to study the monoclonal antibody market

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

National Institute of Pharmaceutical Education and Research, S.A.S. Nagar

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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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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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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)




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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Deloitte Analysis

Access to Affordable Biologics

Regulatory Assessment

Payer Assessment

Prescriber Acceptance

Patient Acceptance

Biosimilars presence



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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



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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


to study the monoclonal antibody market

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