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We are constantly confronted with emerging scientific breakthroughs that make us wonder what the future holds and whether what we have now is still relevant or should be superseded.

Consider this…

Cassettes were a staple of many of our childhoods growing up in the twentieth century. Audio or video cassettes are now largely redundant in the entertainment industry, having been replaced by more complex and sophisticated memristors*, which deliver ultra-high-definition pictures and films to viewers. In our society, which values innovation, technological change is unavoidable. Similarly, the pharmaceutical industry is undergoing its own scientific revolution as new biologic drugs emerge. Are biologics the pharmaceutical industry’s equivalent of memristors? Will conventional drugs, like cassettes, fade into obscurity?

From conventional medicine to biologics: A Journey

Chemists manufacture conventional medicines in enormous factories utilizing other chemicals as the basic ingredients. Their molecules have distinct, straightforward structures. It’s a different story with biologic medicines. A biologic is created using a biological system, such as a plant, animal, or microbial cell. The majority of biologics are composed of many, extremely complicated components. Recombinant DNA technology is used to manufacture numerous biologics.

Do we comprehend what is meant by biologics?

“The product is the process” in the case of biologics. Manufacturers must guarantee product consistency, quality, and purity by making sure that the production process stays mostly the same throughout time because the completed product cannot be adequately defined in the laboratory. Contrarily, a medicine manufacturer can significantly alter the manufacturing process and evaluate the final product to confirm that it is identical to what it was prior to the manufacturing alteration.

What’s in Store for Biologics in 2031?

We seem to be entering the era of biologics, despite the fact that conventional therapeutics have dominated the pharmaceutical market since the advent of modern medicine. For instance, five of the top ten medications sold worldwide in 2021 were biologics.

Do biosimilars count as biologics too?

One of the markets for prescription products with the greatest growth is biologics. A biosimilar is a biologic product created to be strikingly similar to a reference medicine that has already received FDA approval. Biosimilars, like generic medications, are intended to be interchangeable with the biologic they aspire to replace. FDA’s approval of further interchangeable biologic drugs and biosimilar drugs may help close the gap. Patients will have more options for treatment and perhaps more affordable alternatives.

Realizing the Middle East’s Biologic Potential

Given the recent growth of biologic sales, the MEA market is still regarded as precocious in terms of the acceptance of biosimilars and is emerging as an appealing region with potential for biosimilars. Compared to traditional generics, the biosimilar market requires a distinct strategy for success. Estimating the genuine potential of biosimilar products is challenging since market realities diverge from theoretical predictions.

Looking ahead, 2020-2030 will be a watershed moment in the global healthcare arena, with an increase in biologics acceptance across multiple therapy areas and the rise of biosimilars.

*Digital memory, logic circuits, biological, and neuromorphic systems all use memristors. They are equipped with the capacity to easily and efficiently store both analogue and digital data.

Source: Pharma state – www.pharmastate.academy

 

 

Introduction

Molecular diagnostics (MDx) is the application of the molecular biology technique used in the study of human diseases, including infectious diseases, inherited conditions as well as cancer. The molecular diagnostics research focuses on genomic and proteomic analysis to identify the disease biomarkers, thereby creating better diagnostic assays that ultimately find new treatments and potential cures. The techniques used in the molecular diagnostic applications comprise core molecular biology methods, for instance, nucleic acid isolation and quantification, PCR amplification, sequencing, and STR analysis.

MDx utilizes powerful tools such as gene expression profiling, DNA sequence analysis, and the detection of biomarkers to determine the susceptibility of individuals to certain diseases or an existing disease stage. Various conventional tests have been replaced by molecular testing methods in many areas of laboratory medicine, including clinical chemistry, infectious diseases, cancer, and clinical genetics. Molecular diagnostic testing will continue to enhance the accuracy and speed with which the detection of microbial infections or study of a patient’s genes is possible and is becoming an increasingly important part of patient-tailored treatments and medicines. It is one of the essential techniques used in hospitals, clinical laboratories, and other healthcare modalities for the identification and analysis of disease.

The molecular diagnostics market in the MENA region is undoubtedly the most rapidly rising segment of the in vitro diagnostics industry owing to the various developments in the reagents, kits, and instruments, along with the introduction of a wide array of newer products for the disease management. The introduction of cost-effective and automated systems comprising developed amplification methods will also drive the rate of market penetration and growth.

Speaking of the COVID-19 impact on the MENA healthcare sector, MENA countries have made several updates to their healthcare sector. For instance, the UAE healthcare sector has undergone substantial infrastructure and procedural changes to elevate itself as a global leader in healthcare service providers. As per the Dubai Health Authority report 2021, in order to expand capacity for COVID-19 patients, the UAE government created many field hospitals. On April 18, 2020, the Dubai Field Hospital in the Dubai World Trade Center (DWTC) opened its doors. Four field hospitals were opened in the northern emirates by the end of April 2020, expanding capacity by 5,000 beds. The improvements have been more recently recognized during the COVID-19 pandemic as there have been continued investments made to improve the sector’s hard and soft infrastructure. The UAE government also launched an interactive health map that includes data for 13 drive-through COVID-19 testing centers in addition to hospitals, healthcare centers, and clinics across the country. Thus, with the rise in facilities, the demand and need for testing will also increase, subsequently increasing the demand for analyzers and kits, which is expected to positively impact the market.

Along with significantly impacting the healthcare operations in the region, COVID-19 has entailed tightening of financial operations, which has decreased the economic activity in the region. However, although this situation is likely to continue for a while, the leading healthcare payers are constantly making investments, building partnerships, and exploring acquisition feasibility in an effort to expand the business models and contain costs as the world shifts to hybrid care models in the future.

Of note, the UAE in 2020 reported an increase of 8% in the insurance premiums, thereby accelerating the inflation rate. The Dubai healthcare expenditure is also rising, and the regional payers are modifying the reimbursement policies to accelerate the shift to value-based reimbursement models.

 

Molecular Diagnostics Market drivers in the MENA

The MDx market in the MENA region is driven primarily due to the rising prevalence of infectious diseases and various cancers and the increase in research and development activities and funding in the molecular diagnostics domain. Traditionally, culture-based techniques are considered to be the gold standards for pathogen detection. However, the longer turnaround time associated with these techniques due to the overnight culturing and the pathogen isolation tends to limit the demand up to a certain extent. In the past few years, the development and application of molecular diagnostic techniques have resulted in a revolution in diagnosing and monitoring the infectious form of diseases. The product launches and acquisitions pertaining to the molecular diagnostics market are also considered the most widely adopted market strategies by the market players.

The molecular diagnostic testing for the COVID-19 has been considered the key to the global response to the COVID-19 pandemic. Since testing remains a crucial step in the containment of the disease, the government organizations in all the countries in the MENA region are thereby supporting the laboratories in streamlining the COVID-19 testing procedures. In line with this, the specific country regulatory authorities have utilized the methods to speed up the approval of the molecular diagnostic products. Moreover, major companies have undertaken strategic development initiatives to introduce COVID-19 rapid tests and nullify the impact of the COVID-19 on their operational capabilities, thereby helping in the containment efforts to mitigate the COVID-19 pandemic. Apart from that, the severity of the crisis and the rising capacity issues associated with PCR-based testing have also accelerated the development of rapid diagnostic solutions to meet the demands for mass testing. Consequently, companies have also scaled up their operations for the testing and tracking of the COVID-19.

The rising healthcare expenditure and the rising adoption of the analyzers and software for molecular diagnostics will also create an opportunity for the Middle East and African Molecular Diagnostic market. Further, rising awareness about prenatal genetic testing for the early detection of chromosomal abnormalities during pregnancy has also led to an enhancement in the use of molecular diagnostics in the MENA region.

Epidemiological insights in MENA countries that demand Molecular Diagnostics

• According to the International Diabetes Federation (IDF), the adult diabetes prevalence in 2021 was 18.7% in Saudi Arabia. IDF reported Saudi Arabia to be the seventh-highest country for new cases of type-1 diabetes every year.
• As per the GLOBOCAN statistics in the year 2020, the number of new cancer cases in Saudi Arabia had accounted for about 27,885 people and the number of deaths due to cancer was observed to be 13,069.
• As per the World Bank statistics in 2019, the incidence of people suffering from tuberculosis was 9.9 per 100,000 people in Saudi Arabia.
• As per the World Bank Statistics, the incidence of people suffering from tuberculosis was 1 per 100,000 people in the UAE in 2020.
• As per the World Bank Statistics, the incidence of people suffering from tuberculosis was 8 per 100,000 people in Saudi Arabia in 2020.
• According to the research article “Seroprevalence of Viral Hepatitis B and C among Blood Donors in the Northern Region of Riyadh Province, Saudi Arabia,” in 2021 written by Alqahtani et al., the overall prevalence of HBV and HCV in Saudi Arabia accounts for 3.2%, and 1.2% respectively for the year 2020.

Due to the factors mentioned above, including a surge in chronic disorders and infectious diseases, the market for diagnosis and monitoring of such diseases is expected to expand in the MENA region. Moreover, as the COVID-19 outbreak has led to a sense of urgency worldwide, including the MENA region, molecular diagnostic techniques have become indispensable to cater to the increased demand for SARS-Cov2 diagnosis.

The MDx technology will revamp the healthcare scenario of the Middle East countries. Even the molecular diagnostic technology will be paramount in completing the vision of an integrated healthcare system proposed by the Saudi government, thereby instigating operational efficiency and cost savings across public and private healthcare ecosystems.

Steps that were taken by the various governments in MENA to raise awareness regarding molecular diagnostics testing

Various steps have been taken specifically by various governments of the MENA region to improve the molecular diagnostics market in the MENA region. In response to the growing demand for molecular diagnostics in the MENA countries, the national and international governments across the MENA countries have taken key initiatives such as increasing insurance coverage towards a “universalized coverage” system, construction of 50–60 major hospitals, rising private-sector involvement, and investment in healthcare services. These initiatives are instrumental in the increase in molecular diagnostics demand and forecasted growth of the molecular diagnostics market in the MENA regions. For instance, in Saudi Arabia, the Saudi Ministry of Health has planned an expenditure of approximately SAR 23 Billion on the upcoming initiatives within the healthcare industry in the coming years. The Saudi Arabian government has also set the target for privatizing around 295 hospitals and 2,259 healthcare facilities by 2030, as per the Saudi Vision 2030 plan. Thus, due to the privatization of hospitals to address the rising demand for healthcare by the population and the continued spike in the levels of infectious diseases amongst the population, there will be greater demand for the molecular diagnostics devices in the healthcare facilities, thus improving the molecular diagnostics market in Saudi Arabia.

Also, on January 13, 2022, HiberGene Diagnostics, Ireland’s leading diagnostics manufacturer, launched an innovative PCR adapt COVID-19 test at the Arab Health 2022. Moreover, on June 21, 2021, the G42 Healthcare, a leading health-tech company that is on a mission to develop the world-class healthcare sector in the UAE and beyond, and Seegene Inc., a global biotech company that specializes in the domain of molecular diagnostics, signed a Memorandum of Understanding [MoU] to offer fully equipped mobile diagnostics and testing laboratories across the MENA region. The partnership will, in turn, offer an innovative Seegene Mobile Station, a laboratory on-wheels facility offering the optimized molecular diagnosis and tests at any location for safeguarding the health of community. Also, on December 24, 2021, AstraZeneca and G42 Healthcare partnered to boost the research and diagnostics pertaining to molecular diagnostics technology in the UAE.

On November 19, 2018, Medlab, the MENA region’s largest medical laboratory exhibition and congress, announced the launch of the inaugural Artificial Intelligence (AI) conference. On April 28, 2021, a new research fund to counter the global threat posed by infectious diseases was launched by the Saudi foundation, Community Jameel, to support the collaborative research between Saudi Arabia’s King Abdulaziz University (KAU) and Imperial College London, UK. Moreover, on October 08, 2018, OncoDNA, the healthcare technology company making precision medicine a reality, announced that it had signed an agreement with the world-class International Medical Center (“IMC”) in Saudi Arabia to provide the diagnostic services to the world-class IMC hospital.

Conclusion

The molecular diagnostic market in the MENA region is expected to grow. The efforts taken by governments to establish local manufacturing hubs in their own countries are further expected to drive the demand for the molecular diagnostic market. Several MENA countries have identified the investment in the healthcare sector as a priority for expanding healthcare and molecular diagnostic testing beyond the cities, including rural areas in the countries in the MENA region. Further, along with the increasing cases of epidemics and pandemics, the healthcare companies are continuously focusing on making new and innovative solutions for improving, combating, and curing the diseases around the region.

Molecular diagnostic devices play a crucial role in securing people’s lives by providing accurate diagnosis and prognosis, thus allowing improvised monitoring and treatment. Both the public and the private healthcare officials constantly rate quality care and the value for money as a major health priority, and therefore there is an extreme need to cater to high-quality laboratory testing.  Moreover, rapid technological advancement in the molecular diagnostic product arena, increasing demand for point-of-care diagnostics, and rising consumer awareness regarding quick diagnostics will drive the molecular diagnostic market in MENA.

Source: DelveInsight – www.delveinsight.com

 

The occurrence of thalassemia is an issue of major concern in the health sector of certain countries, including the Middle East and North Africa (MENA region), Southeast Asia, Central Asia, and the Indian subcontinent. According to DelveInsight’s analysis based secondary sources, countries in the MENA region, particularly the Gulf Cooperation Council countries (GCC) and the UAE, have a higher  Alpha-thalassemia prevalence than in Europe and North America – the reported prevalence amongst the countries in the region ranges from 2 to 10 %. The condition has also become increasingly prevalent in nonendemic Europe, North America, and Australia owing to population migrations. The issue is, therefore, assuming global significance.

In addition to rising Alpha-thalassemia prevalence, the management of the condition also remains a challenge. In the past, major pharma companies were afraid to enter the Alpha thalassemia market of Africa and certain countries in the Middle East owing to the lack of health care infrastructure to help adequately diagnose and treat patients, which limited the business potential in those otherwise viable markets. However, recent trends point to an increase in genetic counseling, newborn screening, and a significant increase in interest of big pharma giants such as Agios and Silence Therapeutics to capture a fair share of the market for Alpha thalassemia patients in the region.

Current State of Newborn Screening (NBS) and Genetic Counseling in the MENA Region

• Reports indicate that screening for hemoglobinopathies in thalassemia-endemic regions first began in the Mediterranean basin in the latter part of the twentieth century. Greece and Cyprus started their thalassemia prevention programs in the early 1970s with premarital, preconceptional, or antenatal screening. In Cyprus, these programs, which were mandatory or quasi-mandatory, were based on ethnicity. In the Middle East, Israel began performing targeted thalassemia screening of at-risk ethnicities in 1980. By the first decade of the twenty-first century, a majority of Middle Eastern countries had implemented nationwide mandatory premarital thalassemia screening programs.
• The UAE government initiated various measures to reduce the incidence of thalassemia, including the launch of a national campaign in 2008 to promote premarital screening to provide non-instructive genetic counseling to non-at-risk couples. Additionally, since 1995, the Maternal and Child Health Department – Ministry of Health, UAE – has offered newborn screening as a service to families with new babies. Moreover, in 2017, the UAE, based on research and proposal submitted by the UAE Genetic Diseases Association, introduced significant legislation regarding premarital and prenatal screening programs.

 

• The Thalassemia International Federation has proposed mandatory NBS and maintenance of registries that can catalog the outcomes of screening programs, determine the appropriate Alpha thalassemia treatments, prevention policies, health services, and resource allocation, and guide research related to hemoglobinopathies. The majority of screening programs involve voluntary screening. However, premarital screening is mandatory in the Maldives, Middle Eastern countries, and Cyprus, though decisions regarding marriage and conception are left to individual couples. The other Middle Eastern countries or regions with mandatory premarital screening and genetic counseling programs include Lebanon, Iran, the Gaza Strip, Saudi Arabia, Jordan, and the Kurdistan region in northern Iraq.

Screening programs have now been established in all continents, in both hemoglobinopathy-endemic and hemoglobinopathy-nonendemic regions, targeting either entire national populations or high-risk groups. Increased NBS has turned out to be a pragmatic approach in the MENA region, as it has helped open the window for early detection and treatment of the condition, thereby reducing the healthcare expenditure and cost burden on thalassemia patients and their caregivers.

Updates on Emerging Drug Development in the MENA region

As in the case of the US and Europe, the emerging Alpha thalassemia pipeline in the MENA region is virtually dry as there are only a few key players investigating their products for the patient pool.

• In 2021, Agios Pharmaceuticals initiated its registrational Phase III trials for the evaluation of its key product Mitapivat in the United States, Europe, and Canada. However, the company’s global clinical trials will enroll patients in North America, Europe, the MENA region, the Asia-Pacific region, and Latin America. The company expanded its partnership with Centogene, under which Centogene will provide genetic testing and clinical trial support for Agios’ three global, pivotal trials in thalassemia and sickle cell disease. The collaboration will also offer patients access to genetic testing to help identify causative mutations, including HBA1, HBA2, and HBB genes.
• As per DelveInsight’s forecast estimations and analysis, Mitapivat is expected to benefit from the first-mover advantage, considering that there is no approved therapy for Alpha thalassemia till now. We also expect the drug to enter the US market by 2025. The drug’s potential is attributed to the strong safety and efficacy demonstrated by the drug during clinical development.
• Silence Therapeutics is investigating its product SLN124 in a Phase I trial for the treatment of ‘iron-loading’ anemias, thalassemia, and myelodysplastic syndrome. Recently, the company announced that the first patient was dosed at the Jordan University Hospital, Amman, Jordan, which happens to be one of 25 trial sites for the global, multicenter study, which spans Europe, the Middle East, and Southeast Asia.

In the past, the attention of companies was focused on patients with beta-thalassemia. However, recent years have witnessed a shift in interest of the leading companies to Alpha thalassemia. Owing to the lack of drugs in the region for effective management of the condition, the upcoming therapies by Agios and Silence may give them a first-mover advantage globally, particularly in the MENA region. In this space, it will be interesting to watch the progress of approval and market access of these drugs in the near future.

Progress in Reducing the Burden of Alpha thalassemia in the MENA Region

The growing thalassemia prevalence and its resultant burden is definitely an issue in the MENA region. The problem is compounded by the fact that significant data gaps exist, which come in the way of a proper appraisal of the burden and thalassemia treatment in this region. Therefore, an increase in research and awareness in the field is recommended. Interestingly, in the last decade, the UAE has made significant progress in preventive management resulting in a significant reduction in the prevalence of thalassemia. The mandatory premarital screening program is the most important part of the national preventive campaign against thalassemia. These tests necessitate the public to undergo screening before getting married in the UAE. Moreover, although the emerging pipeline for α-thalassemia in this region is relatively dry at present, physicians and researchers are working rigorously toward increasing awareness, improving diagnosis, and researching for developing novel and potential therapies in the future.

In conclusion, recent years have witnessed an increase in premarital counseling and newborn screening to facilitate early detection and effective thalassemia management in the MENA region. The region holds a vast scope for further advancement in the development of effective therapies at a reasonable cost and their approval and market access!!

References:

1. Abu-Shaheen, A., Heena, H., Nofal, A., Abdelmoety, D. A., Almatary, A., Alsheef, M., & AlFayyad, I. (2020). Epidemiology of Thalassemia in Gulf Cooperation Council Countries: A Systematic Review. BioMed Research International, 2020. https://doi.org/10.1155/2020/1509501
2. (n.d.). Centogene Expands Rare Blood Disease Partnership with Agios. Retrieved December 28, 2021, from https://www.pharmtech.com/view/centogene-expands-rare-blood-disease-partnership-with-agios
3. Laghmich, A., Alaoui Ismaili, F. Z., Barakat, A., Ghailani Nourouti, N., Khattab, M., & Bennani Mechita, M. (2019). Alpha-Thalassemia in North Morocco: Prevalence and Molecular Spectrum. BioMed Research International, 2019. https://doi.org/10.1155/2019/2080352
4. Lanka, S., & Lanka, S. (2018). Population Screening for Hemoglobinopathies. Rev. Genom. Hum. Genet, 19, 355–380. https://doi.org/10.1146/annurev-genom-091416
5. NMC Royal Women’s Hospital. (n.d.). Newborn screening | NMC Royal Women’s Hospital, Abu Dhabi, UAE. Retrieved December 28, 2021, from https://www.nmcroyalwomenshospital.ae/newborn-screening-womens-hospital-abu-dhabi-uae.html
6. Shivappa, P., Bernhardt, G. V., Mufti, M. M., & Banu, A. (2021). A Review on Epidemiology and Thalassemia Distribution, in Relevance to United Arab Emirates Population. https://doi.org/10.3844/ojbsci.2021.280.284
7. Silence Therapeutics. (n.d.). Silence Therapeutics – Silence Therapeutics – First patient dosed in GEMINI II. Retrieved December 28, 2021, from https://silence-therapeutics.com/investors/press-releases/press-releases-details/2021/Silence-Therapeutics—First-patient-dosed-in-GEMINI-II/default.aspx
8. WHO EMRO. (n.d.). WHO EMRO | Expanding the comprehensive national neonatal screening programme in the United Arab Emirates from 1995 to 2011 | Volume 20, issue 1 | EMHJ volume 20, 2014. Retrieved December 28, 2021, from http://www.emro.who.int/emhj-vol-20-2014/volume-20-issue-1/expanding-the-comprehensive-national-neonatal-screening-programme-in-the-united-arab-emirates-from-1995-to-2011.html

Source: DelveInsight – www.delveinsight.com