Rheumatoid Arthritis (RA) is a chronic, progressive and currently incurable autoimmune disease that primarily affects the joints. It is characterized by synovial inflammation and gradual bone erosion over many years. Disease progression results in stiffness and pain, especially in the hands and feet, which hinders mobility. Without treatment, the disease leads to joint destruction and disability.
The chronic nature of the disease, which requires ongoing treatment, and the relatively high annual cost of therapy (ACoT) have made RA treatment a highly lucrative market. The RA therapeutic market has become very competitive due to the high number of new drug approvals. Competition is fierce, particularly among TNF-α inhibitors, which dominate the treatment market for RA patients who are refractory to traditional disease-modifying anti-rheumatic drugs (DMARD).
Despite this, 30% of RA patients fail to attain a clinical response when treated with TNF-α inhibitors. However, other targeted programs, as well as newly marketed small-molecule DMARDs such as the Janus kinase (JAK) inhibitor Xeljanz (tofacitinib), have the potential to replace ineffective TNF-α inhibitors. Recently published study results of Xeljanz have shown a significant reduction in the risk of developing cardiac diseases such as heart attack and stroke in patients with RA.
Despite the superior efficacy of recently marketed therapies over traditional DMARD therapies, there is a need to improve safety in the therapeutic landscape. Elevated rates of infection are a frequent consequence of the immunosuppression involved in treatments, but this is required to suppress the autoimmune responses responsible for the symptoms of the condition.
As a result, these biological therapies are not recommended to patients who are susceptible to infection. In addition, there is a need to create biologics with more convenient and less invasive drug-delivery methods, as all existing therapies are administered subcutaneously or intravenously.
These routes of administration are frequently associated with pain, rash, and allergic reactions at the injection or infusion site and, in the case of infusion, flu-like illness, fever, chills, nausea, and headache. Therefore convenient and safe administration without significant compromise of therapy efficacy remains an unmet need.
Although the recently approved drug Xeljanz is an orally administered small-molecule drug, indicated as a second-line treatment for RA patients who have not shown an adequate response to methotrexate, and as a third-line therapy for patients who have not responded sufficiently to biologics, it carries a black-box warning in the US due to the safety issues of serious infections and malignancy.
- The current Asia-Pacific RA market contains novel products, including sirukumab, an anti-IL-6 human mAb; Peficitinib, Upadacitinib and Filgotinib, which are JAK1 inhibitors; Olokizumab, an anti-IL-6 humanized IgG4 mAb; and RCT-18, a recombinant human B-lymphocyte stimulating factor (BLyS) receptor-antibody fusion protein.
- What are the competitive advantages of the existing novel drugs?
- There are over 480 active pipeline molecules, and most of the late-stage investigational drug candidates feature improved dosing regimens and administration routes in comparison to currently marketed products and combination therapies.
- Which classes of novel drugs are most prominent in the pipeline?
- What is the potential for pipeline products to address unmet needs in the RA market?
- Analysis of clinical trials since 2006 identified that the failure rates of RA molecules were highest in Phase II, at 72.6%, with the overall attrition rate for RA standing at 94.6%.
- How do failure rates vary by stage of development, molecule type, and molecular target?
- How do other factors, such as average trial duration and trial size, influence the costs and risks associated with product development?
- Over the 2016-2023 forecast period, the Asia-Pacific RA therapeutics market is expected to increase in value at a compound annual growth rate of 8.2%, from $5.6 billion to over $9.7 billion.
- Which markets make the most significant contribution to the current market size?
- What are the epidemiology trends in these markets?
- Will new market entrants lead to substantial changes in annual therapy costs?
- How will different treatment usage patterns impact growth in the five assessed Asia-Pacific markets?
- A rising RA prevalence population and the uptake of newer therapies will lead to significant market growth over the forecast period, despite the launch of biosimilars of blockbuster anti-TNFs.
- Will the launch of biosimilars or emerging pipeline molecules threaten the commercial success of existing drugs?
- Licensing deals are the most common form of strategic alliance in the RA therapeutics market, with deal values ranging from under $10m to over $1 billion.
- How do deal frequency and value compare between target families and molecule types?
- What were the terms and conditions of key licensing deals?
Reasons to buy
- Understand the clinical context of RA by considering epidemiology, symptoms, etiology and pathophysiology, diagnosis, prognosis, treatment guidelines and options, and biologic registries.
- Identify the therapeutic strategies, products, and companies that dominate the current marketed products landscape and recognize gaps and areas of unmet need.
- Identify key pipeline trends in terms of molecule type, administration route, molecular target, and novelty.
- Consider market opportunities and potential risks by examining trends in RA clinical trial size, duration, and failure rate by stage of development, molecule type, and molecular target.
- Recognize the late-stage pipeline molecules that have demonstrated strong therapeutic potential in RA by examining clinical trial data and multi-scenario product forecast projections.
- Compare treatment usage patterns, annual therapy costs, and market growth projections for India, China, Australia, Japan and South Korea.
- Discover trends in licensing and co-development deals concerning RA products and identify the major strategic consolidations that have shaped the commercial landscape.