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Rest of World Services

Tridents global network and unique value proposition combines technical with commercial and operational skills to form a one-stop solution to biotech, pharma and MedTech companies that provides a launchpad for regional development of the current biotech boom. Our mission and vision are to support successful access of medicines to regions where traditional market access has been poor due to complex regulatory, political, cultural and payor requirements.
 
What sets us apart from other service providers is, aside from our technical consulting arm, we operate further up the value chain and are actively involved in supporting commercial infrastructure for launch of key pharma assets both in the EU/USA but also in Rest of World (RoW) countries where there is currently an increased appetite for biosimilars, orphan drugs and speciality formulations. The current industry focus on rare disease and orphan drugs means traditional market access decisions by sponsors needs to include RoW regions due to the low patient population in western markets, i.e., monetizing an orphan asset quicker means looking at the wider market sooner than later relative to "normal" products.

The pandemic has forced government policies to focus on restructuring and reduction of regulatory and commercial burdens for healthcare assets. The team at Trident understands this “paradigm shift” and we actively seek partnerships with companies that are looking to launch products in key regional markets. We do not subscribe to a “one size fits all” policy and our expertise is in guiding clients to a commercialization plan that is driven by cultural, regulatory, patient and payor needs which can only be done by having local knowledge that can balance the risk associated with penetrating new markets.
 
We are constantly growing our alliance network and currently can provide full-service support in the following RoW markets in addition to our core markets of EU, North America and Australia

Middle East & North Africa (MENA)

Trident BioPharm Solutions

The MENA region is still “untapped” and has massive potential for the biopharmaceutical market, not just in terms of sales in the region (> 60 billion USD) but also for establishment of a local/regional manufacturing base.
 
TBS leverages the following trends to support growth for companies looking to enter the MENA region:
 

  • In recent years, there has been an increase in investments in the biopharmaceutical sector driven by legislative changes to reduce dependence on imports and maturation of the private sector – this now includes now a more refined clinical trial/operations infrastructure in places like United Arab Emirates (UAE), which is a key driver of organic biopharm growth

  • Increased public/private spending on healthcare and hospital/pharmacy supply chain

  • Restructuring of health insurance and reimbursement schemes in several key economies in the GCC and North Africa.

  • An increase in chronic diseases in the region that has resulted in strong demand for access to healthcare

  • A geopolitical shift in the region to move away from an oil-led economic policy to a more diversified industrial base in technology, finance and healthcare, e.g., roll out of Saudi Arabia’s vision 2030 and UAE industrial strategy 2030, which includes specific growth objectives to grow the healthcare/pharma sector

2

China 

Trident BioPharm Solutions

The Chinese pharmaceutical market is currently experiencing its “golden age” and is undergoing a dynamic and explosive growth period. For the past decade, global development plans (which often “skipped” China) have needed to reshape their strategy to tap into the full commercial potential in the region. Constantly changing legislation, political uncertainty driven by the covid pandemic, as well as number of compliance scandals, has led to much needed regulatory reform in China.
 
The implementation of the updated GMP guidelines (environmental discharge compliance), policy adjustment to intellectual property, pricing (adjustments every 3 years), and clinical trial data means an increased cost of goods for most sponsors in this market. Internal and external pressures to improve the quality aspects of Chinese made products also means a higher regulatory burden than 10 years ago. In essence, market regulation of the pharmaceutical industry in China is relatively strict, especially market entry and price control.
 
TBS recommends partnering discussions “earlier” in development life cycles when thinking about China to help secure best value.

Specific areas in China showing considerable market opportunities include:

  • Surge in the biologics and ATMPs sector backed by mega mergers and cross border collaboration

  • Increased sales growth across the board (MedTech and Pharma)

  • Rural and Suburban areas becoming more relevant due to gentrification

  • Off-patent generic growth (with increased enforcement)

  • Increased shift to home-grown manufacturing in China, with a shift away from just Active Pharmaceutical Ingredient’s (API/DS) but also Finished Products (DP/FP) for both small and large molecules

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