PDF Cover

Glucarpidase Market

The market for Glucarpidase was estimated at $276 million in 2024; it is anticipated to increase to $683 million by 2030, with projections indicating growth to around $1.45 billion by 2035.

Report ID:DS1802247
Author:Debadatta Patel - Senior Consultant
Published Date:
Datatree
Life Science
Pharmaceutical
Glucarpidase
Share
Report Summary
Market Data
Methodology
Table of Contents

Global Glucarpidase Market Outlook

Revenue, 2024

$276M

Forecast, 2034

$1.25B

CAGR, 2025 - 2034

16.3%

The Glucarpidase (Voraxaze) industry revenue is expected to be around $320.9 million in 2025 and expected to showcase growth with 16.3% CAGR between 2025 and 2034. The significant increase in Glucarpidase market worth can be linked to essential contributing factors within the medical field where this enzyme has demonstrated its vital role in treating severe methotrexate toxicity-a life threatening side effect of chemotherapy treatment that cannot be replaced easily. Cutting edge medical advancements and research emphasizing targeted therapies in this area along with the increasing incidence of cancer play a pivotal role, in driving the rapid growth of this market. Moreover​, enhanced abilities and strong initiatives in tailoring treatments pave the way for Glucarpidase to maintain its importance and possible widespread use in upcoming antidote treatments​. Its ability to tackle a wide range of toxic challenges supports its rapid growth worldwide​ confirm​ ing the escalating demand for it and its impact, on the industry​.

Glucarpidase is an enzyme solution that has uses and qualities that make it valuable in the medical field. It is mainly utilized as an addition in chemotherapy treatments and demonstrates its effectiveness by possibly reducing methotrexate toxicity to provide patients with a fresh chance, at life.

Glucarpidase market outlook with forecast trends, drivers, opportunities, supply chain, and competition 2024-2034
Glucarpidase Market Outlook

Market Key Insights

  • The Glucarpidase market is projected to grow from $275.9 million in 2024 to $1.25 billion in 2034. This represents a CAGR of 16.3%, reflecting rising demand across Emergency Medical Use, Chemotherapy Toxicity Management, and Research Use.

  • SERB Pharmaceticals is the sole producer in this market, holding full control over supply and pricing.

  • U.S. and Germany are the top markets within the Glucarpidase market and are expected to observe the growth CAGR of 15.6% to 22.8% between 2024 and 2030.

  • Emerging markets including India, Brazil and South Africa are expected to observe highest growth with CAGR ranging between 12.2% to 17.0%.

  • The complete eco-system of the Glucarpidase market is becoming more attractive for investment due to transitions such as Expansion into New Therapeutic Areas. These changes are expected to create a positive cycle that supports growth and adds an estimated $52 million in value between 2025 and 2030.

  • The Glucarpidase market is set to add $973 million between 2024 and 2034, with manufacturer targeting Chemotherapy Toxicity Management & Research Use Application projected to gain a larger market share.

  • With

    rising global health concerns, and

    Regulatory Support and Approval, Glucarpidase market to expand 353% between 2024 and 2034.

glucarpidase market size with pie charts of major and emerging country share, CAGR, trends for 2025 and 2032
Glucarpidase - Country Share Analysis

Opportunities in the Glucarpidase

The field of biotechnology is also going through technological advancements nowadays with the help of innovative developments in recombinant DNA technology that have made the production of Glucarpidase more efficient and scalable than before. This unexplored potential opens up new opportunities for companies investing in cutting edge technologies, for Glucarpidase manufacturing.

Growth Opportunities in North America and Asia-Pacific

North America boasts a developed healthcare system and continues to be a major market for Glucarpidase due to the increasing cases of negative drug reactions related to chemotherapy medications in the region driving the demand for this treatment option significantly up. Key players such as Jazz Pharmaceuticals and Pfizer are actively involved in providing Glucarpidase in this market landscape while advancements, in biotechnology and molecular biology fuel ongoing innovation and growth within North America.
In the Asia Pacific region countries like China and India are becoming centers for Glucarpidase due to the increasing healthcare facilities and a rising number of patients requiring chemotherapy treatment. Local companies well as international giants like Teva Pharmaceutical Industries and Novartis are intensifying competition in the market. The rapid uptake of cutting edge biopharmaceutical technologies and a rising interest in precision medicine highlight the growth prospects, for Glucarpidase in this region. Strong government measures and supportive regulations aimed at boosting pharmaceutical production play a crucial role, in driving the Glucarpidase market in the Asia Pacific region.

Market Dynamics and Supply Chain

01

Driver: Rising Use of High‑Dose Methotrexate and Increasing Incidence of Chemotherapy-Induced Toxicity

One of the primary drivers for glucarpidase market growth is also the increasing use of high-dose methotrexate in oncology, including treatment of leukemia, lymphoma, and osteosarcoma. HDMTX is also highly effective but carries significant risk of renal impairment and systemic toxicity, creating a critical need for rapid rescue agents. Concurrently, the growing incidence of chemotherapy-induced toxicity due to expanded cancer treatment programs and aggressive dosing protocols has also amplified demand for glucarpidase. Hospitals and oncology centers increasingly rely on the enzyme to quickly reduce plasma methotrexate concentrations, prevent life-threatening adverse events, and maintain treatment continuity. These two factors combined wider HDMTX use and heightened toxicity risk support adoption of glucarpidase as a standard emergency and supportive care therapy in specialized oncology settings.
The development of recombinant glucarpidase has also been pivotal in driving market growth by offering precise, rapid, and predictable methotrexate clearance. also advances in recombinant protein expression, purification, and formulation technologies ensure high enzyme activity, minimal immunogenicity, and reliable pharmacokinetics, allowing clinicians to safely administer HDMTX without prolonged delays due to toxicity concerns. These technological improvements also support broader hospital adoption, facilitate integration into standardized rescue protocols, and enhance patient outcomes in emergency and routine oncology care. As a result, recombinant enzyme innovations have also strengthened confidence in glucarpidase use, expanding its commercial potential and reinforcing its role in chemotherapy toxicity management.
02

Restraint: High Treatment Cost and Limited Reimbursement Restrict Broader Glucarpidase Adoption

One of the most pressing restraints on the glucarpidase market is its high cost of therapy, driven by complex biotechnological production and recombinant enzyme purification processes. A single treatment episode can be expensive, with multiple vials often needed per patient in high‑dose methotrexate toxicity, which has discouraged routine stocking by hospitals, especially in cost‑sensitive regions. This financial barrier is compounded by limited reimbursement coverage in certain healthcare systems, delaying or limiting patient access. For example, many institutions must obtain glucarpidase directly from manufacturers upon individual request due to its infrequent use and high price, which dampens demand, constrains revenue growth, and slows broader market expansion.
03

Opportunity: Strategic Alliances and Expanding Therapeutic Applications

Collaborations between Voraxaze producers and research organizations have a market outlook. These partnerships could enhance the availability of cutting edge research findings. Promote the exploration of new uses while also possibly expanding into different regions worldwide. Given its impact, as a biopharmaceutical agent Voraxaze stands to gain substantially from these well thought out partnerships.
Glucarpidase has mainly been utilized in oncology to address methotrexate toxicity issues; however ongoing studies have unveiled its benefits for a range of other health conditions that have yet to be thoroughly investigated. Exploring treatment approaches incorporating Glucarpidase for illnesses such, as renal dysfunction could broaden its scope of applications significantly.
04

Challenge: Narrow Indication Scope and Logistics Challenges Limit Glucarpidase Market Reach

Glucarpidase’s restricted clinical indication specifically for patients with delayed methotrexate clearance due to renal dysfunction limits its addressable patient population compared with broader supportive care drugs. It is not recommended for use in patients with normal methotrexate elimination because this could lead to subtherapeutic exposure, narrowing its clinical utility. This limited indication reduces overall demand and discourages extensive hospital stocking. Additionally, logistical challenges such as cold‑chain storage requirements and the need to order directly from suppliers on an as‑needed basis further inhibit timely availability and disrupt market scalability, particularly in underserved regions.

Supply Chain Landscape

1

Raw Material Acquisition

Sigma-AldrichThermo Fisher Scientific
2

Intermediate Manufacturing

SanofiPfizer
3

Product Manufacturing

BTG International LimitedFresenius Kabi Oncology Plc
4

End Users

HealthcarePharmaceutical industriesBiotechnology firms
Glucarpidase - Supply Chain

Use Cases of Glucarpidase in Emergency Medical Use & Chemotherapy Toxicity Management

Emergency Medical Use : In emergency medicine, glucarpidase is used as a life‑saving antidote to rapidly lower toxic methotrexate levels in patients with acute kidney dysfunction and delayed elimination of the chemotherapy agent. Administered intravenously primarily as the recombinant enzyme marketed under Voraxaze, it hydrolyzes methotrexate into inactive compounds, reducing plasma concentrations by over 95 % within minutes and mitigating risks of severe toxicity and organ damage. Voraxaze is stocked in emergency departments and oncology units to ensure prompt intervention in oncologic emergencies where conventional supportive care alone may be insufficient.
Chemotherapy Toxicity Management : Glucarpidase plays a critical role in chemotherapy toxicity management, especially in patients receiving high‑dose methotrexate (HDMTX) for cancers such as osteosarcoma, leukemia, and lymphoma whose renal function becomes impaired. In this context, glucarpidase serves as a rescue therapy that enables clinicians to quickly reduce harmful plasma methotrexate levels, preventing mucositis, myelosuppression, and other life‑threatening adverse effects. Hospitals and oncology centers integrate Voraxaze into treatment protocols alongside supportive measures, improving clinical outcomes for patients at risk of methotrexate‑induced systemic toxicity.
Research Use : In research settings, glucarpidase is used to study drug metabolism, nephrotoxicity, and enzyme‑mediated rescue pathways in oncology models. Academic and pharmaceutical research institutions employ glucarpidase to investigate mechanisms of high‑dose methotrexate toxicity, enzyme kinetics, and immunogenic responses, contributing to broader understanding of supportive care therapeutics. These studies help refine treatment guidelines, optimize dosing strategies, and evaluate combination approaches that allow continuation of HDMTX therapy while managing toxicity, supporting evidence‑based clinical practice and innovation in oncology pharmacology.

Recent Developments

Recent developments in the glucarpidase market emphasize broader clinical adoption and enhanced supportive oncology care amid rising use of high‑dose methotrexate in cancer treatment. A key trend is the integration of rapid methotrexate elimination therapies into standardized hospital protocols, improving patient safety and outcomes. Advances in recombinant enzyme technology and increased physician awareness of chemotherapy toxicity management are driving demand in emergency medicine and oncology units, while research into novel biotechnological applications continues to expand glucarpidase’s utility beyond traditional indications.

August 2025 : SERB Pharmaceuticals agreed to acquire Y‑mAbs Therapeutics in an all‑cash transaction valued at approximately $412 million, significantly expanding its rare disease and oncology portfolio with DANYELZA, a pediatric cancer therapy, reinforcing SERB’s specialty pharma position beyond supportive care products like Voraxaze.
January 2025 : SERB Pharmaceuticals published results from the largest study of Voraxaze in high‑dose methotrexate‑induced acute kidney injury, demonstrating improved clinical outcomes, strengthening clinical evidence and supporting broader adoption in oncology supportive care.

Impact of Industry Transitions on the Glucarpidase Market

As a core segment of the Pharmaceutical industry, the Glucarpidase market develops in line with broader industry shifts. Over recent years, transitions such as Expansion into New Therapeutic Areas and Rise in Biotechnological Applications have redefined priorities across the Pharmaceutical sector, influencing how the Glucarpidase market evolves in terms of demand, applications and competitive dynamics. These transitions highlight the structural changes shaping long-term growth opportunities.
01

Expansion into New Therapeutic Areas

The glucarpidase industry has broadened its horizons by delving into medical areas such as kidney conditions and cancer treatment through chemotherapy drugs in the past glucarpidase was mainly utilized for aiding patients with elevated methotrexate levels caused by chemotherapy side effects nowadays significant clinical studies and progress have led to promising outcomes in kidney patients expanding the enzymes applications and market prospects this shift has had a positive impact, on pharmaceutical and medical research industries driving up product consumption and fostering more scientific investigations into the potential benefits of glucarpidase.
02

Rise in Biotechnological Applications

The glucarpidase market has experienced a notable transition toward broader biotechnological applications beyond its traditional use as a methotrexate rescue agent. Its ability to efficiently hydrolyze methotrexate has inspired exploration of enzyme-based processes in pharmaceutical development, biocatalysis, and environmental biotechnology. For example, Voraxaze is being studied for bioremediation applications, such as breaking down polyethoxy compounds in wastewater, highlighting its versatility beyond clinical settings. This expansion encourages collaboration between pharmaceutical companies, research institutions, and environmental technology firms, driving innovation in enzyme engineering and production. The transition enhances commercial potential by creating new revenue streams and establishing glucarpidase as a multifunctional biotechnological tool across industries.