Definition
CD is a form of chronic inflammatory bowel disease (IBD) which causes transmural inflammation in the digestive tract. The disease course is characterized by periods of remission sporadically interspersed with inflammatory flares.
Latest Key Takeaways
CD is a form of chronic inflammatory bowel disease (IBD) which causes transmural inflammation in the digestive tract. The disease course is characterized by periods of remission sporadically interspersed with inflammatory flares.
Latest Key Takeaways
- As specialty products, therapies for Crohn’s disease (CD) can be expensive, and formulary positioning is paramount to product uptake. Payers are settled in vital contracts that lead them to prioritize broad immunology drugs Humira and Remicade. This has posed a high barrier to newer entrants to the market, which cannot compete in volume and rebates. Biosimilar and generic competition will further undermine the likely premium pricing of newer drugs and pipeline products.
- Over the next decade, all key marketed brands for CD will have faced patent expiry. Thus far, the European market has taken the brunt of biosimilar erosion, with earlier launches and more acceptance compared to other countries. In the US, biosimilars will face challenges in usurping branded anti-TNFs, with adalimumab biosimilars not expected until 2023, substantial originator rebates, and exclusive contracting with payers. Over time, biosimilar penetration is anticipated to gain more momentum as international real-world evidence accumulates and long-term data support biosimilar efficacy and safety. This should allow physicians and patients to grow their confidence and familiarity with biosimilars, and encourage uptake.
- Nevertheless, the CD market is projected to expand, propelled by a growing patient caseload and the introduction of pipeline products. The publisher estimates that in 2018, there were 6.1 million prevalent cases of CD worldwide, and forecasts that number to increase to 6.5 million prevalent cases by 2027.
- The entry of novel drug classes will drive growth of the CD market, despite facing cost-related barriers to uptake. The pipeline holds distinct prospects that aim to treat non-responders, including the oral JAK inhibitors Jyseleca and Rinvoq. These will be welcomed for their distinguished mechanisms of action, and their oral formulation will further offer unprecedented convenience in the CD treatment algorithm. Targeting global markets broadens their commercial potential as they are being investigated across the US, Japan, and Europe. Advantageously, over the forecast period, Rinvoq and Jyseleca will not encounter the increasing biosimilar competition that will directly erode sales of already marketed drugs. On the other hand, newer premium-priced entrants will likely be relegated to later lines of therapy after cheaper conventional drugs and biosimilars.
- Significant unmet needs include targeting inadequate responders to biologic and conventional therapies, as well as underserved patients with fistulas. In terms of clinical trials, active comparators and the endoscopic endpoints should be prioritized as there is a stark absence of head-to-head data and the field is moving towards endoscopic treatment goals. Additionally, new mechanisms of action and convenient oral therapies that are safe and effective are desirable. Pricing will be critical to secure favorable positioning in formularies and maximize commercial opportunities.
Table of Contents
OVERVIEW
DISEASE BACKGROUND
TREATMENT
EPIDEMIOLOGY
KEY REGULATORY EVENTS
LICENSING AND ASSET ACQUISITION DEALS
CLINICAL TRIAL LANDSCAPE
DRUG ASSESSMENT MODEL
FUTURE TRENDS
RECENT EVENTS AND ANALYST OPINION
UNMET NEEDS
LIST OF FIGURES
LIST OF TABLES
