Bacteriophage Therapy Market

Bacteriophage Therapy Overview

The global bacteriophage therapy market, also known as phage therapy market, is estimated to be USD 74 million in 2022, growing at a CAGR of 8% during the forecast period. Antimicrobial resistance (AMR) has been identified as one of the greatest threats to public health. According to the Centers of Disease Control and Prevention, more than 2.8 million cases of AMR infections are identified in the United States on an annual basis, leading to death of more than 35,000 people. Further, World Health Organization (WHO) has estimated that, by 2050, the increasing burden of such infections is expected to increase the healthcare expenditure by USD 1.2 trillion, annually. To address this situation, WHO has developed a global action plan for raising public awareness, reducing the incidence of infections, and optimizing the use of antimicrobial drugs, paving the way for the development of alternative anti-infectious modalities. One such example of these modalities includes bacteriophage therapy, also known as phage therapy. These therapeutics have been used in healthcare for over a century, providing an alternative approach to target the disease-causing multi-drug resistant bacteria; however, their use has been limited. With the growing need for therapies targeting AMR infections, phage therapy is now gaining more traction. These therapeutics tend to cause minimal drug toxicity, replicate themselves at the site of action, have reduced side-effects, and have the potential to self-decompose when the infection causing bacteria have been exterminated. Given the afore-mentioned advantages of bacteriophage therapy and promising insights from the ongoing research, various clinical trials have been registered for the clinical evaluation of bacteriophage therapies.

Key Market Insights

The “Bacteriophage Therapy Market - Distribution by Therapeutic Area (Infectious Diseases, Oncological Disorders, and Other Disorders), Route of Administration (Oral, Topical, Rectal and Intravenous), and Geography (North America, Europe and Asia-Pacific): Industry Trends and Global Forecasts, 2022-2035” report features an extensive study on the current market landscape and market size, offering an informed opinion on the likely evolution and future opportunities associated with the phage therapy market. The study underlines an in-depth analysis, highlighting the key drivers and the market trends related to this evolving segment of the pharmaceutical industry.

Market Analysis: Phage Therapeutics Market Size

The global bacteriophage therapy market is valued at USD 74 million in 2022, mainly driven by the sales of marketed phage therapeutics. Russia, Poland and Republic of Georgia currently employ phage therapy in their routine medical practice. There are multiple challenges restraining the market growth of the global phage therapy market including the lengthy process of identifying the right phage against the patient’s bacterial isolate, concern with the stability of phage preparations during storage and transportation, and the possibility of developing phage resistance. The industry is developing strategies to overcome these challenges and we expect the phage therapy market size to witness expansion as the wider adoption of this therapeutic approach is successful to provide an effective solution for the increasing multi-drug-resistant bacterial infections. The market for bacteriophage therapy will grow at a CAGR of more than 8% during the forecast period.

Indication Analysis: Infectious Diseases Will be the Leading Segment of the Bacteriophage Therapy Market

The therapeutic efficacy of bacteriophages against infections caused by multi-drug resistant pathogens (such as, Staphylococcus aureus, Escherichia coli, Klebsiella pneumonia and Pseudomonas aeruginosa) has been demonstrated for human use. They are used as an anti-infective treatment for conditions such as respiratory infections, urinary tract infection, and rhinosinusitis. However, some drug developers are also evaluating the efficacy of phage therapy in indications such as ulcers as well as cancer. As an anticancer agent, the bacteriophages are used to deliver apoptotic agents or oligonucleotide drugs to cancer cells. However, the use of bacteriophage for treatment of diseases beyond infectious diseases is in early stages of development and more research efforts will be required to prove their potential in these therapeutic areas.

Regional Analysis: North America is Re-evaluating the Phage Therapy Potential

In 1940s, attributing to the improper ways of storage and purification processes used, along with the selective nature of various phages, which could not be recognized at that time, the US and majority of the Europe abandoned the use of these phage therapies, marking them as a failure. However, phage therapy has made a comeback to the attention of pharmaceutical industry in North America and Europe owing to the focus on antimicrobial resistance. In June 2018, the first phage therapy centre - Center for Innovative Phage Applications and Therapeutics (IPATH) - opened in UC San Diego School of Medicine with the aim to provide phage therapy to patient with multi-drug resistant infections under FDA’s compassionate use program. Additionally, in March 2021, the National Institutes of Health (NIH) awarded USD 2.5 million in grants to 12 institutes around the world, showing their support for the phage therapy. Companies headquartered in the US are evaluating their candidates in multiple clinical trials and collaborating for research and development of phage therapeutics. The future of phage therapy in North America looks promising with the market size likely to witness growth in the long-term as phage therapies receive FDA approval and acceptance amongst the physician community.

Trends Analysis: Clinical Trials, Publications, Patents, Funding and More

With the widespread participation of stakeholders in the research and development of bacteriophage therapy, clinical studies evaluating this drug class have increased at a growth rate of more than 30% over the last few years. Moreover, the volume of affiliated scientific literature (2,200+ related publications since 2018) has also increased, demonstrating the growing popularity of phage therapy and related technologies. Given the encouraging results, this domain has piqued the interest of many private and public investors who have invested more than USD 1 billion over the last few years. With increasing R&D efforts, promising clinical data, and financial support from investors, we anticipate the phage therapy market to witness notable market growth during the forecast period.

Recent Developments in Bacteriophage Therapy Market

Several recent developments have taken place in the field of bacteriophage therapy. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

• In June 2023, Adaptive Phage Therapeutics received USD 12 million investment from funds managed by Deerfield Management and the AMR Action Fund with an aim to advance their innovative phage therapy platform. 
• In May 2023, Adaptive Phage Therapeutics entered into a license agreement with Phage Therapy Center (IPTC) of the Hebrew University of Jerusalem and Hadassah Medical Center with an aim to discover several phages that have exceptionally broad coverage against antibiotic resistant bacteria. 
• In March 2023, Armata Pharmaceuticals published positive topline results from the completed Phase 1b/2a SWARM-P.a. trial evaluating AP-PA02, a novel, inhaled multi-phage therapeutic, used for the treatment of patients suffering from chronic pulmonary Pseudomonas aeruginosa infections. 

Scope of the Report

Key Report Attributes	Details
Forecast Period	2023 – 2035
Market Size 2022	USD 74 million
CAGR	8%
Base Year	2022
Target Therapeutic Area	Infectious Diseases, Oncological Diseases, Other Disorders
Route of Administration	Oral Route, Topical Route, Rectal Route, Intravenous Route
Geographical Regions	North America, Europe, Asia-Pacific

Amongst other elements, the report includes:

• A summary of the key insights from the bacteriophage therapy market. It offers a high-level view on the current state of the market and its likely evolution in the mid to long term.
• A general overview of the historical evolution of bacteriophages and their biology. It also includes a detailed discussion on applications of bacteriophage therapy. The chapter concludes with a discussion on the various advantages and limitations associated with the bacteriophage therapy.
• A detailed overview of the overall market landscape of phage therapy, including information on their current status of development (marketed, clinical, preclinical and discovery), key therapeutic areas (infectious diseases, oncological disorders, and other disorders), type of bacterial strain (Pseudomonas aeruginosa, Escherichia coli, Staphylococcus aureus, Klebsiella pneumoniae, Salmonella, Streptococcus, Acinetobacter baumannii and others), target disease indication (lung infection, bone infection, urinary tract infection, gastrointestinal infection, bacterial infection, blood infection, other disorders, and multiple infections), type of therapy (monotherapy, combination therapy, and both), route of administration (oral route, topical route, rectal route and intravenous route), and information on bacteriophage related technologies.
• An overview of the current status of the market with respect to the players engaged in the manufacturing of bacteriophage therapy, featuring information on the year of establishment, company size, location of headquarters, and leading developers.
• Elaborate profiles of the prominent players engaged in the development of bacteriophage therapy (shortlisted based on the number of drugs progressed to advanced phases of development). Each profile features a brief overview of the company, its financial information (if available), details on its product portfolio, and a section on recent developments and an informed future outlook.
• An in-depth analysis of completed, ongoing and planned clinical studies, based on several relevant parameters, such as trial registration year, trial phase, enrolled patient population, study design, type of sponsor / collaborator, most active players (in terms of number of registered trials), registered trials, and geographical region (by number of registered trials and number of enrolled patient population).
• An in-depth analysis of the various patents that have been filed / granted related to phage therapy. It includes information on key parameters, such as type of patent (granted patents, patent applications and others), publication year, application year, number of granted patents and patent applications, geographical distribution, Cooperative Patent Classification (CPC) symbols, and type of applicant. It also highlights the leading industry and non-industry players and individual assignees (in terms of number of patents filed / granted). 
• An in-depth analysis of various publications for bacteriophage therapeutics, based on several relevant parameters, such as year of publication, type of article, popular keywords, most popular publishers (in terms of number of publications), key journals (in terms of number of articles published and journal impact factor). It also highlights benchmarking of the publications to develop more insightful opinions on the recent trends related to research and development in this area.   
• A detailed study of the various grants that have been awarded to research institutes engaged in projects related to phage therapy, since 2017, highlighting various important parameters, such as year of award, amount awarded, funding institute, support period, grant type, purpose of grant, focus area, type of recipient organization, and leading recipient organizations.
• An in-depth analysis of the investments made, including grants, venture capital financing, initial public offering, secondary offering, private placement, equity and debt funding, at various stages of development, in companies that are focused on developing bacteriophage therapeutics.
• A detailed study of the recent collaborations and partnership established in bacteriophage market since 2017, including the details of deals that were / are focused on the development of phage therapy, which were analyzed based on several parameters such as year of partnership, type of partnership (research and development agreement, product development agreement, licensing agreement, merger / acquisition, commercialization agreement, manufacturing agreement, clinical trial agreement, supply agreement, distribution agreement and other agreement), therapeutic area (infectious diseases, hepatological disorders, chronic inflammatory disorders, skin disorders and women’s health), application areas (human health, animal health, diagnostic test, aquaculture, food safety, food safety and environment protection and livestock farming), and regional distribution of partnerships. 
• An analysis of the various start-ups engaged in the development of bacteriophage therapeutics, based on relevant parameters, such as pipeline strength, pipeline maturity, indication diversity, number of patents, financial support and partnership activity.

One of the key objectives of the research report was to estimate the current market size and potential market growth opportunities, over the forecast period. Based on various parameters, such as target patient population, region specific adoption rates, and the likely selling price of such therapeutic products, we have provided informed estimates on the evolution of the market in the short to mid-term and long term, for the period 2022-2035. In order to evaluate the current and future opportunity associated with the bacteriophage therapy market, our year-wise projections have been segmented based on several relevant parameters such as, target therapeutic area (infectious diseases, oncological disorders, and other disorders), route of administration (oral, topical, rectal and intravenous), and geographical region (North America, Europe, Asia Pacific, and rest of the world). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the market’s evolution.

The opinions and insights presented in the report were influenced by discussions held with senior stakeholders in the industry. The report features detailed transcripts of interviews held with the following industry stakeholders:

• Antoine Culot (Chief Executive Officer, Rime Bioinformatics)
• Iddo Weiner (Senior Director, Head of Data-Science, BiomX)
• Mathieu Medina (Project Leader, Hospices Civils De Lyon)
• Mohammadreza Azizkhani (Independent Consultant) 

All actual figures have been sourced and analysed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

Frequently Asked Questions

Question 1: What are bacteriophages?

Answer: Bacteriophages are viruses that have the ability to infect and kill the bacteria without affecting human or animal cells.

Question 2: What is phage therapy?

Answer: Phage therapy refers to the use of bacteriophages as a therapeutic modality for several infectious diseases, mainly bacterial infections.

Question 3: Is there any FDA approved phage therapy?

Answer: Phage therapy has been available for compassionate use in the US. However, no phage therapy is approved by FDA yet for commercialization in the US.

Question 4: What diseases can be treated with phage therapy?

Answer: Phage therapy is mainly used for the treatment of infectious diseases, specifically bacterial infections such as multi-drug resistant respiratory infections, urinary tract infections, rhinosinusitis etc.

Question 5: Which route of administration for bacteriophage therapy is most popular?

Answer: Oral route is the most popular route of administration for bacteriophage therapy.

Question 6: What is the market size for phage therapy?

Answer: The global bacteriophage therapy market, also known as phage therapy market, is estimated to be USD 74 million in 2022.

Question 7: What is the phage therapy market growth?

Answer: The global phage therapy market is estimated to grow at a CAGR of 8% during the forecast period.

Question 8: Which region has the highest market share in the global bacteriophage market?

Answer: Europe holds the largest market share in the global bacteriophage market in 2022.

Question 9: Who are the leading players engaged in the development of bacteriophage therapy?

Answer: Examples of key players engaged in the phage therapy market (which have also been captured in this report) include Adaptive Phage Therapeutics, ContraFect, Eliava BioPreparations, Micreos, NPO Microgen, Phagelux, and Pherecydes Pharma.