Description
Introduction
Over the last 12 months, there have been encouraging developments in the osteoporosis pipeline, with new therapies either receiving regulatory approval or launching. Moreover, both in the clinical and preclinical pipeline, companies continue their quest to bring to market a new, safe, effective, and affordable anabolic drug to address unmet need in the osteoporosis market.
Features and benefits
- Understand key dynamics in the R&D pipeline for new osteoporosis therapies
- Benchmark novel and existing therapies using the target product profile identified by Datamonitor
- Support R&D decision making by evaluating osteoporosis clinical trial designs that have set a precedent, as well as analysis of discontinued projects
- Access Datamonitor's prediction of how the treatment landscape may change in the next 20 years
Highlights
- The osteoporosis pipeline remains well stocked, with several products continuing their clinical trials and no significant discontinuations. There most exciting novel candidates with new mechanisms of action continue to be the new antiresorptives cathepsin K inhibitors and the anti-sclerostin monoclonal antibodies anabolics.
- The osteoporosis treatment paradigm has been largely static for the past 20 years, but this trend is likely to change as new drugs reach the market. It is probable that the fracture prevention strategy will evolve from just focusing on increasing bone mineral density to improving the bone quality and strength.
- The major change in the treatment of osteoporosis will be the launch of new efficacious and safe anabolic treatments, allowing physicians to use these treatments earlier in the algorithm and in a wider category of patients. In particular companies are targeting the Wnt pathway, bone morphogenetic proteins, and insulin-like growth factor.
Your key questions answered
- What are the key trends in the osteoporosis pipeline?
- What is the clinical gold standard and how do new candidates have to compare to this to successfully penetrate the market?
- How will new osteoporosis treatments evolve in the next 20 years?
- What are the requirements of European and US regulatory bodies to ensure approval of a novel candidate?
TOC
Executive Summary
- Strategic scoping and focus
- Datamonitor key findings
- Related reports
OVERVIEW
CLINICAL PIPELINE OVERVIEW
- Osteoporosis pipeline
- The osteoporosis pipeline remains robust
- Companies are focusing on developing anabolics as competition in the antiresorptive market increases
- Mechanism of action
- Late-stage development compounds recently discontinued
TARGET PRODUCT PROFILE
- Comparator therapies
- Fosamax (alendronate; Merck & Co)
- Target product profile versus current level of attainment
CLINICAL TRIAL DESIGN IN OSTEOPOROSIS
- Preclinical trials
- Two different animal species tests are required by both the FDA and EMA
- Preclinical trial design should reflect the clinical indication
- Clinical trials
- The FDA and EMA have different patient inclusion requirements for osteoporosis trials
- Clinical endpoints
- Future developments in clinical trial design
- Trial endpoints unlikely to change
INNOVATIVE EARLY-STAGE APPROACHES
- New targets for osteoporosis treatments
- Targets for antiresorptive treatment
- Targets for anabolic treatment
THE FUTURE OF TREATMENT OF OSTEOPOROSIS
- Screening and osteoporosis diagnosis
- Increased use of FRAX will lead to more osteoporosis prevention
- Change in treatment outcomes
- New treatment strategies
- Anabolic treatments are likely to be used earlier in the treatment algorithm
- Combination therapies
- Personalized medicine
BIBLIOGRAPHY
APPENDIX
- Contributing experts
- Conferences attended
- Report methodology
