Global Darolutamide API Market Size, Share, Growth, Trends, and Global Industry Analysis: By Dose Type, and Region Forecast 2020-2031

Global Darolutamide API Market Size, Share, Growth, Trends, and Global Industry Analysis: Size, Share, Growth, Trends, and Global Industry Analysis By Dose Type (300 Mg), and Region Forecast 2020-2031

Darolutamide API Market size was valued at US$ 1,568.9 million in 2024 and is projected to reach US$ 1,740.3 million by 2031, growing at a CAGR of 1.5% from 2025-2031. In terms of units sold 28.0 million units of Darolutamide tablet, and 8,405.9 Kg of API is produced in 2024. Moreover, in the USA, the Darolutamide API Market size was valued at US$ 947.5 million in 2024 and is projected to reach US$ 1,419.2 million by 2037, growing at a CAGR of 2% from 2025 to 2037. 9.8 million units of Darolutamide tablets are sold, and 2,952.8 Kg of API is produced in 2024.

The Darolutamide API market is growing as a result of the growing incidence of prostate cancer, rising need for sophisticated androgen receptor inhibitors, and increased demand for cost-saving treatments. Rising demand owing to the growth of drug manufacturing plants, particularly in developing economies, increases the availability of Darolutamide API.

Additionally, the government favors generic approval, allowing quicker market penetration. Yet the complexity of synthesis, stringent regulatory compliance requirements, and competition from established androgen receptor antagonists Enzalutamide and Apalutamide pose growth barriers. Despite these challenges, growth opportunities arise through contract manufacturing, strategic API supply arrangements, and formulation development for greater bioavailability and patient compliance. In addition, highlighting the use of sustainable production methods and compliance with Good Manufacturing Practices (GMP) also goes the extra mile in defining the market towards Darolutamide API as a necessary compound in the new prostate cancer treatment regimen.

Key Players

The global Darolutamide API Market share includes several key companies, such as MSN Laboratories Limited, Hetero Drugs Limited, BDR Pharmaceuticals International Pvt. Ltd., Sun Pharma, Zydus Lifesciences, Glenmark Pharmaceuticals, Alembic Pharmaceuticals Ltd, Lupin, Actavis (Watson Pharmaceuticals), Teva Pharmaceutical Industries Ltd., and others.

Key Takeaways

In 2021, 1,840.2 kgs of Darolutamide was consumed globally. The consumption of Darolutamide expected to grow at 11.5% CAGR over the forecast years to reach 31,798.5 Kgs by 2037. Indication expansion for darolutamide for certain types of prostate cancers is a key factor surge the growth of market over the forecast years.

The market value of darolutamide tablets was US$ 321.1 million in 2021 and it has grown at 70% CAGR over the historic years (2021-2024) to reach US$ 1,568.9 Mn in 2024 and the market is expected to grow at 1.5% CAGR over the forecast years to reach US$ 2,214.0 Mn by 2037

In terms of units sold, around 6.1 million units of darolutamide tablets were purchased worldwide in 2021. Interestingly, the volume is expected to increase significantly to reach 106.0 million units by 2037.

Key Developments

  • January 2025: Bayer submitted an application to China’s NMPA for darolutamide (NUBEQA) in metastatic hormone-sensitive prostate cancer (mHSPC) based on Phase III ARANOTE trial results. Approval could expand treatment options, delay disease progression, and boost Bayer’s revenue amid rising prostate cancer incidence and awareness in China.
  • October 2024: Bayer submitted an application to the EMA for darolutamide (NUBEQA) in metastatic hormone-sensitive prostate cancer (mHSPC) based on Phase III ARANOTE trial results. Approval could expand treatment options, delay disease progression, and boost Bayer’s revenue amid rising prostate cancer incidence and aging populations in Europe.
  • September 2024: Bayer submitted an sNDA to the FDA for darolutamide (NUBEQA) in metastatic hormone-sensitive prostate cancer (mHSPC) based on Phase III ARANOTE trial results. Approval could expand treatment options, delay disease progression, and drive Bayer’s revenue growth amid rising prostate cancer incidence and an aging population in the U.S.

Darolutamide API Market Segmentation

Based on the Dose type:

  • 300 mg

Darolutamide API Market Summary

Study Period

2025-2031

Base Year

2024

CAGR

1.5%

Largest Market

Europe

Fastest Growing Market

Latin America

Darolutamide API Market Dynamics

Drivers

One of the most important driver for the increase in the market is the increasing prevalence of prostate cancer. Prostate cancer accounted for over 1.4 million new cases in 2023 globally, and nearly all of them were reported in high-income economies. Overall, prostate cancer trends will rise at a growing pace by 2040, and thus, therapeutic routines need to be effective. Darolutamide API, an androgen receptor inhibitor (ARi), is among the most sought-after active pharmaceutical ingredients employed in prostate cancer therapy based on its property in inhibiting the activity of androgens and suppressing tumor development. Pharmaceutical manufacture, regulatory compliance, and cost-effective production procedures fuel market growth.

In addition, a focus on GMP adherence and sustainable API manufacturing fuels market growth. Since the prevalence of prostate cancer is rising all over the world, the demand for Darolutamide API will also be increasing, representing the demand for effective yet affordable treatment.

Restraints

The market is also governed by several limitations that hinder extensive usage and growth. The cost of API manufacturing is among the principal constraints that limit the availability of therapy using Darolutamide in low-resource health centers. Apart from that, even though Darolutamide is a very potent prostate cancer drug, its dose comes with adverse effects such as fatigue, hypertension, and musculoskeletal pain that could result in patient noncompliance, dose reduction, or treatment delay, compromising the general effectiveness of the treatment.

Additional androgen receptor antagonist competition by Enzalutamide and Apalutamide is also a concern, as these mature drugs are readily available everywhere and at relatively low prices. Also, harsh regulatory conditions for manufacturing and approval of APIs are an entry barrier, particularly in high-compliance countries. Potential future opportunities of drug resistance also deter Darolutamide from thriving in the market in the long run, thereby restricting its growth prospects.

Opportunities

The market provides enormous opportunities both in terms of growth and innovation in expanded therapeutic applications, combination therapies, and new markets. Primarily sold for prostate cancer treatment, further research into its effectiveness as a treatment for earlier-stage prostate cancer or other androgen-mediated illnesses could open up more significant regulatory approval and increase market visibility. Moreover, combination therapy development is on the skyline, with pharmaceutical firms looking at synergistic combinations with chemotherapy or novel androgen receptor antagonists to further increase effectiveness and increase patient lifespan. Emerging Asia-Pacific and Latin American economies offer untapped growth potential grounded in increased investment in healthcare, improved cancer diagnosis, and improved patient access to novel treatments.

Additional API capacity in these economies would increase affordability and improve supply chain efficiencies. Furthermore, strategic alliances, contract manufacturing, and cost-reduction strategies—like tiered pricing plans and patient support programs—can drive market penetration to make Darolutamide-based therapies more readily available globally.

Trends

Darolutamide API operations are also experiencing paradigm-shifting advancements in precision oncology, ongoing research, and convergence of digital health. Precision-based therapy targets gene markers and biomarkers to speed up the use of Darolutamide in a manner that can sidestep side effects and improve its efficacy against prostate cancer. Precision-based therapy maximizes treatment impacts and broadens its clinical applications. The second trend of high importance is expansion in clinical trials for Darolutamide's evaluation of its future use in other indications and as a combination with other drugs. Pharmaceutical firms and research centers are investigating its future use outside prostate cancer, possibly to longer approval by regulatory authorities and wider market uptake. Lastly, digital health technology is revolutionizing cancer care in oncology. Artificial intelligence-enabled analytics, telemedicine, and remote monitoring facilitate the real-time monitoring of patient response to treatment, dosing, and adherence. These tools enhance patient activation and clinician support, promoting greater adoption of Darolutamide within the future prostate cancer treatment landscape.

Darolutamide API Market Segmentation Analysis

Report Benchmarks

Details

Report Study Period

2025-2031

Market Size in 2024

US$ 1,568.9 million

Market Size in 2031

US$ 1,740.3 million

Market CAGR

1.5%

By Dosage type

  • 300 mg

By Region

  • North America (U.S., Canada)
  • Europe (Germany, U.K., France, Italy, Russia, Spain, Rest of Europe)
  • Asia-Pacific (China, India, Japan, Australia, Southeast Asia, Rest of Asia Pacific)
  • Latin America (Mexico, Brazil, Argentina, Columbia, Rest of Latin America)
  • Middle East & Africa (GCC, Egypt, Nigeria, South Africa, Rest of Middle East and Africa)

Analyst Review

The market is experiencing steady growth, driven by the rising prevalence of prostate cancer, increasing adoption of advanced androgen receptor inhibitors, and expanding API production capabilities. The global market, valued at USD 1,568.9 million in 2024, is projected to reach USD 2,214.0 million by 2037, growing at a CAGR of 1.5% during the forecast period. The U.S. market, holding a significant share, is anticipated to expand at a 2% CAGR, reflecting the rising demand for innovative prostate cancer treatments. Despite competition from Enzalutamide and Apalutamide, Darolutamide’s improved safety profile and efficacy continue to drive market penetration. Key factors influencing growth include increasing regulatory approvals, contract manufacturing partnerships, and government support for generic drug development. However, challenges such as high manufacturing costs and stringent compliance requirements persist. Future market opportunities lie in expanded indications, combination therapies, and penetration into emerging markets, particularly in Latin America and Asia-Pacific.

Key Features of the Report

  • The darolutamide api market report provides granular level information about the market size, region market share, historic market (2020-2024), and forecast (2025-2031)
  • The report covers in-detail insights about the competitor’s overview, company share analysis, key market developments, and key strategies.
  • The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market.
  • The report tracks recent innovations, key developments, and start-up details that are actively working in the market.
  • The report provides a plethora of information about Market entry strategies, regulatory framework, and reimbursement scenarios.
  • The report analyses the impact of the socio-political environment through PESTLE Analysis and competition through Porter's Five Force Analysis.

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Frequently Asked Questions

Darolutamide api market size was valued at US$ 1,568.9 million in 2024 and is projected to reach US$ 1,740.3 million by 2031, growing at a CAGR of 1.5%.

? Rising Prevalence of Prostate Cancer
? Increasing Adoption of Androgen Receptor Inhibitors (ARIs)
? Expanding Pharmaceutical Manufacturing Capabilities

? Expansion of Clinical Trials for New Indications
? Rise in Combination Therapies
? Growth in API Manufacturing and Outsourcing

The market reports cover the Dose Type and Region.

The market size includes several companies, such as MSN Laboratories Limited, Hetero Drugs Limited, BDR Pharmaceuticals International Pvt. Ltd., Sun Pharma, Zydus Lifesciences, Glenmark Pharmaceuticals, Alembic Pharmaceuticals Ltd, Lupin, Actavis (Watson Pharmaceuticals), Teva Pharmaceutical Industries Ltd., and others.

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Author

Muni Kumar Meravath

Muni Kumar Meravath is a seasoned Healthcare Market Research Analyst with over 6 years of experience in the healthc.....

1.Executive Summary
2.Global Darolutamide API Market  Introduction 
2.1.Global Darolutamide API Market   - Taxonomy
2.2.Global Darolutamide API Market   - Definitions
2.2.1.Dosage type
2.2.2.Region
3.Global Darolutamide API Market  Dynamics
3.1. Drivers
3.2. Restraints
3.3. Opportunities/Unmet Needs of the Market
3.4. Trends
3.5. Product Landscape
3.6. New Product Launches
3.7. Impact of COVID 19 on Market
4.Global Darolutamide API Market  Analysis, 2020 - 2024 and Forecast 2025 - 2031
4.1.  Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
4.2.  Year-Over-Year (Y-o-Y) Growth Analysis (%) 
4.3.  Market Opportunity Analysis 
5.Global Darolutamide API Market   By Dosage type, 2020 - 2024 and Forecast 2025 - 2031 (Sales Value USD Million)
5.1. 300 mg
5.1.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
5.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
5.1.3. Market Opportunity Analysis 
6.Global Darolutamide API Market   By Region, 2020 - 2024 and Forecast 2025 - 2031 (Sales Value USD Million)
6.1. North America
6.1.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
6.1.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.1.3. Market Opportunity Analysis 
6.2. Europe
6.2.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
6.2.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.2.3. Market Opportunity Analysis 
6.3. Asia Pacific (APAC)
6.3.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
6.3.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.3.3. Market Opportunity Analysis 
6.4. Middle East and Africa (MEA)
6.4.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
6.4.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.4.3. Market Opportunity Analysis 
6.5. Latin America
6.5.1. Market Analysis, 2020 - 2024 and Forecast, 2025 - 2031, (Sales Value USD Million)
6.5.2. Year-Over-Year (Y-o-Y) Growth Analysis (%) and Market Share Analysis (%) 
6.5.3. Market Opportunity Analysis 
7.North America Darolutamide API Market  ,2020 - 2024 and Forecast 2025 - 2031 (Sales Value USD Million)
7.1. Dosage type Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
7.1.1.300 mg
7.2.  Country Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
7.2.1.United States of America (USA)
7.2.2.Canada
8.Europe Darolutamide API Market  ,2020 - 2024 and Forecast 2025 - 2031 (Sales Value USD Million)
8.1. Dosage type Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
8.1.1.300 mg
8.2.  Country Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
8.2.1.Germany
8.2.2.France
8.2.3.Italy
8.2.4.United Kingdom (UK)
8.2.5.Spain
9.Asia Pacific (APAC) Darolutamide API Market  ,2020 - 2024 and Forecast 2025 - 2031 (Sales Value USD Million)
9.1. Dosage type Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
9.1.1.300 mg
9.2.  Country Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
9.2.1.China
9.2.2.India
9.2.3.Australia and New Zealand (ANZ)
9.2.4.Japan
9.2.5.Rest of APAC
10.Middle East and Africa (MEA) Darolutamide API Market  ,2020 - 2024 and Forecast 2025 - 2031 (Sales Value USD Million)
10.1. Dosage type Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.1.1.300 mg
10.2.  Country Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
10.2.1.GCC Countries
10.2.2.South Africa
10.2.3.Rest of MEA
11.Latin America Darolutamide API Market  ,2020 - 2024 and Forecast 2025 - 2031 (Sales Value USD Million)
11.1. Dosage type Analysis  and Forecast  by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.1.1.300 mg
11.2.  Country Analysis 2020 - 2024 and Forecast 2025 - 2031 by Sales Value USD Million, Y-o-Y Growth (%), and Market Share (%) 
11.2.1.Brazil
11.2.2.Mexico
11.2.3.Rest of LA
12. Competition Landscape
12.1.  Market Player Profiles (Introduction, Brand/Product Sales, Financial Analysis, Product Offerings, Key Developments, Collaborations, M & A, Strategies, and SWOT Analysis) 
12.2.1.MSN Laboratories Limited
12.2.2.Hetero Drugs Limited
12.2.3.BDR Pharmaceuticals International Pvt. Ltd
12.2.4.Sun Pharma
12.2.5.Zydus Lifesciences
12.2.6.Glenmark Pharmaceuticals
12.2.7.Alembic Pharmaceuticals Ltd
12.2.8.Lupin
12.2.9.Actavis (Watson Pharmaceuticals)
12.2.10.Teva Pharmaceutical Industries Ltd.
13. Research Methodology 
14. Appendix and Abbreviations 

Key Market Players

  • MSN Laboratories Limited
  • Hetero Drugs Limited
  • BDR Pharmaceuticals International Pvt. Ltd
  • Sun Pharma
  • Zydus Lifesciences
  • Glenmark Pharmaceuticals
  • Alembic Pharmaceuticals Ltd
  • Lupin
  • Actavis (Watson Pharmaceuticals)
  • Teva Pharmaceutical Industries Ltd.

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