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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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Japan Pricing and Reimbursement

$2,995.00

Pricing and reimbursement processes are closely connected in Japan, with drug pricing largely dependent on innovation. However, achieving premium pricing is difficult, thereby limiting sales potential.
November 4, 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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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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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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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 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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Psoriatic Arthritis: Market Access Pricing & Reimbursement

$2,995.00

Tumor necrosis factor (TNF)-alpha inhibitors Enbrel, Humira, and Remicade have long held dominant positions in the psoriatic arthritis market.
October 17, 2016
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Chronic Heart Failure Pricing, Reimbursement, and Access

$2,995.00

Payers were originally extremely worried about the potential cost burden of Entresto, however, the level of concern surrounding the drug is currently moderate as physician uptake has been lower than expected.
April 13, 2018
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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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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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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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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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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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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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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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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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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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Russia Pharmaceutical Market Dynamics

$2,995.00

With the Russian economy recovering from the recession experienced in 2009, the pharmaceutical market has also returned to growth.
November 2, 2016
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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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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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India Regulatory Issues

$2,995.00

The drug approval process in India is not complex, although poor patent protection and government policies favoring generic companies make multinational companies (MNCs) wary of launching new drugs in the country.
November 1, 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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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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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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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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New Pharma Models for a New Healthcare Era

$2,995.00

This analysis includes insights from eight interviewed experts from pharma, medical device, or digital health companies.
December 20, 2018
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UK Healthcare System Overview

$2,995.00

Reform of the NHS is underway despite widespread controversy and opposition from physicians, and will necessitate a change in the way pharmaceutical companies work with key stakeholders.
November 2, 2016
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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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Access Trends in Emerging Markets

$3,000.00

This report provides an in-depth analysis of the market access climate in emerging pharmaceutical markets. Focusing in particular on the E7 countries (Brazil, Russia, India, China, Mexico, Indonesia, and Turkey), it charts recent developments, assesses their potential impact on market access, and pinpoints areas in which further change is anticipated.
February 20, 2019
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Biosimilars Market Access in Psoriasis

$2,995.00

Tumor necrosis factor (TNF)-alpha inhibitors Enbrel, Humira, and Remicade have long held dominant positions in the psoriasis market; however, these market leaders face patent expirations and consequent biosimilar launches
March 6, 2017
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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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2019 Biomedtracker / Datamonitor Healthcare Post-AAN Report

$2,995.00

The 71st Annual Meeting of the American Academy of Neurology (AAN) was held in Philadelphia, Pennsylvania, from May 4-10, 2019.

May 28, 2019
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Value-Based Reimbursement in the US

$2,995.00

The US healthcare environment has been witnessing a slow albeit continuous shift from volume- to value-based reimbursement over the past couple of decades
August 22, 2018
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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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Latest Trends in Orphan Drug Pricing and Reimbursement

$2,995.00

It is now some 35 years since the passage of the first law designed specifically to encourage investment in the discovery and development of rare disease treatments. Activity in the sector has been transformed since then.
February 1, 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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HER2+ Breast Cancer Pricing and Reimbursement

$2,995.00

Despite their high prices, Kadcyla and Perjeta are widely reimbursed in the US and have experienced fast uptake as payers have limited options for cost control in this indication.
November 4, 2016
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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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Indonesia Healthcare System Overview

$2,995.00

With only 2.6% of GDP spent on healthcare in 2010, the healthcare system in Indonesia has huge potential for growth.
November 2, 2016
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Indonesia Pharmaceutical Market Dynamics

$2,995.00

Kalbe Farma is the leading player by some margin, with a market share of 13% in 2011, while GlaxoSmithKline is the largest foreign player with a 3% share.
November 2, 2016
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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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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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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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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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