Global Pharmaceutical Innovation to 2029: Trends, Challenges and Brazil's Place

The global pharmaceutical and biotechnology industry is experiencing a period of accelerated growth in drug use and spending, driven by therapeutic innovations and increased access in several regions. Recent projections from the IQVIA Institute's report "The Global Use of Medicines: Outlook through 2029 – Increasing Access, Use, and Spending" estimate that global drug spending will reach approximately US$2.4 trillion by 2029 .

Innovative therapies launched in the last decade, from cancer immunotherapies to breakthrough drugs for diabetes and obesity, have transformed patient care on a global scale. However, significant disparities in access to these innovations persist between developed and emerging markets.

Differences in regulation, launch speed, and adoption capacity for new therapies result in distinct realities: while some countries quickly incorporate the latest advances, others face bottlenecks that delay the arrival of cutting-edge medicines to the population.

In this article, we analyze the main global trends in drug use and pharmaceutical innovation through 2029 , highlighting the crucial role of new biotech therapies. We examine interesting facts and market perspectives presented in the IQVIA report, such as the rapid advancement of biological treatments, the expansion of biosimilars , the phenomenon of GLP-1 agonists for diabetes and obesity, and the evolution of oncology treatments.

Next, we compare the Brazilian scenario with international practices, highlighting differences in access and regulation . Brazil, Latin America's largest pharmaceutical market, faces the challenge of balancing growth and innovation with equitable access policies and financial sustainability. We will examine how regulatory, economic, and structural bottlenecks impact the incorporation of new medicines in the country, and how initiatives to overcome them are beginning to take shape.

The goal is to offer an analytical perspective that connects global data with current events in Brazil. This way, stakeholders in the healthcare innovation ecosystem, such as startups , academia, government, funding agencies, investors, and corporations, will be able to understand both the global landscape and the opportunities and obstacles within the national context. Finally, we will discuss ways to foster healthcare innovation in Brazil.

Global Pharmaceutical Innovation Outlook: Growth in Drug Use and Innovations through 2029

Projections from the IQVIA Institute indicate that global pharmaceutical use will continue its upward trajectory, albeit at a moderate pace. After 14% growth over the past five years, the volume of medications used worldwide is expected to increase by approximately 4% by 2029 , representing an additional 154 billion defined doses per day (DDD). This growth is primarily driven by increased access to medications in several regions of the world, notably in emerging markets in Asia and Latin America, while per capita consumption in developed regions is already more stable.

In terms of spending, the world will see a significant increase driven by innovations. In addition to the trillion-dollar figure already mentioned, it's worth noting the shift in spending profile by product type and therapeutic area. The global trend is a shift toward more complex, high-value therapies , as innovative and biotechnological drugs gain ground over traditional treatments.

Wealthier countries direct a larger share of their spending to originator (reference) drugs , while lower-income countries rely more on generics and non-originator versions. This difference reflects both economic power and health policies: nations with greater resources are able to invest in cutting-edge therapies as soon as they are launched, while emerging markets often prioritize lower-cost alternatives.

A striking statistic from the report is that more than 1,000 new medicines (new active substances) have been launched globally in the last 20 years, with 394 in the last 5 years alone . This is an unprecedented wave of innovation, led by fields such as oncology, neurology, and infectious diseases , each with more than 100 new substances since 2005.

Oncology, in particular, has seen a marked acceleration: in the second half of the 2010s, an average of 29 new oncology drugs were launched worldwide each year , compared to just 8 per year in the 2005-2009 five-year period. These advances are redefining the treatment of multiple diseases , from cancer to autoimmune disorders, improving survival and quality of life for millions of patients.

However, the report highlights that access to these new products is highly unequal . Regional differences are pronounced: of the 394 new substances launched globally between 2020 and 2024, 205 were launched in the US , 164 in Europe (EU + UK), and 169 in Japan. China launched 209—but about 40% of these Chinese launches were restricted to its domestic market and did not reach other countries. In other words, some innovation today is glocal —global in number, but local in availability.

Yet, while the US remains the primary debut market for most drugs (often the first country where the new therapy is made available), many countries will only approve and introduce these treatments years later, creating considerable gaps in global access.

This context brings to the fore crucial debates on health policy and international trade , as noted by the IQVIA Institute. Concern about differences in access and pricing between countries has grown in recent years, along with proposals to reform global markets and control drug prices, notably in the US and Europe, to balance innovation and sustainability.

For all stakeholders (industry, governments, payers, and patients), the challenge in the coming years will be to ensure that the value and benefits of new therapies reach broad populations without compromising the economic viability of healthcare systems.

Importance of Pharmaceutical and Biotechnological Innovation

Innovation in healthcare is not an end in itself, but a means of saving lives, extending survival, and improving quality of life . Recent years have given us remarkable examples of this transformative power: gene therapies that cure previously incurable rare diseases, immunotherapies that "teach" the immune system to fight tumors, and drugs like GLP-1 agonists , originally developed for diabetes, which have proven revolutionary in the treatment of obesity. These innovations often come with high costs and require healthcare systems prepared to integrate them but their positive impacts in terms of clinical outcomes are undeniable.

In the pharmaceutical field, much of the recent innovation has been biological in nature. Biological drugs, produced from living cells or through bioengineering, range from monoclonal antibodies to hormones and next-generation vaccines.

In the last five years, 42% of new drugs launched globally were biologics . In contrast, in China (which has emerged as a major pharmaceutical hub), this share was smaller, around 33%, indicating that recent Chinese innovation has included proportionally more traditional synthetic molecules. In any case, the era of biologics is already here: these products have expanded therapeutic options for autoimmune diseases, cancer, genetic disorders, and much more.

Along with biologics, biosimilar drugs have emerged, which are copies of reference biologics after their patents expire. Just as generics did for synthetics, biosimilars bring competition and potential price reductions to high-cost treatments.

European countries have adopted proactive policies to encourage biosimilars and have reaped the benefits in terms of access and cost savings. Worldwide, the adoption of biosimilars has already generated billions in savings and, according to IQVIA, will moderate spending growth in areas such as immunology in the coming years, as leading biotech drugs for arthritis, inflammatory diseases, and other conditions gain biosimilar competitors .

In Brazil, biosimilars have been regulated since 2012 and represent the promise of expanding access to complex treatments at lower costs. However, despite regulatory advances, the expansion of these products still faces implementation challenges in the country . Among the bottlenecks are initial distrust among some medical professionals , the need for education on the efficacy and safety of biosimilars, and commercial issues (e.g., exclusivity agreements and limited competition in certain markets).

In 2024, ANVISA updated its biosimilar registration regulations (RDC 875/2024) to simplify and streamline the process, which could boost new approvals in the coming years. Following Europe's lead, biosimilars are expected to gradually gain traction in Brazil, especially in areas such as oncology and autoimmune diseases, reducing treatment costs and allowing more patients to begin previously inaccessible therapies .

Another prominent area of pharmacological innovation is GLP-1 (glucagon-like peptide type 1) agonists . These drugs, originally indicated for type 2 diabetes , have proven highly effective in weight management, leading to approval for obesity indications. The IQVIA report indicates that this class has seen rapid adoption in both diabetes and obesity treatment, predominantly in the US and other developed markets . Over the past 18 months, there has been dramatic growth in global use, driven particularly by weight loss.

In 2021, the FDA approved injectable semaglutide (Wegovy) for obesity; in 2023, another agonist (tirzepatide) was approved in the US under the name Zepbound . These approvals triggered exponential demand. According to IQVIA, the volume of GLP-1 medications prescribed for obesity practically exploded from these dates.

Today, we're witnessing a veritable pharmaceutical "gold rush" for obesity : GLP-1 agonists are among the most talked-about and sought-after products globally. In 2024, sales of these drugs (combining uses for diabetes and obesity) reached $110 billion and are expected to surpass $150 billion by 2029 .

The obesity treatment segment is projected to surpass US$75 billion by 2029 , growing at an impressive rate of ~25% per year, ranking among the therapeutic areas with the highest percentage growth. This would make obesity one of the 10 largest global therapeutic markets , approaching traditional areas such as infectious or respiratory diseases in spending. It is worth noting that this category did not even exist in the pharmaceutical market just a few years ago, a clear example of innovation creating new medical and market demand .

In the healthcare ecosystem , these innovations bring benefits, but they also require adaptations. Startups and biotechnology companies, often in partnership with academic centers, have been key players in the development of new platforms (such as gene therapies and mRNA vaccines). Governments and payers, in turn, seek to balance stimulating innovation (through patent protection, accelerated approval, tax incentives) with access policies (price controls, volume purchase negotiations, subsidy programs). And society as a whole is called upon to discuss issues such as the cost-benefit of extremely expensive drugs, resource prioritization, and the extent to which public systems should invest to incorporate advances.

In short, pharmaceutical and biotechnology innovation through 2029 promises to continue increasing the supply of transformative therapies , while challenging health systems to reduce the gaps between scientific discovery and effective public benefit .

Differences in Access and Launches: Brazil vs. Global Markets

Although Brazil is among the 10 largest pharmaceutical markets in the world , the country still does not fully benefit from all the innovation available globally. The IQVIA report highlights this gap. Among the new drugs launched globally in the last decade (2013–2022), Brazil approved only 227 out of a total of 593, equivalent to approximately 38% of the new active substances available worldwide .

This is one of the best performances among middle-income nations. Even so, it means that almost two-thirds of recent pharmaceutical innovations have not officially reached the Brazilian market . In low- and lower-middle-income countries, the situation is even more dramatic: five of the 14 emerging countries studied approved fewer than 20 new drugs in ten years , or less than 3% of the global total. In short, there is a clear international divide in access to innovation , and Brazil, despite being better positioned than many of its neighbors, still lags behind developed countries.

Several factors explain this difference. One of the main ones is regulatory and market bottlenecks that delay (or discourage) drug launches in Brazil. Historically, there has always been some time lag: a drug approved in the US or Europe can take years to be registered and marketed in Brazil. A study by the Latin American Federation of the Pharmaceutical Industry (FIFARMA) quantified this wait for oncology and rare disease drugs: Latin American patients wait an average of 1.9 to 4.5 years from FDA approval to gaining local access. In other words, an innovative drug approved today in the US may only be available in Brazil (or other countries in the region) four years later , a critical timeframe for those facing a serious illness.

Furthermore, of the 228 drugs examined in the study, only 130 were available in at least one Latin American country, and only 86 in all eight countries analyzed. These figures reveal a significant access gap and the need for coordinated action to reduce it .

From a regulatory perspective, ANVISA has made efforts in recent years to streamline approvals and harmonize procedures internationally. In 2021, it joined Project Orbis , an initiative of global regulatory agencies for the simultaneous evaluation of oncology drugs.

A survey conducted by Interfarma in 2024 brought encouraging news: in a span of just a few weeks (June 25 to July 17, 2024), ANVISA granted 20 regulatory approvals faster than the FDA and EMA (European agency), largely for new indications and expanded uses of already registered drugs. Approximately 75% of these cases were biological drugs, and the speed of approval was achieved precisely through international collaboration with Orbis. This result demonstrates the technical capability of the Brazilian agency and shows that, in specific situations, we can indeed keep pace with large markets .

However, there are structural and legal obstacles that still impose delays. One example is the requirement under Law 6,360/1976 that, to register a new drug in Brazil, the company must present the Pharmaceutical Product Certificate (CPP) from the country of origin . In practice, this means that if a laboratory discovers and develops a drug here, it will first need approval abroad to obtain national registration; and if it is discovered abroad, it often waits for approval from the FDA/EMA before submitting to ANVISA.

This somewhat anachronistic requirement could delay the arrival of new therapies in the case of innovative products, as Brazil forgoes simultaneous evaluation with the US/Europe and ends up following them. There are ongoing discussions about updating this legislation to allow parallel submissions, which would streamline the process without compromising safety.

Another point to consider is the economic incentive for companies to launch in Brazil . The country has price controls through the CMED (Medicine Market Regulation Chamber), which sets the maximum price for manufacturers. While this protects against abusive prices, laboratories sometimes deem the authorized price too low compared to the international market and choose not to launch or delay bringing the product into the market.

Furthermore, the Brazilian market, although large in volume, may have access restrictions that limit the effective sales of an expensive drug (for example, if the SUS (Brazilian Unified Health System) does not incorporate it, it is restricted to a few patients with health plans or out-of-pocket expenses). Thus, from a commercial perspective, some innovations are not prioritized in pharmaceutical companies' global strategies for immediate launch in Brazil.

That said, there are positive signs of change. ANVISA is undergoing a modernization process, with greater adherence to international practices and efforts to reduce review times . Until 2017, a new drug registration application took an average of 270 days to review; administrative reforms have sought to reduce this time. The industry recognizes the progress, but even though it requires more investment in personnel, the agency's staffing levels have reached historic lows, which poses an operational challenge.

In parallel, CONITEC (the Ministry of Health commission that evaluates the incorporation of technologies into the SUS) has also refined processes to evaluate new medications more quickly and transparently, although it is still overwhelmed by the amount of demand.

Another Brazilian phenomenon is lawsuits over access to medication , the so-called judicialization of healthcare . When a medication is not available through the SUS (either because it has not been incorporated or because it has not even been registered in the country), many patients resort to the courts to obtain the medication through the government. This happens frequently with high-cost oncology and rare disease medications .

On the one hand, judicialization serves as an individual escape valve for those who cannot wait for bureaucracy; on the other, it highlights flaws in the evaluation and provisioning system and can lead to budgetary disorganization (judicial procurement is often more expensive and lacks clear priority criteria). Ideally, fewer patients will need to go to court because more therapies will be officially available and covered by the system. This is a goal that requires coordination between ANVISA, the Ministry of Health, and the industry.

In short, Brazil faces a gap between innovation and practical use . While developed countries typically receive virtually all global drug launches (the US has approved over 800 new substances since 2005, and large European markets around 650), Brazil still receives only a fraction. Closing this gap requires regulatory agility, innovative access models (such as early access programs, public-private partnerships, local production via technology transfer), and financing policies that support the introduction of high-cost therapies. The result would be worthwhile: reducing the therapeutic gap would mean Brazilians benefiting sooner from life-saving and life-extending medicines.

Regulation, Access and Bottlenecks in Brazil

An analysis of access differences would not be complete without understanding Brazil's specific bottlenecks in the incorporation of innovations. We have already discussed some regulatory and economic ones, but we will delve deeper into four critical areas : (1) approval and incorporation processes, (2) financing and pricing, (3) infrastructure and training, and (4) local production and R&D.

1. Regulatory Approval and Incorporation: This includes procedures with ANVISA (health registration) and CONITEC (incorporation into the SUS). Registration with ANVISA is a prerequisite for any commercialization in the country and also for states or municipalities to adopt a drug on their own.

After registration, in the case of the public system, CONITEC evaluates whether the drug will be offered free of charge by the SUS (Unified Health System). This two-step process means that even after health approval, it can take time for the drug to actually reach SUS shelves (if approved, and many are not). We saw in the FIFARMA study that this second step (reimbursement/incorporation) adds years to the waiting list in Latin American countries.

In Brazil, CONITEC has up to 180 days (extendable for an additional 90 days) to issue a recommendation after submitting an application. In some complex cases, this deadline is extended. Furthermore, there are budgetary considerations: even if CONITEC issues a favorable opinion, the actual offer depends on resource allocation and distribution logistics.

2. Financing and Pricing: Innovative medicines often have high prices, reflecting R&D investments and added value. Brazil, through the CMED, controls maximum prices, seeking a balance between access and incentives. Even so, many of these treatments remain out of reach for a large portion of the population unless they are provided by the SUS (Brazilian Unified Health System) or health plans.

Private plans, in turn, have a mandatory list of procedures from the National Health Agency (ANS) that defines what they must cover, and new drugs are only added to the list after evaluation , a process that also takes time. Thus, a drug may be registered in the country, but neither in the SUS nor covered by plans , leaving only the option of direct disbursement.

This has happened with several oncology medications in recent years and, more recently, with obesity medications (GLP-1): to date, no pharmacological treatment for obesity is offered by the SUS (Brazilian Unified Health System), and health plans also tend not to cover it because it's not listed. The result: those who wanted to join the "pen weight loss" trend had to pay around R$1,000.00 per month for treatment. This reliance on direct payment limits access to the wealthiest and contributes to inequalities.

Financing sustainability is a global dilemma, and Brazil is no exception: the government must carefully choose which innovations to incorporate (given a finite budget), and society must debate the extent to which medications that sometimes cost hundreds of thousands of reais per patient per year should be funded. Risk-sharing models and price negotiations based on volume or clinical performance are international trends that Brazil is also beginning to explore to facilitate access without breaking the bank.

3. Infrastructure and Training: Even when an innovative drug is approved and funded, practical implementation challenges remain . Many cutting-edge treatments, especially biotechnological ones, require adequate healthcare infrastructure: specialized centers, equipment for infusion or side effect management, and trained professionals. For example, CAR-T cell therapies (which reprogram a patient's cells to attack cancer) require highly trained centers; radioligands for cancer involve the manipulation of radioactive material; even a simple intravenous monoclonal antibody requires an infusion clinic or hospital accessible to the patient.

In Brazil, the provision of these services is uneven regionally, with a concentration in the South-Southeast region. Therefore, incorporating an innovation into the SUS may not automatically translate into widespread access if there is no infrastructure to offer it nationwide . Professional training programs and investment in referral centers are necessary to keep pace with innovation and ensure quality care .

4. Local Production and National R&D: A historical bottleneck in Brazil is its low participation in global pharmaceutical innovation . Few new drugs are developed locally; the overwhelming majority of innovations come from centers in the US, Europe, or, more recently, Asia. This means relying on imports and the commercial strategies of multinationals.

In recent years, the Brazilian government has sought to circumvent this dependence through Productive Development Partnerships (PDPs) , in which public laboratories (such as FIOCRUZ, Butantan) sign agreements with companies to transfer technology for medicines considered strategic, starting to produce them locally for the SUS.

Several biologics (including biosimilars) and vaccines have followed this path. It's a way to internalize technology and ensure sustained supply, as well as potentially reduce costs in the long term. Examples include monoclonal antibodies for rheumatoid arthritis and cancer, whose domestic production has been made possible by PDPs. However, PDPs have faced setbacks and require careful selection (it's important to choose which products are worth the investment).

At the same time, efforts are underway to stimulate domestic innovation, invest in pharmaceutical research, support biotechnology and healthtech startups, and create technology hubs. The healthcare startup ecosystem in Brazil has grown, with companies operating in everything from telemedicine and electronic health records to the development of new drugs and diagnostics.

The integration of these entrepreneurs, academia (which generates basic knowledge), and established industries can generate solutions tailored to local needs, potentially cheaper or disruptive. We're still in our infancy in this regard, but there are promising cases, such as national research into vaccines against dengue, Zika, and COVID-19, or Brazilian companies developing innovative molecules for neglected tropical diseases. In the long term, strengthening local R&D reduces access bottlenecks , as the country would have greater autonomy to decide priorities and allocate innovation according to its epidemiological profile.

In short, it's clear that multiple factors combine to create barriers between innovation and Brazilian patients . But identifying these bottlenecks is the first step toward overcoming them. Whether by adjusting laws (such as the certificate of origin), modernizing processes at ANVISA and CONITEC, or investing in production capacity and infrastructure, Brazil has ways to bridge the gap that currently separates it from the developed world in terms of available therapies.

It's also worth noting that the country presents interesting contradictions : even with all the barriers, some advances are entering the Brazilian market in significant, sometimes even surprising, ways. For example, IQVIA highlights that, among emerging countries ("pharmerging"), Brazil stands out in the consumption of new obesity medications, to the point of practically leading this category outside the developed world. In 2024, the use of GLP-1 agonists for weight loss in so-called "pharmerging" countries surpassed that of the main European countries, driven almost entirely by the increased use in Brazil .

This indicates that when there is high public demand (in this case, fueled by aesthetic interest and media coverage), the Brazilian market responds, albeit via the private sector and with patients paying out of pocket. The flip side of this coin is that the cost falls on individuals , creating scenarios of informal access and potential misuse.

So much so that ANVISA had to intervene, requiring prescription retention for the sale of semaglutide (Ozempic) and tirzepatide (Mounjaro) pens, given the explosive and sometimes indiscriminate demand for them as weight-loss drugs. In other words, innovation is arriving, but in a disorganized and uneven manner. Only the integration of these therapies into the healthcare system, with appropriate protocols, can ensure their rational and widespread use.

Innovative Therapies in Focus: Biologics, Biosimilars, GLP-1 and Oncology

In this section, we focus on four classes of innovative therapies mentioned in the scope: biological medicines, biosimilars, GLP-1 agonists, and oncology treatments . We will analyze how each one emerges in global trends and how it stands in Brazil in terms of adoption, access, and future prospects.

Biologicals: Therapeutic Revolution and Access Challenges

Biological medicines have been the driving force behind much of recent pharmaceutical innovation. Globally, their importance is only expected to grow. Looking ahead to 2029, areas dominated by biologics, such as immunology (treatment of autoimmune diseases, for example), are estimated to reach annual spending of US$234 billion.

Even with the entry of biosimilars slowing growth somewhat, immunology will still be the third-largest therapeutic group in terms of spending, behind only oncology and diabetes. In wealthy countries, biological drugs for rheumatoid arthritis, psoriasis, inflammatory bowel disease, severe asthma, etc. have been standard treatments for years and continue to evolve with new generations and indications.

In Brazil, many of these biologics arrived somewhat late, but today they are included in treatment protocols and even on the SUS list in some cases. For example, infliximab (the first monoclonal antibody against Crohn's disease and arthritis) was incorporated into the SUS more than 15 years after its global launch, but is now available; adalimumab (used in several autoimmune conditions) took almost a decade to be incorporated after registration, but is now also offered for some indications. Even so, gaps remain. Some of the most modern or second-line biologics are only accessible through private plans or court-ordered purchases. The high cost is undoubtedly the biggest limiting factor.

This is precisely where biosimilars come in. Several patents on classic biologics have expired in recent years (rituximab, trastuzumab, etanercept, adalimumab, among others), paving the way for copycats. In the European Union , which led this movement, competition from biosimilars has resulted in price reductions and expanded use of biologics. Countries like the United Kingdom, Germany, and Norway have managed to save billions and reinvest in more treatments.

Brazil, in turn, approved its first biosimilars around 2015 (e.g., infliximab and erythropoietin). Since then, biosimilars of several monoclonal antibodies have been approved by ANVISA. However, the practical adoption of these biosimilars in the Brazilian market is still slow. Part of this is due to commercial issues (Brazil has not implemented active automatic substitution policies or usage targets like some countries have).

Another factor stems from cultural and informational barriers. Doctors and patients may be wary of switching from a stable reference biologic to a similar one, even if science shows equivalence. Initiatives such as Global Biosimilars Week (an annual awareness campaign) have been taking place, including with the participation of Brazilian organizations, seeking to educate about the safety and benefits of biosimilars.

The expectation is that, over time, biosimilars will also gain ground in Brazil , generating savings and allowing more patients to be treated with the same budget. This is crucial, for example, in oncology: biosimilars of trastuzumab (for HER2+ breast cancer) and bevacizumab (for various tumors) could allow the expansion of these therapies to more public hospitals.

In short, biologics represent a leap in efficacy for many diseases, but they come at a cost. Brazil is committed to making them more accessible , either through local production (partnerships between Butantan, Biomanguinhos, and private companies to manufacture some of these agents) or through the uptake of biosimilars. In the coming years, we will see whether the policies implemented will be sufficient to replicate Europe's success in expanding access to biologics thanks to biosimilars.

GLP-1 Agonists: A New Era for Diabetes and Obesity

Rarely has a class of medications attracted as much recent attention as GLP-1 agonists . These drugs, such as semaglutide (brand names Ozempic® for diabetes and Wegovy® for obesity) and liraglutide (Victoza® for diabetes and Saxenda® for weight loss), have changed the paradigm of type 2 diabetes treatment , providing effective glycemic control with significant weight loss, and are now revolutionizing the management of obesity in patients without diabetes.

The IQVIA report demonstrates the scale of this impact. In 2019, global sales of GLP-1 drugs totaled US$17 billion; by 2024, they reached US$110 billion , an impressive leap. In other words, in five years, they added US$93 billion in sales, becoming one of the most profitable classes in the industry.

It's important to note that, of this growth, US$70 billion corresponded to drugs initially approved for diabetes (such as Ozempic), many of which have also been used by people with obesity. Indeed, the "crossover" use is significant: estimates suggest that in 2024, approximately 12 to 15% of global spending on diabetes medications was on obese patients using GLP-1 for weight loss, especially semaglutide and tirzepatide. In the US, these drugs were so successful that they generated temporary stockouts in 2023 and significant debate over coverage by health plans.

In the near future, GLP-1s are expected to continue their rise, increasingly driven by obesity indications . New formulations (such as higher-dose oral and weekly injectable versions) and possibly new molecules from the same family (dual/triple agonists) are expected to come to market. IQVIA projects that sales specifically for obesity treatment will double in the next five years, from US$24 billion (2019-2024) to US$51 billion (2025-2029) in absolute growth .

Not to mention the already large diabetes market. So much so that, in terms of therapeutic areas, obesity is expected to jump to 9th place in global spending by 2029 (US$76 billion) , surpassing, for example, spending on mental health or respiratory diseases. And if we consider spending on diabetes (the 2nd largest area, projected at US$259 billion), a substantial portion of it will also be directed to GLP-1s. In other words, incretin-based drugs (GLP-1/GIP) will likely dominate the entire metabolic disease landscape.

In Brazil , the arrival of these drugs caused a huge stir. Ozempic (semaglutide 1mg) was approved by Anvisa in 2018 for type 2 diabetes and quickly became popular not only among diabetics but also off-label among people seeking weight loss. Novo Nordisk (the manufacturer) then submitted the obesity-specific version, Wegovy (semaglutide 2.4mg) , which was approved by Anvisa in January 2023. With this, Brazil became one of the first countries to approve Wegovy outside the US.

However, as mentioned, none of the obesity medications have been incorporated into the SUS (Brazilian Unified Health System). The cost in pharmacies (approximately R$900 to R$1,200 per month) limits their continued use to those who can afford it. Even so, demand has soared: reports from clinics and doctors indicate waiting lists to start treatment, and cases of occasional shortages of the medication have been observed, reflecting the global shortage of semaglutide in 2023. Demand was so high that ANVISA, concerned about potential abuse and risks of unsupervised use, began requiring a prescription to be retained for the purchase of any GLP-1 agonist used for weight loss .

The good news for those who need these therapies is that there are moves to make them more accessible in Brazil. The Ministry of Health confirmed that it will begin evaluating the incorporation of semaglutide into the SUS (Unified Health System) for patients with obesity and comorbidities in 2025. The request specifically involves Wegovy, and CONITEC has until mid-2025 to deliberate. There's no guarantee it will be approved (the analysis considers efficacy, safety, cost-effectiveness, and budgetary impact), but the mere fact that it's on the agenda is already a step forward.

Meanwhile, a potentially game-changing factor is that the Ozempic/Wegovy patent expires in 2026. With the end of exclusivity, Brazilian laboratories will be able to produce generics (or biosimilars, in the case of synthetic biological products). The mayor of Rio de Janeiro even announced his intention to provide Ozempic free of charge in the municipal health system starting in 2026, precisely because of the patent lapse and the availability of cheaper versions. Although this is a local promise and conditional on own resources, this exemplifies the expectation that the cost of these drugs will fall in the coming years, allowing for a public offering.

An important point is that even in developed countries , healthcare systems have been reluctant to fund weight-loss treatments , given the potential millions of users and the extremely high total cost. In the US, many private plans do not cover Wegovy; in European countries, there is debate over whether obesity should be treated with medication in the public system or only with lifestyle changes and surgery in severe cases.

IQVIA notes that, globally, insurance/state coverage of obesity medications is much lower than for other diseases , and that most of the volume has been paid for by the patient themselves, even in countries where this was not common, indicating the appeal of these therapies. This phenomenon of direct consumer demand is something to be considered in public policy: obesity is a population health problem, and if an effective treatment exists, it would be beneficial to make it widely available. However, the financial cost is heavy.

Perhaps we'll see approaches in Brazil focused on specific profiles (for example, releasing them through the SUS (Brazilian Unified Health System) for morbidly obese individuals with decompensated diabetes, where savings from diabetes complications can offset the cost of the medication). In any case, GLP-1 agonists are here to stay , and pressure for access will only increase in the coming years, following the global trend.

Oncology: Innovations vs. Market Reality

Oncology is traditionally the area that concentrates the most investment in R&D and new drug launches. As we have seen, 307 of the 1,005 new drugs launched globally since 2005 were for cancer, the highest number among all specialties. This is reflected in spending: in 2024, oncology was the largest global therapeutic market and will continue to be so.

Global spending on cancer drugs is expected to reach US$441 billion by 2029 , growing at an average annual rate of 11% to 14%. This rapid growth stems from the continued flow of new treatments (PD-1/PD-L1 immunotherapies, mutation-specific targeted therapies, cell therapies, etc.), combined with rising cancer incidence and expanded access to diagnosis and treatment in emerging markets.

However, the adoption of these oncology innovations is quite uneven worldwide . In terms of treatment volume (therapy days), the majority still consists of traditional (cytotoxic) chemotherapy drugs . Globally, 73% of cancer treatment days in 2024 were with chemotherapy, 15% with hormonal agents, and only 12% with modern targeted therapies.

In developed countries, this share of targeted treatments is higher (33% in the US, for example), but in pharmerging countries, it reaches a mere 20% of modern therapies and 80% of chemotherapy . This indicates that in emerging countries like Brazil, despite increasing access to innovation (e.g., already approved immunotherapies), the average cancer treatment still relies primarily on older drugs . New drugs are often restricted to centers of excellence or patients with resources.

In Brazil , the Unified Health System (SUS) offers a set of nationally standardized chemotherapy agents and has been gradually incorporating some important targeted therapies, albeit very sparingly. A recent advance was the incorporation of CDK4/6 inhibitors (palbociclib, abemaciclib) for advanced breast cancer, something patients had been waiting for years for. In 2024, the Ministry of Health updated its breast cancer protocol to include five new procedures, including this class of innovative drugs.

Another example: in May 2024, the SUS (Brazilian Unified Health System) incorporated durvalumab , an immunotherapy, for patients with unresectable stage III non-small cell lung cancer. This anti-PDL1 antibody has improved survival in this population; its availability in the SUS is a milestone, but it will initially benefit only a few dozen patients (an estimated 36 in the first year, 187 by the fifth year) due to the strict criteria. This illustrates the dynamic: an expensive drug is incorporated, but only for a specific, carefully defined subgroup, ensuring that the budgetary impact is controlled (in this case, <200 patients in 5 years).

Still, many other cutting-edge cancer treatments are not available in the public health system . Immunotherapies for advanced melanoma, kidney cancer, and several types of tumors have not yet been incorporated. Neither have cutting-edge targeted therapies for diseases such as mutated lung cancer (ALK, ROS1, RET, etc.). Patients with these conditions rely on court injunctions or access through high-end health plans.

Even within the plans, the situation is not perfect: until 2023, health plans in Brazil were not required to cover oral home medications for cancer that were not on the ANS list, leading many patients to sue to obtain oral targeted drugs (such as osimertinib for EGFR-mutated lung cancer), a distortion that has only been partially corrected with new legislation. The Oncoguia Institute and other organizations frequently point out that Brazil has a gap in the provision of modern cancer treatments , which impacts the survival of cancer patients compared to developed countries.

Looking ahead, Brazil is expected to accelerate the incorporation of new oncology drugs , partly due to pressure from medical societies and patients. CONITEC has been evaluating technologies such as new immunotherapies for metastatic lung cancer and drugs for leukemia and lymphoma. Some have received negative opinions (due to unfavorable cost-effectiveness), while others are still pending.

One alternative is clinical trials : Brazil participates in many international trials of new cancer treatments, which allows some patients early access. However, clinical trials are not public policy and only benefit a small fraction of patients.

A relevant point is that cancer treatment involves more than just medication, but an integrated network of diagnosis and care . There's no point in having the latest medication if the patient is diagnosed late or unable to access an oncologist. Therefore, the fight to improve oncology in Brazil also involves strengthening cancer care as a whole, screening campaigns, expediting exams, expanding radiotherapy and oncological surgery services, etc. Pharmaceutical innovation is an important, but not the only, component.

In short, on the oncology front , we face a dichotomy : globally, science is advancing at a rapid pace (new modalities such as cell therapies, cancer vaccines in development, personalized drugs based on genetic markers). In Brazil, the healthcare system is trying to gradually absorb these advances, but it faces financial and structural constraints, adopting an incremental approach.

The consequence is that many Brazilian patients still receive standard treatments from 10–20 years ago , missing out on the better outcomes that more current therapies could provide. Reducing this gap will require targeted investments and perhaps alternative access models (e.g., special price negotiations with the SUS, partnerships with philanthropic organizations, or company-managed access programs).

Perspectives and Trends: Brazil in a Global Context

When comparing the Brazilian scenario with the global trends outlined in the IQVIA report, it becomes clear that Brazil will have to carefully navigate the coming years to increase access to innovations without losing sight of sustainability. The report suggests some paths that could equally apply to the country:

• Growth focused on innovation and access: Brazilian pharmaceutical spending is expected to continue growing above the global average. Projections indicate that Latin America as a whole will see annual growth in pharmaceuticals exceeding 7% through 2029, driven by economic recovery and expanded access. Brazil, in particular, is expected to remain the largest and fastest-growing Latin American market , although there may be pressure to contain costs if the pace is too high. This means we will see more drugs being consumed (in volume) and new therapeutic classes gaining market share . However, government agencies can adopt measures to curb spending if these threaten to exceed resources, either through price negotiations or by postponing certain incorporations. Finding the right balance is a complex health management task that will be at the heart of policymaking in the coming years.

  
  

• Diffusion of biosimilars and advanced generics: Globally, as discussed, biosimilars will reduce spending growth in immunology and other areas. In Brazil, a similar trend is expected: as more antibody biosimilars arrive and are accepted, the cost of treating rheumatological, oncological, and related diseases may fall per patient, freeing up budgets to cover novel therapies. Furthermore, around 2028-2030, some innovative drugs from the 2010s will lose patents (including the first cancer immunotherapeutics). Preparing the regulatory and production landscape to receive these copies will be important. The country already has a robust chemical generics sector; it would be desirable to also develop a strong domestic "biological generics" (biosimilars) sector to compete and reduce prices.

  
  

• Adoption of new emerging therapeutic areas: Among the biggest global trends for 2029 are advances in neurology (new treatments for Alzheimer's, depression, and neuromuscular diseases) and the rare convergence between pharmacotherapy and other technologies (e.g., drugs and digital devices, personalized medicines based on genetics). Brazil should benefit from some of these advances. For example, new drugs for Alzheimer's (such as the anti-β-amyloid antibodies recently approved in the US) could transform dementia treatment if they demonstrate robust clinical efficacy. It is crucial that the country monitors these scientific developments and structures rapid assessments when such products arrive, to determine whether and how to incorporate them. Telemedicine and digital health can also help expand the reach of innovative treatments (tele-oncology, app-based diabetes monitoring to optimize GLP-1 use, etc.).

  
  

• International and regional partnerships: Given the global nature of the industry, Brazil must continue to cooperate. Whether through clinical trials (ensuring the participation of national centers in phase 3 research, which sometimes accelerates post-approval access), regulatory convergence (as already done within the ICH and other forums), or even regional consortium purchases . An example of the latter was the discussion during the pandemic of joint vaccine purchases by Latin American countries to obtain better prices. In the future, this could apply to high-cost drugs, with the union of markets for negotiation. Brazil can lead regional initiatives given its size, reinforcing the idea of collectively fostering access in emerging countries .

  
  

• Patient-centricity and value in healthcare: The modern trend is to evaluate innovation based on the value it delivers: gains in survival, quality of life, and reductions in other costs (such as hospitalizations). Increasingly sophisticated health technology assessment (HTA) tools help determine whether paying a certain amount for a new drug is justified by the clinical benefits. In Brazil, CONITEC (National Institute of Health and Human Services) already adopts cost-effectiveness and budget impact analyses. This will likely intensify, with potential risk-sharing agreements (outcome-based payment: the SUS only pays in full if the patient actually improves, for example). This value-driven approach tends to guide future negotiations with manufacturers, especially for ultra-expensive therapies (e.g., single-dose gene therapies costing millions of reais).

  
  

Amid these prospects, Brazil holds an asset: a growing and collaborative healthcare innovation ecosystem . The actors in this ecosystem— startups , universities and ICTs, investors, funding agencies, and large companies—form a fundamental fabric for transforming challenges into opportunities. Each bottleneck can inspire creative solutions: if there's a lack of real-world data to prove the value of a drug in Brazil, big data healthtechs can fill them; if there are logistical challenges in distributing a new drug in remote areas, perhaps healthcare supply chain startups can offer tools; if the cost is high, national companies can seek partnerships for local production or the development of innovative analogues.

The Brazilian healthcare market has the potential to be not only an importer of innovation, but also a leading player . We are a continental country with 210 million inhabitants, a robust private healthcare sector, and a universal public healthcare system. This gives us volume and diversity, ideal conditions for testing and implementing solutions at scale. Furthermore, local problems (such as tropical diseases, high obesity rates, and population aging) can serve as catalysts for "made in Brazil" innovation to emerge, focusing on these areas, and eventually conquer the world.

There are historical examples, such as Brazil's leadership in dengue and HIV research in the 1990s. Today, with emerging technologies (artificial intelligence, synthetic biology, precision medicine), there is potential for even greater leaps forward with investment and coordination.

Pharmaceutical and biotechnology innovation has emerged this decade as a key factor in improving global health , bringing new hope for treatments for previously intractable conditions. The IQVIA Institute report outlines a future of expanded access, growing use, and significant spending on medicines by 2029 , driven by advances in areas such as oncology, metabolic diseases, and immunology. At the same time, it highlights the disparity between different regions , where countries like Brazil still face a gap in achieving the levels of access seen in developed nations.

The Brazilian scenario, when compared internationally, highlights both challenges and opportunities . The challenges manifest themselves in regulatory bottlenecks, budgetary constraints, and structural constraints that slow the arrival of innovation to patients. Opportunities, however, lie in our ability to learn from global best practices (such as the adoption of biosimilars and technology assessment models) and to mobilize the local ecosystem to seek solutions adapted to our reality.

Differences in access, regulation, drug launches, and adoption of innovative therapies are not merely statistical; they ultimately translate into additional or decreased years of life and quality of life for millions of people. Reducing these differences is, therefore, an ethical as well as a technical imperative. Fortunately, Brazil has the human capital, competent institutions, and a vibrant innovation sector ready to contribute to this mission.

The coming years will likely see Brazil become more agile in approving and incorporating innovations, whether due to the maturation of ANVISA and CONITEC, or due to social pressure for rapid access (as in the case of obesity medications). We will also see if we can capitalize on the wave of growth in the healthcare market to strengthen our industry and research , reducing external dependencies.

The goal of becoming a regional leader in health innovation, a Latin American hub for development and access, is on the horizon and feasible, as long as there is coordination between government, academia, and the private sector.

In conclusion, the importance of pharmaceutical and biotechnological innovation cannot be overestimated: it saves lives, improves public health, and generates economic development. But innovation only fulfills its purpose if it truly reaches the people who need it. May we, as a country, shorten the path from invention to treatment, breaking down barriers and building bridges—regulatory, financial, and knowledge—to put Brazil on the map of global health leaders .

The journey described throughout this article shows that, despite the obstacles, Brazil has immense potential for growth in innovation and access to healthcare. The Brazilian Health Innovation Institute - IBIS acts as a connected hub for science, technology, and innovation in healthcare , connecting startups to the market, supporting investor decisions with data intelligence, and helping corporations and governments find innovative solutions. The future of Brazilian healthcare depends on collaboration and bold vision!

References:

• IQVIA Institute – The Global Use of Medicines: Outlook through 2029 – Increasing Access, Use, and Spending : https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/the-global-use-of-medicines-outlook-through-2029

• IQVIA Institute – Global data on new medicines and unequal access.

• IQVIA Institute – Growth by therapeutic areas and projections (Oncology, Diabetes/Obesity, Immunology).

• IQVIA Institute – Global GLP-1 adoption trends and Brazil’s role.

• MIT Technology Review (Brazil) – “Biosimilars: the expansion of copies of biological medicines” .

• Fifarma – WAIT Indicator 2023 – Waiting time for oncology drugs in Latin America.

• Gov/Anvisa Agency – Interfarma survey on the performance of Anvisa vs FDA/EMA.

• CNN Brasil – “Ministry of Health will evaluate Ozempic in the SUS in the first half of 2025” .

• Ministry of Health – News on incorporations (durvalumab in the SUS, etc.).

• Gov.br Portal – Anvisa Resolution on prescription retention for GLP-1.

• Chamber of Deputies / Oncoguia – Debates on the incorporation of oncological patients (general reports).

• Public domain data (ANVISA, CMED, Conitec) on deadlines and processes.

by Marcio de Paula

Brazilian Health Innovation Institute - IBIS