Case Study: How Merck Turned KEYTRUDA into a Blockbuster Marvel

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STUDY OVERVIEW

KEYTRUDA’s (pembrolizumab) journey to blockbuster success was remarkable but not always certain. What began as a promising discovery in a Dutch lab at Organon nearly ended in obscurity, buried under the weight of corporate mergers and low expectations. This immune checkpoint inhibitor, targeting PD-1, was on the verge of being shelved indefinitely—deemed a low-priority asset in a crowded pipeline. But in 2010, the landscape shifted dramatically when Bristol Myers Squibb (BMS) published groundbreaking results for its drugs, Yervoy and Opdivo. This pivotal moment rekindled Merck’s interest in KEYTRUDA, marking the start of an extraordinary journey.

Merck responded with an ambitious plan that combined expansive clinical trials, targeted marketing efforts, and strategic alliances to carve out a dominant position in the immuno-oncology market. Despite being second-to-market, KEYTRUDA quickly gained momentum, ultimately securing over 48 indications across 1,600+ trials to date and generating $25 billion in revenue by the end of 2023.

Merck’s ongoing efforts to expand KEYTRUDA’s reach have not come without challenges. With patent expiration looming in 2028, Merck faces intensifying competition and legal battles, driving the need for innovative approaches to sustain its market leadership.

This Best Practices, LLC case study explores the key strategies, critical decisions, and five-pronged framework that turned a nearly forgotten drug into a leader in immuno-oncology. Explore how Merck’s relentless focus on clinical excellence and market positioning not only saved KEYTRUDA from the brink but also propelled it to blockbuster success, offering valuable insights for future product launches.

KEY TOPICS

KEYTRUDA’s Journey: How a Long-View Clinical Strategy Transformed a Second-to-Market Checkpoint Inhibitor into the Immuno-Oncology Market Leader
Market Entry: Using a Five-Pronged Framework to Enter and Navigate the Competitive Oncology Market Landscape
Clinical Insight and Daring: KEYTRUDA’s Bold Clinical Strategy Spawned 1600 Clinical Trials + 48 Indications by 2024
Sales Uptake: Keytruda’s 51% CAGR Produced a Blockbuster Sales Curve
Partnerships: Merck Used Partnerships to Extend Reach and Provide Leverage through Shared Funding Sources
DTC Campaigns: Direct-To-Consumer Commercials Support Disease Education and the Power of KEYTRUDA across Cancer Types
Patient Services: Patient Programs Help with Access, Reimbursement and Support
Development Pipeline: Merck Continues to Plan for New Indications and Uses of KEYTRUDA
Legal Challenges: Great Success Brings Patent Litigation and Challengers Awaiting Patent Expiration
Lessons Learned and Winning Strategies from Keytruda

SAMPLE KEY FINDINGS

Five-Factors Framework: KEYTRUDA successfully entered the competitive oncology market by leveraging a 5-Factors Framework that emphasized targeted biomarker strategies, increased resource allocation, strategic market positioning, securing Breakthrough Therapy Designation (BTD), and fostering inter-organizational alliances. These five tactics collectively enabled KEYTRUDA to navigate challenges and establish a strong foothold in the oncology space.

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.

METHODOLOGY

Best Practices, LLC conducted extensive secondary research to examine how Merck transformed KEYTRUDA into a leader in the immuno-oncology segment despite being second to market.

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

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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: 5820

Features:

Pages/Slides: 74

Published: 2024

Delivery Format: Online PDF Document

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