THE PRODUCT AND INDUSTRY EVOLUTION

CHAPTER 2

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Dr. Katia ISKANDAR
Pharm.D, MPH, Ph.D epidemiology
 LEARNING OBJECTIVES

 Assess how the pharmaceutical industry identifies a good product for development

 Identify and describe the new Drug Application process

 Discuss how the pharmaceutical industry and its product base pipeline have evolved over time.

 Differentiate the generic and over-the-counter approval process from the prescription approval
process and the impact of the difference.

 Describe the necessary components of a prescription drug label and analyze their impact on the
product’s marketing efforts.

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Dr Katia ISKANDAR
 New Product Development Process

Step 1: Idea Generation

 Scientists and researchers are involved in the development of new drugs
 Other parties involved in idea generation are external to the company like customers, competitors,
distributors.
 The discovery process begins by focusing on specific diseases and patient needs.

 Scientists search for biological targets within the body that play a role in a given disease.

 They screen millions of molecules against the targets to pick promising leads.

 After the discovery process produces a promising lead, that compound is still a long way from being
ready for testing in people.
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Dr Katia ISKANDAR
New Product Development Process
Examples of sources for Idea generation:

• The pandemic of COVID-19 infection

• World Health organization : Priority pathogens for antibiotic discovery
• Innovative criteria for antibiotic discovery
• New technology like new rapid diagnostics
• New mechanism of action for targeted drug delivery
• Preventive medicines : new vaccines
• Genomics
• Metabolomics
• Microbiome studies
 Researchers have been studying and
working with mRNA vaccines for decades.
 Interest has grown in these vaccines
because they can be developed in a
laboratory using readily available materials
 mRNA vaccines have been studied before
for flu, Zika, rabies, and cytomegalovirus
(CMV).
 Future mRNA vaccine technology may
allow for one vaccine to provide protection
against multiple diseases (decreasing the
number of shots)
 Beyond vaccines, cancer research has used
mRNA to trigger the immune system to
target specific cancer cells.
The cave microbiome as a source for drug discovery: reality or pipe dream?

READING:
Ghosh S, Kuisiene N, Cheeptham N. The cave microbiome as a source for drug
discovery: reality or pipe dream?. Biochemical pharmacology. 2017 Jun 15;134:18-34.
Emerging Applications Of Metabolomics In Drug Discovery And Precision Medicine

READING:
Wishart DS. Emerging applications of metabolomics in drug discovery and precision
medicine. Nature reviews Drug discovery. 2016 Jul;15(7):473-84.
 Metabolomics is an emerging 'omics' science involving the comprehensive characterization of
metabolites and metabolism in biological systems.
 Recent advances in metabolomics technologies are leading to a growing number of mainstream
biomedical applications.
 Metabolomics is increasingly being used to diagnose disease, understand disease mechanisms,
identify novel drug targets, customize drug treatments and monitor therapeutic outcomes.
 Metabolomics is revealing surprising metabolic causes and metabolite biomarkers for several
prominant diseases such as diabetes, Alzheimer disease, atherosclerosis and cancer. These findings are
identifying previously unsuspected therapeutic targets and novel potential therapeutic strategies.
 The use of metabolomics to phenotype tumours and to design custom cancer therapies represents the
most 'cutting-edge' example of metabolomics enabling precision medicine.
IMPACT OF GENOMICS ON DRUG DISCOVERY

READINGS:

1-Emilien G, Ponchon M, Caldas C, Isacson O, Maloteaux JM. Impact of genomics on

drug discovery and clinical medicine. Qjm. 2000 Jul 1;93(7):391-423.

2-Roden DM, Van Driest SL, Wells QS, Mosley JD, Denny JC, Peterson JF. Opportunities
and challenges in cardiovascular pharmacogenomics: from discovery to
implementation. Circulation research. 2018 Apr 27;122(9):1176-90.
IMPACT OF GENOMICS ON DRUG DISCOVERY
 Genomics has created new opportunities for drug discovery
 Knowledge of all the human genes and their functions may allow effective preventive measures,
and change drug research strategy and drug discovery development processes.
 Pharmacogenomics is the application of genomic technologies to drugs in clinical development
and on the market.
 It applies the large-scale systematic approaches of genomics to speed the discovery of drug response
markers, whether they act at the level of the drug target, drug metabolism, or disease pathways.
 The potential implication : disease could be treated according to genetic and specific individual
markers, selecting medications and dosages that are optimized for individual patients.
 Defining patient populations genetically may improve:
 outcomes by predicting individual responses to drugs
 safety and efficacy in therapeutic areas such as neuropsychiatry, cardiovascular medicine,
endocrinology (diabetes and obesity) and oncology

Emilien G, Ponchon M, Caldas C, Isacson O, Maloteaux JM. Impact of genomics on drug

discovery and clinical medicine. Qjm. 2000 Jul 1;93(7):391-423.
 New Product Development Process
Step 2: Idea Screening
1.Is there a real value to the customer?
 Is there a real need and desire for the product?
 Will the product satisfy the customers?
2.Can we succeed?
 Does the company have the resources to make such process?
3.Does the product fit the company’s growth strategy by offering sufficient profit potential?
• What are the market size, potential and forecasts?
• Will the product be profitable once manufactured and delivered to customers at target price?
• What is the current or expected competition?

Questions are answered through situation analysis

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Dr Katia ISKANDAR
 HIT FINDING STRATEGIES

The lead sources are categorized depending on the initial hit-finding strategy.

1. Known, this might be the endogenous ligand or a molecule taken from the published
literature or patents.
2. Random Screen, usually a high-throughput screen of a large compound collection.
3. Structure-based drug design (SBDD), in silico screening of compound collections,
including the use of the target protein 3D structure.
 Broadly, in silico means biological experiments conducted on a computer or via computer simulation. In silico screening uses virtual
screening tools to make predictions about the behavior of different compounds. It achieves that by modeling the interactions
between chemical molecules and their biological targets.

4. Directed Screen, screening of smaller sets of compounds which are selected based on
prior knowledge of the target or chemical class. Also known as focused, targeted or biased
screening.
5. Fragment Screen, typically libraries with a few thousand compounds or less of low
molecular weights (<200 Da), screened at high concentration
6. DNA encoded library, screening of very large collections of small molecule compounds,
using a technology that involves the conjugation of molecule to a DNA tag.
https://www.cambridgemedchemconsulting.com/resources/overview/hit_iden.html
HIT TO LEAD

 Once a promising drug target has been identified, researchers aim to identify molecules that
can interact with the target to produce desired biological effects.
 A hit compound is a molecule that shows the desired type of activity in a screening assay.
 It is important to develop pharmacologically relevant screening assays for hit discovery and for
the subsequent hit-to-lead selection process.
 Lead compounds are selected from a collection of hits by refining the screening criteria to
enable the selection of the most promising molecules for further development.
 The secondary assays employed for lead selection may screen for off-target effects as well as
physico-chemical and ADME (absorption, distribution, metabolism and excretion)
characteristics.

Video Link: https://youtu.be/yyq8TpFF1a8

HIT TO LEAD
 There are several ways to find hit molecules.
 Researchers may use traditional high-throughput screening techniques to find hit molecules
from thousands of chemicals contained in a chemical library.
 Other methods include:
 affinity selection[MS1] of large chemical libraries
 fragment-based techniques[MS2]
 target-focused libraries
 identifying biologically active compounds from living organisms
 use of biotechnology to harness living systems to produce new potential drug candidates and
computer-aided structure-based drug design.
 Biologics (antibodies, vaccines, RNAi etc.) account for about one third of new drug approvals today.
Especially monoclonal antibodies are a growing trend for biologics based therapies. Screening of
antibody libraries against the target molecule is a possible source for hit identification.
https://drugdevelopment.fi/drug-development/hit-to-lead/
 HIT TO LEAD

 Once hit molecules are identified, their analogues can be tested in order to determine structure-
activity relationships (SAR) of the compounds.
 SAR information may be used for the selection and design of structural analogs with improved
activity, and for the confirmation of the core structures of the molecules.
 In general, the purpose of the hit-to-lead process is to improve the potency, selectivity and
physicochemical properties (e.g. solubility and stability) of the compounds for further in vitro
and in vivo testing and for subsequent lead optimization.

https://drugdevelopment.fi/drug-development/hit-to-lead/
HIT TO LEAD

 At this stage, it is time to perform early-phase preclinical pharmacokinetic and safety

assessment of the potential lead compounds.
 These tests are typically performed both in vitro and in vivo, and may also involve
physiologically-based pharmacokinetic modeling.
 A successful lead molecule should be absorbed into the bloodstream, distributed to the site of
action, metabolized efficiently, excreted effectively from the body, and, above all, it should
pass early-phase safety studies such as cytotoxicity and genotoxicity tests.
 Also, researchers should already be thinking about the final drug, its possible formulations, and
how it will be administered to patients, for example orally or intravenously.
 The feasibility of its large-scale synthesis must also be considered, as well as its GMP
manufacturing process. These aspects should be kept in mind throughout the subsequent phases
of the drug discovery and development process
https://drugdevelopment.fi/drug-development/hit-to-lead/
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Dr Katia ISKANDAR
 New Product Development Process

Step 3: Idea Development

 Scientists learn much more about how the new compound metabolizes in the body and intervenes in
the disease.

 Is there a viable way to deliver the molecule to the biological target?

 How is this affected by chemical composition, the size of the molecule, and natural barriers
within the body's tissues and organs?

 Should the delivery vehicle be an oral method, an injection, or something else?

 How fast is the medicine released and distributed in the body?

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Dr Katia ISKANDAR
Proving Safety And Efficacy

 Clinical studies and approval processes aim to prove that a potential new
medicine is safe for patients and effective in treating the target disease.

 Clinical studies are conducted around the world

 That means , the company must work through regulatory approval processes
in country after country in order to bring innovative cures to patients
worldwide.

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Dr Katia ISKANDAR
Eli LILLY
 CLINICAL STUDIES

 For each clinical trial , the protocol, investigators and their qualifications and the investigation
site(s) must be presented and approved.

 Each clinical trial must also be approved and overseen by an Institutional review board ( IRB)

 Not only stakeholders in the pharmaceutical industry pay close attention to the actions of FDA
and the various sanctions and penalties it places on pharmaceuticals but so does the Wall street
and financial advisors / investigators.

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Dr Katia ISKANDAR
 NEW DRUG APPROVAL (NDA) PROCESS

 In the US , for a drug to be approved by the FDA , a pharmaceutical manufacturer must go

through a lengthy series of FDA-required research studies and application processes to prove
the medication is safe and effective

 It typically can take anywhere from 10 to 15 years to complete and cost in excess of $1 billion.

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Dr Katia ISKANDAR
 New Drug Application (NDA)

 Upon completion of Phase III studies demonstrating the drug is safe and effective, the manufacturer
can submit and NDA to the for approval to manufacture and market the drug.

 The NDA is a compilation of data obtained from the IND as well as data from all the drugs’ clinical
trials and a comprehensive analysis of the drugs chemistry , pharmacology and toxicology.

 The manufacturer must describe the manufacturing site and process with the assurance that the
marketed product complies with existing good manufacturing processes GMPs and submit the
proposed drug labeling.

 The FDA then evaluates the NDA with regard to the drugs’ chemistry, biopharmaceutics,
pharmacology, statistics and medical information.

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 Post Marketing Surveillance - Phase IV Studies

Following the full FDA review process, which can take several month to years , the
FDA takes one of the following actions:

 Approves NDA Allowing the manufacturer to market the drug in the US.

 Deems the NDA approvable , indicating significant deficiencies.

 Deems the NDA approvable but not provided with approved status and require

additional studies to demonstrate efficacy and safety

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 Post Marketing Surveillance - Phase IV Studies

 Postmarketing surveillance is conducted after FDA approves NDA and often these
studies are suggested by the FDA during approval process.
 These studies have become recognized as providing important information concerning
rare side effects that were not detected during Phase I, II and III clinical trials because
of the small number of patients
 Phase IV can detect drug interactions or adverse drug events that might occur when
the drug is used in real word settings and often provides new safety information
communicated through labeling changes.
 Several drugs have had significant label changes (e.g. black box warning) or even
withdrawn from the market because of Phase IV findings.

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Dr Katia ISKANDAR
 Black Box Warning

 A black box warning is the FDA’s most strict warning for drugs and medical devices on the market.
 Black box warnings alert the public and health care providers to serious, permanent or fatal side effects.
 The FDA requires drug companies to add a warning label to medications that have a black box warning.
 FDA black box warnings take their name from the black border around the warning information.

Video link:
https://fast.wistia.net/embed/iframe/q8fi6603ze?autoPlay=true
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https://www.drugwatch.com/fda/black-box-warnings/
 Black Box Warning
 Boxed warnings first appeared on medications in the 1970s.
 Only the FDA has the authority to issue a black box warning
 Before adding a boxed warning to a medication or medical device, the FDA must have evidence that the
drug poses a significant risk.
 This evidence comes from observations and studies conducted after a drug has been on the market.
 After determining a drug needs a black box warning, the FDA contacts the drug company to add a
warning to its labeling.
 The drug company then submits its language for FDA approval
 Once the FDA approves the language, it is printed on the drug or device’s package and on the medication
insert
 Once a drug receives a black box warning, its manufacturer must also create a medication guide that
describes how patients can safely use the drug 28
Dr Katia ISKANDAR
https://www.drugwatch.com/fda/black-box-warnings/
 FDA’s Black Box Warning Process

The FDA uses boxed warnings to highlight risks in the following situations:
 If evidence shows a drug causes a serious adverse reaction — potentially fatal, life-threatening or
permanently disabling — where the risks might outweigh the benefits
 A serious side effect can be avoided or reduced in severity or frequency by appropriate use of the drug,
such as avoiding use in specific situations, observing patients, careful patient selection or avoiding using
the drug with certain medications
 The FDA approved the drug only for restricted use to ensure public safety
 The drug is less effective or dangerous to certain populations such as the elderly, children or pregnant
women
 The FDA doesn’t often remove warnings, but when it does it requires clinical evidence proving that the
drug’s risks are less severe than previous studies showed
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Dr Katia ISKANDAR
https://www.drugwatch.com/fda/black-box-warnings/
 Issues with Boxed Warnings
 Lack of Physician Compliance: a study showed that black box warnings among doctors varied
from 0.3 to 49.6 percent.
 May Discourage People from Taking Medication: a study showed that black box warnings
decreased antidepressant use but increased the suicide attempt rate among young people.
 Lack of Transparency: Researchers say that the FDA’s process for adding or removing warnings
is not clear enough and must require more evidence to remove a black box warning.
 Fast-Tracked Drugs Are More Likely to Have Boxed Warnings: a study showed that fast-
tracked drugs were 3.5 times more likely to receive a boxed warning after they already made it
into In the last several years, the FDA has approved record numbers of new drugs. While drug
approvals are up, so are their safety risks — many of these lead to black box warnings.
 Increased Use of Black Box Warnings : In a 2017 JAMA study found that nearly a third of all
drugs cleared by the FDA pose a safety risk
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Dr Katia ISKANDAR
https://www.drugwatch.com/fda/black-box-warnings/
 Adding or Removing a black Box Warning
 Researchers point to two instances where drug makers approached the FDA to remove black boxes on
their medications with weak evidence

 In the first case, Pfizer petitioned the FDA to remove a black box for “severe psychiatric events” and
suicide from its smoking-cessation aid Chantix. After a committee meeting and reviewing the five short-
term studies Pfizer presented, the FDA opted to keep the warning

 But in the second case, GlaxoSmithKline was successful in getting the black box for heart problems
removed from its Type 2 diabetes drug Avandia. It provided data from one randomized trial

 Researchers said FDA must require more evidence to remove a warning.

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Dr Katia ISKANDAR
https://www.drugwatch.com/fda/black-box-warnings/
 Challenges to R&D
 Economic barriers: Funding sources
 Technical: the rapid pace of technological change, new technologies
 Sociological : sociological issues
 Logistic: technical staffing shortages, aging infrastructures
 Financial: inflation and its effects on increasing costs
 Competition: global competition
 Lack of expertise especially for small and medium enterprises
 Translational Failures Using Animal Models
 the inability of animal models to accurately predict efficacy as a challenge to drug development.
 Lack of Clinical Phenotyping and Patient Stratification
 the heterogeneity of patient populations necessitates larger, more complex, and thus more expensive clinical
trials. 32
Dr Katia ISKANDAR
 Barriers and Incentives for Drug Discovery
 Global initiatives: CARB-X
 Partnership between academia and pharmaceutical industry
 Government support
 New regulations
 Public, private and public-private intiatives
 DRIVE-AB
 PUSH and PULL incentives for Antibiotic discovery
READINGS:
1-Renwick M, Mossialos E. What are the economic barriers of antibiotic R&D and how can
we overcome them?. Expert opinion on drug discovery. 2018 Oct 3;13(10):889-92.

2-Incentives to stimulate antibiotic innovation: The preliminary findings of DRIVE-AB 34

Dr Katia ISKANDAR
 PRODUCT LIFE CYCLE (PLC)

Sales and Profits Over the Product’s Life From

Introduction to Decline
Sales and
Profits ($)

Sales

Profits

Time
Product Introduction Growth Maturity Decline
Develop-
ment

Losses/

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Investments ($)

Dr Katia ISKANDAR
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Dr Katia ISKANDAR
 ROLE OF MARKETING DURING PRODUCT
DEVELOPMENT

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Dr Katia ISKANDAR
 Development stage Marketing role

 Compound  Disease focused research and analysis

identification and
screening
 Size of the disease market/ market potential

 Competition within the disease state/target

market

 Disease population trends and future

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Dr Katia ISKANDAR
 Development stage Marketing role

 Preclinical  Further in-depth market analysis

 Product vision and strategy

 Identification of products possible key

marketable attributes

 Needs and wants and demands of potential

customers (Physicians and patients)

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 Development stage Marketing role

 Phase I and II  Identification of market segments and determination of

positioning strategy for those of various segments.

 Development of market entry and pricing strategy

depending on the competitive environment.

 Identification of minimally acceptable levels of clinical and

pharmacoeconomic significance.

 Determination of optimal initial primary product

indication.

 Initial identification and targeting of key opinion leaders in

the disease field.

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Dr Katia ISKANDAR
 Development stage Marketing role

 Phase III  Determination of product name

 Publication strategy
 Engaging the identified key opinion leaders
 Finalization of pricing and reimbursement
strategies
 Final preparation for ultimate approval and
launch

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Dr Katia ISKANDAR
 Development stage Marketing role

 Post-FDA approval  Continual evaluation of all product movement ,

strategies , and dynamics

 Continual analysis of usage and adoption statistics

, leading to identification of possible new
indications , claims and so forth

 Continual evaluation of pricing and

reimbursement strategies

 Continual interaction with manufacturing so as to

avoid possible customer issues /complaints

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Dr Katia ISKANDAR
 Drug Patency
 In the US, drug patent lasts 20 years by law, but, since a patent is usually applied for before
clinical trials, the actual life of protection for an on-the-market drug varies a lot,
some drugs have protection for as short as 7 years, some could be 12 years or even longer.
A drug can be manufactured as a generic drug when the following apply:

 Its patent has expired

 The company that would manufacture the generic drug certifies that the patents held on the drug
are either unenforceable, are invalid or would not be infringed upon

 There has never been any patents on the drug before

 In countries where the drug has no patent protection

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 Difference Between Patency and Exclusivity
 Patents and exclusivity work in a similar fashion but are distinctly different from one another.

 Patents are granted by the patent and trademark office anywhere along the development lifeline
of a drug and can encompass a wide range of claims.

 Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can
run concurrently with a patent or not.

 Exclusivity is a statutory provision and is granted to an NDA applicant if statutory

requirements are met.

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Dr Katia ISKANDAR
 Duration of Patency and Exclusivity

 Patents expire 20 years from the date of filing. Many other factors can affect the duration of
a patent.
 Exclusivity depends on what type of exclusivity is granted.
Orphan Drug (ODE) - 7 years
New Chemical (NCE)- 5 years
"Other" Exclusivity - 3 years for a "change" if criteria are met
Pediatric Exclusivity (PED) - 6 months added to existing Patents/Exclusivity
Patent Challenge – (PC) – 180 days (this exclusivity is for ANDAs only)

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Dr Katia ISKANDAR
 Blockbuster Definition

 An extremely popular drug, usually one that generates annual sales of at least $1 billion.
 A blockbuster drug can be highly profitable, but it has some potential disadvantages.
 Common blockbuster drugs are Vioxx, Lipitor, and Zoloft, COVID-19 vaccines
 If the drug is discovered to have serious side effects, a company may actually lose money on it.

 A blockbuster drug eventually loses patent coverage, and the company that developed the drug
no longer has exclusive rights to it.

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Recently approved treatments by the FDA or European Medicine Agency (EMA) measured by their sales forecast.
 Orphan Drugs
 The FDA Orphan Drug Designation program provides orphan status to drugs and biologics
which are defined as intended for the safe and effective treatment, diagnosis or prevention of
rare diseases/disorders.

 There may be as many as 7,000 rare diseases. The total number of Americans living with a rare
disease is estimated at between 25-30 million

 There are many different causes of rare diseases. The majority are thought to be genetic,
directly caused by changes in genes or chromosomes. In some cases, genetic changes that cause
disease are passed from one generation to the next.

 Many rare diseases, including infections, some rare cancers, and some autoimmune diseases,
are not inherited.
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 unknown.
Dr Katia ISKANDAR
Orphan Drugs Incentives

 Grants

 Research design support

 FDA fee waivers

 Tax incentives

 Orphan drug market exclusivity

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 Product And Industry Evolution
 Historically, manufacturers have been able to rely on the R&D pipeline to identify promising
chemical entities.
 Recently, larger manufacturers have seen:
 Fewer successes and shrinking pipelines

 Advances of technology have enabled smaller companies to excel in product discovery

 These factors as well as increased level of competition, have led to an industry where manufacturers
have sought to enhance pipelines and product offerings through: Mergers and Acquisitions (M&A)
 Consolidation is the mergers or acquisitions of many smaller companies into much larger ones
 Merger is a combination of two companies to form a new company
 Acquisition is the purchase of one company by another in which no new company is formed
 It is a way to cut costs and maintain profits

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 Merger and Acquisitions

 Over the last 2 decades, 60 Pharma companies have become just 10 Big Pharma
companies
 This consolidation has helped to:
 Add value to the companies by increasing the corporate control in the market
 Diminish the competition
 Achieve growth
 Expend their portfolios in a tough market
 Cut-off costs of R&D

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 World Health Effects

 Dozens of pharmaceutical companies have disappeared over the last 20 years, not just small

companies but major ones like Upjohn, Pharmacia, Searle, Warner-Lambert and Schering-Plough

 Excellent for business reasons but has resulted in fewer scientists pursuing new innovative

diseases treatments

 In the long term, that doesn't benefit the world's health.

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 SANOFI MERGER AND ACQUISITION
(M&A) ANALYSIS 1995 TO 2015
 Sanofi is the result of series of mergers between Sanofi-Synthélabo and Aventis.
 Sanofi-Synthélabo was formed in 1999 when Sanofi merged with Synthélabo.
 Aventis was formed in 1999 by Rhône-Poulenc S.A. merger with Hoechst Marion
Roussel (HMR).
 HMR itself was formed from the 1995 merger of Hoechst AG with Cassella,
Roussel Uclaf and Marion Merrell Dow.
 Sanofi-Aventis was formed in 2004 when Sanofi-Synthélabo acquired Aventis for
$65.0 billion.
 In year 2010, Sanofi-Aventis acquired Chattern Inc. for around $1.9 billion.
 After acquiring Genzyme for around $20.1 billion in year 2011, Sanofi-Aventis
changed its name to Sanofi.
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 MARKETING PLAN

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 Marketing Plan
 All strategies including the four Ps , segmentation, targeting and positioning, come together
in the marketing plan.

 The marketing plan is the single document that holds all the research, strategy, forecast for a
company and its products/services.

 The document itself focus on one product or service or to be the company overall marketing
strategy.

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 Executive Summary
 Overview of the marketing plan

 Highlights key areas, decisions and expected outcomes.

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 Situation Analysis : External Environment

 What regulatory, political, economic or social issue can affect the product?

 Can the product be marketed globally?

 Is new technology being implemented?

 How rapidly is the technology changing?

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 Situation Analysis : Internal Environment

 What are the vision, mission and strategic intent associated with the product?

 How does the product fits with other product line of the company?

 What are the profits? Return on investment?

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 Product And Category Review

 What is the product category , background, technology?

 What are the nature and characteristics of consumer demand for the product?

 What are the sales trend associated with the product category ( total sales,
market share)?

 What is the current pricing and how it will affect product development and
profit potential?

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Consumer Analysis
 Who are the consumers?

 What influences purchase decisions?

 What are the demographic , epidemiological, psychological characteristics that

affects purchases?

 Is there loyalty for existing brands?

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 Competitive Analysis

 What is the overall degree of competition?

 Competition strength, weaknesses, from a marketing perspective such as

product itself, pricing, market share?

 Where is the competition positioned in the minds of purchasers?

 Hat are the competition trends for advertising?

 Are there any plans for product improvements?

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 Brand Review

 For existing product , what are the current positioning, sales trends and pricing
history?

 Where is the product in the product life cycle?

 Are there new areas in the business that has been identified?

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 Data Collection
 The main resources used for analyzing market situation is International Marketing Services (IMS) data.

 IMS is a set of data gathered from the private market and /or hospital line.

 It classifies the products by categories and outlines the sales per units and per monetary values for a specified period of
time.

Other sources of data include:

 Tenders data requested from agents and distributors

 Scientific information e.g. Literature, clinical data

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 SWOT Analysis
 Strengths (Internal to the company)

 Weaknesses (Internal to the company)

 Opportunities (External to the company)

 Threats (External to the company)

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 Strategic Planning

 What are the marketing objectives in term of sales, market share or formulary status?

 What strategies will be employed to achieve marketing objectives?

 Targeting and segmentation: Who are the customers, what are the characteristics of market
segments?

 What is the desired product positioning in the consumer mind?

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 MARKETING MIX

 Product: How will the product be managed ? How will product data and information from
production, research and development shape marketing mix decisions?

 Place: Where the product will be sold? How will the product be distributed?

 Price: What are the pricing objectives and strategies?

 Promotion: What form of promotion will be employed?

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 Control , Evaluation And Feedback

 Forecasting and benchmarking: What are the expectations for the product?

 Budgeting: Assessment of marketing budgets and achievement of goals and objectives.

 Scheduling and timing: Setting time frame for the evaluation of success.

 Evaluation and feedback: What results are being achieved ? What need to change and remain
the same.

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 Causes of New Product Failures

 Overestimation of Market Size

 Product Design Problems

 Product Incorrectly Positioned, Priced or Advertised

 Costs of Product Development

 Competitive Actions

 Antimicrobial resistance

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END OF CHAPTER 2