Market Size & Trends
The North American topical drug CDMO market was estimated at USD 14.73 billion in 2024 and is projected to grow at a CAGR of 10.88% from 2025 to 2030. Growing trends of outsourcing, increasing R&D investments due to the rising prevalence of various skin diseases, and expiration of existing patents are driving the topical drugs CDMO market in North America. Integration of advanced development and manufacturing technologies, cost-effectiveness, and a heightened number of CDMOs are some significant factors positively influencing market growth. In addition, CDMOs have better expertise and resources pertaining to clinical trials and offer cost-effective manufacturing compared to pharmaceutical companies. Moreover, the development of innovative drugs for a specific therapeutic application is effectively managed by CDMOs, which contributes to their demand.
Growing need for novel innovation and new product development is expected to improve demand in the North American topical drugs CDMO industry, and competitive pressure & pricing concerns are driving companies to outsource new drug development & manufacturing. We expect this to propel overall market growth. In addition, an emerging focus on developing advanced drug delivery technologies for enhanced drug stability and patient outcomes is expected to propel market growth. Moreover, technological advancements enable CDMOs to cater to diverse therapeutic needs in topical drugs. This includes treatment for various skin conditions, wound care, pain management, and dermatological disorders, accelerating market growth.
Experts predict that the increasing prevalence of skin disorders and topical ailments across North America will enhance market demand. Skin conditions such as eczema, psoriasis, acne, and dermatitis have become increasingly prevalent. In addition, environmental changes, stress, dietary patterns, and genetic predispositions are some of the factors contributing to the growing patient pool, prompting a heightened need for effective topical treatments. As per the American Academy of Dermatology Association data, acne is the most common skin disorder in the U.S., affecting over 50 million people annually. Furthermore, an estimated 9,500 individuals receive a skin cancer diagnosis daily. Hence, the surging number of skin cancer patients in the U.S. is expected to drive demand for novel therapeutics, accelerating market growth. Furthermore, according to the American Burn Association, over 500 thousand individuals have burn injuries annually in the U.S. We expect this growing patient pool with burn injuries to enhance the demand for topical drugs.
Moreover, growing consumer concern about self-care is increasing the consumption of pharmaceutical products and cosmeceuticals. The growing need for topical drugs and the rising trend for outsourcing among topical drugs promote expanding manufacturing capabilities in various locations to meet the demand. For instance, in November 2023, SOHM, Inc. introduced a new Good Manufacturing Practice (GMP) manufacturing facility in Carlsbad, California, to manufacture topical products with a capacity of 1,892 liters per day. Similarly, in April 2022, BORA Pharmaceuticals invested USD 10 million to expand its oral solid dose capabilities at its Taiwan, Zhunan, and Mississauga, Ontario facilities. BORA Pharmaceuticals planned the investment for the next two years to meet the increasing client demand.
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Market Concentration & Characteristics
The market is currently experiencing rapid growth. The North American topical drugs CDMO industry is characterized by evolving technologies, regulations, increasing product demand for cosmetic products, and increasing outsourcing of manufacturing processes to leverage cost advantages and specialized capabilities.
Drug delivery mechanisms, formulation technologies, and the creation of novel compounds continue to progress. CDMOs invest extensively in research and development (R&D) activities to enhance efficacy, safety, and patient outcomes. Their work includes exploring innovative delivery systems such as transdermal patches, microencapsulation techniques, or nanotechnology-based formulations that enable better skin penetration and controlled release of active pharmaceutical ingredients. Such advancements and innovations in CDMOs drive market growth in the region.
Stringent quality protocols and regulatory norms by the U.S. FDA and Health Canada highly impact operational capabilities in the North American market. Market participants with robust compliance measures and a track record of fulfilling regulatory standards gain credibility and preference from biopharmaceutical sponsors.
Mergers and acquisition activities in the North American market are increasing and exhibiting similar growth during the analysis timeframe. Several companies integrate advanced facilities and form strategic alliances to achieve synergies in capabilities and resources to enhance their competitiveness.
The market comprises a large number of CDMOs and small players specialized in topical drug manufacturing. Specialization in specific technologies and materials has led to a fragmented market scenario.
CDMOs are implementing geographic expansion strategies to tap into new markets to establish a stronger presence in key countries within North America. Companies that effectively tailor their services to regional needs and regulatory nuances gain a competitive edge in the North American topical drugs CDMO industry.
Product Insights
The semi-solid formulations segment led the market with a revenue share of 66.47% in 2024. The segment growth is driven by increasing interest in semi-solid dosage forms, rising R&D activities, and a growing pipeline of semi-solid topical drugs. Semi-solid dosage forms are usually present in various formulations, such as creams, ointments, and lotions. These dosage forms consist of active dissolved or uniformly dispersed ingredients in a suitable base and excipients. In addition, various advantages of semi-solid formulations include ease of use, rapid preparation, and local delivery capabilities.
Moreover, CDMOs play a significant role in increasing product pipelines for several biopharmaceutical and pharmaceutical companies. This has resulted in many companies working together and expanding their efforts to create semi-solid formulations for treating diseases. Over the forecast period, we expect this trend to boost segment growth. For instance, in June 2023, Swiss-American CDMO, a manufacturer of topical solutions and a global company offering skin & personal care products, and BioNTX announced a partnership to launch the Biotechnology and Healthcare Industry Alliance of North Texas (BHIANT).
On the other hand, the demand for liquid formulation drugs has increased among pharmaceutical manufacturers owing to rapid action & fast absorption and product standards aligned with dermatological, cosmetic, and protective requirements. Thus, the need for CDMOs is growing for topical liquid formulations, which is anticipated to drive the segment growth during the forecast period.
Moreover, these drug formulations are widely used in clinical practice and offer various advantages, such as rapid action, quick absorption, various routes of administration, the ability to reduce the irritation of certain drugs, mask the odor of drugs, increase the stability of the preparation, and ease of use. In addition, liquid formulation drugs intend to leave a light deposit of active substance on the skin once evaporated from the dispersion medium.
Service Insights
The contract manufacturing segment dominated the market in 2024. The growth of the segment can be attributed to the surge in the number of CDMOs entering the topical drugs CDMO industry. Several pharmaceutical companies are outsourcing the manufacturing of topical formulations to CDMOs because it is cost-effective and requires less capital investment, both of which are key factors contributing to the growth of this segment. Furthermore, the strong presence of small and mid-sized market players with advanced manufacturing capabilities in the region leads to the introduction of high-quality end products. It guarantees the efficacy and safety of pharmaceutical products, thereby bolstering the market. Moreover, rising adoption of generic drugs and the growing trend of Rx-to-OTC switches positively impact topical drug outsourcing to cater to a large customer base with an affordable price range, which is expected to support segment growth.
We anticipate the contract development segment to grow at the fastest CAGR during the forecast period. Factors such as increasing R&D investment in topical drugs and advancements in topical drug development technology drive the segment's growth. Moreover, topical drugs benefit pharmaceutical companies with standard design, production, and analysis of topical drug products. As a result, numerous pharmaceutical & biopharmaceutical companies are turning to contract-based services for topical drug development and manufacturing. This trend has led to an increase in R&D investment in topical drugs, which is expected to boost segment growth. For instance, in October 2023, DermBiont, a clinical-stage biotechnology company, announced a Series B financing of USD 35.2 million to support R&D of two topical drugs, SM-020 and SM-030, aimed at addressing Seborrheic Keratoses (SKs) and melasma.
End Use Insights
Pharmaceutical companies accounted for the largest market revenue share in 2024. Increasing R&D investments by pharmaceutical companies to develop and commercialize topical drugs are propelling market demand. We expect the large presence of small and medium-scale pharmaceutical companies, with limited infrastructure and capital investment, to drive overall market demand. Moreover, the increasing number of pharmaceutical companies stepping up their investments and product innovations in topical drugs is driving the market demand. Most pharmaceutical companies are looking to outsource the manufacturing of topical drugs in order to streamline their facilities. Furthermore, a significant increase in regulatory approvals for various topical products by pharmaceutical companies is boosting the demand for outsourced services. For instance, in July 2022, Incyte announced U.S. FDA approval for the topical cream Opzelura for the treatment of vitiligo. Hence, constant outsourcing of topical drugs and innovation of products in pharmaceutical companies have led market players to increase their product sales, which is expected to drive the market growth.
Biopharmaceutical companies are expected to register the fastest CAGR during the forecast period. Outsourcing end-to-end services, particularly from small, midsized, and established biopharmaceutical companies lacking expertise in topical drug development, drives this segment. Moreover, a growing number of biopharmaceutical companies are investing in developing and producing topical drugs for several skin conditions, which is fueling segment growth.
Country Insights
The U.S. topical drugs CDMO industry dominated the North American market and accounted for 85.97% revenue share in 2024. Top manufacturing hubs for highly reliable, complex, and high-end pharmaceuticals are responsible for this growth. Moreover, biopharmaceutical companies are focusing on the U.S. market due to the booming healthcare industry in the country, which is supporting the country’s considerable market revenue. Increased outsourcing practices by topical drug companies and support from CDMOs for reducing operational and capital expenses are among the key factors accelerating market growth. In addition, strong R&D practices in the country and promotion of new therapeutics have significantly contributed to the considerable market share held by the U.S. Furthermore, we anticipate that the need to maintain high client satisfaction amid intense competition will fuel market expansion in the country.
Canada's topical drugs CDMO industry is projected to witness a stable CAGR over the forecast period. The pharmaceutical and biopharmaceutical sector in Canada is witnessing advancements due to an increase in investments, partnerships, and other strategic initiatives undertaken by CDMOs that initiate research in the area of skin diseases to address various skin-related and dermatological conditions. Moreover, research on topical & transdermal drug delivery systems is of significant importance in the country.
Key North America Topical Drugs CDMO Company Insights
Some of the key players operating in the market include The Lubrizol Corporation, DPT Laboratories Ltd., Pierre Fabre Group, and Bora Pharmaceutical CDMO.
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The Lubrizol Corporation has innovative pharmaceutical & medical device products. It provides polymers, excipients, and product design, development, and manufacturing services. The company develops OTC products or prescription drug formulations in the topical drug delivery business. The company provides Noveon, polycarbophil, Carbopol, Pemulen, and other topical IID-listed polymers for the development of effective and safe topical products. The product qualities include aesthetic and sensory attributes, bioadhesion and mucoadhesion properties, as well as efficient rheology modification and thickening for topical semisolids.
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DPT Laboratories Ltd. is a CDMO. DPT, a Mylan company, has expertise in semi-solid and liquid dosage forms and a legacy of excellence. It develops pre-formulation, formulation, analytical, packaging, process development, stability testing, microbiology, and clinical trial supplies. The company also offers manufacturing for semi-solids & liquids, aerosol foams & sprays, and site & technology transfers.
Cambrex Corporation, Contract Pharmaceuticals Limited, and MedPharm Ltd. are some of the emerging market participants in the North America topical drugs CDMO industry.
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Cambrex Corporation is a prominent Contract Development and Manufacturing Organization (CDMO). The company provides the full range of services & support to create topical formulations, such as OTC products and prescription dermatological drugs. The technologies and equipment support a range of ointment, lotion, gel, and cream manufacturing services.
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MedPharm Ltd. offers dermal route formulation development services and supports early-phase discovery for process development. It mitigates risks & optimizes products prior to reaching costly clinical phases.
Key North America Topical Drugs CDMO Companies
- The Lubrizol Corporation
- Cambrex Corporation
- Contract Pharmaceuticals Limited
- Bora Pharmaceutical CDMO
- Ascendia Pharmaceuticals
- Pierre Fabre S.A.
- Piramal Pharma Solutions
- DPT Laboratories, LTD.
- MedPharm Ltd.
- Zenvisionpharma
Recent Developments
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In November 2023, SOHM, Inc. announced the establishment of a new manufacturing facility in Carlsbad. The new facility will manufacture SOHMbrand Rx topical and OTC products. It would handle all orders while its main facility in downtown San Diego is being renovated. IAdditionally, the company has allocated 2,500 square feet for the storage of finished products.These investments will broaden the company’s service offerings and gain a competitive edge in the market.
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In October 2023, Ascendia Pharmaceuticals, Inc. partnered with Ampio Pharmaceuticals, Inc. to provide services to support Ampio’s OA-201 clinical development for treating symptomatic osteoarthritis pain. This has enhanced the company’s revenue generation capabilities.
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In December 2022, Formulated Solutions LLC announced an agreement to acquire a new 455,000 ft² FDA-approved pharmaceutical semisolids, liquids, aerosol, BoV, and metered-dose nasal spray production facility in Cleveland. The acquisition is anticipated to enhance the services offered by Formulated Solutions LLC in topical products.
North America Topical Drugs CDMO Market Report Scope
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Report Attribute |
Details |
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Market size value in 2024 |
USD 16.24 billion |
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Revenue forecast in 2030 |
USD 27.22 billion |
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Growth Rate |
CAGR of 10.88% from 2025 to 2030 |
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Historical data |
2018-2023 |
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Forecast period |
2025-2030 |
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Report updated |
May 2025 |
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Quantitative units |
Revenue in USD million/billion and CAGR from 2025 to 2030 |
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Report coverage |
Revenue forecast, company ranking, competitive landscape, growth factors, and trends, capacity outlook, pricing analysis |
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Segments covered |
Product, service, end use, and country |
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Country scope |
U.S.; Canada; Mexico |
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Key companies profiled |
The Lubrizol Corporation, Cambrex Corporation, Contract Pharmaceuticals Limited, Bora Pharmaceutical CDMO, Ascendia Pharmaceuticals, Pierre Fabre S.A., Piramal Pharma Solutions, DPT Laboratories, LTD., MedPharm Ltd., Zenvisionpharma |
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Customization scope |
We offer free report customization, equivalent to up to 8 analysts' working days, with every purchase. You can add or alter the scope of the country and segment. |
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Pricing and purchase options |
Avail yourself of customized purchase options to meet your exact research needs. Explore purchase options |
North America Topical Drugs CDMO Market Report Segmentation
This report forecasts revenue growth at regional and country levels and provides an analysis of the latest industry trends in each of the subsegments from 2018 to 2030. For this study, MIR has segmented the North America report on the CDMO market for topical drugs based on product, service, end use, and country.
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Product Outlook (Revenue, USD Million, 2018-2030)
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Semi-solid Formulations
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Creams
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Ointments
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Lotions
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Others
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Liquid Formulations
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Suspensions
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Solutions
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Solid Formulations
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Transdermal Products
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Service Outlook (Revenue, USD Million, 2018 - 2030)
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Contract Development
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Formulation Development
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Analytical Testing
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Stability Testing
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Others
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Contract Manufacturing
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Clinical
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Commercial
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End Use Outlook (Revenue, USD Million, 2018 - 2030)
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Pharmaceutical Companies
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Biopharmaceutical Companies
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Others
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Country Outlook (Revenue, USD Million, 2018-2030)
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U.S.
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Canada
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Mexico
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