Pharmamarketing - strategic challenges

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Pharmamarketing - strategic challenges Biomedicine Master Program Lund University Course: Biomedicine the Profession Anna Chérouvrier Hansson, MSc. December 16th, 2014

1. Pharmamarketing - definitions and development 2. Challenges and opportunities 3. Case study 4. Q&A

1. Pharmamarketing - definitions and development 2. Challenges and opportunities 3. Case study 4. Q&A

WHAT IS PHARMAMARKETING?

Definition Pharmaceutical marketing, sometimes called medico-marketing or pharma marketing in some countries, is the business of advertising or otherwise promoting the sale of pharmaceuticals or drugs.

WHEN DOES PHARMA MARKETING ENTER THE BUSINESS MODEL?

Pharmaceutical value chain Up to $5 billion* to develop a new medicine 10 to 15 years 19 in 20 medicines in experimental development fail, meaning a great many companies fail too 95% of the experimental medicines that are studied in humans fail to be both effective and safe * Forbes, PHARMA & HEALTHCARE 8/11/2013

Pharmaceutical revenue model ~20 years from application date RETURN ON INVESTMENT SALES

HOW MANY COMPANIES IN THE COMPETITION AND HOW MUCH CAN THEY EARN?

Source: Statista.com

Around 200 large companies competing

Pharma s biggest blockbusters

WHO REGULATES PHARMACEUTICAL MARKETING AND PROMOTION?

Directive 2001/83/EC Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community REGULATIONS code relating to medicinal products for human use.

Directive 2001/83/EC Advertising Pharmaceuticals in EU Member States must prohibit any advertising of a medicinal product for which a marketing authorisation has not been granted. The REGULATIONS advertising of a medicinal product must encourage the rational use of the product and may not be misleading.

US regulation Food and Drug Administration Federal Food, Drug, and Cosmetic Act Tis a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the safety of food, drugs, and cosmetics. This law requires that advertisements for prescription drugs be accurate and not misleading. Prescription Drug Marketing Act of 1987 An Act to amend the Federal Food, Drug, and Cosmetic Act to ban the reimportation of drugs produced in the United States, to place restrictions on the distribution of drug samples, to ban certain resales of drugs by hospitals and other health care facilities, and for other purposes

Professional Codes of Conduct The Pharmaceutical Research and Manufacturers of America (PhRMA) European Federation of Pharmaceutical Industries and Associations

HOW MUCH IS SPENT IN PROMOTION?

Global Promotional Spend Benchmarks $90 Billion: Total Spend of 34 Audited Countries Worldwide

PHARMA DETAILING

Pharmaceutical detailing is a 1:1 marketing technique used by pharmaceutical companies to educate a physician about a vendor's products in hopes that the physician will prescribe the company s products more often.

PHARMA SAMPLING

Pharma samples can be provided to healthcare professionals with restriction in some countries. They give immediate access to the medication and the patient can begin treatment right away.

MEETINGS AND SEMINARS

Pharmaceutical companies can invite healthcare porfessionals to attend meetings and seminars with the objective of updating/training them on their products and technologies. This can be considered as continued medical education and in some countries can give educational points.

KEY OPINION LEADERS ENDORSEMENT

Peer influence or Key Opinion Leader (KOL) endorsement is a critical success factor for pharma marketing success. KOL, or "thought leaders", are respected individuals, who influence physicians through their professional status. Pharmaceutical companies generally engage KOLs early in the drug development process to provide advocacy and key marketing feedback.

ADVERTISING

Pharmaceutical advertising aims at delivering the pharmaceutical product s sales message to physicians or direct to consumer in print, television, radio broadcast or internet.

CLINICAL TRIALS

Phase IV trial or post-marketing surveillance trial involves the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold. Phase IV studies may be required by regulatory authorities or may be undertaken by the sponsoring company for competitive (finding a new market for the drug) or other reasons (for example, the drug may not have been tested for interactions with other drugs, or on certain population groups such as pregnant women, who are unlikely to subject themselves to trials).

DTC DIRECT TO CONSUMERS

This form of advertising is directed toward patients, rather than healthcare professionals. To date only two nations permit DTC (Nation, year of legalization, link to legislation permitting DTC) New Zealand (1981) and the United States (1997). New ways to reach to the patients: via patient associations and internet.

EU regulation on Advertising to general public (patients) Medicinal products may be advertised to the general public if they can be/are safe to be used without the advice of a doctor or pharmacist (OTC - Over The Counter drugs) All advertising must include name of the medicinal product; necessary information for correct use of the medicinal product; specific and legible invitation to read carefully the instructions in the package leaflet. No sampling to patients! Directive 2001/83/EC

MAILING

Mailing is a way to keep in contact with customers and inform them about the pharmaceutical product development. Traditional paper mail is being replaced by e- mailing in many markets.

1. Pharmamarketing - definitions and historical development 2. Challenges and opportunities 3. Case study 4. Q&A

From last week s seminar What are the implications on pharma marketing?

The burden of chronic disease is soaring

Chronic diseases like Diabetes will see their prevalence growing everywhere and will include a large active population Social and economic value of treatments will rise accordingly Important to reach to the patient community!

Increasing influence of policy makers/payers on prescribing decisions

Increasing focus on treatment protocols to be followed by healthcare professionals E-prescribing and incentives to prescribe the recommended treatment Pharma industry to collaborate closely with policy makers and payers and support the increase in patient compliance develop the salesforce to reach to these groups

Need for specialised salesforce to focus on key decision makers By 2020, the role of the traditional sales representative will be largely obsolete. Conversely, the industry will have much greater need of people with the expertise to build brands; manage a network of external alliances; negotiate with governments and health insurers; liaise with secondary-care specialists; and communicate with patients.

Increase in pay-for-performance

FROM TO

High costs need a proof of efficacy! Biologicals to dominate the pharma market, in 2014 8 of 10 top-sellers expected to be large molecules! Cost of treatment per day Small molecule: US$1 Biological drug: US$22

Focus on best medical practice thorough pharmacoeconomic evaluations Availability of information and patient involvement in their therapies influence Pharma industry to prove that its medicine really work and this message will have to be conveyed by talented professionals and performant communication platforms

Increased focus on prevention rather than treatment

Pharma to enter the Health Management arena and change focus: from disease to prevention Patients empowered, actively working on their treatment Pharma to work on gaining patients and healthcare providers trust on their good intention

1. Pharmamarketing - definitions and historical development 2. Challenges and opportunities 3. Case study 4. Q&A

1. Pharmamarketing - definitions and historical development 2. Challenges and opportunities 3. Case study 4. Q&A

Sources Pharma 2020: Marketing the future - Which path will you take? PricewaterhouseCoopers, 2009 Pharma 2020: Supplying the future, PricewaterhouseCoopers, 2011 The Cost Of Creating A New Drug Now $5 Billion, Pushing Big Pharma To Change, Forbes, 2013 How Much Does Pharmaceutical Innovation Cost? A Look At 100 Companies, Forbes, 2103 THE CHANGING FACE OF THE TOP 10 PHARMACEUTICAL COMPANIES, IMS 2013 Pharmaceutical Promotional Spending: Global Trends, Cegedim, 2013 The shifting pharmaceutical industry landscape. Accounting and regulatory trends affecting reporting for 2012 and planning for 2013, Ernst&Young A wake-up call for Big Pharma, Lower profit margins suggest a need for new business models. December 2011 byvivian Hunt, Nigel Manson, and Paul Morgan, McKinsey Big pharma: Business model choices for the new market, Deloitte 2013 Global pharmaceutical industry is in a strategic crisis Business models must be adjusted, RolandBerger 2013 www.gabionline.net/biosimilars/research/opportunities-for-biosimilar-development