Table of Contents
Targeted therapeutics is fast emerging as the key focus area in biopharmaceutical industry. Oral targeted therapeutics has attracted many drug developers due to the ease of administration it offers to patients (especially pediatric and geriatric patients). In the case of leukemia, current marketed oral drugs include Gleevec, Tasigna, Sprycel, Bosulif, Imbruvica and Iclusig.
The high price of these drugs still remains a major constraint to the market growth. Further, as leukemia accounts for about 3% of all cancer cases per year, most of the companies are targeting other cancer indications offering a wider market prospective. The oral targeted drugs market is expected to be driven by new generation and new class of inhibitors. Several pharmaceutical companies, both big and small, are looking to capture a share of the leukemia market, where orally delivered drugs are well accepted.
Despite the impending patent expiry of some drugs (especially Gleevec), the market is set to rise after a likely dip in growth rate in the short-term. There are specific opportunities which remain to be tapped in the mid-long term; emerging drug therapies such as third generation tyrosine kinase inhibitors (TKIs), multi kinase inhibitors, FLT3 inhibitors, AKT kinase inhibitors and BTK inhibitors are likely to sustain the interest of drug makers.
SCOPE OF THE REPORT
The ‘Oral Oncolytics Series: Leukemia, 2014 - 2024’ report provides an extensive study of the market of oral targeted leukemia drugs, specifically focusing on currently commercialized drugs, those under development and the likely future market evolution. Targeted therapeutics have tremendous potential and the market is expected to grow steadily over the coming few years. The focus of our report is on drugs which target a specific marker / antigen on leukemia cells and are delivered through mouth. The report covers various aspects such as regulatory approvals, treatment cost, historical sales, product pipeline and industry research programs.
With the upcoming patent expiry of some well-known drugs, we have looked at how the market landscape is likely to change in the coming years. In fact, one of the key objectives of this report is to understand the current and future state of the oral targeted leukemia drugs. This is done by analyzing the following:
- Marketed oral targeted leukemia drugs
- Products in pipeline
- Competing technologies and innovations
- Growing target patient pool
The base year for the report is 2013. The report provides short-mid term and long term forecasts for the period 2014 - 2024. This forecast is supported by detailed research and analysis of drugs (both marketed / pipeline) which we believe will have a far-reaching impact on the market. Owing to the uncertainties associated with drug development and customer adoption trends, we have presented three different market scenarios for each of the drugs studied in this exercise:
- Conservative Scenario: This represents our most pessimistic view of the success / adoption of each individual drug.
- Base Scenario: This represents the most-likely success / adoption of respective drugs.
- Aggressive Scenario: This is the bullish scenario wherein we have been aggressive in terms of the penetration rates of respective drugs and the likely market size.
1. The market for oral targeted leukemia therapeutics was valued at USD 7,388 million in 2013; CML drugs currently dominate the market.
2. US, with a 40.6% share, is currently the biggest market. According to the Leukemia & Lymphoma Society, there are an estimated 310,046 people living with, or in remission from, leukemia in the US
3. Gleevec, the market leader, has been quite popular amongst patient population. However, its nearing patent expiry (2014, 2015, 2016 in Japan, the US and Europe respectively) will open the space for low cost generics
4. There are several upcoming drugs, with a sizeable number in phase II and phase III clinical trials. Opportunities for drug developers exist in all forms of leukemia.
5. AML has the most extensive pipeline; in addition to tyrosine kinases, hedgehog, JAK, PI3K inhibitors, drug developers are also exploring the use of epigenetic agents such as histone deacetylases (HDAC) and nuclear export inhibitors such as XPO1 inhibitor.
6. Novartis is the most active company in this market, with two marketed drugs and another eight in clinical trials. Specifically, within AML (which currently has no marketed oral drug), Novartis’ Midostaurin is expected to have the first mover advantage.
Most of the data presented in this report has been gathered by secondary research. We have also conducted interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will shape up across different regions and drug segments. Where possible, the available data has been checked for accuracy from multiple sources of information.
The secondary sources of information include
- Annual reports
- Investor presentations
- SEC filings
- Industry databases
- News releases from company websites
- Government policy documents
- Other analysts’ opinion reports
While the focus has been on forecasting the market over the coming ten years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.
Chapter 2 provides an executive summary of the insights captured in our research. The summary offers a high level view on the likely evolution of oral targeted leukemia market.
Chapter 3 provides a general introduction to leukemia. We have discussed, in detail, about types of leukemia, common signs and symptoms, its occurrence / prevalence and the current treatment regimes.
Chapter 4 provides an overview of the global leukemia therapeutics market, specifically the targeted therapeutics which includes small molecule inhibitors and monoclonal antibodies. The market has been analyzed on the basis of the type of leukemia, drug classes, and leading drugs in each segment.
Chapter 5 analyzes the current and future state of the worldwide market of oral targeted leukemia drugs. This chapter includes detailed profiles of all the marketed drugs and the drugs in phase III clinical trials. We have presented our estimates of the overall market value of oral targeted leukemia drugs till 2024.
Chapter 6 offers a region wise market analysis of the oral targeted leukemia drugs. This chapter covers the geographical availability and reimbursement policies of the oral targeted leukemia drugs. The major regional markets considered are the US, Europe and Japan.
Chapter 7 provides our analysis of the strengths, weaknesses, opportunities and threats impacting the oral targeted leukemia market, capturing key elements likely to influence future growth.
Chapter 8 summarizes the overall report. In this chapter, we provide a recap of the key takeaways and our independent opinion based on the research and analysis described in earlier chapters.
Chapters 9 and 10 are appendices, which provide the list of companies and tabulated data for all the figures presented in the report.
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