Outlook 2019

Examples of unfinished business from 2019 include no legislation passed to reform OTC monograph program; FDA putting off until May the planned publication of an NPRM to allow firms to submit OTC NDAs with extra-label information to help guide consumers' self-selection; and no OTC naloxone for opioid overdose approved even after FDA's unprecedented step of developing model DFLs sponsors could use for their own label comprehension studies.

Looking look back on US wellness market developments and events in 2019, HBW Insight finds a firm that doesn’t compete in the dietary supplement sector, Amarin, made a good bit of news that affected the industry during the year. We track news across the wellness space from the past year.

As HBW Insight looks back on notable US wellness market developments and events for the previous 12 months, we find that news in the CBD space from the FDA and the industry dominated the sector throughout 2019.

Scrip highlights the key transactions involving Indian firms in 2019. Divestments and licensing were among the prominent themes that dotted the deal landscape in the year gone by.

Net price growth of 0.3% for branded drugs in 2018 was 1.6% below Consumer Price Index inflation, while invoice prices grew an average of 5.5%.

As the pipeline and market for novel cell and gene therapies expands, it is time for drug developers to address other critical aspects in the logistical chain – and for these complex therapies a lot of those issues relate to manufacturing. Looking at specific cases, In Vivo has underlined the main manufacturing challenges facing cell and gene therapy developers, and highlighted methods and approaches being used to generate solutions. 

2019 could be a monumental year for the South Korean pharma industry, as several new drug assets await the green light from the US FDA.

2019 promises to be action-packed for Indian firms as they stay hungry for M&A and on course to transition to a more innovation-led play. But election year surprises in India, rising patient awareness, and the entry of non-traditional players like Amazon could well up the variable quotient for pharma, industry pundits tell Scrip.

After much turmoil in 2018, the biopharma sector in China is embracing multiple uncertainties in the year of the boar.

A New Year and a new look. For 2019 we have merged the Scrip 100 with In Vivo’s annual preview magazine, creating a new beast known as Outlook. This encompasses all the best aspects of both issues and covers more topic areas than ever before.

Lift the burden of paper on drug quality reviews and the pace of innovation is no longer a problem for structural engineers or couriers – or even print or electronic document rooms. The focus at the US FDA is now on enabling direct transmission and analysis of critical quality data.

Lift the burden of paper on drug quality reviews and the pace of innovation is no longer a problem for structural engineers or couriers – or even print or electronic document rooms. The focus at the US FDA is now on enabling direct transmission and analysis of critical quality data.

The relative absence of blockbuster M&A within medtech in 2018, compared with recent years, does not mean that consolidation of the industry – and of providers and payers – will not continue apace in 2019 and beyond. In fact, it is written – if not in the stars then possibly in digital coding – that there will be fewer and bigger entities at the top end of the ecosystem of medtech stakeholders. And rising demand will be met more and more by digital tools and functionalities.

The relative absence of blockbuster M&A within medtech in 2018, compared with recent years, does not mean that consolidation of the industry – and of providers and payers – will not continue apace in 2019 and beyond. In fact, it is written – if not in the stars then possibly in digital coding – that there will be fewer and bigger entities at the top end of the ecosystem of medtech stakeholders. And rising demand will be met more and more by digital tools and functionalities.

High valuations, an uncertain biopharma macro environment and widespread use of US tax reform benefits for share buybacks and capital investments resulted in less major M&A than expected. Opinions vary widely on whether 2019 will be any different.

High valuations, an uncertain biopharma macro environment and widespread use of US tax reform benefits for share buybacks and capital investments resulted in less major M&A than expected. Opinions vary widely on whether 2019 will be any different.

Sanofi and Gilead moved down in the rankings of Scrip's top 100 pharmaceutical companies, based on 2017 pharma sales, while Johnson & Johnson, GSK and AbbVie moved up. Shire joined the top 20 just as it is about to be consumed by Takeda.

Sanofi and Gilead moved down in the rankings of Scrip's top 100 pharmaceutical companies, based on 2017 pharma sales, while Johnson & Johnson, GSK and AbbVie moved up. Shire joined the top 20 just as it is about to be consumed by Takeda.

Scrip's latest rankings of the top 100 revenue earners in the medical technology industry, published in Outlook 2019, show the groups leading the global market tightening their grip further in 2017. This was partly a function of providers choosing to partner more and more with fewer suppliers who can offer a wider provision of services. But it was steady as she goes for most of the multinational medtechs, with some major exceptions, and there will be more M&A reflected in next year's rankings, based on 2018 revenues.

In Vivo's latest rankings of the top 100 revenue earners in the medical technology industry show the groups leading the global market tightening their grip further in 2017. This was partly a function of providers choosing to partner more and more with fewer suppliers who can offer a wider provision of services. But it was steady as she goes for most of the multinational medtechs, with some major exceptions, and there will be more M&A reflected in next year's rankings, based on 2018 revenues.