2018 promises to be a year of continued innovation in the biopharmaceutical industry across therapy areas.
The Biopharmaceutical Industry in 2018: Key Events and Trends to Watch for by Therapy Area", provides an insight-rich overview of the key events and trends that our analysts expect to occur during 2018. This forward-looking view of the industry identifies key events that will occur across the major therapeutic areas - oncology, immunology, neurology, cardiovascular diseases, metabolic disorders, infectious diseases, and ophthalmology - and provides analyst insight on the potential ramifications of each event.
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In this report, GlobalData’s analysts highlight a selection of highly anticipated events, including regulatory approvals, product launches, and clinical trial milestones throughout the year.
For each therapeutic area, the report includes a timeline of events by quarter and analysis of each event. Selected events and insights include -
- Within the oncology space, GlobalData anticipates that Keytruda will receive FDA approval for adjuvant treatment of melanoma during Q4 2018. In December 2017, the FDA approved Bristol-Myers Squibb’s PD-1 inhibitor Opdivo (nivolumab) as an adjuvant treatment for patients with completely resected melanoma with lymph node involvement or metastatic disease.
Although Keytruda’s head-to-head competitor Opdivo has a head start in this lucrative setting, the adjuvant indication could help close the gap for Keytruda. GlobalData expects Keytruda to be a bonafide rival to Opdivo in the adjuvant melanoma setting, with the two drugs splitting the market equally by 2026.
- Within the immunology space, GlobalData anticipates 2018 BLA submissions of DBV Technologies’ Viaskin Peanut and Aimmune’s AR-101 for peanut allergy (PNA). Armed with positive clinical results from recent pivotal trials, both companies are slated to submit BLAs in 2018 for their respective peanut allergy therapies.
Currently available drugs on the market treat the inflammatory symptoms that occur following the accidental exposure to peanut and not the underlying allergy itself. Therefore, these novel immunotherapies will be the first to launch for treating the disease and will revolutionize the field.
- In the vaccines market, GlobalData anticipates the initial data from Takeda’s pivotal Phase III study evaluating the efficacy and safety of its dengue vaccine candidate, TAK-003, to be announced in H2 2018. The results of this study, which has enrolled over 20,000 children and adolescents across eight dengue-endemic countries, could propel Takeda ahead of rival Sanofi in the dengue vaccine space.
Takeda is also investigating the immunogenicity and safety of TAK-003 in non-endemic areas in an ongoing Phase III study (NCT03341637), with initial results also expected in 2018.
This report helps readers to
- Identify the most impactful anticipated regulatory approvals and drug launches in the industry in 2018 by therapeutic area.
- Gain insight into the potential ramifications of key product approvals, including the effect of their market entrance on the competitive landscape.
- Understand which clinical trial milestones and data readouts in 2018 are likely to make the greatest impact on treatment paradigms across multiple indications, including both large, well-established disease markets and smaller markets for underserved diseases.
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