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Flevy Management Insights Case Study
Global Scaling Strategy for Pharma Start-Up in Rare Diseases


There are countless scenarios that require Organizational Effectiveness. Fortune 500 companies typically bring on global consulting firms, like McKinsey, BCG, Bain, Deloitte, and Accenture, or boutique consulting firms specializing in Organizational Effectiveness to thoroughly analyze their unique business challenges and competitive situations. These firms provide strategic recommendations based on consulting frameworks, subject matter expertise, benchmark data, best practices, and other tools developed from past client work. Let us analyze the following scenario.

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Consider this scenario: A newly established pharmaceutical start-up focuses on developing treatments for rare diseases, facing challenges in organizational effectiveness due to its rapid growth and the complexity of global markets.

The company has encountered a 20% shortfall in projected revenue due to regulatory hurdles and difficulty in establishing a solid presence in key markets. Additionally, it faces intense competition from established pharmaceutical companies and challenges in supply chain management, contributing to a decrease in market penetration rates. The primary strategic objective of the organization is to scale globally while maintaining innovation in drug development and streamlining operations to improve market reach and financial performance.



The organization, despite its innovative approach to rare disease treatment, struggles with the scalability of its operations and the effective management of regulatory challenges across different geographies. The underlying issues appear to be a lack of streamlined processes and an underdeveloped strategy for entering and expanding within global markets. Moreover, the company's focus on innovation has not been matched with equal emphasis on operational excellence and market strategy, which are crucial for successful global expansion.

Industry Analysis

The pharmaceutical industry is characterized by high investment in research and development (R&D), stringent regulatory environments, and a significant emphasis on patent protection. The industry is witnessing a shift towards personalized medicine and treatments for rare diseases, driven by technological advancements and a better understanding of genetic markers.

Examining the competitive landscape reveals:

  • Internal Rivalry: Competition is fierce, especially in the rare diseases segment, where innovation can lead to significant market advantage.
  • Supplier Power: High, given the specialized nature of raw materials and components required for pharmaceutical production.
  • Buyer Power: Varies significantly across geographies due to differences in healthcare systems and insurance coverage.
  • Threat of New Entrants: Moderate to high, facilitated by rapid technological advancements and the expiration of patents.
  • Threat of Substitutes: Low, as effective substitutes for rare disease treatments are limited.

Emerging trends include the rise of digital health technologies, increasing focus on patient-centric care, and global regulatory harmonization. These trends signal:

  • Opportunities for leveraging digital technologies to streamline clinical trials and patient monitoring.
  • Risks associated with global regulatory complexities and the need for adaptive strategies to navigate different markets.

A PEST analysis highlights the significance of regulatory factors, advancements in biotechnology, socio-economic factors influencing healthcare access, and the environmental considerations of pharmaceutical production.

Learn more about PEST Competitive Landscape Industry Analysis

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Internal Assessment

The start-up boasts cutting-edge research and development capabilities and a passionate team dedicated to addressing unmet needs in the treatment of rare diseases. However, it faces challenges in scaling operations globally and navigating complex regulatory landscapes.

SWOT Analysis

Strengths include innovative R&D and a strong commitment to rare diseases. Opportunities are evident in expanding global markets and leveraging technology for drug development and patient engagement. Weaknesses lie in limited operational scale and regulatory expertise. Threats encompass intense competition and diverse global regulatory requirements.

Value Chain Analysis

Analysis of the organization's value chain uncovers inefficiencies in supply chain management and regulatory compliance processes. Strengthening these areas can significantly enhance operational efficiency and speed to market.

Distinctive Capabilities Analysis

The company's distinctive capabilities revolve around its innovative research in rare diseases and agile approach to drug development. Enhancing capabilities in global market entry strategies and regulatory compliance will be critical for scaling operations effectively.

Learn more about Supply Chain Management Agile Value Chain

Strategic Initiatives

  • Global Market Entry and Expansion: This initiative aims to establish and expand the company’s presence in key international markets, focusing on strategic partnerships for regulatory compliance and market access. The expected outcome is increased market share and revenue growth in global markets. This will require strategic alliances, market research, and investment in local operations.
  • Operational Excellence in Supply Chain Management: Enhancing supply chain efficiency to reduce costs and improve delivery times, directly impacting profitability and customer satisfaction. Streamlining the supply chain will create value through cost reduction and improved market responsiveness. Investment in technology and process optimization is required.
  • Regulatory Strategy Optimization: Developing a comprehensive regulatory strategy to navigate the diverse and complex global regulatory landscape effectively, aiming to accelerate time to market for new treatments. The value lies in minimizing delays and maximizing market impact. This initiative demands investment in regulatory expertise and global compliance systems.
  • Organizational Effectiveness Improvement: Focusing on internal processes and structures to support global scaling efforts, ensuring the organization remains agile and efficient as it grows. This will involve process optimization and the development of a culture that supports innovation and operational excellence. Resources needed include change management expertise and systems implementation.

Learn more about Operational Excellence Change Management Supply Chain

Organizational Effectiveness Implementation KPIs

KPIS are crucial throughout the implementation process. They provide quantifiable checkpoints to validate the alignment of operational activities with our strategic goals, ensuring that execution is not just activity-driven, but results-oriented. Further, these KPIs act as early indicators of progress or deviation, enabling agile decision-making and course correction if needed.


Efficiency is doing better what is already being done.
     – Peter Drucker

  • Market Penetration Rate: Measures success in entering new markets and expanding market share.
  • Regulatory Approval Times: Critical for evaluating the efficiency of the regulatory strategy.
  • Supply Chain Cost Reduction: Indicates operational efficiency improvements.

These KPIs provide insights into the effectiveness of the strategic initiatives in achieving global expansion, operational efficiency, and regulatory compliance. Continuous monitoring will enable timely adjustments to strategies and operations.

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Organizational Effectiveness Deliverables

These are a selection of deliverables across all the strategic initiatives.

  • Global Market Entry Plan (PPT)
  • Operational Excellence Framework (PPT)
  • Regulatory Strategy Roadmap (PPT)
  • Organizational Effectiveness Playbook (PPT)

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Global Market Entry and Expansion

The strategic team applied the Market Entry Modes framework to guide the organization's approach to entering new international markets. This framework is instrumental in evaluating different entry strategies—such as exporting, licensing, franchising, and joint ventures—to determine the most effective method based on market conditions, regulatory environments, and company capabilities. The application of this framework was pivotal in identifying the optimal entry modes for various target markets, ensuring alignment with the company's strategic objectives and operational capabilities.

Following this framework, the organization undertook several steps:

  • Conducted a comprehensive market analysis for each target country to understand the regulatory environment, market demand, and competitive landscape.
  • Evaluated the company's internal capabilities and resources to determine the most feasible market entry modes.
  • Selected joint ventures and strategic partnerships as the preferred entry modes in markets with high regulatory barriers and established local partnerships to facilitate market access and compliance.

Additionally, the company utilized the Core Competence framework to ensure that its unique capabilities in rare disease treatment research and development were central to its global expansion strategy. This framework, developed by C.K. Prahalad and Gary Hamel, emphasizes the importance of focusing on core competencies that provide competitive advantage and create value for customers. By aligning its global expansion efforts with its core competencies, the organization was able to differentiate itself in new markets and leverage its strengths in innovation and specialized knowledge.

Implementation actions included:

  • Identifying the company’s core competencies in innovative drug development and patient-centric approaches.
  • Aligning market entry strategies with these competencies, ensuring that new ventures leveraged the company's strengths.
  • Communicating the value of the company's core competencies to potential partners and stakeholders in new markets to build collaborative and supportive relationships.

The results of implementing these frameworks were significant. The organization successfully entered multiple new international markets, establishing a presence in regions that were previously inaccessible. Strategic partnerships formed through joint ventures enabled the company to navigate regulatory challenges more effectively and accelerated market penetration. Furthermore, by focusing on its core competencies, the organization was able to establish a unique position in new markets, driving growth and enhancing its global reputation in the field of rare diseases treatment.

Learn more about Competitive Advantage Core Competencies Core Competence

Operational Excellence in Supply Chain Management

To achieve operational excellence in supply chain management, the organization adopted the Lean Management framework. Lean Management focuses on minimizing waste within manufacturing systems while simultaneously maximizing productivity. This framework was chosen for its effectiveness in identifying inefficiencies and optimizing processes, which are crucial for improving supply chain operations in the pharmaceutical industry. The deployment of Lean Management practices led to a more streamlined, cost-effective supply chain, enhancing the organization's ability to deliver treatments to market efficiently.

The Lean Management implementation process involved:

  • Mapping out the entire supply chain process to identify areas of waste, including unnecessary steps, delays, and resource inefficiencies.
  • Implementing lean principles such as just-in-time production, continuous improvement (Kaizen), and error-proofing (Poka-Yoke) to eliminate waste and improve process flow.
  • Training staff across the supply chain on lean management techniques and fostering a culture of continuous improvement.

The introduction of Lean Management practices to the supply chain resulted in a significant reduction in operational costs and improved the speed and reliability of drug delivery to markets. The organization witnessed a marked improvement in supply chain efficiency, with a reduction in production lead times and inventory levels. These enhancements not only contributed to the company's financial performance but also improved its ability to respond to market demands quickly, providing a competitive edge in the fast-paced pharmaceutical industry.

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Key Findings and Results

Here is a summary of the key results of this case study:

  • Successfully entered multiple new international markets, establishing strategic partnerships that facilitated market access and compliance.
  • Identified and leveraged core competencies in innovative drug development, enhancing the company's global reputation in rare disease treatment.
  • Achieved significant supply chain cost reductions and improved delivery times through the implementation of Lean Management practices.
  • Accelerated regulatory approval times by developing a comprehensive global regulatory strategy, minimizing market entry delays.
  • Increased market penetration rate in newly entered markets, though falling short of the projected 20% revenue growth target.

The strategic initiatives undertaken by the pharmaceutical start-up have yielded notable successes, particularly in global market entry and expansion, operational excellence in supply chain management, and regulatory strategy optimization. The decision to focus on strategic partnerships for market entry has proven effective in navigating regulatory complexities and establishing a presence in challenging markets. The emphasis on core competencies has enhanced the company's global reputation, setting a solid foundation for future growth. However, the initiative fell short in achieving the ambitious 20% revenue growth target, primarily due to underestimation of market entry timelines and the intensity of competition in new markets. Additionally, while supply chain efficiencies were significantly improved, the full potential of Lean Management practices has yet to be realized across all operational areas. An alternative strategy that could have enhanced outcomes includes a more aggressive investment in digital technologies for market analysis and customer engagement, potentially accelerating market penetration and revenue growth.

Based on the analysis, the recommended next steps include a deeper focus on digital transformation to enhance market analysis, customer engagement, and operational efficiencies. This should involve investing in advanced analytics for real-time market insights and leveraging digital platforms for patient engagement. Additionally, a review of market entry strategies in highly competitive markets is advised, potentially exploring more innovative partnership models or acquisition strategies to accelerate market access. Continuous improvement in supply chain management should remain a priority, with an emphasis on integrating digital technologies to further reduce costs and improve responsiveness. Finally, fostering a culture of agility and continuous learning will be crucial to adapt to the rapidly changing global pharmaceutical landscape.

Source: Global Scaling Strategy for Pharma Start-Up in Rare Diseases, Flevy Management Insights, 2024

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