bishwjit ghoshal_summer internship report 2015

A Summer Internship Project

Market Opportunity Assessment for

‘Alpha’ products of ‘AB Pharma’

June 4th- August 4th, 2015

Market Opportunity Assessment for Alpha products 2015

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Prepared by,

Bishwjit Ghoshal Summer Intern, PharmaAce Analytics

MBA (Pharm.)

DOPM, NIPER-Mohali

Guided by,

Ms. Onisha Dhar Consultant, PharmaAce Analytics

Pune

Mr. Amit Pharande Consultant, PharmaAce Analytics

Submitted to,

Dr. Anand Sharma, Ph.D. Professor, In-charge,

Dept. of Pharmaceutical Management

NIPER-Mohali


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TABLE OF CONTENTS:

1. Acknowledgement………………………………………………………….4

2. Preface………………………………………………………………………5

3. Declaration………………………………………………………………….6

4. Executive Summary………………………………………………………..7

5. Company Profile……………………………………………………………9

6. Project Work……………………………………………………………...11

Therapy Analysis……………………………………………………..11

Pipeline Analysis………………………………………………….11

Cell Therapy Industry……………………………………………..16

Geographical Market Analysis……………………………………...20

Customer Profiling…………………………………………………...24

Competitors’ Analysis………………………………………………..26

7. Learnings…………………………………………………………………..27


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Acknowledgement An internship project is a golden opportunity for learning and self-development. I consider

myself very lucky and honored to have so many wonderful people lead me through in

completion of this project.

I take this opportunity to express my profound gratitude and deep regards to my guides Mr.

Amit Pharande and Ms. Onisha Dhar, consultants at PharmaAce analytics, Pune for their

exemplary guidance, monitoring and constant encouragement throughout the course of this

thesis.

I also take this opportunity to express a deep sense of gratitude to Mr. Anuj Kumar, Delivery

Head, PharmaAce analytics for his cordial support, valuable information and guidance, which

helped me in completing the task through various stages.

I am obliged to all team members of PharmaAce analytics, Pune for the valuable information

provided by them in their respective fields. I am grateful for their cooperation during the period

of my assignment.

A humble thanks to our beloved Professor Dr. Anand Sharma, Associate Professor, In-charge,

Dept. of Pharmaceutical Management, National Institute of Pharmaceutical Education and

Research- Mohali whose help, suggestions and encouragement gave the right direction toward

completion of project.

Lastly, I thank almighty, my parents and friends for their constant encouragement without which

this assignment would not be possible.


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Preface It has been an immense pleasure for me to present research on “Market Opportunity

Assessment for ‘Alpha’ products of ‘AB Pharma’” as a part of curriculum of my

course MBA in Pharmaceutical Management.

It was a great learning during two months of my training period. This project gave me an

opportunity to have an understanding on Knowledge services value chain including Secondary

market research, Data analysis, Reporting and Business development. I would like to thank all

experts for giving their valuable time and data that helped me to complete my project.

I would like to thank PharmaAce analytics for giving me an opportunity to work on this

project. Once again my sincere thanks to Mr. Anuj Kumar, Delivery Head and my guides Ms.

Onisha Dhar and Mr. Amit Pharande , Consultants, PharmaAce analytics, Pune for guiding me

during this project. Without their guidance it wouldn’t have been possible for me to complete

this project.


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Declaration I hereby declare that project titled “Market Opportunity Assessment for Alpha Products”

original piece of analytical work carried out by me under the guidance and supervision of Mr.

Anuj Kumar, Delivery Head; Ms. Onisha Dhar and Mr. Amit Pharande, consultants,

PharmaAce analytics. The information has been collected from genuine & authentic sources. The

work has been submitted in partial fulfilment of MBA (Pharm.) degree in Dept. of

Pharmaceutical Management, National Institute of Pharmaceutical Education and Research

(NIPER) - Mohali.

Name: Bishwjit Ghoshal

Signature:

Date: October 15, 2015


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Executive Summary

About the Project- Market Opportunity Assessment:

Our client AB pharma manufactures components and systems for injectable drug delivery and

plastic packaging, and delivery system components for the healthcare and consumer products.

The project was related to the market opportunity assessment for one of its breakthrough

products i.e. Alpha.

About the Product: ‘Alpha’

Alpha is the unique insert needle design that minimizes potential contamination and product

waste caused by manufacturing and performance issues associated with traditional glass and

staked-needle syringe systems.

The core competencies of the product can be divided into 3 sections:

Minimize Risk

• Highly break resistant

• No silicone oil, tungsten and adhesive in the drug contact areas

• Very low visible and subvisible particles

• Maximizes stability, purity and efficacy of your drug product

• Manufactured to exacting standards in a clean room environment

• Assurance of an established material from the market leader in drug packaging

materials

• Established relationships with leading contract fillers

Maximize Value

• 100% vision inspection to minimize defects • Potential to reduce protein aggregation caused by loose particles, tungsten, and silicone

oil • Excellent glass-like transparency • Minimal investment in additional manufacturing technology

• Suitable for sensitive drugs and biologics • Potential to reduce total cost of ownership


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Enhance Delivery

• Superior functional performance without silicone oil

• Overcomes the limitations of glass • Suitable for high-viscosity products

• Dimensional precision for optimal performance in delivery devices • Predictable piston release and travel forces over time • 100% X-ray inspection of the needle minimizes defects that may increase injection pain

• Suitable for drug products that require low-temperature storage • Custom design and molding capabilities provide the flexibility to develop innovative

new systems

About Project Research:

The activities performed during the execution of project can be classified into four sections. The

sections have been formed based on the commonality in the activities performed.

SECTIONS ACTIVITIES

THERAPY ANALYSIS

Analysis of 566 phase 1 oncology drugs

Pipeline Assessment of 1120 all phase

oncology drugs

Pipeline assessment of 818 drugs- all phase-

various diseases

Cell Therapy Industry Analysis

Analysis of Phase 2 SC biologics

GEOGRAPHICAL MARKET ANALYSIS Assessment of Japan as a market for AB

Pharma

IV Fluid Bag Market

CUSTOMER PROFILING

Preparation of decks of potential customers of

our client:

(a) Alkermes; (b) Baxalta

COMPETITORS’ ANALYSIS

Analysis of the potential competitors for the

client in the following fields:

(a) Devices,

(b) Contract Manufacturing,

(c) Patient Services,

(d) Labs & analytical services providers


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1. Company Profile

PharmaAce Analytics Private Ltd, Pune

A US-headquartered life sciences focused company that provides analytic solutions for efficient

commercialization of pharmaceutical products. Its services are designed to provide clients with

business critical research and insights enabling them to make informed decisions related to their

sales and marketing. It helps Life Sciences companies address challenges spanning across

commercial functions. It delivers custom made solutions addressing the critical business

question. Institutionalizing analytics driven decision making through value demonstration.

How does PharmaAce helps its clients globally?

• Identify activities/positions that are offshorable in ensuring cost containment

• Onshore/offshore support optimization

• Migrate processes for cost/quality benefits

• Process standardization and improvement

• Value driven delivery and engagement models

• Creating service level benchmarks


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Services Offered The services offered by PharmaAce analytics can be divided into two sections.

MARKETING ANALYTICS

• FORECASTING

• COMPETITIVE INTELLIGENCE

• MARKET ASSESSMENTS AND SIZING

SALES

ANALYTICS

• PERFORMANCE REPORTING

• SALES ANALYTICS AND DASHBOARD

• SEGMENTATION

ENGAGEMENT MODEL

Project Based Engagement

Flexibility while engaging without any

long term commitments

Cost containment in comparison to on

shore team

A reasonable “Proof of Concept” model

Flexible Services Model

Common resources and shared learning

over multiple projects

Real time analyst support

Alternative to internal expansions in

addition to bringing in cost efficiencies


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THERAPY ANALYSIS

Under therapy analysis, following activities were performed:

Analysis of 566 phase 1 oncology drugs

Pipeline Assessment of 1120 all phase oncology drugs

Pipeline assessment of 818 drugs- all phase- various diseases

Cell Therapy Industry Analysis

(A) PIPELINE ANALYSIS

Pipeline analysis involves the analysis of the products of different companies belonging

to different classes that are not yet in the market and are in developmental stage. This

involves the drugs that are in 1st, 2nd or 3rd stage of clinical trials.

Under this, analysis of 566 phase 1 oncology drugs, 1120 drugs all phase oncology drugs

and 818 drugs, all phase, various diseases.

Oncology: Some facts and figures

Global cancer incidence rates are expected to increase over the next 20 years by a

rate of 75% from 12.5 mn patients in 2008 to 22.5 mn patients in 2030.

The market has increased from roughly USD 9 bn in 1998 to USD 70 bn in 2013.

It is estimated that by 2018 the oncology market will reach more than USD 110

bn with a CAGR of 9.0

At present there are more than 500 oncology products are in pipeline which is

way more than any other therapeutics area.


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Why Oncology?

High unmet needs:

Nearly all metastatic solid tumors are uniformly fatal and many opportunities to improve

outcomes in earlier stages

Significant unmet needs remain in many hematologic malignancies, despite progress

Receptive innovation:

Key actors in market generally have been receptive to innovation (providers, patients,

payers, regulators)

Favorable dynamics:

Limited & concentrated provider universe

Historically favorable pricing, reimbursement & access environment


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METHODOLOGY:

The methodology for carrying out pipeline analysis involves Top Down approach in which we

start from total oncology products, and subsequently screen based on various parameters to

eventually arrive at a list of potential products. These products are then scored and ranked.

1. Database of oncology products from PharmaCircle is looked into

PharmaCircle is a paid database having information from various sources like patents,

company websites, clinical trials records and daily news feed. The reason for its selection

is its extensive coverage that includes 10000+ companies, 26,000+ molecules, 37,000+

FDA products and many more.

2. Validation of details by performing Secondary Research

The data and information given by PharmaCircle was needed to be validated upon before

including that into the final output. The secondary search was done to ensure its

authenticity. The sites included in secondary search were clinicaltrials.gov, umin,

ascopubmed, ncbi, etc.

3. Removal of unwanted products from PharmaCircle list

Three different pipeline analyses were performed. In the first and the second project, only

phase 1 active trials were required. Thus, all the other products that were in other phases

and the ones in phase 1 which were inactive, suspended, terminated were eliminated from

the list.

Similarly, the third activity that included the products from all phases and all diseases, no

such filtering was done.


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4. Scaling of parameters

Not all the parameters assigned to the drugs hold equal weightage. Thus, in scaling the

parameters are assigned weightage in accordance with their importance. The scores are

provided on a scale of 1-3 and final scores are calculated by multiplying weightage and

scores.

A Snapshot of the rating mechanism

used


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5. Sorted List of Products

Finally, based upon the scores calculated for the products, ranking is given to them and

the top products and companies are found out.

Summary of all oncology Phase 1

opportunities for CZ

1

16.95

14.9

13.45

13.3

11.25

10.75

10.35

10

9.8

9.5

9.35

9.35

9.3

9.15

8.35

7.15

7.05

6.75

6.3

6

7

7

7

6

5

5

6

5

5

5

6

5

4

4

5

4

4

5

3

3

Bristol-Myers Squibb Co.

Pfizer Inc.

GlaxoSmithKline Plc

AbbVie Inc.

Roche

Amgen Inc.

Genentech, Inc.

Regeneron Pharmaceuticals Inc.

Immunogen Inc.

Medimmune, LLC

Inovio Pharmaceuticals, Inc.

Seattle Genetics Inc.

OncoMed Pharmaceuticals, Inc.

Imclone Systems Inc.

Immunomedics Inc.

Agensys, Inc.

Juno Therapeutics, Inc.

OncoTherapy Science, Inc.

Daiichi Sankyo Co Ltd.

MacroGenics, Inc.

Score No. of Molecules

Top 20 companies based on product scores

Remaining 285 institutes have an average score of <6

• Companies are ranked based on the

cumulativ e score of their potential products

• Major companies that hav e a lot of

potential molecules f or CZ are BMS, Pf izer

GSK, Abbv ie, Roche, Amgen etc.

64%15%

12%

9%

IV NA

IM or SC Others*

48%

29%

22%

1%

Large Small

Cell Therapy NA

Most of the oncology products are Large molecules and are administered intrav enously

Route of Administration Molecule Type

Note: *Others comprise of intranodal, intradermal, intraperitoneal, intratumoral

and intrapleural; NA: Information Not avaiable


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(B) CELL THERAPY INDUSTRY

Cell therapy is defined as the administration of live whole cells or maturation of a

specific cell population in a patient for the treatment of a disease

Cell therapy treatment strategies include isolation and transfer of specific stem cell

populations, administration of effector cells, induction of mature cells to become

pluripotent cells, and reprogramming of mature cells

Various disease in which cell therapy is being used nowadays include blood

disorders like anemia, leukemia, lymphomas and certain types of immunodeficiency

diseases

3

Cell Therapy

Mainstream Medicine Alternate medicine

Cells of a human donor are injected into the recipient

Animal materials are injected in order to cure diseases

Allogeneic Cell Therapy

Human embryonic stem

cell therapy

Neural Stem Cell Therapy

Mesenchymal Stem Cell therapy

hematopoietic stem cell therapy

Stem Cells Services

Cord Blood Banking

Bone Marrow Transplants

Stem Cell Therapies


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Cell Therapy Projects by Therapy Area:

Major Players in Cell Therapy:

• BRITS team’s analysis of the 592 commercial cell therapy

projects that were identified highlights that the cell therapy sector is a sector that spans all key therapeutic application areas

• Oncology constitutes the largest area in which new cell therapies

are being developed as 26.2% of cell therapy projects • Followed by neurology (15.4%), alimentary/metabolic (13.4%),

cardiovascular (11.3%), and musculoskeletal as the largest therapeutic markets cell therapy projects


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Current Marketed Products

Product Company Description Route of Administration

Carticel Genzyme Autologous Cultured

Chondrocytes

Implantation of intraspinal

catheter

Epicel Genzyme Cultured Epidermal

Autograft

Topical Application

Cartistem Medipost Mesenchymal Stem

Cells derived from

umbilical cord blood

Surgical Administration

Apligraf Organogenesis Living Bi-layer skin

substitute

Topical Application

Grafix Osiris Therapeutics Cryopreserved

placental membrane

Topical Application

DeNovo Nt Zimmer and ISTO

Technology

Cartilaginous

Allograft tissue

Implantation

Trinity Evolution Orthofix Mesenchymal Stem

Cell

Implantation

Provenge Dendreon Autologous Cellular

Immunotherapy

Intravenous

BioDfence BioDlogics Allograft from Human

amniotic tissue

Implantation

ChondroCelect Tigenix Autologous Cartilage

Cells

Implantation

LaViv Fibrocell Autologous Cellular

Product

Intradermal

MACi Genzyme Autologous

Chondrocytes

Implantation


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Drivers and Barriers for Cell Therapy Market

DRIVERS BARRIERS

Advances in Basic science

revealing the nature of cell growth,

differentiation and proliferation

Advances by industry to

manipulate and determine cell

growth towards specific

therapeutic solutions

Low barrier to entry for

competitors in the market

Broad range of applications for

cell/tissue advances to many

different specialties with modest

adaptation needed

Strong venture funding

• Regulatory pathways still

emerging and can be complex

• Investor avoidance of pre-clinical

phase programs

• Hard to manage demonstration of

clinical safety and efficacy

• Move from small scale GMP

process to large scale

manufacturing is difficult

• New model of delivery required


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GEOGRAPHICAL MARKET ANALYSIS

JAPAN’S MARKET: A SOURCE OF IMMENSE OPPORTUNITIES

Japan as a market is a very attractive destination for our client. Its old age population,

favor to generic products, etc. prove to be favorable factors for a pharmaceutical

company.

AN OVERVIEW:

Japan is the World’s second largest pharmaceutical market by country

contributing to ~9.7% of the total world pharmaceutical market

Japan is the second largest medical device market in the world, behind USA and

is the World’s 3rd largest device importer

A relatively low barrier to reimbursement compared to many EU markets with a

streamlined reimbursement system compared to the complicated processes in

other countries and where Pharmacoeconomics analysis is rarely used to make

listing decisions

Until recently the Japanese pharma market, has traditionally been thought of as

isolated with domestic players mainly focused on servicing the local markets.

Now, the Japan market is becoming more open, both to foreign companies

entering the Japanese market and to Japanese companies investing abroad

Around $ 1.7 billion worth of biosimilars are going off patent in 2015 in Japan

making it lucrative for the companies and diagnosis procedure combination

(DPC) system hospitals. Anticipating the opportunity and favorable macro-

forces, a number of companies planning to enter the Japanese market

With new policies that favor generic growth, generic players across the globe are

eyeing Japan’s markets


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Trends in the Japanese Market

Establishing International Presence

Finding domestic growth opportunities amidst Japan’s biennial drug price

reduction initiatives is very difficult

In the last several years, a number of Japan's larger pharma companies have been

branching out by setting up R&D sites around the world

Mergers and Acquisitions

With very few blockbuster drugs in the market and scarce innovative treatments

in the pipeline, pharma companies around the world are refining their research

priorities and consolidating growth with a tendency for aggressive mergers and

acquisitions (M&A)

Japanese pharmaceutical companies, who were relatively absent from M&A

activities as compared to global trends, are also eyeing M&A opportunities in new

markets

Foreign Participation growing in Japanese pharmaceutical sector

Traditionally international firms have struggled to adapt to Japan's regulatory

system and working culture, but today most major pharma companies maintain a

successful presence

Government reforms like greater harmonization with EU and US regulatory

regimes and R&D tax credits have helped persuade companies to set up shop in

Japan

Japan has gradually become a popular destination for multi-regional clinical trials

(MRCTs) since 2006, shortening the time and expense involved in getting new

drugs to Japanese patients safely


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Favorable policies for Generic growth

Japan is attempting to incentivize higher use of generic drugs as a means to

reduce healthcare spending

Generic drugs have struggled to gain share in the Japan market until recently

Unconfirmed reports suggest that Japan’s government wants generic penetration

of 60% in 2017, up from just 30% in 2014

Thus generic manufacturers from around the world - especially generic specialists

like India - are looking to Japan as a source of future expansion

Medical Device Regulatory Pathway

1. Determine Regulatory Pathway

Device classification according to the PMDL

(Class 1, 2, 3, 4; classes are rated as per increasing risk to patient or user) and

Availability of a JMDN code

(Broadly based on Global Medical Device Nomenclature) Need fluency in

Japanese to make correct selection)

2. Appoint Market Authorization Holder

Manufacturers with no local presence in Japan must appoint a Marketing

Authorization Holder (MAH) or Designated MAH* to

Manage their device registration process and

Liaise with the PMDA, Japan’s medical device market regulator

3. Submit Foreign Manufacturer Accreditation Application

Submitted to the PMDA by your MAH/DMAH

Application for medical device Foreign Manufacturer Accreditation (Form No.

18)

Supporting documentation such as medical certificates, product lists and facilities

summaries

Registration form to obtain a manufacturing code


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Domestic manufacturers must register their manufacturing facilities with their

local prefectural authorities

4. Quality System Compliance

For Class II, III and IV devices manufacturers

Compliant with the PAL and MHLW Ordinance #169 (Japan QMS Regulation)

Submit QMS Conformity Assessment Application

Similar to ISO 13485 and US Quality System Regulation (21 CFR Part 820)

5. Submission to PMDA or RCB

Based on class

Class 1: Submit pre-market submission to PMDA

Class 2(Specified Controlled ): Submit pre-market Certification Application to

Registered Certification Body

Class 2, 3, 4: Prepare Pre-market Approval Application and Supporting

documents as attachment with documents in Summary Technical Document

Format and Submit to PMDA

The PMDL will allow more Class II as well as some Class III devices to qualify

for third-party certification

6. Quality System Auditing

Based on class

Class 2(Specified Controlled ): QMS Audit by RCB

Class 2, 3, 4: QMS Audit by the PMDA for foreign manufacturers or by the

Prefectural Regulatory Authority for domestic manufacturers

The PMDA conducts on-site audits for new medical devices, Class IV devices

and devices requiring clinical investigations

7. Final PMDA or RCB certification

Class 1: Self-declaration; No Certification from PMDA (0mths)

Class 2(Specified Controlled ): Pre-market Certification issued by RCB (3-6

mths)

Class 2, 3, 4: Pre-market Approval Certificate Issued by MHLW; Certificate does

not expire (8-16mths)

Approvals do not expire but are subject to ongoing QMS requirements.


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CUSTOMER PROFILING

Our client being a producer of drug delivery devices is constantly in search of the customers that

can use its devices to dispense their medications.

During the search for ideal customers, two companies i.e. Alkermes and Baxalta were analyzed

upon and decks were prepared.

Reasons for the selection of Alkermes and Baxalta

Both Baxalta and Alkermes are emerging companies. It is easier for our client to tap the

emerging companies than the more established ones.

There has been a steady increase in the revenue of both these companies. This implies the

higher sale of products of these companies making them a perfect partner to work with.

Alkermes and Baxalta have collaborations with big companies regarding one or more

products. This provides our client an indirect access to these big companies via them.

Majority of the inline as well as pipeline products of Baxalta and Alkermes are

injectables. Since, the core competency of our client is in injectables section, this makes

them a perfect match.

Both the companies are involved with the manufacture of bio logics. Since, the most

preferred route for biologics is through injections, thus, the companies are good options

for our client..


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Attributes

Location

Wilmington, US; Dublin,

Ireland; Athlone, Ireland;

Gainesville, US; Waltham,

Massachussetts

Cambridge, Massachussetts;

Northern Illinois, US

Revenue $618.78 mn (2014) $6 bn (2014)

Business Partners Johnson & Johnson; Lily; Elan

technologies; Acceleron; Astra

Zeneca; Acorda; Civitas

Nektar; Kaketsuken;

Halozyme; Kamada;

Momenta; Onconova;

Coherus; Cti; Merrimack

Inline Products Risperdal Consta; Vivitrol;

Bydureon; Ampyra; Xeplion;

Invega Sustenna

Advate; Rixubis;

Recombinate; Bebulin; Feiba;

Obizur; Hyqvia; Aralast;

Glassia

Pipeline Products ALKS 5461; ALKS 3831;

ALKS 8700; RDB 1450;

ALKS 7119

BAX 817; BAX 111; BAX

855; BAX 335; BAX 930;

BAX 2200; SM 101; BA 923;

Gammagard Liquid; etc


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COMPETITORS’ ANALYSIS

• With the passage of time, AB is planning to explore new geographies and along with that

new dimensions what it has not touched yet

• AB, being a leader in packaging devices, now plans to move into other areas like contract

manufacturing, Patient consultancy services and analytical services sector

• The competitors’ analysis section gave an overview of the potential competitors that AB

needs to face in its area of expertise i.e. Medical Devices and the areas that it is yet to

explore

Process:

• The competitors’ analysis process consisted of first identifying the competitors that AB

has in various fields

• After the identification, information was gathered with regard to their location, their

revenue, history, core competencies and most important, the services each of them

provide

• The companies analyzed belonged to 4 sectors:

Medical Devices

Contract Manufacturing

Patient Consultancy Services

Labs and Analytical Services Providers


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Competitors of AB Pharma (Devices, Contract Manufacturing & Patient Services)

Competitors of AB Pharma (Labs and Analytical Service Providers)

LEARNINGS:

1. ART OF PRESENTATION

Present information in a compact manner

To say a lot in few words

2. INTRODUCTION TO CONSULTING

Got introduced with various aspects of consulting:

Market analysis

Competitive intelligence

Pipeline assessment


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3. CLINICAL TRIALS SEARCH

Search of around 2000 drugs

Good practice of clinical trials search

Awareness of the sources of clinical trials, eg clinicaltrials.gov; ASCO pubmed;

UMIN.ac.jp; etc.

4. DATA ENTRY AND ANALYSIS

Good practice of excel

Got introduced with new features of excel and their usage

5. DATA VALIDATION

Got idea about the methodology of validation, and

Rectification of mistakes, if any

6. KNOWLEDGE OF PHARMA WORLD

Overview of different aspects of market

Every activity performed provided great deal of knowledge about that topic

bishwjit ghoshal_summer internship report 2015

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