Introduction to Pemigatinib
Pemigatinib, marketed as Pemazyre, is a selective inhibitor of fibroblast growth factor receptors (FGFRs), particularly FGFR1, 2, and 3. It has been approved for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement, and more recently for myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement[2][3].
Market Size and Growth
The global pemigatinib market is experiencing significant growth, driven by advancements in precision medicine and targeted therapies for cancer treatment. As of 2024, the market size was valued at USD 95.11 million and is projected to reach USD 258.76 million by 2032, with a Compound Annual Growth Rate (CAGR) of 9.83% during the forecast period of 2025 to 2032[1].
Key Drivers of Market Growth
Growing Focus on Precision Medicine
The increasing incidence of cancer, particularly cholangiocarcinoma, is a major driver of the pemigatinib market. According to the World Health Organization (WHO), the number of new cancer cases is expected to rise from 18.1 million in 2018 to 29.4 million by 2040, which will boost the demand for targeted cancer therapies like pemigatinib[1].
Advancements in Companion Diagnostics
Technological advancements such as next-generation sequencing (NGS) have facilitated patient selection for pemigatinib therapy by identifying FGFR genetic alterations. This personalized approach enhances treatment outcomes and fosters research into combination therapies, improving efficacy and addressing resistance mechanisms[1].
Expanding Indications
Pemigatinib has received FDA approval for two indications: cholangiocarcinoma with FGFR2 fusion or rearrangement and MLNs with FGFR1 rearrangement. Ongoing clinical trials are exploring its effectiveness in various solid tumors, which is expected to further expand its market[2].
Regulatory Approvals and Market Access
Regulatory approvals in multiple regions have widened market access for pemigatinib. For instance, it has conditional marketing authorization from the UK's Medicines and Healthcare products Regulatory Agency (MHRA)[3].
Geographical Market Dynamics
North America
North America is expected to dominate the pemigatinib market due to the presence of major key players, a well-developed healthcare sector, and advancements in treatment options. The robust infrastructure and increasing investment in cancer therapies in this region contribute to its leading position[1].
Asia-Pacific
The Asia-Pacific region is anticipated to show significant growth in the pemigatinib market. This is driven by increasing research and development activities, rising investments in the healthcare sector, and growing government support aimed at enhancing cancer treatment options and improving patient outcomes[1].
Financial Trajectory
Cost-Effectiveness and Pricing
The cost-effectiveness of pemigatinib is a critical factor in its financial trajectory. According to the Canadian Agency for Drugs and Technologies in Health (CADTH), the incremental cost-effectiveness ratio (ICER) for pemigatinib compared to active symptom control (ASC) and mFOLFOX plus ASC is high, requiring significant price reductions to be considered cost-effective. For instance, a price reduction of 95% to 100% would be needed for pemigatinib to achieve an ICER of $50,000 per quality-adjusted life-year (QALY) gained compared to mFOLFOX and ASC[4].
Market Segmentation and Distribution
The pemigatinib market is segmented by type (4.5 mg, 9 mg, and 13.5 mg), application (cholangiocarcinoma and others), dosage (tablet and others), route of administration (oral and other), end-users (clinic, hospital, and others), and distribution channel (hospital pharmacy, retail pharmacy, and online pharmacy). This segmentation helps in targeting specific patient populations and healthcare settings, optimizing market reach and revenue[1].
Revenue Projections
The annual revenue from pemigatinib is substantial, with the 28-day cycle cost estimated at $15,499, or $202,039 annually if patients remain on therapy for a full year. This revenue is expected to grow as the market expands and more patients are treated with pemigatinib[4].
Challenges and Opportunities
High Testing Costs
The high cost of testing to identify patients eligible for pemigatinib therapy is a significant challenge. It is estimated that testing costs around $38,000 to identify a single patient, which affects the overall cost-effectiveness of the treatment[4].
Emerging Markets
Countries such as India and Brazil are investing heavily in healthcare infrastructure and oncology treatments, presenting significant opportunities for pemigatinib. These emerging markets can provide a substantial growth avenue for the drug as healthcare systems prioritize advanced therapies[1].
Adverse Events and Safety Profile
Pemigatinib is associated with various adverse events, including hyperphosphatemia, increased AST and ALT, mucositis, and stomatitis. Managing these side effects is crucial for maintaining patient compliance and overall treatment outcomes[5].
Key Takeaways
- Growing Market: The global pemigatinib market is projected to grow from USD 95.11 million in 2024 to USD 258.76 million by 2032.
- Precision Medicine: The drug's efficacy in treating FGFR-related cancers is driven by advancements in precision medicine.
- Expanding Indications: Pemigatinib has multiple approved indications and is being explored for various solid tumors.
- Geographical Dynamics: North America and Asia-Pacific are key regions driving market growth.
- Cost-Effectiveness: High testing and treatment costs pose challenges to its cost-effectiveness.
- Emerging Markets: Investments in healthcare infrastructure in emerging economies offer significant growth opportunities.
Frequently Asked Questions (FAQs)
What is pemigatinib used for?
Pemigatinib is used for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with FGFR2 fusion or rearrangement, and for myeloid/lymphoid neoplasms (MLNs) with FGFR1 rearrangement[2].
What are the common side effects of pemigatinib?
Common side effects include hyperphosphatemia, increased AST and ALT, mucositis, stomatitis, and other gastrointestinal and hematological adverse events[5].
How does pemigatinib work?
Pemigatinib works by inhibiting fibroblast growth factor receptors (FGFRs), specifically FGFR1, 2, and 3, which are involved in the growth and proliferation of cancer cells[3].
What is the projected market size of pemigatinib by 2032?
The global pemigatinib market is projected to reach USD 258.76 million by 2032, with a CAGR of 9.83% during the forecast period of 2025 to 2032[1].
Which regions are expected to dominate the pemigatinib market?
North America is expected to dominate the market due to its well-developed healthcare sector and advancements in treatment options, while the Asia-Pacific region is anticipated to show significant growth driven by increasing research and development activities[1].
Cited Sources:
- Data Bridge Market Research: Global Pemigatinib Market – Global Size, Share, and Trends Analysis Report.
- NCODA: Incyte Announces FDA Approval of Pemazyre® (pemigatinib) as the First and Only Targeted Treatment for Myeloid/Lymphoid Neoplasms (MLNs) with FGFR1 Rearrangement.
- Scottish Medicines Consortium: Pemigatinib 4.5mg, 9mg, and 13.5mg tablets (Pemazyre®).
- NCBI: Pharmacoeconomic Review - Pemigatinib (Pemazyre).
- e-CRT: Global Expanded Access Program for Pemigatinib in Patients with Cholangiocarcinoma.
