In stark contrast to the regulatory delays increasingly affecting conventional new drug applications, the review and approval of vaccines by the FDA appears less fraught. This week alone the FDA approved two new paediatric vaccines: Sanofi-Aventis’ Pentacel and GlaxoSmithKline’s Kinrix, both combination vaccines against multiple childhood diseases.
For many years not considered a particularly trendy or revenue generating therapeutic area, vaccines is now a hot segment of the industry. According to analyst consensus forecasts from EvaluatePharma, the vaccines market is set to be the fastest growing therapeutic area over the next five years, with an annual growth rate of 14% even superior to oncology’s 11% growth, generating $35.1bn in sales by 2012.
|WW Rx & OTC Sales by Therapy Area - top 15 categories||WW sales ($m)||CAGR (07 - 12)||Market Share|
|11||Antacids and Anti-ulcerants||20,250||14,390||(7%)||3.4%||1.8%|
|12||Bone calcium regulators||10,863||13,883||5%||1.8%||1.8%|
|15||Platelet aggregation inhibitors||10,908||13,070||4%||1.8%||1.7%|
|Sum top 15 categories||317,495||405,036||5%||53.5%||52.0%|
|Total WW Rx & OTC Sales||593,503||779,315||6%|
In terms of total sales, oncology remains easily the largest therapeutic area with global revenues a staggering $73.4bn by 2102. However, perhaps surprisingly given the relative lack of analyst and media exposure the vaccine market gets, vaccines rank a very respectable fifth out of all therapeutic categories.
An important contributor to sales growth for this area is the relative lack of expected generic competition over the next five years and even when patents do expire, erosion rates are significantly lower than all the other main categories.
The world’s biggest-selling vaccine by 2012 is set to be Merck & Co / Sanofi-Aventis’ new cervical cancer vaccine Gardasil. With sales of $4.36bn by 2012, three times the revenues GlaxoSmithKline’s rival Cervarix vaccine is expected to make, shows Gardasil the clear winner from what was at one stage a very close race between the two.
|WW sales ($m)|
|Market Status||Product||Company||Pharmacological Class||2007||2012|
|Marketed||Gardasil||Merck & Co + Sanofi Pasteur MSD||Human papillomavirus (HPV) vaccine||1,957||4,360|
|RotaTeq||Merck & Co + Sanofi Pasteur MSD||Rotavirus vaccine||553||1,765|
|Cervarix||GlaxoSmithKline||Human papillomavirus (HPV) vaccine||20||1,469|
|Phase III||13-Valent Pneumococcal||Wyeth||Pneumococcal vaccine||-||556|
|Filed||Synflorix||GlaxoSmithKline||Streptococcus pneumoniae & Hib vaccine||-||492|
|Phase II||Imvamune||Bavarian Nordic||Smallpox vaccine||-||348|
|Phase III||H5N1 Influenza Vaccine||Baxter International||Influenza vaccine||-||100|
|Pre-clinical||Hepatitis B vaccine||Akorn||Hepatitis B vaccine||-||53|
Of the vaccines currently in development, Wyeth's 13-Valent Pneumococcal and GlaxoSmithKline's Synflorix look set to extend the impressive vaccine portfolios of these companies.
The overall vaccines market is dominated by three big pharma companies, Sanofi-Aventis, Merck & Co and GlaxoSmithKline, with a combined 73% share of the sector in 2007 and 2012. Sanofi Pasteur MSD is the European joint venture established to sell Sanofi-Aventis' and Merck's vaccines in the region.
|Top 10 Companies - Vaccines sales in 2012||WW sales ($m)||CAGR (07 - 12)||Market Share|
|Sanofi-Aventis + 50% of Sanofi Pasteur MSD||4,528||8,915||15%||24.5%||25.4%|
|Merck & Co + 50% of Sanofi Pasteur MSD||4,998||8,698||12%||27.1%||24.8%|
|Sum top 15 companies||17,930||33,971||97.2%||96.8%|
|Rest of market||526||1,116|
|Total vaccine market||18,456||35,087||14%|
Given the fact the vaccines market is controlled by just a few companies, the massive deal terms often associated with drugs in the main therapeutic categories are not so prevalent.
The biggest headline deal over the last 18 months occured in July last year when Novartis licensed rights to an influenza vaccine, Agrippal- IC31, from Intercell for up to $494m. Roche was involved in the next biggest deal, licensing a new cervical cancer vaccine, TG 4001/R3484, from Transgene for up to $328m in April 2007.
A relative wave of consolidation within the sector occured during 2005 and 2006, the biggest deal being Novartis' acquisition of the remaining 56% of Chiron it did not already own for $5.4bn, marking the Swiss company's entrance to the vaccine market.
|Year||Company||Acquired Company||No. of vaccines acquired (marketed and pipeline)||Date of Acquisition||Deal value ($m)|
|2008||AVANT Immunotherapeutics||Celldex Therapeutics||2||Mar 2008||75|
|2007||Pfizer||Coley Pharmaceutical||10||Dec 2007||164|
|Schering-Plough||Organon BioSciences||5||Nov 2007||15600|
|2006||Pfizer||PowderMed||6||Dec 2006||~ 400|
|Crucell||SBL Vaccin||12||Nov 2006||50|
|Endo Pharmaceuticals||RxKinetix||2||Oct 2006||115|
|Dynavax Technologies||Rhein Biotech GmbH||3||Apr 2006||12|
|Crucell||Berna Biotech||39||Feb 2006||420|
|2005||GlaxoSmithKline||ID Biomedical||16||Dec 2005||1400|
|Celtic Pharma||Xenova||3||Sep 2005||45|
|Emergent BioSolutions||Microscience||5||Jun 2005||26.6|
Of the remaining independent vaccine specialists that have not already struck significant licensing deals with bigger partners which would prove a major barrier to an acquisition, Dutch group Crucell, Danish biotech Bavarian Nordic, US specialist Akorn and UK company Acambis appear the most likely candidates to be snapped up if big pharma decides it needs to gain a foothold in this fast growing area.