://www.gabionline.net/Biosimilars/General/Biosimilars-of-bevacizumab

15. Source : http://www.biosimilarnews.com/mylan-launched-hertraz-in-india

16. Source : http://www.business-standard.com/article/companies/roche-s-patent-pain-to-be-biocon-s-gain-113081701007_1.html

- 62

http://www.business-standard.com/article/companies/roche-s-patent-pain-to-be-biocon-s-gain-113081701007_1.html

http://www.business-standard.com/article/companies/roche-s-patent-pain-to-be-biocon-s-gain-113081701007_1.html

http://www.biosimilarnews.com/mylan-launched-hertraz-in-india

http://www.gabionline.net/Biosimilars/General/Biosimilars-of-bevacizumab

http://archivepharma.financialexpress.com/20091215/expressbiotech23.shtml

https://en.wikipedia.org/wiki/Novartis_v._Union_of_India_%26_Others

http://articles.economictimes.indiatimes.com/keyword/oncology

http://www.who.int/cancer/country-profiles/ind_en.pdf?ua=1

http://icmr.nic.in/cancer.pdf

http://www.who.int/cancer/en/

http://www.who.int/mediacentre/factsheets/fs297/en/

http://www.slideshare.net/krea/10-things-about-oncology-in-india?qid=52b57fad-afae-4d75-9055-ff08bf0f984c&v=qf1&b=&from_search=12

http://www.slideshare.net/krea/10-things-about-oncology-in-india?qid=52b57fad-afae-4d75-9055-ff08bf0f984c&v=qf1&b=&from_search=12

http://www.pharmabiz.com/NewsDetails.aspx?aid=75263&sid=1

http://articles.economictimes.indiatimes.com/2013-05-09/news/39143930_1_oncology-market-cancer-cases-targeted-therapy

http://articles.economictimes.indiatimes.com/2013-05-09/news/39143930_1_oncology-market-cancer-cases-targeted-therapy

http://www.slideshare.net/RenukaShankar1/oncology-intelligence-2013

http://www.cancer.gov/about-cancer/treatment/types/

17. Source : http://www.fiercepharma.com/story/roche-nabs-european-approval-time-saving-formulation-rituxan/2014-03-28

18. Source : http://www.fiercepharma.com/special-reports/xeloda

- 63

http://www.fiercepharma.com/special-reports/xeloda

http://www.fiercepharma.com/story/roche-nabs-european-approval-time-saving-formulation-rituxan/2014-03-28

http://www.fiercepharma.com/story/roche-nabs-european-approval-time-saving-formulation-rituxan/2014-03-28

Appendix

LIST OF CHARTS

Chart No. Title Page

2.2.1

2.2.2

Revenue of leading players in Indian oncology market

Market share (2015)

29

30

Table No. Title Page

1.2.1

1.2.2

1.2.3

1.2.4

4.1.1

4.1.2

4.1.3

4.1.4

4.1.5

4.1.6

Different therapy segments

Different Class segments

Different group segments

Different subgroup segments

Global market drug type analysis

Indian market drug type analysis

Market analysis based on mechanism of action

Top anti-neoplastic molecules

Company wise top brands

Sales of leading brands in Indian oncology market

5

6

7

7

52

53

54

55

56

59

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