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CAPSTONE PROJECT

TITLE: PRODUCT LIFE CYCLE MANAGEMENT OF TAPENTADOL

(ANALGESIC) WITH COMPARISON AMONGST FOUR BRANDS WITH

THE REFERENCE TO PRODUCT CANNIBALIZATION TECHNIQUE

SUBMITTED BY: INDRANEEL SINHA

POST GRADUATE DIPLOMA IN PHARMACEUTICAL MANAGEMENT

INDIAN INSTITUTE OF HEALTH MANAGEMENT & RESEARCH, JAIPUR

25 NOVEMBER 2011

MENTOR & FACULTY CO ORDINATOR: Dr. SEEMA MEHTA

INDIAN INSTITUTE OF HEALTH MANAGEMENT & RESEARCH, JAIPUR

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ACKNOWLEDGEMENT

I take immense pleasure in thanking the IIHMR, Jaipur Administrators and Faculty members for giving

me the opportunity to work in Capstone Project 2011 as a Project Researcher.

I wish to express my deep sense of gratitude to my Mentor, Dr. Seema Mehta, IIHMR, Jaipur for

guiding me throughout my project and for her wise suggestions and crisp advice which helped me

complete the project in time.

I would like to thank Mr. Makrand Upadhaya and Mr. Abhishek Dadhich for their guidance.

I would also like to thank Dr.Monika Chowdhury (mentor, Faculty, IIHMR) for her timely guidance

during the conduct of training.

Finally, yet importantly, I would like to express my heartfelt thanks to my beloved parents for their

blessings, my friends/classmates for their help and wishes for the successful completion of this project.

Indraneel Sinha

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INDEX

S.NO. CONTENT PAGE NO.

1 INTRODUCTION 7

2 BACKGROUND 11

3 RATIONALE 13

4 LITERATURE REVIEW 14

5 PRODUCT LIFE CYCLE MANAGEMENT 18

6 PRODUCT LIFE CYCLE 23

7 OBJECTIVES 28

8 BRIEF PROCEDURE OUTLINE 29

9 STUDY DESIGN &RESEARCH

METHODOLOGY 30

10 ANALYSIS & RESULTS 33

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11 FINDING & CONCLUDARY REMARKS 37

12 QUESTIONNAIRES 39

13 REFERENCES 42

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LIST OF FIGURES

S.no. Content of figures Page no.

1 Generic life cycle of product 7

2 Stages of life cycle of product 10

3 Product Life Cycle with aid of Product

Cannibalisation 13

LIST OF GRAPHS

S. No. Content of Graphs Page No.

1 PLC Curve 23

2 Graphical representation of Primary

data from Chemists 33

3 Graphical representation of Primary

data from Doctors 34

4 Graphical representation of Primary

data from Medical Representatives 35

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LIST OF TABLES

S. no Table content Pg.

No.

1 Stages of PLC 9

2 Major players in Indian Pharmaceutical Sector 12

3 Possible Strategies of PLCM Phases 38

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INTRODUCTION

In industry, product lifecycle management (PLM) is the process of managing the entire lifecycle of a

product from its conception, through design and manufacture, to service and disposal. PLM integrates

people, data, processes and business systems and provides a product information backbone for

companies and their extended enterprise.

Product lifecycle management (PLM) should be distinguished from 'Product life cycle management

(marketing)' (PLCM). PLM describes the engineering aspect of a product, from managing descriptions

and properties of a product through its development and useful life; whereas, PLCM refers to the

commercial management of life of a product in the business market with respect to costs and sales

measures.

Fig 1: Generic Life Cycle of a Product

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Product life-cycle management (or PLCM) is the succession of strategies used by business

management as a product goes through its life cycle. The condition in which a product is sold

(advertising, saturation) changes over time and must be managed as it moves through its succession of

stages.

Product life cycle (PLC) Like human beings, products also have a life cycle. From birth to death,

human beings pass through various stages e.g. birth, growth, maturity, decline and death. A similar life

cycle is seen in the case of products. The product life cycle goes through multiple phases, involves many

professional disciplines, and requires many skills, tools and processes. Product life cycle (PLC) has to

do with the life of a product in the market with respect to business/commercial costs and sales measures.

To say that a product has a life cycle is to assert three things:

Products have a limited life,

Product sales pass through distinct stages, each posing different challenges,

opportunities, and problems to the seller,

Products require different marketing, financing, manufacturing, purchasing, and human

resource strategies in each life cycle stage.

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Table 1: Stages of Product Life Cycle

All products and services have certain life cycles. The life cycle refers to the period from the product’s

first launch into the market until its final withdrawal and it is split up in phases. During this period,

significant changes are made in the way that the product is behaving into the market i.e. its reflection in

respect of sales to the company that introduced it into the market. Since an increase in profits is the

major goal of a company that introduces a product into a market, the product’s life cycle management is

very important. Some companies use strategic planning and others follow the basic rules of the different

life cycle phase that are analyzed later.

The understanding of a product’s life cycle, can help a company to understand and realize when it is

time to introduce and withdraw a product from a market, its position in the market compared to

competitors, and the product’s success or failure. For a company to fully understand the above and

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successfully manage a product’s life cycle, needs to develop strategies and methodologies, some of

which are discussed later on.

Fig 2: Stages in Life Cycle of a Product

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BACKGROUND: The Indian Pharma Scenario

India currently represents just U.S. $6 billion of the $550 billion global pharmaceutical industry but its

share is increasing at 10 percent a year, compared to 7 percent annual growth for the world market

overall. In addition, while the Indian sector represents just 8 percent of the global industry total by

volume, putting it in fourth place worldwide, it accounts for 13 percent by value, and its drug exports

have been growing 30 percent annually.

The “organized” sector of India's pharmaceutical industry consists of 250 to 300 companies, which

account for 70 percent of products on the market, with the top 10 firms representing 30 percent.

However, the total sector is estimated at nearly 20,000 businesses, some of which are extremely small.

Approximately 75 percent of India's demand for medicines is met by local manufacturing. According to

the German Chemicals Association, in 2005, India's top 10 pharmaceutical companies were Ranbaxy,

Cipla, Dr. Reddy's Laboratories, Lupin, Nicolas Piramal, Aurobindo Pharma, Cadila Pharmaceuticals,

Sun Pharma, Wockhardt Ltd. and Aventis Pharma. Indian-owned firms currently account for 70 percent

of the domestic market, up from less than 20 percent in 1970. In 2005, nine of the top 10 companies in

India were domestically owned, compared with just four in 1994.

India's potential to further boost its already-leading role in global generics production, as well as an

offshore location of choice for multinational drug manufacturers seeking to curb the increasing costs of

their manufacturing, R&D and other support services, presents an opportunity worth an estimated $48

billion in 2007.

Different area of pharmaceutical sector broadly includes –

Research & Development

Production

Clinical trials

Marketing

Sales

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Table 2: Some major players in the Indian pharmaceutical sector

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RATIONALE

Pain is an unpleasant and discomforting sensation generally evoked by noxious stimulants, which may

be internal or external. Pharmaceutical and Medical industry’s answer to solving this issue was the

development of Analgesics, which in layman’s language is more popularly known as pain killers. There

are numerous formulations and APIs that are being developed and sold by many Indian pharmaceutical

organisations.

Thus, it paved a way for us to focus my interest on analgesics as a product of choice as for the

accomplishment of this project, as securing well profound data would be easier to procure. Once we

finalised the product category, it struck us that why not study the PLC of it. As a general basic

guideline, greater understanding of the molecule is only possible if we carefully study the details of the

product starting from its inception to its decline.

Another interesting fact that struck us was a well-known and widely popular analgesic was Tramadol

(Instril by DRL, Nexdol by Zuventus, and Trabest by Lupin). It was launched back in the 1980s and was

a hugely successful molecule. But as of late this product is being pushed out by Tapentadol ( Transdol

by Lupin, Tapenta by Zuventus, Tapel by MSN, Neap by DRL). This product is superior than its

predecessor in numerous aspects which has been discussed later. This particular technique of PLC is

known as Product Cannibalism. In this study we have taken special interest to understand that how a

predecessor product is followed by a newer, modified much better product in the same category to

prevent decline of it. It also gives me the chance to understand how the market dynamics will be

affected by the newer product as it starts to grow from the peak of the pre-existing product.

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LITERATURE REVIEW

“Pharmaceutical Product Lifecycle Management Technology Gaining Momentum”:

Datamonitor report by Markella Kordoyanni

Growing regulatory pressure, competition will drive adoption of product lifecycle management (PLM)

software and services in the pharmaceutical industry. This is according to a new report by independent

market analyst Datamonitor titled "Streamlining Information in the Pharmaceutical Industry with

PLM." The report estimates spend on PLM by the pharmaceutical industry in Europe, North America,

China and Japan will total $460.2 million by the end of 2007 and expects this to more than double by

2012.

The report offers insight into four key attributes that pharmaceutical companies should look for in a

PLM technology vendor, discusses successful PLM strategies, and argues that collaborating with a

technology vendor is beneficial to both the pharmaceutical company and the vendor. It notes that while

PLM at its core aligns closely with the pharmaceutical industry's business processes, most current PLM

technologies lack configurability attributes and other essential features.

"Product lifecycle management (PLM) software and services solutions are still a nascent market for the

pharmaceutical industry," says Markella Kordoyanni, pharmaceutical technology analyst at Datamonitor

and author of the study. "Although the industry is starting to recognize the potential benefits of PLM in

drug development, unless pharmaceutical companies adopt a strategic mindset about PLM, with all the

process management changes and cultural adaptations it requires, PLM will remain a tactical solution

whose potential is not maximized."

Pharmaceutical companies constantly strive to accelerate drug development processes, and decrease the

time it takes to bring a drug to market, since the window from discovery to launch is both lengthy and

costly. As competition from generic drugs grows, the industry has an additional motive to shorten the

time it takes to bring a drug to market. Furthermore, as mergers and acquisition (M&A) activity

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continues, companies are in need of tools, such as PLM, to harmonize their product portfolios and

enhance visibility across the entire pipeline.

PLM addresses the challenges of managing a portfolio of tens or hundreds of drug candidates, from

disparate research and development (R&D) facilities and manufacturing plants spread across the globe.

Adding to the business drivers for investing in PLM is the increasing pressure by regulatory bodies that

emphasize compliance to ensure drug safety. As a result, the industry is in need of sophisticated tools

that automate research processes and create electronic trails that can help reduce non-compliance errors.

PLM supports regulatory compliance by including applications that track adherence to regulation codes

and identify risks of non-compliance.

In such a data-rich industry as Pharma, knowledge tends to be diluted quickly unless each organization

adopts an effective methodology for transferring knowledge and for ensuring visibility and access to

critical information when and where it is needed. In addition to being a data-rich environment, the

pharmaceutical drug development process is characterized by heterogeneity and fluidity. Here,

scientists, compliance staff, and engineers work with multiple protocols, materials, internal and external

partners, constantly adapting their workflows according to experimental results. Although the degree of

variability tends to decrease as the drug lifecycle progresses, a flexible PLM system that can keep up

with this iterative process is crucial in supporting the development needs of the drug lifecycle.

Datamonitor believes that only an enterprise-wide system will maximize the value of PLM in a

pharmaceutical company by offering the visibility, and flexibility the organization needs across its

otherwise isolated functional departments. Furthermore, recognizing the value of an enterprise PLM

solution indicates that the organization has a strategic view of PLM, rather than a tactical and merely

technical view. In fact, a strategic approach to PLM necessitates an enterprise-wide system.

Today, PLM solutions have been slow in adoption by the pharmaceutical industry primarily because

implementation takes anywhere between six months and two year. This indicates that current PLM

products sold to pharmaceutical and biotechnology companies require tremendous amount of

customization and configuration before they can be used within that type of environment. Datamonitor

believes that PLM technology for the pharmaceutical industry will be widely adopted once vendors are

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able to offer configurable packages rather than customized PLM projects or horizontal packaged

solutions that may lack the necessary applications needed for the industry.

In the meantime, collaborating with a vendor may be a necessary strategy for pharmaceutical

companies. Some of the most successful and innovative pharmaceutical companies have collaborated

with a technology vendor to pursue a customized enterprise PLM implementation. Partnerships can

ensure that the technology fits the company's needs. Partnerships also provide technology vendors will a

longer-term success than simply selling PLM products and services. By working collaboratively with

the organization to develop the solution, vendors can gain the organization's loyalty, trust and business

for years to come. Datamonitor believes that partnerships can be most successful when vendors fit the

following four criteria: a long-term commitment to the project, a flexible and innovative mindset for

conducting business, an efficient implementation strategy, and a record of accomplishment of success.

Kordoyanni concludes:

"PLM must begin earlier and be more comprehensive than it has been in the past. Only those PLM

technologies that are aligned with business processes will maximize value within the organization.

Organizations which do not make the necessary transition to PLM, either alone or through partnerships,

will shortly find themselves lagging behind their more forward-thinking competitors who will be

enjoying the benefits of their new knowledge-based centralized resources."

Datamonitor's report, "Streamlining Information in the Pharmaceutical Industry with PLM" analyzes

the pharmaceutical product lifecycle management (PLM) market and offers insight into four key

attributes that pharmaceutical companies look for in a PLM technology vendor. The research

methodology is based in part on Datamonitor's Business Trends surveys and primary interviews with

vendors and end-users. Geographic coverage includes the US, Canada and Western Europe.

Markella Kordoyanni, pharmaceutical technology analyst at Datamonitor and author of this report, is

available for comment.

Datamonitor is a premium businesses information company specializing in industry analysis. They help

clients, 5000 of the world's leading companies, to address complex strategy issues. Through their

proprietary databases and wealth of expertise, they provide clients with unbiased expert analysis and in-

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depth forecasts for six industry sectors; Automotive, Consumer Markets, Energy, Financial Services,

Healthcare and Technology. Datamonitor maintains its headquarters in London and has regional offices

in New York, Frankfurt, Hong Kong, Shanghai, Sydney and Tokyo.

- “Pharmaceutical Product Lifecycle Management Technology Gaining Momentum”:

Datamonitor report by Markella Kordoyanni

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UNDERSTANDING PLC MANAGEMENT WITH THE REFERENCE OF:

PRODUCT CANNIBALISATION TECHNIQUE

Getting to the product: TAPENTADOL

Introduction

Tapentadol (brand name Nucynta by Jhonson & Jhonson) is a centrally acting analgesic with a dual

mode of action as an agonist at the μ-opioid receptor and as a norepinephrine reuptake inhibitor. While

its analgesic actions have been compared to Tramadol and oxycodone, its general potency is somewhere

between tramadol and morphine in effectiveness. Tapentadol is a new molecular entity that is

structurally similar to Tramadol. It has opioid and non opioid activity in a single compound.

November 25, 2008- The US Food and Drug Administration (FDA) has announced approval of

18apentadol hydrochloride (Johnson & Johnson), an oral tablet for the relief of moderate to severe acute

pain. Due to the dual mechanism of action as an opioid agonist and norepinephrine reuptake inhibitor,

there is potential for off label use in chronic pain.

Doctors use serotonin and norepinephrine reuptake inhibitors in chronic pain management to increase

the effectiveness of opioids and, to a lesser extent NSAIDs (along with other analgesics) against

neuropathic pain and from certain specific contributing causes such as fibromyalgia and diabetic

neuropathy.

Its dual mode of action provides analgesia at similar levels of more potent narcotic analgesics such

as hydrocodone, oxycodone, and pethidine (meperidine) with a more tolerable side effect profile.

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Chemical structure

Name

Tapentadol

Synonyms

3-((1R,2R)-3-(Dimethylamino)-1-ethyl-2-methylpropyl)phenol

Molecular Structure

Molecular Formula

C14H23NO

Molecular Weight

221.34

CAS Registry Number

175591-23-8

Mechanism of action

Tapentadol was characterized as an µ-opioid receptor agonist and a norepinephrine transporter inhibitor

in receptor binding assays and in functional µ-opioid receptor and norepinephrine synaptosomal

reuptake assays. Norepinephrine and µ-opioid receptor reuptake inhibitors have analgesic effects,

although the pain conditions in which these two drug classes are most efficacious may be different. For

example, it appears that µ-opioid receptor agonists are mostly effective against acute moderate-to-severe

pain, whereas norepinephrine reuptake inhibitors are particularly effect against chronic pain. This

implies that a medication that combines both mechanisms of action may be effective a broad spectrum

of pain conditions.

Pharmacodynamics

Tapentadol is a centrally acting oral analgesic with a dual mechanism of action, combining µ-opioid

receptor agonist and norepinephrine reuptake inhibition in a single molecule. Norepinephrine plays a

role in the endogenous descending pain inhibitory system, and the analgesic efficacy of norepinephrine

reuptake inhibitors has been shown in neuropathic pain.

Analgesic effect of tapentadol has been demonstrated in a wide range of animal models of pain with

nociceptive and neuropathic components, and development of tolerance to its analgesic effect was

twice as slow as that of morphine. Although tapentadol has a 50-fold lower binding affinity to µ-opioid

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receptor, its analgesic potency is only 2 to 3 times lower than that of morphine, indicating that the dual

mode of action may result in an opiate-sparing effect.

Pharmacokinetics

Absorption:

Mean absolute bioavailability after single-dose administration (fasting) of tapentadol is approximately

32% due to extensive first-pass metabolism. Maximum serum concentrations of tapentadol are

observed between 3 and 6 hours after administration of NUCYNTA™ CR. Dose proportional

increases in serum AUC were observed following administration of NUCYNTA™ CR as single doses

over a range of 50-250 mg. The increase in serum Cmax values was greater than proportional to the

increase in dose over this range. The deviation from dose-proportionality for mean Cmax values

ranged from 14% to 26% with each increase in dose from 50 to 250 mg.

Steady-state exposure of tapentadol is attained following the third dose (i.e., within 36 hours after first

twice-daily multiple dose administration). Mean serum tapentadol Cmax values accumulated

approximately 1.7-times following dosing with 150 mg every 12 hours, relative to single-dose

administration. The serum accumulation ratio is primarily determined by the dosing interval and

apparent half-life of tapentadol.

Distribution:

Tapentadol is widely distributed throughout the body. Following intravenous administration, the

volume of distribution (Vz) for tapentadol is 540 +/- 98 L. The plasma protein binding is low and

amounts to approximately 20%.

Metabolism and Elimination:

In humans, the metabolism of tapentadol is extensive. About 97% of the parent compound is

metabolized. Tapentadol is mainly metabolized via Phase 2 pathways, and only a small amount is

metabolized by Phase 1 oxidative pathways. The major pathway of tapentadol metabolism is

conjugation with glucuronic acid to produce glucuronides. After oral administration, approximately

70% (55% O-glucuronide and 15% sulfate of tapentadol) of the dose is excreted in urine in the

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conjugated form. A total of 3% of drug was excreted in urine as unchanged drug. Tapentadol is

additionally metabolized to N-desmethyl tapentadol (13%) by CYP2C9 and CYP2C19 and to hydroxy

tapentadol (2%) by CYP2D6, which are further metabolized by conjugation. Therefore, drug

metabolism mediated by the cytochrome P450 system is of less importance than phase 2 conjugation.

Side Effects

Weak or shallow breathing, weak pulse, slow heartbeat;

Seizure (convulsions);

Severe drowsiness or dizziness;

Confusion, problems with speech or balance; or

Agitation, hallucinations, fever, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea,

loss of coordination, fainting.

Mild nausea or vomiting;

Constipation;

Mild dizziness, drowsiness;

Dry mouth;

Itching;

Increased sweating.

Dosage and Administration

Recommended dose for adults is 50-100mg by mouth as needed every 4-6 hours without regard

to meals.

If adequate pain control is not achieved following the initial dose, a second dose can be

administered as early as 1 hour following the initial dose, with dose titration up to a maximum

total daily dose of 700mg on the initial day of therapy.

Subsequent maximum daily dosing is 600mg.

Hepatic Impairment

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o No dose adjustment recommended in mild impairment

o In patients with moderate hepatic impairment, an initial dose of 50mg every 8 hours is

recommended, with further dose/frequency titration based on resulting analgesia and

tolerability.

o Use of tapentadol in severe hepatic impairment (Child-Pugh Class C) has not been

studied and is not recommended.

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PRODUCT LIFE CYCLE

PART 1: PRODUCT LIFE CYCLE MODEL DESCRIPTION

The product’s life cycle - period usually consists of five major steps or phases:

Product development,

Product introduction,

Product growth,

Product maturity and finally

Product decline.

These phases exist and are applicable to all products or services from a certain make of automobile to a

multimillion-dollar lithography tool to a painkilling molecule. These phases can be split up into smaller

ones depending on the product and must be considered when a new product is to be introduced into a

market since they dictate the product’s sales performance.

Graph 1: PLC with aid of Product Cannibalisation

Existing Product

(Tramadol)

New Product

(Tapentadol)

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1. PRODUCT DEVELOPMENT PHASE

Product development phase begins when a company finds and develops a new product idea. This

involves translating various pieces of information and incorporating them into a new product. A product

is usually undergoing several changes involving a lot ofmoney and time during development, before it is

exposed to target customers via test markets. Those products that survive the test market are then

introduced into a real market place and the introduction phase of the product begins. During the product

development phase, sales are zero and revenues are negative. It is the time of spending with absolute no

return.

2. INTRODUCTION PHASE

The introduction phase of a product includes the product launch with its requirements to getting it

launch in such a way so that it will have maximum impact at the moment of sale. This period can be

described as a money sinkhole compared to the maturity phase of a product. Large expenditure on

promotion and advertising is common, and quick but costly service requirements are introduced. A

company must be prepared to spent a lot of money and get only a small proportion of that back. In this

phase distribution arrangements are introduced. Having the product in every counter is very important

and is regarded as an impossible challenge. Some companies avoid this stress by hiring external

contractors or outsourcing the entire distribution arrangement. This has the benefit of testing an

important marketing tool such as outsourcing. Pricing is something else for a company to consider

during this phase. Product pricing usually follows one or two well structured strategies. Early customers

will pay a lot for something new and this will help a bit to minimize that sinkhole that was

mentioned earlier. Later the pricing policy should be more aggressive so that the product can become

competitive. Another strategy is that of a pre-set price believed to be the right one to maximize sales.

This however demands a very good knowledge of the market and of what a customer is willing to pay

for a newly introduced product. A successful product introduction phase may also result from actions

taken by the company prior to the introduction of the product to the market. These actions are included

in the formulation of the marketing strategy. This is accomplished during product development by the

use of market research. Customer requirements on design, pricing, servicing and packaging are

invaluable to the formation of a product design. A customer can tell a company what features of the

product are appealing and what are the characteristics that should not appear on the product. He will

Pre-existing

product (Tramadol)

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describe the ways of how the product will become handy and useful. So in this way a company will

know before its product is introduced to a market what to expect from the customers and competitors. A

marketing mix may also help in terms of defining the targeted audience during promotion and

advertising of the product in the introduction phase.

3. GROWTH PHASE

The growth phase offers the satisfaction of seeing the product take-off in the marketplace. This is the

appropriate timing to focus on increasing the market share. If the product has been introduced first into

the market, (introduction into a “virgin”market or into an existing market) then it is in a position to gain

market share relatively easily. A new growing market alerts the competition’s attention. The company

must show all the products offerings and try to differentiate them from the competitors ones. A frequent

modification process of the product is an effective policy to discourage competitors from gaining market

share by copying or offering similar products. Other barriers are licenses and copyrights, product

complexity and low availability of product components. Promotion and advertising continues, but not in

the extent that was in the introductory phase and it is oriented to the task of market leadership and not in

raising product awareness. A good practice is the use of external promotional contractors. This period is

the time to develop efficiencies and improve product availability and service. Cost efficiency and time-

to-market and pricing and discount policy are major factors in gaining customer confidence. Good

coverage in all marketplaces is worthwhile goal throughout the growth phase. Managing the growth

stage is essential. Companies sometimes are consuming much more effort into the production process,

overestimating their market position. Accurate estimations in forecasting customer needs will provide

essential input into production planning process. It is pointless to increase customer expectations and

product demand without having arranged for relative production capacity. A company must not make

the mistake of over committing. This will result into losing customers not finding the product “on the

self”.

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4. MATURITY PHASE

When the market becomes saturated with variations of the basic product, and all competitors are

represented in terms of an alternative product, the maturity phase arrives. In this phase market share

growth is at the expense of someone else’s business, rather than the growth of the market itself. This

period is the period of the highest returns from the product. A company that has achieved its market

share goal enjoys the most profitable period, while a company that falls behind its market share goal,

must reconsider its marketing positioning into the marketplace. During this period new brands are

introduced even when they compete with the company’s existing product and model changes are more

frequent (product, brand, model). This is the time to extend the product’s life. Pricing and discount

policies are often changed in relation to the competition policies i.e. pricing moves up and down

accordingly with the competitors one and sales and coupons are introduced in the case of consumer

products. Promotion and advertising relocates from the scope of getting new customers, to the scope of

product differentiation in terms of quality and reliability. The battle of distribution continues using multi

distribution channels2. A successful product maturity phase is extended beyond anyone’s timely

expectations. A good example of this is “Tide” washing powder, which has grown old, and it is still

growing.

5. DECLINE PHASE

The decision for withdrawing a product seems to be a complex task and there a lot of issues to be

resolved before with decide to move it out of the market. Dilemmas such as maintenance, spare part

availability, service competitions reaction in filling the market gap are some issues that increase the

complexity of the decision process to withdraw a product from the market. Often companies retain a

high price policy for the declining products that increase the profit margin and gradually discourage the

“few” loyal remaining customers from buying it. Sometimes it is difficult for a company to

conceptualize the decline signals of a product. Usually a product decline is accompanied with a decline

of market sales. Its recognition is sometimes hard to be realized, since marketing departments are

usually too optimistic due to big product success coming from the maturity phase. This is the time to

start withdrawing variations of the product from the market that are weak in their market position. This

must be done carefully since it is not often apparent which product variation brings in the revenues. The

prices must be kept competitive and promotion should be pulled back at a level that will make the

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product presence visible and at the same time retain the “loyal” customer. Distribution is narrowed. The

basic channel is should be kept efficient but alternative channels should be abandoned.

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OBJECTIVES & PROBLEM STATEMENTS

To analyse the market of analgesics and learn about PLCM for product: Tapentadol (centrally

acting analgesics).

To study Product Life Cycle Management with the aid of Cannibalization Technique

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BRIEF PROCEDURE OUTLINE

After selecting the brands, we prepared a questionnaire for CHEMISTS, DOCTORS &

MEDICAL REPRESENTATIVES (Data pool).

We divided the entire questionnaire in the ratio of 60:20:20 (Chemists:Doctors:MR)

The entire questionnaire was based on product life cycle management (PLC).

The survey was decided to be conducted in various areas like;- Jaipur, Ajmer, Bhilwara, Kolkata,

Saharanpur, Haridwar, Dehradun, Bhusawal, Siliguri, Bengaluru etc..

Initial survey conducted on Chemist (asking the questions regarding Tapentadol like- “How you

came to know about Tapentadol?” ; “What is its market perception?” etc...)

After collecting the appropriate information from the Chemists we then approached Doctors and

asked her/his perception about the Tapentadol.

Finally, we visited some medical representatives and asked them their strategy regarding launch

of Tapentadol.

The reason for taking Tapentadol as a subject for project was to find out the market share of

Tapentadol in today’s market against the common prescribed drug Tramadol

Tramadol was launched in 1970’s, factually it is in its maturity phase since the last few years so

to prevent the eviction of the product from the market in analgesic category companies had

launched a new product named Tapentadol with dual mode of action, better effects and less side

effects.

Each of the companies prefers to follow the process of cannibalisation. Cannibalisation is most

commonly a technique where a company is selling the same category (analgesic) product in its

modified and newer form.

By cannibalisation method, companies did not withdraw Tramadol from the market all of a

sudden but now focuses on the growth of Tapentadol (which is superior) depicting it as a more

effective drug in such a way that sale of Tapentadol does not affect the sales figure of Tramadol,

instead it (Tapentadol) will grow starting from the matured phase of its predecessor (Tramadol)

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STUDY DESIGN & RESEARCH METHODOLOGY UNDERTAKEN

The goal of the research project was to acquire new knowledge, or deepen understanding of the topic or

issue. This process took three main forms:

Exploratory research, which structures and identifies new problems.

Constructive research, which develops solutions to a problem.

Empirical research, which tests the feasibility of a solution using empirical evidence.

Primary research: Was based on the original findings in the field. A detailed set of questionnaire

was carefully prepared keeping the objectives and problem statement in mind. The primary

research yielded the data which was known as primary data. The data was collected manually in

local areas of Jaipur. To add a more interactive side to the project further, the form was e-mailed

and sent across to other parts of India such as: Kolkata, Siliguri, Dehradun, Haridwar,

Bengaluru, Bhusawal, Ajmer & Bhilwara. This enabled us to get access to a wide pool of data

from diversified locations spanning across India.

Secondary research: The primary data acquired was assessed and was then compared and

analyzed with available data. The sources of available data were: Field reports available at online

portals, sale turnovers from chemists etc. These were then compared with the primary data to get

a secondary data, and the process by which it was got is categorized as secondary research.

Qualitative research was conducted to understand human behavior and the reasons that govern

such behavior. Broad and open ending question method was followed and collecting word-type

data was done. This type of research looks to describe a population without attempting to

quantifiably measure variables or look to potential relationships between variables. It is viewed

as more restrictive in testing hypotheses because it is extremely expensive and time consuming,

and typically limited to a single set of research subjects. Qualitative research helped us for

exploratory research as a basis for later quantitative research hypotheses.

31

Quantitative research is systematic empirical investigation of quantitative properties and

phenomena and their relationships. We framed narrow questions (statistics oriented) and

collected numerical data to analyze utilizing statistical methods. The quantitative research

designs are experimental, correlational, and survey (or descriptive). Statistics derived from

quantitative research can be used to establish the existence of associative or causal relationships

between variables.

My Capstone Research Project was conducted using the hourglass model structure of research.

The hourglass model starts with a broad spectrum for research, focusing in on the required

information through the methodology of the project (like the neck of the hourglass), then

expands the research in the form of discussion and results.

Methodology is generally a guideline for solving a problem, with specific components such as phases,

tasks, methods, techniques and tools.

A project methodology tells us what we have to do, to manage our projects from start to finish. It

describes every step in the project life cycle in depth, so we know exactly which tasks to complete,

when and how. Whether we are an expert or a novice, it helps us to complete tasks faster than before.

Steps evolved in Research Process:

o Data Collection Method- Data is collected qualitatively by asking the select data pool to fill the

questionnaire prepared for each individual category.

o Sample Size- Total hundred questionnaires were prepared by dividing the pool into ratio of:

sixty chemists, twenty doctors and twenty medical representatives.

o Sampling extent- Jaipur, Ajmer, Bhilwara (Rajasthan); Kolkata, Howrah, Siliguri (West

Bengal); Bhusawal (Maharashtra); Dehradun, Haridwar (Uttarakhand); Saharanpur ( Uttar

Pradesh) & Bengaluru (Karnataka)

32

o Sampling Method- The method used by the group is convenient sampling which is the part of

Non Probability Sampling Method

o Contact Method- The pool was contacted in person, by phone and by emails.

o Tool for Data Collection- Various parameters included in tools for data collection comprises of

appropriate questionnaires, observation sheet, interview schedule, data sheets.

o Tool for Data Analysis- Data is analyzed by Graphical techniques (Bar graphs & Pie charts) and

Frequency Counts Methods using MS Excel.

33

ANALYSIS & RESULTS

Graph 2: REPRESENTATION OF PRIMARY DATA FROM CHEMISTS (Data pool 1)

INFERENCE:

Evidently, from the graph we can make out that in the category Prescriptive Analgesics, Tramadol is the

leader and it is in its Maturity phase. On an average the market data we procured, it was equated

approximately that Tramadol sales in the market was higher, but on seeing the recent developments 30-

40% of the Tramadol sales shares are being captured by Tapentadol (Cannibalising approach). The

reasons for such a shift being dual mode of action of Tapentadol and lesser costs. The highest selling

product in this category is Transdol by Lupin. The market perception for it is bright and promising. Well

recognition of brand, availability of good scientific literature and effective marketing has boosted sales

0

5

10

15

20

25

30

35

40

45

Prescriptive Medicine

Non Prescriptive Highest selling product

Market Perception

Tramadol

Aceclofenac

Tapentadol

Diclofenac

Ibuprofen

Nimesulide

Lupin

MSN

DRL

Zuventus

Promising

Satisfactory

Don’t know

Nu

mb

er o

f R

esp

on

den

ts

34

for Lupin. This has also propelled them to launch another generic product by the name of Lucynta in

another division.

Graph 3: REPRESENTATION OF PRIMARY DATA FROM DOCTORS (Data pool 2)

INFERENCE:

While the data came in from the medical professionals, i.e the Doctors, Tapentadol is the clear leader

indicating that, this new molecule has an effective introduction and is steadily building its growth curve.

This molecule though a bit costlier than Tramadol, but still is popular nowadays with doctors due to its

sheer quality and dual mode of action, lesser side effects, good analgesic effectivity. Doctors perceive

Tapentadol’s market as bright and promising compared to its predecessor analgesic (Tramadol) and

thus Tramadol is losing out on the Maturity phase and will be moving into the Decline phase in the near

0

2

4

6

8

10

12

14

16

18

20

Prescriptive Analgesics

Does price matter

Brand preferred

Product information

Opinion and future

perspective

Tramadol

Aceclofenac

Diclofenac

Tapentadol

Yes

No

Sometimes

Lupin

Ranbaxy

DRL

Zuventus

MR

Company Program

Very Bright

Promising

Don’t know

Nu

mb

er o

f R

esp

on

den

ts

35

future. Lupin is most popular with the doctors as it has superior market recognition, well proven

scientific and clinical track record. Effective marketing by the MRs with good scientific literature and

visual aids also boosts Tapentadol’s sales for Lupin (Transdol). Trabest (Tramadol by Lupin) which was

released in 1970s has already reached its sales peak in the analgesic category. Lupin thus to prevent on

losing out in this category has thus, now devised a more advanced molecule Transdol (Tapentadol) that

will work with better efficiency than Tramadol. Thus again the Cannibalising approach is clear,

indicating the release of a new molecule to compensate and better efficate the sales.

Graph 4:REPRESENTATION OF PRIMARY DATA FROM MRS (Data pool 3)

INFERENCE:

Lupin Ltd, headquartered in Mumbai is the clear market leader for Tapentadol. Transdol by Lupin is the

clear market leader of Tapentadol variant, which has a superior sales ratio when compared to Tramadol

version. Medical Representatives are the premier sales force of any pharmaceutical organisation. They

possess the best first hand details and knowledge about the product and are equally equipped to predict

the future of a product. They perceive Tapentadol’s future as very bright and promising and expects it to

substitute Tramadol in the near future. Going by the PLC of Tramadol, it had had its share as the market

0

2

4

6

8

10

12

14

16

18

Best Brands for Tapentadol

Sales Ratio (Tramadol : Tapentadol)

Sales Figure (in boxes)

Opinion

Transdol by Lupin

Tapenta by Zuventus

Niap by DRL

Tydol by Ranbaxy

70:30:00

75:25:00

60:40:00

Lupin

DRL

Zuventus

Ranbaxy

Very Bright

Satisfactory

Don't Know

Nu

mb

er o

f R

esp

on

den

ts

36

leader, but advent of newer modifications has made way for Tapentadol to be the new leader.

Tapentadol is a much better product with lesser side effects, aptly supportive dual mode of action etc.

Tramadol in the present day has its nose ahead in terms of sales but slowly and steadily Tapentadol is up

its heels and catching up is faster. Thus, Lupin has equally answered to the changing market trends by

producing Tapentadol (Transdol) which is Cannibalising Tramadol.

37

FINDINGS & CONCLUDARY REMARKS

Product cannibalization occurs when a company decides to replace an existing product (Tramadol) and

introduce a new one in its place (Tapentadol), regardless of its position in the market. This is due to

newly introduced technologies and it is most common in larger companies. As all things in life there is

negative and positive cannibalization.

In the normal case of cannibalization, an improved version of a product replaces an existing product as

the existing product reaches its sales peak in the market. The new product is sold at a high price to

sustain the sales, as the old product approaches the end of its life cycle. Nevertheless there are times that

companies have introduced a new version of a product, when the existing product is only start to grow.

In this way the company sustain peak sales all the time and does not wait for the existing product to

enter its maturity phase. The trick in cannibalization is to know when and why to implement it, since

bad, late or early cannibalization can lead to bad results for a company sales.

In our project findings we came to know Lupin’s Tapentadol variant is the market leader in the segment.

They have followed the method of Positive Cannibalization. Trabest (Tramadol variant of Lupin),

though was still in good sales perception but was steadily progressing towards a stagnant maturity phase

which would have ultimately led to its decline. Thus to prevent its sales figures from drooping in the

analgesics category, the Lupin officials were quick to implement the technique and implement a newer

product with much elaborate advantages (Transdol) over its successor.

38

Table 3: Table depicting possible strategies of PLCM phases

39

QUESTIONNAIRES

CAPSTONE PROJECT: Product Life Cycle

Questionnaire for Chemists

Chemist name:

Address:

1. Which type of prescriptive drug do you sell for cases of moderate to severe pain?

2. In cases of no prescriptions, which products do you offer to customers for moderate to severe pain?

3. Do you know about Tapentadol? If yes, how did you come to know about it?

4. If you are dealing in Tapentadol, which brands do you house and why?

5. What is the response of the customers to that particular brand of Tapentadol?

6. Which is the product for moderate to severe pain in the highest and lowest growth category?

Reasons for it.

7. What is the nature of interaction between you and MR? Is regular updating being undertaken by the

companies?

40

8. For product, promotion is the company giving you adequate benefits? What would you like to be

done further to boost sales?

9. Are all the brands differentiated and diversified clearly to prevent misbranding in all aspects?

10. What is your personal opinion about Tapentadol (under the particular brand)? How do you perceive

its market in the future? Any suggestions?

41

CAPSTONE PROJECT: Product Life Cycle

Questionnaire for Doctors

Doctor’s name: Speciality:

Address:

1. In case of moderate to severe pain which molecule do you generally prescribe?

2. Does the price of the product matter to you while prescribing the product?

3. If the product you are prescribing is new, how do you cope with it and what criterions you

look for in it?

4. If you are prescribing Tapentadol, then which company do you prefer and why? If not then

what do you use?

5. How long have you been using the particular product?

6. Do your patients complain about the product?

7. What are the benefits of using Tapentadol? (if answer in Q4 is, Yes)

8. If you are prescribing Tapentadol, how did you come to know about this product?

9. To patients whom you prescribe Tapentadol, is there any increase in the frequency of your

prescribing the drug in the past two months?

10. What is your opinion about the product? And how do you perceive its future?

42

Product Life Cycle

Questionnaire for Medical Representatives

Medical Representative’s name: Company:

Area:

1. Under what generic name Tapentadol is being marketed? Moreover when was it launched?

2. How many competing brands presently exist in the market for the same molecule?

3. According to you which one is the best and which is the least preferred brand in Tapentadol

category?

4. What is the sales ratio (market acceptability) of Tramadol and Tapentadol? Substantiate

with reasons?

5. What was the market introduction strategy adopted by your company?

6. What is the primary and secondary sales figure of Tapentadol?

7. What strategies does your company adopt to boost the sales of the product?

8. What strategies does your company adopt to overcome decline of the product?

9. In the maturity stage of the product what does your company imply to navigate further into

log phase rather than lag phase?

10. What is your opinion about the product? Moreover, how do you perceive its future?

43

REFERENCES & BIBLIOGRAPHY

ONLINE PORTALS:

http://en.wikipedia.org/wiki/Product_lifecycle_management

http://en.wikipedia.org/wiki/Product_life-cycle_management_(marketing)

http://www.medicalnewstoday.com/releases/82989.php

www.urenio.org/tools/en/Product_Life_Cycle_Management.pdf

http://www.emedicinehealth.com/drug-tapentadol/article_em.htm

http://www.nlm.nih.gov/medlineplus/druginfo/meds/a610006.html

http://www.chemblink.com/products/175591-23-8.htm

http://www.medlink.com/medlinkcontent.asp

http://toxwiki.wikispaces.com/Tapentadol

FIGURES:

Product’s_lifecycle.jpg: National Institute of Standards and Technology’s Manufacturing Engineering

http://www.google.co.in/imgres?q=pharmaceutical+product+life+cycle&um=1&hl=en&rls=com

http://www.google.co.in/imgres?q=sectors+in+pharma+company&um=1&hl=en&rls=com.microsoft:en

-inbooks

Box, J. (1983) Extending product lifetime: Prospects and opportunities, European Journal of

Marketing, vol 17, 1983, pp 34–49.

Day, G. (1981) The product life cycle: Analysis and applications issues, Journal of Marketing, vol

45, Autumn 1981, pp 60–67.

Levitt, T. (1965) Exploit the product life cycle, Harvard Business Review, vol 43, November–December

1965, pp 81–94.

44

OTHER SOURCES:

Barringer P. H. “Why you need practical reliability details to define life cycle costs

for your products and competitors products”, Barringer & Associates, on-line

<http://www.barringer1.com>

Business Studies “The product Life Cycle”, on-line <http://www.learn.co.uk>

Clifford D. “Managing the Product Life Cycle”, European Business Journal, July

1969.

Cox W. E. “Product Life Cycles as Marketing Models”, The Journal of Business, p.p.

375-384, October 1967.

Daft L. Organizational Theory And Design, West Publishing, St Paul Minnesota,

1992.

Drummond G. Ensor J. Strategic Marketing: Planning and Control, Butterworth –

Heinemann, 2001.

LITERATURE REVIEW

“Pharmaceutical Product Lifecycle Management Technology Gaining Momentum”: Datamonitor report

by Markella Kordoyanni

Product Life Cycle Management, Ioannis Komminnos

Electronic Engineer, B.Eng M.Sc.(Eng), Thessaloniki

Urban and Regional Innovation Research Unit, Faculty of Engineering

Aristotle University of Thessaloniki

William D. & McCarthy J. E. Product Life Cycle: “Essentials of Marketing”, Richard D Irwin

Company, 1997.