What is Docetaxel used for?

Docetaxel is a chemotherapy medication used for treating various cancers including breast, lung, and prostate cancer.

Where can I buy bulk Docetaxel?

Shaanxi Zhonghong Investment Technology Co., Ltd. supplies GMP-grade Docetaxel in bulk for pharmaceutical manufacturing.

How is Docetaxel priced in 2025?

Pricing depends on factors like raw material costs, production scale, and regulatory compliance. Our detailed analysis provides insights into cost drivers and market trends.

Docetaxel—one of the world’s most widely used taxane APIs—continues to be a strategic oncology ingredient for injectable formulations, nano-drug delivery systems, and global generic markets. As we enter 2025, Docetaxel pricing shows noticeable fluctuations driven by upstream raw materials, global supply shifts, regulatory tightening, and freight volatility.

This article provides an in-depth, industry-grade analysis of the 2025 pricing structure, cost drivers, production considerations, quality parameters, and purchasing strategies for international B2B buyers. Content is based on real GMP-grade manufacturing experience, validated specifications, and regulatory references.

1. Global Docetaxel Market Overview in 2025

The global Docetaxel API market remains moderately tight in supply due to:

Limited availability of 10-Deacetylbaccatin III (10-DAB), the essential taxane precursor
Higher compliance and GMP costs for sterile oncology production
Increased demand from injectable formulation manufacturers in India, EU, LATAM, and Southeast Asia
Regulatory pressures from EMA/FDA requiring stronger impurity control

Market pricing in Q1-2025 has stabilized but remains slightly higher than pre-2023 levels.

2. Key Cost Drivers Affecting Docetaxel Pricing

2.1 Raw Material Costs: 10-DAB as the Primary Price Driver

10-Deacetylbaccatin III accounts for 35–45% of total manufacturing cost.
2025 considerations:

Yew-derived 10-DAB remains supply-constrained
Seasonal harvest cycles impact availability
Suppliers face stricter pesticide residue and heavy metal requirements
Semi-purified 10-DAB needs chromatographic purification, increasing cost

Raw material parameters buyers should check:

Purity: ≥95% (HPLC)
Moisture: <2%
Residual solvents: methanol / acetone under ICH Q3C limits
Pesticide residues: meet USP <561>

2.2 Semi-Synthetic Production Complexity

Docetaxel is produced via a multi-step semi-synthetic process requiring:

Side-chain synthesis
Esterification
Deprotection
Purification and crystallization
Microbial & environmental control via GMP

This adds labor, time, and solvent-usage cost—particularly for GMP-grade Docetaxel used in injectables.

2.3 GMP / Compliance Cost in 2025

Regulatory tightening in 2024–2025 increased API manufacturers’ burden:

Higher cost of environmental controls
Stricter nitrosamine risk assessments
More frequent impurity profiling
Certification renewals (ISO, GMP)
Quality audits for injectable-grade APIs

These compliance-related expenses typically account for 20–30% of manufacturing cost.

2.4 Energy & Solvent Recovery Costs

Taxane purification consumes large volumes of solvents:

Dichloromethane
Methanol
n-Hexane
Ethyl acetate

Solvent recovery systems require high electricity and maintenance, creating cost fluctuations with global energy prices.

2.5 Logistics & Trade Policy Factors

Freight costs are still higher than pre-pandemic levels:

DG-class chemical handling requirements
Cold-chain needs for some formulations
Export restrictions for taxane intermediates
Higher customs compliance cost

3. Average Docetaxel API Pricing in 2025

(Reference range, not a public quotation)

Docetaxel 99% API (GMP Grade): USD 11,500 – 16,000/kg
Docetaxel 99% API (Non-GMP / R&D Grade): USD 7,800 – 10,500/kg
High-purity Injectable Grade (Low Impurity B): USD 16,000 – 19,000/kg

Prices vary by region, batch size, and compliance requirements (GMP, CEP, DMF).

To check detailed batch parameters, buyers can refer to the Docetaxel COA and specifications available through our product page:
👉 https://aiherba.com/docetaxel/

4. Quality Standards That Influence Price

4.1 Pharmacopoeial Standards (USP / EP / ChP)

Docetaxel 99% API must meet:

HPLC purity ≥99%
Impurities: below EP/USP limits
Residual solvents per ICH Q3C
Heavy metals ≤10 ppm
Pesticide residues per USP <561>
Microbial limits for non-sterile APIs

4.2 Critical Parameters Buyers Should Verify

Category	Specification	Why It Impacts Price
Purity (HPLC)	≥99%	Higher purity = higher processing cost
Impurity B	≤0.5%	A key regulatory-controlled taxane impurity
Residual Solvents	Within ICH limits	Impacts safety for injectable use
Particle Size	D90 < 20 μm	Critical for injectable formulations
DAB Origin	Botanical / Semi-purified	Directly affects upstream cost
Microbial Load	<1000 CFU/g	Required for GMP-grade API

5. Market Supply Outlook for 2025–2026

5.1 Supply Is Tight but Stable

2025 supply improved compared with 2023–2024 disruptions, but major constraints remain:

Limited number of GMP-certified Docetaxel API manufacturers
Environmental controls limiting taxane intermediate production
High R&D demand from nanomedicine & polymer-conjugate research
Regulatory tightening on Chinese export pipelines

5.2 Regional Supply Insights

China: World’s largest producer; strong semi-synthetic capability
India: Strong demand for formulation manufacturing
EU: Regulatory-driven demand for low-impurity material
LATAM: Growing oncology generic market

6. Purchasing Strategy for B2B Buyers

6.1 Verify GMP Compliance & Regulatory Documentation

Essential documents:

GMP certificate
ISO9001 / ISO14001
DMF (open/closed)
Impurity profile
Stability study
HPLC chromatogram
Microbial & heavy metal report

6.2 Choose Suppliers with Real Manufacturing Capability

A qualified bulk Docetaxel supplier should:

Control 10-DAB sourcing
Operate GMP-grade extraction & purification lines
Provide annual production capacity >500 kg
Provide production batch photos / facility tour
Offer real COA with batch traceability

6.3 Long-Term Contracting Strategy

Because 10-DAB is seasonal, buyers can reduce cost by:

Signing 6–12 month supply contracts
Booking material during low-price seasons
Planning inventory for oncology production cycles

6.4 Check Real-World Experience & Case Studies

Manufacturers with 10+ years experience usually provide:

Smoother audits
Higher batch consistency
Better impurity control
Faster document support for FDA/EMA filings

As a supplier with long-term production experience, we offer consistent batches of GMP-grade Docetaxel 99% API with validated impurity and residual-solvent profiles:
👉 https://aiherba.com/docetaxel/

7. Sample COA Overview (Key Parameters)

Category	Test Item	Specification	Method
Assay	Docetaxel	≥99.0%	HPLC
Impurity B	≤0.5%	HPLC
Heavy Metals	Pb ≤10 ppm	ICP-MS
Residual Solvents	DCM ≤600 ppm	GC
Pesticide Residues	USP <561> compliant	GC-MS
Microbial Limits	<1000 CFU/g	Plate Count

8. FAQ: Docetaxel Purchasing & Pricing (2025 Edition)

1. What is the biggest factor influencing Docetaxel API price?

10-DAB raw material availability and purity.

2. Why do GMP-grade batches cost significantly more?

Higher purification requirements, environmental controls, and injectable-grade impurity limits.

3. How can I confirm Docetaxel purity claims?

Request full Docetaxel COA and specifications including HPLC chromatograms.

4. What’s the typical MOQ for Docetaxel 99% API?

Usually 100–500 g, depending on batch availability.

5. Do you provide sample material for formulation R&D?

Yes—small R&D samples are available upon request.

6. How should Docetaxel be stored?

Store below 8°C, in a light-resistant, airtight container.

7. Which pharmacopoeia standards are commonly followed?

USP, EP, ChP—depending on market destination.

8. How do energy prices affect the API price?

Solvent recovery is energy-intensive; electricity cost directly affects processing cost.

9. Can I request a GMP audit before purchase?

Yes—third-party and customer audits are supported.

10. Do you offer long-term supply agreements?

Yes—recommended for cost stabilization and priority allocation.

9. References (PubMed, FDA, NIH, Pharmacopoeia)

PubMed – Docetaxel mechanisms: https://pubmed.ncbi.nlm.nih.gov/
FDA Orange Book: https://www.accessdata.fda.gov/scripts/cder/ob/
NIH ChemIDplus: https://chem.nlm.nih.gov/chemidplus/
USP: https://www.uspnf.com/
EMA Guidelines on API impurities: https://www.ema.europa.eu/