Sickle Cell Disease Drugs Market Size & Share, Drug Class (Pain Management, Disease-Modifying Therapies, Gene Therapy); Distribution Channel - SWOT Analysis, Competitive Strategic Insights, Regional Trends 2025-2037

Sickle Cell Disease Drugs Market Growth Drivers and Challenges:

Growth Drivers

• Growth in global patient pool: Rise in the number of sickle cell disease patients drives the market to raise demand for the drug to reduce the health risk. As per the report of the Centers for Disease Control and Prevention, more than 98,000 cases of sickle cell are diagnosed. Betterment in the diagnosis infrastructure and mandate of newborn screening led to growth in pediatric diagnosis by 18% in North America. This raised the demand for sickle cell disease drugs in the concerned region. Europe also experienced a growth of sickle cell disease patients with 24% since 2018, which accelerated the market for the specific drug to overcome the health risk.
• FDA acceleration: The Approval receiving period and duration to launch the new product in the market is one of the important growth factors that promote market scalability. For instance, the Food and Drug Administration, Fast Track approvals for Casgevy and Lyfgenia drugs in 2023 ensured a high market adoption rate and expanded the gene therapy. An assessment was made that with the help of the approval made by the FDA, the market revenue accumulation capacity expands to USD 4.1 billion by 2030. The scope of the innovation gap is leveraged through approval and fast adoption in the market, which helps the market to generate more revenue and promote development. Viral vector manufacturing, implemented a bottleneck limiting production, which is approximately more than 550 doses each year throughout the world.  

Manufacturing Strategies to Ensure Sickle Cell Disease Drugs Market Expansion

The key strategies incorporated by the manufacturer to conduct market expansion include research and development, strategic collaboration, pricing innovation, and many more. For instance, Pfizer followed the acquisition strategy to expand their business and acquired Global Blood Therapeutics in 2022. This led to securing Oxbryta and holding more than 30% of the U.S. hemoglobin modulator market. FDA-approved gene therapy is focused on VerteX/CRISPR’s Casgevy. This is anticipated for the business to accumulate revenue of approximately USD 1 billion annually by 2026. Price reduction of over 55% in Africa is conducted by Novartis through collaboration with the Gates Foundation.  

The following table denotes revenue opportunities for manufacturers:

Key Market Dynamics for Historical Patient Growth

A consistent growth in the global sickle cell disease drugs market is addressed within the period of 2014 to 2024. Betterment in the diagnosis infrastructure is the key factor that has raised the number of patients in the global market and driven the higher demand for sickle cell disease drugs. Regulatory push for mandatory newborn screening and an increase in life expectancy rate led the government to take sincere initiatives that advocated for the growth of the market. Therapeutic advancement is introduced that provides better patient outcomes, which has led to more prescribed references for the sickle cell disease drugs throughout the world. Historical expansion directed the U.S.  and EU markets to adopt hydroxyurea elevate over 290%. The undiagnosed population in the emerging markets of Africa and India is targeted to scale up significant demand for gene therapy and leverage the demand for sickle cell disease drugs.

The following table denotes historical patient growth in the past ten years across different countries:

Challenges

• Patient affordability: The developing countries possess a high number of low to medium-income groups of population that face major barriers to accessing the premium treatment. High cost of production leads to the sickle cell disease drugs to elevated, which becomes out of budget in the developing countries. As per the study by the World Health Organization, hydroxyurea costs more than USD 48 per year, which is less accessible for 92% of the population in India, and faces a struggle to adapt to the new biologics. Africa also experienced the same issues, where over 78% of the patients fail to afford the crizanlizumab and leading to low accessibility in the market. Low insurance coverage resulted to be the major barrier for the market to achieve free growth in the developing country.