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The Biopharmaceutical Industry in 2018: Key Events and Trends to Watch for by Therapy Area

The Biopharmaceutical Industry in 2018: Key Events and Trends to Watch for by Therapy Area

  • March 2018
  • 55 pages
  • ID: 5363160
In this report:
In 2017, Prolia generated $##.##B in sales for Amgen in the US, commanding a ##% share of the market.
In August 2017, the FDA approved Melinta's Vabomere (meropenem/vaborbactam) for the treatment of adults with complicated urinary tract infections (cUTIs) caused by susceptible strains of E. coli, K. pneumoniae, and E. cloacae species complex.
Melinta Acquisition: Melinta Therapeutics completed its acquisition of The Medicine Company's infectious diseases business unit as part of a $##M agreement on January ##.

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The Biopharmaceutical Industry in 2018: Key Events and Trends to Watch for by Therapy Area

Brief

GlobalData's "The Biopharmaceutical Industry in 2018: Key Events and Forecasts to Watch for by Therapy Area", offers an insight-rich overview of the main events and forecasts that our analysts expect to occur during 2018. This forward-looking view of the industry determines top events that will occur across the main therapeutic areas - oncology, immunology, neurology, cardiovascular diseases, metabolic disorders, infectious diseases, and ophthalmology - and provides analyst insight on the thinkable ramifications of each event.

2018 promises to be a year of continued innovation in the biopharmaceutical industry across therapy areas. In this industry report, GlobalData's analysts highlight a selection of highly anticipated events, containing regulatory approvals, product launches, and clinical trial milestones throughout the year.

Overview

For each therapeutic area, the market research includes a timeline of events by quarter and analysis of each event.

Selected events and business insights contain -

- 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 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. Armed with positive clinical results from new pivotal trials, both companies are slated to submit BLAs in 2018 for their respective peanut allergy therapies. Currently available drugs on the sector 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.

Great reasons to purchase

- Identify the most impactful anticipated regulatory approvals and drug launches in the industry in 2018 by therapeutic area.

- Gain insight into the plausible ramifications of main product approvals, containing the effect of their market entrance on the ambitious 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 big, well-established disease markets and smaller markets for underserved diseases.

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