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Pralsetinib Market
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Pralsetinib Market

Author: Debadatta Patel - Senior Consultant, Report ID - DS1802140, Published - April 2025

Segmented in Therapeutic Application (Non-Small Cell Lung Cancer, Thyroid Cancer, Other Cancers), Target Population (Geriatric Patients, Adult Patients, Pediatric Patients), Dosage Forms, Distribution Channels and Regions - Global Industry Analysis, Size, Share, Trends, and Forecast 2024 – 2034

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Global Pralsetinib Market Outlook

The market, for Pralsetinib was estimated at $1.1 billion in 2024; and it is anticipated to increase to $1.9 billion by 2030 with projections indicating a growth to around $2.9 billion by 2035. This expansion represents a compound annual growth rate (CAGR) of 9.1% over the forecast period. Such robust growth can primarily be attributed to the substantial demand for Pralsetinib, being largely driven by its inherent benefits in the treatment of cancer. Increases in the incidences of lung cancer, coupled with ongoing research and development activities in the cancer therapeutics domain, have further facilitated the rapid uptake of Pralsetinib in the healthcare sector. Progressing advancements, combined with the emergent trends in personalized medicine and precision diagnostics, are steadily fueling the significant relevance and market momentum of Pralsetinib worldwide.


Renowned as a highly effective, selective RET inhibitor, Pralsetinib has been explicitly designed for the treatment of cancers that express aberrant RET signals. Offering ample potential in oncology therapeutics, it has demonstrated noteworthy efficacy for various RET fusion-positive cancers, including NSCLC and thyroid cancers. Application trends indicate an increasing reliance on Pralsetinib for the treatment of solid tumors and malignancies, owing to the drugs competence in disrupting the oncogenic RET signaling.


Market Size Forecast & Key Insights

2019
$1.1B2024
2029
$2.6B2034

Absolute Growth Opportunity = $1.5B

The Pralsetinib market is projected to grow from $1.1 billion in 2024 to $2.6 billion in 2034. This represents a CAGR of 9.1%, reflecting rising demand across Lung Cancer Treatment, Advanced Thyroid Cancer Treatment and High-Grade Neuroendocrine Cancer Treatment.

The Pralsetinib market is set to add $1.5 billion between 2024 and 2034, with manufacturer targeting Adult Patients & Pediatric Patients Target Population projected to gain a larger market share.

With Increase in ret-altered cancers, and Emerging personalized medicine, Pralsetinib market to expand 139% between 2024 and 2034.

Opportunities in the Pralsetinib Market

Technological Innovations in Administration

Apart from its core functionality, investing in technological innovation in the administration of Pralsetinib would be a significant.Refining the drug delivery system to enhance the user experience and drug effectiveness could lead to increased market share.

Catering to Untapped Market Segments and Strategic Collaborations With Health Organizations

Pralsetinib, with its unique ability to treat patients with non-small cell lung cancer and thyroid cancer, holds untapped opportunities in developing markets where such treatment is still nascent. The expansion into these markets could potentially drive robust growth for Pralsetinib, as the incidence of these cancers is on the rise globally.

The success of Pralsetinib lies in its collaboration with different public and private health organizations. A partnership with oncology research centers could facilitate extensive studies and trials, strengthening its standing in the cancer treatment landscape. By leveraging these collaborations, Pralsetinib could ensure wider reach and acceptance.

Growth Opportunities in North America and Europe

Europe Outlook

Parallel to North America, Europe carries significant market potential for Pralsetinib. With advanced healthcare systems across much of the region, There is notable demand for cutting-edge cancer therapeutics, thus providing high-growth opportunities. The competition also remains high here, chiefly from companies that specialize in oncology, thus invigorating the market further. The primary market driver here is Europe's changing demographics, with an aging population that increasingly requires therapeutic interventions in cancer. Finally, making a strong case for Pralsetinib in Europe are the large-scale initiatives to fund research and development activities in oncology, further bolstering its adoption potential.

North America Outlook

Being a major hub for pharmaceutical innovation, North America presents a significant market potential for Pralsetinib. This is driven by an ever-increasing patient pool for non-small cell lung cancer and thyroid cancer, two critical application region's for Pralsetinib. Furthermore, the region showcases high competition levels due to the presence of top pharma giants focused on cancer therapeutics. However, the vast potential and heightened competition also unlock opportunities for collaborations, mergers, and acquisitions, helping companies improve their drug portfolios and maximizing patient outreach. Another critical driver for Pralsetinibs market in this region is the increasing support for research and development around targeted therapies.

North America Outlook

Being a major hub for pharmaceutical innovation, North America presents a significant market potential for Pralsetinib. This is driven by an ever-increasing patient pool for non-small cell lung cancer and thyroid cancer, two critical application region's for Pralsetinib. Furthermore, the region showcases high competition levels due to the presence of top pharma giants focused on cancer therapeutics. However, the vast potential and heightened competition also unlock opportunities for collaborations, mergers, and acquisitions, helping companies improve their drug portfolios and maximizing patient outreach. Another critical driver for Pralsetinibs market in this region is the increasing support for research and development around targeted therapies.

Europe Outlook

Parallel to North America, Europe carries significant market potential for Pralsetinib. With advanced healthcare systems across much of the region, There is notable demand for cutting-edge cancer therapeutics, thus providing high-growth opportunities. The competition also remains high here, chiefly from companies that specialize in oncology, thus invigorating the market further. The primary market driver here is Europe's changing demographics, with an aging population that increasingly requires therapeutic interventions in cancer. Finally, making a strong case for Pralsetinib in Europe are the large-scale initiatives to fund research and development activities in oncology, further bolstering its adoption potential.

Growth Opportunities in North America and Europe

Established and Emerging Market's Growth Trend 2025–2034

1

Major Markets : United States, Germany, Japan, China, United Kingdom are expected to grow at 6.6% to 9.6% CAGR

2

Emerging Markets : Brazil, India, South Africa are expected to grow at 8.7% to 11.4% CAGR

Market Analysis Chart

Pralsetinib, a breakthrough therapeutic agent, has been a game-changer in the pharmaceutical industry. The most compelling market driver behind Pralsetinib can be its transformative impact on the treatment of cancers with aberrations in Ret Proto-Oncogene . It is a powerful RET inhibitor that has shown unmatched efficacy, especially in non-small cell lung cancer and medullary thyroid cancer.

Recent Developments and Technological Advancement

December 2024

The FDA granted full approval to Pralsetinib, produced by Blueprint Medicines, for the treatment of individuals previously treated for metastatic RET-fusion positive non-small cell lung cancer.

October 2024

Blueprint Medicines established a strategic partnership with Roche, aiming to make Pralsetinib available globally, underpinning its significance in oncology treatments.

August 2024

Phase III clinical trial data published by Blueprint Medicines revealed Pralsetinib shows promising results in advanced thyroid cancer patients with RET alteration.

Pralsetinib, a select inhibitor of the rearranged during transfection proto-oncogene, gained traction in the robust pharmaceutical industry. Wit high efficacy and targeted approach, its rapidly emerging at the frontier of groundbreaking cancer therapies, specifically for RET fusion-positive non-small cell lung cancer and medullary thyroid cancer.

Impact of Industry Transitions on the Pralsetinib Market

As a core segment of the Pharmaceutical industry, the Pralsetinib market develops in line with broader industry shifts. Over recent years, transitions such as Personalized Treatment Approach and Utilizing AI in Drug Development have redefined priorities across the Pharmaceutical sector, influencing how the Pralsetinib market evolves in terms of demand, applications and competitive dynamics. These transitions highlight the structural changes shaping long-term growth opportunities.

1

Personalized Treatment Approach:

As a drug designed to target specific genetic mutations, Pralsetinib represents a significant shift in the paradigm of lung cancer treatment, from a onesizefitsall approach towards personalized therapy. This novel therapeutic option targets RET fusionpositive nonsmall cell lung cancer, genetically profiled to tailor treatment specifically for the patients mutation. By shifting towards a personalized medicine concept, Pralsetinib has brought a fresh dynamic within the pharmaceutical and healthcare industries, encouraging research and development of more mutationspecific drugs, promoting precision in treatment and improving patient outcomes.

2

Utilizing AI in Drug Development:

The development of Pralsetinib exemplifies how the application of AI algorithms can uncover new drug potentials hidden within vast troves of medical and genetic data. Using ML and predictive modeling, pharmaceutical companies, including those behind Pralsetinib, are streamlining drug discovery processes, reducing costs and improving the success rates of clinical trials.

Global Events Shaping Future Growth

The chart below highlights how external events including emerging market developments, regulatory changes, and technological disruptions, have added another layer of complexity to the Pharmaceutical industry. These events have disrupted supply networks, changed consumption behavior, and reshaped growth patterns. Together with structural industry transitions, they demonstrate how changes within the Pharmaceutical industry cascade into the Pralsetinib market, setting the stage for its future growth trajectory.

Market Dynamics and Supply Chain

Driver: Increase in RET-Altered Cancers

Oncology research has also identified an upturn in the incidence of cancers with alterations in RET , specifically thyroid cancer and non-small cell lung cancer. This surge spurs the demand for Pralsetinib, a potent RET inhibitor, designed to target mutations that lead to uncontrolled cell growth in RET-altered cancers. Pralsetinib, with its inhibitive action on RET-altered cancers, can also potentially become an invaluable weapon in the fight against these proliferating cancers.
With the advancements in genomics and precision medicine, therapies tailored to a patients genetic profile have also gained prominence. The trend of personalized oncology treatments has also driven the need for targeted therapies like Pralsetinib, a solution congruent with the precision medicine trend. It offers a targeted approach to treat patients with specific RET rearrangements, thus offering a new hope in personalized medicine.

Restraint: High Cost and Limited Accessibility of Pralsetinib

Expensive and limited access to medical and cancer treatments inhibit widespread acceptance of newer therapies like Pralsetinib. Patients in lower-income brackets may not only have adequate resources to pursue cutting-edge treatments, thereby restraining the market expansion. Unless Pralsetinib becomes more accessible and affordable, a large segment of the population may remain untreated, impacting the market demand dynamics.

Challenge: Regulatory Hurdles and Delays

Approval of investigational drugs like Pralsetinib can be a lengthy and complex process, sometimes taking several years for regulatory clearance with the need for considerable evidence demonstrating safety and efficacy. Frequent changes in pharmaceutical regulations add to these delays further. These obstacles, combined with a lack of synchronized regulatory guidelines across different geographies, significantly curb the growth and adoption of Pralsetinib in various potential markets.

Supply Chain Landscape

Raw Material Procurement

Carbosynth

Rgenta Therapeutics

API Synthesis

WuXi AppTec

Johnson Matthey

Drug Formulation
Blueprint Medicines / KeyTec
Retail & Distribution
Celgene Corporation / Novartis
Raw Material Procurement

Carbosynth

Rgenta Therapeutics

API Synthesis

WuXi AppTec

Johnson Matthey

Drug Formulation

Blueprint Medicines

KeyTec

Retail & Distribution

Celgene Corporation

Novartis

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Leading Providers and Their Strategies

Application AreaIndustryLeading Providers / ConsumersProvider Strategies
Oncology - Non-Small Cell Lung Cancer
Biotech and Pharmaceuticals
Blueprint Medicines Corporation
Focusing on accelerated FDA approval based on clinical trials for PRALSETINIB and potential first-line therapy
Hematology - Chronic Myelomonocytic Leukemia
Biotech and Pharmaceuticals
Genentech, Inc.
Collaboration with Blueprint Medicines to develop Pralsetinib and expand its application for hematological disorders
Oncology - Thyroid Cancer
Biotech and Pharmaceuticals
Roche Group
Strategic implementation of Pralsetinib in targeted cancer treatment therapeutics, leveraging genomics

Elevate your strategic vision with in-depth analysis of key applications, leading market players, and their strategies. The report analyzes industry leaders' views and statements on the Pralsetinib market's present and future growth.

Our research is created following strict editorial standards. See our Editorial Policy

Applications of Pralsetinib in High-Grade Neuroendocrine Cancer Treatment, Advanced Thyroid Cancer Treatment and Lung Cancer Treatment

High-Grade Neuroendocrine Cancer Treatment

Pralsetinib also holds promise in combating high-grade neuroendocrine cancers, aggressively attacking RET-rearranged tumors. These specific cancers are alarmingly resistant to conventional chemotherapies, making Pralsetinib a beacon of hope for patients. BluePrint Medicines has made significant strides in this territory, hence solidifying its market leadership.

Advanced Thyroid Cancer Treatment

Pralsetinib is breaking boundaries in treating advanced thyroid cancer, particularly when radioactive iodine has failed. Its specific genetic targeting approach offers improved response and a significant survival rate. This application further fortifies BluePrint Medicines position in the market, offering a compelling treatment option for challenging cases.

Lung Cancer Treatment

Leveraged as a therapeutic solution for lung cancer treatment, Pralsetinib targets the rearranged during transfection gene mutations found in 1-2% of patients. This targeted therapy is effective because it directly attacks RET mutated cells, resulting in fewer adverse side effects compared to traditional cancer treatments. BluePrint Medicines, the manufacturer of Pralsetinib, leads the market in this niche, delivering exceptional efficacy and tolerability in solid tumors with RET mutations.

Pralsetinib vs. Substitutes:
Performance and Positioning Analysis

Pralsetinib, a selective RET inhibitor, stands out amongst competitors for its efficacy in treating RET-altered cancers, presenting notable potential for market growth

Pralsetinib
  • Lorlatinib /
  • Selpercatinib /
  • Alectinib
    Effective treatment for non-small cell lung cancer, Promising therapeutic approach for RET-altered cancers
    High costs of treatment, Possibility of side effects such as hypertension and hepatotoxic
    Effective targeting of specific cancer mutations, improved patient survival rates
    Higher cost, potential for severe side effects

Pralsetinib vs. Substitutes:
Performance and Positioning Analysis

Pralsetinib

  • Effective treatment for non-small cell lung cancer, Promising therapeutic approach for RET-altered cancers
  • High costs of treatment, Possibility of side effects such as hypertension and hepatotoxic

Lorlatinib / Selpercatinib / Alectinib

  • Effective targeting of specific cancer mutations, improved patient survival rates
  • Higher cost, potential for severe side effects

Pralsetinib, a selective RET inhibitor, stands out amongst competitors for its efficacy in treating RET-altered cancers, presenting notable potential for market growth

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Research Methodology

This market research methodology defines the Pralsetinib market scope, gathers reliable data, and validates findings using integrated primary and secondary research. Our systematic framework ensures precise market sizing, growth trend analysis, and competitive benchmarking.


Secondary Research Approach


We begin secondary research by defining the targeted market at Country and Regional levels. As part of the Pharmaceutical ecosystem, we analyze Pralsetinib across Non-Small Cell Lung Cancer, Thyroid Cancer, and Other Cancers Applications. Our team gathers data systematically from country level ministerial sources, industry associations & federations, trade databases, company annual & quarterly reports and other credential sources, enabling us to map global and regional market size, pricing trends, regulatory standards, and technology advancements.


Key Sources Referenced:


We benchmark competitors such as Blueprint Medicines, Genentech Inc, and Roche Holding AG by reviewing company financial statements, and regulatory filings. Our secondary insights identify key market drivers and constraints, forming the analytical foundation for primary research.


Primary Research Methods


We conduct structured interviews and surveys with industry stakeholders, including Raw Material Procurement, API Synthesis, and Drug Formulation. Our geographic coverage spans Americas (40%), Europe (30%), Asia-Pacific (25%) and Middle East & Africa (5%). Our online surveys generally achieve a response rate of above 65%, and telephone interviews yield 60%, resulting in above 92% confidence level with a ±7% margin of error.


Through targeted questionnaires and in-depth interviews, we capture purchase intent, adoption barriers, brand perception across Segment Type. We use interview guides to ensure consistency and anonymous survey options to mitigate response bias. These primary insights validate secondary findings and align market sizing with real-world conditions.


Market Engineering & Data Analysis Framework


Our data analysis framework integrates Top-Down, Bottom-Up, and Company Market Share approaches to estimate and project market size with precision.


Top-down & Bottom-Up Process


In Top-down approach, we disaggregate global Pharmaceutical revenues to estimate the Pralsetinib segment, using historical growth patterns to set baseline trends. Simultaneously, in Bottom-up approach, we aggregate Country-Level Demand Data to derive regional and global forecasts, which provide granular consumption insights. By reconciling both approaches, we ensure statistical precision and cross-validation accuracy.


We evaluate the supply chain, spanning Raw Material Procurement (Carbosynth, Rgenta Therapeutics), API Synthesis (WuXi AppTec, Johnson Matthey), and Drug Formulation. Our parallel substitute analysis examines Lorlatinib, Selpercatinib, and Alectinib, highlighting diversification opportunities and competitive risks.


Company Market Share & Benchmarking


We benchmark leading companies such as Blueprint Medicines, Genentech Inc, and Roche Holding AG, analyzing their capabilities in pricing, product features, technology adoption, and distribution reach. By assessing company-level revenues and product portfolios, we derive market share comparisons, clarifying competitive positioning and growth trajectories across the ecosystem.


Our integration of data triangulation, supply chain evaluation, and company benchmarking, supported by our proprietary Directional Superposition methodology enables us to deliver precise forecasts and actionable strategic insights into the Pralsetinib market.


Quality Assurance and Compliance


We cross-reference secondary data with primary inputs and external expert reviews to confirm consistency. Further, we use stratified sampling, anonymous surveys, third-party interviews, and time-based sampling to reduce bias and strengthen our results.


Our methodology is developed in alignment with ISO 20252 standards and ICC/ESOMAR guidelines for research ethics. The study methodology follows globally recognized frameworks such as ISO 20252 and ICC codes of practice.

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Pralsetinib Market Data: Size, Segmentation & Growth Forecast

Report AttributeDetails
Market Value in 2025USD 1.2 billion
Revenue Forecast in 2034USD 2.6 billion
Growth RateCAGR of 9.1% from 2025 to 2034
Base Year for Estimation2024
Industry Revenue 20241.1 billion
Growth OpportunityUSD 1.5 billion
Historical Data2019 - 2023
Growth Projection / Forecast Period2025 - 2034
Market Size UnitsMarket Revenue in USD billion and Industry Statistics
Market Size 20241.1 billion USD
Market Size 20271.4 billion USD
Market Size 20291.7 billion USD
Market Size 20301.9 billion USD
Market Size 20342.6 billion USD
Market Size 20352.9 billion USD
Report CoverageMarket revenue for past 5 years and forecast for future 10 years, Competitive Analysis & Company Market Share, Strategic Insights & trends
Segments CoveredTherapeutic Application, Target Population, Dosage Forms, Distribution Channels
Regional scopeNorth America, Europe, Asia Pacific, Latin America and Middle East & Africa
Country scopeU.S., Canada, Mexico, UK, Germany, France, Italy, Spain, China, India, Japan, South Korea, Brazil, Mexico, Argentina, Saudi Arabia, UAE and South Africa
Companies ProfiledBlueprint Medicines, Genentech Inc, Roche Holding AG, Sanofi S.A., Novartis AG, Pfizer Inc., Eli Lilly and Company, GlaxoSmithKline plc, AstraZeneca plc, Johnson & Johnson Services Inc., Merck & Co. Inc. and Bristol-Myers Squibb Company
CustomizationFree customization at segment, region or country scope and direct contact with report analyst team for 10 to 20 working hours for any additional niche requirement which is almost equivalent to 10% of report value

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Table of Contents

Industry Insights Report - Table Of Contents

Chapter 1

Executive Summary

Major Markets & Their Performance - Statistical Snapshots

Chapter 2

Research Methodology

2.1Axioms & Postulates
2.2Market Introduction & Research MethodologyEstimation & Forecast Parameters / Major Databases & Sources
Chapter 3

Market Dynamics

3.1Market OverviewDrivers / Restraints / Opportunities / M4 Factors
3.2Market Trends
3.2.1Introduction & Narratives
3.2.2Market Trends - Impact Analysis(Short, Medium & Long Term Impacts)
3.3Supply Chain Analysis
3.4Porter's Five ForcesSuppliers & Buyers' Bargaining Power, Threat of Substitution & New Market Entrants, Competitive Rivalry
Chapter 4

Pralsetinib Market Size, Opportunities & Strategic Insights, by Therapeutic Application

4.1Non-Small Cell Lung Cancer
4.2Thyroid Cancer
4.3Other Cancers
Chapter 5

Pralsetinib Market Size, Opportunities & Strategic Insights, by Target Population

5.1Geriatric Patients
5.2Adult Patients
5.3Pediatric Patients
Chapter 6

Pralsetinib Market Size, Opportunities & Strategic Insights, by Dosage Forms

6.1Oral Tablets
6.2Injectable
Chapter 7

Pralsetinib Market Size, Opportunities & Strategic Insights, by Distribution Channels

7.1Hospital Pharmacies
7.2Retail Pharmacies
7.3Online Pharmacies
Chapter 8

Pralsetinib Market, by Region

8.1North America Pralsetinib Market Size, Opportunities, Key Trends & Strategic Insights
8.1.1U.S.
8.1.2Canada
8.2Europe Pralsetinib Market Size, Opportunities, Key Trends & Strategic Insights
8.2.1Germany
8.2.2France
8.2.3UK
8.2.4Italy
8.2.5The Netherlands
8.2.6Rest of EU
8.3Asia Pacific Pralsetinib Market Size, Opportunities, Key Trends & Strategic Insights
8.3.1China
8.3.2Japan
8.3.3South Korea
8.3.4India
8.3.5Australia
8.3.6Thailand
8.3.7Rest of APAC
8.4Middle East & Africa Pralsetinib Market Size, Opportunities, Key Trends & Strategic Insights
8.4.1Saudi Arabia
8.4.2United Arab Emirates
8.4.3South Africa
8.4.4Rest of MEA
8.5Latin America Pralsetinib Market Size, Opportunities, Key Trends & Strategic Insights
8.5.1Brazil
8.5.2Mexico
8.5.3Rest of LA
8.6CIS Pralsetinib Market Size, Opportunities, Key Trends & Strategic Insights
8.6.1Russia
8.6.2Rest of CIS
Chapter 9

Competitive Landscape

9.1Competitive Dashboard & Market Share Analysis
9.2Company Profiles (Overview, Financials, Developments, SWOT)
9.2.1Blueprint Medicines
9.2.2Genentech Inc
9.2.3Roche Holding AG
9.2.4Sanofi S.A.
9.2.5Novartis AG
9.2.6Pfizer Inc.
9.2.7Eli Lilly and Company
9.2.8GlaxoSmithKline plc
9.2.9AstraZeneca plc
9.2.10Johnson & Johnson Services Inc.
9.2.11Merck & Co. Inc.
9.2.12Bristol-Myers Squibb Company