Great Expectations

The year has barely begun and the pharma industry has already witnessed two interesting merger and acquisition (M&A) announcements, both of which are within the field of oncology. 

On 3 January, Bristol-Myers Squibb revealed it will be acquiring Celgene (1) for US$74 billion (approximately €64 billion) and then four days later on 7 January, Eli Lilly announced a definitive agreement to acquire Loxo Oncology (2)-a relatively young company that already has a portfolio including several approved and investigational medicines (3).

So, what has spurred this impressive beginning to the year, and can we expect to see more?

Rapid progression 
in cancer treatments

According to a report from the IQVIA Institute for Human Data Science, cancer treatments have rapidly progressed over the past few years and global spending on cancer medicines has continued to rise with a majority of money being spent on a limited number of therapies (4). In the report, IQVIA anticipates that the global market for oncology therapeutic medicines has the potential to reach US$200 billion (approximately €173 billion) by the year 2022, half of this total growth is anticipated to be in the US market alone.

Additionally, immuno-oncology (I-O) therapeutics, which are mainly focused on PD-1 and PD-L1 checkpoint inhibitors, have been touted as influential for the overall biopharmaceutical industry, as laid out in GlobalData’s latest report, “The State of the Biopharmaceutical Industry-2019” (5). In the report, nearly a third of respondents stated that I-O will have the greatest impact on the pharma sector over the coming 12 months. Personalized medicines were also recognized as a trend expected to greatly impact the industry in 2019 (5).

With these predicted upward trends and potential for market growth offered by this specific therapeutic field, it is unsurprising that Big Pharma companies are looking to broaden their oncology offerings through M&A activity.

Regulatory trends

In terms of regulatory trends, there has been an increasing number of drug approvals over the past couple of years after the low level the industry saw in 2016. A good proportion of these new approvals has comprised biological drugs, with some of the major regulatory news stories of 2018 involving approvals for personalized medicine, such as Kymriah’s European approval, which was announced in August. 

This increase in biological and personalized medicines can be attributed to regulatory initiatives to help drive and support the development of therapies that target unmet medical needs, such as the Priority Medicines (PRIME) scheme in Europe (6). Through initiatives like PRIME, assessment of medicines can be accelerated at the time of application for a marketing authorization.

A costly business requires efficiency

However, development of oncology therapies, along with I-O and personalized medicines, is notoriously expensive, leading to the need for ways to maximize process efficiencies. As specified by Rita Peters, editorial director, in a recent article, ‘Ideas and Incentives to Adopt Advanced Manufacturing,’ featured in the January issue of our sister title, Pharmaceutical Technology, the industry needs more advanced manufacturing technologies to reduce the cost of biopharmaceutical manufacturing. However, adoption of these technologies has been slow, which is unsurprising considering the regulatory environment facing bio/pharma companies.

In a trend forecast published by Syneos Health towards the end of 2018 (7), it was also noted that flexibility, agility, and responsiveness will be key to the biopharmaceutical decision making, which would also indicate that adoption of advanced manufacturing technologies would be a beneficial step in the right direction.

Changes afoot

Yet, 2019 is also going to be a year of some significant change, in particular for the European pharmaceutical market. Not only will industry be required to comply with the new Falsified Medicines Directive but also, and closely following the implementation of the FMD deadline, the United Kingdom will meet the deadline for its departure from the European Union, which will undoubtedly cause disruptions.

Additionally, 2019 marks the 30th anniversary for Pharmaceutical Technology Europe, making the coming 12 months even more interesting as we continue to set the industry standard by providing comprehensive insight and analysis from the bio/pharma industry.

References

1. BMS, “Bristol-Myers Squibb to Acquire Celgene in $74-Billion Deal,” Press Release, 3 Jan. 2019, https://bestofbiopharma.com/press-releases/.

2. Eli Lilly, “Lilly to Acquire Loxo Oncology,” pharmtech.com, 7 Jan. 2019, https://investor.lilly.com/news-releases/news-release-details/lilly-announces-agreement-acquire-loxo-oncology.

3. Loxo Oncology, “Pipeline Overview,” loxooncology.com, www.loxooncology.com/pipeline (accessed 8 Jan 2019).

4. IQVIA, “Global Oncology Trends 2018,” iqvia.com, Institute Report, 24 May 2018.

5. PharmTech, “Immuno-oncology Drug Development and Personalized Medicine in 2019,” PharmTech.com, 21 Dec. 2018.

6. EMA, “PRIME: Priority Medicines,” ema.europa.eu, www.ema.europa.eu/en/human-regulatory/research-development/prime-priority-medicines (accessed 10 Jan. 2019).

7. Syneos Health, “2019 Health Trend Ten,” syneoshealth.com, Report, 27 Nov. 2018.

Article Details

Pharmaceutical Technology Europe
Vol. 31, No. 1
January 2019
Page: 5

Citation

When referring to this article, please cite it as F. Thomas, “Great Expectations," Pharmaceutical Technology Europe 31 (1) 2019.