Next-generation broadly neutralizing antibodies (bnAbs) have the potential to transform the fight against global health threats like HIV, malaria, and Ebola. The commercialization of these innovative antibody therapies could save millions of lives annually. But turning promise into reality requires foresight and commitment.
Broadly neutralizing antibodies are a type of protein that can recognize and neutralize a wide range of pathogens, including multiple strains of viruses such as HIV. This versatility makes them highly valuable in medicine, promising effective treatments and preventive measures against infectious diseases. New discoveries are improving the potency and durability of antibodies in general.
But significant roadblocks, particularly concerning manufacturing investments, impede the path of antibody therapies from the lab to the clinic. The cost of producing bnAbs far exceeds that of small-molecule drugs, making their production financially unfeasible without the promise of substantial returns. Compared to other biologics, bnAbs could cost more than the new weight loss drugs to produce, though less than CAR-T cell therapy. This cost structure is particularly prohibitive when considering the economic constraints in the low-income countries where these treatments are most urgently needed.
Think about using a biannual regimen of bnAbs for HIV, which could dramatically reduce transmission rates. The HIV Vaccine Trials Network is currently identifying bnAbs for a Phase 2B trial to fill unmet need. Yet, the cost of producing such a regimen is prohibitive, according to estimates made by Infectious Economics, the company I founded. Our data, which I’m presenting at the HIV Vaccine Trials Network Full Group Meeting on May 1 in Washington, D.C., place the U.S. market potential at more than $1.3 billion. But in a country like Malawi, which has high HIV transmission rates and low per-capita income, the price per dose must be as low as $8 — far below the production cost — to be economically viable.
This disparity raises a critical question: Why would a pharmaceutical firm invest in a product that many of its most desperate customers cannot afford? Our analysis shows that bridging this gap would require targeted financial interventions ranging from $1 million to $20 million per country annually to make such therapies viable in key low- and middle-income markets.
My perspective on the need for accessible antibody therapies is shaped by extensive experience in both the public and private sectors. As an infectious disease epidemiologist and pharmaceutical economist, I’ve led essential research on the real-world effectiveness and economic value of drugs, vaccines, and diagnostics. Serving in the White House during the early stages of the Covid-19 pandemic, where I helped shape policies that balanced rapid vaccine and therapeutic development with economic considerations, provided me with firsthand insight into the complexities of scaling medical innovations in crisis situations.
The case of Covid-19 antibodies are a good example of this. Rapidly developed and deployed in high-income countries, their utility waned with the advent of mRNA vaccines and the emergence of Omicron variants, illustrating the complex dynamics of pharmaceutical economics, dynamics that are heightened in poorer regions. Evusheld was initially approved in the United Kingdom in March 2022, which then changed course by August. The U.K.’s National Institute for Health and Care Excellence said, “The rapidly evolving nature of Covid-19 means we need to have a way of establishing the cost effectiveness of existing medicines against current variants in an agile way.”
One lesson learned from Covid products was the importance of monitoring real-world data to reevaluate how the effectiveness of a medicine may change over time as a disease agent evolves.
The FDA’s recent approval of a long-acting antibody for preventing respiratory syncytial virus (RSV) in infants signals a growing recognition of the value of such antibody treatments. Yet without systemic changes, the promise of antibodies for diseases like malaria, Ebola, Zika, Lassa fever, and others remains unfulfilled. The global health community broadly agrees that it must reduce production costs and improve distribution systems to make these therapies accessible where they are most needed. Writing in STAT, physician-scientist Utibe R. Essien coined the term pharmacoequity to portray a health system in which everyone, regardless of race, class, or availability of resources, has access to the highest quality, evidence-based medical therapy indicated for their condition. Unitaid has discussed how this effort will require novel business models and new partnerships among governments, industry leaders, and philanthropic organizations, mirroring successful precedents like the PEPFAR program, which has saved 25 million lives.
I propose a versatile business model wherein a consortium — including pharmaceutical companies and philanthropic organizations — establishes manufacturing capabilities not just in one facility, but potentially in several of them, ideally located in middle-income markets like Brazil. As I described at the HIV Vaccine Trials Network Full Group Meeting, this approach could enable a diversified portfolio of products to reduce financial risks for the manufacturer. In this portfolio, higher-revenue antibodies, such as certain cancer treatments, would provide robust profits due to their higher prices and stable demand. These profits would, in turn, subsidize the production of less-profitable but crucially needed antibodies for infectious diseases like malaria and HIV. The financial risks associated with producing lower-margin products would be mitigated by the guaranteed returns from high-demand drugs.
Licensing fees paid to the intellectual property holders of the high-revenue drugs would ensure that they receive appropriate compensation for them. To maintain market differentiation and protect brands in high-income markets, products would be sold under different brand names. This strategic partitioning would maximize global access while safeguarding profitability and brand integrity.
Immediate steps toward this goal should include securing upfront funding and commitments from governments and private funders to offset the initial risks for manufacturers. Fostering community engagement and building local capacities are also essential for the sustainable adoption of these bnAb innovations.
As the pharmaceutical market stands today, the alignment of economic incentives with global health goals is off track. Aligning them is not only a moral imperative but a practical necessity for economic security. Without decisive action, the next medical breakthrough could languish in development limbo, out of reach for those who need it most.
It is time for a concerted effort to ensure that the next wave of antibody innovations — potentially as transformative as vaccines — reaches all corners of the globe. Only through collaborative innovation and equitable health policies can the power of these groundbreaking therapies be truly harnessed. Waiting for another global health crisis to force action would be disastrous. The time to incentivize sustainable global access to innovation is now.
Blythe Adamson, Ph.D., is a health economist and pharmacoepidemiologist, founder of Infectious Economics, head of international outcomes research and evidence generation at Flatiron Health, and an affiliate professor in The Comparative Health Outcomes, Policy and Economics Institute at the University of Washington.