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Biosimilar Commercial Strategies and Tactics

$2,995.00

The challenges faced by biosimilar developers are not unlike those confronting their branded counterparts. First, companies must develop high-quality biosimilars and obtain regulatory approval. Next, they must then navigate the vast array of commercial nuances that exist at the national level in order for their products to be used in the clinical setting.
May 14, 2019
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Gene Editing: The Next Breakthrough in Regenerative Medicine

$2,995.00

Believed to be one of the great biotechnology breakthroughs, gene editing is a powerful tool in pharmaceutical research that could radically change how certain diseases are treated.
September 1, 2017
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Hemophilia Pricing, Reimbursement, and Access

$2,995.00

Over the last two decades, clinical care of hemophilia has improved significantly, extending the life expectancy for this patient population closer to that of the general population. The emergence of virally inactivated plasma-derived clotting factors and then of recombinant clotting factor replacement therapy in the 1980s has revolutionized care for these patients.
January 18, 2017
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Gene Therapy Deal-Making Trends, 2012–17

$2,995.00

A robust deal-making market has enabled gene therapy drug development to be advanced and adequately funded through alliances and financings, and in many cases has provided exits for investors through acquisitions.
February 14, 2018
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Key Trends in European Market Access

$2,995.00

This strategy report focuses on Key Trends in European Market Access including accelerating access to medicines, health technology assessment and harmonization, developments in health technology assessment, pricing, and reimbursement delays.
January 26, 2016
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Vaccines Market Access in Emerging Markets

$3,000.00

Emerging markets account for approximately 18% of the global vaccines market, which is valued at more than $24bn. However, there are indications that this is an underestimate, and some observers forecast that the overall marketplace will reach $50bn by the mid2020s.
August 29, 2019
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US Pricing and Reimbursement

$2,995.00

Historically, few pricing controls have been implemented in the US; however, there is greater pressure to implement controls to help contain costs associated with the expansion of public healthcare provision.
November 2, 2016
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Ovarian Cancer Pricing, Reimbursement, and Access

$2,995.00

Ovarian cancer medicines have traditionally been subject to low restrictions, as most patients usually start and remain on inexpensive platinum-based therapies. However, beginning with the launch of vascular endothelial growth factor inhibitor Avastin, followed by poly (ADP-ribose) polymerase (PARP) inhibitor Lynparza, payers are seeing an uptick in spend for the indication.
March 5, 2018
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Prostate Cancer: Market Access Pricing & Reimbursement

$2,995.00

The prostate cancer market has become saturated in the metastatic castration-resistant prostate cancer (CRPC) setting; the approval of second-generation antiandrogens, radiotherapies, and chemotherapies has resulted in a great deal of development targeting earlier stages of the disease.
June 1, 2018
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EGA Biosimilars Conference 2015

$2,995.00

With the entry of the first monoclonal antibody biosimilar in most European markets and approval of the first biosimilar in the US, 2015 promises to be a landmark year for the biosimilars market. The savings potential of biosimilars in a time of constrained healthcare budgets is an attractive value proposition for many payers, and regulators’ positive stance in terms of making the approval and development process as efficient as possible is advantageous for the sector.
November 2, 2016
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Spain Healthcare System and Drug Regulatory Analysis

$2,995.00

The market environment in Spain is extremely challenging, with cost-containment measures introduced in 2010–12 contributing to an overall reduction in pharmaceutical spending.
November 2, 2016
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Biosimilars Market Access in the U.S.

$2,995.00

The route to a formal US regulatory pathway for biosimilar approval was established with the creation of the Biologics Price Competition and Innovation Act of 2010. However, it took five more years for the first biosimilar to be launched in the US through this pathway, namely Zarxio.
March 13, 2017
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Drug Pricing in the US

$2,995.00

Drug prices in the US have been the subject of intense debate over the past 2–3 years, following a surge in spending on prescription medicines and steep price increases in some categories
July 5, 2017
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Argentina Healthcare System Overview

$2,995.00

With a growing economy and 40 million inhabitants, Argentina is one of the most important emerging market destinations in South America.
November 3, 2016
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Chronic Obstructive Pulmonary Disease (COPD): Market Access Pricing & Reimbursement

$7,000.00

Long-acting beta 2 agonist/long-acting muscarinic antagonist (LABA/LAMA) combination inhalers have been gaining traction due to an expanding evidence base for their wider use, and competitive pricing.
October 17, 2016
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Beyond-the-Pill Services and Solutions: Pharma’s Next Frontier?

$2,995.00

Payers and governments are striving toward cost-effective treatment outcomes and more efficient care, and waves of new digital health technologies are offering patients unprecedented opportunities to be more engaged in their own health management.
November 2, 2016
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UK Regulatory Issues

$2,995.00

Recently there have been several new regulatory changes in the UK aimed at reducing the regulatory burden and allowing earlier access to medicines which are seen as a positive development for the pharmaceutical industry.
November 2, 2016
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Crohn’s Disease and Ulcerative Colitis Pricing, Reimbursement, and Access

$2,995.00

Payers view spending on inflammatory bowel disease (IBD) drugs as significant, as there is a large patient base requiring expensive biologic therapies. The market has been long dominated by the TNF-alpha inhibitors Humira and Remicade, but more recent biologic launches such as Entyvio and Stelara have focused on novel mechanisms of action.
March 16, 2018
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ISPOR Europe 2018 Whitepaper

$2,995.00

Datamonitor Healthcare attended the ISPOR 21st Annual European Congress held in Barcelona on 10–14 November. Here, we present some of the hot topics discussed at the event.

November 23, 2018
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India Pricing and Reimbursement

$2,995.00

Affordability of healthcare is a serious challenge for the majority of the population in India. The lack of properly funded and effective public health services drives a large number of people to receive health services from the private sector.
November 4, 2016
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Biosimilars in Emerging Markets

$2,995.00

Follow-on biologics have been embraced enthusiastically in most emerging markets, where they promise to deliver much-needed improvements in access to a generation of products that remains beyond the reach of many patients.
April 20, 2017
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Japan Regulatory Issues

$2,995.00

Historically Japan has been plagued with delays, with new drug approvals sometimes taking three or four years longer than in the US and EU.
November 2, 2016
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Key Trends in BRICMIST Market Access

$2,995.00

Brazil, Russia, India, China, Mexico, Indonesia, South Korea, and Turkey – known collectively as the BRIC/MIST countries – have been a source of welcome growth for a pharmaceutical industry struggling to generate significant gains in its traditional core markets.
October 17, 2016
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US Specialty Drug Market Access

$2,995.00

High-touch specialty drugs for complex, chronic, high-cost, or rare diseases are an increasingly significant component of the US pharmaceutical market. A sharp growth in regulatory approvals accompanied by high prices has driven rapid increases in expenditure on specialty therapies by both public and private payers.
November 4, 2016
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Germany Healthcare System Overview

$2,995.00

Already high and rising healthcare expenditure coupled with unfavorable demographic dynamics are prompting the German government to introduce changes in order to ensure healthcare system sustainability.
November 2, 2016
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France Healthcare System Overview

$2,995.00

France spent more of its gross domestic product (GDP) on healthcare in 2010 than the average of other key developed markets.
November 2, 2016
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From R&D Investment to Externalization: Where is the Pharma Industry Maximizing Value?

$2,995.00

Pharmaceutical companies are attempting to maximize value from all angles, including internal investment in R&D and externalization via deal-making.
June 8, 2017
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France Generics and Biosimilars

$2,995.00

Traditionally considered an immature generics market, France has seen the introduction of measures aimed at increasing generics use in order to cut healthcare costs.
November 3, 2016
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Digital Pharma: Are We Nearly There?

$2,995.00

Digital’s potential to transform every aspect of the pharmaceutical value chain, from discovery to commercial, is widely documented.
August 14, 2018
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First-In-Class Therapies’ Shrinking In-Class Monopolies

$2,995.00

Competition from drugs in the same class (with the same mechanism of action and treating the same disease) presents a clear challenge to a first-in-class market entrant. And the speed with which these competitors arrive impacts market dynamics, commercial strategies, and, increasingly, drug prices. Therapies that enjoy extended monopolies as sole entrants in a particular class have greater commercial flexibility in negotiating with payers. Multiple drugs in the same class give payers better leverage with which to negotiate rebates and discounts with drug companies.
November 15, 2018
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