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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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Indonesia Generics and Biosimilars

$2,995.00

In 2011, branded generics accounted for 89% of Indonesia’s overall prescription pharmaceutical market, which was valued at IDR25.04tn ($2.84bn). The overwhelming dominance of generics – both branded and unbranded – leaves very little room for innovative products, other than those whose patents have already expired (i.e. “long-listed drugs”).
November 3, 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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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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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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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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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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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 Potential Drug Launches in 2020

$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 2020.

May 28, 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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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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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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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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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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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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Market Access Trends in Europe

$3,000.00

Health technology assessments (HTAs) have become an integral part of procedures employed to inform new drug coverage and pricing decisions across Europe. Methodological approaches to HTA vary, however, while disparities are also apparent in the pertise and financial resources to conduct multidisciplinary assessments, and in the relative weight accorded to recommendations issued by national (or regional) HTA agencies (ICOM, 2017)
November 16, 2018
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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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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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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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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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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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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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Poland Pricing and Reimbursement

$2,995.00

The average drug price in Poland is the lowest in the EU, mainly due to the high proportion of generic pharmaceuticals, low availability of innovative drugs, and high price pressure on reimbursed drugs.
November 4, 2016
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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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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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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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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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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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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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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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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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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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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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Trends in CNS Dealmaking, 2012–16

$2,995.00

Diseases of the central nervous system (CNS) offer considerable opportunity to drug developers and marketers.
August 8, 2017
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Turkey Pricing and Reimbursement

$2,995.00

To contain overall healthcare expenditure and to rein in the rapid growth of pharmaceutical expenditure, in 2004 Turkey introduced price-setting procedures using an external reference system based on 5–10 reference countries (all from the EU).
November 4, 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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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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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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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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US Healthcare System Overview

$2,995.00

Continued growth in healthcare expenditure and the high number of individuals without health insurance coverage were the key drivers of the passage of the healthcare reform law.
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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US Regulatory Issues

$2,995.00

Key regulatory developments include the new Prescription Drug User Fee Act (PDUFA-V), which aims to improve interaction between the FDA and drug developers.
November 2, 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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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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