Isotretinoin Drugs Market Size, Share & Trends Analysis Report By Form (Capsules, Injection), By Indication Type (Severe Acne, Neuroblastoma, Cutaneous T-Cell Lymphoma, Harlequin Ichthyosis, Xeroderma Pigmentosum, Fibrodysplasia Ossificans Progressiva, Squamous Cell Skin Cancers, Others), By Distribution Channels (Hospitals Pharmacies, Retail Pharmacies, Online Pharmacies) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2023-2031

Market Overview

The global isotretinoin drugs market size was valued at USD 1,337 million in 2022. It is estimated to reach USD 2,053 million by 2031, growing at a CAGR of 4.88% during the forecast period (2023–2031).

Isotretinoin, a chemical named 13-cis-retinoic acid, is a synthetic vitamin A derivative and works by inhibiting the function of the sebaceous gland and keratinization. Isotretinoin drugs are used to treat severe inflammatory acne and other skin disorders. However, the drug must be taken with utmost care and following prescriptions strictly due to side effects related to the drug, including congenital disabilities, if accepted by a pregnant woman.

Market Dynamics

global isotretinoin drugs market drivers

Increasing prevalence of acne among teens and young adults

Teens and young adults undergo hormonal imbalances in their lifespan's adolescent and post-adolescent stages. It is a common medical condition that occurs among people following different cultures, traditions, and lifestyles. Acne can also spread faster in the population because of certain medications, bad diets, and stress. These factors lead to excess oil production that is clogged in hair follicles. The clogged oil is infected by bacteria, further causing inflammation. In addition, the rising occurrence of a severe type of acne, such as cystic acne, is advancing the demand for isotretinoin drugs.

Another factor reported as the cause of acne was the individual's genetic makeup. According to the survey conducted by the European Academy of Dermatology and Venereology, the individuals affected by acne preferred topical creams for treatment. This factor creates opportunities for market players to develop new isotretinoin topical creams and lotions.

Rising incidence of neuroblastoma

Increasing cases of neuroblastoma among adolescents drive the demand for isotretinoin drugs. The prevalence of neuroblastoma is surging due to demographic or environmental factors. However, isotretinoin is used in neuroblastoma chemotherapy sessions as it contains a retinoid that acts upon the cell nucleus, further inhibiting cell growth. Since neuroblastoma has fatal consequences if untreated, market firms are pouring a lot of money into R&D operations to create novel formulations.

Furthermore, the market players are working on the different compositions of isotretinoin with components such as aldesleukin, dinutuximab, vorinostat, and sargramostim to enhance the efficacy and effectiveness of the drug. Monoclonal antibodies, such as dinutuximab, constitute tumor growth-blocking properties that prevent neuroblastoma cells in diagnosed adolescents and children. Such strategies are assessed to raise market demand in the projected period.

global isotretinoin drugs market restraint

Concerns pertaining to drug side effects

The use of isotretinoin medication during pregnancy poses health risks. The drug can cause several congenital disabilities, such as cleft palate and heart defects. Other complications hindering the isotretinoin drugs market include dry skin, severely chapped lips, nosebleeds, dry and irritated eyes, and dry mouth. Additionally, the medication was reported to cause temporary side effects such as worsening acne, night blindness, thinning hair, and muscle or joint pain. The potential long-term side effects of isotretinoin drugs include erectile dysfunction, genital numbness, and loss of libido. The medication was also reported to cause depression, psychosis, suicidal thoughts, neurological problems, and internal organ damage. Such factors are expected to hamper the market growth over the forecast period.

global isotretinoin drugs market opportunities

Introduction of new micronized formation for severe recalcitrant nodular acne treatment

Isotretinoin drug is known to treat severe nodular acne. Introducing micronized formulated drugs provides an extra edge to patients suffering from severe recalcitrant nodular acne problems. The new micronized formulation shows improved bioavailability with negligible food effects. The formulation is safe with a lower risk of mucocutaneous events and hypertriglyceridemia. Moreover, the minimal risk factors allow market players to formulate new drugs.

Additionally, the industry players are developing newly acquired micronized isotretinoin-based oral therapy to treat nodular acne. For instance, in January 2019, Almirall LLC launched Seysaratm (Sarecycline) to treat acne vulgaris with varying levels of inflammation ranging from moderate to severe medical conditions. Likewise, in February 2020, Sun Pharma introduced Absorica LD capsules in the US with micronization technology to treat severe recalcitrant nodular acne. The newly formulated drug optimizes absorption at a lower dose with a higher level of efficacy and safety. The improved version of isotretinoin drugs with higher efficiency is expected to create new possibilities for industry providers.

Regional Analysis

By region, the global isotretinoin drugs market is divided into North America, Europe, Asia-Pacific, and the Rest of the World.

North america dominates the global market

North America is the highest contributor to the global isotretinoin drugs market and is anticipated to grow at a CAGR of 5.26% during the forecast period. North America has the highest market share in the isotretinoin drugs market due to developed healthcare infrastructure, favorable government regulations, rising prevalence of various skin problems, genetic disorders, and cancer, and increased R&D investment in the region. According to the Global Burden of Disease article, acne vulgaris affects approximately 85%of young adults aged 12 to 25. On the other hand, acne is still one of the most common skin problems in North America. Hence, acne treatment methods and pharmaceuticals were in high demand as the number of acne sufferers expanded. The launch of new products by key players is also driving the market in the region. For instance, in April 2021, Teva Pharmaceutical Industries Ltd (US) launched Absorica (isotretinoin) capsules in the US, the first generic version for treating severe recalcitrant nodular acne.

Europe is expected to grow at a CAGR of 3.84% over the forecast period. The regional growth can be mainly attributed to the rising cases of various genetic disorders and skin cancer, the rapidly developing healthcare sector, rising healthcare spending, and increasing awareness of illnesses and diseases. Moreover, critical players headquartered in the area are innovating and driving growth in the global isotretinoin drugs market regional market. For instance, in the UK, isotretinoin can only be given by or under the supervision of a consultant dermatologist who has experience using systemic retinoids to treat severe acne and a complete understanding of the risks and monitoring needs of isotretinoin therapy.

Asia-Pacific is the fastest-growing regional market for the isotretinoin drugs market, as it is developing rapidly and has witnessed the emergence of many players. The presence of several market players in the region, such as Sun Pharma company (India) and Dr. Reddy's Laboratories Ltd (India), is driving the regional market's growth. Isotretinoin producers in India are experiencing high demand for isotretinoin drugs. The manufacturing of pharmaceutical isotretinoin drugs is increasing because there are new economies in the area, and more people are learning about isotretinoin drugs. Additionally, due to the increase in funding from investors, the use of isotretinoin is continuously rising among users in more disadvantaged areas, with Asia-Pacific seeing a proportionally higher increase in usage.

The Rest of the World comprises the Middle East and Africa and Latin America. The Middle East region has higher growth potential due to the increasing rate of acne conditions in women and the rising prevalence of skin diseases in the region. In South Africa, lower doses of systemic isotretinoin are widely used for milder cases of acne vulgaris, which dermatologists and general practitioners prescribe. Dermatologists educate primary care physicians about this practice through lectures and literature. The efficacy of this method is emphasized, but alternative recommended treatments are ignored, giving the impression that long-term low-dose isotretinoin is the treatment of choice for all acne cases. The region's market growth is majorly due to the presence of developed countries in the Middle East, especially the GCC countries.

Furthermore, Brazil is Latin America's largest isotretinoin market, with annual sales of over 50 USD million and the medical sector proliferating. Isotretinoin is accessible for free through the Brazilian national health system. According to recent research, Isotretinoin was the primary choice for treating moderate and severe acne in the private sector in Brazil, with 76.7% and 94.6% of dermatologists prescribing it, respectively. In addition, Isotretinoin is widely advised in Brazilian private healthcare and is typically accessible in the public sector, although more knowledge is required regarding when it should be prescribed and how effective it is.

Segmental Analysis

The global isotretinoin drugs market is segmented into form, indication type, and distribution channel.

By form, the global market is divided into capsules and injections.

The capsules segment is the highest contributor to the market and is expected to grow at a CAGR of 4.35% during the forecast period. The acne medication isotretinoin capsules are compelling. Isotretinoin pills are sold under the trade names Roaccutane and Rizuderm. By reducing the amount of skin's natural oil production and the likelihood of clogged pores, isotretinoin pills treat severe acne. The medicine also kills the bacteria that cause acne, making the skin less red and sore.

Moreover, Accutane, also known as isotretinoin, treats acne in several ways. It reduces oil production on one's skin, slows the growth of skin cells that can clog pores, and kills bacteria in pore spaces that cause acne and inflammation. Accutane treatment for four to five months usually clears up acne. Accutane was one of Roche's (Switzerland) best-selling medications, with yearly sales of about USD 200 million when its patent expired in 2002. It has been used by more than 13 million individuals globally.

Isotretinoin steroid injections are mainly used to treat acne that causes painful lumps beneath the skin's surface (nodules and cysts). These disorders can take weeks to get better on their own. Steroid injections reduce pain, flatten lumps, and allow the skin to clear up acne and other skin disease conditions. Steroid injections are typically a short-term or sporadic treatment for stubborn cysts and nodules. Due to the potential side effects and the need for frequent doctor visits, they are not used to treat widespread acne.

By indication type, the global market is divided into severe acne, neuroblastoma, cutaneous t-cell lymphoma, harlequin ichthyosis, xeroderma pigmentosum, fibrodysplasia ossificans progressiva, squamous cell skin cancers, and others.

The severe acne segment owns the highest market share and is estimated to grow at a CAGR of 6.26% over the forecast period. Severe acne is a common dermatological condition that affects most high school students based in the US. According to a recent population-based study, the prevalence of severe acne in teenagers in the US rises steadily from 1.7%at age 11 to 12.1%at age 17. Various co-morbid conditions, including depression, anxiety, insomnia, and attention deficit disorder, have been related to severe acne. Furthermore, the increasing prevalence of skin diseases is a major driving force in the global market for isotretinoin drugs. Urban and unhealthy lifestyles can impact skin problems. On the other hand, the rising prevalence of acne in women is also increasing the demand for isotretinoin drugs.

Neuroblastoma, a neoplastic expansion of a neural crest in the evolving sympathetic nervous system, is children's most common extracranial solid tumor. A genetic defect in germ cells, a change in lifestyle, and a family history of neuroblastoma could all contribute to the disease's emergence. It may be caused by fertility drugs, the mother's use of hair dye, infection, or allergic conditions in some cases. According to the 2016 Report from the American Pediatric Cancer Organization and the International Agency for Research on Cancer (IARC), 80,000 people die each year from childhood cancer globally. Technological advancements and the increasing prevalence of neuroblastoma are expected to drive this segment's growth in the global market.

By distribution channel, the global market is divided into hospital pharmacies, retail pharmacies, and online pharmacies.

The hospital pharmacies segment owns the market share and is anticipated to grow at a CAGR of 4.30% over the forecast period. A hospital pharmacy is a specialized branch of pharmacy that is an integral part of patient health care in a hospital. Hospital pharmacies are expected to hold a substantial market share due to the availability of medical experts such as dermatologists and neurologists, cancer specialists, and hospital accessibility. Moreover, hospital pharmacies currently account for 20–25% of hospital revenue. However, some hospitals use their pharmacy services in other clinical processes. This role is undoubtedly evolving, and with the implementation of a value-driven strategy, it has the potential to grow even further.

An online pharmacy is a store that sells pharmaceutical preparations, such as non-prescription and prescription drugs, over the Internet and through the mail. The convenience and familiarity of online purchasing have prompted many patients to seek virtual care medications and wellness options, increasing the need for online pharmacies to advertise and acquire more customers via digital platforms. The COVID-19 pandemic has ramped up this shift, as most healthcare professionals and patients have adapted to purchasing medications online. Online pharmacies provide better pricing than offline pharmacies, increased access, lower transaction and product costs, convenience, and greater anonymity for consumers driving the segment's growth.

Recent Developments

• December 2022- Hoffman La Roche Ltd. announced that Lunsumio® (mosunetuzumab-axgb) had been approved by the U.S. Food and Drug Administration (FDA) for adult patients with relapsed/refractory follicular lymphoma (FL) after two or more lines of systemic therapy.