Cosmetovigilance Market Size Worth USD 18.35 Bn by 2034

According to Precedence Research, the global cosmetovigilance market size will grow from USD 12.26 billion in 2025 to nearly USD 18.35 billion by 2034, with an expected CAGR of 4.59% from 2025 to 2034. Europe dominated the global market with a 37.8% share in 2024, while North America is projected to record the fastest growth during the forecast period.

Ottawa, Oct. 24, 2025 (GLOBE NEWSWIRE) -- The global cosmetovigilance market size is expected to be worth over USD 18.35 billion by 2034, increasing from USD 12.26 billion in 2025, with a CAGR of 4. 59% between 2025 and 2034. Increased ease of reporting adverse events, technological advancements, and effective government regulations in developed countries are fueling market growth.

The Complete Study is Now Available for Immediate Access | Download the Sample Pages of this Report@ https://www.precedenceresearch.com/sample/4062

Cosmetovigilance Market Key Takeaways

• Europe accounted for the largest market share of 37.8% in 2024.
• The North America is expected to expand at a notable CAGR from 2025 to 2034.
• By service type, the post-marketing services market segment held the major market share of 64% in 2024.
• By service type, the pre-marketing services segment is growing at a strong CAGR between 2025 and 2034.
• By categories, the skincare segment contributed the biggest market share of 33% in 2024. 
• By service provider, the contract outsourcing segment generated the highest market share of 60% in 2024.
• By phase type, the Phase IV segment accounted for the largest market share of 76% in 2024.
  

Market Size and Forecasts 2025 to 2034

• Market Size in 2025: USD 12.26 Billion
• Market Size in 2026: USD 12.83 Billion
• Forecasted Market Size by 2034: USD 18.35 Billion
• CAGR (2025-2034): 4.59%
• Largest Market in 2024: Europe
• Fastest Growing Market: North America

What is Cosmetovigilance?

The cosmetovigilance market refers to the production, distribution, and use of cosmetovigilance, which is a new concept of safety monitoring of cosmetic products. It may be considered an important component of public health activities. Cosmetovigilance systems are genuine means of obtaining information on the safety of cosmetic products and their ingredients. Cosmetovigilance is the ongoing and systematic monitoring of the safety of cosmetics in terms of human health.

The aim is to detect the adverse effects of cosmetic products and to prevent adverse effects by taking appropriate measures. Csometovigilance represents the vigilant surveillance and monitoring of adverse events and potential risks associated with cosmetic products. It is the continuous compilation, evaluation, and monitoring of cosmetic products’ safety, concerning human health.

➡️ Become a valued research partner with us ☎ https://www.precedenceresearch.com/schedule-meeting

What are the Major Government Initiatives for Cosmetovigilance?

1. U.S. Modernization of Cosmetics Regulation Act of 2022 (MoCRA) - This initiative significantly expanded the U.S. Food and Drug Administration's (FDA) authority over cosmetic safety. It mandates the reporting of serious adverse events to the FDA, requires the registration of cosmetic facilities and the listing of cosmetic products, and grants the FDA mandatory recall authority.

2. EU Cosmetics Regulation (EC) No 1223/2009 - This is the main legal framework for cosmetics within the European Union, which aims to ensure a high level of human health protection. It requires manufacturers to submit a Product Information File (PIF) to demonstrate product safety and mandates the reporting of Serious Undesirable Effects (SUEs) to national authorities.

3. India's Cosmetics Rules, 2020 - These rules mandate stricter quality and safety standards for cosmetics and introduced a voluntary recall mechanism. The initiative also makes importers and manufacturers fully accountable for the quality of their products and requires regular inspections of manufacturing premises.

4. China's Cosmetic Supervision and Administration Regulation (CSAR) - CSAR regulates the entire lifecycle of cosmetic products in China, and its accompanying measures establish a national online monitoring system for adverse reactions. The regulations mandate that manufacturers, importers, and distributors establish systems to collect, evaluate, and report adverse reactions to the National Medical Products Administration (NMPA).

5. Canada's Cosmetics Incident Reporting System - Managed by Health Canada, this system expects the "Responsible Person" (e.g., manufacturer or importer) to investigate and report any serious adverse incidents to the agency. While not based on a formal adverse event report form, the system requires timely reporting when a product poses a health risk and gives Health Canada the power to order mandatory recalls.

What are the Key Trends of the Cosmetovigilance Market?

• Increased Regulatory Scrutiny and Harmonization: Governments and regulatory bodies globally, like the U.S. FDA with MoCRA and the EU with Cosmetics Regulation (EC) No 1223/2009, are imposing stricter mandatory reporting requirements and oversight. This leads to greater pressure on manufacturers to invest in comprehensive cosmetovigilance systems to ensure compliance across different markets.
• Digital Transformation and AI-driven Monitoring: The market is rapidly adopting advanced technologies like artificial intelligence (AI), machine learning (ML), and big data analytics to automate the collection, analysis, and processing of adverse event reports. These AI-driven solutions are capable of monitoring vast amounts of unsolicited data, such as social media, e-commerce reviews, and consumer forums, to detect potential safety signals earlier and more efficiently.
• Rise of Consumer Awareness and Digital Reporting: Modern consumers are more informed and have higher expectations for transparency and safety from cosmetic brands. This growing awareness, combined with the availability of online platforms and mobile apps for reporting adverse effects, is leading to an increase in consumer-driven reporting and greater accountability for manufacturers.
• Expansion of Outsourced Cosmetovigilance Services: As regulatory demands intensify, more cosmetic companies are choosing to outsource their cosmetovigilance activities to specialized service providers like Contract Research Organizations (CROs) and Business Process Outsourcing (BPO) firms. This trend allows manufacturers to reduce operational costs, leverage specialized expertise, and ensure compliance without dedicating significant in-house resources.
• Shift to Proactive, Predictive Risk Management: The market is moving away from purely reactive post-market surveillance toward a more proactive, predictive approach to risk management. By leveraging technology, companies can forecast potential safety issues during the product development stage and take corrective action before a product is even launched, thus minimizing the risk of costly recalls and reputational damage.
  

➤ Get the Full Report @ https://www.precedenceresearch.com/cosmetovigilance-market

Cosmetovigilance Market Opportunity

Digital Transformation

Digital transformation in cosmetovigilance will be an opportunity for the market. Digital transformation in cosmetovigilance includes product development, distribution channels, and customer engagement, shaping new opportunities. Digital transformation is shaping the cosmetic industry by using virtual 3D models, artificial intelligence, big data, personalized cosmetic products, implementing automated processes, and selling products online.

Digital transformation in the cosmetics industry benefits include more innovation, shorter cycles, better product development, smarter decisions with reliable data, full visibility of warehouse & supply chain management, more efficient work, and high customer satisfaction and loyalty.  

Cosmetovigilance Market Challenges

Concerns about Data Privacy

Data privacy concerns can limit the growth of the market. Cosmetovigilance also includes concerns like regulatory gaps, emerging risks, safety concerns, undesirable effects, and data for recurring adverse reactions. Issues like the insufficient ingredient transparency, counterfeit products, and the use of potentially harmful ingredients. The main challenges of cosmetovigilance include varying regulatory standards and the rise of online markets.

Cosmetovigilance Market Report Coverage

Report Attributes	Details
Market Size in 2024	USD 11.72 Billion
Market Size in 2025	USD 12.26 Billion
Market Size in 2026	USD 12.83 Billion
Global Market Size by 2034	USD 18.35 Billion
CAGR from 2025 to 2034	CAGR of 4.59%
Largest Market	Europe
Base Year	2024
Forecast Period	2025 to 2034
Segments Covered	Service Type, Categories, Phase Type, Service Provider, and Region
Regions Covered	North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa

Set up a meeting at your convenience to get more insights instantly! https://www.precedenceresearch.com/schedule-meeting

What is the Europe Cosmetovigilance Market Size?

The Europe cosmetovigilance market size is valued at USD 4.63 billion in 2025 and is projected to grow from USD 4.85 billion in 2026 to approximately USD 6.95 billion by 2034, growing at a CAGR of 4.61% from 2025 to 2034.

Europe dominated the global market in 2024 due to the product-specific demand, counterfeit products, high demand for cosmetics, stricter regulations, an increase in adverse reactions, and rising consumer awareness in the region. Cosmetovigilance is essential to ensure the safety of cosmetic products in the European Union and the United Kingdom.

Key points of regulatory framework in the European Union include reporting of serious adverse events, safety assessment, and responsible person (RP). The awareness of adverse reactions has increased in consumers, and the growing social media influence, fostering this growth. Additionally, the focus on the adoption of big data and AI to enhance post-market surveillance, the integration of cosmetovigilance with pharmacovigilance, and strategic partnerships for data sharing contribute to this growth.

German Cosmetovigilance Market Trends

Germany currently leads the European market, primarily due to its well-established regulatory framework, strong cosmetic and pharmaceutical industries, and a culture of stringent consumer safety standards. The country has implemented formal cosmetovigilance systems that ensure thorough monitoring and reporting of adverse effects related to cosmetic products.

German regulatory authorities are proactive in collecting and analyzing post-market surveillance data, which helps maintain high product safety and compliance. Additionally, Germany's leadership in technological innovation and research further supports its advanced safety monitoring systems.

North America is anticipated to grow at the fastest rate in the market during the forecast period because of the strategic partnerships, consulting & services, data analytics, technology & software, increasing number of consumers, and stricter regulations in the region. The U.S. Food and Drug Administration (FDA) and the U.S. Attorney General can take action against any company that markets an unsafe cosmetic product. The strict regulations for the modernization of the cosmetics regulation Act of 2022 and technological advancements, like machine learning and AI, are fueling the market. Additionally, growing trends of integration with pharmacovigilance for improved safety monitoring contribute to this growth.

The U.S. Cosmetovigilance Market Trends

The U.S. dominates the market in North America, driven by its advanced regulatory infrastructure, expansive cosmetics industry, and increasing consumer demand for product safety and transparency. The US Food and Drug Administration (FDA) plays a key role in monitoring cosmetic safety through regulations and post-market surveillance, ensuring that adverse effects related to cosmetic products are reported and addressed. The country's large population, combined with a highly competitive and innovative beauty industry, contributes to the continuous introduction of new products, which in turn necessitates robust cosmetovigilance practices.

Cosmetovigilance Market Segmentation Insights

Service Type Insights

Which Service Type Dominates the Cosmetovigilance Market?

The post-marketing services segment dominated the market during 2024. Post marketing services in cosmetovigilance are designed to help bio-pharma companies navigate the complexities of post marketing surveillance and ensure the safety of their products. Post-marketing surveillance, also known as pharmacovigilance, means the drug safety monitoring process. This surveillance starts once the drug is approved for market use, after successful clinical trial completion. The main aim of post-market surveillance is to monitor the safety and effectiveness of a drug once it is available to the public.    

The pre-marketing services segment will gain a significant share of the market over the studied period of 2025 to 2034. Pre-marketing refers to the marketing, solicitation, and providing of information or materials to prospective investors before a fund is actually live or conducting an active offering. Pre-marketing helps create awareness and interest well before the launch, ensuring that the target audience knows about the product and eagerly anticipates its release. This early engagement may lead to a more receptive market when the product finally launches.  

Categories Insights

What Made the Skincare Dominate the Cosmetovigilance Market?

The skincare segment dominated the market in 2024. The skincare benefits include treatment, self-care, relaxation, stress relief, pollution, sun damage, helps with acne and skin inflammation, better mental health, basic skincare needs, youthful skin, protection, brightening the complexion, anti-aging, improving the appearance of pores, improves texture, hydration, hydrates the skin, maintains skin health, fights aging, environmental conservation, brightens the skin, boosts confidence, and maintaining healthy skin.

The haircare segment is projected to experience the highest growth rate in the market between 2025 and 2034. The benefits of haircare include soothes sensitive scalps, saves money long-term, reduces frizz, prevents breakage, preventing damage, nourish the scalp, moisturizes, handling split ends, improve hair growth, cleansing, being better for the environment, balances doshas for holistic hair health, reduces dandruff. Additionally, the factors like protects hair from heat, choosing hair products wisely, boosting confidence, reduces hair fall, strengthen hair, promotes hair growth, purifies scalp, and improving hair health.

Phase Type Insights

How Phase IV Segment Leads the Cosmetovigilance Market?

The phase IV segment led the market. Phase IV is a type of clinical trial that studies the side effects caused over time by a new treatment after it has been approved and is on the market. These trials look for side effects that were not seen in earlier trials and may also study how well a new treatment works over a long period of time. Phase IV clinical trials happen after a treatment has been approved by a government regulatory agency for use by the public. Their main objective is to monitor the drug’s performance in real-world settings, providing valuable data that were not captured during earlier phases of clinical research.

The phase III segment is set to experience the fastest rate of market growth from 2025 to 2034. The phase III trials provide critical evidence of a drug’s efficacy. They help researchers to assess the drug’s ability to achieve the desired outcome in a larger patient population. Phase III trials provide a more precise drug’s effectiveness, by including a significant number of participants. Additionally, phase III trials play an important role in encouraging the adoption of the drug by healthcare providers.

Service Provider Insights

Which Service Provider Dominates the Cosmetovigilance Market?

The contract outsourcing segment dominated the market in 2024. Contract outsourcing benefits include prioritize core competencies, outsourcing services increases efficiency, maintaining control, lack of stability, improved quality, ensuring quality, decrease payroll expenses, controlled costs, and access to advanced technology & infrastructure. The market is further experiencing growth due to factors like internal staff development, global talent pool, flexibility, access to specialized talent, risk management, high competitiveness, confidentiality, scalability, cost savings, and more.

The in-house segment is anticipated to grow with the highest CAGR in the market during the studied years. The benefits of in-house services include on-site availability, easier to perform quality control, clearer communication, and more direct to control over the situation. In-house businesses retain direct control over their day-to-day operations. Managers can monitor tasks directly, which makes them guarantees that the services offered fit the corporate image and quality.

You can place an order or ask any questions, please feel free to contact at sales@precedenceresearch.com | +1 804 441 9344

Top Companies in the Cosmetovigilance Market and Their Offerings

• Sciformix: Expand its existing pharmacovigilance expertise to provide specialized cosmetovigilance services for global adverse event data intake, processing, and reporting.
• Tecnimede Group: A pharmaceutical group focused on R&D, it could leverage its existing regulatory and quality infrastructure to create a dedicated cosmetovigilance unit for its personal care product line.
• Bioclinica: Already a leader in clinical safety, it could extend its adverse event reporting and signal detection capabilities to offer a comprehensive cosmetovigilance platform for cosmetic companies.
• PHARMALEX GMBH: Building on its extensive experience in monitoring and signal detection for pharmaceuticals, it could customize these services for the specific regulatory requirements of cosmetovigilance.
• CORONIS Research SA: Already offering drug and patient safety services, it could expand its offerings to provide full-service cosmetovigilance solutions to cosmetic manufacturers.
• TheraSkin: A company focused on dermatological products, it could formally establish a dedicated cosmetovigilance program to specifically manage and report safety data from its line of cosmetic and skin care products.
• KMJ pharma sp. z o. o.: As a pharma and regulatory affairs specialist, it could expand its pharmacovigilance services to formally assist cosmetics clients with cosmetovigilance compliance, adverse event reporting, and risk assessment.
• Pure Drug Safety: Already specializing in pharmacovigilance, it could extend its core offerings to systematically collect, evaluate, and monitor undesirable cosmetic product effects for beauty brands.
• Cliantha: Leveraging its extensive dermatological research and clinical trial experience, it could provide post-market surveillance and risk analysis specifically for cosmetic products.
• MSL Solution Providers: Already a provider of regulatory and testing services for the cosmetics industry, it could formally integrate cosmetovigilance services, including adverse event reporting and Safety Data Sheet maintenance, into its compliance portfolio.

Other Key Companies

• POSEIDON CRO
• FMD K&L
• ZEINCRO Group
• Safety
• Preclinical
• OC Vigilance
• Skill Pharma
• Pharmathen
• Di Renzo
• Axial Group
• AB Cube
• PharSafer
• AxeRegel
• Poseidon CRO

Recent Developments

• In May 2025, the launch of to consumer (D2C) skincare brand, YES SKINCARE, was announced by TLL Elements Pvt. Ltd, a subsidiary of Trident Lifeline Ltd. in an exciting development. YES SKINCARE includes an effective, clean, and purposeful skincare brand, which is designed for the modern Indian consumer who values both self-care and science. (Source: https://www.business-standard.com)
• In September 2025, Hairmonist, for customized, sustainable haircare products, was launched by Clariant. The Hairmonist concept addresses the rising consumer demand for personalized beauty experiences. (Source: https://www.premiumbeautynews.com)

Segments Covered in the Report

By Service Type

• Pre-marketing Services
  • Clinical Safety Testing
  • Document Writing
  • Risk Management
• Post-marketing Services
  • Case Intake
  • Case Triage
  • Data Entry & Acquisition
  • Tracking & Reporting
    

By Categories

• Skincare
• Makeup
• Haircare
• Perfumes and deodorants
• Hair colorants
• Others

By Phase Type

• Pre-clinical
• Phase I
• Phase II
• Phase III
• Phase IV
  

By Service Provider

• In-house
• Contract Outsourcing
  • Contract Research Organizations (CROs)
  • Business Process Outsourcing Organizations (BPOs)
    

By Region

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East and Africa
  

Thank you for reading. You can also get individual chapter-wise sections or region-wise report versions, such as North America, Europe, or Asia Pacific.

Immediate Delivery Available | Buy This Premium Research Report@ https://www.precedenceresearch.com/checkout/4062

Stay Ahead with Precedence Research Subscriptions

Unlock exclusive access to powerful market intelligence, real-time data, and forward-looking insights, tailored to your business. From trend tracking to competitive analysis, our subscription plans keep you informed, agile, and ahead of the curve.

Browse Our Subscription Plans@ https://www.precedenceresearch.com/get-a-subscription

About Us

Precedence Research is a worldwide market research and consulting organization. We give an unmatched nature of offering to our customers present all around the globe across industry verticals. Precedence Research has expertise in giving deep-dive market insight along with market intelligence to our customers spread crosswise over various undertakings. We are obliged to serve our different client base present over the enterprises of medicinal services, healthcare, innovation, next-gen technologies, semi-conductors, chemicals, automotive, and aerospace & defense, among different ventures present globally.

Web: https://www.precedenceresearch.com

Our Trusted Data Partners:

Towards Healthcare | Towards Packaging | Towards Automotive | Towards Chem and Materials | Towards FnB | Towards Consumer Goods | Statifacts | Towards EV Solutions | Towards Dental | Nova One Advisor | Market Stats Insight

Get Recent News:

https://www.precedenceresearch.com/news

For the Latest Update Follow Us:

LinkedIn | Medium | Facebook | Twitter

✚ Related Topics You May Find Useful:        

➡️ Cosmetic Chemicals Market: Explore how innovative formulations and sustainable ingredients are transforming the beauty manufacturing landscape.

➡️ Beauty and Personal Care Products Market: Understand evolving consumer preferences driving demand for natural, multifunctional, and ethical beauty products.

➡️ Cosmetic Preservatives Market: Examine the growing shift toward clean-label and non-toxic preservatives ensuring product safety and longevity.

➡️ Skin Care Products Market: Track innovations in dermocosmetics and active ingredient formulations shaping global skincare routines.

➡️ Cosmeceuticals Market: Discover how science-backed beauty solutions are blurring the line between cosmetics and pharmaceuticals.

➡️ Hair Transplant Market: Analyze technological advancements and rising aesthetic awareness fueling demand for hair restoration procedures.

➡️ Beauty Devices Market: See how AI, IoT, and at-home innovations are redefining personalized beauty care experiences worldwide.

Legal Disclaimer:

EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.