US Acute Lymphocytic Leukemia (ALL) Therapeutics Market Analysis

US Acute Lymphocytic Leukemia (ALL) Therapeutics Market Analysis

The US Acute Lymphocytic Leukemia (ALL) Therapeutics Market is at around US $1.38 Bn in 2022 and is projected to reach US $2.17 Bn in 2030, exhibiting a CAGR of 5.8% during the forecast period.

Acute lymphocytic leukemia (ALL) is a blood cancer marked by the swift growth of immature white blood cells, or lymphoblasts, in the bone marrow. A genetic mutation typically affects developing lymphocytes, leading to an accumulation of undifferentiated lymphoid cells. It presents with various symptoms like frequent infections, swollen lymph nodes, weight loss, bone pain, and more. ALL treatment is extensive, lasting months or even years, encompassing chemotherapy, targeted therapy, CAR-T cell immunotherapy, and, in severe instances, stem cell transplantation. These advancements have notably boosted the cure rate, reaching up to 80% in children and young adults.

It is estimated that the number of ALL cases in the US increased by 6,540, with children under five having the highest risk of developing ALL. The mortality rate for ALL stands at approximately 1,390 cases, with around 700 occurring in males and 690 in females. The market is therefore driven by major factors like the surge in incidence of ALL, new product approvals, and consumer knowledge of the therapeutics industry. However, conditions such as the complex regulatory structure of the US FDA, limited insurance coverage, and others hinder the growth and potential of the market.

One of the notable players in the market is Amgen, which has obtained approval for the drug BLINCYTO® (blinatumomab), a treatment for adult and paediatric patients with B-cell ALL from the US-FDA.

Market Dynamics

Market Growth Drivers

Surge in the incidence of ALL: There was an estimated increase of 6540 ALL cases in the US. The mortality of ALL is about 1,390, out of which 700 are males and 690 are females. According to the American Cancer Society, the risks of developing acute lymphocytic leukemia are high in children younger than five. These numbers are anticipated to increase steadily in the forecast period, boosting market growth.

New product development and approval: The rapid progression of leukemia and new products are expected to propel this sector forward in the forecasted years. The approval of drugs like Kymriah by Novartis AG in different geographic regions is further driving the growth.

Increased awareness: The US market for acute lymphocytic leukemia treatments is seeing growth due to the proactive efforts of both governmental and private entities. Furthermore, initiatives like the "Childhood Cancer Targeted Therapeutics Workshop" and "Therapeutically Applicable Research to Generate Effective Treatments (TARGET)" have rolled out various programs and collaborated with multiple global research institutions, such as the University of New Mexico and St. Jude Children's Research Hospital, aiming to facilitate early diagnosis and enhanced care for leukemia patients.

Technological Advancements: Treatment outcomes for ALL patients are anticipated to be improved by drug development innovations, including gene therapy and customized medicine, which will drive the growth of the market.

Market Restraints

Regulatory Challenges: The regulatory environment in the US is very complex, with the FADA as the major regulatory authority for drugs and therapeutics. The process of approval is time-consuming, which can delay the approval of new products, ultimately driving up the cost and likely hampering the growth of the industry.

Insurance Cover Limitations: The limited insurance coverage in US will act as a restraining factor for patient access to drugs and therapeutics, which will impact market growth.

Competition: The therapeutic and pharmaceuticals market in the US healthcare sector is highly competitive and dominated by many players which can further limit market growth, decreasing its attractiveness and profitability in the forecasted period.

Notable Recent Updates

June 2023, Amgen reported that BLINCYTO® (blinatumomab) supplemental biologics license application (sBLA) has been authorized by the U.S. Food and Drug Administration (FDA) for the treatment of adult and pediatric patients with CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL).

July 2021, The US FDA allowed the fast-track designation to Eryapase which was manufactured by Erytech Parma for the treatment of ALL.

Healthcare Policies and Regulatory Landscape

The healthcare policy and regulatory environment in the US is complex, with several governmental agencies regulating multiple aspects of the healthcare system. The Food and Drug Administration (FDA), the Centers for Medicare & Medicaid Services (CMS), and the Department of Health and Human Services (HHS) are the primary regulatory authorities.

The FDA, which is in charge of ensuring the efficacy and safety of pharmaceuticals, medical devices, and other healthcare products, must approve a healthcare product or service before it can be licensed. This is a complex process, including steps such as pre-clinical research and development, clinical trials, FDA submission and approval, post-approval monitoring, reimbursement, and coverage.

The US healthcare policy and regulatory environment are framed by these governing bodies and procedures.

Competitive Landscape

Key Players

• Pfizer Inc.
• Novartis AG
• Sanofi S. A
• Bristol-Myers Squibb Company
• Merck & Co., Inc
• GlaxoSmithKline plc
• AbbVie Inc.
• Amgen, Inc
• Takeda Pharmaceuticals Company Limited
• Teva Pharmaceutical Industries Ltd.