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

2018 promises to be a year of continued innovation in the biopharmaceutical industry across therapy areas. 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.

Scope

GlobalData’s 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.

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.

Reasons to buy

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.

Companies mentioned

Companies with anticipated major events in 2018 – from clinical trial milestones to product approvals – in each of the following therapeutic areas are mentioned: oncology, immunology, neurology, cardiovascular diseases, metabolic disorders, infectious diseases, and ophthalmology.

Table of Contents

Introduction

Classification of Events

Major Events Year-to-Date: January

Major Events Year-to-Date: February

Oncology

Key Anticipated Events in Oncology and Hematology in 2018

Key Events and Trends to Watch for in Hematological Cancers

Key Events and Trends to Watch for in Gastrointestinal Cancers

Key Events and Trends to Watch for in Genitourinary Cancers

Key Events and Trends to Watch for in Skin Cancers

Key Events and Trends to Watch for in Lung and Brain Cancers

Immunology

Key Anticipated Events in Immunology in 2018

Key Events and Trends to Watch for in Autoimmune Diseases

Key Events and Trends to Watch for in Dermatology

Key Events and Trends to Watch for in Respiratory and Gastrointestinal Diseases

Key Events and Trends to Watch for in Rare and Other Immunological Diseases

Neurology

Top Players in Neurology in 2017

Key Events and Trends to Watch for in Epilepsy

Key Events and Trends to Watch for in Multiple Sclerosis

Key Events and Trends to Watch for in Migraine

Key Events and Trends to Watch for in Parkinson’s Disease and Alzheimer’s Disease

Key Events and Trends to Watch for in Diabetic Neuropathic Pain, Acute Ischemic Stroke, and Amyotrophic Lateral Sclerosis

Cardiovascular and Metabolic Disorders

Key Anticipated Events in CVMD in 2018

Key Events and Trends to Watch for in Osteoporosis and Endometriosis

Key Events and Trends to Watch for in Selected Metabolic Disorders

Key Events and Trends to Watch for in Diabetes

Key Events and Trends to Watch for in Cardiovascular Diseases

Infectious Diseases

Key Anticipated Events in Infectious Diseases in 2018

Key Events and Trends to Watch for in HIV and Hepatitis C

Key Events and Trends to Watch for in Vaccines

Key Events and Trends to Watch for in Antimicrobials

Ophthalmology

Key Anticipated Events in Ophthalmology in 2018

Key Events and Trends to Watch for in Glaucoma

Key Events and Trends to Watch for in Uveitis

Key Events and Trends to Watch for in Age-Related Macular Degeneration

Key Events and Trends to Watch for in Dry Eye Syndrome and Macular Edema

Appendix

Contributors

About GlobalData

Contact Us

Disclaimer

List of Tables

Table 1: Classification of Events

Table 2: Key Anticipated Events in Oncology in 2018

Table 3: Key Events and Trends to Watch for in Hematological Cancers

Table 4: Key Events and Trends to Watch for in Gastrointestinal Cancers

Table 5: Key Events and Trends to Watch for in Genitourinary Cancers

Table 6: Key Events and Trends to Watch for in Skin Cancers

Table 7: Key Events and Trends to Watch for in Lung and Brain Cancers

Table 8:Key Anticipated Events in Immunology in 2018

Table 9:Key Events and Trends to Watch for in Autoimmune Diseases

Table 10: Key Events and Trends to Watch for in Dermatology

Table 11: Key Events and Trends to Watch for in Respiratory and Gastrointestinal Diseases

Table 12: Key Events and Trends to Watch for in Rare and Other Immunological Diseases

Table 13: Key Anticipated Events in Neurology in 2018

Table 14: Key Events and Trends to Watch for in Epilepsy

Table 15: Key Events and Trends to Watch for in Multiple Sclerosis

Table 16: Key Events and Trends to Watch for in Migraine

Table 17: Key Events and Trends to Watch for in Parkinson’s Disease and Alzheimer’s Disease

Table 18: Key Events and Trends to Watch for in Diabetic Neuropathic Pain, Acute Ischemic Stroke, and Amyotrophic Lateral Sclerosis

Table 19: Key Anticipated Events in CVMD in 2018

Table 20: Key Events and Trends to Watch for in Osteoporosis and Endometriosis

Table 21: Key Events and Trends to Watch for in Selected Metabolic Disorders

Table 22: Key Events and Trends to Watch for in Diabetes

Table 23: Key Events and Trends to Watch for in Cardiovascular Diseases

Table 24: Key Anticipated Events in Infectious Diseases in 2018

Table 25: Key Events and Trends to Watch for in HIV and Hepatitis C

Table 26: Key Events and Trends to Watch for in Vaccines

Table 27: Key Events and Trends to Watch for in Antimicrobials

Table 28: Key Anticipated Events in Ophthalmology in 2018

Table 29: Key Events and Trends to Watch for in Glaucoma

Table 30: Key Events and Trends to Watch for in Uveitis

Table 31: Key Events and Trends to Watch for in Age-Related Macular Degeneration

Table 32: Key Events and Trends to Watch for in Dry Eye Syndrome and Macular Edema

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