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  • Published On : Nov 2022
  • Code : CMI5315
  • Industry : Biotechnology
  • Pages : 177
  • Formats :

Clostridium difficile is a causative agent for various gut disorders with symptoms such as diarrhea, nausea, colon inflammation, and others. Furthermore, frequent use of antibiotic medication is also responsible for clostridium difficile infection, as antibiotics kill normal flora (good bacteria) and allow for multiplication of C. difficile bacteria. Common symptoms of clostridium difficile infection include watery diarrhea, dehydration, fever, nausea, loss of appetite, and weight loss. Life threatening symptoms of the disease includes abdominal distension, severe abdominal pain, and profuse diarrhea. Clostridium difficile infection management includes diagnosis of the infection using various tests and medication therapies using antibiotics such as Vancomycin and Fidaxomicin.

Global clostridium difficile diagnostics market is estimated to be valued at US$ 838.05 million in 2022 and is expected to exhibit a CAGR of 7.1 % during the forecast period (2022-2030).

Figure 1.Global Clostridium Difficile Diagnostics Market Share (%), by Diagnostic Test, 2022

Clostridium Difficile Diagnostics  | Coherent Market Insights

Global Clostridium Difficile Diagnostics Market- Drivers

The increasing prevalence of clostridium difficile infection (CDI) is anticipated to boost the demand for its diagnosis, which is expected to drive the global clostridium difficile diagnostics market growth. For instance, according to the data published by Cureus, an open access medical journal, in December 2021, C. difficile infection (CDI) impacts 13 in every 1,000 patients globally and about 75% of cases are considered hospital-acquired. Higher rates of hospital admissions and antibiotic use have been linked with increased rates of healthcare-associated CDI (HA-CDI). Nosocomial CDI is linked to increased morbidity and mortality.

Moreover, increasing approval of diagnostics tests/assays by regulatory authorities is expected to drive the market growth over the forecast period. For instance, in November 2018, Singulex, Inc., an immunodiagnostics company, announced the commercial introduction of its Clarity C. difftoxin A/B assay, a rapid, high-sensitivity, high-precision, for C. difficile toxin testing. The assay matches the sensitivity and specificity of cell cytotoxicity neutralization assays, giving it the potential to reduce the false positives of polymerase chain reaction-based tests and the false negatives of current, less-sensitive toxin immunoassays.

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Clostridium Difficile Diagnostics Market Report Coverage

Report Coverage Details
Base Year: 2021 Market Size in 2022: US$ 838.05 Mn
Historical Data for: 2017 to 2020 Forecast Period: 2022 to 2030
Forecast Period 2022 to 2030 CAGR: 7.1% 2030 Value Projection: US$ 1,450.29 Mn
Geographies covered:
  • North America: U.S. and Canada
  • Latin America: Brazil, Argentina, Mexico, and Rest of Latin America
  • Europe: Germany, U.K., Spain, France, Italy, Russia, and Rest of Europe
  • Asia Pacific: China, India, Japan, Australia, South Korea, ASEAN, and Rest of Asia Pacific
  • Middle East: GCC Countries, Israel, and Rest of Middle East
  • Africa: South Africa, North Africa, and Central Africa
Segments covered:
  • By Diagnostic Test: Enzyme Immunoassays, Real-Time Polymerase Chain Reaction (RT-PCR), Nucleic Amplification Tests (NAAT), Stool Test (GDH Antigen Test, Toxin A and B Test), Blood Test, Colonoscopy or Sigmoidoscopy, Others
  • By End User: Hospitals, Diagnostic Centers, Specialty Clinics, Others
Companies covered:

F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific, Merck & Co., Inc., Pfizer, Inc., Actelion Pharmaceuticals, Inc., Abbott Laboratories, Trinity Biotech Plc., Summit Therapeutics, Sanofi S.A., Novartis AG, and AstraZeneca Plc

Growth Drivers:
  • Increasing prevalence of clostridium difficile infection (CDI)
  • Increasing approval of diagnostics tests/assays by regulatory authorities
Restraints & Challenges:
  • Low awareness about clostridium difficile infection symptoms and associated effects

Figure 2.Global Clostridium Difficile Diagnostics Market Share (%), by Region, 2022

Clostridium Difficile Diagnostics  | Coherent Market Insights

Global Clostridium Difficile Diagnostics Market– Impact of Coronavirus (COVID-19) Pandemic

Since the COVID-19 virus outbreak in December 2019, the disease has spread to over 100 countries across the globe and the World Health Organization had declared it a public health emergency on January 30, 2020.

COVID-19 has affected the economy in three main ways: by directly affecting production and demand of drugs and vaccines, by creating disruptions in distribution channels, and through its financial impact on firms and financial markets. Due to nationwide lockdowns, several countries, such as China, India, Saudi Arabia, U.A.E., Egypt, and others, faced problems with regard to the transportation of drugs and vaccines from one place to another. COVID-19 had limited impact on the global clostridium difficile diagnostics market. For instance, according to an article published by Elsevier Inc., in August 2022, during the COVID-19 pandemic, several factors, such as improved hand hygiene, social distancing, and restricted hospital referral, may have had an influence on the epidemiology of Clostridioides difficile infections (CDI).  

Global Clostridium Difficile Diagnostics Market: Key Developments

In 2021, the two German companies, Novatec Immundiagnostica GmbH and Virotech Diagnostics GmbH, collaborated to form Gold Standard Diagnostics Europe. The newly formed company is focusing on both human and veterinary markets, as it is manufacturing diagnostic kits for infectious diseases (bacterial, viral, and parasitic diseases), hormones, and autoimmunity.

Global Clostridium Difficile Diagnostics Market: Restraint

Low awareness about clostridium difficile infection symptoms and associated effects is expected to restrain the growth of the clostridium difficile diagnostics market over the forecast period.

For instance, according to an article published by Cambridge University, in 2017, titled ‘Prevalence of Clostridium difficile infection and colonization in a tertiary hospital and elderly community of North-Eastern Peninsular Malaysia’, an awareness survey population was conducted amongst University hospital staff (i.e. doctors, non-clinical medical professionals, and paramedics) and students (i.e. undergraduates and postgraduates) who were involved with in-hospital patient care, which comprised of five multiple-choice questions.

Global Clostridium Difficile Diagnostics Market- Key Players

Major players operating in the global clostridium difficile diagnostics market include F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific, Merck & Co., Inc., Pfizer, Inc., Actelion Pharmaceuticals, Inc., Abbott Laboratories, Trinity Biotech Plc., Summit Therapeutics, Sanofi S.A., Novartis AG, and AstraZeneca Plc

Clostridium difficile infection (CDI) is diagnosed with the help of conventional laboratory testing methods, however, rapid point-of-care diagnostic tests are also available, which can save time and costs significantly. Clostridium difficile is a disease caused by bacteria. The illness manifests as a variety of symptoms, such as diarrhea, nausea, and colon inflammation. Furthermore, since antibiotics kill healthy bacteria in the body and promote the growth of C. difficile bacteria, they are also responsible for clostridium difficile infection when taken frequently. Watery diarrhoea, dehydration, fever, nausea, loss of appetite, and weight loss are typical signs of clostridium difficile infection. Diagnostic assays used for detection of CDI include enzyme immunoassays (EIAs) for toxins A/B. However, these are no longer considered stand-alone primary tests due to poor sensitivity. Other tests include glutamate dehydrogenase enzyme immunoassay and molecular assay based on polymerase chain reaction. Isothermal amplification technology has also been approved by the U.S. Food & Drug Administration for diagnosis of CDI. Manufacturers such as Cepheid, BD Diagnostics, DiaSorin, Inc., Abbott Laboratories, Thermo Fisher Diagnostics, and Luminex Corporation offer advanced diagnostic tests for clostridium difficile infection. For instance, Cepheid GeneXpert test, Nanosphere Verigene SP by Luminex Corporation offer sensitivity and timely results for clostridium difficile infection.

Market Dynamics

Factors such as rising prevalence of clostridium difficile infection, availability of precise and advanced diagnostic techniques such as real time-polymerase chain reaction (RT-PCR), and presence of generic versions of standard antibiotics such as metronidazole is expected to boost growth of the clostridium difficile diagnostics and treatment market over the forecast period. Furthermore, various organizations and manufacturers are working towards increasing awareness about clostridium difficile infection and its severity. For instance, in March 2018, C Diff Foundation awarded its “Making a Difference” award to CutisPharma, Inc.—a pharmaceutical company, for contribution of the company towards increasing awareness and expanding treatment options.

Key features of the study:

  • This report provides an in-depth analysis of the global clostridium difficile diagnostics market, and provides market size (US$ Million) and compound annual growth rate (CAGR%) for the forecast period (2022–2030), considering 2021 as the base year
  • It elucidates potential revenue opportunities across different segments and explains attractive investment proposition matrices for this market
  • This study also provides key insights about market drivers, restraints, opportunities, new product launches or approval, market trends,  regional outlook, and competitive strategies adopted by key players
  • It profiles key players in the global  clostridium difficile diagnostics market  based on the following parameters – company highlights, products portfolio, key highlights, financial performance, and strategies
  • Key companies covered as a part of this study include F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific, Merck & Co., Inc., Pfizer, Inc., Actelion Pharmaceuticals, Inc., Abbott Laboratories, Trinity Biotech Plc., Summit Therapeutics, Sanofi S.A., Novartis AG, and AstraZeneca Plc
  • Insights from this report would allow marketers and the management authorities of the companies to make informed decisions regarding their future product launches, type up-gradation, market expansion, and marketing tactics
  • The global  Clostridium Difficile Diagnostics market report caters to various stakeholders in this industry including investors, suppliers, product manufacturers, distributors, new entrants, and financial analysts1
  • Stakeholders would have ease in decision-making through various strategy matrices used in analyzing the global  Clostridium Difficile Diagnostics market

Detailed Segmentation:

  • Global  Clostridium Difficile Diagnostics Market, By Diagnostic Test:
    • Enzyme Immunoassays
    • Real-Time Polymerase Chain Reaction (RT-PCR)
    • Nucleic Amplification Tests (NAAT)
    • Stool Test
      • GDH Antigen Test
      • Toxin A and B Test
    • Blood Test
    • Colonoscopy or Sigmoidoscopy
    • Others
  • Global  Clostridium Difficile Diagnostics Market, By End User:
    • Hospitals
    • Diagnostic Centers
    • Specialty Clinics
    • Others
  • Global  Clostridium Difficile Diagnostics Market, By Region:
    • North America
      • By Country
        • U.S.
        • Canada
    • Latin America
      • By Country
        • Brazil
        • Mexico
        • Argentina
        • Rest of Latin America
    • Europe
      • By Country
        • Germany
        • U.K.
        • France
        • Italy
        • Spain
        • Russia
        • Rest of Europe
    • Asia Pacific
      • By Country
        • China
        • India
        • Japan
        • Australia
        • South Korea
        • ASEAN
        • Rest of Asia Pacific
    • Middle East
      • By Country
        • GCC
        • Israel
        • Rest of Middle East
    • Africa
      • By Region/Country
        • South Africa
        • Central Africa
        • North Africa
  • Company Profiles
    • F. Hoffmann-La Roche Ltd *
      • Company Highlights
      • Products Portfolio
      • Key Highlights
      • Financial Performance
      • Strategies
    • Thermo Fisher Scientific
    • Merck & Co., Inc.
    • Pfizer, Inc.
    • Actelion Pharmaceuticals, Inc.
    • Abbott Laboratories
    • Trinity Biotech
    • Summit Therapeutics
    • Sanofi S.A.
    • Novartis AG
    • AstraZeneca Plc

“*” marked represents similar segmentation in other categories in the respective section.

Frequently Asked Questions

Global clostridium difficile diagnostics market size is estimated to be valued at US$ 838.05 million in 2022 and is expected to exhibit a CAGR of 7.1% between 2022 and 2030.
Factors such as the increasing prevalence of clostridium difficile infection (CDI) and increasing approval of diagnostics tests/assays by regulatory authorities are expected to drive the market growth.
Enzyme Immunoassays is the leading diagnostic test segment in the market.
The major factors hampering growth of the market include low awareness about clostridium difficile infection symptoms and associated effects.
Major players operating in the market include F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific, Merck & Co., Inc., Pfizer, Inc., Actelion Pharmaceuticals, Inc., Abbott Laboratories, Trinity Biotech Plc., Summit Therapeutics, Sanofi S.A., Novartis AG, and AstraZeneca Plc

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