PERSPECTIVE article

Front. Pediatr., 23 June 2026

Sec. Children and Health

Volume 14 - 2026 | https://doi.org/10.3389/fped.2026.1845146

Breaking the sound barrier: global monoclonal antibody pharmacoequity

  • 1. Fred Hutch Cancer Center, Vaccine and Infectious Disease Division, Seattle, WA, United States

  • 2. South African Medical Research Council, Cape Town, South Africa

  • 3. Infectious Disease and Oncology Research Institute, University of Witwatersrand, Johannesburg, South Africa

  • 4. BK Biopharma Consulting, LLC, Burlingame, CA, United States

Abstract

Monoclonal antibodies represent one of biomedicine's greatest successes, yet global access remains profoundly inequitable, with low- and middle-income countries bearing the brunt of limited access. This perspective proposes that long-acting infectious disease mAbs, starting with WHO-recommended nirsevimab for RSV prevention, could catalyze transformation by connecting with existing WHO Essential Medicines List mAbs. Picture two static half-circles: WHO Essential Medicines List mAbs with proven value but limited access, and infectious disease prevention mAbs with transformative potential. Connected, they form a complete wheel capable of rolling toward the aspirations of global pharmacoequity. HIV antiretroviral therapy demonstrates precedent—costs declined 100-fold through political mobilization, not technological breakthroughs.

1 Introduction: the static half-circles

Monoclonal antibodies (mAbs) represent one of biomedicine's greatest successes—yet global access remains profoundly inequitable. While more than 130 mAbs are approved in the United States (), only sixteen appear on the current WHO Essential Medicines List (Table 1), and billions lack access to these life-saving drugs (). The long-acting infectious disease mAb nirsevimab for RSV prevention when combined with the existing WHO Essential Medicines List mAbs create a critical mass that could catalyze improved access to mAbs in LMICs. As additional infectious disease mAbs for malaria and HIV gain approval, this combined effort could grow like a snowball.

Table 1

mAbTargetYear approvedEML section & indicationsAnnual tonnage for unmet need (tons)**
Cancer
blinatumomab (Blincyto)aAnti-CD1920148.2.3 B-cell acute lymphoblastic leukemia0.001
rituximab (Rituxan/MabThera)aAnti-CD2019975.1.2 multiple sclerosis 8.2.2 Burkitt lymphoma, diffuse large B-cell lymphoma, chronic lymphocytic leukemia, follicular lymphoma1.1
trastuzumab (Herceptin)HER2 receptor19988.2.2 HER2-positive breast cancer2.8
nivolumab (Opdivo)PD-1 checkpoint20148.2.3 metastatic melanoma0.2
pembrolizumab (Keytruda)PD-1 checkpoint20148.2.3 metastatic cervical cancer, metastatic colorectal cancer, metastatic non-small cell lung cancer, metastatic melanoma0.6
atezolizumab (Tecentriq)PD-L1 checkpoint20168.2.3 metastatic non-small cell lung cancer3
cemiplimab (Libtayo)PD-1 checkpoint20188.2.3 metastatic non-small cell lung cancer0.9
Hematology
emicizumab (Hemlibra)aFactor IX-a & X201710.2 hemophilia A1
Inflammatory disease
infliximab (Remicade)aTNF-alpha*19988.1 immunomodulators for non-malignant disease 13.4 medicines affecting skin differentiation and proliferation 29.3 medicines for juvenile joint diseases1.1
adalimumab (Humira)aTNF-alpha*20028.1 immunomodulators for non-malignant disease 13.4 medicines affecting skin differentiation and proliferation 29.3 medicines for juvenile joint diseases6.5
certolizumab pegol (Cimzia)aTNF-alpha*20088.1 immunomodulators for non-malignant disease 13.4 medicines affecting skin differentiation and proliferation 29.3 medicines for juvenile joint diseases2.7
golimumab (Simponi)TNF-alpha*20098.1 immunomodulators for non-malignant disease 29.3 medicines for juvenile joint diseases0.3
ustekinumab (Stelara)aIL-12 & IL-23 antagonist202313.4 medicines affecting skin differentiation and proliferation1.1
Infectious disease
Anti-rabies mAbs (Rabishield)aRabies virus19.2 sera, immunoglobulins and monoclonal antibodies1.1
ansuvimab-zykl (Ebanga)aEbola virus20236.7 medicines for Ebola virus disease0.004
atoltivimab, maftivimab, odesivimab (Inmazeb)aEbola virus20236.7 medicines for Ebola virus disease0.012
Nirsevimab (Beyfortus)***RSV2023Not on EML7-14
Clesrovimab (Enflonsia)RSV2025Not on EML***
Total30-37

Who 2025 essential medicines list mAbs and RSV mAbs: global unmet need estimate.

a

Also listed on the Essential Medicines List for Children (EMLc).

*

Several mAbs are interchangeable, this is taken into account in the calculations.

**

Order-of-magnitude estimates based on global disease burden and standard dosing regimens, assuming ∼100 LMIC without access, 70 kg body weight, 1.7 m2 surface area.

***

Nirsevimab is the WHO-recommended long-acting RSV mAb for all infants (single dose protection). Clesrovimab represents an alternative long-acting option. The math for global access remains similar regardless of which RSV mAb is used.

Picture two half-circles lying motionless on the ground (Figure 1). The first represents the monoclonal antibodies on the WHO Essential Medicines List—rituximab (approved 1997), trastuzumab (1998), infliximab (1998), and others that transformed cancer and autoimmune disease treatment in high-income countries. Despite being available in high-income countries for 15-30 years, these therapeutic breakthroughs remain largely inaccessible to billions of people in approximately 100 low- and middle-income countries (LMICs). This half-circle, representing roughly 23 metric tons of annual unmet global need, sits static—powerful in potential but unable to generate momentum for systemic change (). Is the inertia driven by cost of goods or that drug companies simply are not interested in those markets because of poor ROIs?

Figure 1

The second half-circle represents long-acting infectious disease prevention mAbs, starting with nirsevimab for prevention of respiratory syncytial virus (RSV). Nirsevimab when administered at birth or at the start of RSV season is highly effective in preventing severe RSV disease ().

2 The wheel begins to roll: infectious disease mAbs as infrastructure

The WHO recommendation for nirsevimab for RSV prevention represents both an unprecedented public health opportunity and the key to unlocking systemic transformation (). The two half-circles represent complementary volumes and populations. The first half-circle—WHO Essential Medicines List mAbs—requires 23 metric tons annually but serves smaller, targeted populations with cancer and autoimmune diseases. The second half-circle—long-acting infectious disease prevention mAbs starting with nirsevimab—requires 7-14 metric tons annually but reaches 140 million infants globally. Like the segments and peel of an orange, these complementary volumes create a complete, integrated whole when connected. The combination of RSV and WHO Essential Medicines List mAbs requires 30-37 metric tons, the production scale needed to make both economically viable.

The fragmented, disease-specific approach to mAb access is exemplified by pembrolizumab in India, where despite the country's position as a global biosimilar manufacturing hub, less than 1% of eligible patients access this life-saving therapy at ∼$6,000 per cycle, because individual disease markets lack the volume to justify dedicated manufacturing that could reduce costs to $50-100/gram (). This demonstrates why WHO Essential Medicines List mAbs cannot achieve momentum independently—even powerful cancer immunotherapies remain trapped in high-cost, low-access paradigms when treated as isolated markets rather than components of a unified therapeutic class.

This requires expanded manufacturing capacity—whether through scaling existing facilities or establishing new production sites closer to demand—plus temperature-controlled distribution networks, integration with maternal-child health programs, harmonized regulatory pathways, and community demand generation. Once this RSV + WHO Essential Medicines List connection is established and working, the same manufacturing and delivery systems can absorb malaria mAbs, HIV mAbs, and eventually grow to accommodate the full infectious disease portfolio as it gains approval: malaria prevention for 110 million children, HIV pre-exposure prophylaxis for 20-100 million children and adults, and HIV treatment for up to 40 million people living with HIV ().

The predictability is equally transformative. Birth cohorts, malaria-endemic populations, HIV incidence and prevalence, cancer incidence change slowly year-to-year, enabling long-term contracts and planning.

3 The historical precedent: HIV treatment's 100-fold cost reduction

The history of HIV antiretroviral therapy (ART) provides a crucial precedent demonstrating that barriers to affordable biologics are primarily structural and political rather than technical. Between 2000 and 2008, ART costs in LMICs declined from approximately $10,000 per person-year to less than $100—a 100-fold reduction achieved in less than eight years not through manufacturing breakthroughs, but through political mobilization ().

Many actors and events created a perfect storm of political pressure, intellectual property flexibility, guaranteed procurement volumes, and manufacturing capacity. The 13th International AIDS Conference in Durban, South Africa in 2000 proved pivotal—where 11-year-old Nkosi Johnson, born with HIV, spoke to delegates about the human cost of unequal access. The Treatment Action Campaign in South Africa, the Doha Declaration on TRIPS and Public Health (2001), PEPFAR and Global Fund establishment (2003), and Indian generic manufacturing scale-up transformed global treatment access. The same molecules—manufactured using identical or similar processes—cost 40-fold more in high-income countries ($3,000) than LMICs ($75) in 2024, a differential sustained for two decades through structural barriers ().

This comparison reveals that monoclonal antibodies have followed the slowest learning curve among major technologies over nearly four decades, declining only 33-fold despite innovations from establishment of Chinese Hamster Ovary cell lines platforms and initial scaling (era 1, 1975-1998) to blockbuster mAb commercialization (era 2, 1999-2019), to unprecedented clinical development and scale-up to >30 tons annual production of COVID-19 mAbs (era 3, 2020-2023), to further optimization and expansion in the present era 4 (). When political intervention created alternative market dynamics for ART, costs declined faster than mAb manufacturing optimization achieved through pure technological advancement.

Unlike complex antibody-drug conjugates, these mAbs are relatively simple—nirsevimab is an IgG1 antibody with YTE (3 amino acid mutation in the Fc part to extend the half-life by about 3-fold) as the only mutation. The persistence of high costs for such straightforward molecules highlights how structural barriers, not technical complexity, drive pricing.

This fragmentation persists today with devastating consequences. WHO recommends nirsevimab for all infants globally to prevent RSV disease, yet the same organization has not prequalified the medicine and excludes it from the Essential Medicines List (). This bureaucratic dysfunction prevents UNICEF procurement while 100,000 children die annually from preventable RSV disease in LMICs without access to nirsevimab—history repeating itself with tragic precision (). Just as HIV treatments existed in the 1990s but structural barriers delayed access for a decade, we now witness the same pattern with pediatric RSV prevention.

The lesson is clear: innovation alone is necessary but insufficient. Structural barriers—intellectual property regimes, procurement fragmentation, manufacturer market power—often determine access more than scientific breakthroughs.

4 The second wheel: eight segments for pharmacoequity

Moving from efficacy in a clinical trial to global population-level effectiveness requires addressing eight elements (segments, Figure 2) in parallel: (1) Efficacy demonstration in trials, (2) Regulatory approval through harmonized pathways, (3) Availability via technology transfer and local manufacturing, (4) Accessibility through delivery infrastructure, (5) Affordability via pooled procurement and TRIPS flexibilities, (6) Awareness among providers and patients, (7) Appropriateness for local contexts, and (8) Ask/Aspiration/Political will—the fundamental demand that life-saving interventions should be universally accessible regardless of geography or income () and the political will with concomitant budget allocation either at a government level or by global procurement agencies. The critical insight is parallel rather than sequential implementation. Engage the Medicines Patent Pool and generic manufacturers during Phase 3 trials. Negotiate technology transfer before licensure.

Figure 2

The “Aspiration” element may prove most fundamental. For decades, people in low-income countries were told antiretrovirals were too expensive, too complex to work outside high-income settings. This self-fulfilling prophecy that led to 10-12 million deaths () was shattered by among others the Treatment Action Campaign's assertion of equal right to life-saving treatment and studies showing that adherence to ART was better in rural Uganda than in the US (, ). The same assertion is required for mAbs: children in Mali and Kenya have identical rights to RSV protection as children in London and New York. More than 100,000 children die of RSV each year in LMIC that do not have access to nirsevimab, compared to less than 500 (before introduction of nirsevimab) in high-income countries that now have access (). Infants and toddlers can't advocate for themselves. We have to do that.

5 Expanded infectious diseases scope: mAbs for antimicrobial resistance, influenza prevention, pandemic preparedness capacity

Expanding the wheel’s momentum, monoclonal antibodies targeting influenza, antimicrobial resistance (AMR) and pandemic preparedness represent the next frontier for integrated global access.

The COVID-19 pandemic demonstrated both the potential and limitations of mAb responses. While therapeutic mAbs like bebtelovimab provided crucial treatment options, production delays and strain-specific targeting limited global impact. The integrated manufacturing infrastructure proposed here could enable rapid pandemic mAb deployment, with established production capacity, regulatory pathways, and delivery networks ready for activation during emerging infectious disease outbreaks (, ).

Seasonal influenza causes 290,000-650,000 deaths annually, with disproportionate impact in LMICs (). Monoclonal antibodies targeting influenza are in clinical development (, ).

AMR causes approximately 1.27 million deaths annually, with particularly severe impact in LMICs where healthcare-associated infections encounter limited treatment options. mAbs against Staphylococcus aureus and Clostridium difficile are in advanced clinical development (). Unlike traditional antibiotics facing inevitable resistance, mAbs can target virulence factors, biofilms, and immune evasion mechanisms while potentially maintaining efficacy longer. For 50 million annual patients requiring AMR prophylaxis (100-500 mg doses), approximately 5-25 metric tons would be needed—adding meaningful volume to infectious disease mAb infrastructure while addressing one of modern medicine's greatest threats.

6 Era 5: is there a mAb for that?

Following the four eras of mAb development outlined above we could now enter era 5, characterized by cost-driven accessibility and therapeutic expansion. The rolling wheel unlocks therapeutic possibilities currently constrained by cost and fragmentation. With manufacturing costs decreasing further, mAbs become viable for indications beyond traditional oncology and autoimmune diseases. AMR, influenza prevention, migraine prevention, allergies, Alzheimer's disease, substance use disorders including fentanyl addiction—countless therapeutic targets remain unexplored because current mAb pricing makes development economically unfeasible or clinically inaccessible. The integrated manufacturing and delivery infrastructure creates the foundation for systematic exploration of the full therapeutic potential of monoclonal antibodies (, ).

The One Health approach reveals an additional volume catalyst: veterinary mAbs. With 900 million dogs, 600 million cats, and billions of livestock globally, animal health represents massive untapped demand. Existing veterinary mAbs like lokivetmab (Cytopoint, 2017) for atopic dermatitis, bedinvetmab (Librela, 2021) for canine osteoarthritis, and frunevetmab (Solensia, 2022) for feline pain demonstrate market viability. The same manufacturing infrastructure serving human infectious disease mAbs could simultaneously produce veterinary products, creating additional volume to drive costs down while serving both human and animal health needs.

7 The rolling wheels: integrated delivery vision

Once the wheel begins rolling, integrated delivery becomes possible. Maternal-child health programs delivering nirsevimab can simultaneously distribute WHO Essential Medicines List mAbs. The same cold chain infrastructure, community health workers, and regulatory pathways serve multiple products. This integration transforms episodic, disease-specific interventions into comprehensive pharmacoequity infrastructure. The wheel's momentum creates economies of scale—where delivering multiple mAbs together costs less than delivering each separately.

8 Breaking the sound barrier

“Breaking the sound barrier” represents the breakthrough moment when accumulated momentum overcomes systemic resistance. Like an aircraft breaking the sound barrier or encountering turbulence, the combined wheel of WHO Essential Medicines List mAbs and infectious disease prevention faces ups and downs, challenges and obstacles, as it travels the long and winding road to pharmacoequity. Individual efforts—whether rituximab access programs or standalone RSV campaigns—encounter turbulence and often stall. But when sufficient momentum builds through integrated volume, manufacturing scale, and delivery infrastructure, the wheel can break through to sustained, equitable access.

The barrier is not technical—we know how to manufacture these mAbs at scale. The barrier is structural: fragmented markets, intellectual property constraints, procurement silos, and regulatory inefficiencies. Once broken, the barrier reveals clear skies ahead: predictable demand, streamlined production, integrated delivery, and ultimately, pharmacoequity as the foundation rather than the exception.

9 Challenges and limitations

This vision faces significant challenges. Intellectual property regimes may limit generic competition. Regulatory harmonization requires unprecedented coordination. Cold chain infrastructure demands substantial investment. Political commitment must sustain across electoral cycles. Most critically, the approach requires viewing mAbs as a class of drugs rather than individual products—a shift from disease-specific silos to integrated pharmacoequity infrastructure.

Yet these challenges reflect structural barriers, not technical impossibilities. The HIV treatment precedent demonstrates that political mobilization can overcome seemingly insurmountable obstacles when the imperative is clear.

10. Conclusion: the wheels in motion

The two half-circles lie before us: WHO Essential Medicines List mAbs with proven therapeutic value but limited access, and infectious disease prevention mAbs with transformative potential but uncertain implementation. Separately, they remain static. Together, they form a complete wheel capable of rolling toward global pharmacoequity.

An African proverb reminds us: “If you want to go fast, go alone. If you want to go far, go together.” Individual mAb access programs—rituximab biosimilars, standalone RSV campaigns, disease-specific initiatives—may achieve rapid initial progress. But sustainable pharmacoequity requires going together: connecting WHO Essential Medicines List mAbs with infectious disease prevention, integrating manufacturing with delivery, aligning regulatory pathways across therapeutic areas. This collaborative approach may seem slower initially, but it builds the momentum needed to go far—toward a future where pharmacoequity is the foundation, not the exception.

The wheel can start rolling today by connecting nirsevimab for RSV with existing WHO Essential Medicines List mAb initiatives. As malaria and HIV mAbs gain approval, the wheel grows like a snowball, building momentum that becomes increasingly difficult to stop. Manufacturing investments become profitable. Delivery infrastructure becomes sustainable. Pharmacoequity becomes inevitable.

Thirty years after the first therapeutic mAb, we stand at an inflection point. We can continue the fragmented, fast-but-limited approach that has left billions without access to essential medicines—an approach that, for mAbs, has proven neither fast nor effective despite decades of effort. Going together may be the only viable path to mAb pharmacoequity. Together, we can connect the two half-circles and get the wheel rolling toward a future where place of birth no longer determines access to these essential medicines.

Statements

Data availability statement

Publicly available datasets were analyzed in this study. This data can be found here: https://www.who.int/data/sets/health-inequality-monitor-dataset#ihme-gbdhttps://www.who.int/publications/i/item/B09474.

Author contributions

HG: Visualization, Writing – original draft, Writing – review & editing, Conceptualization. GG: Writing – review & editing, Writing – original draft. BK: Writing – review & editing, Writing – original draft.

Funding

The author(s) declared that financial support was not received for this work and/or its publication.

Conflict of interest

BK was employed by BK Biopharma Consulting, LLC.

The remaining author(s) declared that this work was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Generative AI statement

The author(s) declared that generative AI was not used in the creation of this manuscript.

Any alternative text (alt text) provided alongside figures in this article has been generated by Frontiers with the support of artificial intelligence and reasonable efforts have been made to ensure accuracy, including review by the authors wherever possible. If you identify any issues, please contact us.

Publisher’s note

All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher.

References

Summary

Keywords

access to medicines, biologics, disease prevention, essential medicines, monoclonal antibodies, pharmacoequity, RSV (respiratory syncytial virus) prophylaxis, volume catalyst

Citation

Gelderblom HC, Gray G and Kelley B (2026) Breaking the sound barrier: global monoclonal antibody pharmacoequity. Front. Pediatr. 14:1845146. doi: 10.3389/fped.2026.1845146

Received

01 April 2026

Revised

13 May 2026

Accepted

25 May 2026

Published

23 June 2026

Volume

14 - 2026

Edited by

Lindsay Keir, G20 & G7 Health and Development Partnership, United Kingdom

Reviewed by

Peter J. Gardner, LifeArc, United Kingdom

Updates

Copyright

*Correspondence: Huub C. Gelderblom

Disclaimer

All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.

Outline

Figures

Cite article

Copy to clipboard


Export citation file


Share article

Article metrics