China Archives - European Industrial Pharmacists Group (EIPG)

UK will participate to European research programmes


by Giuliana Miglierini The divergent road opened as a consequence of the Brexit, in January 2021, between the European Union (EU) and the United Kingdom (UK) is now converging again as for the possibility for UK researchers to participate to Read more

Insights to the Industrial Pharmacist role for the future


A concept paper from EIPG Advisory Group on Competencies vol.2, 2023 This paper is an update of the previous EIPG paper and intends to raise awareness of the changing requirements of the professional profile of Industrial Pharmacists for Pharmacists at Read more

EMA’s reflection paper on AI in the pharmaceutical lifecycle


by Giuliana Miglierini The rapidly evolving role of artificial intelligence (AI) and its possible application in the pharmaceutical field led the European Medicines Agency (EMA) to publish a draft Reflection paper on the use of AI along the entire lifecycle Read more

EFPIA’s Annual Report on the Pharmaceutical industry 2022

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by Giuliana Miglierini

In the 21 years from 2000 to 2021 – in which time we’ve come through the Global Financial Crisis and a pandemic – EFPIA companies have more than doubled production, increased exports by a factor of six, and recorded a trade balance that puts it far ahead of other high-tech sectors in Europe”, writes EFPIA’s Director General Nathalie Moll commenting the Annual Report2022.

Despite this marked growth, many challenges are still to be faced to allow the European pharmaceutical industry to maintain and even strengthen its role as primary hub of innovation, thus contributing to the overall success of the EU’s economy. It can be expected, for example, that the energy crisis will be highly impacting pharmaceutical productions, also in the form of increased difficulties to guarantee a constant supply of raw materials. This would represent just the last drop adding to existing regulatory barriers slowing down R&D and to the impact of fiscal austerity policies that may discourage investors.

At the same time, we have seen the growth of Brazilian, Chinese and Indian markets outstrip growth in the top 5 European markets. Our global competitors have prioritised life sciences and we must respond with similar ambition”, adds Nathalie Moll.

The 2021 of the pharmaceutical industry

According to EFPIA’s Annual Report 2022, the value of production for the research-based European pharmaceutical industry has grown from 127.5 billion euro in year 2000 to 300 billion in2021. Even more relevant is the growth of export, increased from €90.9 bln to €565 bln over the same period. In 2021 imports counted for €390 bln, with a positive trade balance of €175 bln.

The research-based pharma industry employed last year 840,000 units (125,000 of which in R&D) and invested €41.5 bln in research and development activities.

The total European pharmaceutical market value at ex-factory prices increased from €89.4 bln in 2000 to €255 bln in 2021. The pharmaceutical expenditure supported by statutory health insurance systems (and referred to ambulatory care only) grown from €76.9 bln to €157.5 bln over the same time.

Despite these positive figures, EFPIA warns about the danger of migration of many R&D activities from Europe towards fast-growing markets such as Brazil, India and China, thanks to the more favourable conditions. The pharmaceutical market in these countries grown, respectively,11.7%, 6.7% and 11.8% in the period 2016-2021, compared to 5.8% of top EU countries (France, Germany, Italy, Spain and United Kingdom) and 5.6% of the US.

North America still represents the wider market area for pharmaceuticals (49.1%, vs 23.4% for Europe), and accounts for the higher proportion of new launches (64.4%, vs 16.8% of top five EU countries). In 2020 China marked the higher pharmaceutical R&D expenditure (78,5 billion Yuan, from 1.9 bln Yuan in 2000), overcoming for the first time the US ($72.4 bln), while Europe is positioned far behind (€39,7 bln). Not less interesting is the 3.2% market share assigned to emerging, high-growth pharmaceutical markets including many African, South American and Asiatic countries (Algeria, Argentina, Bangladesh, Brazil, Colombia, Chile, China, Egypt, India, Indonesia, Kazakhstan, Mexico, Nigeria, Pakistan, Philippines, Poland, Russia, Saudi Arabia, South Africa, Turkey and Vietnam).

Parallel trade is a characteristic of the European pharmaceutical market, due to the persistent fragmentation of many policies in different countries. Denmark saw in 2020 the higher share of parallel imports in pharmacy market sales (26.9%), well above other countries (e.g. 10.9% Sweden,9.1% UK, 8.3% Germany).

 Issues slowing down R&D

According to EFPIA, the length of time needed to bring a new medicine to the market (up to 12-13 years) is still a major issue impacting the attractiveness of European R&D. An average of one-two new synthetic substances out of every 10 thousand exiting the labs passes all the scrutiny steps needed to reach approval. The total costs of R&D was estimated in 2014 to reach €1.97 billion, indicates the report.

Germany, Switzerland and the UK are the European countries more active in research and development (€7.8 bln, €7.4 bln and € 5.6 bln expenditure in 2020, respectively). Clinical research accounts for the higher percentage of investment (44.1%, mainly in phase III studies), far above pre-human and pre-clinical research (14.9%) and phase IV studies aimed to post-marketing surveillance (11.5%). Approval studies account for 4.3% of the total R&D expenditure.

The US generated 159 new chemical entities (both chemical and biological) in years 2017-2021, almost doubling Europe (72) and a group of other countries (71), excluding Japan (41). Even more worrying, in 2021 China lagged just behind Europe as originator of new active substances launched for the first time on the world market (18 vs 19, respectively), while the US confirmed its leading position (35). According to EFPIA, this trend is associated with a marked lower annual growth rate of pharmaceutical R&D expenditure in Europe (4.0% for years 2017-2021), compared to that in the US (8.5%) and China (12.9%). Despite this, health industries still position at the first place of the ranking of industrial sectors by overall R&D intensity (12.4%, vs 8.7% of ITC services and 7.4% of ITC products).

The pharmaceutical production

Switzerland, Germany and Italy are the leading European hubs for pharmaceutical production (€53.2 bln, €32.3 bln and €34.3 bln of value, respectively). This corresponds in Germany to a significant higher number of people employed in the sector (115,519, vs 66,400 in Italy and 47,000 in Switzerland). EFPIA also mentions that the research-based pharmaceutical industry generates about three times more indirect employment along its value chain (both upstream and downstream) than it does directly, thus significantly contributing to the overall European job market. This is even more true for highly skilled jobs, thus preventing the phenomenon of brain-draining towards more attractive countries for scientific talents.

The US remains the favoured trading partner for the EU pharmaceutical industry, accounting for 32.2% EU exports and 30.2% imports. Switzerland is at the first place for EU imports (36.4%, and 11.8% EU exports); more distanced are the UK, China and Japan.

Fragmentation still impacts the European market

Fragmentation of policies on price and reimbursement and different VAT rates for medicinal product sis a very typical phenomenon still limiting the potentiality of the European pharmaceutical market.

According to EFPIA, in 2020 the retail price of a medicine corresponded on average to 66.8% rewarding for the manufacturer, 17.4% for the pharmacist, 10.6% for the State and 5.2% for the wholesaler. The top 5 countries for market value at ex-factory prices were Germany (€42.9 bln), Italy (€23.4 bln), France (€29, 5 bln), the UK (€24.6 bln) and Spain (€17.6 bln); Russia also represented a relevant market (€18,4 bln). Italy sees the higher market share for generics (67.6%), well above Poland (58%) and Austria (49%). EFPIA also monitored the VAT rates applied to prescription and OTC medicines in different European countries, compared to the standard VAT rates. Malta (0%), Sweden (0%), France (2.1%), Switzerland (2.5%), Luxembourg (3%), Spain (4%), Lithuania, Croatia, Cyprus, Hungary (5%) marked the lower VAT rates on prescription medicines. In some case, these same rates applies also to OTC products (Croatia, Cyprus, Hungary, Luxembourg, Malta, Spain, Switzerland), while in other countries the rates for this category of medicines is higher (France 10%, Lithuania 21%, Sweden 25%).


A record year for biotech investments in UK, a year after the Brexit

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by Giuliana Miglierini

One year after the Brexit, the UK’s economic landscape is far from being suffering for leaving the European Union. On the contrary, 2021 has been a record year for many sectors, including UK’s biotech and life sciences. A recent report from the BioIndustry Association (BIA) and Clarivate shows that £4.5 billion was raised in public and private financings in the field, £1.7 bln (60%) more than in 2020.

There is an obvious gap that we must plug in the UK’s financing environment. The large fundraises seen in 2021 are largely the result of welcome overseas investment, meaning that significant value creation will also be offshored. History has handed the UK two world-leading sectors: life sciences and finance. A symbiosis should exist between these two, but it doesn’t, yet. There is great opportunity to turbo-charge the UK’s biotech and life sciences sector and capture more of its economic value for the UK by building better connections between the UK’s financial institutions and our innovative scaling businesses”, said Steve Bates OBE, Chief Executive of the BIA.

A higher attractiveness than the US

More in detail, UK companies attracted more than half of all biotech venture capital in 2021, for a total value in the period 1 December 2020 – 30 November 2021 of £2,518 million (+81%from 2020; 56% of total investments). Even higher has been the increase of Initial Public Offerings (IPOs), for a total of £1,304 million (+434% from 2020; 29% of total); all other public financings raised £684 million (15% of total). Thirteen investment deals were more than £100meach (vs 3 in 2020), and a further 27 raised more than £20 million each (vs 12 in 2020).

The positive trends of investments marked in 2021 are not unique to the UK; the level of venture capital investments raised 10% in the last year compared to 2020, reaching the global value of £28.1 billion for the biotech sector. The attractiveness of the UK reached 79%, compared to 49% for the US’s Boston Massachusetts cluster, while the San Francisco one marked -21%; total investments in the US reached £18.8 billion (+11%). Negative trends characterised Europe (-12%venture investments, for a total of £5 billion) and China (-12%, £3.4 bln).

We value the significant investment that comes from overseas, but we must complement it with the full financial firepower of the City of London so that more companies stay in the UK. This is why our ambitious 2021 Life Sciences Vision sets out our firm commitment to helping UK life sciences and biotech firms access long-term scale-up capital from investors here at home, who are committed to building successful companies. Scaling up UK companies will help both grow our economy and improve access to innovative diagnostics and treatments.”, added George Freeman MP, Minister for Science, Research and Innovation.

Venture capitals looking for new opportunities

The UK has been a key point of innovation during the pandemic, generating many new vaccines and treatment opportunities. The interest of investors in UK’s science is acknowledged by the£128 million invested into startup companies, more than four times the amount seen in previous years. A trend that paralleled later-stage rounds of financings into mature projects.

The bigger deal (£195 mln fundraise prior to the London IPO) involved Oxford Nanopore, a company specialised in the development of innovative sensing techniques based on the use of nanopores embedded in high-tech electronics. These can be used to sequence small or large fragments of DNA and RNA, for example; the platform may be also adapted for the detection of other types of molecules, e.g. proteins.

At the second place is the Exscientia’s deal (£158 mln, round D). The company offers AI-driven drug discovery services aimed to deeply innovate how new medicines are developed. Its AI platform is being used to completely design from scratch new molecules; algorithms are used also to optimise properties in parallel, rather than sequentially, and to reduce the overall development time thanks to the higher capacity of analysis of complex data.

Vaccitech attracted the third deal (£118 mln, round B); the company is the spin-off of the Oxford University specifically created to commercialise the technology platform behind the Oxford/AstraZeneca Covid-19 vaccine.

IPOs reached record values

Oxford Nanopore and Exscentia also represent the higher values for IPOs operated by UK biotech companies in 2021. The former deal worth £350 million, representing the largest amount raised in a listing on the London Stock Exchange by a biotech company. Exscentia attracted a £256mln value at Nasdaq; the total amount raised by UK biotech through IPOs in 2021 reached £1.3billion (42.8% of all the money raised by UK biotechs at IPO in the past decade, a huge amount if compared to the £244 million raised in 2020).

Three companies were listed at the London’s Alternative Investment Market (AIM): Poolberg Pharma (£25 mln) is a clinical stage infectious diseases pharmaceutical company, aiming to become a “one-stop shop” to find Phase II ready products for development and commercialisation. Arecor Therapeutics (£20 mln) has developed a proprietary platform for the reformulation of already available medicines, while BiVictriX Therapeutics (£7,5 mln) is developing new targeted cancer therapies.

When looking at the international scenario, 133 companies raised £19 billion in IPOs in 2021 at the global level (+30% vs 2020). In the US, 86 companies raised £9.7 billion; the most attractive biotech clusters were again Boston Massachusetts and San Francisco. The number of IPOs in Europein creased to 29 (vs 12 in 2020), for a total of £3.3 billion raised (+218% vs 2020); to this instance, according to BIA’s report the UK accounted for 31% of the European IPOs and 40% of the capital raised. No significant changes involved listed companies in China (14), but on this market the average IPO was three-times larger than that achieved by the average American or European listing.

Follow-on financing of quoted biotech companies almost halved in 2021 compared to the previous, record year (£684 million vs £1.18 billion raised, respectively).

A main contribution came from Blackstone’s investement in Autolus at the Nasdaq (£183 million) to support the development of the company’s CAR-T cell therapy currently in Phase III stage of development. A strategic investment of £50 million in Oxford Biomedica, received from the Serum Institute of India, will support the expansion of the advanced therapy manufacturing facilities near Oxford.

Mergers & Acquisitions and Licensing deals

Jazz Pharmaceuticals acquired in 2021 GW Pharma, a company specialised in the development and commercialisation of cannabinoid-based epilepsy treatments. The biotech Kymab, thoseplatform is used for the development of fully-human monoclonal antibodies, was acquired by Sanofi in a deal involving £1,073 million upfront payment and up to $350 million in milestone payments.

The licensing deal signed between AstraZeneca and VaxEquity would allow the multinational company to use the University College London spin-out’s saRNA platform for the development of up to 26 drug targets.

Early-stage biotech companies are often supported by research grants; to this instance UK’s biotech received in 2021 over £50m in non-dilutive grant funding.