Author | Lightnews

HazemYacoub @hazemyacoub.bsky.social · 3h

For MENA pharma companies looking to expand beyond their own borders, the EU holds plenty of opportunities.

But these opportunities aren't without complexity. Understanding the different expansion pathways available will help you plan an expansion that fulfils your needs.

Regulatory Pathways for Pharma Expansion into the EU - Insuvia

Learn how MRP, DCP, and RUP shape EU pharma expansion. Choose the right regulatory pathway to control cost, speed approvals, and reduce risk.

insuvia.com

HazemYacoub @hazemyacoub.bsky.social · 2d

AI-powered drug discovery is rapidly gaining attention, and oral solid dosage forms are leading the segment.

As one of the most commercially viable dosage forms for manufacturers, AI-assisted drug formulation is only going to create more opportunities for manufacturers to grow.

AI-Powered Drug Formulation Market Insights and Analysis

The global AI-powered drug formulation market AI-driven drug formulation enhances healthcare outcomes by optimizing R&D, reducing costs, and accelerating next-generation therapeutic discoveries.

www.precedenceresearch.com

HazemYacoub @hazemyacoub.bsky.social · 2d

Chronic diseases are on the rise in the MENA region, which is fuelling the expansion of clinical trials. With this expansion comes more locally relevant clinical data, allowing drug developers to identify unmet medical needs and explore ways to translate these into pharmaceutical opportunity.

HazemYacoub @hazemyacoub.bsky.social · 7d

The market for simple oral solids is oversaturated, but there are still plenty of opportunities in more complex OSDs. By perfecting complex generics, manufacturers can escape the intense price pressure traditionally associated with OSDs while still delivering convenient dosage forms for patients.

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HazemYacoub @hazemyacoub.bsky.social · 9d

Infrastructure and a lack of healthcare spending are no longer holding back emerging markets, which accounted for ~40% of pharma revenue growth in 2024. The biggest challenges now will be regulatory variability and supply chain vulnerabilities, but strategic firms can easily navigate these.

Emerging Market to Reach USD 2.92 Trillion by 2034

The global emerging pharmaceutical and healthcare markets are at a transformative inflection point As healthcare systems in Asia Pacific Latin America Africa and the Middle East modernize these regions are no longer peripheral participants in the global health economy they ...

www.openpr.com

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HazemYacoub @hazemyacoub.bsky.social · 11d

Egypt's plans to localize pharma manufacturing aren't just designed to strengthen the nation's pharmaceutical security, but also to position it as a regional leader.

By boosting both pharma infrastructure and investment in talent, Egypt is setting the stage for growth.

Egyptian Drug Authority outlines strategy to localize pharma manufacturing - Dailynewsegypt

The Egyptian Drug Authority (EDA) recently held its 16th Board of Directors meeting, led by Ali El-Ghamrawi, Head of the Authority, at its headquarters in the New Administrative Capital. This gathering was part of ongoing efforts to advance Egypt’s pharmaceutical sector, enhance local manufacturing, and bolster the nation’s pharmaceutical security. A key focus of the

www.dailynewsegypt.com

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HazemYacoub @hazemyacoub.bsky.social · 14d

North American drug manufacturers are using AI to enhance the manufacturing process and boost resilience during a time of uncertainty, which raises the question: could AI be the key to strengthening the global industry against disruption?

HazemYacoub @hazemyacoub.bsky.social · 16d

In drug manufacturing, control and consistency matter.

But as drugs get more complex, maintaining this using traditional methods becomes more difficult, and companies may find themselves struggling with yield losses.

But AI-enabled digital twins could be the key to eliminating these issues.

HazemYacoub @hazemyacoub.bsky.social · 18d

Despite all the challenges facing the global pharmaceutical sector, there's no doubt that healthcare will always remain a top priority across the globe.

That sentiment is fuelling international expansions into the MENA region, particularly for US firms looking for greater stability.

From West to East: building biotech bridges across APAC and the Middle East

Amid rising geopolitical uncertainty, US biotech companies are looking beyond tariffs and trade tensions to expand into Asia-Pacific and the Middle East

manufacturingchemist.com

HazemYacoub @hazemyacoub.bsky.social · 21d

Oral solid dosage forms don't have to be inflexible.

By combining double-dipping, enteric coating, 3D printing, and injection molding, pharma manufacturers can unlock a new level of formulation flexibility and personalization. Make that your competitive advantage.

Next generation Capsules: Emerging Technologies in Capsule Fabrication and Targeted Oral Drug Delivery

Capsule-based drug delivery has undergone significant advancements, offering enhanced protection for active pharmaceutical ingredients (APIs) and enab…

www.sciencedirect.com

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HazemYacoub @hazemyacoub.bsky.social · 23d

Solid tablets are popular, but for children, the elderly, and disabled patients, they can be difficult to swallow

Fast-melt tablets are helping to eliminate that problem, and pharma companies that embrace them are finding new opportunities to capture greater market share.

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HazemYacoub @hazemyacoub.bsky.social · 25d

Antitrust action in Europe's pharma industry is heating up, with the European Court of Justice's decision on Teva underlining the importance of getting communication and patent strategies right. MENA-based companies looking to enter the market will benefit from paying close attention.

Antitrust in life sciences—key European developments for pharma companies

We round up the most important recent events in the antitrust space that life sciences companies should be aware of.

www.aoshearman.com

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HazemYacoub @hazemyacoub.bsky.social · 26d

I still believe Comapnies have fragmented departments and everyone is focused on its own objectives, few have effecient PMO office and tools that can solve this

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HazemYacoub @hazemyacoub.bsky.social · 28d

For European #biopharma companies, the Middle East represents a new horizon.

Getting this expansion right will depend on your ability to adapt, not just to MENA's unique regulatory environment, but also to it's local norms and dynamics.

#MarketEntry #GlobalExpansion

AIM presents guide for biopharma expansion into the GCC region

For biopharma companies looking to grow, international expansion is key.

www.consultancy-me.com

HazemYacoub @hazemyacoub.bsky.social · Oct 1

#OralSolidDosage manufacturing is complicated.

But instead of turning to other #DosageForms, manufacturers are enlisting the help of #CDMOs—and it's starting to pay off.

Source: https://uk.finance.yahoo.com/news/oral-solid-dosage-manufacturing-market-081500236.html

#Pharma

HazemYacoub @hazemyacoub.bsky.social · Sep 29

Slow and steady wins the race.

As #OralSolids manufacturers prioritize speed to clinic, they can't afford to forget the importance of front-loaded #RiskIdentification. The earlier you spot a compound's red flags, the easier it is to work around them.

#DrugDevelopment

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HazemYacoub @hazemyacoub.bsky.social · Sep 26

Planning to hand over your high-potent #OraldSolidDose manufacturing to a #CDMO?

There are a few steps you need to take to make sure everything goes smoothly, starting with establishing a robust project management framework.

#Pharmaceuticals #Manufacturing

Six Essential Steps Identified for Transferring High-Potent Oral Solid Dose Drug Manufacturing to CDMOs - GeneOnline News

A recent analysis highlights six critical steps for suc […]

www.geneonline.com

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HazemYacoub @hazemyacoub.bsky.social · Sep 24

How do you develop an #OralSolidDosage form for a poorly soluble drug?

Despite technological advancements, this challenge remains a key barrier in #DrugDevelopment. However, that could soon change. By using AI to identify potential formulations, we may be able to speed up the process.

#Pharma

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HazemYacoub @hazemyacoub.bsky.social · Sep 22

#DrugManufacturers in Europe shouldn't overlook the value of entering the MENA market.

By commercializing 3 #biosimilars in the region, Polpharma Biologics is tapping into an underutilized market and bringing better MS treatment to everyone.

#Pharmaceuticals

Partnership to bring Ocrevus biosimilar drug for MS to MENA region

A new partnership will bring three new medications to the Middle East and North Africa, including an Ocrevus biosimilar drug for MS patients.

multiplesclerosisnewstoday.com

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HazemYacoub @hazemyacoub.bsky.social · Sep 19

The global #pharma market is set to grow at a CAGR of 7.7% until 2033, making this an excellent time for companies to invest in their own growth.

For companies looking to expand into new markets, #Europe offers a stable and resilient market thanks to its mature health systems.

#GlobalStrategy

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HazemYacoub @hazemyacoub.bsky.social · Sep 17

Highly potent APIs don't come without risk. The need to avoid operator exposure and environmental and cross-contamination when handling these ingredients is only making #OralSolidDosage manufacturing more difficult.

Could investing in AI and IoT-powered contamination control be the solution?

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HazemYacoub @hazemyacoub.bsky.social · Sep 15

"Race to the bottom" approach to #OralSolidDosage generics pricing is driving up shortage risks.

These lower prices yield thinner profit margins, which is leading to earlier market exits and increased supply instability. What can we do to fill the gap?

#DrugShortages #Pharma

Long-Lasting Drug Shortages Highlight Fragile Supply Chains and Systemic Market Pressures

Drug shortages challenge US health care, driven by systemic issues like low pricing and manufacturing concentration, impacting patient care and safety.

www.pharmacytimes.com

HazemYacoub @hazemyacoub.bsky.social · Sep 12

Did you know that #OralSolids account for 88% of all oral drug delivery?

Innovation in controlled-release formulations is helping to sustain this dominance, creating new opportunities for smaller firms to leave their mark on the market at the same time.

#MarketTrends #Pharmaceuticals

HazemYacoub @hazemyacoub.bsky.social · Sep 10

Getting ready to expand into European markets? You'll need to be aware of the changes introduced by the EU's #PharmaPackage.

Although some areas will stay the same, especially when it comes to #advertising, there are some important changes that could make or break your next launch.

#Pharma

The New EU “Pharma Package”: Advertising – A Comparison of Commission/Parliament/Council Positions

In this ninth and final alert in our weekly series on the EU Pharma Package, we consider the proposals of the European Commission, European Parliament and the Council of the EU as regards the…

www.crowell.com

HazemYacoub @hazemyacoub.bsky.social · Sep 8

#ContinuousManufacturing is at the very heart of #OralSolids manufacturing, but that doesn't change the fact that it's complex.

The integration of #AI and machine learning tools will help ease some of these challenges, paving the way for greater efficiency and improved product quality.

#Pharma

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