South Africa Autosomal Dominant Polycystic Kidney Disease Therapeutics Market Analysis

South Africa Autosomal Dominant Polycystic Kidney Disease Therapeutics Market Analysis

The South Africa Autosomal Dominant Polycystic Kidney Disease Therapeutics Market was valued at around US $7 Mn in 2022 and is projected to reach US $12 Mn in 2030, exhibiting a CAGR of 7.03% during the forecast period.

Autosomal dominant polycystic kidney disease (ADPKD) is a hereditary condition affecting multiple systems, caused by mutations in the PKD1 and PKD2 genes. It leads to the development of numerous cysts in the kidneys, causes renomegaly, and often progresses to end-stage kidney disease (ESKD). Presently, there is no cure for ADPKD, but several therapeutic options exist to manage symptoms and slow disease progression. Tolvaptan (Jinarc), created by Otsuka Pharmaceutical Co. Ltd., is an approved drug in many countries and belongs to the vasopressin V2 receptor antagonists (V2RAs) class. Tolvaptan has demonstrated the ability to decelerate cyst formation and the decline in kidney function in certain ADPKD patients. Alongside Tolvaptan, other treatment approaches include pain management and lifestyle adjustments.

The prevalence of ADPKD in South Africa is presumably low as compared to other countries, and the approximate prevalence estimate remains between 1 in 1000 individuals. The reasons for low prevalence include a limited ethnic population and genetic admixtures between them, which dilute the mutation. The market is therefore driven by major factors like government initiatives towards making ADPKD a priority condition and increased awareness about the condition in the population. However, conditions such as the non-availability of diagnostic modalities that lead to underdiagnosis in several cases, financial barriers to accessing expensive treatment, and other factors hinder the growth and potential of the market.

Market Dynamics

Market Growth Drivers

Government initiatives: The South African government decided to prioritize disorders such as ADPKD. It is working on many policies to assist rare diseases, reimbursement schemes, and taxation for companies looking to enter the market, thereby promoting market expansion.

Increased awareness: The South African market for ADPKD treatments is expanding as a result of proactive government measures such as the South African Nephrology Society and worldwide market changes. They advocate for higher research funding, better access to healthcare, and public education. This promotes market growth by encouraging early detection, adequate treatment options, and comprehensive management of disease.

Market Restraints

Limited knowledge on prevalence: The prevalence of ADPKD is considered to be presumably low as compared to all countries due to the limited availability of data about the condition. There are no clear statistics available to estimate the overall prevalence, which can therefore delay the growth of the therapeutics market.

Underdiagnosis: In South Africa, professional and general public awareness of the condition is low, resulting in delayed diagnosis and treatment of suspected patients. Diagnostic services, such as ultrasonography and genetic testing for confirmed diagnosis, are limited in public sector facilities. This leads to missed opportunities for case detection and slows market expansion.

Financial barriers: Tolvaptan, the current treatment for ADPKD, is expensive, putting a significant financial strain on both South African patients and the healthcare system. A significant portion of population lives in poverty and lacks access to costly therapies due to a lack of safe insurance options. Affordability issues lead to treatment non-adherence in many patients, slowing market growth.

Healthcare Policies and Regulatory Landscape

South Africa's healthcare policies and regulations fall under the purview of the Department of Health (DoH) and are predominantly guided by laws such as the Medicines and Related Substances Act and the Pharmacy Act. The South African Health Products Regulatory Authority (SAHPRA) is responsible for overseeing the regulation of medicines, medical devices, and diagnostics within the country.

Obtaining a license for healthcare products in South Africa requires strict adherence to SAHPRA's regulations. Companies aiming to register pharmaceuticals and medical devices must secure authorization for marketing and registration from SAHPRA, a process that involves submitting scientific and technical data to validate the product's safety, quality, and effectiveness. Additionally, companies must appoint a local importer or distributor for product liability, with certain low-risk products possibly exempt from the registration requirement.

Both the public and private healthcare sectors in South Africa present diverse opportunities for businesses operating in the healthcare industry.

Competitive Landscape

Key Players

• Otsuka Pharmaceutical Co., Ltd
• Regulus Therapeutics
• Palladio Biosciences
• Reata Pharmaceuticals
• Galapagos NV
• Exelixis Inc
• AceLink Therapeutics, Inc
• Sanofi
• Xortx Therapeutics
• Pano Therapeutics