A biopharmaceutical, also known as a biologic(al) medical product, biological, or biologic, is any pharmaceutical drug product manufactured in, extracted from, or semi-synthesised from biological sources. Different from totally synthesised pharmaceuticals, they include vaccines, blood, blood components, allergenics, somatic cells, gene therapies, tissues, recombinant therapeutic protein, and living cells used in cell therapy. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be living cells or tissues. They (or their precursors or components) are isolated from living sources—human, animal, plant, fungal, or microbial.
Biopharma: Growth and opportunity
The growth of the biopharma industry has been unprecedented. In 2015, the global market for biopharmaceuticals was valued at $176.9 billion. It was estimated at $ 192.2 million for the year 2016 and is projected to reach $291 billion by the year 2021. The estimated CAGR during the forecast period (2016-2021) is 8.6% and predicted to continue at that rate for the foreseeable future.
Biopharma products have a higher efficacy and safety as compared to conventional pharma products, this is due to the biological derivation of the products. This fact combined with their ability to address previously untreatable conditions, allows pharma companies to command high prices for innovative drugs. Biopharmaceuticals have set new standards for blockbuster drugs as well. Blockbusters are traditionally defined as drugs that have $1 billion or more in annual sales; the top 15 biopharma products each enjoy annual revenue of more than $2 billion, with some, such as the anti-inflammatory drug Humira, generating sales of more than $10 billion a yeari. With these figures, it’s no surprise that major pharmaceutical companies around the world are increasingly shifting their R&D and sourcing focus towards biopharmaceutical products.
As biopharma moves from the forefront of science into the mainstream of business, the industry will increasingly be forced to confront the same challenges faced by other businesses: maintaining competitiveness by ensuring affordability, quality, and delivery performance.
One of the key considerations to maintaining competitiveness involves creating an environment where ideas can flourish. Where smaller companies can access funding to compete and bring their disruptive ideas to the top of the pile.
“The H2020 SME instrument offers a real solution for biopharma companies to get crucial funding”
What’s next: Evolving in a booming industry
Global innovators will be the driving force behind product innovation in order to continue to command premium prices, shifting the frontier of technology and exploring new operational setups (such as the design and deployment of their future network). Biosimilars players will have to focus on cost, quality, and scale. For them, speed, process innovation, and operational excellence are must-win battles. Players based in emerging-market nations will have to find their own niches with the right operational and quality performance to make the best use of privileged access to, and knowledge of, their local markets. Contract-manufacturing organizations will have to be at the leading edge of process innovation and operational efficiency while retaining or building a spotless reputation for service and performance. Beyond these generic player archetypes, each company will need a detailed view of its own strategic position, asking itself what it stands for in the market and what it needs to do in order to win.
Biopharma and the EU
BioTechNow indicates that in 2013 only four European biotech companies went public whereas 23 IPOs can be attributed to the US market. In order to prevent Europe from risking a further loss of entrepreneurs and competitiveness, several stakeholders came together today in Brussels to take part in a high-level dialogue on financing in the biopharmaceutical market. EU officials from the European Investment Bank and the European Commission, as well as SME representatives and Venture Capital angels analysed current financing mechanisms and sought to identify solutions to overcome the so called ‘death-valley’ that many entrepreneurs are facing beyond the early stage and seed financing level.
This highlights the importance of funding mechanisms such as H2020 SME instrument. They offer a real solution for biopharma companies to get the crucial funding they require to take their idea from lab to marketii.
Adeel Irfan, PhD
GAEU Horizon Centre of Excellence