Dry Eye Disease - Market Insight, Epidemiology and Market Forecast - 2034

Key Highlights

• The main treatment options for ALL include chemotherapy, targeted therapy, immunotherapy, surgery, radiation therapy, and stem cell transplant.
• In 2021, the market size of ALL in the 7MM was approximately USD 1.10 billion, which is further expected to increase by 2032.
• In the 7MM, the US accounted for the largest market size in 2021, with approximately USD 800 million.
• Among the emerging CAR-Ts, obecabtagene autoleucel is anticipated to be the first to enter the market among the upcoming therapies, giving it a competitive edge over other emerging assets.
• In August 2022, Gamida Cell announced that the United States Food and Drug Administration (US FDA) accepted the company’s Biologics License Application (BLA) for omidubicel for the treatment of patients with blood cancers in need of an allogeneic hematopoietic stem cell transplant. Moreover, the US FDA granted Priority Review for the BLA and has set a Prescription Drug User Fee Act (PDUFA) target action date of January 30, 2023.
• In July 2022, the US FDA granted Fast Track Designation (FTD) and Rare Pediatric Disease Designation (RPDD) for WU-CART-007 by Wugen for the treatment of patients with R/R T-ALL.
• In May 2022, Jazz Pharmaceuticals completed the Marketing Authorisation Application (MAA) submission to the European Medicines Agency (EMA) for a Monday/Wednesday/Friday (M/W/F) dosing schedule and intramuscular (IM) and intravenous (IV) administration for JZP458 with the potential for approval in 2023. The company is also advancing the program for potential submission, approval, and launch in Japan.

This report delivers an in-depth understanding of ALL, historical and forecasted epidemiology as well as the ALL market trends in the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan.

The ALL market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM ALL market size from 2019 to 2032. The report also covers current ALL treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain), and the United Kingdom
• Japan

Study Period: 2019-2032

Acute lymphocytic leukemia Understanding and Treatment Algorithm

Acute lymphocytic leukemia Overview

Acute lymphocytic leukemia (ALL), also known as acute lymphoblastic leukemia, is a type of cancer that affects the blood and bone marrow. It starts from young white blood cells called lymphocytes in the bone marrow; mainly characterized by an overproduction of immature white blood cells, called lymphoblasts or leukemic blasts. Because the bone marrow is unable to make adequate numbers of red cells, normal white cells, and platelets, people with ALL become more susceptible to anemia, recurrent infections, and bruising and bleeding easily. The blast cells can then spill out of the bone marrow into the bloodstream and accumulate in various organs including the lymph nodes or glands, spleen, liver, and central nervous system (brain and spinal cord).

Acute lymphocytic leukemia Diagnosis

Tests and procedures used to diagnose ALL include:

Blood tests- The Complete Blood Count (CBC) measures the numbers of red blood cells, white blood cells, and platelets. This test is often done along with a differential that looks at the numbers of the different types of white blood cells. For the peripheral blood smear, a drop of blood is smeared across a slide and then looked under a microscope to see how the cells look. Changes in the numbers and the appearance of the cells often help diagnose leukemia.

Bone marrow test- During bone marrow aspiration and biopsy, a needle is used to remove a sample of bone marrow from the hipbone or breastbone. The sample is sent to a lab for testing to look for leukemia cells. Doctors in the lab will classify blood cells into specific types based on their size, shape, and other genetic or molecular features. They also look for certain changes in the cancer cells and determine whether the leukemia cells began from B lymphocytes or T lymphocytes.

Imaging tests- Imaging tests such as an X-ray, a computerized tomography (CT) scan, or an ultrasound scan may help determine whether cancer has spread to the brain and spinal cord or other parts of the body.

Spinal fluid test- A lumbar puncture test, also called a spinal tap, may be used to collect a sample of spinal fluid - the fluid that surrounds the brain and spinal cord. The sample is tested to see whether cancer cells have spread to the spinal fluid.

Acute lymphocytic leukemia Treatment

Treatment of ALL includes:

Induction Therapy - The main purpose of the first phase of treatment is to kill most of the leukemia cells in the bone marrow and blood and also to restore normal blood cell production.

Consolidation Therapy -Consolidation therapy is also known as post-remission therapy. The main purpose of this therapy is to completely wipe out remaining leukemia in the body, such as in the brain or spinal cord. Consolidation therapy is also known as post-remission therapy.

Maintenance Therapy - This is known as the third phase of treatment, which prevents leukemia cells from regrowth. However, the treatment used in this stage is often given at much lesser doses for a long period, of years.

Preventive treatment to the spinal cord - In this phase of therapy, a patient suffering from ALL may receive additional treatment from killing leukemia cells which are located in the central nervous system. Also, in this type of treatment phase chemotherapy drugs are often injected directly into the fluid that covers the spinal cord.

Although, depending on the condition of a patient and the phases of treatment of ALL treatment may include chemotherapy, immunotherapy, targeted therapy, radiation therapy, and stem cell transplant.

Acute Lymphocytic Leukemia Epidemiology

As the market is derived using a patient-based model, the ALL epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total incident cases of ALL, gender-specific cases of ALL, age-specific cases of ALL, subtype-specific cases of ALL, genetic-mutation specific cases of ALL, and total treated cases of ALL in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan from 2019 to 2032.

• Among the 7MM, the US accounted for the highest number of incident cases of ALL.
• The total incident cases of ALL in the US comprised approximately 6,200 cases in 2021 and are projected to increase during the forecast period.
• Amongst EU4 and the UK, Germany accounted for the highest number of incident cases of ALL, while Spain accounted for the lowest number of cases.
• Among the gender-specific cases, males accounted for nearly 3,500 cases, while females accounted for 2,700 in the US in 2021.
• Among the type-specific cases of ALL, the incident cases of B-ALL accounted for nearly 85%, while that of T-ALL accounted for nearly 15% in the US.

Acute Lymphocytic Leukemia Drug Chapters

The drug chapter segment of the ALL report encloses a detailed analysis of ALL marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the ALL pivotal clinical trial details, recent and expected market approvals, patent details, advantages and disadvantages of each included drug, the latest news, and recent deals and collaborations.

Marketed Drug

TECARTUS (brexucabtagene autoleucel): Gilead Sciences

TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, which binds to CD19-expressing cancer cells and normal B cells. Studies demonstrated that following anti-CD19 CAR-T cell engagement with CD19-expressing target cells, the CD28 and CD3-zeta costimulatory domains activate downstream signaling cascades that lead to T cell activation, proliferation, acquisition of effector functions, and secretion of inflammatory cytokines and chemokines. This sequence of events leads to the killing of CD19-expressing cells. In October 2021, the US FDA approved TECARTUS for adult patients with R/R B-ALL. It was approved by the EC in September 2022.

KYMRIAH (tisagenlecleucel): Novartis

KYMRIAH is a CD19-directed genetically modified autologous T cell immunotherapy that involves reprogramming a patient’s T cells with a transgene encoding a chimeric antigen receptor (CAR) to identify and eliminate CD19-expressing malignant and normal cells. The CAR is comprised of a murine single-chain antibody fragment that recognizes CD19 and is fused to intracellular signaling domains. Upon binding to CD19-expressing cells, the CAR transmits a signal to promote T cell expansion, activation, target cell elimination, and persistence of the KYMRIAH cells. In August 2017, the US FDA approved KYMRIAH for the treatment of patients up to age 25 years with R/R B-ALL. It was approved by the EC in August 2018, and by the MHLW in March 2019.

RYLAZE (asparaginase Erwinia chrysanthemi recombinant/JZP458): Jazz Pharmaceuticals

RYLAZE is an asparagine-specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen. The pharmacological effect of RYLAZE is based on the killing of leukemic cells due to the depletion of plasma asparagine. Leukemic cells with low expression of asparagine synthetase have a reduced ability to synthesize asparagine and, therefore, depend on an exogenous source of asparagine for survival. In June 2021, Jazz Pharmaceuticals announced the US FDA approval of RYLAZE for use as a component of a multi-agent chemotherapeutic regimen for the treatment of ALL. In May 2022, the company completed the MAA submission to the EMA for an M/W/F dosing schedule and IM and IV administration for JZP458 with the potential for approval in 2023. The company is also advancing the program for potential submission, approval, and launch in Japan.

Emerging Drug

Orca-T: Orca Biosystems

Orca-T is a first-in-class high-precision cell therapy that combines purified cells from a matched donor. It is designed to replace a patient’s diseased blood and immune system with a healthy one while lowering the risk of developing Graft-versus-host disease (GvHD) and other life-threatening transplant-related side effects.

In August 2022, Orca Bio announced that the Precision-T, its pivotal Phase III study, is open, enrolling and treating patients at various clinical trial sites. In October 2020, the US FDA granted RMAT designation to Orca-T for treating patients with blood cancers (acute myeloid leukemia, acute lymphoid leukemia, myelodysplastic syndrome, and myelofibrosis) who are eligible for a hematopoietic (blood) stem cell transplant. In addition, Orca-T has received ODD from the US FDA for enhancing cell engraftment in patients who qualify for a hematopoietic stem cell transplant.

Daratumumab: Janssen Research & Development

Daratumumab is a human IgG1k monoclonal antibody that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. Daratumumab is being developed by Janssen Biotech under an exclusive worldwide license to develop, manufacture, and commercialize daratumumab from Genmab. Currently, the company is evaluating the efficacy and safety of daratumumab in the Phase II trial in pediatric and young adult patients for the treatment of R/R Precursor B-cell or T-cell ALL.

Obecabtagene autoleucel (obe-cel): Autolus Therapeutics

Obe-cel is an autologous CD19 CAR-T cell therapy with a unique CD19 CAR. The CAR is designed to have a fast-off kinetic, which mimics physiological T-cell receptor interactions. Obe-cel has demonstrated that this enhanced kinetic profile results in increased T-cell persistence and reduced T-cell exhaustion, leading to high levels of durable remissions and remarkably low levels of cytokine release syndrome. Autolus Therapeutics recently announced that the FELIX Phase II trial of obe-cel in R/R adult ALL has continued to progress well, and the company is on track to report initial results from the trial in the fourth quarter of 2022. In March 2022, obe-cel was granted Orphan Medical Product Designation by the EMA for the treatment of ALL, having previously received ODD by the US FDA for B-ALL. In April 2022, the US FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to obe-cel for the treatment of adult B-ALL. Obe-cel also received PRIME designation from the EMA and Innovative Licensing and Access Pathway (ILAP) by the Medicines and Healthcare Products Regulatory Agency (MHRA), United Kingdom.

Drug Class Insights

In the past, targeted therapy has demonstrated impressive efficacy and the development of protein kinase inhibitors (PKIs) has a promising impact on acute leukemia patients. The role of molecular monitoring and the use of tyrosine kinase inhibitors after stem cell transplantation are areas of active investigation, and the results of ongoing trials will help to clarify the optimal management of these patients. The development and application of BCR-ABL1 - targeted tyrosine kinase inhibitors (TKIs), such as GLEEVEC (imatinib mesylate), SPRYCEL (dasatinib), and ICLUSIG (ponatinib) in Ph+ ALL has dramatically changed care and improved survival. Second-generation TKIs, such as dasatinib, overcome most TKI resistance by BCR-ABL1 KD mutation although they are ineffective against the T315I mutation. Several pharmaceutical companies are working on more effective small inhibitors because previously approved inhibitors have been quite successful in certain groups of cancer patients. In the last few years, immunotherapy has undergone a new phase of development which is linked to the development of CAR-T cell therapy, a personalized treatment involving the use of genetically modified T lymphocytes to attack the cancer cells. KYMRIAH (tisangenlecleucel) in single perfusion has provided durable remission with long-term persistence in both pediatric and young adult patients with R/R B-cell ALL, with transient high-grade toxic effects.

Acute Lymphocytic Leukemia Market Outlook

The treatment options for ALL, include chemotherapy, post-remission therapy (consolidation and maintenance therapy), targeted therapy, immunotherapy, and CAR-T cell therapy. In addition to this, stem cell transplant is also used early in therapy for patients with high-risk subtypes of ALL. In December 2018, the US FDA approved ASPARLAS (calaspargase pegol-mknl) by Servier Pharmaceuticals which is an asparagine-specific enzyme, as a component of a multi-agent chemotherapeutic regimen for ALL in pediatric and young adult patients aged 1 month to 21 years. In June 2021, the US FDA approved RYLAZE (asparaginase erwinia chrysanthemi (recombinant)-rywn) by Jazz Pharmaceuticals as a component of a multi-agent chemotherapeutic regimen for the treatment of ALL and LBL in adult and pediatric patients 1 month or older who have developed hypersensitivity to E. coli-derived asparaginase. Amgen’s cancer drug BLINCYTO (blinatumomab) accomplished one of the fastest approvals on record until 2014. It is a bispecific CD19-directed CD3 T cell engager (BiTE) immunotherapy. Therapies based on CAR-T cells may have a huge potential clinical impact. In 2017, the US FDA made a historic decision by approving the first-ever CAR-T cell therapy for the treatment of ALL, that is, KYMRIAH (tisangenlecleucel) by Novartis. Companies like AbbVie and Roche (venetoclax), Gamida Cell (omidubicel), Orca Biosystems (Orca-T), Janssen Research & Development (daratumumab), Jazz Pharmaceuticals (CPX-351), Syndax Pharmaceuticals (SNDX-5613), Autolus Therapeutics (obecabtagene autoleucel), Wugen (WU-CART-007), Servier/Allogene (UCART19), Cellectis (UCART22), and several others are testing their products for the treatment of ALL. The future of the ALL treatment landscape is anticipated to be dominated by CAR-T cell therapies. There are several CAR T-cell Therapies in the pipeline such as UCART19, UCART22, WU-CART-007, AUTO1/22, and others. Among the aforementioned therapies, some have shown good efficacy and safety profile.

• The total market size of ALL in the 7MM was approximately USD 1.10 billion in 2021 and is projected to increase during the forecast period (2023-2032).
• Amongst EU4 and the UK, Germany accounted for the largest market size in 2021, while Spain occupied the bottom of the ladder.
• Among the therapies, BLINCYTO is expected to generate the highest revenue in the 7MM by 2032.

Acute Lymphocytic Leukemia Drugs Uptake

This section focuses on the rate of uptake of the potential drugs expected to be launched in the market during the study period 2019-2032. The analysis covers ALL market uptake by drugs; patient uptake by therapies; and sales of each drug.

Acute Lymphocytic Leukemia Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III and Phase II. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for ALL emerging therapies.

KOL Views

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts contacted for insights on ALL evolving treatment landscape, patient reliance on conventional therapies, patient’s therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers; American Cancer Society; Hematologist and Professors; MD, FACS, Chair of the Department of Department of Hematology, University of Texas MD Anderson Cancer Center; and others.

The analysts connected with 30+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Their opinion helps understand and validate current and emerging therapy treatment patterns or ALL market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Analyst views. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

The analyst analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry.

In efficacy, the trial’s primary and secondary outcome measures are evaluated. Further, the therapies’ safety is evaluated wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials.

Market Access and Reimbursement

Reimbursement is a crucial factor affecting the drug’s market access. Often, the decision to reimburse comes down to the price of the drug relative to the benefit it produces in treated patients. To reduce the healthcare burden of these high-cost therapies, payers and other industry insiders are considering many payment models. Understanding insurance and out-of-pocket costs shouldn’t be overwhelming. JazzCares supports patients at every step of their journey. With a JazzCares Savings Card, pay as little as USD 10 for RYLAZE medication. If insurance is a concern, RYLAZE may be available at no cost.

Patients whose healthcare professionals have prescribed TECARTUS therapy can work with Kite Konnect. This integrated technology platform provides information and assistance throughout the therapy process for Kite’s commercialized CAR-T therapies, including courier tracking for shipments and manufacturing status updates. Kite Konnect provides support for eligible patients receiving TECARTUS, and it includes information for the healthcare teams supporting their patients.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

• The report covers a segment of key events, an executive summary, descriptive overview of ALL, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, disease progression, and treatment guidelines has been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the ALL market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM ALL market.

Acute Lymphocytic Leukemia Report Insights

• Patient Population
• Therapeutic Approaches
• ALL Pipeline Analysis
• ALL Market Size and Trends
• Existing and future Market Opportunity

Acute Lymphocytic Leukemia Report Key Strengths

• Ten Years Forecast
• The 7MM Coverage
• ALL Epidemiology Segmentation
• Key Cross Competition
• Drugs Uptake and Key Market Forecast Assumptions

Acute Lymphocytic Leukemia Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs

• What was the ALL total market size, the market size by therapies, and market share (%) distribution in 2019, and what would it look like in 2032? What are the contributing factors for this growth?
• Which class is going to be the largest contributor in 2032?
• What are the pricing variations among different geographies for approved and off-label therapies?
• What are the disease risks, burdens, and unmet needs of ALL? What will be the growth opportunities across the 7MM concerning the patient population of ALL?
• What is the historical and forecasted ALL patient pool in the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan?
• What are the current options for the treatment of ALL? What are the current guidelines for treating ALL in the US and Europe?
• How many emerging therapies are in the mid-stage and late stage of development for the treatment of ALL?
• What are the recent novel therapies, targets, mechanisms of action, and technologies being developed to overcome the limitations of existing therapies?
• What key designations have been granted for the emerging therapies for ALL?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios.
• What are the country-specific accessibility issues of expensive, current therapies? Focusing on the reimbursement policies.

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the ALL market.
• Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the Analyst view section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies of current therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.