Global Selpercatinib (Retevmo) Market Forecast, 2025 - 2033: Competitive Landscape, Growth Trends, And Future Prospects

Report Overview

Selpercatinib, marketed under the brand name Retemo, represents a significant advancement in the treatment of RET-driven cancers, including non-small cell lung cancer (NSCLC) and medullary thyroid cancer (MTC). Approved by the FDA in 2020, Retemo is the first selective RET kinase inhibitor approved for these indications, marking a pivotal moment in the oncology treatment landscape. Its market success has been largely driven by its targeted mechanism of action, which effectively addresses RET alterations that drive tumorigenesis in these cancers. As the Selpercatinib market continues to expand, key factors such as the drug’s exclusivity period, competitive landscape, and ongoing clinical trials will influence future market dynamics. While the drug's exclusivity is not set to expire in the near term, the potential entry of competitive therapies and biosimilars could influence market positioning. This evolving environment presents both challenges and opportunities for pharmaceutical stakeholders as they seek to maximize the drug's potential while preparing for increased competition in the coming years.

Key Report Deliverables

• Market Landscape Analysis: Assess the current market size and growth drivers, including the rise of targeted therapies and ongoing clinical trials for new indications of Selpercatinib.

• Market Growth Forecast: Project market growth considering factors like expanding indications, competitive pressures, and access strategies in key global markets.

• Regulatory and Market Barriers: Analyze regulatory challenges and market access barriers, particularly in emerging regions, and the impact on Selpercatinib’s market expansion.

• Competitive Landscape: Examine Selpercatinib’s competitive position against other RET inhibitors and emerging therapies, focusing on market share and pricing dynamics.

• Regulatory Barriers: Evaluate the regulatory hurdles for Selpercatinib’s approval and market access, particularly for new indications and in diverse regions.

• Strategic Implications: Identify strategic opportunities for expansion, partnerships, and innovation, including geographic growth and patient support programs. 

Exclusivity and Intellectual Property

Selpercatinib (Retemo) is protected by patent rights, with exclusivity extending until 2034. This exclusivity is crucial for maintaining the drug's position as the only FDA-approved selective RET kinase inhibitor for treating RET-driven cancers such as non-small cell lung cancer (NSCLC) and medullary thyroid cancer (MTC). During this period, Selpercatinib holds a significant advantage in the oncology market. 

As the exclusivity period progresses, opportunities to extend market exclusivity are centered on the approval of additional indications or new formulations. For instance, gaining regulatory approval for Selpercatinib in additional RET-positive cancers will extend its market exclusivity and expand its treatment options for a broader patient population.

Additionally, the development of combination therapies, including those paired with immune checkpoint inhibitors, will enhance Selpercatinib’s efficacy and solidify its position in the market. These approaches will not only extend the drug's utility across multiple cancer types but also reinforce its differentiation. 

Regulatory exclusivity extensions for new formulations or treatment regimens, such as higher-dose versions or alternate delivery methods, will also bolster Selpercatinib’s market presence. These strategic efforts ensure that Selpercatinib remains a key player in the oncology market, maximizing its potential and delaying the impact of generic or biosimilar competition.

In summary, Selpercatinib’s exclusivity period offers a clear opportunity to solidify its market leadership, with strategies focused on expanding indications and treatment regimens to sustain its competitive edge. 

Current Market Scenarios 

The Selpercatinib (Retemo) market is currently at a pivotal stage, with significant opportunities for growth in the treatment of RET-driven cancers, particularly non-small cell lung cancer (NSCLC) and medullary thyroid cancer (MTC). Since its approval in 2020, Selpercatinib has demonstrated strong efficacy in targeting RET mutations, establishing itself as the first FDA-approved selective RET kinase inhibitor for these indications. The drug has performed well commercially, generating increasing revenue driven by its targeted treatment profile. However, as the market for RET inhibitors expands, Selpercatinib faces growing competition, particularly from other RET-targeting therapies. 

The RET kinase inhibitor market is becoming more competitive, with emerging therapies such as pralsetinib (Gavreto) positioning themselves as direct competitors. These therapies offer similar mechanisms of action and target the same patient populations, which challenge Selpercatinib's market share as their indications broaden and more treatment options become available. The competitive landscape will be shaped by these new entrants and also by the potential for combination therapies, which may offer improved outcomes compared to single-agent treatments. 

The regulatory environment for Selpercatinib is favorable, with FDA approvals for new indications continuing to support market growth. The drug's exclusivity period, lasting until 2034, provides a window of opportunity to expand its clinical use and market presence. However, as the exclusivity period progresses, the potential for the entry of biosimilars or next-generation inhibitors could introduce price competition, especially in markets where cost sensitivity is high. 

For Eli Lilly, the challenge will be to retain Selpercatinib's competitive edge amid the growing number of RET inhibitors entering the market. Strategies to maintain market share will likely include expanding into additional indications, pursuing combination therapies, and continuing to advance clinical trials to reinforce Selpercatinib's therapeutic profile. Enhancing patient access programs and building strong brand loyalty will also be critical in a market increasingly influenced by competition and pricing pressures. Selpercatinib market is poised for growth but must navigate an evolving competitive landscape. By focusing on expanding indications and enhancing its positioning within combination therapies, Selpercatinib can continue to strengthen its market presence as it faces increasing competition from biosimilars and emerging therapies in the oncology space.

Market Dynamics 

“Rising Prevalence of RET-Driven Cancers Fuels Market Growth”

The market for Selpercatinib is growing rapidly, driven by the increasing recognition of RET-driven cancers like non-small cell lung cancer (NSCLC) and medullary thyroid cancer (MTC). As more people are diagnosed with RET mutations, the demand for targeted treatments like Selpercatinib continues to rise, especially in developed regions like North America, Europe, and Japan. Selpercatinib is the first FDA-approved selective RET kinase inhibitor, making it a key option for patients with these types of cancers. As healthcare providers continue to shift toward personalized medicine, this drug is gaining more traction due to its ability to directly target the RET mutation and stop cancer progression.

In emerging markets like Asia, Latin America, and Africa, healthcare access is improving, and more people are getting diagnosed with these cancers. This is creating a huge opportunity for Selpercatinib. With more governments focusing on healthcare reforms and increasing oncology spending, the adoption of targeted therapies is expanding. As more patients are identified as having RET mutations, the demand for a treatment like Selpercatinib will continue to grow. 

“The Competitive Landscape: Growing Threats from Other RET Inhibitors”

Despite its strong position, Selpercatinib is not alone in the RET inhibitor market. Pralsetinib (Gavreto), another RET-targeting therapy, is also approved for treating RET-positive cancers, and it is likely to take market share as more indications are added. As more RET inhibitors enter the market, Selpercatinib will need to work harder to maintain its competitive edge. Factors like clinical efficacy, safety profiles, and the ability to be combined with other therapies will become critical for Selpercatinib to stand out.

Even with its exclusivity period lasting until 2034, Selpercatinib could face some challenges. As more competitors enter the scene, pricing pressures will likely increase, especially in emerging markets where healthcare systems are highly cost-sensitive. This is where biosimilars and other generic therapies will become a factor as their approval and market entry could drive prices down. 

“Opportunities for Selpercatinib: Expanding Indications, Formulations, and Global Reach”

1. Expanding Indications: Currently approved for NSCLC and MTC, there’s a real opportunity for Selpercatinib to be used in other RET-driven cancers, like colorectal and pancreatic cancer. Approval for these new indications would open up new patient populations and further solidify Selpercatinib's role in oncology treatment.

2. Formulation Advancements: A major opportunity lies in improving how Selpercatinib is delivered to patients. Developing extended-release formulations or finding ways to make dosing more convenient could increase patient adherence. If Selpercatinib can be offered in an easier-to-administer form, it would have a significant edge in terms of patient compliance and overall competitiveness.

3. Emerging Markets: The rise of healthcare access in places like Asia, Latin America, and Africa is a big opportunity for Selpercatinib. As these regions invest more in healthcare and oncology treatments, there is more room for innovative therapies. By working with local healthcare providers and tailoring its pricing strategies to meet regional needs, Selpercatinib can strengthen its foothold in these rapidly developing markets. 

“Post-Exclusivity Competition and the Role of Precision Medicine”

After its exclusivity period ends in 2034, Selpercatinib will face new challenges as biosimilars and other RET inhibitors enter the market. To stay competitive, Eli Lilly will need to adopt strategies like value-based pricing and enhanced patient support programs to maintain market share. However, the growing trend of personalized medicine offers an exciting opportunity for Selpercatinib. As genomic testing becomes more common, more patients will be identified with RET mutations, making Selpercatinib an even more valuable treatment option. By leveraging companion diagnostics and focusing on precision oncology, Selpercatinib can continue to differentiate itself from emerging therapies, ensuring it remains a leading choice for RET-positive cancers.  

Overview of Alternative Therapeutics

The Selpercatinib (Retemo) market is increasingly facing competition from other RET inhibitors and emerging therapies, which could impact its market share. One of the main competitors is pralsetinib (Gavreto), another selective RET kinase inhibitor that has been approved for the treatment of RET-positive cancers, including non-small cell lung cancer (NSCLC) and medullary thyroid cancer (MTC). Both Selpercatinib and Pralsetinib offer targeted treatments for RET mutations, making them direct competitors in the same therapeutic space. The growing presence of pralsetinib and other similar agents could lead to price and market share competition as more treatment options become available for RET-driven cancers. 

In addition to these selective RET inhibitors, there is a rising interest in combination therapies for RET-positive cancers. Selpercatinib is already being investigated in combination with other therapies, including immune checkpoint inhibitors and chemotherapies, which could offer enhanced efficacy for patients with advanced cancers. These combinations are gaining traction in clinical settings, which could shift treatment paradigms and provide patients with more comprehensive treatment regimens. 

Furthermore, biosimilars targeting RET inhibitors may enter the market once Selpercatinib’s exclusivity period ends in 2034, offering cost-effective alternatives to the originator product. The introduction of biosimilars will likely be a key factor in shaping market dynamics, especially in price-sensitive markets, where cost is a significant consideration for healthcare providers and patients. 

The competitive landscape for Selpercatinib is also influenced by the broader trend of precision medicine in oncology, with an increasing number of targeted therapies for various genetic mutations, including RET, being developed. As more molecularly targeted therapies gain approval, Selpercatinib will need to differentiate itself by demonstrating superior clinical outcomes, particularly in advanced and combination treatment regimens, to retain its position as a leading option for RET-positive cancers.

Competitive Landscape

The competitive landscape for Selpercatinib (Retemo) is driven by several key companies that are advancing the field of RET-targeted therapies and precision oncology. These companies represent both direct and indirect competition for Eli Lilly, the manufacturer of Selpercatinib. Blueprint Medicines is the primary direct competitor to Eli Lilly in the RET inhibitor market. Their drug Pralsetinib (Gavreto) is approved for the treatment of RET-positive non-small cell lung cancer (NSCLC) and medullary thyroid cancer (MTC). Both Pralsetinib and Selpercatinib target the same genetic mutation, making Blueprint Medicines a direct competitor. Pralsetinib has carved out a significant position in the market, and Blueprint Medicines is expected to continue leveraging its clinical data to expand the use of Pralsetinib in additional RET-driven cancers, which will increase competition between the two companies. 

Another competitor in the RET-positive cancer treatment space is Roche, a major player in oncology. While Roche has not yet entered the RET inhibitor market with a direct competitor to Selpercatinib, it has significant presence through other targeted therapies like Tecentriq (atezolizumab), an immune checkpoint inhibitor used in combination with other therapies. The growing trend toward combination treatments in oncology, including potential combinations of immune checkpoint inhibitors with RET inhibitors, positions Roche as an indirect competitor. Roche’s ability to offer comprehensive treatment regimens that include targeted therapies and immunotherapies could challenge Selpercatinib's market share in advanced cancers. 

Merck & Co. is another indirect competitor, particularly through their Keytruda (pembrolizumab), which has proven efficacy in solid tumors. Merck’s focus on combination therapies, especially those that pair immunotherapy with targeted therapies such as RET inhibitors, could create competitive pressure. Merck’s vast experience and established oncology portfolio make it a formidable player in precision oncology and a potential competitor in the RET-positive cancer space if they develop a RET kinase inhibitor or combination treatment. 

Further indirect competition comes from Novartis, which, although not focused on RET inhibitors, is a key player in the oncology market with treatments for solid tumors and other precision oncology therapies. Novartis has a strong presence in targeted therapies and could potentially enter the RET inhibitor space with new drugs or combination therapies, competing for a share of the market in RET-positive cancers. 

Additionally, biosimilars targeting RET inhibitors are expected to enter the market after Selpercatinib’s exclusivity period ends in 2034, introducing lower-cost alternatives to Selpercatinib. Companies like Samsung Bioepis, Mylan, and Amgen are already active in the biosimilars space, and their future entrance into the RET inhibitor market could put significant pricing pressure on Eli Lilly. These biosimilars would offer cost-effective alternatives, particularly in price-sensitive markets such as Asia and Latin America, where healthcare systems are often more focused on affordability. 

Eli Lilly will need to differentiate Selpercatinib by focusing on its unique clinical profile, particularly in RET-positive cancers, and its potential in combination therapies. Additionally, Eli Lilly will continue expanding Selpercatinib’s use in new indications, such as colorectal cancer or pancreatic cancer, to secure its position as a leader in precision oncology for RET-driven tumors.

North America Selpercatinib (Retemo) Market

The North American market for Selpercatinib is a cornerstone of its commercial success, driven primarily by the United States, where the demand for targeted therapies is increasing. Selpercatinib benefits from robust healthcare infrastructure, strong insurance coverage, and an established preference for personalized oncology treatments. Medicare and private insurers in the U.S. play a critical role in ensuring Selpercatinib’s broad accessibility for RET-positive cancer patients. However, the market is becoming more competitive with the entry of Pralsetinib (Gavreto), a direct competitor for RET-driven cancers. The upcoming expiration of Selpercatinib's exclusivity period in 2034 will lead to the expected entry of biosimilars, which could exert significant downward pressure on pricing. Despite these challenges, Selpercatinib benefits from its strong clinical data and efficacy, which help maintain its market leadership. Eli Lilly will likely need to enhance its value-based pricing models and leverage expanded indications to maintain market share against future biosimilars and other competitive therapies entering the market. 

Europe Selpercatinib (Retemo) Market

In Europe, Selpercatinib is well-positioned in established healthcare markets such as Germany, France, and the UK, where there is a strong inclination toward targeted therapies and personalized cancer treatment. These countries have well-organized oncology reimbursement systems, which support the adoption of Selpercatinib. However, the European market is not without challenges. Cost containment strategies in countries like Spain, Italy, and Eastern European markets are tightening, leading to increasing pressure on pricing and reimbursement policies. The upcoming introduction of biosimilars in the coming years, coupled with the availability of Pralsetinib and other RET inhibitors, will create additional competitive pressure. Selpercatinib’s ability to maintain a competitive edge in Europe will depend on clinical differentiation, continued clinical trial support, and strategies to address the region’s price-sensitive markets. As biosimilars and alternative therapies become available, Eli Lilly must focus on expanding indications and patient access programs to ensure Selpercatinib’s ongoing role in European treatment regimens.

Asia-Pacific Selpercatinib (Retemo) Market

The Asia-Pacific region is witnessing increasing demand for targeted therapies in oncology, and Selpercatinib is benefiting from this trend, particularly in developed markets such as Japan and Australia, where genomic profiling and personalized medicine are becoming integral parts of cancer treatment. These countries have solid oncology infrastructures and favorable regulatory environments, which facilitate the adoption of innovative therapies like Selpercatinib. Japan in particular is expected to remain a key market, thanks to its advanced cancer care systems and high adoption of precision oncology. However, in emerging markets such as China and India, the high cost of Selpercatinib poses a significant barrier. The growing focus on affordable cancer treatments in these regions means that Selpercatinib may face competition from biosimilars and generic therapies once the exclusivity period ends. Although Selpercatinib has substantial potential in these rapidly developing markets, its future success will depend on strategic partnerships, pricing flexibility, and local patient access programs to ensure wider adoption, especially as cost remains a key factor in these regions.

Latin America Selpercatinib (Retemo) Market

The Latin American market for Selpercatinib is showing gradual growth, with increased demand for advanced cancer treatments in key markets such as Brazil and Mexico. The region is seeing improved oncology infrastructure and rising awareness of RET-positive cancers, which supports the adoption of Selpercatinib. However, cost remains a significant barrier in many Latin American countries, and this is where biosimilars and generic alternatives to RET inhibitors will have a strong impact. The high price of Selpercatinib limits its availability, especially in countries with constrained healthcare budgets. While larger markets like Brazil may see increasing adoption of targeted therapies, the broader Latin American market will require more affordable pricing strategies and patient support programs from Eli Lilly to ensure continued growth. The introduction of biosimilars and local healthcare reforms will also play a role in shaping the market dynamics over the next few years.

Middle East and Africa Selpercatinib (Retemo) Market

The Middle East and Africa (MEA) market for Selpercatinib is experiencing slow but steady growth, particularly in more developed regions such as the UAE, Saudi Arabia, and South Africa, where rising awareness of RET-positive cancers and increased healthcare spending are creating demand for advanced oncology treatments. The region’s growing focus on personalized medicine and oncology care has created an opportunity for Selpercatinib, especially in countries with improving healthcare systems. However, in emerging markets across Africa, affordability remains a major barrier. The high cost of Selpercatinib restricts its adoption in many parts of the region, and biosimilars will likely increase competition in cost-sensitive markets. Despite these challenges, Eli Lilly can benefit from strengthening patient access programs and working with local healthcare providers to expand Selpercatinib’s reach. Market growth in the MEA region will depend on the increase in healthcare investments and efforts to make targeted therapies more accessible to underserved populations. 

Analyst Perspective

The Selpercatinib market is at a critical juncture where clinical efficacy and pricing strategy will define its future growth. While Eli Lilly has established a strong presence in RET-positive cancers, its ability to maintain dominance will be challenged by Pralsetinib (Gavreto) and the future entry of biosimilars post-2034. The key to sustaining its position lies in expanding indications and leveraging combination therapies to differentiate Selpercatinib from competitors. Additionally, addressing accessibility in emerging markets through affordable pricing models will be crucial as competition intensifies. The focus on value-based pricing and patient access programs will determine Selpercatinib’s ability to remain competitive against the growing number of RET inhibitors and biosimilars entering the market.

Case Study (Recent Engagement): Keytruda Patent-Cliff & Price- Erosion Impact Model

PROJECT OBJECTIVE 

To evaluate the potential revenue, price, and patient access implications of Keytruda’s 2028 patent cliff, incorporating biosimilar entry dynamics, country-specific adoption curves, and Merck’s lifecycle defense strategies (remarkably the subcutaneous formulation). The goal was to provide the client with a transparent, scenario-based model to anticipate outcomes and inform strategy

GVR SOLUTION 

• Built a bottom-up commodity-flow and analogue-based model, anchored on Merck’s $29.5B Keytruda sales in 2024.

• Integrated jurisdictional LOE timelines (EU mid-2028, U.S. 2028-2029 pending litigation outcomes).

• Modeled biosimilar adoption S-curves calibrated to oncology antibody analogues (EU faster via tenders, U.S. slower via contracting).

• Applied price-erosion benchmarks (EU -15-30% Yr-1, deepening to -45-60% by Yr-3; U.S. -10-25% net decline over same horizon).

• Layered lifecycle defenses (SC uptake assumptions of 25-40% of innovator units, combo refresh, contracting) to quantify buffers.

• Delivered outputs as a dynamic Excel scenario tool and a management-ready PPT deck with revenue bridges, sensitivity tornadoes, and SC migration visuals. 

IMPACT FOR CLIENT

• Enabled the client to quantify downside vs. defense-optimized revenue trajectories:

  • Base case: 30-40% global revenue decline by Year-3 post-LOE.

  • Downside: 45-55% decline in tender-heavy markets.

  • Defense-optimized: Contained erosion to ~-20-25% with strong SC adoption.

• Gave the client a clear view of which markets drive early erosion (EU) and where strategic contracting or SC migration can preserve share (U.S.).

• Equipped decision-makers with a playbook of watch-points (tender concentration, litigation outcomes, SC IP coverage, combo pipeline) to guide commercial strategy.

• Provided a transparent methodology that could be presented to boards/investors with evidence-backed assumptions

WHY THIS MATTERS

• Keytruda is the world’s best-selling cancer drug, representing nearly one-third of Merck’s revenue.

• Patent expiry will reshape both Merck’s earnings profile and global oncology access dynamics.

• Payers and governments stand to benefit from biosimilar entry through lower costs, but manufacturers need to manage cliff risk while capturing upside from lifecycle innovations.

• Understanding how quickly revenues erode and how patient access expands post-biosimilar is critical for:

  • Biopharma companies (strategic planning, pipeline prioritization).

  • Investors (valuing Merck’s cash flows beyond 2028).

  • Payers and policymakers (budgeting for oncology drug spend).

A robust patent cliff model helps clients navigate the dual challenge of price erosion and patient expansion, ensuring strategies are grounded in real-world benchmarks.