The next generation complement therapeutics market is anticipated to grow at an annualized rate of >25% for drugs in advanced development stages, claims Roots Analysis

Published: May 2022

The approval and success of Soliris® and other complement therapeutics has paved for the development of several drugs targeting different pathways of complement system for the treatment of a wide range of disease conditions


Roots Analysis has announced the addition of “Next Generation Complement Therapeutics Market, 2022-2035” report to its list of offerings. 

The potential of complement therapeutics to ease the treatment of complement-associated diseases has greatly expedited the progress of these therapeutics into clinical stages of development. Since the complement system is a complex and multidimensional system, many different therapeutic targets are likely to be discovered for a variety of disease indications, such as paroxysmal nocturnal hemoglobinuria, hereditary angioedema, renal diseases and several others, in the future. The main focus is to develop innovative therapies targeting proteins other than C5, with reduced cost and increased safety.

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Key Market Insights 

Presently, 190+ complement therapeutics have been marketed / are being evaluated across different phases of development for the treatment of various disease indications
Close to 80% of the pipeline candidates are under clinical evaluation. Further, therapeutics, namely Berinert®, Cinryze®, ORLADEYO®, Ruconest® and TAKHZYRO®, have been approved for the treatment of Hereditary Angioedema. Majority (84%) of these candidates are biologics, followed by small molecules (16%).

Around 50 industry and non-industry players are engaged in the development of next generation complement therapeutics
North America has emerged as the hub, featuring the presence of approximately 50% developers. The market is currently dominated by the presence of mid-sized players (37% of the total number of stakeholders). Interestingly, 15% of the players are big pharma companies engaged in the development of such therapeutics for multiple therapeutic areas.

More than 850 clinical trials have been registered for the evaluation of next generation complement therapeutics, worldwide 
The clinical research activity, in terms of number of trials registered, is reported to have increased at a CAGR of 21%, during the period 2017-2021 (till October). Of the total number of trials registered, close to 60% have already been completed, while 24% of the studies are actively recruiting participants.

Close to 1,450 articles related to next generation complement therapeutics, have been published in reputed scientific journals, since 2017
More than 40% of the articles focused on next generation complement therapeutics were published post-2019. Popular journals that have published multiple articles include Frontiers in Immunology, Allergy & Asthma Proceedings, Journal of Immunology and Molecular Immunology.

Close to 1,250 grants have been awarded to support research on next generation complement therapeutics, since 2017
Grants worth USD 835 million have been awarded to various companies / organizations working in this domain during 2017-2021. Around 20% of the grants were funded by the National Cancer Institute.

Over 3,490 patents have been filed / granted related to next generation complement therapeutics, since 2016
More than 650 patents were filed / granted in 2021 (till November). Further, around 45% of the patents were filed in Europe It is worth highlighting that majority of the patents were granted / filed for indications, including angioedema, meningitis, microangiopathy, neuromyelitis optica, periodontitis and psoriasis.

Partnership activity in this field has increased at a CAGR of nearly 55%, between 2017 and 2021 (till November)
More than 45% of the reported deals were product development and commercialization agreements. Further, majority of the agreements were signed by players based in North America (66%).

Close to USD 14 Billion has been invested by both public and private investors for the development of next generation complement therapeutics
Around 40% of the companies engaged in this domain primarily received funding through secondary offerings. Further, 70% of the funding instances were reported by players headquartered in North America.

North America is anticipated to capture over ~80% of the global market share for phase III complement therapeutics, by 2035
In 2035, close to XX% of the market revenues are expected to be generated from sales of therapeutics intended for infectious diseases. Further, therapies designed for subcutaneous route of administration are expected to occupy a larger share (XX%) of the overall market in 2035.

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Key Questions Answered 
  • Who are the leading industry and non-industry players engaged in the development of next generation complement therapeutics?
  • Which are the key drugs being developed across early and late stages of development?
  • Which geographies are the most active in conducting clinical trials related to next generation complement therapeutics?
  • What is the focus area of various publications related to the next generation complement therapeutics?
  • Which are the leading funding institutes / centers supporting the research related to next generation complement therapeutics?
  • What kind of partnership models are commonly adopted by industry stakeholders?
  • Who are the key investors, active in the field of next generation complement therapeutics?
  • What are the different initiatives undertaken by big pharma players for the development of next generation complement therapeutics in the recent past?
  • How is the current and future market opportunity, related to next generation complement therapeutics likely to be distributed across key market segments?

The financial opportunity within the next generation complement therapeutics market has been analyzed across the following segments:

  • Target Disease Indication
  • Atypical Hemolytic Uremic Syndrome
  • Cardiac Transplantation Rejection
  • Cold Agglutinin Disease
  • COVID-19
  • Generalized Myasthenia Gravis
  • Guillain-Barre Syndrome
  • Hereditary Angioedema
  • Neuromyelitis Optica
  • Paroxysmal Nocturnal Hemoglobinuria
  • Therapeutic Area
  • Cardiovascular Disorders
  • Genetic Disorders
  • Hematological and Vascular Disorders
  • Infectious Diseases
  • Neurological Disorders
  • Neuromuscular Disorders
  • Type of Molecule
  • Biologic
  • Small Molecule
  • Target Pathway
  • Alternate Pathway
  • Classical Pathway
  • Lectin Pathway
  • Terminal Pathway
  • Type of Therapy
  • Monotherapy
  • Combination Therapy
  • Route of Administration
  • Intravenous
  • Oral 
  • Subcutaneous
  • Key Geographical Regions 
  • North America
  • Europe
  • Asia-Pacific

The research also includes detailed profiles of the key players (listed below) engaged in the development of next generation complement therapeutics; each profile features an overview of the company, its financial information (if available), details on product portfolio, recent developments and an informed future outlook.

  • Amgen
  • CSL Behring
  • Innovent Biologics
  • Novartis
  • Regeneron
  • Roche
  • Sanofi
  • Takeda
  • UCB

For additional details, please email at
Gaurav Chaudhary
+1 (415) 800 3415
+44 (122) 391 1091


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