MEA Biologics and Biosimilar Market

MEA Biologics and Biosimilar Market Snapshot

The MEA biologics and biosimilar market is expected to enjoy a valuation of USD 512.6 Million in the year 2023, and further expand at a CAGR of 5.5% to reach a valuation of ~USD 875.6 Million by the year 2033. According to a recent study by Future Market Insights, adalimumab in the drug segment is leading the market with a share of about 36.7% in the year 2022, within the MEA market.

Market Outlook:

Data Points	Market Insights
Market Value 2022	USD 485.9 Million
Market Value 2033	USD 875.6 Million
CAGR 2023 to 2033	5.5%
Market Share of Top 5 Countries	87.2%
Key Market Players	AbbVie Inc.; Eisai Co Ltd; Zydus Cadila(Cadila Healthcare); Amneal Pharmaceuticals, Inc.; Pfizer Inc.; Celltrion, Inc.; Coherus BioSciences, Inc.; F. Hoffmann–La Roche Ltd (Genentech, Inc.); Alexion(AstraZeneca); Johnson & Johnson; Amgen; and Hikma pharmaceuticals plc.

Sales Analysis of MEA Biologics and Biosimilar Market from 2017 to 2022 Vs Market Outlook for 2023 to 2033

The market value for MEA biologics and biosimilar market was approximately 3.1% of the overall ~USD 15.4 Billion global biologics and biosimilar market in 2021.

The most common cancers are breast cancer, lung and bronchus, colon and rectum, prostate, stomach, liver, cervix uteri, oesophagus, thyroid, and bladder.

to improve cancer patient care and ensure sure they have access to more effective, convenient, and affordable treatment options. MEA's expansion in oncology innovation is being fuelled by a flurry of new, oncology–focused biotech businesses and increased cancer research.

due to the rising incidence of numerous cancers, the market for biosimilar drugs is anticipated to expand in this region.

Manufacturers of biologics are adopting various strategies to respond to potential entrants in biosimilars.

Pharmaceutical manufacturers are concentrating on ways to broaden and improve formulations, dosing, expression systems, and delivery mechanisms.

For MabThera, for instance, Roche created a novel subcutaneous formulation that reduces treatment time from 2.5 hours to 5 minutes. This can enhance patient adherence and healthcare results.

To remain competitive and ensure a robust product pipeline, leading biopharmaceutical companies are continuing to focus on the development of innovative drugs associated with regular treatments and technologically advanced healthcare solutions to increase the adoption rate.

Over the next ten years, originator biologicals' patents and other intellectual property rights will expire, thus creating opportunities for biosimilars to enter the market and raising industry competition.

Governments using biosimilars as a less expensive alternative to cut healthcare costs is fueling demand. The value of the industry is also rising due to government initiatives, strategic partnerships, and an increase in the incidence of new diseases.

The market share of biosimilars is also growing as a result of deeper penetration into emerging markets in MEA countries.

New product approvals are expected to drive the market and provide prospects for manufacturers to present a diverse and innovative product portfolio.

There are several clinical trials ongoing for the development of biosimilars that have proved to be a better alternative to biologics. For instance, manufacturers are focused on the development of trastuzumab and rituximab biosimilars; some of these are approved, and others are still in the development stage.

Thus, the switch to biosimilars has the potential to have a significant impact. Moreover, developing nations require biosimilar drugs, as compounding pharmacies are extremely rare in these countries, which creates a huge market for manufacturers of biosimilars

Thus, owing to the forenamed factors, the MEA biologics and biosimilar market is expected to grow at a CAGR of 5.5% during the forecast period from 2023 to 2033.

What are the Key Opportunities for the Manufacturers Operating in MEA Biologics and Biosimilar Market?

Ustekinumab surpassed other medications in terms of annual increases in medical inflation-adjusted prices. Innovative strategies, such as the creation of biosimilars to improve patient access to care, are essential for reducing cost growth above inflation.

Global industry leaders are developing extended indications for already licensed biologics. The strategic approach involves the extension of the indication by conducting additional clinical investigations on the licensed biologics candidate.

The most advanced portfolios of biologics and biosimilars are held by early market leaders including AbbVie, Eisa Co Ltd., and Janssen Pharmaceuticals, a division of Johnson & Johnson.

According to WHO (2022), Non-communicable disease mortality is dramatically increasing in Middle Eastern and African (MEA) nations. 74% of all deaths in MEA are caused due to non-communicable diseases, which cause more than 38 million deaths annually worldwide.

For non-communicable diseases with a high prevalence, like cancer, diabetes, and rheumatoid arthritis, biosimilar drugs are readily available across major therapeutic categories.

The global picture of biologic therapy access is still uneven across high–income and low-income nations, and it reflects other inequalities in infrastructure, infrastructure, and economy.

The reinvestment of savings related to lower costs on biosimilar medicines compared to innovator biologic drugs has resulted in improved and more equitable access to biologic therapies and to healthcare in general in various countries.

This can be considered an opportunistic factor for the manufacturers operating within the MEA biologics and biosimilar market.

What are the Factors Restraining Demand for MEA Biologics and Biosimilar Market?

The number of manufacturers that can successfully launch biosimilar pharmaceuticals on the market in various nations throughout the world is constrained by prolonged, expensive, ineffective, and diverse regulatory approval procedures.

Despite the approval of the WHO Similar Biotherapeutic Product (SBP) guideline in 2009, several countries have failed to actively accept and execute the WHO's recommendations for biosimilar medicines.

There are a variety of off-patent biologic drugs available in low- and middle-income countries (LMICs), some of which are quality-assured biosimilars by WHO guidelines, but others are not, creating complexity. The level of regulatory maturity varies substantially throughout the Middle East and Africa (MEA) region.

Thus, stringent government regulations can be a major hindrance that can restrict the market growth in MEA.

Biologic therapeutics are not always accessible to eligible patients, due to high co–payments, limited or non–existent utilization, and/or lack of reimbursement for the original biologic product.

A significant portion of the population in the United Arab Emirates (UAE) is covered by private payers. The complexity of providing affordable access is increased by the growth of private payers and health insurance programs.

Many physicians prefer to be loyal to the original pharmaceutical manufacturers, whose products they are familiar with and have used for years. The utilization of biosimilar medications remains limited even when a payer adds one to their regimen.

Therefore, the lack of reimbursement for the costlier biologics can limit the use of biologics in the MEA region.

The mentioned factors collectively propose an adverse effect on the developmental growth of the MEA biologics and biosimilar market.

Country-wise Insights

What Makes the KSA a Large Market for the Biologics and Biosimilar?

The KSA accounted for around 34.1% market share in the MEA biologics and biosimilar market in 2022, and a similar trend is expected over the forecast period.

KSA is evolving towards a more favorable environment for significant uptake of biosimilars, taking into account growing government emphasis on enhancing patient access to medications, financial restrictions, and the presence of a regulatory framework. The availability of medications in the KSA biologics and biosimilar market has increased as a result of expectations that KSA will be the most lucrative nation in the biologics and biosimilar industry.

What Makes the UAE a Highly Lucrative Market for Biologics and Biosimilar?

In 2022, UAE held the highest market share of about 19.3% 2022 in the UAE biologics and biosimilar market.

There has been increased investment by local and regional companies in the biosimilar space considering the untapped opportunity UAE in partnership with Biocad, Sedico. Anticancer biologics are also used in the region because cancer is now the second most frequent cause of death, after heart disease.

What is the Outlook for Kuwait in the biologics and biosimilar Market?

Kuwait held approximately 14.8% market share in the MEA biologics and biosimilar market in 2022. Because of the expanding population and rising medication demand, Kuwait is developing quickly. Nowadays, the perspectives of stakeholders, physicians, and pharmacists have changed. Their strong conviction in generics and biosimilars is rising as a result of their low cost and convenient administration manner.

Category-wise Insights

Which Drug is Driving Market Growth?

The adalimumab segment in the drug category of the MEA biologics and biosimilar market accounts for a market share of about 36.7% in the MEA market in 2022.

Patients with moderate to severe active psoriatic arthritis benefit from adalimumab treatment, which lessens joint and skin symptoms of the condition as well as disability brought on by joint destruction. Adalimumab shows a quick onset of effect and continued efficacy over the course of treatment.

Which Drug Class in the MEA Biologics and Biosimilar Market is Largely in Focus Globally?

The TNF Alfa Inhibitors in the drug class segment have become more and more popular, accounting for the greatest proportion of 29.1% in 2022. TNF-alpha inhibitors can be helpful for a variety of inflammatory conditions, including psoriasis, spondyloarthritis, rheumatoid arthritis (RA) and inflammatory bowel disease (IBD). TNF-alpha inhibitors offer a targeted approach in contrast to the non-specific immunosuppressive medications that are frequently utilised to treat the bulk of inflammatory diseases.

Which Dosage Form is Preferred within the MEA Biologics and Biosimilar Market?

The subcutaneous dosage form segment accounts for around 52.2% of the global market share in 2022. Individuals or healthcare professionals utilizing a variety of different drug delivery systems can administer therapeutics subcutaneously. SC administration lowers the fixed expenses associated with running a medical facility because it allows patients to self-administer in outpatient or home settings. The anatomical infusion location is flexible with SC administration, and alternatives include the stomach, thighs, and backs of the arms.

Which Indication is Largely in Focus in the MEA Biologics and Biosimilar Market?

Arthritis in the indication segment accounts for a global market share of around 28.2% in 2022. A person's total function and mobility may be impacted by arthritis, which may lead to activity and other limits. According to recent studies, the likelihood of developing arthritis increases with age, body mass index, physical inactivity, and declining physical and mental health. Adults who are unable to work, incapacitated, or have fair or poor self–rated health have the highest rates of arthritis.

Which Distribution Channel is Preferred the Most for Sales within the Biologics and Biosimilar Market in MEA?

With 85.1% of the market share, the institutional sales segment in the distribution channel category dominated the MEA biologics and biosimilar market in 2022. Institutional sales leaders from the biotech, pharmaceutical, and medical device sectors collaborate with GPOs, ACOs, and IDNs to launch successful products across the country, thus propelling segment value.

Competitive Landscape

The leading players invest in several product launches, expansions, partnerships, mergers, and acquisitions to increase their market share globally and enhance their business strategies. The major companies in the MEA biologics and biosimilar market have embraced these as their top–tier primary promotional methods.

• Abbott Operations Uruguay S.R.L. and Shanghai Henlius Biotech, Inc. announced their semi-exclusive licencing agreement in May 2022 for the marketing of Henlius' independently developed HANLIKANG (rituximab) and HANQUYOU (trastuzumab, also known as Zercepac® in Europe) in Brazil.
• Ligand Pharmaceuticals Corporation (Ligand) acquire Pfenex Inc. (Pfenex) in September 2020. Pfenex is a producer of biosimilar medications such teriparatide, ranibizumab, and pegfilgrastim.

Hikma Pharmaceuticals announced in July 2022 that it has signed a marketing agreement for Celltrion's YuflymaTM drug.

Similarly, recent developments have been tracked by the team at Future Market Insights related to companies in the MEA biologics and biosimilar market space, which are available in the full report.

Report Scope as per MEA Biologics and Biosimilar Industry Analysis

Attribute	Details
Forecast Period	2023 to 2033
Historical Data Available for	2017 to 2022
Market Analysis	USD Million for Value & Volume (Units)
Key Region Covered	Middle East & Africa
Key Countries Covered	UAE, Bahrain, Iraq, Jordan, Kuwait, Lebanon, Oman, Qatar, KSA, Iran, and Palestine
Key Market Segments Covered	Drug, Drug Class, Dosage Form, Indication, Distribution Channel and Country
Key Companies Profiled	AbbVie Inc.; Eisai Co Ltd; Zydus Cadila(Cadila Healthcare); Amneal Pharmaceuticals, Inc.; Pfizer Inc.; Celltrion, Inc.; Coherus BioSciences, Inc.; F. Hoffmann–La Roche Ltd (Genentech, Inc.); Alexion(Astrazeneca); Johnson & Johnson; Amgen; Hikma pharmaceuticals plc.
Pricing	Available upon Request

Key Market Segments Covered in MEA Biologics and Biosimilar Industry Research

Drug:

• Adalimumab
• Bevacizumab
• Trastuzumab
• Ustekinumab
• Golimumab
• Eculizumab
• Rituximab

Drug Class:

• Antirheumatics
• TNF Alfa Inhibitors
• VEGF/VEGFR Inhibitors
• HER2 Inhibitors
• Selective Immunosuppressant’s
• Interleukin Inhibitors

Dosage Form:

• Subcutaneous
• Intravenous

Indication:

• Cancer
• Arthritis
  • Rheumatoid
  • Psoriatic
  • Others
• Skin Disorders
  • Plaque-Type Psoriasis
  • Hidradenitis Suppurativa
• Inflammatory Bowel Disease (IBD)
  • Crohn's Disease
  • Ulcerative Colitis
• Rare Disease
• Others

Distribution Channel:

• Hospitals
  • Specialty Clinics
  • Cancer Research Centers
• Retail Sales
  • Retail Pharmacies
  • Mail Order Pharmacies /Online Sales

Country:

• UAE
• Bahrain
• Iraq
• Jordan
• Kuwait
• Lebanon
• Oman
• Qatar
• KSA
• Iran
• Palestine

Frequently Asked Questions

How Large is the Market Presently?

The overall market value is estimated to be around USD 875.6 million in 2023.

Who are the Leaders in the Market?

AbbVie, Eisai, and Zydus Cadila are some top service providers in the MEA market.

Which is the Size of the Market in KSA region?

KSA leads and accounted for 34.1% of the total sales in MEA in 2022.

What is the Key Market Strategy in MEA?

Improving patient access to healthcare and reducing cost growth above inflation.

Which Drug Segment Dominates the Market?

The adalimumab drug segment accounted for 36.7% of the regional market in 2022.