Strategic Marketing for Specialty Medicines: A Practical Approach

By Franck Radenne

This book delves into some principles of strategic marketing for the pharmaceutical and biotech sectors, with a specific emphasis on specialty medicines and orphan drugs.

• Language: English
• Publisher: Lulu.com
• Release date: Jun 1, 2023
• ISBN: 9781447670780

Book preview

A Practical Approach

1st Edition

Copyright © 2023 Franck Radenne

All rights reserved.

ISBN: 975-1-4476-7078-0

PREFACE

The pharmaceutical and biotech industries are complex and constantly changing, making effective marketing vital to ensure the right drugs reach the right patients. This book delves into some principles of strategic marketing for the pharmaceutical and biotech sectors, with a specific emphasis on specialty medicines and orphan drugs, but many aspects can also be applied to the MedTech industry in general. It adopts a pragmatic approach, offering practical advice and real-world examples of successful marketing strategies.

This book is primarily intended for individuals who possess a basic to moderate understanding of marketing in the field of life sciences. Its main objective is to offer valuable insights and practical guidance. The author aspires to share his knowledge and expertise in strategic marketing, aiming to assist readers in achieving success in this field.

The pharmaceutical and biotech industries are heavily regulated, which poses challenges for marketers. These challenges are present at every step of the drug life cycle, from launch readiness and commercialization to patent expiration and competition from generic drugs or biosimilars.

Marketing specialty medicines and orphan drugs poses unique challenges and opportunities. These drugs tend to be expensive and may require specialized distribution and support services, and may target small patient populations or rare diseases. The book addresses these specific considerations and strategies for marketing these drugs.

The book will not cover the tactical options for positioning, promoting, or educating about a product, but it will focus on several strategic points that influence those tactical options, such as customer segmentation and communication strategy.

CONTENT

About the Author

Specialty Medicines Definitions

Introduction

Small Molecules, Biologics and Cell & Gene Therapies

Branded, Generics and Biosimilars

Specialty drugs

Orphan drugs

Strategic Analysis

Introduction

Forecasting

BCG Matrix

Ansoff Matrix

Porter’s Five Forces Analysis

Commercialization Models

Pre-Launch Readiness

Introduction

US market specificities

Ex-US Market Specificities

Challenges Specific to Organizational Structure and Size

The Reality of Launch Timing

Global Pre-Launch Planning

Building the product

Shaping the market

Readying the company

Example of Launch Planning Steps

Stakeholders Identification and Segmentation

Stakeholders Mapping

Prescriber segmentation

Patient segmentation

Launch Execution

Introduction

Launch Sequencing

Launch Process

Launch Essentials

Launching an Orphan Drug

Brand Planning

Introduction

Situation Analysis

PESTEL Analysis

Patient Flow & Patient Journey

Leverage Points

Patient Personas

SWOT / Strategic SWOT

Core insights & Strategic Objectives

Implementation Objectives

Brand Positioning

Brand Narrative / Story Flow

Brand House

Tactical Plan

Communication Strategy

Portfolio Management

Introduction

Portfolio Theory Overview

Portfolio Organization

Portfolio Planning

Life Cycle Management

Introduction

Example of Real-Life Life Cycle Management Strategies

The Innovation Wheel

Overview of Potential LCM Strategies

Key Performance Indicators & Metrics

Introduction

Pre-Launch Metrics & KPIs

Launch Preparation Metrics & KPIs

Launch Execution Metrics & KPIs

Launch Optimization Metrics & KPIs

Post-Launch Metrics & KPIs

Abbreviations

ABOUT THE AUTHOR

Franck Radenne is an accomplished healthcare commercial professional with over 25 years of experience in product strategy, launch planning, life cycle management, and growth opportunity identification and valuation. With his extensive knowledge and experience in the healthcare industry, Franck is an expert in the Biopharma international marketing, but also has a strong experience in the Medical Devices and Diagnostics sectors.

With a notable educational background in Cell Biology, Pharmaceutical Chemistry, and a Master's in Cellular and Molecular Engineering, Franck has always been passionate about the intersection of science and business.

His career has taken him across different countries and companies, starting with R&D at Innogenetics in Belgium, then to Roche France, where he oversaw pre-sales, training, and technical support of the PCR portfolio for half of France before moving to Roche Molecular Diagnostics to become a Global Senior Product Specialists.

Franck's passion for marketing led him to pursue an International MBA at ESCP Business School in Paris in 2002, after which he led the regional marketing of the DNA microarray and pre/postnatal and oncology biomarkers portfolio at Abbott Molecular Diagnostics in Germany. After a period in leading the regional marketing of medical devices in companies such as Haemonetics, he joined Merck Serono in Switzerland in 2008 to lead the strategic marketing efforts of a growth hormone and its associated injection devices and coordinate the development and organize the pre-launch activities of a new formulation of this biologic.

In recent years, Franck has focused on leading global marketing and commercial excellence for various biopharma companies. In 2014, he joined Shire to relaunch an epilepsy rescue medication in Europe before taking over the global marketing and commercial excellence lead of the pediatric neuroscience portfolio in 2016. In 2019, Franck took over the global marketing of a growth hormone indicated in ultra-rare short bowel syndrome after the acquisition of Shire by Takeda.

In 2021, he joined Swedish Orphan Biovitrum to lead the international launch of a drug indicated in two rare hematology indications.

Franck created Radenne Consulting in 2020 and provided commercial analysis and input to Arvelle Therapeutics’ Business Development and Licensing team to assess the business potential of in-licensing products.

In 2022, he decided to use his extensive background in life sciences marketing to write this book and present several very important aspects of what is biopharmaceutical strategic marketing about.

ACKNOWLEDGEMENT

The author would like to express his appreciation to the following people for their suggestions and input to this book:

Camilla Soenderby

Petra Molan

Orlando Oliveira

Sébastien de Chilly

Hassan Jaroudi

Per Helbo

Georg Thies

Cover picture from Lionel Didier

DISCLAIMER

This book contains personal knowledge, experience, analysis, and opinions of the author. The information provided in this book is intended for informational purposes only and should not be considered as a substitute for professional advice or services. This book does not contain confidential information. The author makes no representations or warranties, express or implied, as to the accuracy, completeness, or suitability of the information provided. The reader should consult with a qualified professional for advice and services related to their specific situation. The author disclaims any liability, loss, or risk incurred as a consequence, directly or indirectly, of the use and application of any of the contents of this book. This book should not be solely relied upon as a basis for any decision or action that may affect your business, and local laws and regulations must be respected at all times.

SPECIALTY MEDICINES DEFINITIONS

INTRODUCTION

Renowned marketing author Philip Kotler defined marketing in 2018 as the process by which companies engage customers, build strong relationships with them, and create value for them in order to get value in return.

The concept of marketing is evolving around anticipating the needs of potential customers and meeting them more effectively than competitors can. These needs are not always identified by costumers, in which case, the role of marketing is to identify and to reveal these needs before satisfying them.

The total global pharmaceutical market was valued at $1.42 trillion by the end of 2021 (source: statistica.com). In this competitive market, marketing plays a crucial role in differentiating companies and drugs from one another. Typically, large companies spend more on pharmaceutical marketing than on research and development in the United States (US) (source: www.ahip.org).

Breakdown of the world pharmaceutical market – 2021 sales

Adapted from IQVIA (MIDAS) Q4 2021 MAT, May 2022; data relate to the 2021 global retail and hospital pharmaceutical market (prescription only) at ex-factory prices. Note: Europe includes Belarus, Turkey, Russia, and Ukraine; percentages might not add up due to rounding.

From Consumer Marketing to Life Sciences Marketing

Life sciences marketing involves marketing drugs, medical devices or services to healthcare professionals, other customers, and consumers (patients). To be successful, pharmaceutical marketers must identify customers’ needs and find solutions to meet them. Pharmaceutical customers are generally classified as prescribers, pharmacists, consumers/patients, payers and distributors.

Prescribers are the physicians who prescribe the drug to their patients. Other healthcare professionals (HCPs) may have an interest in a product/service being prescribed or acquired; these HCPs could become influencers.

Pharmacists dispense medications as prescribed by physicians, or suggest an over-the-counter (OTC) product to patients.

Consumers are the end users or patients who use the medications prescribed by physicians.

Payers are government agencies or insurance companies that fund the product/service.

Distributors are partners responsible for local logistics and distribution of the product/service.

Strategic Marketing

In the pharmaceutical industry, strategic marketing refers to the process of developing and implementing long-term plans and strategies for promoting and selling drugs and medical devices. This process involves a thorough analysis of the market, customers, and competition, as well as identifying opportunities and challenges.

The goal of strategic marketing is to create and sustain a competitive advantage for a company's products and to achieve business objectives such as increasing revenue and market share. This comprehensive approach encompasses various significant components such as product positioning, customer segmentation and targeting, formulating effective communication plans, and working on product differentiation, pricing, and launch strategy. Ultimately, it involves making strategic decisions and plans to ensure a company's products' success in the market.

Strategic marketing usually comes in action in the middle of clinical development Phase II or at the beginning of phase III, depending on the companies, and will play a key role until the end of the drug’s life. But since marketeers are close to the market needs, they should also be able to provide commercial input into early clinical phase projects and partner with the Business Development & Licensing (BD&L) and Research & Development (R&D) teams.

Strategic marketing influence in the drug’s life cycle

Adapted from EFPIA 2021

Marketing to Healthcare Customers

Of course, there are more stakeholders considered as customers by the pharmaceutical industry, such as wholesalers, distributors, etc. Never-the-less, the marketing activities are mainly targeting four types of customers: patients, which include surrounding stakeholders such as patient advocacy groups (PAGs) and carers, prescribers and HCPs in general including key opinion leaders (KOLs), public and private payers, and pharmacists.

Marketing to Prescribers

Marketing to physicians is the most effective channel for pharmaceutical companies and remains the top priority. Physicians are the decision-makers when it comes to prescribing drugs. Several factors can influence prescriptions, but the most important are access to the drug, financial coverage of the drug, drug performance (efficacy and safety) and recommendations/experience of use; all those aspects are inter-connected. The task of the pharmaceutical marketer is to identify the physician's needs, highlight them when they are not clear to the physician and creatively address them. One of the most important needs of the physician is to provide adequate treatment to his patients.

Marketing to Patients

In the past, patients went to their doctors for diagnosis, information and ultimately prescriptions or medical solutions. Today, while physicians are still the ultimate decision makers, patients are more informed than ever, and sometimes mis-informed. This is especially true when it comes to rare diseases, for which patients are particularly involved in their diagnosis and treatment. Most patients use the Internet to search for information about certain diseases or drugs. The role of pharmaceutical marketers outside the US is to provide reliable and balanced information to these patients or patient organizations, often relying on digital tools, on HCPs or on PAGs to convey that information. In the US, because direct-to-consumer (DTC) marketing is allowed, the role of marketers is slightly different.‍

Marketing to Payers

The role of marketers is to understand the needs of payers and provide the information necessary to fund the supported treatment. Payers need to know how innovative the treatment is, where it fits in the treatment algorithm, what potential treatment it is intended to replace, and what additional benefits it will provide to patients or the health care system. The Market Access team is usually in charge of those tasks.

Marketing to Pharmacists

Marketing to pharmacists only concern certain types of treatments. Nevertheless, pharmacists must have access to all relevant information about the treatment being provided. Hospital pharmacists may have the authority to decide whether to make a treatment available to patients. In the US, chain pharmacies would also decide which treatment to offer, thus becoming an important stakeholder to target.

SMALL MOLECULES, BIOLOGICS AND CELL & GENE THERAPIES

Biological products refer to a diverse range of products, including vaccines, blood components, gene therapy, tissues, and recombinant therapeutic proteins. They may be composed of complex combinations of sugars, proteins, or nucleic acids, or may even be living entities like cells and tissues, isolated from human, animal, or microorganism sources. Gene-based and cellular biologics are at the forefront of biomedical research and may offer treatments for conditions with no other available treatments.

Size and complexity difference between small molecules and biologics

Adapted from Amgen Inc. Biologics and Biosimilars: An Overview March 2014

Differences Between Small Molecules and Biologics

Unlike most chemically synthesized drugs, which are mainly small molecules, biologics are complex mixtures that are not easily characterized and are heat-sensitive and susceptible to contamination. Therefore, aseptic principles must be used from initial manufacturing steps. Despite the challenges, biological products may represent the most effective means of treating medical conditions that presently have no other treatments available and represent cutting-edge biomedical research.

However, biologics also have different safety profiles compared to conventional drugs. They elicit an immune response with the consequent production of anti-drug antibodies (ADA), which can lead to a loss of efficacy or adverse events. This means that it is essential to monitor patients receiving biologics for ADA development and tailor treatment plans accordingly.

When it comes to marketing strategy and operational marketing, the differences between biologics and conventional drugs are relatively minor and are more related to disease, price and product life cycle. Biologics are often priced at higher levels than small molecules due to their complex development and production processes. However, this also means that biologics may treat rare diseases and benefit from specific conditions, such as the Biden administration's recent act, which can influence the product's life cycle.

Biologics are often at the forefront of medical research and can provide innovative treatments for a range of medical conditions that were previously untreatable. As biologics are relatively new therapeutic options, it is crucial for marketers to focus on educating healthcare providers on the appropriate use of these treatments.

Education is essential to ensure that healthcare providers are familiar with the indications, dosing, and administration of biologics. This is important to ensure that patients receive optimal care and to prevent medication errors or adverse events.

The development of biosimilars can be more challenging than that of generic small molecules due to the complexity of biologics and the difficulty in replicating their structure and manufacturing process. This gives biologics an advantage in terms of market share and market monopoly, as biosimilars may take longer to develop and gain regulatory approval.

The advantage of biologics in the market is not limited to the difficulty of developing biosimilars. Biologics also tend to treat rare diseases and conditions, which often have no other effective treatments, giving them a competitive edge in the market. Additionally, the patent protection for biologics is longer compared to small molecules, providing an extended period of market exclusivity for the manufacturer.

Cell & Gene Therapies

Despite being classified as biologics, there are some unique challenges that need to be addressed when it comes to commercializing gene and cell therapies. These include the costs and limitations in production methods, which can impact the pricing and availability of these treatments. Additionally, the administration of these therapies can be complicated, particularly in the case of autologous treatments, where strict controls and quality standards must be maintained throughout the processing, modification, and re-administration of a patient's sample. Prescribers must be educated about those challenges and proper processes must be implemented in hospitals.

Another challenge that gene and cell therapy companies face is the lack of robust long-term safety and efficacy data for many of these treatments. This can make it difficult to convince regulators and payers to approve and reimburse these therapies, which are mostly priced at a premium, reflecting their innovative nature and the significant investment required in their development. This is even more the case in the absence of demonstrated significantly increased clinical value over existing therapies, since payers are less and less ready to pay for convenience.

Never-the-less, cell and gene therapies are the new revolution in pharmaceuticals and all major companies have invested in those technologies. In July 2022 a total of 3,633 therapies were in development from pre-clinical to pre-registration stages. Gene and RNA therapies accounted for more than three quarters of those therapies (source: Pharmaprojects / Informa July