How Can Pharma Companies Boost Preclinical Trial Success?
durgesh final
1. Summer Internship Project Report
Submitted in Partial Fulfillment of the requirement for the award
Of POST GRADUATE DIPLOMA IN PHARMACEUTICAL
MANAGEMENT
On
“ ONCOLOGY THERAPY GAP AND ANALYSIS”
Submitted to
SIES COLLEGE OF MANAGEMENT STUDIES
Nerul, Navi Mumbai
Submitted by
Durgeshnath B Mishra
Roll No- 27
PGDM (Pharma)
2014-16
2. 1
Declaration
I, Mr. Durgeshnath B Mishra studying in the second year of POST GRADUATE DIPLOMA IN
MANAGEMENT (PGDM) at SIES College of Management Studies, Nerul, Navi Mumbai,
hereby declare that I have completed the Summer Internship Project
Titled “Oncology Therapy Gap and Analysis” as a part of the course requirements for POST
GRADUATE DIPLOMA IN PHARMACEUTICAL MANAGEMENT (PGDM)
I also declare that the work undertaken by me is original and has not been copied from any
sources.
I further declare that the information presented in this project is true and original knowledge and
has not been submitted to SIESCOMS.
Signature of the Student
Date:
Name of the Student: Durgeshnath B Mishra
Roll No.: 27
Place:
4. 3
Certificate by Faculty Project Guide
This is to certify that Mr. Durgeshnath B Mishra, studying in the second year of POST
GRADUATE DIPLOMA IN MANAGEMENT (PGDM) at SIES College of Management
Studies, Nerul Navi Mumbai, has completed the Summer Internship Project titled “Oncology
Therapy Gap and Analysis” as a part of the course requirements for POST GRADUATE
DIPLOMA IN PHARMACEUTICAL MANAGEMENT (PGDM) Program.
Signature of the Faculty Guide
Name: Prof Dr. Shuchi Midha
Date:
Place:
5. 4
Acknowledgement
The Project work in this report is an outcome of continual and structured data collection i.e
Primary and Secondary data. Materials for the Project obtained from official websites and
journals. Obligations thus incurred in completing this Project have been many. It is therefore
almost impossible to express adequately the debts to all RPG Life Sciences Ltd. People who
have been instrumental in imparting this work a successful status. It is however been
contributing to bring about this project.
I take opportunity to thank “RPG LIFE SCIENCES LTD.” for providing me the opportunity and
facilities for undertaking this project.
I would to like to express my gratitude to Dr. Shuchi Midha (IPR Faculty) Mr. Sudhanshu
Sharma (National Sales Manager) and Mr. Monish Chandwani (Senior Product Executive) for
allocating me this project and extending full co-operation and support to me. Their invaluable
and frequent suggestions were immensely helped me during course of my project. Their
suggestions helped me to maintain good quality work. I express deep gratitude to them.
Signature:
Date:
6. 5
Executive Summary
Oncology segment is a Super-Specialty segment dealing with Targeted therapy, Cytotoxic
therapy, Hormonal therapy and Supportive care or Palliative care. Total global spending on
Oncology is approximately $100 billion (IMS Institute).Among them $68 billion (France,
Germany, Italy, Japan, Spain, UK, USA) $11 billion (Pharma-emerging countries) and $21
billion (Rest of World).Pharmerging countries consists of Targeted therapy (35%), Hormonal
therapy (8%), Cytotoxic therapy (30%) and Supportive or Palliative care (27%). Frost and
Sullivan forecast Indian Oncology market revenues at Rs. 3831 Crores with 15.46 % CAGR by
2017.
The objective of the research is to find and analyze Therapy gap in the Oncology division
(Neolife) of the company. For this, an extensive market research is conducted in Mumbai and
Suburban parts including all major hospitals such as Tata Memorial Hospital, Bombay Hospital,
Saifee Hospital, KEM Hospital, Kokilaben Hospital, BSES Hospital, etc Stockist such as
Shubham pharmaceuticals, D Vijay Pharma, Royal Medical Pvt. Ltd, Milton Pharma etc, and
Pharmacy attached to the hospitals. Medical Oncologist, Onco-surgeon, Radiologist opinion
being taken with one to one interaction.
The research methodology adopted was of mix type (i.e. both Qualitative and Quantitative) and
by Random sampling technique. Also Online survey was conducted through Survey Monkey
through direct email and responses of the oncologist collected and interpreted in the overall
study. A structured two questionnaire containing open and close ended survey was prepared to
get deeper understanding of Oncology Segment.
The research findings states need to emphasize on Supportive care treatment as it comprises 24%
of Indian Oncology market (Frost and Sullivan). Since Neolife currently have only two
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molecules in this category i.e. Filgrastim and Cyclosporin. Four molecules including Aprepitant,
Fosaprepitant, Caspofungin, Voriconazole found to be major potential molecules. There is also
need to launch product in Antioxidants as well as Targeted Molecules such as Monoclonal
Antibodies.
It is observed that most of the Oncologist have Opinion about Indian Pharmaceutical companies
to engage in Supportive/ Palliative care and Targeted therapy. Systematic research design
adopted to come-up with above potential molecule with stepped manner by firstly concentrating
on finding major gap in the Segment and then directing specific approach towards identifying a
Potential molecule.
From the finding it is concluded that most of the Oncologist suggested to expand product basket
in Supportive/ Palliative care as Aprepitant, Fosaprepitant, Voriconazole and Caspofungin
proved to be potential molecule with immense opportunity to gain market share. It is
recommended that company launch product in this category hence offering unique blend of
product in its portfolio.
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Table of Content
Sr. No. Particulars Page No
1. Introduction 9-11
Company Overview 9
Project Background 9-10
Objective and Scope of the Project 10
Purpose and Significance 11
Limitation of Project 11
2. Review of Literature 12-24
Indian Pharmaceutical Industry 12-14
Oncology Market 15
Major Therapy Areas 16
Common Side-effects during Treatment 16
Supportive care Overview 17-24
Supportive or Palliative care market 24
9. 8
3. Methodology 25-28
Research objective and Design 25
Qualitative and Quantitative Research 26
Primary and Secondary data 27
Sources of Data collection 27
Hypothesis 28
Sampling 28
4. Data analysis and Interpretation 29-41
5. Conclusion 42
6. Recommendations and Suggestions 43
7. Reference 44
8. Appendices 45-48
10. 9
Introduction
Company Overview:
RPG Life Sciences (RPGLS) is an Indian Pharmaceutical Company founded in 1993. Formerly
known as Searle (India) Ltd, RPG Life Sciences is part of RPG Enterprises. It has its corporate
office in RPG House Worli Mumbai. Its three major activities are manufacturing and marketing
of bulk drugs, also known as API, (Active Pharmaceutical Ingredients), pharmaceutical
formulation and fermentation & biotechnology. RPGLS is present in the domestic as well as the
international market. It exports its products primarily to Europe, Latin America, Australia &
South East Asian countries. Neolife division started in 2010 dealing with Oncology Segment.
RPGLS has more than 50 products, which cater to various therapeutic segments such as
gastroenterology, diabetes, cardiology, oncology, psychiatry, anti-infective, antibiotics and
recently planning to launch dermatology division.
Project Background:
Title of the project is “Therapy Gap and Analysis of Neolife (Oncology)”. Over the last fifty
years the field of oncology has gone through a spectrum of changes showing major paradigm
shifts from Single cell cycle theory to cellular biology and genetics in cancer. During the initial
developmental phase, cancer was considered as rapidly dividing cells, which had lost their
normal growth control and divided continually and uncontrollably. In the last two decades the
shift in limelight came on treating the molecular defect and focus came to be on oncogenes,
tumor suppression genes, angiogenesis and apoptosis. The modern concept of cancer
management is focusing on mechanism based, rational anticancer drugs and the treatment of
disseminated disease. Inhibitors of oncogene function, check point repair processes, angiogenesis
and cancer cell immunization will form the fundamentals of cancer therapy in next years to
come.
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The major areas where the next decade will see changes in cancer management are
I) Radiation and chemotherapy protectors.
II) Use of IMRT and Stereotactic RT
III) Immunotoxin and cancer vaccines
IV) Angiogenesis
V) Antisense inhibition of genes and gene therapy.
Main task is to find the gap in the product offering by category and Finalizing potential
molecules to be launched in near future.Systematic market research with structured questionnaire
at each step taken and one to one interaction with all major customers including Oncologist,
Stockist and Pharmacist being done.
Objectives and Scope of the Project:
1. To identify therapy gap in Oncology Segment.
2. To find potential molecules considered to be launched in near future.
Project is extensive in nature as step wise approach taken to narrow- down the findings.
General and Specifically focused market survey is done considering different therapy
areas. Online market research across the India and one to one interaction through
structured questionnaire is conducted.
12. 11
Purpose and Significance:
Oncology segments in India growing at CAGR of 15.46 % (Frost and Sullivan) thus providing
immense opportunity for Indian pharmaceutical companies to invest in this segment. As more
focused approach towards treatment of cancer patients is taking place. RPGLS wants to expand
its portfolio with unique offering in different category thus avoiding intense competition.
It is very significant to launch potential molecule which have better future prospects and
different from competition.
Limitation of Project:
The project emphasizes in finding therapy gap and launching new product. Opinion and feedback
taken by oncologist may be biased due to predetermined notion about Indian companies.
As most of the oncologist prefer MNC companies it is very important to establish the brand in
mind of the prescriber by promoting it on factual basis and organizing educational campaign and
effective promotional strategies.
13. 12
Review of Literature
Indian Pharmaceutical Industry:
Indian Pharmaceutical Industry has witnessed a robust growth over the past few years moving on
from a turnover of approx. US $ 1 billion in 1990 to over US $ 20 billion in 2010 of which the
export turnover is approximately US $ 8 billion. The industry ranks 3rd in terms of volume and
is 14th in terms of value globally. It has shown tremendous progress in terms of infrastructure
development, technology base creation and a wide range of products.
It has established its presence and determination to flourish in the changing environment.
The industry now produces bulk drugs belonging to all major therapeutic groups requiring
complicated manufacturing technologies. Formulations in various dosage forms are being
produced in GMP compliant facilities. Strong scientific and technical manpower and pioneering
work done in process development have made this possible. The country now ranks 3rd
worldwide by volume of production and 14th by value thereby accounting for around 10% of
world's production by volume and 1.5% by value. Globally, it ranks 4th in terms of generics
production and 17th in terms of export value of bulk actives and dosage forms.
PHARMERGING ONCOLOGY MARKET
Targeted therapy,
35 %
Cytotoxic therapy,
30 %
Supportive care,
27 %
Hormonal therapy,
8 %
14. 13
Indian exports are destined to more than 200 countries around the globe including highly
regulated markets of US, West Europe, Japan and Australia.
Recognizing the potential for growth, the Government of India took up the initiative of
developing the Indian Pharmaceuticals sector by creating a separate Department in July 2008.
The Department is entrusted with the responsibility of policy, planning, development and
regulation of Pharmaceutical Industries. An assessment of the Indian Pharmaceutical Industry
strength reveals the following key features:
Strong export market- India exported drugs worth US$ 8 billion to more than 200 countries
including highly regulated markets in the US, Europe, Japan and Australia. Large Indian Pharma
companies have emerged as among the most competitive in the evolving generic space in North
America and have created an unmatched platform in this space. Indian companies are also
making their presence felt in the emerging markets around the world, particularly with a strong
portfolio in anti-infective and anti- retroviral.
Large domestic pharmaceutical companies have continued to grow, assuming leadership
position in many therapies and segments in the Indian market as well as creating a strong
international exports back-bone.
Competitive markets with the emergence of a number of mid-sized Indian companies with new
and innovative business modules.
Indian players have also developed expertise in significant biologics capabilities.
Biologic portfolio while still nascent in India are being built with an eye on the future.
Multinational companies have continued to invest significantly in India and are making their
presence felt across most segment of the Indian Pharmaceutical market. Companies have also
15. 14
begin to invest in increasing their presence in tier II cities and rural areas and making medical
care more accessible to large section of the Indian population.
Massive investments by Indian pharmaceutical companies - currently projects worth more
than 1.2 billion dollars are under implementation on various products
Self-reliance displayed by the production of 70% of bulk drugs and almost the entire
requirement of formulations within the country.
Low cost of production.
Low R&D costs.
Innovative and Scientific manpower
Excellent and world-class national laboratories specializing in process development and
development of cost effective technologies.
Increasing balance of trade in Pharmaceutical sector.
An efficient and cost effective source for procuring generic drugs, especially the drugs going
off-patent in the next few years.
An excellent center for clinical trials in view of the diversity in population.
16. 15
Oncology Market:
Oncology products have grown at more than double the rate of global pharmaceuticals, with a
CAGR of 8.39% during 2004–08. Reasons for the robust growth of the oncology
Market (IMS Institute)
• Increased use of targeted therapeutics, including more patients accessing modern
Therapies in emerging markets.
• Premium pricing for targeted brands as compared to cytotoxic therapies and
Anti-hormonal therapies
• Longer treatment duration for patients due to longer survival and adjuvant treatment.
• Earlier detection of disease with the availability of new screening procedures.
It is found that Indian pharmaceutical market is growing at CAGR of 15.46 % and expected to
reach 3831 crores by 2017.
INDIAN ONCOLOGY MARKET
Targeted therapy,
46 %
Supportive care,
24 %
Cytotoxic therapy,
20 %
Hormonal therapy,
1.2 %
17. 16
Major therapy Areas:
Chemotherapy, Biologics, Targeted therapy, Hormonal therapy and Supportive care are the
different types of available cancer treatment in India. Targeted therapy (46%), Supportive care
(24%), Chemotherapy (20 %) and Hormonal therapy (10 % ) in India. Whereas Pharmerging
countries comprise Targeted therapy (35 %), Supportive care (27 %), Chemotherapy (30%) and
Hormonal therapy (8 %) according to IMS Institute report.
Hence there is immense opportunity to invest in Supportive or Palliative care as well as Targeted
therapy.
Common side-effects during Cancer Treatment:
Fatigue, Nausea and Vomiting, Pain ,Hair loss, Anemia, Infection, Blood clotting problem,
Mouth ,Gum and Throat problem, Diarrhea and Constipation, Nerve and Muscle effects,
Radiation recall, Fluid retention , Flu like symptoms etc ( American Cancer Society).
It is observed through research that Pain, Nausea and Vomiting, Skin problem and Neutropenia
is very common.
18. 17
Supportive Care Overview:
The supportive care involves the collaborative efforts of an interdisciplinary team that includes
patient, his/her family, care givers and involved health care providers. It is also necessary that
care givers and health care provider’s own emotions are also balanced in respect to care they are
providing. The supportive care definitely includes focus on patient’s common physical
symptoms as pain, nausea, vomiting, weight loss etc. Supportive treatment modalities like blood
component therapy, nutritional support, antimicrobial support and recent advances like growth
factors, interferon long term venous access and cytoprotection. The scope of supportive care
extends to some issues related to medical ethics, survivorship issues, spiritual care, care of
elderly, pediatric and AIDS patients
.
supportive
/pallative
care
anti-emetic, pain
management
proteinsupplement,
Multivitamin,minerals
cream/gel
gargle/artificial
saliva
19. 18
CANCER PAIN: Various studies have shown that around 30-60% of cancer patients
experience pain during active therapy and more than two thirds of those with advanced disease
get pain4. Pain is associated with heightened psychological distress and interferes with ability to
eat, sleep, think and interact with others. It may be incapacitating and
preclude a satisfying quality of life.
The pain syndromes associated with cancer can be either acute or chronic. Whereas acute pains
experienced by patients relate usually to diagnostic and therapeutic interventions, chronic pains
are most commonly caused by direct tumor effects. Adverse consequences of
cancer therapy (surgical, chemo or radiotherapy) account for 15-25% of chronic cancer pain
problems.
WHO Analgesic Ladder Steps..
Step 1 : Non opioid (± Adjuvant) Pain increasing or persisting
Step 2 : “weak” opioid for mild to moderate pain ± Non opioid ± adjuvant Pain increasing
or persisting
Step 3 : ‘Strong” opioids for moderate to severe pain
Freedom from pain ± Non opioid ± adjuvant.
B. NAUSEA AND VOMITING: Nausea and vomiting in a patient with malignancy can be
broadly of two types.
1. Chemotherapy related nausea and vomiting
2. Chronic nausea and vomiting
1. Chemotherapy related nausea and vomiting: This is one of the most feared effects of
cancer treatment. Approximately 70-80% of all patients who receive chemotherapy
experience nausea and vomiting. Various chemotherapeutic agents have been classified into
different levels depending on the frequency with which they cause vomiting.
These are classified as:
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1) Level 1 < 10% frequency
2) Level 2 10-30% frequency
3) Level 3 30-60% frequency
4) Level 4 60-90% frequency
5) Level 5 > 90% frequency
2. Chronic Nausea and vomiting: The chronic nausea and vomiting are common and
trouble some problems in patients with advanced cancer. It has been observed that nausea and
vomiting developed in 62% of terminal cancer patients with prevalence rates of 40% in last 6
weeks of life with higher rates in women and younger patients.
Chronic nausea is presence of nausea for more than 1 week in absence of a well identified, self-
limiting cause. It is often multifactorial and requires long term treatment. The common causes of
chronic nausea are:
1. Delayed chemotherapy induced emesis
2. Radiation therapy.
3. Opioids
4. Other drugs like antibiotics, NSAIDs
5. Anxiety
6. Increased intracranial pressure
7. Autonomic dysfunction
8. Bowel obstruction, constipation
9. Metabolic abnormalities
10. Peptic ulcer disease
22. 21
C. NEUTROPENIAS AND ANTIMICROBIAL SUPPORT:
In oncological practice, a significant fever is defined are a single reading more than 38.5OC or
three reading (at least an hour apart) of more than 38OC. A Fever of Unknown Origin (FUO) is
defined as an illness lasting at least 3 weeks with a fever higher than 38 C on more than one
occasion and which lacks a definitive diagnosis after 1 week of evaluation in a hospital.
The four main types in usage are:
1) Fligrastim(E.Coli derived G-CSF)
2) Sargramostim (yeast derived GM-CSF)
3) Molgramostim (E.coli derived GM-CSF)
4) Second Generation Growth factor (under evaluation).
D. NUTRITIONAL SUPPORT: The patients with malignancy have highest prevalence of
malnutrition among any hospitalized group of patients (other than AIDS now). In its most severe
form, weight loss due to malignancy is termed the “Anorexia - Cachexia Syndrome” and is
characterized by anorexia, skeletal muscle atrophy, tissue wasting and organ dysfunction.
Malnutrition associated with malignancy is a poor prognostic indicator and is associated with
higher morbidity and mortality rates. The potential causes of malnutrition in cancer patients
include direct and indirect effects of tumor such as change in taste, dysphagia, pain, GI
obstruction and early satiety as well as due to antineoplastic therapy in form of chemotherapy &
radiotherapy, anorexia, nausea, mucosal ulcerations or infections.
Also the patients with various malignancies may have altered metabolism of nutrients
and significant amount of calories may be lost in futile pathways leading to major losses in both
total weight and lean body mass over the long term.
E. HAEMATOLOGIC SUPPORT: Cytopenia are a frequent and sometimes dangerous
complication of malignancy and its treatment. The causes are quite varied and difficult to
establish. Earlier we used to have only transfusion products and time as the tools to fight them
23. 22
but now we have some valuable additions to our tools that are quite effective, though expensive
at present.
Anemia
More than 50% of all cancer patients are anemic regardless of treatment received and approx.
20% of all patient undergoing chemotherapy will require RBC transfusion during their treatment
course. Patients with lung cancer, lymphoma, genitourinary tumors and gynecological
malignancies have the highest transfusion rates. Anemia within hematological malignancies is
always seen.
The etiology of anemia is multifactorial and is consequence of disease as well as its treatment.
Erythropoietin plays a key role in RBC production and in anemia due to cancer. It acts by
stimulating the burst forming units – Erythroid (BFU-E) and colony forming units -
Erythroid (CFU-E). Malignancy can affect erythropoietin functioning by decreasing marrow
responsiveness to it or by decreasing erythropoietin production, as tumor necrosis factor and
some nephrotoxic agents can. So erythropoietin supplementation becomes crucial in treatment of
anemia of malignancy. The debate about level of anemia requiring transfusion continues. The
concept has been that acute anemia always require blood transfusions while in chronic anemia,
various compensatory mechanisms come into play, plasma volume is compensated, cardiac
output is maintained and they do not need blood transfusion.
However there is new evidence that all cancer patients, even those with chronic anemia, benefit
significantly from hemoglobin levels near normal, hence the role of transfusions in such patients
needs to be re-discussed.
Novel Erythropoiesis - Stimulating Protein (NESP) (darbopoietin alpha) is an erythropoietin
analogue with increased glycosylation and a bigger molecule. Its half-life is greater in i/v as well
as S/C dosages and it can given at weekly intervals.
Neutropenia
It is one of most common, dose limiting toxicity of chemotherapy regimens. About 10% of
neutropenic patients may have fever and mortality due to neutropenia may be as high as 3%.
Neutropenia with or without fever has already been discussed in detail earlier in this
24. 23
Part along-with different type of growth factors.
Thrombocytopenia
The complications due to thrombocytopenia vary from harmless echymoses and petechiae to
disruptive epistaxis and gingival bleeds, to life threatening gastrointestinal and intracranial
hemorrhages.
The treatment of thrombocytopenia is still the same: prevent or treat the hemorrhage by
supplementing the platelet levels. The prophylactic platelet transfusions are common, frequent
and are standard of care in oncology patient. However the threshold at which
Platelet
F. ISSUES IN PALLIATIVE CARE: Although palliative care is a part of broader term
“Supportive Oncology”, it is beyond the scope of present chapter. It involves discussion on
various models of palliative care, hospice care, communication at end of life, palliative
chemo/radio/surgical therapies.
The issues of home care, symptoms of an actively dying patient, spirituality, bereavement care,
staff care and burnout are some of common issues in palliative care. We also need to form
guidelines on palliative care and Physician Assisted Death, ethics and law in this regard. The
Rehabilitative therapy, long term survivorship issues and palliative care in HIV/AIDS patient
and ICU settings are some of other contentious issues for routine and emergency hematological
and other malignancies, it is important to have long term venous access for patients with
malignancy. There are two types of venous access systems:
1) Peripherally introduced Central Catheter (PICC)
2) Centrally inserted catheters (CIC)
The PICC utilizes one of superficial veins like veins in arm or leg while CIC uses sub-clavian or
internal jugular veins. Both these catheters may have external access available or implanted part
system which are placed subcutaneously.
PICC lines are indicated for short duration therapy (upto 6 months), for low volume injuries and
single or sequential chemotherapeutic agents. The problems involved are occlusion
25. 24
(requiring weekly flushing) and phlebitis, maintenance is difficult, patients daily activities are
limited. In case of implantable ports, patients activity is not affected, maintenance is easy,
infection rates are low and longevity of device is better. However these are expensive and
difficult to place. CIC lines with external access are easy to use, can be used for large volumes of
fluids, also for blood sampling and multiple drug infusions are possible.
The catheter infection can occur in catheter, at exist site, tunnel or pocket. The incidence of late
catheter thrombosis is quite high.
Supportive or Palliative Care Market:
It is one of the major part in cancer treatment and comprise approximately 24 % of total
oncology market in India. Anti-emetics ( Aprepitant, Palonosetron, Granisetron) , Analgesics(
Acetaminophen, NSAID, mild to moderate opioids), Artificial Saliva, Mouthwashes, High
Protein supplement , Multi-Vitamin and Minerals, Skin Cream, Antifungal ( Voriconazole,
Caspofungin) are used in supportive or Palliative care.
Among them Aprepitant, Palonosetron, Dexamethasone, Voriconazole, Caspofungin,
Fosaprepitant , Mesna have more potential for growth.
26. 25
Methodology
Research Objectives and Design:
Objectives of the Research is-
1. To identify therapy gap in Oncology Segment.
2. To find potential molecules considered to be launched in near future.
3. To analyze Oncology Market for Indian companies.
Research Design:
Literature and
Article
• Secondary data collection
• Journal Review
Target population
selection and
Sample size
• Questinnaire design
• Random Sampling
AnalyzingData and
Interpretation
• Conclusion
• Recommendation
27. 26
Qualitative and Quantitative Research:
Qualitative Research:
Secondary data Collection- Extensive data from research paper published on Oncology
Segment and Articles evaluated before proceeding for Primary Research. Collected data helped
in identifying the basic approach towards developing research design.
Interviewing- Interview of stockists, Oncologists and Pharmacists is done to narrow- down
the research objective. Specific target group and Sampling techniques considered after meeting
few specialists and stockists.
Quantitative Research:
Exploratory Research- Its primary objective was to gain some insights and
comprehension during market research. Initial questionnaire designed to gain insights about the
current trend in Oncology Segment in India and Interpretation of those insights for further
development of more specific approach of the research.
Descriptive Research- It is one the main research methodology in collecting quantitative
data. Available data from major research firms being compared with the research finding and
collaborated to come to conclusion.
28. 27
Primary and Secondary Data:
Primary data is collected through field survey as well as online survey. Specific number of
Doctors were interviewed along with Stockist and Pharmacist of attached hospitals. Major
trends in the Mumbai and Sub-urban region observed through the market survey.
Secondary data were collected from reputed journals and articles in and around the globe. Major
Hospitals were considered according to number of cases of cancer in India and Authentic data
from government websites studies and interpreted to determine the objective of the research.
Both Primary and Secondary data helped to come to conclusion about more potential molecule
which can be considered for launching in the near future in Neolife Division of RPGLS.
Sources of Data Collection:
Following are the different sources of data collection-
1. Online Journals , Articles , Research Publication .
2. Websites of major organizations such as American Cancer Society.
3. Questionnaire designed for well-defined objective of the project.
4. Online survey using “Survey Monkey” to get more accurate data.
5. Data from Research firm such as IMS, AIOCD etc.,
6. Data from Stockists engaged in supply of Oncology product.
29. 28
Hypothesis-
Ho- There is need to launch more unique oncology product having more potential and less
competition.
Ha- There is no need to launch more unique oncology product having more potential and less
competition.
Sampling:
Sample Size- 30 (10= Initial questionnaire, 5= Online survey, 15= Specific questionnaire)
Random Sampling technique is done as it included all major hospital in Mumbai region
including Tata Hospital, Bombay Hospital, Kokilaben Hospital, KEM Hospital, Saifee Hospital,
Nanavati Hospital, Shushrut Hospital, Sanjivani Hospital and BSES Hospital across Mumbai and
Navi-Mumbai Region.
30. 29
Data Analysis and Interpretation
Findings (Part-I)
1. Which type of cancers common in India?
SR. NO. TYPE OF CANCER
1 Lip/oral cancer
2 Breast cancer
3 Lung cancer
4 Cervix cancer
5 Stomach cancer
6 Head & neck cancer
7 Colorectal cancer
8 Ovarian cancer
9 Pharynx cancer
10 Prostate cancer
31. 30
2. What other potential molecule you use in supportive care/ chemotherapy?
SR.NO. MOLECULES MAJOR THERAPY
1 Sorafenib Solid tumor
2 Lenalidomide Hematology
3 Defersirox Hematology
4 Rasburicase Hematology
5 Ibandronate Solid tumor
6 Leuprolide Solid tumor
7 Methotrexate Solid tumor
8 Topetecan Solid tumor/Hematology
9 Zolendronic acid Supportive care
10 Cytarabin Hematology
32. 31
3. What are company lacking in dealing with oncology segment and how should Indian
companies work to be a best companion in cancer treatment?
Lacking in Research and Development
Lacking in infrastructure and facilities
Reluctance to deal with Supportive or Palliative care treatment
Me too products
Companies should collaborate with major hospitals and educate cancer patients
and support group
Companies should start Cancer Week in which emphasis should be given to
launch new initiative and help the needy.
33. 32
Total Oncologists Surveyed (Specialty-wise) = 30
51 %
25 %
18 %
6 %
Specialty
Medical Oncologist
Oncosurgeon
Radio-Oncologist
Supportive/Palliative care
35. 34
The following things are emerged from analysis of survey:
Initial survey finding suggest to focus more for supportive or palliative care. It is common
opinion of most of the oncologist to deal with supportive care as most of the companies are
either reluctant or lacking unique blend of product portfolio in this category.
Total 10 doctors surveyed to find the therapy gap in general in Indian Oncology Segment.
It is observed that more preference is given to Supportive care followed by Targeted therapy,
Chemotherapy and Hormonal therapy.
Therapy Preference
Chemotherapy 6
Supportive care 10
Targeted therapy 8
Hormonal therapy 4
Above table suggest that Supportive care or Palliative care is having immense potential to grow
in terms of market value and companies unique portfolio will leverage the growing category.
chemotherapy
24%
supportivecare
39%
targeted
therapy
32%
hormonal therapy
5%
preference
36. 35
Further market survey including both field survey and online survey concentrated to find
potential molecules in supportive or palliative care.
Total 20 Oncologist were surveyed and following things emerged from questionnaire:
Most Common side-effects during Cancer treatment
It can be interpreted from above data that Nausea and Vomiting is more common followed by
Pain, Neutropenia, Infection, Fatigue and Skin problem.
16 %
23 %
18 %
17 %
10 %
16 %
No of Reasponse
Neutropenia
Nausea and Vomiting
Pain
Infection
Skin Problem
Fatigue
37. 36
It is analyzed that following molecule have more potential in the market:
Sr. No. Molecules
1 Voriconazole
2 Aprepitant
3 Fosaprepitant
4 Caspofungin
5 Curcumin,Lycopene and other Anti-oxidants
Following observed from above table:
It is Analyzed that molecules Aprepitant, Fosaprepitant, Voriconazole, Caspofungin and
Antioxidants has great potential to capture the market and companies with this blend of portfolio
will gain market share.
All above data analysis and interpretation then collaborated with the Research forms data and
following observed:
20 %
26 %
17 %
20 %
17 %
Response
Voriconazole
Aprepitant
Fosaprepitant
Caspofungin
Antioxidants
38. 37
Voriconazole
Market size
(in crores)
April 2015
Market size
(in crores)
April 2014
Y-O-Y
Growth
Market size
(in units-000)
April 2015
Market size
(in units-000)
April 2014
Y-O-Y
Growth
30.1 36.6 -17.8% 130.4 159.2 -18.1%
Top Performers
Company Brands Market Value
( Crore)
Y-O-Y
Growth
Torrent VHOPE 0.2 585.7%
Intas VORIFIT 0.4 386.3%
Dr. Reddys VERZ 3.3 116.8%
Top Brands and Competitors
VORIER ZYDUS CADILA
VORITROL LUPIN LTD
VORITEK CIPLA LTD.
VERZ DR. REDDYS LABORATORIES
LTD
VORAZE SUN PHARMA LABORATORIES
LTD.
VORIZOL NATCO PHARMA LTD
VFEND PFIZER LTD
VOSICAZ GLENMARK
PHARMACEUTICALS LTD.
VORZU RANBAXY LABORATORIES
LTD
39. 38
Aprepitant
Market size
(in crores)
April 2015
Market size
(in crores)
April 2014
Y-O-Y
Growth
Market size
(in units-000)
April 2015
Market size
(in units-000)
April 2014
Y-O-Y
Growth
2.6 2.5 3.9% 27 27.2 -0.7%
Top Performers
Company Brands Market Value
( Crore)
Y-O-Y
Growth
Intas APRECAP 0.1 201.2%
Ranbaxy APRELIFE 0.3 112.6%
Lupin APRISTAR 0.3 16.7%
Top Brands and Competitors
EMPOV DR. REDDYS LABORATORIES
APRISET KIT ALKEM LABORATORIES
APRECAP GLENMARK
PHARMACEUTICALS
APRELIFE KIT RANBAXY LABORATORIES
APRISTAR LUPIN
APREPEP INTAS PHARMACEUTICALS
EMVOID TORRENT PHARMACEUTICALS
40. 39
Caspofungin
Market size
(in crores)
April 2015
Market size
(in crores)
April 2014
Y-O-Y
Growth
Market size
(in units-000)
April 2015
Market size
(in units-000)
April 2014
Y-O-Y
Growth
55.8 62.4 -10.6% 69.6 72 -3.3%
Top Performers
Company Brands Market Value
( Crore)
Y-O-Y
Growth
Intas CANDIDAL 1 1969.7%
Wockhardt WOFUNGIN 0.5 961.1%
Cipla CASPOGIN 12.1 361.5%
Top Brands and Competitors
CANCIDAS MSD PHARMACEUTICALS
CASPOGIN CIPLA
CASPERCID SANOFI
CASPORAN RANBAXY LABORATORIES
CASFUNG GLENMARK PHARMACEUTICALS
CANDIDAL INTAS PHARMACEUTICALS
41. 40
Fosaprepitant ( New Molecule)
Market size
(in crores)
April 2015
Market size
(in crores)
April 2014
Y-O-Y
Growth
Market size
(in units-000)
April 2015
Market size
(in units-000)
April 2014
Y-O-Y
Growth
2.6 0.0 --------------- 14.9 0.00 ---------------
Top Performers
Company Brands Market Value
( Crore)
Y-O-Y
Growth
MSD EMEND 2.2 -------
Ranbaxy FOSARAN 0.4 --------
Top Brands and Competitors
EMEND MSD PHARMACEUTICALS
PRIVATE LTD.
FOSARAN RANBAXY LABORATORIES LTD
42. 41
Compiled data
Total Market Value (In Crore) = 91.1 crore
Total Market in Unit (000)
Caspofungin
55.8
Voriconazole
30.1
Aprepitant
2.6
Fosaprepitant
2.6
Caspofungin
69.6
Voriconazole
130.4
Aprepitant
27
Fosaprepitant
14.9
43. 42
Conclusion
1. Supportive care or Palliative care Segment contribute approximately 24 % in terms of
market value in Oncology Segment.
2. Targeted therapy is growing above industry expectation in recent years followed by
Chemotherapy.
3. RPG Life Sciences Ltd. Has good amount of molecules in chemotherapy but only two
molecules in Supportive or Palliative care i.e Filgrastim and Cyclosporine.
4. Most of the Oncologist suggested to have unique offering in Supportive care treatment.
5. Voriconazole, Aprepritant, Fosaprepitant, Caspofungin and Anti-oxidants are the
molecules which RPGLS should launch in near future to get lead in Supportive or
Palliative care neglected by other Companies dealing with Oncology segment.
6. Company can think about launching molecules in Targeted therapy in coming years as it
has great scope but need significant amount of investment.
.
44. 43
Recommendation and Suggestion
As per Doctors feedback Company should launch molecule in Supportive care segment.
Voriconazole, Aprepritant, Fosaprepitant, Caspofungin and Anti-oxidants should be
launched in near future.
Patient awareness program should be run by company in collaboration with major
Hospital to show that it care about them.
Company should classify its molecules in terms of more prescription generated in whole
country.
Company should select 5 molecule in each quarter from all category to be promoted on
priority basis.
RPGLS should consider the option of in-licensing and para IV filing to get first mover
advantage.
RPGLS should launch Sorafenib as it has great potential and less player in market.
45. 44
References
Kothari,C.,2004. Research methodology. Methods and Techniques. 2nd revised edition.
New Delhi: New Age International page no 2-5.
Kotler Philip 2012, Marketing Management: A South Asian Perspective,13th
Edition,Page no. 88-110.
http://www.cancer.org/treatment/treatmentsandsideeffects/palliativecare/index.
http://www.researchgate.net/journal/1433-7339_Supportive_Care_in_Cancer.
http://www.cancer.gov/publications/pdq/information-summaries/supportive-care.
http://www.cancer.org/
http://www.biospectrumindia.com/biospecindia/reports-white-papers/188385/indian-
oncology-market-grow-1546-2017-report.
http://www.business-standard.com/article/current-affairs/india-has-1-8-mn-cancer-
patients-but-only-one-oncologist-to-treat-every-2-000-114052401140_1.html.
http://www.marketresearch.com/Netscribes-India-Pvt-Ltd-v3676/Oncology-
Pharmaceuticals-India-8650206/
http://www.indiamedicaltimes.com/2014/04/07/three-healthcare-giants-set-on-the-path-
of-changing-ecology-of-oncology-in-india/
46. 45
Annexure- Structured Interview
I.
Name-
Specialization-
Hospital-
Contact no.
1. According to you which type of cancer is very common?
2. What other molecules you use in supportive care except Filgrstim?
3. Which molecule do you use as Gold Standard in Chemotherapy?
4. According to you which molecule will be promising in future?
5. What according to you companies are lacking in dealing with Oncology Segment and
how should Indian companies work to be a best companion in cancer treatment?
47. 46
II.
Name-
Specialization-
Hospital-
1. What are the most common Side-effects of Chemo/Radiotherapy?
2. Which of the following do you prescribe for Supportive or Palliative care?
a. Analgesic b. Anti-emetic c. Antifungal d. Mouthwash/Gargle/Artificial Saliva
d. Protein Supplement e. Multivitamin/Minerals g. Skin cream/Gel h. Other
3. Please rank in order of prescription
i. Analgesic ii. Antiemetic iii. Mouthwash/Gargle/Artificial Saliva
iv.Protein Supplement v. Antifungal vi. Multivitamin/Minerals vii.Skin
cream/ Gel.
4. Which are the common Analgesic do you prescribe in Cancer treatment?
5. Which is the most common and reliable Antiemetic do you prescribe?
6. Which type of Protein supplement do you prefer most ?
a. High Protein Supplement b. Low Protein Supplement c. Both
7. Most common Ingredients used in protein Supplement.
8. Which is the most common Antifungal Agents do you prescribe?
48. 47
9. Which of the following composition do you prefer for Skin Cream / Gel?
a. Zinc Oxide + Benzalkonium Chloride
b. Ofloxacin + Ornidazole + Terbinafin + Clobetasol
c. Silver Nitrate
d. Povidone Iodine
e. Others
10. Common components used for Mouthwash/Gargle /Artificial Saliva
11. Which according to you companies are lacking in dealing with Supplementary or Palliative
care?
49. 48
Table/ Charts/ Graphs
LIST OF STOCKIST WITH FULL ADDRESS
SR NO STOCKIST ADDRESS
1 SHUBHAM
PHARMACEUTICALS
FRONT HALL, 2ND
FLOOR,MIMRAJ BLDG,405
KALBADEVI ROAD,MUMBAI-400002
info@shubhampharma.com
2 D. VIJAY PHARMA PVT
LTD
1ST
FLOOR, UNIT NO 107,MARATHON MAX-II,LBS
ROAD,MULUND (W)MUMBAI-400080
mumbai@dvijaypharma.com
3 SHREE KRISHNA
PHARMACEUTICALS
SHOP NO.7,NARMADA DHAM BLDG,GROUND
FLOOR,NAVGHAR ROAD, BHYANDAR (E)THANE
shreekrishnapharmaceutical@gmail.com
4 EUPHORIA
HEALTHCARE PVT LTD
UNITNO. 3, 3RD
FLOOR,EMPREE NUCLEUS BLDG,NEAR
VISHAL HALL,OFF ANDHERI-KURLA
ROAD,GONDAVALI,ANDHERI(E)MUMBAI
BHAVESH SHAH(DIRECTOR)
08377801486
5 SUPER SPECIALTIES
PHARMA
201,CIVIC CENTRE,MMGS ROAD,DADAR(E)MUMBAI-
400014
www.specialtiespharma.com
6 CSC
PHARMACEUTICALS
CHAITNYA SHAH, PADHYA BLDG,2ND
FLOOR, 11,
BHASKAR BHAU LANE, GAMDEVI, MUMBAI-400007
91-8447497516
7 BALAJI MEDICALS NEAR BEST BUS DEPO, KANDIVALI(E)MUMBAI
8 MILTON PHARMA MARINE LINES, MUMBAI
