To study the Monoclonal Antibody market and its Potential in India
Major Research Project
Submitted By: Bishwjit Ghoshal
14-PMM-483MBA (4th sem)
National Institute of Pharmaceutical Education and Research, S.A.S. Nagar 105/03/2023
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Flow of Presentation Introduction• What is an Antibody?• Structure of an Antibody• Monoclonal Antibody and its types• Applications of monoclonal antibodies
Need for the Study, Objectives of the Study and Research Methodology
Monoclonal Antibody Market• Growth of monoclonal antibody market• Marketed monoclonal antibody products• Status of monoclonal antibody products in pharmaceutical
market• Pipeline Analysis• Potential of monoclonal antibodies in India
Findings and Recommendations
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INTRODUCTION
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What is an Antibody?
Antibody is a blood protein produced in response to and counteracting a specific antigen. These bind chemically with substances which the body recognizes as aliens like bacteria, viruses and foreign substances in blood.
Genesis of Antibodies
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Structure of an Antibody
• Two heavy and two light polypeptide chains identical in nature held together by disulfide bond
• Light chains contain 1 variable region and one constant region
• Heavy chains contain 1 variable region and 3 or 4 constant regions
• All antibodies hinged between constant region 1 and constant region 2 to provide flexibility to the antibody structure
• The paired variable and constant regions above this hinge are referred to as antigen binding fragment (Fab) of antibody
• The paired constant regions below the hinge are called constant fragment (Fc) of the antibody
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Monoclonal Antibodies
Monoclonal antibodies are the antibodies that recognize a single epitope within an antigen. They are usually generated from a single B cell of an immunized mouse leading to the formation of identical antibodies recognizing a particular epitope of antigen.
Types of monoclonal antibodies
Murine Chimeric Humanized Human
Decreasing Immunogenicity
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Applications of Monoclonal Antibodies
Applications of
Monoclonal Antibodies
Diagnostic Applications
Therapeutic Applications
• In research and laboratory• Gene cloning• Protein Purification• Identification of cell surface markers• Analysis of cell functions
• Cancer Therapy (e.g. Herceptin)• Autoimmune Diseases (e.g. Humira)• Other Diseases (e.g. Prolia)
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NEED FOR THE STUDY, OBJECTIVES OF THE STUDY,RESEARCH METHODOLOGY
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Need for the Study
By 2017 biologics will have an estimated sale of approximately 221
billion USD
Biologics will cover 19-20% of the total
pharmaceutical sales generated
The monoclonal antibodies segment should reach around 90 billion USD by 2017.i.e. more than one-third of
the total biologics sale
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Research Objectives
Primary Objective
• To analyze the monoclonal antibody market in terms of products, both marketed and pipeline and to analyze its potential in India
Secondary Objectives
• To find out the current status of monoclonal antibody products in present pharmaceutical market
• To track the growth of monoclonal antibody market since its inception
• To analyze the marketed monoclonal antibody products in terms of their indications and mechanism of action
• To analyze the factors responsible for growth of the monoclonal antibody market
• To assess the pipeline of companies to look for the monoclonal antibody products being developed by them
• To suggest recommendations for further improvement in the existing condition
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Research Methodology
• Type of Research- Exploratory Research
• Method Used- Secondary Research
• Common Research Objective- Model Building
• Source of Data- E-books; Websites; Reports
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MONOCLONAL ANTIBODYMARKET
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Growth of Monoclonal Antibody Market
• The first monoclonal antibody came in the market in 1986 i.e. Orthoclone OKT3 used for preventing graft rejection
• Since then, the growth of the monoclonal antibody market has been tremendous
1986 20132006
Inception 26 billion USD 75 billion USD
Year
Revenue
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Growth of Monoclonal Antibody Market
Another factor contributing to the growth of the market are the growing number of approved products in the market. Approximately 26% of the products in phase 2 of clinical trials may achieve market approval in a time span of approximately seven years.
19821984
19861988
19901992
19941996
19982000
20022004
20062008
20102012
201401234567
Number of monoclonal antibody approvals per year
Products approved, but subsequently removed from the marketMabs and Mab related products
Year of Approval
No.
of P
rodu
cts a
ppro
ved
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Marketed Monoclonal Antibody Products
• According to July 2015 edition of American Pharmaceutical Review, 47 monoclonal antibody products are available globally for commercial sale globally.
47 marketed products
Mammalian Cell Culture
E.Coli. culture
Full length naked
Fc fusion protein
Fc fusion proteins
Antibody drug conjugates
Radio-labelled Conjugate
Fab protein
Bi-specific antibody
Antigen binding fragments
44
3
1 2
1
1
2
8
31
1
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Marketed Monoclonal Antibody Products
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Marketed Monoclonal Antibody Products
Analysis of the marketed monoclonal antibody products
13%
15%
11%
15%4%
4%
6%
32%
Mechanism of ActionInterleukin inhibitor
CD directed an-tibody
Anti-VEGF
TNF Blocker
Fc fusion protein
EGFR antagonist
HER2/neu receptor antagonist
Others
36%
43%
4%
17%
Indication
Cancer
Autoimmune
Graft Rejection
Others
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Marketed Monoclonal Antibody Products
Analysis of the marketed monoclonal antibody products
Abbott Laboratorie
s
Human Genome S
cience
s
Janssen
Novartis P
harma
Regenero
nBMS
Biogen Id
ec
Centoco
r
Amgen
Genentec
hOthers
0
4
8
12
16
2 2 2 2 2 3 3 3 48
16Marketed MAb products by company
Company
Num
ber o
f Dru
gs
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Status of monoclonal antibody products in pharmaceutical market
Rank 1 12,890 million USD global sale (2014)
Rank 3
Rank 4
Rank 6
Rank 8
8,915 million USD global sale (2014)
8,807 million USD global sale (2014)
7,547 million USD global sale (2014)
7,018 million USD global sale (2014)
Rank 9 6,863 million USD global sale (2014)
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Pipeline Analysis
Methodology Adopted
Database of Monoclonal Antibodies formed using secondary search
Information collected about the product using websites like clinicaltrials.gov and adisinsight.com
The data collected included product name, preferred name, phase of clinical trial in which they are, their proposed indications and the
company sponsoring the trials.
The data was then analyzed using charts and graphs in excel
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Pipeline Analysis
39%
43%
15%
2%1%
Phase 1Phase 2Phase 3Pre-registrationRegistered
52%
18%5%
25%CancerAutoimmunehypersensitivityOthers
Pipeline MAb products by phase of development
Pipeline MAb products by therapeutic indications
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Potential of Monoclonal Antibodies in India
WHY INDIA?
Large Patient
Base
Growing Economy
Abundant Manpower
Low R&D cost
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Summary of cross country analysis by Deloitte
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Potential of Monoclonal Antibodies in India
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Deloitte Analysis
Access to Affordable Biologics
Regulatory Assessment
Payer Assessment
Prescriber Acceptance
Patient Acceptance
Biosimilars presence
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Potential of Monoclonal Antibodies in India
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Access to affordable biologics
• annual per capita income of people in India in 2015 was Rs 87, 7481
• healthcare expenditure in India in 2015, it comes out to be 120 USD annually a minimal 8.5% of the income2
• price of the biologics is very high (e.g. Herceptin- Rs 124000 for 440 mg injection; Remicade- Rs 41039 for 100 mg injection; Lucentis- Rs 75000 for 0.5 mg injection, etc.3
Regulatory Assessment
• A well developed regulatory system exists for approval of biologics
• the approval process of biologics governed by a single body called DCGI i.e. Drug Controller General of India
• bodies associated with the approval process namely:
GEAC, RDAC, RCGM, IBSC, SBCC, DLC
For Biologics approval process, click here
Payer Assessment
• Gross Domestic Product (GDP) spending on healthcare has been slightly over 4%4
• Low levels of public expenditure on healthcare which stands at approximately 33% of the total healthcare spending
• 75% of the total population in India is without health insurance5
• The total premium for health insurance increased from Rs 3,999 crore in 2006-07 to Rs 19,677 crore in 2013-146
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Prescriber Acceptance
• a Deloitte survey found out that physicians were willing to prescribe biologics as first line therapy, if it was offered at a 60-70% discount
• alignment of physicians towards the biologics
• some physicians remain skeptical with regards to the safety and efficacy of similar biologics and are slow to adopt these drugs7
Patient Acceptance
• Two factors contribute to the limited patient acceptance for the products: Price of the products and income of the patient
• An average patient in India is not able to afford the products
• Unlike the developed countries where the healthcare costs are borne by third party payers, in India, majority of the cost is borne by patients
Biosimilars Presence
• a strong presence of biosimilars• the Indian market accounts for
about 60 approved biologics today, of which more than half are Biosimilars8
• sale was expected to expand at a 14.5% compounded annual rate9
• By 2016, there are 12 biosimilars of monoclonal antibodies approved for sale in India.10
• For list of marketed MAb biosimilars, click here
National Institute of Pharmaceutical Education and Research, S.A.S. Nagar
Potential of Monoclonal Antibodies in India
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FINDINGS AND
RECOMMENDATIONS
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Blockbuster Products in the
Market
Key Findings
Growth in the Sale
Rich pipeline of products
Auto-immune and
oncology dominate
the segment
Blockbuster Products in the Market
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RECOMMENDATIONS
Cover New Diseases
Come up with more biosimilars
Reduce the cost of monoclonal antibody
products
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THANK YOU
National Institute of Pharmaceutical Education and Research, S.A.S. Nagar
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