KEYTRUDA Case Study: Bold Moves Behind Blockbuster Success

STUDY OVERVIEW
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KEY FINDINGS
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KEYTRUDA’s (pembrolizumab) rise from near obscurity to blockbuster status was anything but certain. Initially discovered in a Dutch lab, this immune checkpoint inhibitor was nearly abandoned amid corporate mergers, considered a low-priority asset destined for the sidelines. But in 2010, a breakthrough publication by Bristol Myers Squibb (BMS) scientists showcasing the promising results of ipilimumab (Yervoy) and nivolumab (Opdivo) reignited Merck’s interest, sparking a remarkable turnaround.

Merck’s bold strategy involved extensive clinical trials, direct-to-consumer campaigns, strategic patient targeting, and partnerships that redefined cancer treatment, propelling KEYTRUDA from a second-to-market product to a $25 billion cornerstone of Merck’s immuno-oncology portfolio by the end of 2023. With over 48 indications and 1,600+ trials to date, KEYTRUDA has surpassed all expectations.

As Merck continues to explore new indications for KEYTRUDA, the company faces challenges from patent litigation and competitors preparing for patent expiration in 2028. This has pushed Merck to adopt innovative strategies to sustain revenue growth.

This Best Practices, LLC case study analyzes the pivotal decisions, innovative approaches, and relentless pursuit of potential that turned a nearly-shelved drug into a leader in immuno-oncology. Discover how Merck’s five-pronged framework made KEYTRUDA a global success and the lessons it offers for future product launches.

Video Brief:

Industries Profiled:
Pharmaceutical; Health Care; Biotech; Biopharmaceutical; Clinical Research; Laboratories

Companies Profiled:
Merck; Advaxis; Ascentage Pharma; Astellas; AstraZeneca; Bristol-Myers Squibb; Cold Genesys; Compass Therapeutics; Eisai; Eli Lilly and Company; ENB Therapeutics; Fusion Pharmaceuticals; Genome & Company; Gilead Sciences; Hanmi Pharmaceuticals; IDEAYA Biosciences; Incyte; Medicenna Therapeutics; Microbiotica; OncoSec Medical; Ono Pharmaceuticals; Organon; Pfizer; PharmAbcine; PMV Pharmaceuticals; Sanofi; Schering-Plough; Seagen; Seven and Eight BioPharmaceuticals; TetraLogic Pharmaceuticals; Viralytics; Wellmarker Bio

Study Snapshot

Best Practices, LLC conducted extensive secondary research to uncover the key factors behind Merck’s remarkable success with KEYTRUDA. Despite entering the immuno-oncology market as a second-to-market product, KEYTRUDA not only caught up with its competitors but also became a dominant force in the field. This study examines Merck’s strategic decisions, including bold indications planning, expansive clinical trial investments, innovative marketing approaches, and strategic partnerships. The analysis provides insights into how these efforts collectively propelled KEYTRUDA to the forefront of cancer treatment, establishing it as a blockbuster drug and a cornerstone of Merck’s oncology portfolio.

Key Findings

Select key insights uncovered from this report are noted below. Detailed findings are available in the full report.

Broad Clinical Program Validates Efficacy: Merck's extensive clinical program for KEYTRUDA included over 1600 trials, establishing a robust “wall of data” to validate its efficacy as both a monotherapy and in combination therapies across a wide variety of cancers and treatment settings.

DTC Evolution: DTC campaigns cascaded from HCPs to patients -- educating the market on biomarkers, patient experience, & immuno-oncology.

Patient Support: The KEY+YOU Program offers continuous assistance to KEYTRUDA patients and their caregivers around the clock.

Table of Contents

Sr. No.	Topic	Slide No.
I.	KEYTRUDA’s Journey: How a Long-View Clinical Strategy Transformed a Second-to-Market Checkpoint Inhibitor into the Immuno-Oncology Market Leader�	Pg. 3-14
II.	Market Entry: Using a Five-Pronged Framework to Enter & Navigate the Competitive Oncology Market Landscape	Pg. 15-21
III.	Clinical Insight and Daring: KEYTRUDA’s Bold Clinical Strategy Spawned 1600 Clinical Trials + 48 Indications by 2024�	Pg. 22-39
IV.	Sales Uptake: Keytruda’s 51% CAGR Produced a Blockbuster Sales Curve	Pg. 40-43
V.	Partnerships: Merck Used Partnerships to Extend Reach & Provide Leverage through Shared Funding Sources	Pg. 44-47
VI.	DTC Campaigns: Direct-To-Consumer Commercials Support Disease Education and the Power of KEYTRUDA across Cancer Types	Pg. 48-55
VII.	Patient Services: Patient Programs Help with Access, Reimbursement & Support	Pg. 56-61
VIII.	Development Pipeline: Merck Continues to Plan for New Indications and Uses of KEYTRUDA	Pg. 62-63
IX.	Legal Challenges: Great Success Brings Patent Litigation & Challengers Awaiting Patent Expiration	Pg. 64-66
X.	Lessons Learned and Winning Strategies from Keytruda�	Pg. 67-73
XI.	About Best Practices, LLC�	Pg. 74

KEYTRUDA Case Study: How Merck Used Bold Indications Planning Coupled with Expansive Clinical Trials to Lift a Second-To-Market Product into the Annals of Blockbuster Launch History

ID: PSM-392

Features:

Pages: 74

Published: 2024

Delivery Format: Shipped

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