MENA BIOLOGICS & BIOSIMILARS MARKET ANALYSIS

MENA biologics & biosimilars market is estimated to be valued at US$ 502.2 Mn in 2023, and is expected to exhibit a CAGR of 4.6% during the forecast period (2023-2030).

Analysts’ Views on MENA Biologics & Biosimilars Market:

A biosimilar is exactly what its name implies.  It is a biologic that is 'similar' to another biologic medicine (known as a reference product), which is already licensed by the U.S. Food and Drug Administration (FDA). Biosimilars are highly similar to the reference product in terms of safety, purity, and potency, however, it may have minor differences in clinically inactive components. In approving biosimilars, the U.S. FDA may require that manufacturers conduct a clinical study (or studies) sufficient to establish safety, purity for which the reference product is licensed. The main advantage of biosimilars is its cost. Biologics and biosimilars are specialty drugs that are often on the highest tiers of health insurance plan formularies, that means patients usually have to pay high coinsurance rates for coverage.

Figure 1. MENA Biologics & Biosimilars Market Share (%), By Product Type, 2023

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MENA Biologics & Biosimilars Market– Drivers

• Increasing investments and funding activities to strengthen the business: Increasing investments and funding activities to strengthen business in the region is expected to drive the growth of the market in the near future. For instance, on January 7, 2021, Abu Dhabi Developmental Holding Company, an Investment company has, announced two strategic investments, significantly expanding its healthcare and pharma portfolio. ADQ acquired Pharmax Pharmaceuticals FZ-LLC, a UAE-based pharmaceutical company that manufactures and markets affordable, branded generic medication, and invested minority stake in Biocon Biologics Limited ("Biocon Biologics"), a subsidiary of Biocon Ltd. that specializes in developing, manufacturing, and marketing high-quality, affordable biosimilars across global markets.

Key players are focusing on facility expansion  

The key players in the region are focusing on facility expansion, which is expected to drive the growth of the market in the near future. For instance, on June 21, 2023, the Public Investment Fund (PIF), Saudi Arabia’s global investment organization, announced that it had launched Lifera, a commercial-scale contract development and manufacturing organization (CDMO). The CDMO will enable the growth of the local bio/pharmaceutical industry, strengthen national resilience, and support Saudi Arabia’s position as a global pharmaceutical manufacturing destination.

Figure 2. MENA Biologics & Biosimilars Market Share (%), By Region/Country, 2023

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MENA Biologics & Biosimilars Market- Regional Analysis

Among region, the Gulf region is estimated to hold a dominant position in the MENA biologics & biosimilars market over the forecast period owing to increasing government initiatives for vaccination campaigns that boosts thesegment growth. For instance, on October 16, 2020, the Ministry of Health (Kuwait) launched a seasonal vaccination campaign for infectious diseases such as seasonal influenza and pneumococcal pneumonia.

MENA Biologics & Biosimilars Market– Impact of Coronavirus (COVID-19) Pandemic

The COVID-19 pandemic and lockdown in various countries across the globe have positively impacted the financial status of businesses across all sectors. The biotechnology sector is one such sector that has been heavily impacted by the pandemic.

Factors such as investments, research, and development of novel medicines targeting COVID-19, as well as funding by various companies operating in the MENA are expected to drive the MENA Biologics & Biosimilars Market growth during the COVID-19 pandemic. For instance, in March 2020, the government of Saudi Arabia announced that it had donated US$ 10 million as financial support to the World Health Organization (WHO). The money is allocated for research and development of vaccines, diagnostics, and therapeutics for disease treatment. In April 2020, the Coalition for Epidemic Preparedness and Innovations (CEPI) and Gavi, the Vaccine Alliance, announced that Group 20 of Kingdom of Saudi Arabia granted US$ 150 million for the development of the COVID-19 vaccine for COVID-19 infection. CEPI is working with Curevac, Inovio Pharmaceuticals, Moderna, Novavax, The University of Hong Kong, The University of Oxford, The University of Queensland, and a consortium led by Institut Pasteur for COVID-19 vaccine development projects.

MENA Biologics & Biosimilars Market Segmentation:

The MENA biologics & biosimilars market is segmented by product type, by therapeutic application, and by region.

• By product type, the market is segmented into influenza vaccines, factor VIII, erythropoietin, aflibercept (EYLEA), ziv-aflibercept (ZALTRAP). Out of which, influenza caccines segment is expected to hold a dominant position in the MENA biologics & biosimilars market during the forecast period, and this is attributed to increasing disease awareness by government authorities.
• By therapeutic application, the market is segmented into hemophilia, age-related macular degeneration, kidney diseases, influenza, others. Out of which, influenza segment are expected to dominate the market over the forecast period due to increasing prevalence of infectious diseases in the MENA region.
• Among all the segments, influenza vaccines segment is expected to dominate the market over the forecast period, and this is attributed to the increasing initiatives by government authorities for vaccination programs in the region.

MENA Biologics & Biosimilars Market- Cross Sectional Analysis:

Among region/country, Product type segment in Gulf region is expected to dominate the market owing to the market players are focused on the increasing inorganic activities such as  agreements, which are expected to drive market growth in the region. For instance, on April 4, 2022,  Intas Pharmaceuticals Ltd. (Intas), a pharmaceutical company, signed an exclusive license and supply agreement with Axantia Holding (Axantia), a pharmaceutical company in the Middle East operating through its pharmaceutical subsidiaries, Pharma International Pharmaceutical & Chemical Manufacturing Co. Ltd. and Med City Pharmaceutical Industries, for Ranibizumab (a biosimilar of Lucentis). Under the terms of the agreement, Axantia has  marketing authorization, and can commercialize Ranibizumab in certain territories, including Saudi Arabia, Jordan, Iraq, Lebanon, and GCC countries.

MENA Biologics & Biosimilars Market: Key Developments

• On February 7, 2023, Saudi Pharmaceutical Industries & Medical Appliances Corporation announced the details of its revamped 5-year strategy. The strategy focused on building the National Champion in the Saudi pharma industry by capitalizing on long-term opportunities offered by the conducive market outlook, while aiming at improving the wellbeing of patients and benefiting all groups of the Company’s stakeholders in the long-term.
• On July 13, 2020, CanSino Biologics, a China-based vaccine developer, announced its plans for a Phase III trial of its experimental COVID-19 vaccine in Russia, Brazil, Chile, and Saudi Arabia.

MENA Biologics & Biosimilars Market: Key Trends

• Increasing inorganic activities such as agreements: The market players are focused on adopting strategies such as agreements to gain a strong foothold in the region. For instance, in November 2022, Hikma Pharmaceuticals PLC (Hikma), a multinational pharmaceutical company, announced a new exclusive licensing agreement with Celltrion Healthcare Co., Ltd. conducts worldwide marketing, sales, and distribution of biological medicines for CT-P43 (ustekinumab). CT-P43 is a monoclonal antibody that is a proposed biosimilar to Janssen’s Stelara. Under the terms of the agreement, Hikma will have exclusive rights to commercialize CT-P43 in all of its MENA markets, and Celltrion Healthcare will develop, manufacture, and supply CT-P43 to Hikma.

MENA Biologics & Biosimilars Market: Restraint

Compliance with stringent regulatory guidelines

• Regulations are sets of standards and norms that manufacturers must follow to ensure maximum public protection from developed products. Biological product regulation involves the overall management system to secure high levels of safety and quality for biological products. Stringent regulatory guidelines mandated by different regulatory bodies for biologic products are expected to hamper market growth over the forecast period. The approval of biologics follows a sequential process and involves various authorities such as the Institutional Biosafety Committees, the Institutional Animal Ethics Committee, the Review Committee on Genetic Manipulation (RCGM), the Genetic Engineering Advisory Committee, the Drug Controller General of India Office, and the Food and Drugs Control Administration. These guidelines for similar biologics provide the regulatory requirements regarding manufacturing processes and quality aspects and comparative exercise for preclinical studies, clinical studies, and post-marketing requirements.
• Counterbalance: A unified guideline must be established that is based only on scientific yet logical proposals in order to enable cost-effective development and cost reduction without compromising safety and efficacy.

MENA Biologics & Biosimilars Market - Key Players

Major players operating in the MENA biologics & biosimilars market include Pfizer, Inc., F. Hoffmann-La Roche Ltd, Takeda Pharmaceutical Company Limited, Regeneron Pharmaceuticals Inc., Sanofi, and Amgen Inc.

Definition: Biologics include medicines that generally come from living organisms, which can include animal cells and microorganisms such as yeast and bacteria. Biologics (including insulin) generally come from living organisms, so nature varies and structures are generally more complex. A biosimilar is a biologic that is highly similar to another biologic that is already regulatory-approved (known as the original biologic). It is both normal and expected for both biosimilars and original biologics to have minor differences between batches of the same medication. This means that biologics cannot be copied exactly, and that is why biosimilars are not identical to  original biologic.