What barriers prevent global access to antibiotics?

To understand how to fix antibiotic access, we first need to understand where it's broken. 

Part 0: Methods

We're working on a project to identify promising potential interventions for improving rates of access to antibiotics in low and middle income countries (LMICs). Before we start developing a long list of potential interventions, we wanted to take some time to understand what current barriers and bottlenecks prevent access to antibiotics. To do this, we decided to conduct an exploratory literature analysis.

First, we compiled a list of relevant papers. We asked Claude to put together a list of literature that explored barriers preventing access to antibiotics in low and middle income countries, searched up relevant keywords on Google Scholar, and looked through the references made in each of these papers. Next, we skimmed through the papers we found and decided to focus our analysis on the following subsection: 

Title	Author(s)	Publication date
The multifaceted nature of lack of access to antibiotics: types of shortage and specific causes, consequences, and solutions	Baraldi et al.	2025
The broken wheel of access for antimicrobials: barriers to rolling out antimicrobials in LMICs	Center for Global Development	2024
2026 Antimicrobial Resistance benchmark	Access to Medicine Foundation	2026
Mitigating inequitable access to appropriate antibiotics in low- and middle-income countries	Idemudia Imonikhe Otaigbe	2025
SECURE’s economic and procurement tools	SECURE	2024

Some papers cited in this analysis are not included in the table above because we referenced only specific sections of those works rather than analyzing them in full.

We decided to organize this literature analysis based on the framework proposed by Ming Ong in A Comprehensive Framework Identifying Barriers to Global Health R&D Innovation and Access, which maps the sequence of steps required for health technologies to reach high-burden populations. Ong 2023 identified the first step towards health technologies is that the product exists. In the case of antibiotics, this requirement is often not met due to increasing rates of resistance. However, we will not address this issue here, focusing on barriers to access once a drug has already been developed. 

Part 1: Framework

We noticed that the prevalence of a barrier is often dependent on i) the specific antibiotic ‘archetype’; ii) the definition of access; and iii) the typology of countries’ health systems. 

1.1 Antibiotic Archetypes 

SECURE identifies three different types of antibiotic ‘archetypes’: 

1. Archetype 1: High volume, off-patent antibiotics characterized by low margins. These antibiotics were often in the “Access” category. 

2. Archetype 2: Antibiotics that are of medium volume, possibly off-patent. These antibiotics were often classified under the “Watch” category. 

3. Archetype 3: On-patent, typically recently introduced antibiotics, that are used at low volume and are highly priced. These antibiotics are typically “Reserve” or lower volume “Watch” antibiotics.

The types of barriers that create access issues are different for each of these archetypes. For example, recurrent shortages caused by inaccurate forecasting, manufacturing constraints, or by suppliers ceasing production are often barriers for Archetype 1 antibiotics. On the other hand, Archetype 2 antibiotics face challenges related to cost considerations relative to national budgets, omission from procurement policies, and frequent product shortages. Archetype 3 antibiotics struggle with prices, financial constraints and inconsistent and segmented demand, leading to limited registration across essential geographical areas

1.2 Types of Access Failure

Beyond the ‘archetype’ of the antibiotics, the type of ‘lack of access’ matters. Baraldi et al. define 4 ways types of  “lack of access” to antibiotics:

1. Short-term shortage: unavailability lasting <3 months

2. Long-term shortage: unavailability lasting >3 months

3. Deregistration: product withdrawn from a market where it was previously available

4. Lack of registration: product never approved or filed in a given market

Baraldi et al. also point us to two further aspects of access that were noted as part of Indicator 46 in the Millennium Development Goals:

5. Financial inaccessibility: product is registered and physically present but unaffordable

6. Physical inaccessibility: product exists in country but is not reachable within one hour's walk of the population

In their analysis, they note that the types of barriers that cause these different types of ‘lack of access’ are often different. For example, shortages are usually caused by protracted supply chain problems whereas deregistration is often the result of insufficient revenues.

1.3 Health System Typology

There are significant differences between countries’ health systems, affecting which access barriers are prominent and which access failures manifest as a result. We’ve put together a table that outlines different classifications of countries’ healthcare systems. This is far from a comprehensive list and countries might belong to more than just one typology. 

Archetype	Defining feature	Example countries
Large mixed markets with fragmented private sector	High population, large private/informal retail channel running alongside under-resourced public system, weak quality assurance for over-the-counter routes	India, Pakistan, Nigeria, Indonesia, Bangladesh
Small markets manufacturers structurally underweight	Volumes too small to support individual manufacturer business case for registration	Tunisia, Tuvalu, Vanuatu
UMICs with strong regulators and HTA capacity	Functional national medicines regulator, established HTA function, public payer with reimbursement architecture	South Africa, Thailand, Malaysia
Participants in regional regulatory or procurement harmonisation	Country is a member of a functioning regional regulatory or procurement bloc that can be approached collectively	ZaZiBoNa members (Botswana, Namibia, Zambia, Zimbabwe, etc.); EAC AMRH (Kenya, Tanzania, Uganda, Rwanda, Burundi); ECOWAS via AMRH; PAHO Strategic Fund participants
LMICs with public tendering systems that exist but underperform	Functional central procurement architecture exists but suffers from forecasting gaps, race-to-bottom tendering, fragmented sub-national purchasing	Kenya (KEMSA), Ghana
Fragile, conflict-affected, or sanctioned states	No functional market or procurement architecture; access runs through humanitarian or parallel channels	Somalia, South Sudan

Part 2: Analysis

Barrier 1: Failure to Register Products in Target Markets

Once an antibiotic exists, it must be registered in relevant markets. Unfortunately, registration in LMICs is far from a given. Of the 25 new antibiotics approved between 1999 and 2014, only 12 had registered sales in more than 10 countries, and availability in multiple regions and country classes was “rarely seen within a few years of market authorisation” (Kållberg et al., 2018). 

1.1: Low Expectation of Revenue 

Because developing antibiotics is a capital-intensive venture, pharmaceutical companies tend to focus on countries with significant market potential or large market sizes. In most cases, the estimated ROI of introducing these products in LMICs isn’t enough to justify the resources needed to overcome the challenges associated with these markets. Oftentimes the expected ROI is insufficient because of low-intrinsic demand, but there are also several external factors that prevent demand from being realised (CGD 2024).

1.1.1: Small Market Size

Newly developed antimicrobials (usually classified as Reserve antibiotics) are usually indicated for very specific purposes and should “only be used as a last resort when all other antibiotics have failed”. Because of this, these medicines often have low intrinsic sales volumes. However, despite low-intrinsic demand for these types of antibiotics, it is also true that healthcare systems in some countries are not strong enough to efficiently diagnose patients as requiring Reserve antibiotics (CGD 2024).

1.1.2: Poor Demand Generation

LMICs often don’t have the surveillance systems needed to track resistance patterns, antibiotic consumption, and the efficacy of existing antibiotics. This makes it difficult for companies to estimate the number of patients who would benefit from their medication and therefore make the business case for entering the market. 

1.1.3: Unclear pricing policies

Even if potential for commercial demand exists, companies will still often choose not to register their drug in LMIC markets where pricing policies are often unclear and unpredictable (CGD 2024).

1.1.4: Weak purchasing procedures in LMICs

The operational mechanics of LMIC procurement systems frequently prevent the right antibiotics from being purchased in the right quantities. This is often related to poor demand forecasting capabilities (Baraldi et al.) as referenced above. However, while some of this is due to a lack of infrastructure and capacity, it is also true that antimicrobials, more than other drugs, are subject to large swings in demand because outbreaks can drive sudden surges in use. For example, the amoxicillin shortages in late 2022 and early 2023 followed a wave of respiratory infections across many countries. US demand in October 2022 ran 345% above October 2019 levels (CGD 2024).

1.1.5: Competing products already on the market

Where existing antibiotics already work well enough, companies expect too little additional revenue to justify the cost of registering a new product. This is especially problematic for novel Reserve antibiotics where clinicians and procurement officers in LMICs might default to cheaper, older alternatives, even when resistance patterns have rendered them clinically suboptimal (AMF 2021).

1.2: Regulatory Complexity and Burden of Filing 

Once a developer has made the commercial decision to pursue registration in a given LMIC, the regulatory pathway itself imposes substantial costs, delays, and uncertainty.

1.2.1 Data and infrastructure requirements 

Registering a drug in a new country requires significant data collection and infrastructure, both before and after introduction. Before entering a market, companies must conduct surveillance to understand which infections are dominant and determine what clinical trial data the relevant regulatory authority will require for approval. They must also assess the broader medical landscape to understand what drugs are currently in use and how appropriately, whether guidelines for appropriate use are in place, and what diagnostic usage rates look like. Once a product is on the market, companies are also typically required to conduct post-marketing surveillance, monitoring for adverse events, track consumption patterns, and submit periodic safety update reports to the regulatory authority (CGD 2024).

1.2.2 Divergent registration requirements across different countries

Unlike in the European Union, where a centralized procedure enables a single marketing authorization to cover all member states, companies seeking to register products in LMICs must typically file individual applications to each national regulatory authority. Filing costs accumulate country by country, further weakening the commercial case for markets where expected returns are already low.

1.2.3 Regulatory authorities lack capacity

National regulatory authorities also sometimes lack the technical expertise to assess registration dossiers which can often result in long waiting times before approval (ATMF 2021). Furthermore, because these regulatory authorities often must rely on documentation or on other authorities’ certifications, there is a much higher risk that substandard products slip through. Weak regulatory oversight and limited resources make it challenging to detect poor-quality or falsified antibiotics entering the supply chain.

1.3: Insufficient Public Infrastructure 

Firms tend to enter markets where infrastructure already exists, but governments see little reason to invest in infrastructure for a drug that is not available locally, and companies cannot justify building it themselves given the limited returns (CGD 2024).

1.4: Fear That Resistance Will Develop and Undermine HIC Markets

In settings where prescription rules are weakly enforced and antibiotics are sold freely through pharmacies, informal vendors, and unregulated outlets (Sorn 2026), pharmaceutical companies often argue that their products will be overused and resistance will emerge faster as a result, eventually undermining value in the high-income markets that generate most of the revenue. Others are skeptical, suggesting resistance concerns can serve as a convenient reason for decisions driven by other factors (CGD 2024).

1.5: Political Instability, Conflict, and Economic Sanctions

Some access barriers are structural and exist largely independently of commercial or regulatory incentives. Political instability, active armed conflict, and economic sanctions create overlapping obstacles that can make meaningful antibiotic access impossible in the near term regardless of what actions companies or international bodies take.

1.6 Deregistration / Product Withdrawal

In addition to a lack of registration in certain countries, Baraldi et al. also identified ‘deregistration’ or product withdrawal as an issue. Unlike a shortage, which is temporary by definition, deregistration converts a contingent access gap into a permanent one. The primary driver of commercially motivated deregistration is insufficient revenue to justify ongoing regulatory compliance costs due to small market sizes. 

1.6.1 Race-to-the-bottom purchasing practices 

Race-to-the-bottom purchasing refers to public procurement systems that select antibiotics almost entirely on price, pushing each successive tender round to a lower price than the last. The previous winning price becomes the benchmark for the next, compressing margins until production stops being profitable. At that point, manufacturers either leave the market or cut corners on quality (Baraldi et al.).

1.6.2 Winner-takes-all tendering

Winner-takes-all tendering refers to procurement systems that award the entire national contract to a single supplier for a fixed period. Any manufacturer that loses the tender earns nothing from that market for the duration of the contract, making it commercially irrational to maintain registration, local stock, or distribution capacity in the hope of winning next time. It also leaves the system fragile: if the winning supplier fails to deliver, there is no qualified backup ready to step in (Baraldi et al.).

1.6.3 Old products with difficult-to-upgrade manufacturing sites

Many older generic antibiotics are made in ageing plants built to standards that no longer meet current Good Manufacturing Practice (GMP) requirements. Bringing these facilities up to standard is expensive, and the low margins on old generics rarely justify the investment. When regulators require upgrades, manufacturers often find it cheaper to withdraw the product than to retrofit the site (Baraldi et al.).

1.6.4 Prioritisation of new antibiotics with higher margins

Companies with limited resources concentrate their registration, distribution, and marketing efforts on newer, patented products where margins are highest. Older generics, which earn very little per unit, tend to be deprioritised regardless of their clinical importance.

Barrier 2: Manufacturing and Supply Chain Fragility

Even when products are registered, the supply chain from Active Pharmaceutical Ingredient (API) to finished dosage form is highly concentrated and therefore fragile.

2.1 API Production Concentrated in Very Few Countries

Antibiotic API production is concentrated in a small number of countries, with China and India as the largest suppliers of generic antibiotic APIs (CDDEP 2019). China accounted for roughly 42% of global antibiotic API exports by value in 2021 (Yang 2024). India, despite being one of the world's largest generic manufacturers, imports about 70% of its APIs from China overall, and for some essential antibiotics like penicillin, azithromycin, and cephalosporins, that dependence rises above 90%. This leaves global supply vulnerable to disruption at just a handful of sites (Economic Times, 2020).

If any disruption occurs at one of these limited sources, whether a factory shutdown, raw material shortage, or quality control failure, it can trigger worldwide shortages. For example, in 2016, an explosion at a Chinese API plant triggered a global shortage of piperacillin-tazobactam, a broad-spectrum antibiotic used in hospitals across both high and low income countries (Wells 2024). 

2.2 Finished Dosage Form Production Concentrated in Very Few Countries

Finished dosage form (FDF) manufacturing is more diversified than API production, but remains heavily skewed toward a handful of countries. High-income producers such as Italy, Germany, Canada, and the US play a significant role, but India dominates exports of finished generics globally. India is the leading originating country for FDFs, accounting for 31.9% of total imported volume and 18.2% of total imported cost (Socal 2025). For LMICs in particular, Indian manufacturers supply the overwhelming majority of generic antibiotics consumed across Sub-Saharan Africa, South Asia, and Latin America.

2.3 Supply Chain Shocks

Both short-term and long-term shortages are often caused by supply chain problems including production accidents or quality issues, raw material scarcity, and disruptions due to natural disasters and geopolitical conflicts. These supply problems are exacerbated by vulnerable supply chains with a single MAH or upstream nodes, limited demand forecast ability of suppliers and of local healthcare facilities, especially in LMICs (Baraldi 2025).

Barrier 3: Procurement Failures

Even when antibiotics are registered and manufactured in adequate quantities, procurement systems can prevent the right products from being purchased in the right amounts. 

3.1 Poor demand forecasting

Demand forecasting is the projection of which products will be purchased, where, when, in what quantities, and by whom (Otaigbe 2025). In addition to affecting countries’ ability to generate demand for specific antibiotics (1.1.2), poor demand forecasting also impacts their ability to procure the correct amount of the drugs they need. Accurate forecasting is the precondition for everything downstream: it determines order volumes, sets the demand signal that manufacturers respond to, and prevents both stockouts and the over-ordering that wastes constrained budgets on expired stock. In many LMICs this function is weak, undermined by absent or poor-quality consumption data, incomplete and untimely reporting from facilities, workforce shortages, coordination issues, and financing uncertainty that delays procurement cycles (Bilal et al. 2024). Furthermore, informal relationships between clinicians, procurement officers, and suppliers can distort the demand signal. When informal arrangements shape which supplier wins a contract, which products get reordered, or which products clinicians actually prescribe, the demand signals that flow back to manufacturers, wholesalers, and central procurement bodies are distorted. 

3.2 Formulary gaps and non-inclusion

In most countries, several Reserve antibiotics on the WHO Essential Medicines List are missing from national EMLs or not registered locally (Cohn 2024). Being left off a national formulary or essential medicines list effectively removes a product from public sector procurement, regardless of how clinically important it is. Even inclusion on a national EML is no guarantee of access: in LMIC healthcare facilities, listed medicines are available roughly 62% of the time, compared to about 27% for medicines not on the list (Rethink 2023).

3.3 Tendering and contract design failures

Many LMIC procurement systems run short-term, price-competitive tenders that award contracts to the lowest bidder, with little weight given to supply security or quality. The result is a system that does too little to encourage developers to bring new antimicrobials to market, rewards overuse by tying profit to sales volume, and fails to deliver reliable access. Single-winner tenders also create fragility: when the contracted supplier cannot deliver, no backup has been qualified or contracted to step in (Wells, 2024). 

Barrier 4: Pricing and Financial Inaccessibility

Even when antibiotics are registered, manufactured, procured, and physically present in a health facility, patients may be unable to access them because of cost.

4.1 High prices for on-patent and novel antibiotics

Bringing a new antibiotic to market is expensive, and developers typically need to recover those costs through pricing that is well out of reach for most LMIC public budgets. To make the numbers work, manufacturers tend to focus their commercial efforts on countries with large populations of paying patients, which in practice means HICs and a handful of upper-middle-income markets (Otaigbe 2025).

LMIC governments, working with limited pharmaceutical budgets and many competing health priorities, generally cannot afford Reserve antibiotics at HIC list prices, even in small quantities. The result is that novel last-resort antibiotics often go unprocured, leaving clinicians without options when older drugs fail.

4.2 Limited health financing and insurance coverage

In LMICs, despite the high demand for antibiotics driven by the infectious disease burden, there's a limited capacity to pay for them.Government health budgets are thin, household incomes are low, and the country-specific economic pressures that shape both mean that neither the public sector nor most patients can afford much (Otaigbe 2025). The result is that even when antibiotics are clinically available, financial access often is not.

In most LMICs, the burden of paying for these products falls heavily on patients themselves. In some parts of Africa, close to 90% of medicines are bought out of pocket, making medicine the second-largest household expense after food (Moodley 2019). Where health insurance schemes do exist, antibiotics frequently sit outside the benefit package, or are nominally covered but not reimbursed reliably. Even for the cheapest Access antibiotics, affordability is not a given. Treatment courses for some essential medicines have been estimated to cost the equivalent of 15 days of wages for the lowest-paid government employee in some LMICs, which puts them out of reach for everyone earning less. When patients pay anyway, the result is catastrophic health expenditure. 

4.3 Public sector stockouts

In many LMICs, antibiotics are priced significantly lower in public facilities than in private pharmacies, which in principle should keep them affordable for patients relying on public care. In practice, public sector stockouts are common, and when public supply runs out, patients are pushed into private pharmacies where the same medicines cost substantially more and must be paid for out of pocket.

4.4 Reimbursement delays

In some countries, public health facilities are reimbursed by national insurance schemes. However, there are often delays in reimbursements for public health facilities, which can quickly become liquidity problems at the facility level. The pattern is well-documented across sub-Saharan Africa, where reimbursement delays under cost-reduction policies have led to stockouts of drugs and consumables in health facilities (Meda et al. 2020).

Facilities without ready cash cannot buy from preferred suppliers on standard credit terms, leaving them with two options: wait and risk stockouts, or buy from whichever intermediary will extend credit, at higher prices. Smaller and more rural facilities feel this hardest, since they have less cash on hand and fewer alternative suppliers to fall back on.

4.5 Multi-tier wholesaling and serial markups

In many LMICs, no single distributor has the reach to cover the entire country, so national wholesalers sell on to regional sub-wholesalers, who sell on to sub-sub-wholesalers, and so on. The chain can run as many as six layers deep before a product reaches the retail pharmacy or clinic (Yadav 2015). Each intermediary takes a margin, widening the gap between the price the manufacturer charges and the price the patient pays. Across African countries, private wholesaler markups range from 2% to 380%, and the manufacturer's selling price can amount to as little as 8% of the final price the patient pays (Cameron et al. 2009; WHO 2008).

Barrier 5: Distribution and Physical Access Gaps

Even when an antibiotic has been registered, manufactured, procured, and priced affordably, the final step of reaching the patient in usable form can still fail if the 

5.1 Poor infrastructure

Logistic and infrastructure deficits, such as poor road networks, inefficient transport systems and weak supply chain management systems, result in poor access to antibiotics in rural or remote communities in LMICs. Seasonal inaccessibility, where roads are rendered impassable by rains or flooding for weeks or months at a time, can sever supply lines entirely, producing facility-level stockouts even when national inventories are adequate (Otaigbe 2025). 

Infrastructure gaps exist not only at the logistics level but within antibiotic supply chains as well. Poorly regulated wholesalers, informal markets, and inadequate controls over storage and distribution conditions can all degrade antibiotic quality before products reach patients.

5.2 Proliferation of substandard and falsified medicines

Globally, about 28% of falsified medicines are antibiotics, and between 2014 and 2016, antibiotics accounted for 36% of falsified medicines seized by customs worldwide. According to the WHO, about 17% of substandard or falsified medicines in LMICs are antibiotics, and an estimated $30.5 billion is spent on substandard and falsified medicines in LMICs, accounting for 10.5% of medicine samples in the supply chain (Otaigbe 2025). National authorities attempt to monitor quality through batch testing and pharmacovigilance, but resource limitations mean that not all imported batches are tested, and surveillance is typically concentrated in urban centres rather than the peripheral markets where quality failures are most likely.

The proliferation of falsified products simultaneously undermines individual patient outcomes and, at a population level, exert precisely the kind of selective pressure that accelerates resistance, turning an apparent access solution into a resistance driver.

Conclusion

It’s important to note that the barriers above are cumulative, meaning that access fails when any one of them is unresolved. For example, a product can be developed and registered but still go unprocured if procurement systems are poorly designed. It can be procured but priced out of reach for the patients who need it. It can be affordable on paper but still fail to reach patients because of last-mile breakdowns. 

This document is the foundation for the next stage of the project: building a long list of candidate interventions that target one or more of the barriers set out here. The framework in Part 1 is designed to support that work by letting us ask, for any proposed intervention, which barrier it addresses, in which type of health system, for which antibiotic archetype, and which kind of access failure it is most likely to prevent. 

Because the barriers are cumulative, a useful intervention is rarely a one-to-one match with a single barrier. Reforming procurement design will produce limited gains if the antibiotic in question is missing from the national essential medicines list, or if pricing still keeps it out of reach once it has been procured. The interventions that matter are those that target a barrier known to be binding in a given context, while accounting for any adjacent barriers in the same chain that are also at risk of failing. The next stage of work therefore has two parts: identifying candidate interventions, and identifying, for each one, the conditions under which it is likely to translate into actual access. The second of these is ultimately an empirical question, and will need to be tested against specific country contexts rather than the cross-cutting literature drawn on here.

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