3 Biologics Industry Predictions from 2015 vs the 2016 Reality

For an industry as fast-moving as the biopharmaceutical industry, it is always interesting to look back at past predictions and to compare them to where we currently find ourselves. Last year we sat down with Günter Jagschies, a Senior Director at GE Healthcare Life Sciences, to discuss the trends in different sectors of biopharma. Here we look though Jagschies’ predictions from 2015 and compare them to state of the industry today.

1) Revitalization of the Vaccine Industry

“We are seeing a revitalization of the vaccine industry. Ebola has recently reminded us that we still need to cover many more infectious disease threats, but also there is a new hope that vaccines could become a profitable undertaking for companies.

Everyone understands that vaccines are so much more cost efficient for healthcare because they prevent disease rather than therapeutically treat patients. For example, the success of Prevnar (Pfizer) and Gardasil (Merck) have shown that manufacturers can, in a relatively short time, get a blockbuster vaccine. And they have shown it can be done with a modular, platform approach, whereas in the past you needed a new manufacturing plant and platform for every vaccine coming to market.”

Jagschies’ prediction for the revitalisation of the vaccine industry is something that could not be more timely and correct. It has not even been a year since the Ebola outbreak in 2015, and we are now scrambling to develop a new and effective vaccine to fight the Zika virus.

The virus has been linked to severe birth defects and is spreading rapidly across the Americas. Currently it is estimated that as many as four million people could be infected with the Zika virus by the end of the year, which has prompted the World Health Organisation (WHO) to declare the Zika virus an international public health emergency.

Until recently, the virus had been viewed as relatively benign and is still yet to be fully understood by scientists. A safe and effective vaccine is thought to be many years – maybe even a decade – away from being available to the public.

Now more than ever, we are in need of leading pharmaceutical companies as well as small biotechs to expand vaccine research and development to produce effective vaccines.

The start of this expansion has steadily happened over the past decade as returns on investment have become more appealing. Furthermore, international vaccine funding and development assistance boosted aid for new vaccines from $822 million in 2000 to $3.6 billion in 2014.

This in part has been down to the Bill and Melinda Gates Foundation’s initiative Decade of Vaccines (2011-2020), which with partners such as the WHO, UNICEF, and the GAVI Alliance, has invested in programmes to strengthen and provide support to country immunization systems.

2) Dengue Fever Vaccine

“The industry is experiencing a consolidation of the vaccines industry (e.g., Novartis and GSK). Research is quite active: people are modifying and improving their processes to target some of those 30-40 diseases that don’t yet have a treatment. Currently, a vaccine for Dengue fever seems to be close to market and will meet a very significant demand.”

Sanofi’s vaccine for Dengue fever has now made it to market; late last year it was given the green light in three countries (Mexico, Philippines, Brazil) and more recently a fourth, El Salvador, has approved the vaccine. Sanofi Pasteur is aiming for 100 million vaccine doses annually.

3) Biosimilars Creating Greater Competition

“The industry is also facing greater competition. Biosimilars are coming, as evidenced by the approval for Celltrion’s Remsima (infliximab) as the first biosimilar mAb filed with the FDA. It’s to be expected that the selling price pressure will increase. Then even more focus will be on manufacturing and R&D spending.

In general (and this is my personal view), the industry will see an intensification of vaccine development, and an expansion of therapeutics’ affordability to new markets and regions. Access is driven by lower prices even as incomes grow in the emerging markets. In order to penetrate those markets, the industry will have to go local with their products and their marketing strategies.”

Again, Jagschies’ prediction has now been realised with two biosimilars approved in Europe for Janssen Biotech’s Remicade (infliximab), alongside FDA approval of Celltrion’s Remsima.

Speaking about the news, HyoungKi Kim, CEO of Celltrion said that;

“This is an essential step in increasing acceptance of these critical medicines and increasing access for every patient who needs these treatments. We have experienced the benefits of biosimilars outsite of the U.S., including Europe, and are looking forward to advancing our development program with the FDA.”

He added further that the more affordable biosimilar mAbs are globally seen as high quality biologics that are extremely similar both in safety and efficacy to their originator products.

This of course will increase competition of prices and put pressure on companies to offer affordable products to market.

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