Posted Date: 2/13/2017

Lupus R&D Landscape Set to be Dominated by Big Pharma & Small Biotech Partnerships

The lupus market, which is set to reach $3.2 billion by 2025 and has historically been dominated by inexpensive generic drugs, will see a future R&D landscape dominated by partnerships among Big Pharma and small biotech, according to research and consulting firm GlobalData.

GlobalData’s report, PharmaPoint: Systemic Lupus Erythematosus and Lupus Nephritis – Global Drug Forecast and Market Analysis to 2025, states that drug development for systemic lupus erythematosus (SLE) and lupus nephritis (LN) is associated with high risk of late-stage failures, but also high rewards in terms of commercial potential. Given the enormous challenges and hurdles faced by companies in the past when developing products for the management of SLE and LN, pharmaceutical companies are pursuing a range of different strategies in order to build their product portfolios.

“Companies are focusing on a very narrow patient population in the SLE market. Clinical trials tend to recruit treatment-naïve SLE patients with high disease activity, as this patient population has been shown to have the greatest measurable benefit for a possible clinical outcome,” said Sebastian S. Gehrke, PhD, Healthcare Analyst for GlobalData.

“The high risk associated with late-stage failure means that the burden of development is mostly in the hands of small biotechnology companies, such as Anthera, Aurinia, and ImmuPharma, or is shared among the larger players by strategic partnerships. For example, anifrolumab is developed by AstraZeneca and licensed from Bristol-Myers Squibb (BMS), and Orencia is co-developed by BMS and Ono,” he added.

While in the past LN pipeline drugs were developed to rescue a potential pipeline product developed for SLE or to seek label extension for drugs already approved for the disease, such as GlaxoSmithKline’s Benlysta, GlobalData anticipates that a new corporate strategy in the lupus market is emerging, where development programs are aimed specifically at approval for LN (Aurinia’s voclosporin), or aimed at both SLE and LN (Anthera’s blisibimod and AstraZeneca’s anifrolumab). 

While, GlobalData expects anifrolumab to be the market leader in LN by 2025, with annual sales of $144.9 million, a tremendous amount of unmet need will still be unaddressed, giving other players plenty of opportunity to enter the field.

This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GlobalData’s team of industry experts. 4,000 of the world’s largest companies, including over 70% of FTSE 100 and 60% of Fortune 100 companies, make more timely and better business decisions thanks to GlobalData’s unique data, expert analysis, and innovative solutions, all in one platform. GlobalData’s mission is to help our clients decode the future to be more successful and innovative across a range of industries, including the healthcare, consumer, retail, financial, technology and professional services sectors. Please get in contact if you have any questions about this or other GlobalData products. Analysts are available to comment. Contact the GlobalData press office +44 (0)161 359 5822 or email

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