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Argentina Regulatory Issues

$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 2, 2016
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Multiple Myeloma Pricing, Reimbursement, and Access

$2,995.00

Highlights: The budget impact of multiple myeloma is set to increase While multiple myeloma represents a relatively small patient population in comparison to other cancers, payers are concerned about the rising spend on the indication. New biologic therapies are increasingly gaining label expansions in earlier treatment lines, and with life expectancies improving, patients are requiring […]
March 5, 2019
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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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Early Access to Medicines in the US and Europe

$2,995.00

Faced with pressure from stakeholders – particularly patients – governments, regulators, and some countries have introduced new options and/or processes to speed up access to medicines. This includes access before marketing authorization, and speeding up the marketing authorization, or less often, the health technology assessment processes.

July 15, 2019
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Key Potential Drug Launches in 2021

$2,995.00

As a supplement to our well-known quarterly Outlook report, Biomedtracker is pleased to present a longer-term look at some key late-stage drugs projected to hit the market in 2021.

1.

July 24, 2020
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Managed Entry Agreements

$2,995.00

Managed entry agreements (MEAs) describe a range of mechanisms by which pharmaceutical firms and payers share some of the financial and clinical risk associated with the introduction of a new medicine.
November 4, 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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Indonesia Regulatory Issues

$2,995.00

Challenges for foreign pharma companies in relation to Indonesia’s pharma system include lengthy and variable approval periods, compulsory licenses, and counterfeits.
November 2, 2016
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Malignant Melanoma Pricing, Reimbursement and Access

$2,995.00

This strategy report focuses on Malignant Melanoma Pricing and Reimbursement including how immunotherapies are changing melanoma treatment paradigms with market conext in the US, Japan, and five major EU markets.
September 30, 2015
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Access in Emerging Markets: HTA is Making Inroads

$2,995.00

Generally considered the domain of developed markets, health technology assessment (HTA) is increasingly being used by developing countries as a means of reconciling growing demand for access to health technologies with limited resources. Expanding public health insurance programs, coupled with aging populations and growing patient empowerment, have led in some cases to the fast establishment […]
November 2, 2016
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2019 Post-ADA Report

$2,995.00

The American Diabetes Association (ADA) 79th Scientific Sessions was held in San Francisco, CA from 7–11 June 2019.

July 22, 2019
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CER, HEOR, and Value-Based Frameworks in the US

$2,995.00

It is no secret that Americans spend heavily on healthcare – in 2013, US healthcare expenditure totaled nearly $3bn ($9,255 per person) and accounted for 17.4% of gross domestic product.
October 17, 2016
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The Evolution of Pharmaceutical Sales Strategies Continues

$2,995.00

Pharmaceutical sales forces have evolved from the traditional structure, which was dominated by considerable numbers of field-based representatives detailing a range of products to different physicians on a regular basis.
November 1, 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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China Regulatory Update

$2,995.00

China has recently completed its 2009–11 healthcare reform. The reform has come at a high cost: although the Ministry of Health intended to invest CNY850bn ($135bn) in the plan, total investment has now exceeded CNY1,100bn ($175bn).
November 4, 2016
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Biosimilars in the US and Europe

$2,995.00

Biosimilars have been available in Europe for over a decade, and have offered the opportunity to vastly reduce the cost of treatment for a large number of biologic agents.
June 25, 2019
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Asthma Pricing, Reimbursement, and Access

$2,995.00

The next wave of key therapies in asthma includes biologics, with interleukin (IL)-5 inhibitors first to reach the market.
October 17, 2016
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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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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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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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Integrated Delivery Networks in the US

$2,995.00

Integrated delivery networks (IDNs) are a growing approach to streamlined healthcare in the US, providing support from the cradle to the care home.
June 27, 2017
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Spotlight on Antibody-Drug Conjugates

$2,995.00

The first antibody-drug conjugate (ADC), Mylotarg, reached the market almost two decades ago. Since this time, the ADC field has undergone slow but transformative enhancements, with improvements to technologies and advancements in the pipeline leading to an invigoration of the field. The past couple of years have seen the approvals of three new ADCs: Polivy, Lumoxiti, and Besponsa, increasing the total number of ADCs approved by regulators worldwide to six. These approvals mark the start of a new era in which the ADC field is finally beginning to realize its full potential. With the ADC pipeline swelling to around 250 novel candidates in various stages of preclinical and clinical development, approvals for more ADCs appear firmly on the horizon.

September 20, 2019
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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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Germany Generics and Biosimilars

$2,995.00

The German generics industry is feeling the effects of recent efforts to control drug spending by exerting downward pressure on drug prices.
November 2, 2016
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Bladder Cancer Pricing, Reimbursement, and Access

$2,995.00

Payers are not overly worried about the cost of bladder cancer, due to the relatively small patient population in comparison to other solid tumors.
September 27, 2018
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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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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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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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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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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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Orphan Drug Access and Pricing in Emerging Markets

$2,995.00

This analysis covers the four major emerging regions of the Middle East and Africa, Latin America, Eastern Europe, and Asia-Pacific. Within these regions, relatively wealthier markets with a proven marketplace for orphan medicines have been prioritized.
January 12, 2018
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Psoriasis Pricing, Reimbursement, and Access

$2,995.00

Launch of multiple IL inhibitors with impressive efficacy has significantly reduced unmet need in the disease, and also provided payers with leverage in price negotiations as they seek to control growing treatment cost.
March 28, 2019
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Germany Pricing and Reimbursement

$2,995.00

The German pharmaceutical market has historically been the most attractive European market due to high prices and high drug utilization. However, this is changing, with comparability assessment requirement raising the bar for achieving a higher price point.
November 2, 2016
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Russia Generics and Biosimilars

$2,995.00

Despite high volume uptake, generics still account for only a small proportion of the total market value in Russia, driven by a lack of incentives for generic substitution and the significant originator/generic price differential.

November 3, 2016
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Renal Cell Cancer Pricing, Reimbursement, and Access

$2,995.00

There is moderate concern among payers regarding spend on renal cell cancer (RCC) drugs, but access restrictions remain mild.
August 22, 2018
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2019 Biomedtracker / Datamonitor Healthcare Post-ASCO Report

$2,995.00

The 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) was held in Chicago, IL from May 31st through June 4th, 2019. This year’s conference was highly varied, with key data presented for drugs in numerous different classes and indications.

June 13, 2019
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Turkey Regulatory Issues

$2,995.00

The mandatory requirement imposed by the Turkish authorities for overseas manufacturers exporting pharmaceutical products to Turkey to obtain Good Manufacturing Practice (GMP) certification issued by the Turkish Ministry of Health is causing inordinate delays in the registration of new pharmaceutical products in Turkey. However, these delays can be resolved once the US Food and Drug […]
November 1, 2016
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Orphan Drug Pricing and Reimbursement

$2,995.00

Orphan drugs account for a growing portion of payers’ budgets – and comprise some of the most expensive treatments available.
November 4, 2016
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The Growing Impact of Real-World Evidence

$2,995.00

Real-world evidence (RWE) has become increasingly important in proving the value of drugs and differentiating them from their competition.
July 14, 2017
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CRO Snapshot: Clinical Outsourcing in 2012

$5,000.00

By any standards, last year was a turbulent one for the pharmaceutical sector. The patent cliff claimed some of the industry’s most profitable properties and with the market share of these drugs losing ground to generics, put even more pressure on the top- and bottom-line performance of key players such as Eli Lilly and AstraZeneca, to name just two of the worst hit.

Such pressure – and the drive to cut fixed costs that goes with it – has been a boon for clinical CROs, which have become increasingly indispensable to the business of drug discovery, as clinical development is outsourced and specialist units, such as clinical laboratories, are offloaded to CROs in long-term guaranteed strategic partnerships.
November 3, 2016
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UK Generics and Biosimilars

$2,995.00

Prescribing by international non-proprietary name, pharmacist incentives, and the high price differential between the brands and their generic alternatives are the key drivers of the generics market in the UK.
November 2, 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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NOACs Pricing, Reimbursement, and Access

$2,995.00

A combination of the high cost of novel oral anticoagulants (NOACs) (relative to highly genericized vitamin K antagonists) and the large patient populations these drugs address, has resulted in this class of compounds being a top priority for European payers.
May 10, 2017
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Generics: Regulatory Update

$2,995.00

Regulatory measures continue to shape the generics landscape. Cost-containment strategies continue to impact generics.
November 4, 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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