Be it the expanding population, unmet medical needs, growing middle class population, longer life expectancy, lower mortality rates or rising income levels, the Middle East and North Africa (MENA) region has everything that a pharmaceutical company would want. With the rise in the global demand for quality and affordable
medicine and supplies, the future of pharma companies establishing foot in the MENA region looks promising.

Ketan Agravat, Executive Vice President – Regulatory and Quality, Mumbai-based OMSAV Pharma Research, in conversation with Vasujit Kalia, shares his expertise on the pharma market in the MENA region and feels that this region holds significant potential and a lot of untapped potential. Here is our conversation in a Q&A format.

1.Can you elaborate on MENA pharma market and the expanding labour force?

As per the latest CPhI report, MENA market is turning out to be the most sought after market for the global pharmaceutical arena. With 22 countries in its fold and over 400 million inhabitants, MENA is probably one of the most lucrative markets today. Its current market size was about $36 billion in 2016, with a projected growth rate of 10 per cent. The market value is likely to reach $50 billion by 2025. Naturally, MENA market has become an attraction for businesses in this region.

Figure 1: Moderate Growth Outlook – MENA Pharmaceutical Market Forecast (USD bn)

Figure 2: Projection of MENA’s working-age population, by level of qualification, 2010–2030

Second most striking fact about this region is the availability of labour force, A World Economic Forum (WEF) report suggested that by 2030, the region is set to expand its tertiary educated talent pool by 50 per cent (Figure 2).

As a note, youth unemployment in the MENA region stands at 31 per cent and university graduates are making up nearly 30 per cent of the total unemployed pool. Currently, youth under the age of 25 constitute nearly half of the MENA region’s population and more than a quarter of them are unemployed.

The region urgently needs to create more dignified and productive work and employment opportunities for this cohort of young women and men who have entered or will soon enter the labour force. But, this untapped labour pool can be effectively and efficiently trained for the pharmaceutical industry. In addition, the MENA region offers a doorway to the largely untapped African market.

“I firmly believe MENA region has significant potential to add up to the company portfolio with plentiful untapped opportunities, and is accessible with proper strategy, planning and effective execution under guidance of the regional experts. Additionally, huge labour pool is also waiting to be tapped.”
– Ketan Agravat, Executive VP – Regulatory and Quality, OMSAV Pharma Research

2. What is your take on the MENA region and its potential to cater to the global pharma industry?

  • Indeed, the MENA region has everything that a pharma company would want:
  • Expanding and aging population
  • Unmet medical needs
  • Growing middle class
  • The desire and the ability to pay for branded and generic therapies
  • Longer life expectancy, lower mortality rates and rising income levels.

However, I feel that although the market looks attractive, MENA region is one of the most complex markets due to its different cultures and, simultaneously the global standards are still at large to be followed. However, I firmly believe MENA region has significant potential to add up to the company portfolio with plentiful untapped opportunities, and is accessible with proper strategy, planning and effective execution under guidance of the regional experts. Additionally, huge labour pool is also waiting to be tapped.

3. How do you see the changing regulatory framework in MENA/GCC countries?

I have based my answers on the few examples given below which are seen as changing market access and improving regulatory framework for this region.

  • A country like Egypt produces 90 per cent of consumption locally and Nigeria produces almost 55 per cent products domestically. They primarily produce basic medicine, but for innovative medicine, they still rely on imports. Wealthy oil states still impor t medicinal products due to their high spending capacity.
  • The pharmaceutical industry in Tunisia has grown at an average annual rate of 15 per cent much higher than the global average. The industry produces roughly 50 per cent of country’s need for medicine.
  • Felix Pharmaceuticals is setting up a $365 million manufacturing facility in Salalah Free Zone.
  • On regulatory market front, at least four companies from Nigeria have managed to obtain WHO pre- qualification with more companies aiming for the same. It is maybe one of the first such companies from this region to obtain prestigious WHO Pre- qualification Approval.
  • Zimbabwe and Ghana are reframing their tax structure.
  • Morocco, Tunisia and Algeria have established their own domestic pharmaceutical Industry.
  • Few countries star ted accepting electronic submissions similar to eCTD.
  • The regional authorities are coming up with new/revised guidelines to implement the variations in the dossier via “variation procedures” similar to that in the US & EU region. Changes are inevitable for any regulatory submission life cycle management & economic viability of the product.
  • Pre-approval is required for all types of variations in Kuwait.
  • Pre-approval is not needed for new variation types except for Type IB in UAE
  • A new guideline is implemented on pilot scale for the variations in approved medicinal dossiers in Jordan.
    Many countries have established their own regulatory framework, however the framework still remains fragmented, and following steps are necessary.
  • A centralised registration approach is necessary in the current scenario like Gulf Cooperation Council (GCC), which covers seven member countries: Kingdom of Saudi Arabia, the United Arab Emirates, Kuwait, Qatar, Bahrain, Oman and Yemen.
  • A system for Electronic submissions of dossiers in line with that of eCTD.
  • An effective and practical guideline for variations in approved dossiers.

Few of the Gulf countries accept USFDA or EMA approved product for fast tracked approval procedure, i.e., marketing authorization approval in 30-60 days. This is an important step forward which will help needy patients gain access to innovative medicines, latest drugs and technologies, but this comes at premium of maintaining facilities as per stricter norms, various GDUFA fees, etc. This will add up to product costing.

4. Please tell more about OMSAV Pharma Research Pvt Limited and your future plans?

Headquartered in Mumbai, OMSAV is engaged in FDF research & manufacturing fully backward integrated with own API and state-of-the-art paperless research centre in the outskirts of Ahmedabad, Gujarat. This pharma company was established in 2016 by like- minded technocrats each having more than 20 years of experience in various fields like Business Development, IPR, Research, Operations, Portfolio Management, Regulatory, Quality, etc.

OMSAV aims to make significant impact on the global pharmaceutical market with its in-house developed innovative technologies and targeting US market to submit own ANDAs & DMFs with due course of time.

OMSAV’s strategy

OMSAV has opted for a business model that has an integrated approach for API and formulation due to better predict ability of the business, market sustainability and potential to explore synergetic benefits of the entire value chain. Also, the company’s business model is designed t o provide self – sustainability for research as well as pre-commercial manufacturing through a predictable partnership/ service based model.

There is a gap in the pharma industry wherein many customers in the regulatory market look for API and FDF development together by a partner wherein API can be supported by continuous research. Many of the niche products requires such solutions particularly for the US market. That is why OMSAV’s business model would be to conduct research as self-sustained by providing solutions for API and FDF together and, simultaneously OMSAV will grow its own product pipeline development in R&D with the same earning.

Expanding its portfolio, OMSAV has already created a platform for API Research (in-house) and formulation development (ANDAs) through strategic investors. The current in-house API research capabilities are planned to be integrated with formulation research within the current year. OMSAV is also planning to bring in the intermediate and API manufacturing capabilities in-house through strategic investment. Creating this capability will help control the crucial API component in supply value chain of FDF along with sustainable API SBU.