This report on LATAM Adalimumab market analyzes the current and future prospects of the adalimumab sales pertaining to Latin American countries. The stakeholders of this report include companies engaged in production and commercialization of adalimumab biosimilars across the globe. This report encompasses an elaborate executive summary, with a market snapshot that provides overall information of major market segments and sub-segments included in the study scope. This section also provides the overall information and data analysis of the LATAM Adalimumab market with respect to the leading market segments based on, application and major Latin American countries.
The LATAM Adalimumab market has been segmented on the basis of application, and Latin American countries. The application segment has been further segmented into rheumatoid arthritis, psoriasis, Crohn’s disease, ulcerative colitis and others. The LATAM adalimumab country segment has been further categorized into Brazil, Mexico, Argentina, Colombia and Rest of LATAM. The market for each of these segment has been analyzed on the basis of adalimumab prescription for various disorders and regulatory scenario with respect to biologic drugs in respective countries. Market revenue in terms of US$ Mn for the period between 2013 and 2023 along with the compound annual growth rate (CAGR %) from 2015 to 2023 are provided for all the segments, considering 2014 as the base year.
The market overview section of this report explores market dynamics such as drivers, restraints, and opportunities that have predominant impact on the LATAM adalimumab market presently and could influence the market in future as well. The market attractiveness analysis has been provided in the market overview section in order to elucidate the intensity of competition in the market in different LATAM countries. Furthermore, pipeline analysis of the adalimumab biosimilar molecules in Phase III stage have been provided in market overview section. The market estimations for pipeline molecules are provided assuming the positive entry of these molecules in the market which will have an impact on the sustainability of the companies operating in this market. All these factors would help the market players to take strategic decisions in order to strengthen their positions and expand their shares in the LATAM market.
The LATAM adalimumab analysis with respect to major LATAM countries provides the landscape for the production and marketing of adalimumab biosimilars with the introduction of favorable reimbursement policies, research expertise which paves a path for the local and foreign investments in these countries. The report also profiles major players in the adalimumab market on the basis of various attributes such as company overview, financial overview, business strategies, product portfolio, and recent developments. Some of the major players profiled in this report include AbbVie, Inc., Amgen, Inc., Mylan N.V., Novartis AG, Pfizer, Inc. and others.
The LATAM Adalimumab market is segmented into the following categories:
- LATAM Adalimumab Market, by Application
- Rheumatoid Arthritis
- Crohn’s Disease
- Ulcerative Colitis
- LATAM Adalimumab Market, by Country
- Rest of LATAM
2. Executive Summary
2.1. LATAM Adalimumab: Market Snapshot
2.2. Comparative Analysis: LATAM Adalimumab Market, by Country, 2014 & 2023 (Value %)
2.3. LATAM Adalimumab Market Revenue, by Application, 2014 (US$ Mn)
3. Industry Analysis: LATAM Adalimumab Market
3.2. Market Drivers
3.2.1. Driver 1: Favorable Local Regulations
3.2.2. Driver 2: Expertise in Biologic Product Research To Support Local And Foreign Investments
3.3. Market Restraints
3.3.1. Restraint 1: High Cost of R&D and Clinical trials
3.3.2. Restraint 2: Lack of reimbursement for biosimilars resulting in high out-of-pocket costs
3.4. Market Opportunities
3.4.1. Opportunity 1: LATAM, an attractive base for the biosimilar developers for their product expansion
3.5. Market Attractiveness Analysis– LATAM Adalimumab Market, by Country (2014) (value %)
3.6. Pipeline Analysis: LATAM Adalimumab Market
4. LATAM Adalimumab Market Segmentation – by Application
4.2. LATAM Adalimumab Market Revenue, by Application 2013–2023 (US$ Mn)
4.3. LATAM Adalimumab Market Revenue for Rheumatoid Arthritis, 2013–2023, (US$ Mn)
4.4. LATAM Adalimumab Market Revenue for Psoriasis, 2013–2023, (US$ Mn)
4.5. LATAM Adalimumab Market Revenue for Crohn’s Disease, 2013–2023, (US$ Mn)
4.6. LATAM Adalimumab Market Revenue for Ulcerative Colitis, 2013–2023, (US$ Mn)
4.7. LATAM Adalimumab Market Revenue for Others, 2013–2023, (US$ Mn)
5. LATAM Adalimumab Market Segmentation – by Country
5.2. LATAM Adalimumab Market Revenue, by Country, 2013–2023 (US$ Mn)
5.3. Brazil Adalimumab Market Revenue, 2013–2023 (US$ Mn)
5.4. Mexico Adalimumab Market Revenue, 2013–2023 (US$ Mn)
5.5. Argentina Adalimumab Market Revenue, 2013-2023 (US$ Mn)
5.6. Colombia Adalimumab Market Revenue, 2013–2023 (US$ Mn)
5.7. Rest of LATAM Adalimumab Market Revenue, 2013-2023 (US$ Mn)
7. Company Profiles
7.1. AbbVie, Inc.
7.2. Amgen, Inc.
7.3. Boehringer Ingelheim GmbH
7.4. Eisai Co., Ltd.
7.5. Mylan N.V.
7.6. Novartis AG
7.7. Pfizer, Inc.
Biological drugs constitutes complex mixtures which cannot be easily characterized. According to the standard definition provided by the U.S. Food and Drug Administration (FDA) biologics represent an umbrella term which encompasses several products such as blood and blood components, recombinant therapeutic proteins, vaccines and others. Adalimumab (Trade Names: Humira and Exemptia) constitute the tumor necrosis factor (TNF) inhibiting anti-inflammatory medication which has been approved in the U.S for the treatment of several medical conditions such as rheumatoid arthritis, psoriasis, ulcerative colitis, Crohn’s disease and others.
The market for adalimumab is majorly impacted by the factors such as the U.S. and Europe patent expirations in 2016 and 2018 respectively followed by the upcoming adalimumab biosimilars in development. For instance, the recent approval of Exemptia for the Zydus Cadila in India and the company is in talks with the U.S. and Europe regulatory authorities for the respective approval in these markets. However, the patent holder of the originator drug, AbbVie claims that this product will not face any substantial competition until 2020 as it is a biologic drug unlike any other small-molecule drugs. High cost of the therapy is one of the major restraints thereby making this drug inaccessible in majority of the emerging nations. Emerging markets such as Asia Pacific and Latin America provides lucrative growth opportunities for the upcoming adalimumab biosimilars due to their large target patient population and expected decreased cost of biosimilars as compared to originator drugs. In addition, low cost of the research along with the easy availability of trained research professionals will further favor the growth of adalimumab market in these regions.
The LATAM Adalimumab market was valued at US$ 994.8 million in 2014 and is projected to reach US$ 1,186.4 million by 2023, expanding at a CAGR of 0.4% during the forecast period from 2015 to 2023. Increasing preference for effective medications, possession of medical expertise in biosimilar research followed by low cost of production and marketing for the market players in Latin America will support the adalimumab market growth in this region.
Adalimumab is approved for the treatment of several medical conditions such as rheumatoid arthritis, psoriasis, Crohn’s disease among others. Several research studies support the efficiency of adalimumab to treat aforementioned medical conditions and moreover, the market players are conducting the clinical research trials to prove the efficacy and performance of adalimumab biosimilars for majorly the treatment of rheumatoid arthritis and psoriasis. For instance, Pfizer, Inc., Amgen, Inc., and Novartis AG represent some of the companies conducting the clinical trials for the adalimumab biosimilars of which recently in 2015, Amgen, Inc. has announced the positive results of Phase III trials of their adalimumab pipeline molecule ABP501.
Brazil comprises the major markets in Latin America, followed by Mexico with established regulatory policies in place followed by increasing patient preference for effective biologic drugs and presence of local production facilities resulting in low cost of the drugs. While other countries such as Argentina, Colombia, Chile, Peru and Venezuela among others represent the middle or low income LATAM nations and they lack the presence of established biosimilar regulatory policies and lack of native production facilities and the government support for acceptance of biologic drugs. However, TMR analysts anticipate that the market for the adalimumab in Latin American countries will grow with a slow and steady pace assuming the positive entry of the adalimumab biosimilars in this region post the patent expirations.
The adalimumab market has been dominated by few leading players such as AbbVie, Inc. Amgen, Inc., Pfizer, Inc., and Novartis among others. The production of biosimilars is capital intensive and requires huge research and development expenditures, hence these companies, with heavy investments, will continue to dominate the market during the forecast period from 2015 to 2023.