Cosmetovigilance Market

Market Overview

The global cosmetovigilance market size was valued at USD 3.8 billion in 2023 and is projected to reach a value of USD 6.9 billion by 2032, registering a CAGR of 6.7% during the forecast period (2024-2032). The increased emphasis on physical appearance, rising global cosmetic product usage, and personal disposable income are significant drivers of the Cosmetovigilance market growth.

Cosmetovigilance refers to the monitoring and surveillance of cosmetic items after they have been placed on the market. Cosmovigilance, like pharmacovigilance in the pharmaceutical business, seeks to ensure the safety and quality of cosmetics and personal care products for end users.

The growing demand for cosmetic items worldwide is the primary driver of global cosmetovigilance market growth. Rising awareness of aesthetic appearance, beautification, and attractiveness improvements will drive demand for cosmetovigilance, resulting in market expansion. The growing desire for better aesthetic appearance and body beautification, as well as the increasing purchasing power of developing countries and the growing need of consumers for cosmetic products, will drive up demand for cosmetics, increasing the incidences of risks associated with excessive use of cosmetic products, highlighting the need for cosmetovigilance services. The increasing number of cases resulting from harmful effects caused by contaminants or pollutants in cosmetic items will help expand this market. Furthermore, rigorous government restrictions limiting the adverse effects of various cosmetic items on consumer health would allow the cosmetovigilance business to flourish.

Highlights

• Phase IV accounts for the largest share of the market by phase type.
• Post-marketing is a significant contributor to the market by service type.
• Skincare influenced the market by category.
• Contract outsourcing dominates the service providers' market.

Market Dynamics

Global Cosmetovigilance Market Drivers:

Stringent Regulatory Requirement

The cosmetovigilance industry is being driven primarily by stringent regulatory regulations. Regulatory authorities worldwide apply tight norms and rules to ensure cosmetics' safety and quality. To comply with these laws, cosmetic firms must build thorough cosmetovigilance systems. The European Union's (E.U.) Cosmetics Regulation (Regulation (E.C.) No 1223/2009) establishes severe regulations for the safety evaluation, labeling, and marketing of cosmetic items supplied in the E.U. It requires cosmetic makers to conduct safety assessments, keep complete product safety reports, and immediately report any adverse events to the appropriate authorities. Noncompliance can lead to fines, product recalls, and brand reputational damage.

In the United States, cosmetics are regulated by the F.D.A. under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). While pre-market approval is not required for cosmetic items, cosmetic firms must assure product safety and report adverse events to the F.D.A.'s Voluntary Cosmetic Registration Program (VCRP). Failure to comply with these regulations may result in enforcement proceedings, such as product seizures and injunctions.

Additionally, emerging markets, including China, India, and Brazil, are rapidly enacting rules to improve the safety and quality of cosmetic products. For example, China's National Medical Products Administration (NMPA) mandates cosmetic producers to undergo safety tests and submit product registration dossiers before marketing their products in China. These regulatory developments drive producers' adoption of cosmetovigilance methods to access these markets. 

Global Cosmetovigilance Market Restraints:

Limited Resources and Expertise

Many cosmetic companies and tiny and medium-sized organizations (S.M.E.s) may need more resources, experience, and infrastructure to implement effective cosmetovigilance systems. Implementing comprehensive adverse event monitoring, reporting, and risk assessment procedures necessitates significant investments in technology, staff, and training. Small and medium-sized enterprises (S.M.E.s) may need help to commit sufficient resources to cosmetovigilance efforts, limiting their capacity to meet regulatory requirements effectively.

Furthermore, effective cosmetovigilance requires robust data management systems to collect, analyze, and report adverse occurrences linked with cosmetic goods. Due to financial constraints and technological restrictions, small and medium-sized businesses may need help implementing advanced data management solutions. As a result, they may rely on manual or ad hoc data management processes that are prone to errors and inefficiencies.

In addition, small and medium-sized enterprises (S.M.E.s) form the backbone of the European cosmetics industry, with 776 companies in Italy, the fourth most in Europe. Italy produces over 67% of the makeup consumed in Europe and 55% worldwide. However, many S.M.E.s reported difficulty deploying cosmetovigilance systems due to resource restrictions, such as restricted funds and a lack of experience. This demonstrates the influence of limited resources on the cosmetovigilance capacities of smaller cosmetic enterprises.

Global Cosmetovigilance Market Opportunity:

Globalization of Cosmetic Markets

The globalization of cosmetic markets provides substantial opportunities for cosmetovigilance service providers to broaden their scope and products. As cosmetic firms expand into international markets, they face a broad regulatory framework, cultural preferences, and consumer expectations. Cosmetovigilance service providers may benefit from this trend by providing customized solutions to assist businesses in navigating regional regulatory requirements, ensuring product safety, and building customer trust across borders.

A multinational cosmetics company also intends to offer products in many European, Asian, and North American markets. However, each region has regulatory frameworks and reporting requirements for cosmetic product safety and adverse event monitoring. The organization collaborates with a cosmetovigilance service provider with global experience to create a comprehensive cosmetovigilance plan. Anju Software and ClinChoice joined in June 2023 to develop eClinical solutions for clinical research. The firm provides regulatory information, risk assessment services, and adverse event reporting support personalized to each region, assuring compliance with local regulations and increasing consumer confidence in the company's products worldwide.

In addition, year over year, dollar sales in the U.S. prestige beauty business increased by 14% to USD 31.7 billion in 2023, while mass-market beauty sales increased by 6%. This growth is driven by rising consumer expenditure on personal care goods, increased beauty consciousness, and the expansion of cosmetic markets in emerging economies. With the globalization of cosmetic industries, international corporations increasingly seek cosmetovigilance assistance in navigating regulatory challenges and ensuring product safety and compliance across several locations. This tendency increases the need for cosmetovigilance services and allows providers to expand their global footprint and products.

Regional Analysis

The global cosmetovigilance market share is bifurcated into North America, Europe, Asia-Pacific, the Middle East, Africa, and Latin America.

North America Dominates the Global Market

North America is the most significant global cosmetovigilance market shareholder and is estimated to grow at a CAGR of 6.8% over the forecast period. The prevalence of cutting-edge healthcare infrastructure, increased awareness of the detrimental effects of cosmetics, and extensive use of cosmetovigilance processes all contribute to the region's strong position. Furthermore, the area has tight restrictions that producers must follow when manufacturing cosmetics, which helps the cosmetovigilance market's growth. 

Additionally, the United States leads the North American cosmetovigilance sector due to its strong demand for cosmetics, tight regulations, and sophisticated healthcare infrastructure. For example, 55% of U.S. buyers will spend between USD 51 and USD 200 monthly on cosmetic items in 2023. 69% spend USD 1-USD 100, 62% spend USD 1-USD 50 on bath and shower products, and 61% spend USD 1-50 on body care items. 21% spend USD 201 to USD 500, while 8% spend USD 500 or more. The region also experiences a high rate of adverse reactions to cosmetic items, prompting the development of advanced cosmetovigilance methods and systems. 

Europe is anticipated to exhibit a CAGR of 7.0% over the forecast period. The prevalence of adverse events associated with cosmetic products and increased awareness of the detrimental effects of cosmetics drive market growth. The European Union (E.U.) has implemented strict regulations governing cosmetic item use, fueling business expansion. The availability of cutting-edge medical infrastructure and increased demand for cosmetovigilance goods and services drive market growth. Furthermore, cosmetovigilance techniques are in great demand due to the increasing use of social media platforms for product reviews and recommendations. 

The Asia-Pacific market is expected to increase moderately over the projected period. Many people live in the area, and the need for cosmetics is increasing. However, some countries need more cosmetovigilance regulations and public awareness to ensure cosmetovigilance market growth. Japan and China dominate the cosmetics sector due to their substantial healthcare infrastructure and huge demand. 

Furthermore, the region's market expansion is expected to be supported by cosmetic manufacturers' increasing adoption of cosmetovigilance procedures and government measures to impose strict restrictions.

Segmental Analysis

The global cosmetovigilance market is segmented based on phase type, service type, category, and service provider.

The market is further segmented by phase type into Pre-clinical, Phase I, II, III, and IV.

The Phase IV section had the highest revenue share in 2023. This phase, also known as post-marketing surveillance, takes place after regulatory clearance and entails evaluating the product's safety and effectiveness in real-world use. Researchers continue to collect data on adverse events, drug interactions, and patient outcomes to assure continued safety and uncover any rare or long-term side effects that may have gone undetected in previous rounds. These phases provide an additional degree of protection for cosmetics undergoing clinical trials. Phase IV of clinical trials is critical because it enables the detection of probable adverse pharmaceutical effects. Due to intensive pharmacological testing on a broad patient population, the data obtained and assessed at this stage will likely be relevant following the product's commercialization. 

The Phase III segment is predicted to increase at a profitable CAGR during the projection period. This phase includes large-scale clinical trials on various volunteers to confirm the product's safety, efficacy, and potential advantages compared to existing treatments or a placebo. Researchers gather detailed information about the product's effectiveness in real-world settings, its impact on patient outcomes, and any long-term side effects. Phase III trials offer critical information for regulatory approval and commercialization choices. Product efficacy is determined and established during phase III trials. Before product commercialization, these trials provide further information on potential interactions, safety, and effectiveness. Thus, the increasing importance of Phase III and the large number of pharmaceuticals in Phase III clinical trials are expected to drive segment expansion.

Based on service type, the market is fragmented into pre-marketing and post-marketing.

The post-marketing service category had the highest revenue share in 2023, owing to the rising demand for cosmetovigilance services to reduce unfavorable effects (U.E.s) and significant adverse impacts (SUEs) connected with cosmetics use. Post-marketing cosmetovigilance services include continual surveillance and monitoring of cosmetic items after they have been introduced to the market. These services seek to detect, assess, and manage adverse events and safety concerns related to cosmetic product use in real-world situations.

Furthermore, the cosmetics sector is primarily responsible for analyzing and reporting adverse responses to cosmetic goods. In addition to adverse reaction reporting, post-marketing services include case intake, triage, and data entry and acquisition, contributing to segment growth. 

The pre-marketing category is predicted to increase at a healthy CAGR during the forecast period, owing to the need to assess the safety and efficacy of the cosmetic product. Pre-marketing services in cosmetovigilance are operations before a cosmetic product is released. These services evaluate cosmetic formulations' safety, quality, and regulatory compliance during the development and pre-launch stages. These services will acquire popularity as a result of cosmetic solid product pipelines. Furthermore, the growing need for various pre-marketing services, including the product information file, cosmetic product safety report, security assessment, and others, will boost market advancement.

Based on category, the market is classified into Skincare, Makeup, Haircare, Perfume and Deodorants.

The skincare sector led the market in 2023, accounting for 35% of total revenue, owing to increased demand for face creams, sunscreens, and body lotions. Skincare products include various cosmetic formulas intended to cleanse, moisturize, and protect the skin. This category covers facial cleansers, moisturizers, serums, sunscreens, and anti-aging creams. Cosmetovigilance services for skincare products evaluate the safety, efficacy, and potential dangers of active compounds, preservatives, and formulation procedures to assure consumer safety and regulatory compliance.

Furthermore, face creams and moisturizers are becoming increasingly prevalent worldwide as people become more sensitive to their physical appearance and concerned about skin disorders and diseases. All of the variables above are driving segment growth. 

The perfume and deodorants segment is expected to develop at a profitable CAGR throughout the projection period. Perfume and deodorant products contain fragrances and antiperspirants intended to provide pleasant odors while controlling body odor. This category includes fragrances, colognes, body sprays, and deodorant sticks. Cosmetovigilance services for perfume and deodorant products include assessing the safety and allergenicity of fragrance compounds, preservatives, and antimicrobial agents to prevent skin sensitization, respiratory irritation, and unpleasant reactions.

Additionally, the growing number of adverse effects linked with perfume and deodorant products has contributed to the market segment's growth. The demand for safe and clinically proven scent products will increase due to typical adverse effects such as hair migraine headaches, dizziness, skin rash, and others, which are projected to drive market expansion.

The service provider can further bifurcate the segment into In-house, Contract Outsourcing.

The contract outsourcing segment dominated the market, accounting for 60% of total revenues. Contract outsourcing of cosmetovigilance services entails collaborating with external service providers or cosmetovigilance organizations to outsource individual tasks or full cosmetovigilance functions. These service providers provide specialized knowledge, experience, and resources to help businesses manage safety surveillance, adverse event reporting, regulatory compliance, and risk assessment for cosmetic products. Contract outsourcing enables companies to obtain cost-effective, scalable, and flexible cosmetovigilance solutions without requiring considerable in-house capabilities or infrastructure.

Outsourcing benefits include reduced risk, greater resource flexibility, lower initial outlays, and lower fixed expenses. Contract outsourcing organizations provide solutions such as process design Standard Operating Procedures (S.O.P.), P.V. audits, and other specialized services. Contract outsourcing also allows for more efficient use of internal resources, faster trial approval, and less complexity in clinical research.

In-house cosmetovigilance services entail setting up dedicated internal teams within cosmetic companies to oversee safety monitoring, regulatory compliance, and risk management activities. These teams are responsible for conducting safety assessments, reporting adverse events, detecting signals, and filing regulatory filings for cosmetic items. In-house services provide firms with greater control, confidentiality, and flexibility when managing cosmetovigilance activities, but they necessitate significant investments in resources, experience, and infrastructure.

Recent Developments

• December 2023- Biofrontera AG allowed a U.he i iriS. Patent for a dermatological skin condition therapy employing Photodynamic Therapy (PDT) with two light exposures at different wavelengths to protect its medicine Ameluz.
• March 2024- Accenture acquired Arηs Group to expand its public service digital transformation capabilities in Europe.