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Isotretinoin Drugs Market Share

ID: MRFR//2418-CR | 115 Pages | Author: Rahul Gotadki| February 2022

Severe nodular acne can be a challenging condition, and the well-known drug Isotretinoin has been a go-to treatment for this issue. However, there's a new development in the form of micronized drugs that aims to enhance the treatment for patients dealing with severe recalcitrant nodular acne.

The introduction of micronized formulations is a significant advancement in the field. These new drugs offer an added advantage to individuals struggling with severe nodular acne problems. Unlike traditional formulations, the micronized version demonstrates improved bioavailability. This means that the body can absorb the medication more effectively, leading to potentially better outcomes for patients.

One noteworthy feature of this micronized formulation is its minimal food effect. In simpler terms, patients can take the medication with or without food, and it will still work effectively. This flexibility can be particularly beneficial for individuals with busy lifestyles or those who may have difficulty adhering to strict medication schedules.

Safety is a crucial aspect of any medication, and the micronized formulation addresses this concern. It is designed to have a lower risk of mucocutaneous events and hypertriglyceridemia. This translates to a reduced likelihood of side effects related to the skin and lower risks of elevated levels of triglycerides in the blood. Such safety measures are essential for ensuring that the treatment is well-tolerated by patients.

Moreover, the decreased risk factors associated with the micronized formulation open up new opportunities for pharmaceutical companies. This has led to increased efforts in the development of novel drugs by industry players. They are actively working on creating new formulations of micronized isotretinoin-based oral therapies specifically designed for the treatment of nodular acne.

An example of this progress is evident in the launch of Seysaratm (Sarecycline) by Almirall LLC in January 2019. This drug is tailored to address acne vulgaris, covering a spectrum of inflammation levels from moderate to severe medical conditions. Similarly, Sun Pharma introduced Absorica LD capsules in February 2020 in the United States. These capsules utilize micronization technology and are targeted towards treating severe recalcitrant nodular acne.

The innovation brought about by these newly formulated drugs is noteworthy. Not only do they optimize absorption at lower doses, but they also exhibit a higher level of efficacy and safety. This is a significant leap forward in the field of acne treatment, promising better results for patients while minimizing potential side effects.

In conclusion, the introduction of micronized formulations for the treatment of severe recalcitrant nodular acne represents a positive step in the medical field. The improved bioavailability, minimal food effect, and enhanced safety profile make these drugs a promising option for individuals dealing with this challenging skin condition. The ongoing efforts of industry players in developing and introducing new drugs based on micronized isotretinoin showcase a commitment to advancing medical solutions for the benefit of patients with severe nodular acne.

Covered Aspects:

Report Attribute/Metric Details
Base Year For Estimation 2022
Historical Data 2018- 2022
Forecast Period 2023-2032
Growth Rate 4.68% (2023-2032)

Global Isotretinoin Drugs Market Overview


Isotretinoin Drugs Market Size was valued at USD 1.25 Billion in 2023. The Isotretinoin Drugs market industry is projected to grow from USD 1.30 Billion in 2024 to USD 1.81 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 4.14% during the forecast period (2024 - 2032). The increased prevalence of acne in young adults and teens and the increasing incidence of neuroblastoma cases are the key market drivers enhancing the growth of market.


Isotretinoin Drugs Market1


Source The Secondary Research, Primary Research, MRFR Database, and Analyst Review


Isotretinoin Drugs Market Trends



  • The growing prevalence of acne in teens and young adults is driving the market growth.


Market CAGR for isotretinoin drugs is being driven by the rising prevalence of acne in teens and young adults. Adults and teens are susceptible to hormonal imbalances in their adolescent lifespan and post-adolescent stages, which is a common medical condition that occurs in people following different traditions, cultures, and lifestyles. Medication, stress, and a bad diet can also be the reason for the faster spread of acne in the population.


The genetic makeup of the individual can also be the cause of acne in them. The excess oil production that is clogged in the hair follicles is infected by bacteria, causing inflammation. Furthermore, the increasing occurrence of severe types of acne like cystic acne, is increasing the requirement for isotretinoin drugs. As per the survey carried out by the European Academy of the Dermatology and Venereology, topical application cream for the treatment of acne is preferred by most individuals. This generates an opportunity for the market participants to introduce new isotretinoin topical creams and lotions. The companies are also working on several compositions of isotretinoin with components like vorinostat, dinutuximab, aldesleukin, and sargramostim to improve the efficiency and effectiveness of the drug.


The rising incidence of neuroblastoma in adolescents fuels the requirement for isotretinoin drugs. Environmental or demographic factors are increasing the prevalence of neuroblastoma in individuals. Isotretinoin is utilized in chemotherapy sessions of neuroblastoma as it consists of retinoids that act on the cell nucleus, thus inhibiting the growth of the cell. Neuroblastoma has detrimental consequences when untreated. Thus, the market players are investing largely in R&D operations to create new formulas. Dinutuximab is a monoclonal antibody that has growth-blocking properties that forbid neuroblastoma cells in diagnosed children and adolescents; these techniques and inventions can increase the market demand. Thus, driving the Isotretinoin Drugs market revenue.


However, the side effects concerned with drug consumption will restrain the market growth. The consumption of isotretinoin during pregnancy leads to health risks as this drug cause different congenital disabilities like, heart defects and cleft palate. It has potential long-term side effects includes, including genital numbness, erectile dysfunction, and loss of libido. The medication also leads to depression, psychosis, neurological problems, suicidal thoughts, and internal organ damage. These factors may restrain the growth of the market ly.


Isotretinoin Drugs Market Segment Insights


Isotretinoin Drugs Form Insights


The  Isotretinoin Drugs market segmentation, based on the form, includes Capsules and Injections. The capsules segment dominates the market, accounting for the largest market revenue. Isotretinoin capsules, an acne medication, reduce the amount of natural oil production of skin and the possibility of clogged pores; isotretinoin pills are compelling as it treats severe acne. The drug also kills the bacteria, which leads to acne, making skin less sore and red. On the other hand, injections are majorly utilized to treat acne, which leads to painful lumps under the surface of the skin, which can take weeks to recover on its own. This injection minimizes the pain, reduces the lumps, lets the skin clear the acne, and also treats other skin disease conditions.


Figure 1  Isotretinoin Drugs Market, by Form, 2022 & 2032 (USD Billion)Isotretinoin Drugs Market, by Form, 2022 & 2032


Source The Secondary Research, Primary Research, MRFR Database, and Analyst Review


Isotretinoin Drugs Distribution Channel Insights


The  Isotretinoin Drugs market segmentation, based on distribution channels, includes Hospitals Pharmacies, Retail Pharmacies, and Online Pharmacies. The hospital pharmacies segment is anticipated to dominate the segment market because of the availability of medical experts like dermatologists and cancer specialists, neurologists, and hospital accessibility. Some hospitals utilize their pharmacy services in other clinical processes; with this value-driven strategy, this segment has the capability to grow more. Further, the online pharmacy segment is gaining popularity due to the familiarity and convenience of online purchasing have made patients seek virtual care medication and wellness options.


Isotretinoin Drugs Regional Insights


By region, the study offers market insights into North America, Europe, Asia-Pacific, and the Rest of the World. The North American Isotretinoin Drugs market area is expected to dominate the market because of the developed healthcare infrastructure, rising prevalence of different skin problems, favorable government regulations, genetic disorders, and cancer, and rising research and development investment in the North American region.


Further, the primary countries studied in the market report are The US, Canada, German, France, the UK, Italy, China, Japan, India, Spain, Australia, South Korea, and Brazil.


Figure 2  Isotretinoin Drugs MARKET SHARE BY REGION 2022 (USD Billion) Isotretinoin Drugs MARKET SHARE BY REGION 2022


Source The Secondary Research, Primary Research, MRFR Database, and Analyst Review


Europe's Isotretinoin Drugs market accounts for the second-largest market share due to the fast development in healthcare and spending in healthcare, increasing cases of genetic disorders, and increased investment for innovation by key players in the region. Further, the German Isotretinoin Drugs market held the largest market share, and the UK Isotretinoin Drugs market was the rapid-growing market in the European region.


The Asia-Pacific Isotretinoin Drugs Market is expected to grow at the fastest CAGR from 2023 to 2032. This is due to the presence of various market players, rising investment and the growing manufacturing of pharmaceutical isotretinoin drugs in the region. Moreover, China’s Isotretinoin Drugs market held the largest market share, and the Indian Isotretinoin Drugs market was a rapid-growing market in the Asia-Pacific region.


Isotretinoin Drugs Key Market Players & Competitive Insights


Leading market players are investing heavily in research and development in order to expand their product lines, which will help the Isotretinoin Drugs market grow even more. Market participants are also undertaking the various strategic activities to expand their  footprint, with important market developments including new product launches, mergers and acquisitions, contractual agreements, higher investments, and collaboration with other organizations. To expand and survive in a more competitive and rising market climate, the Isotretinoin Drugs industry must offer cost-effective items.


Manufacturing locally to minimize operational costs is one of the key business tactics used by manufacturers in the  Isotretinoin Drugs industry to benefit clients and increase the market sector. In recent years, the Isotretinoin Drugs industry has offered some of the most significant advantages to medicine. Major players in the Isotretinoin Drugs market, including Hoffmann La Roche Ltd., Dr. Reddy's Laboratories Ltd., Teva Pharmaceuticals Industries Ltd., Sun Pharma, Almirall LLC, Cipher Pharmaceuticals Inc., Catalent Pharma Solutions, Douglas Pharmaceuticals Limited, Chongqing Huapont, and others, are attempting to increase market demand by investing in research and development operations.


Dr Reddy's Laboratories, based in Hyderabad, is an Indian multinational company of pharmaceutical. The company was established by Kallam Anji Reddy, who used to work at the mentor institute of Indian Drugs and Pharmaceuticals Limited. The company manufactures and markets a large range of pharmaceuticals in India and overseas. The product portfolio of the company consists of a whole range of diseases like, oncology, gastrointestinal, cardiovascular, dermatology, nephrology, diabetes, pain management, urology, and many more. In June 2019, the Zenatane was relaunched by Dr. Reddy's Laboratories. The Zenatane is an Isotretinoin capsule, USP, a generic version of the Accutane, which was launched after the approval of the Risk Evaluation And Mitigation Strategy (REMS) program and assisted the company in making its position stronger in the market.


Hoffmann-La Roche AG, founded in 1896, commonly known as Roche, is a multinational healthcare company based in Switzerland. The company operates ly under two divisions, namely, diagnostic and pharmaceuticals. The company research, develop, and manufactures drugs and offers drugs for different diseases like cancer, metabolic, viral infections, central nervous system disorders, and inflammatory diseases and also produces pharmaceutical products for ophthalmology and immunology. In December 2022, Hoffmann La Roche Ltd. Announced that Lunsumio (Mosunetuzumab-axgb) is consented to by the US Food and Drug Administration (FDA) for the adult patients with the problem of relapse/refractory follicular lymphoma (FL) after two and more steps of systemic therapy.


Key Companies in the Isotretinoin Drugs market include



  • Hoffann La Roche Ltd.

  • Dr Reddy's Laboratories Ltd.

  • Teva Pharmaceuticals Industries Ltd.

  • Sun Pharma

  • Almirall LLC

  • Cipher Pharmaceuticals Inc.

  • Catalent Pharma Solutions

  • Douglas Pharmaceuticals Limited

  • Chongqing Huapont


Isotretinoin Drugs Industry Developments


April 2021 The launch of the first generic version of isotretinoin was announced by Teva Pharmaceuticals in the US for patients of age 12 years and older than that. This drug can be utilized to treat severe recalcitrant nodular acne.


February 2020 One of the largest generic pharmaceutical companies ly, Sun Pharma, introduced capsules of ABSORICA LD in the US market for the treatment of severe recalcitrant nodular acne.


January 2019 In order to treat acne vulgaris with different levels of inflammation ranging from moderate to severe conditions in severe acne, Seysaratm (Sarecycline) was launched by Almirall LLC.


Isotretinoin Drugs Market Segmentation


Isotretinoin Drugs Form Outlook



Isotretinoin Drugs Distribution Channel Outlook



  • Hospitals Pharmacies

  • Retail Pharmacies

  • Online Pharmacies


Isotretinoin Drugs Regional Outlook



  • North America

    • US

    • Canada



  • Europe

    • Germany

    • France

    • UK

    • Italy

    • Spain

    • Rest of Europe



  • Asia-Pacific

    • China

    • Japan

    • India

    • Australia

    • South Korea

    • Australia

    • Rest of Asia-Pacific



  • Rest of the World

    • Middle East

    • Africa

    • Latin America



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