Regorafenib Market Report 2025 (Global Edition)

Global Regorafenib Market Report 2025 Market Size Split by Dosage (40 mg, 80 mg, 120 mg), by Application (Colorectal Cancer, Gastrointestinal Stromal Tumors, Hepatocellular Carcinoma, Others)

Regorafenib Market Report Description

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Impact of Tariff Trumph on Pharmaceuticals Industry

The reintroduction of tariffs under President Trump’s “Liberation Day Tariffs” in April 2025 has created significant disruption in global pharmaceutical trade. These tariffs, ranging from 10% to 46%, specifically target pharmaceutical products, APIs (active pharmaceutical ingredients), medical packaging, and machinery from key manufacturers in China and India. This has led to increased production costs, supply chain delays, and regulatory challenges for U.S.-based pharmaceutical companies.

The tariffs have particularly impacted generic drug manufacturers, who rely heavily on APIs from China and India. Biopharmaceuticals and vaccines are also feeling the pressure, with tariffs on critical materials like bioproduction media and cold-chain packaging raising costs by up to 25%. Similarly, contract manufacturing organizations (CMOs) are grappling with the need to identify new suppliers and adjust production plans to mitigate rising costs.

Foreign governments, including the European Union, have retaliated with tariffs on U.S. pharmaceutical exports, further complicating global trade. Clinical trials are also impacted, as tariffs on drugs and diagnostic kits delay trial timelines.

Market research is increasingly crucial for navigating these challenges. By providing real-time data on API pricing, supplier reliability, and tariff impact, pharmaceutical firms can make informed decisions on sourcing, compliance, and investment strategies. This data-driven approach helps mitigate risks, optimize supply chains, and identify alternative manufacturing hubs to offset tariff-related disruptions.

Overall, market research is essential for pharmaceutical companies to adapt to the new tariff landscape, enabling them to maintain competitive advantage and navigate global trade dynamics effectively.

Competitive Landscape of the Regorafenib Market

The competitive landscape of the Regorafenib market includes key pharmaceutical companies such as Bayer AG, Amgen Inc., and Teva Pharmaceutical Industries Ltd., among others, vying for market share through product innovation, strategic collaborations, and geographic expansion. Generic competition and regulatory approvals shape market dynamics, with companies focusing on enhancing the affordability, accessibility, and efficacy of Regorafenib for various cancer indications

Top Companies Market Share in Regorafenib Industry: (In no particular order of Rank)

• Bayer AG (Germany)
• Amgen Inc. (United States)
• Teva Pharmaceutical Industries Ltd. (Israel)
• Novartis International AG (Switzerland)
• Pfizer Inc. (United States)
• Merck & Co.
• Inc. (United States)
• AstraZeneca PLC (United Kingdom)
• Roche Holding AG (Switzerland)
• Takeda Pharmaceutical Company Limited (Japan)
• Bristol Myers Squibb (United States)
• Beacon Pharmaceuticals
• Drug International
• Bayer Pharmaceuticals
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*List of Second Tier Companies, List of Third Tier/ Start-up Companies (Inquire with sales executive) Request Any Company Profile for Preview Purpose OR Data Validation!

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Regional Analysis of the Regorafenib Market

Which Region Dominates the Regorafenib Market in 2024?

According to Cognitive Market Research, North America dominated the market in 2024 and accounted for around 40% of the global revenue. North America emerges as the dominant region in the Regorafenib market due to several key factors. These include an increasing incidence of cancer, particularly colorectal cancer and hepatocellular Carcinoma, for which Regorafenib is indicated. Further, advancements in precision medicine and targeted therapies have expanded the application of Regorafenib in various cancer types. The introduction of generic versions of Regorafenib also contributes to market expansion by enhancing affordability and accessibility. Overall, these factors collectively drive the growth of the North American market for Regorafenib.

Which Region is Expanding at the Fastest CAGR?

Asia-Pacific stands out as the fastest-growing region in the Regorafenib market due to several compelling reasons. Rising cancer prevalence, particularly colorectal cancer, and hepatocellular Carcinoma fuels demand for Regorafenib, approved for these indications. Moreover, improving healthcare infrastructure, increasing awareness of advanced cancer treatments, and expanding access to innovative therapies contribute to market expansion. Additionally, regulatory approvals and advancements in precision medicine drive the adoption of Regorafenib across the region. Furthermore, strategic collaborations between pharmaceutical companies and healthcare providers facilitate market penetration. Overall, these factors, coupled with the growing burden of cancer in the APAC region, drive the growth of the Regorafenib market

The current report Scope analyzes Regorafenib Market on 5 major region Split (In case you wish to acquire a specific region edition (more granular data) or any country Edition data then please write us on info@cognitivemarketresearch.com

• North America (United States, Canada, Mexico)
• Europe (United Kingdom, France, Germany, Italy, Russia, Spain, Sweden, Denmark, Netherlands, Switzerland, Belgium)
• Asia-Pacific (China, Japan, Korea, India, Australia, Philippines, Singapore, Malaysia, Thailand, Indonesia, Rest of APAC)
• South America (Brazil, Argentina, Colombia, Peru, Chile, Rest of South America)
• Middle East and Africa (Saudi Arabia, Turkey, Nigeria, UAE, Egypt, South Africa, GCC Countries, Rest of MEA)

The above graph is for illustrative purposes only.

North America Regorafenib

According to Cognitive Market Research, the global Regorafenib market size was estimated at USD 1558.5 Million, out of which North America held the major market of more than 40% of the global revenue with a market size of USD 623.40 million in 2024 and will grow at a compound annual growth rate (CAGR) of 9.2% from 2024 to 2031. In North America, the Regorafenib market exhibits a promising landscape characterized by increasing incidences of colorectal cancer and hepatocellular Carcinoma, coupled with advancements in precision medicine. Regional analysis reveals that the United States and Canada are the primary contributors to market growth, driven by factors such as favorable reimbursement policies and expanding healthcare infrastructure. Segmentation analysis further highlights the popularity of 40 mg dosage in the region, catering to effective therapy for patients with metastatic colorectal cancer and other indications. Its accessibility and established efficacy contribute to its prominence, providing clinicians with a well-established treatment option. In conclusion, North America presents a lucrative market opportunity for Regorafenib manufacturers, driven by expanding indications, personalized medicine approaches, and increasing adoption of targeted therapies.

• According to Cognitive Market Research, the US had a major share in the Regorafenib market with a market size of USD 491.86 million in 2024 and is projected to grow at a CAGR of 9.0% during the forecast period. The demand is amplified by the nation's growing demand for targeted cancer therapies and advancements in precision medicine, propelling consistent growth.
• The Canada Regorafenib market had a market share of USD 74.81 million in 2024 and is projected to grow at a CAGR of 10.0% during the forecast period. Canada's robust, increasing adoption of targeted therapies and expanding indications contribute to an increased usage of Regorafenib.
• The Mexico Regorafenib market is projected to witness growth at a CAGR of 9.7% during the forecast period, with a market size of USD 56.73 million in 2024.

Europe Regorafenib

According to Cognitive Market Research, the global Regorafenib market size was estimated at USD 1558.5 Million, out of which Europe held the market of more than 30% of the global revenue with a market size of USD 467.55 million in 2024 and will grow at a compound annual growth rate (CAGR) of 9.5% from 2024 to 2031. In Europe, the Regorafenib market presents a dynamic landscape characterized by increasing adoption of targeted therapies and precision medicine approaches. Regional analysis indicates that countries like Germany, the UK, and France are the key contributors to market growth, driven by factors such as expanding approvals for various cancer indications, including colorectal cancer and hepatocellular Carcinoma. Segmentation analysis further highlights the increasing incidences and prevalence in the region, with Colorectal Cancer being the dominant category. This segment reflects a critical component of the oncology landscape in Europe, where Regorafenib plays a pivotal role in addressing the therapeutic needs of patients. In conclusion, Europe represents a lucrative market for Regorafenib manufacturers, driven by expanding indications, personalized medicine initiatives, and increasing adoption of targeted therapies.

• The United Kingdom Regorafenib market had a market share of USD 78.55 million in 2024 and is projected to grow at a CAGR of 10.3% during the forecast period. In the UK, Regorafenib sales witness an upswing due to the nation's favorable healthcare policies and robust infrastructure.
• The France Regorafenib market is projected to grow at a CAGR of 8.7% during the forecast period, reaching a market size of USD 43.01 million in 2024.
• According to Cognitive Market Research, the Germany Regorafenib market size was valued at USD 92.57 million in 2024 and is projected to grow at a CAGR of 9.7% during the forecast period. In Germany, Regorafenib sales surged due to the nation's increasing adoption of targeted therapies and expanding indications.
• The Italy Regorafenib market is projected to grow at a CAGR of 8.9% during the forecast period, reaching a market size of USD 40.21 million in 2024.
• The Russia Regorafenib market is projected to witness growth at a CAGR of 8.5% during the forecast period with a market size of USD 72.47 million in 2024.
• The Spain Regorafenib market is projected to witness growth at a CAGR of 8.6% during the forecast period, with a market size of USD 38.34 million in 2024.
• The Luxembourg Regorafenib market is projected to witness growth at a CAGR of 9.6% during the forecast period, with a market size of USD 14.49 million in 2024.
• The Portugal Regorafenib market is projected to witness growth at a CAGR of 9.3% during the forecast period, with a market size of USD 9.82 million in 2024.
• The Greece Regorafenib market is projected to witness growth at a CAGR of 9.8% during the forecast period, with a market size of USD 5.61 million in 2024.
• Rest of Europe's Regorafenib market is projected to witness growth at a CAGR of 8.2% during the forecast period, with a market size of USD 72.47 million in 2024. 

Asia Pacific Regorafenib

According to Cognitive Market Research, the global Regorafenib market size was estimated at USD 1558.5 Million, out of which Asia Pacific held the market of around 23% of the global revenue with a market size of USD 358.46 million in 2024 and will grow at a compound annual growth rate (CAGR) of 13.0% from 2024 to 2031. In the Asia Pacific region, the Regorafenib market exhibits robust growth prospects driven by increasing healthcare infrastructure and expanding access to innovative treatments. Regional analysis indicates that countries such as China, Japan, South Korea, and India are key contributors to market expansion, with regulatory approvals and strategic collaborations facilitating penetration. Hepatocellular Carcinoma segmentation analysis shows the importance of this segment for Regorafenib. Its approval and utilization as a treatment option for advanced HCC contribute to its prominence in the oncology landscape, addressing the therapeutic needs of patients and offering opportunities for improved outcomes in this challenging indication. In conclusion, the Asia Pacific region presents immense growth opportunities for Regorafenib manufacturers, fueled by regulatory approvals, strategic partnerships, and investment in research and development.

• According to Cognitive Market Research, the China Regorafenib market size was valued at USD 161.30 million in 2024 and is projected to grow at a CAGR of 12.5% during the forecast period—Regorafenib sales surge in China due to the nation's increasing demand for targeted cancer therapies.
• The Japan Regorafenib market is projected to witness growth at a CAGR of 11.5% during the forecast period, with a market size of USD 49.47 million in 2024.
• The India Regorafenib market had a market share of USD 43.01 million in 2024 and is projected to grow at a CAGR of 14.8% during the forecast period. The demand is augmented by India's rising cancer prevalence and improving healthcare infrastructure.
• The South Korea Regorafenib market is projected to witness growth at a CAGR of 12.1% during the forecast period with a market size of USD 35.85 million in 2024.
• The Australia Regorafenib market is projected to witness growth at a CAGR of 12.7% during the forecast period with a market size of USD 18.64 million in 2024.
• The South East Asia Regorafenib market is projected to witness growth at a CAGR of 14.0% during the forecast period, with a market size of USD 24.73 million in 2024.
• The Rest of the Asia Pacific Regorafenib market is projected to witness growth at a CAGR of 12.8% during the forecast period, with a market size of USD 25.45 million in 2024. 

South America Regorafenib

According to Cognitive Market Research, the global Regorafenib market size was estimated at USD 1558.5 Million, out of which Latin America market of more than 5% of the global revenue with a market size of USD 77.93 million in 2024 and will grow at a compound annual growth rate (CAGR) of 10.4% from 2024 to 2031. In Latin America, the Regorafenib market showcases promising growth prospects driven by factors such as rising cancer incidence rates, particularly in colorectal cancer and hepatocellular Carcinoma. Regional analysis indicates that countries like Brazil, Mexico, Argentina, and Chile are significant contributors to market growth. Increasing access to innovative treatments, regulatory approvals, and strategic collaborations further fuel market expansion across the region. Colorectal cancer segmentation analysis reveals a diverse range of applications for Regorafenib in Latin America, driven by increasing incidence rates and the need for effective treatment options. In conclusion, Latin America presents significant growth opportunities for Regorafenib manufacturers, driven by the increasing adoption of precision medicine approaches and investment in research and development.

• According to Cognitive Market Research, the Brazil Regorafenib market size was valued at USD 33.35 million in 2024 and is projected to grow at a CAGR of 11.0% during the forecast period. Regorafenib sales flourish in Brazil due to the nation's favorable healthcare policies and improving healthcare infrastructure.
• The Argentina Regorafenib market had a market share of USD 13.09 million in 2024 and is projected to grow at a CAGR of 11.3% during the forecast period. The demand is augmented by Argentina's opportunities for pharmaceutical companies to address unmet medical needs and enhance cancer care.
• The Colombia Regorafenib market is projected to witness growth at a CAGR of 10.2% during the forecast period, with a market size of USD 6.94 million in 2024.
• The Peru Regorafenib market is projected to witness growth at a CAGR of 10.6% during the forecast period, with a market size of USD 6.39 million in 2024.
• The Chile Regorafenib market is projected to witness growth at a CAGR of 10.7% during the forecast period, with a market size of USD 5.61 million in 2024.
• The Rest of the Latin America Regorafenib market is projected to witness growth at a CAGR of 9.5% during the forecast period, with a market size of USD 12.55 million in 2024. 

Middle East Regorafenib

According to Cognitive Market Research, the global Regorafenib market size was estimated at USD 1558.5 Million, out of which Middle East and Africa held the major market of around 2% of the global revenue with a market size of USD 31.17 million in 2024 and will grow at a compound annual growth rate (CAGR) of 10.7% from 2024 to 2031. MEA, the Regorafenib market, showcases promising growth prospects driven by factors such as Expanding indications, increasing access to innovative treatments, and improving healthcare infrastructure. Regulatory approvals and strategic collaborations further enhance market potential. 80 mg dose plays a crucial role in delivering effective therapy for patients with advanced malignancies. Its accessibility and established efficacy contribute to its prominence, providing clinicians with a valuable treatment option in the management of cancer. In conclusion, MEA presents significant growth opportunities for Regorafenib manufacturers, driven by rising cancer prevalence, increasing adoption of precision medicine approaches, and opportunities for pharmaceutical companies to address unmet medical needs.

• The GCC Countries Regorafenib market is projected to witness growth at a CAGR of 11.5% during the forecast period, with a market size of USD 13.34 million in 2024. Regorafenib sales flourish due to the region's increasing cancer incidence rates.
• The Egypt Regorafenib market is projected to witness growth at a CAGR of 11.0% during the forecast period, with a market size of USD 3.27 million in 2024.
• The South Africa Regorafenib market is projected to witness growth at a CAGR of 11.7% during the forecast period with a market size of USD 4.92 million in 2024. Regorafenib sales flourish in the South Africa due to the region's access to innovative treatments, and improving healthcare infrastructure.
• The Turkey Regorafenib market is projected to witness growth at a CAGR of 10.2% during the forecast period, with a market size of USD 2.68 million in 2024.
• The Nigeria Regorafenib market is projected to witness growth at a CAGR of 9.8% during the forecast period, with a market size of USD 3.27 million in 2024.
• The Rest of MEA Regorafenib market is projected to witness growth at a CAGR of 9.7% during the forecast period with a market size of USD 3.68 million in 2024. 

Regorafenib Market Analysis

Regorafenib Market Dosage Segment Analysis

According to Cognitive Market Research, 40 mg stands out as the dominating category. While the standard starting dose is 160 mg, lower doses may be prescribed for patients with specific needs or those experiencing intolerable side effects. This segment's growth is fueled by increasing recognition of personalized medicine, where dosage adjustments optimize treatment outcomes while minimizing adverse effects. Additionally, ongoing research and clinical trials exploring the efficacy of lower doses contribute to heightened interest and adoption. As healthcare providers tailor treatments to individual patient needs, the demand for a 40 mg dosage of Regorafenib continues to expand, driving segment growth.

80 mg emerges as the fastest-growing category in the Regorafenib market. As clinicians strive to balance efficacy and tolerability, the 80 mg dosage provides a crucial midpoint between the standard 160 mg dose and lower doses for patients with reduced tolerance. This dosage adjustment allows for better management of adverse effects while maintaining therapeutic benefits. Moreover, emerging clinical data and real-world evidence supporting the effectiveness of the 80 mg dose contribute to its increasing adoption. As healthcare providers seek optimized treatment regimens, the 80 mg segment of Regorafenib stands out as the fastest-growing, meeting the demand for tailored therapy approaches.

• 40 mg 
• 80 mg 
• 120 mg

The above Chart is for representative purposes and does not depict actual sale statistics. Access/Request the quantitative data to understand the trends and dominating segment of Regorafenib Industry. Request a Free Sample PDF!

Regorafenib Market Application Segment Analysis

According to Cognitive Market Research, the dominating category is colorectal cancer (CRC). Its prevalence and the approval of Regorafenib as a treatment option post-progression on standard therapies have solidified its position. Widely used for metastatic CRC, Regorafenib addresses a critical need in this indication, contributing significantly to its market share. With CRC being one of the most common cancers globally, the demand for effective therapies like Regorafenib remains high. As a result, CRC continues to drive the market for Regorafenib, underscoring its importance in the treatment landscape for this prevalent and challenging malignancy.

The fastest-growing category in the Regorafenib market is hepatocellular Carcinoma. With rising global incidence rates and the approval of Regorafenib for HCC treatment in certain regions, its market share in this indication is rapidly expanding. HCC, a primary liver cancer, poses a significant health burden worldwide, particularly in regions with high rates of chronic liver disease. Regorafenib's efficacy in HCC offers a promising therapeutic option where few effective treatments exist, driving its accelerated adoption. As awareness increases and regulatory approvals extend, HCC is poised to become a key growth driver for Regorafenib, shaping its market trajectory.

• Colorectal Cancer 
• Gastrointestinal Stromal Tumors 
• Hepatocellular Carcinoma 
• Others

The above Graph is for representation purposes only. This chart does not depict actual Market share.

Author's Detail

Manjiri Kanhere

Senior Research Associate at Cognitive Market Research

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Manjiri Kanhere is an experienced market researcher focused on the Pharma & Healthcare industry. With over 3+ years of experience, She has worked with major pharmaceutical companies and healthcare providers, helping them to understand market trends, identify new business opportunities, and develop effective sales & marketing strategies. Her expertise lies in the ability to analyze complex data sets and deliver insights that drive business decisions. At Cognitive Market Research, she handles the market research related to Pharma and healthcare industry.

Author's Conclusion