Navigating the Red Ocean of Infectious Disease: A CEO's Guide to Six Winning Strategies

Navigating the Red Ocean of Infectious Disease: A CEO's Guide to Six Winning Strategies

The recent Swissmedic authorization of Novartis's Coartem® Baby represents a significant milestone for global health. As the premier malaria therapy developed for infants under 5 kg, it addresses a critical vulnerability in pediatric care.

From a strategic perspective, however, this approval is not a conclusion but a crucial data point. It highlights a profound strategic divergence within the anti-infectives sector. To view this solely as a humanitarian success is to overlook the fundamental market dysfunction that makes such innovations both remarkable and exceedingly rare.

Effective strategy requires a rigorous diagnosis of the core challenge. For novel anti-infectives, that challenge is an industry structure that is inherently hostile to commercial return.

A Diagnosis of Market Failure: The 'Outside-In' View

A Porterian Five Forces analysis reveals an intensely competitive environment that systematically suppresses profitability. This market structure explains why a cohort of disciplined firms—including Eli Lilly, Bristol Myers Squibb, Amgen, and Vertex—have rationally exited the field to focus on more structurally attractive therapeutic areas.

The core pressures include:

  • Consolidated Buyer Power: Major purchasers like The Global Fund and government bodies possess immense negotiating leverage, often enforcing not-for-profit models that cap the return on R&D investment.
  • Pervasive Threat of Substitutes: New assets must compete with a vast arsenal of established, effective, and low-cost generic therapies, placing a permanent ceiling on price.
  • Intense Price-Based Rivalry: With differentiation difficult to sustain, competition often centers on price and distribution channels, eroding margins.

This market diagnosis, while accurate, is incomplete. It cannot explain why industry leaders like Novartis, Merck & Co., Pfizer, and Gilead not only remain but have constructed dominant, billion-dollar franchises in infectious diseases.

Explaining Success: Beyond Market Dynamics

If the market structure dictates failure, the persistence of these leaders suggests other strategic forces are at play. Their success compels a deeper inquiry beyond market positioning alone:

  1. The Resource-Based View (RBV): What distinctive, hard-to-replicate internal capabilities do these companies possess? An "Inside-Out" analysis using a VRIO framework is necessary to identify the unique assets that allow them to thrive where others cannot.
  2. The Market-Creating View: Are these firms simply outcompeting rivals within a hostile market, or are they altering the competitive landscape itself? The development of Coartem® Baby is a classic example of "Value Innovation"—simultaneously delivering radical differentiation (a first-in-class medicine) and conforming to a low-cost access model. This strategic move shatters the conventional trade-off between value and cost.

The current reconfiguration of the anti-infectives landscape is a direct result of firms adopting different answers to these fundamental strategic questions. Their divergent paths are not arbitrary but are coherent strategies grounded in distinct logics. Understanding these multi-lens frameworks is essential for any innovator, investor, or leader seeking to build a defensible position in this—or any—structurally challenging market.


Part 1: Novartis’s Dual Doctrine—Sustaining Leadership Through Non-Commercial Innovation

Novartis's infectious disease strategy is an instructive case study in navigating a structurally hostile market by operating beyond its accepted limitations. The company employs a two-pronged doctrine: it defends its core "Red Ocean" leadership in malaria by erecting competitive barriers, while simultaneously creating new "Blue Ocean" opportunities by solving problems the industry has institutionally abandoned.

This approach stands in stark contrast to the commercially-oriented franchise models of competitors like Merck & Co. (HIV, vaccines) or Gilead (virology). Novartis makes a deliberate strategic choice to target diseases of poverty, a focus that mandates a distinct set of organizational capabilities.

The ability to successfully enact this strategy is, itself, a core VRIO resource. A deconstruction of its components reveals how this defensible advantage is built:

  • Deep Alliance Management Capabilities (VRIO): The Coartem® Baby program, co-developed with partners like Medicines for Malaria Venture (MMV), transcends simple outsourcing. Novartis has cultivated a rare and inimitable capability to manage a complex ecosystem of public funders (like the Bill & Melinda Gates Foundation), academic partners, and in-country clinical trial networks. This core competency functions as a force multiplier, leveraging external capital and expertise to systematically de-risk R&D—an asset competitors cannot readily acquire.
  • Strategic Use of Regulatory Pathways: The decision to use the Swissmedic Marketing Authorization for Global Health Products (MAGHP) was a calculated maneuver. This pathway is a tool designed to trigger a regulatory cascade, greatly accelerating subsequent approvals across 8 African nations that account for nearly half of all malaria cases.
  • Value Innovation to Break Market Constraints: The "not-for-profit" pricing is a central component of the product's value proposition, not a concession. By integrating this access-focused cost model from the outset, Novartis executes a classic Blue Ocean strategy. It effectively eliminates price as a procurement barrier for key buyers while simultaneously raising the delivered value to an unprecedented level for a new patient population (newborns), thus breaking the conventional value-cost trade-off.

Circle representing the three strategic approaches from Novartis to infectious disease

This doctrine is applied not just to pediatric formulations but to the firm’s entire next-generation pipeline, which represents a systematic effort to make future competition irrelevant by solving the problem of drug resistance before it becomes a crisis. The ID portfolio is a coherent set of actions designed to secure future market dominance in a space its largest competitors have chosen not to enter.

Table 1: Novartis Infectious Disease Pipeline as a Strategic Portfolio of Non-Commercial Assets

Table 1: Novartis Infectious Disease Pipeline as a Strategic Portfolio of Non-Commercial Assets

Part 2: A Framework for Mapping the New Competitive Landscape

The challenging economics of the anti-infectives sector have not extinguished competition but have reshaped it into specialized, coherent patterns. In response to market pressures, firms have adopted distinct guiding principles that define their strategic posture.

This has led to the emergence of clear strategic archetypes. To visualize this new competitive topography, we can analyze the industry players along two critical dimensions:

  • Mode of Engagement: Ranging from direct, commercially-driven R&D to indirect, philanthropic contributions and support for external innovation.
  • Breadth of Therapeutic Focus: Spanning from broad, multi-pathogen franchises to narrowly specialized, single-disease or niche pathogen concentrations.

When major firms are plotted against this framework, they do not appear randomly distributed. Instead, they consolidate into distinct clusters, with each archetype representing a different but internally consistent logic for creating value in this demanding field.

Archetypes and strategies of pharma players in infectious diseases

The Six Strategic Archetypes of the Anti-Infectives Sector

The challenging market dynamics in anti-infectives have not eliminated competition; they have channeled it into distinct patterns. Companies have made deliberate choices about their participation, resulting in a new competitive map with six primary archetypes.


Archetype 1: The Diversified ID Franchise Leader

This archetype constructs a dominant, revenue-generating infectious disease business by leading in multiple, commercially viable segments—primarily vaccines and antivirals. Their competitive advantage is built on immense scale, deep R&D capacity, and a portfolio that balances established blockbusters with next-generation assets.

  • Key Players: Merck & Co., Pfizer.
  • Strategic Logic: Broad Market & Resource Dominance. These firms apply extensive R&D budgets and global commercial infrastructure to compete in the most profitable segments of the ID market.
  • Execution: Merck & Co. (MSD) implements a dual-pillar strategy, commanding the HIV market while advancing a formidable vaccine portfolio led by its blockbusterGardasil 9 HPV vaccine ($8.6B in 2024 sales) and its next-generation pneumococcal franchise (Vaxneuvance/Capvaxive). Its pipeline, centered on the first-in-class NRTTI islatravir, is designed to protect this leadership. A deep commitment to hospital anti-infectives, solidified by the acquisition of Cubist, provides another revenue stream with products like Recarbrio and Zerbaxa. Pfizer leveraged the success of its Comirnaty vaccine and Paxlovid oral COVID-19 antiviral to create a powerful financial and technological platform, which it now uses to defend its blockbuster Prevnar pneumococcal franchise and expand into new high-value markets like RSV.
  • Global Health Model: For this group, non-commercial global health is managed through structured, high-profile philanthropic programs (Merck's Mectizan Donation Program, Pfizer's International Trachoma Initiative) or de-risked R&D partnerships (Merck licensing preclinical TB assets to the Gates MRI).


Archetype 2: The Virology Pure-Play Specialist

This archetype achieves dominance through extreme focus. Its strategy is to lead not by breadth, but by being the unrivaled innovator in a single, high-value vertical like virology.

  • Key Player: Gilead Sciences.
  • Strategic Logic: Narrow Focus & Deep Innovation. This is a differentiation focus strategy. Gilead’s market power is derived from its unparalleled institutional knowledge of HIV drug development, a core VRIO resource it defends through relentless innovation.
  • Execution: From early single-tablet regimens to the current market leader Biktarvy ($13.42B in 2024 sales), Gilead consistently advances the standard of care. Its pipeline, featuring the long-acting injectable lenacapavir and ambitious HIV cure programs, reinforces this narrow focus. The company successfully applied this virology expertise to the adjacent HCV market (Epclusa, Harvoni).
  • Global Health Model: Gilead’s pioneering voluntary licensing agreements with the Medicines Patent Pool (MPP) provide massive global access while cementing its therapies as the worldwide standard, creating a formidable competitive barrier.


Archetype 3: The Sustained Global Health Investor (Non-Commercial Focus)

This archetype strategically targets structurally unattractive markets abandoned by commercial players. Its objective is scientific leadership in neglected diseases, a high-risk model viable only through deep integration with the public-private partnership (PPP) ecosystem.

  • Key Players: Novartis, Merck KGaA.
  • Strategic Logic: Niche Creation via Resource-Based Advantage. Success is contingent on a core VRIO resource: the organizational capability to manage the complex PPP ecosystem.
  • Execution: Novartis’s malaria pipeline is a direct output of this model. Similarly, Merck KGaA’s commitment to its novel antimalarial program (M5717) and schistosomiasis research exemplifies this archetype’s logic.


Archetype 4: The Focused Niche Contributor

These firms maintain a targeted presence in infectious diseases, typically centered on a single strong commercial asset or a focused R&D program, without the broader franchise ambitions of the leaders.

  • Key Players: Takeda, Genentech (Roche), AbbVie.
  • Strategic Logic: Targeted Differentiation. These companies apply their core capabilities to specific ID challenges where they can develop a differentiated product.
  • Execution: Takeda has made a concentrated, successful bet on emerging viral disease vaccines, with its dengue vaccine QDENGA® as the centerpiece. Genentech (Roche) uses its R&D strength to support a focused portfolio in influenza (Xofluza) and AMR. AbbVie generates significant revenue from its HCV therapy MAVYRET, , complemented by a small hospital antibiotic portfolio (Avycaz, Dalvance) gained via the Allergan acquisition, while its future R&D is a high-risk bet on an HIV cure program.


Archetype 5: The Strategic Exits & Legacy Managers

This group represents a rational reallocation of capital away from the hostile ID therapeutics market. These firms have formally exited active ID R&D and now manage legacy products or channel efforts through philanthropic arms.

  • Key Players: Bristol Myers Squibb, Eli Lilly.
  • Strategic Logic: Porter-Driven Market Exit. These companies analyzed the market’s competitive forces, deemed them unfavorable, and pivoted.
  • Execution: Their commercial R&D pipelines are now empty of ID candidates. BMS divested its HIV pipeline, while Eli Lilly’s major ID effort in TB is structured as a not-for-profit PPP. Their successful but temporary development of COVID-19 antibodies underscored that their exit was a deliberate strategic choice, not a result of lacking capability.


Archetype 6: The Capability Players (No ID Focus)

This archetype includes major biopharmaceutical firms with world-class scientific capacity that have made a clear strategic decision not to compete in the infectious disease field.

  • Key Players: Amgen, Novo Nordisk, Vertex, Biogen.
  • Strategic Logic: Core Competency Focus. These firms achieve success by maintaining a disciplined concentration on their primary therapeutic areas.
  • Notable Mentions: While Novo Nordisk the company has no ID program, the independent Novo Nordisk Foundation is a major global funder of ID research. Likewise, Regeneron, while not ID-focused, has demonstrated a latent institutional capacity for rapid pandemic response with its antibody cocktails antibody cocktails for Ebola (Inmazeb) and COVID-19 (REGEN-COV).

Table 2: The Six Models of Pharmaceutical Engagement

Table 2: The Six Models of Pharmaceutical Engagement

Part 3: The Coherent Action—Integrating the PPP Ecosystem as a Market-Shaping Force

In a structurally compromised market like anti-infectives, a firm’s internal actions are insufficient for success. The most critical coherent action is therefore external: the decision to deeply integrate with the Public-Private Partnership (PPP) ecosystem. Operating independently against the hostile industry structure we diagnosed is a strategically unviable approach.

To perceive organizations like the Medicines for Malaria Venture (MMV), Drugs for Neglected Diseases initiative (DNDi), the Bill & Melinda Gates Foundation, or funders like the Novo Nordisk Foundation as simple benefactors is to misunderstand their strategic role. They are not passive capital providers but active industry components that fundamentally reshape the competitive environment. Their presence bifurcates the field, creating one arena for firms that operate within the PPP ecosystem and another for those that do not. The strategies of the sector's most committed players are only plausible because they are executed within this altered arena.

A systematic analysis illustrates how the PPP ecosystem reshapes the hostile forces identified in our initial Porterian framework:

1. Mitigation of Overwhelming Buyer Power

While final purchasers like The Global Fund or Gavi retain considerable leverage, a PPP can function as a strategic intermediary and validation body. When MMV co-develops Novartis’s ganaplacide, it confers its scientific legitimacy onto the asset. Similarly, when the Gates Foundation funds a pivotal African trial for a Merck HIV PrEP candidate, it validates the urgent public health need for the product.

A more explicit illustration is the strategic partnership between Gilead and The Global Fund to supply lenacapavir for PrEP to millions at a no-profit price. This arrangement is not a simple procurement transaction; it represents a co-created access strategy designed to establish a new therapy as the global standard of care well before generics can enter, thereby actively shaping the future market.

2. Selective Lowering of Entry & Mobility Barriers

The PPP model serves as an indispensable de-risking mechanism, absorbing the potentially catastrophic financial impact of early-stage R&D failure.

  • The Gates MRI’s licensing of two preclinical TB candidates from Merck & Co. is a clear example, where Merck provides the discovery asset and the non-profit assumes the immense cost and risk of clinical validation.
  • Takeda's partnership with DNDi to screen its compound library for leishmaniasis candidates permits the company to contribute to a neglected disease without diverting substantial internal resources from its primary vaccine business.
  • Even for Strategic Exits like Eli Lilly, its MDR-TB Partnership—which involved donating drugs and transferring manufacturing technology—was a PPP that enabled a major global health contribution without maintaining a commercial stake.

These partnerships not only reduce initial entry barriers for a given project; they also help firms construct durable mobility barriers. A demonstrated ability to collaborate successfully with entities like the Gates Foundation or MMV evolves into a VRIO resource—a complex social capability that new competitors cannot easily imitate.

3. Neutralizing the Threat of Substitutes by Creating New Value Curves

The essential mission of R&D-focused PPPs is to surpass the limitations of existing therapies. They are not structured to fund incremental "me-too" drugs. Their entire function is to finance innovation that makes existing substitutes obsolete for specific, critical problems.

  • When an entity like the AMR Action Fund—backed by a consortium of industry and foundations—invests in a biotech developing a novel antibiotic, its explicit goal is to target pathogens for which established generics are failing.
  • When GSK partners with MMV to advance Tafenoquine for P. vivax relapse, it executes a Blue Ocean strategy. The product solves a problem existing therapies cannot—preventing relapse with a single dose—which neutralizes the threat of substitutes for that precise indication.
  • Pfizer’s 2020 acquisition of Arixa Pharmaceuticals to create an oral version of its beta-lactamase inhibitor is a similar move. This creates a product capable of treating resistant infections outside a hospital, a value proposition that existing IV-only substitutes cannot offer.

4. Reframing Rivalry from Zero-Sum to Managed Competition

The PPP ecosystem cultivates a more collaborative dynamic among competitors. The landmark partnership between fierce rivals Merck & Co. and Gilead to co-develop a long-acting oral HIV regimen is a primary illustration. This collaboration was born from the scientific need to combine two best-in-class novel mechanisms to achieve a genuine breakthrough. In a similar vein, the multi-firm partnership between Pfizer and AbbVie to commercialize the antibiotic Emblaveo (aztreonam-avibactam) shows a shared resolve to address a critical AMR threat. Such alliances, frequently facilitated by public health imperatives, shift rivalry away from a head-to-head battle for market share and toward a managed competition focused on solving a scientific challenge.

Table 3: The PPP Ecosystem as a Market-Shaping Force — A Multi-Lens Analysis

Table 3: The PPP Ecosystem as a Market-Shaping Force — A Multi-Lens Analysis

Consequently, the capacity to operate effectively within this ecosystem has become a central competitive competency. Success in this field is now defined less by isolated internal R&D strength, such as medicinal chemistry expertise, and more by demonstrated excellence in alliance management. This includes the institutional agility required to function within intricate global consortia and the scientific credibility necessary to be chosen as a preferred collaborator.

The strategic approaches employed by the most committed organizations are not acts of defiance against hostile market conditions; they are the result of rigorous strategic logic. These firms are leveraging the PPP ecosystem as a coherent action to selectively reconfigure market forces. By doing so, they are constructing their action plans upon the only viable foundation for sustainable innovation in what is otherwise a structurally unattractive market.


Part 4 : Conclusion: The Inescapable Mandate of Strategic Choice

The intricate landscape of anti-infectives R&D is not a random assortment of corporate actions but the logical result of a rational, if demanding, strategic calculus. The analysis is unambiguous: a rigorous Five Forces assessment confirms that the market for many novel anti-infectives is structurally hostile. This challenging architecture has compelled a Great Reconfiguration, sorting industry participants into one of six distinct strategic archetypes, each guided by its own internally consistent policy for navigating the environment and creating value.

The prior battlefield, characterized by similar, broad-based corporate fleets, has been supplanted by a specialized and interdependent ecosystem. The Diversified ID Franchise Leaders (Merck & Co., Pfizer) and the Virology Pure-Play Specialist (Gilead) function as the capital ships, commanding the high-value commercial waters with their blockbuster HIV, vaccine, and pandemic-response portfolios. The Sustained Global Health Investors (Novartis, Merck KGaA) operate as high-tech destroyers, pushing the scientific frontier in non-commercial territories like malaria. The Focused Niche Contributors (Takeda, Genentech, AbbVie) act as agile frigates, securing specific strategic inlets such as dengue vaccines or hospital antibiotics. Meanwhile, the Strategic Exits (BMS, Eli Lilly) have recalled their assets to port, reallocating resources to different missions while managing their ID legacy through philanthropy. This entire system is defined by its interdependence, increasingly powered by the capital and coordination of the PPP ecosystem.

One may question the relentless logic of the Global Health Investors—why persist on the most perilous front? The answer is not located on quarterly income statements but in the deliberate construction of durable strategic assets. These assets are often invisible to a standard financial analysis but are central to a Resource-Based View (RBV). The seemingly “hidden ROI” from Novartis's sustained investment is a masterclass in this doctrine, built upon several core VRIO resources:

  • The Scientific and Data Moat (VRIO Resource): By solving the most complex problems, from neonatal pharmacology to novel resistance mechanisms, Novartis constructs a fortress of proprietary knowledge. This knowledge base is causally ambiguous and socially complex, making it exceedingly difficult for competitors to replicate and establishing it as a core VRIO asset.
  • ESG Leadership as a Capital and Talent Magnet (VRIO Resource): Achieving a #1 ranking in the Access to Medicine Index is not a vanity project; in an ESG-focused world, it functions as a strategic financial asset. This leadership attracts the stable, long-term capital and premier scientific talent required to sustain its innovative edge, generating a virtuous cycle of resource accumulation.
  • Indispensable Partner Status (VRIO Resource): By developing the solutions to the ecosystem’s most critical threats, such as drug resistance, Novartis cements itself as the preferred partner for every major global health institution. This position grants the company unparalleled strategic influence and a privileged role in defining the future of the field.
  • A Proving Ground for Future Threats (Dynamic Capability): The Global Health unit operates as a high-fidelity training environment. It builds the organizational readiness and institutional capabilities needed to combat future pandemics and climate-driven diseases—a "dynamic capability" of incalculable long-term value.

The four strategic Assets from Novartis in a circle representation

These are not fortunate byproducts; they are the calculated returns on a coherent, long-term strategy. The strategies of the most committed players are not reckless acts of defiance against the market's structure. They are highly sophisticated maneuvers enabled by the PPP ecosystem, which reshapes the competitive terrain for those who can effectively navigate it.

Table 4: Synthesis of Strategic Archetypes & Endgame

Table 4: Synthesis of Strategic Archetypes & Endgame

For innovators, investors, and strategic leaders throughout preclinical biotech, this analysis offers an essential framework. Its utility extends beyond the anti-infectives space to the assessment of any therapeutic area. The central insight is not disease-specific; it is about the discipline of strategy itself. Within any structurally challenging market—whether defined by consolidated buyers, pervasive substitutes, or other adverse forces—an undifferentiated approach is a prescription for failure. Adopting an ambiguous strategic position without coherent, reinforcing actions, a state of being "stuck in the middle," is the most direct path to the destruction of capital.

The strategic imperative is therefore clear. First, a rigorous, multi-lens diagnosis of the competitive landscape is non-negotiable. Second, a decisive choice must be made regarding the fundamental basis of competitive advantage. Third, that choice must be translated into a coherent set of actions designed to leverage the chosen advantage and construct a defensible market position. On the new battlefield of global health, as in all strategic arenas, there is no substitute for clarity.

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Special thanks to my co-author Anabel Perez-Gomez, PhD, MBA, whose critical views and recommendations significantly informed the application of a hybrid strategic framework to biopharma portfolios.

This article is a summarized version. You cand access the extended original version at The Great Reconfiguration: Deconstructing Strategic Choice in the Hostile Anti-Infectives Market.

Visit INBISTRA for more information, reports and insights.


References and Recommended Reading Classic & Foundational Frameworks

Resource-Based and Capability-Based Views

Market and Innovation-Driven Strategy

Strategy Execution and Implementation

Other Influential Strategic Models

Research and Development for Neglected Tropical Diseases & Malaria


Pharmaceutical Company Announcements and Financials


Industry News and Analysis


Additional Corporate and Foundational Links

Anabel Perez-Gomez

Biotech Operations & Strategy | COO at INBISTRA | Portfolio Management, Preclinical Development & Scouting | Vendor Management | Diligence-Ready Programs | PhD | MBA

3mo

Sharp piece! A clear strategic lens on a space too often framed only as a policy failure. 

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