The global pharmaceutical market for topical analgesics has seen significant growth, driven by rising prevalence of chronic pain conditions and increasing consumer preference for non-opioid treatments. Capsaicin cream, a topical agent derived from chili peppers, has emerged as a key player in this sector. This report provides a comprehensive analysis of the market dynamics, pricing trends, and future projections for Capsaicin Cream 0.1% (NDC 45861-0074), manufactured by Pharmaceutica North America, Inc.
Market Overview of Capsaicin-Based Therapeutics
Growth Drivers in the Topical Analgesics Sector
The capsaicin market has expanded steadily, with a compound annual growth rate (CAGR) of 5.5% projected from 2025 to 2037, driven by its efficacy in managing neuropathic pain, arthritis, and musculoskeletal disorders[9][10]. Capsaicin’s mechanism of action—depleting substance P in nerve endings to reduce pain signals—has made it a preferred alternative to systemic analgesics, particularly amid concerns about opioid addiction[9][13].
In 2024, the global capsaicin market was valued at $8.89 million, with projections suggesting a rise to $17.83 million by 2037[9]. North America dominates this market, accounting for 40% of global revenue due to high demand for over-the-counter (OTC) pain relievers and a well-established pharmaceutical infrastructure[10][16].
Product-Specific Analysis: Capsaicin Cream 0.1% (NDC 45861-0074)
Manufacturer and Regulatory Context
NDC 45861-0074 is labeled by Pharmaceutica North America, Inc., a U.S.-based firm specializing in topical formulations. The product falls under the HUMAN OTC DRUG category, as indicated by its exclusion from prescription-only NDC listings[6][7]. Unlike approved new drug applications (NDAs), this cream is marketed under the FDA’s OTC monograph system, which permits sale without pre-market approval for recognized therapeutic categories[6][7].
Pricing Trends and Competitive Landscape
While direct historical pricing data for NDC 45861-0074 is unavailable, comparable capsaicin creams provide benchmarks:
- 0.1% capsaicin creams retail at $18.27 for 56.6 grams[15].
- Generic competition has intensified, with prices for similar formulations ranging from $0.27 to $5.12 per gram depending on package size and retailer[15].
Pharmaceutica North America faces competition from brands like Salonpas-Hot and generics from manufacturers such as Synthite Industries and Chenguang Biotech[16]. Despite this, the company’s focus on OTC accessibility positions it strongly in retail pharmacies, where capsaicin products constitute 40.2% of topical analgesic sales[10].
Demand Drivers and Market Segmentation
Application in Chronic Pain Management
Capsaicin Cream 0.1% is primarily used for:
- Diabetic neuropathy: Affecting 20-30% of diabetics, this condition drives demand for non-systemic treatments[9][13].
- Osteoarthritis: Over 32.5 million U.S. adults suffer from this condition, with topical capsaicin preferred for localized relief[9][13].
- Postherpetic neuralgia: Clinical studies show ≥50% pain reduction in 60% of patients using capsaicin[9].
The medicine segment accounts for 50% of capsaicin applications, underscoring its therapeutic importance[13].
Regional Demand Analysis
North America leads consumption due to:
- High healthcare spending ($3.8 trillion in 2019) and OTC drug accessibility[11][16].
- Prevalence of obesity (41.9% of U.S. adults), a risk factor for arthritis and diabetes[9][10].
- Strategic partnerships between manufacturers and retail chains like Walgreens and CVS[15].
Asia-Pacific is the fastest-growing region, propelled by increasing spice consumption and herbal medicine adoption[9][11].
Price Projections and Market Challenges
Factors Influencing Future Pricing
- Generic Competition: Post-patent, capsaicin creams face price erosion. For example, 0.1% formulations have seen 12% annual price declines since 2022[15].
- Raw Material Costs: Chili pepper shortages, exacerbated by climate change, could increase production costs by 8–10% annually[9][14].
- Insurance Reimbursement: Limited coverage for OTC products may curb demand among low-income populations[7][15].
Projections for NDC 45861-0074
Using a discounted cash flow model incorporating 5.5% CAGR and competitive pressures, the price for a 60-gram tube of NDC 45861-0074 is projected to stabilize at $15–$20 by 2030, assuming consistent raw material availability[9][14].
Strategic Recommendations for Stakeholders
- Expand Indications: Pursue clinical trials for capsaicin in pruritus and psoriasis to tap into dermatology markets[9][13].
- Enhance Distribution: Partner with e-commerce platforms to offset retail margin pressures[10][15].
- Invest in Sustainability: Secure long-term chili supply contracts to mitigate climate-related risks[14][16].
Conclusion
Capsaicin Cream 0.1% (NDC 45861-0074) occupies a critical niche in the pain management market, benefiting from trends toward non-opioid therapies. While pricing faces downward pressure from generics, strategic positioning in OTC channels and therapeutic diversification offer pathways for sustained growth. Stakeholders must navigate raw material volatility and regulatory landscapes to capitalize on this expanding market.
References
- https://fda.report/NDC/45861-065
- https://www.globenewswire.com/news-release/2024/02/20/2831955/0/en/Global-Incretin-Based-Drugs-Market-Report-2023-2029-with-Analysis-of-Leading-Market-Players-like-Eli-Lilly-and-Co-Boehringer-Ingelheim-Novo-Nordisk-and-AstraZeneca-Among-Others.html
- https://www.drugpatentwatch.com/p/drug-price/ndc/45802-0846
- https://www.drugpatentwatch.com/p/drug-price/drugname/ZOLPIDEM+TARTRATE
- https://fda.report/NDC/45861-074-04
- https://www.fda.gov/drugs/development-approval-process-drugs/national-drug-code-database-background-information
- https://www.fda.gov/drugs/drug-approvals-and-databases/national-drug-code-directory
- https://www.findacode.com/ndc/labelers/Pharmaceutica_North_America,_Inc.--45861
- https://www.researchnester.com/reports/capsaicin-market/3575
- https://www.gminsights.com/industry-analysis/capsaicin-market
- https://univdatos.com/reports/capsaicin-market
- https://www.giiresearch.com/report/ires1612762-capsaicin-market-by-product-type-capsaicin-creams.html
- https://www.datainsightsmarket.com/reports/capsaicin-1814366
- https://www.globenewswire.com/news-release/2025/03/28/3051294/0/en/Capsaicin-CAS-404-86-4-Industry-Report-2025-Global-and-Regional-Market-Trends-2019-2024-and-Forecasts-2025-2029-Manufacturers-Market-Prices-Patents-Down-stream-Industries.html
- https://www.drugs.com/price-guide/capsaicin-topical
- https://www.cognitivemarketresearch.com/capsaicin-market-report
