Pediatric drug market and cross-border cooperation trends (Part 2 of International)

Industry Research . . . Trends in The Paediatric Drug Market and Cross-Border Cooperation (International) reviews the latest legislation and incentives to move the field forward in the field of paediatric medicine, providing market trend forecasting, combing of differences in the layout of chinese and foreign therapeutic areas, and analysis of potential challenges.
This paper further analyzes the market opportunities of pediatric drugs from the latitudes of key sub-areas, demand-led dosage form optimization and innovative treatment solutions, and focuses on the interpretation of the global trend of pediatric drug cooperation and the pediatric layout of the five major international pharmaceutical companies, aiming to provide navigational reference for the development of pediatric drugs, product introduction and sea-going of domestic enterprises.
, the respiratory and digestive sector market potential accelerated release, antibiotic resistance to be overcome "2016 Child Drug Safety Survey Report" shows that the higher prevalence of children is respiratory (39.4%) and digestive disorders (20.52%).
The 10-year outpatient survey of Fudan University Paediatric Hospital showed that the number of pediatric outpatients for respiratory diseases increased from 28,329 in 2009 to 101,419 in 2018, with an average annual growth rate of 15.2%, of which bronchitis was the most common, accounting for 27.6% of total visits, followed by pneumonia (18.5%), asthma (10.7%), and rhinitis (9.2%).
other acute respiratory infections are the leading cause of death among children worldwide, with pneumonia accounting for 15 per cent of all deaths among children under five years of age, according to the World Health Organization.
Chart 1: Number of Pediatric Clinics for Respiratory Diseases Photo: Shi et al. BMCPediatrics (2020) 20:115 Respiratory infections are mainly dependent on antibiotics and antiviral drugs, a study shows that 900 cases of acute upper respiratory tract infections in children with antimicrobial drug use rate of 82%, commonly used antimicrobial drugs from high to low in order of azithromycin, cephalosporine, cephalosporine, amoxicillin and cephalosporine 3.
respiratory diseases, gastrointestinal infections are also an important area for the use of antibiotics.
a study of 35,167 Chinese children published in 2020 showed that children with diarrhoea had a total antibiotic use rate of 24.3 percent.
globally, diarrhoea is the second leading cause of death among children under five years of age, with about 1.7 billion children infected each year and 525,000 children under the age of five dying from diarrhoea.
: Antibiotic Prescription Ratio Data Source: J Pediatr. 2020 May; 220:125-131.e5. BCC research shows that the global market for pediatric anti-infectants is expected to grow from $23.7 billion in 2019 to $29.2 billion in 2024, at a compound annual growth rate of 4.3%.
GlaxoSmithKline's Amosilin Augmentin, Merck's injection-based Utamin invanz, and Pfizer's Datomycin Cupicin all received pediatric labeling and accounted for a major share of the global pediatric market for antibiotics.
, however, antibiotic abuse makes drug resistance a global public health problem.
by 2050, antibiotic resistance is expected to kill as many as 10 million people, more than cancer.
, the development of anti-infective drugs to overcome drug resistance is imminent.
Chart 3: Deaths forecast for 2050 However, the low price advantage of antibiotics on the market has become an important obstacle to the entry of a new generation of antibiotics into the market, causing large pharmaceutical companies to withdraw from the development of antibiotic drugs, and some small antibiotic companies that have successfully obtained drug approval have not survived, such as Achaogen, Tetraphase, Paratek and so on.
environment, the U.S. and Europe are taking incentives to push drugmakers to develop antibiotics.
2020, Pfizer, Lilly, Bayer, Merck and others joined forces to create a $1 billion company betting on new antibiotics.
traditional antibiotics belong to broad-spectrum drugs, the development of a new generation of antibiotics was inspired by cancer drugs, major pharmaceutical companies began to try precision antibiotics, ushering in a new era.
CDI developed by Summit Therapeutics through tissue cell division, specific to kill stubborn Thyrobacteria, is already in clinical phase III.
Entasis Therapeutics is developing a combination drug, ETX2514SUL, which is also in clinical phase III.
, children's asthma 13% and traffic pollution-related, Takeda and AbbVie actively layout the gastrointestinal field of antibiotics, pediatric asthma is also the current pediatric respiratory disease drugs hot areas.
2019 Lancet study found that 13 percent of asthma cases diagnosed in children each year were associated with traffic-related pollution.
China is the country with the highest number of traffic pollution-related asthma cases, with 7.6 million cases, followed by India, the United States, Indonesia and Brazil.
another study showed that the prevalence of asthma in China in 1990 was 0.13% to 1.34%, and that the prevalence rate among urban boys was high, with the overall prevalence of asthma among children aged 0-14 in China at 2.12% in 2010, equivalent to 5.16 million children with asthma.
this difference is expected to continue by 2020, with asthma rates among urban four-year-old boys likely to be as high as 10.27 per cent.
Figure IV: Global estimates of population aged 1-18 (A), incidence of asthma (B), average nitrogen dioxide concentration (C) to relieve asthma are more mature, and several companies have extended adult drugs to pediatric use and extended them to lower age groups as much as possible, with further segmentation.
as GlaxoSmithKline's asthma drug, Nucala, targets eosinophilic ideophedric asthma.
drugs used to treat asthma also achieve different administration goals and therapeutic effects by changing different dosage forms, such as the use of aerosols, dry powders, tablets, needles, etc.
in the study of asthma drugs have also entered the clinical phase III, will be on the market one after another.
Chart V: Clinical Phase III Asthma Drug Data Sources: Open Data Collated Pediatric Gastroenterological Diseases Drug Development Focuses on Colitis, Crohn's Disease, and Esotracheitis, Takeda and AbbVie Active Layout, and several Clinical Phase III products are already under study.
the more studied targets are TNF, such as Humira and Simponi®, and blocking alpha-4 beta-7-MAdCAM-1 interactions, such as etrolizumab, SHP647, Entyvio® and so on.
Chart VI: Drug Data Sources for Gastrointestinal Diseases in Research: Public Data Collation III, Significant Changes in Liquids to New Solid Dosage Forms, Rapid Development of Oral Disintegration Tablets and Instant Membranes Effective and Safe Treatment of Childhood Diseases Requires Drug Preparations Suitable for Children.
Often paediatric drug formulations have the following key attributes: adequate and predictable bioavailable and effective use of active pharmaceutical ingredients, toxicological safety of all ingredients, including accessories, accurate drug dosages, good acceptance and drug compliance (easy swallowing, improved taste, needle fear, etc.).
medicines generally include granules, tablets, oral fluids and suspensions.
Although liquid preparations are more convenient for young children to swallow and can precisely control dosages, there are safety risks with the accessories contained in liquid preparations, such as preservatives, antioxidants, etc. (the toxicity risk of ethanol and propylene glycol in Abbott's Kaletra accessories to newborns, the FDA changed the label of the drug in 2012), stability problems with liquid forms, and high transportation and storage costs.
Chart VII: The cost comparison between oral liquid drugs and alternative oral solids has resulted in a significant shift from liquid dosage forms to new solid dosage forms in recent years.
2008, the World Health Organization recommended that infants and young children also use solid dosage forms.
2009, Thomson et al. found that 46 percent of 2-year-olds and 86 percent of 5-year-olds were able to swallow 3 millimeters of microchip.
another study showed that children between 6 and 12 months of age were able to swallow 2 mm microchip tablets and showed better acceptance than sweet liquid formulations.
for infants under 2 years of age, oral disintegration tablets are a promising development direction, combining the advantages of mini-slices and speed solvent-based 8.
a powerful example of the transition from liquid to solid preparations is the 70% proportion of solid preparations in the EU study of paediatric drugs in the field of cardiovascular medicine, significantly higher than liquid preparations (19%).
Dispersed solid drug dosage forms, such as micro tablets (defined as tablets with diameters and heights less than 3 mm), oral disintegration tablets, oral instant membranes, etc., have the advantage of rapid entry and contact with saliva, providing an opportunity for pediatric drugs to further expand the market.
microchips currently on the market include Orfiril long (valproic acid) developed by Bayer Vital GmbH and Enzym Lefax forte (pancrease).
oral instant membranes include Setofilm ® (Norgine BV) and Zuplenz ® (Galena Biopharma) for the treatment of nausea and vomiting caused by cytotoxic chemotherapy, and Risperidon®-Hexal Schmelzfilm (Hexal Pharma GmbH) for schizophrenia.
's novel measurement and administration devices can further promote the market for new oral paediatric drugs, and the portfolio is expected to easily connect with new electronic medical technologies in the near future, further improving pediatric drug therapy and achieving accurate dose measurement of oral drugs.
, marker detection and treatment combined to become the future trend of pediatric drugs more and more enterprises began to pay attention to the combination of marker detection and treatment methods to achieve precision treatment.
has approved several drugs for use in children in recent years, including: In October 2018, Sanofi and Partner Regeneratives jointly announced that the FDA had approved the anti-inflammatory drug Dupixent for the treatment of moderate to severe asthma in adolescents and adults 12 years of age and older.
the treatment of Dupixent and the reduction of marker levels of type 2 inflammation (including specific types of asthma), including FeNO, IgE, acidophilic granulocytic protein 3, etc.
August 2019, the FDA accelerated approval of Rozlytrek's second adaptive disorder for the treatment of children and adults 12 years of age and older with neurotrophic tyrosine-intrinsic kinase (NTRK) gene fusion.
September 2019, GSK's IL-5 monoclonal antibody drug Nucala was approved for the treatment of severe eosinophilic asthma in pediatric patients aged 6-11 years.
note that Nucala is the only targeted biologic approved for use in patients aged 6-11 in the U.S. market.
, the use of cooperation strategy to rapidly expand the product line, to achieve the international layout of pediatric drug research and development enterprises to use cooperation, acquisition, licensing strategy, rapid access to innovative products, expand product lines and market potential.
Tracleer, the FIRST FDA-approved drug to treat congenital pulmonary hypertension in children, is one of the assets of Acelion, which Johnson and Johnson bought for $30 billion, and generic drug giant Lupin has signed a partnership with MonoSol to develop drugs for children using its membrane platform.
, July 2020, Changchun Gaoxin announced that it intends to subscribe for the preferred shares of Grillian Corporation, a U.S. children's drug research and development company, for $28.3 million.
subscription is completed, Changchun Gaoxin will own 42.14 percent of the company, becoming the largest shareholder.
high-rise to use the company's children's drug platform, quickly open up domestic and foreign markets.
2, Eton Pharmaceuticals announced a $5 million and milestone payment in March 2020 for the U.S. marketing rights to ®, a drug owned by Diurnal.
Alkindi Sprinkle is the first drug to treat adrenal cortical insanity (AI) in children, and out-of-the-shelf clinical data in Europe can be applied to the NDA quickly through 505(b)(2) new formulations, avoiding risks and upfront investments, and will have a seven-year market franchise for orphan drugs.
while AI patients need to use Alkindi Sprinkle for long periods of time, resulting in long-term, high-value, and long-lasting returns.
Alkindi Sprinkle has reached the FDA's PDUFA deadline of September 29, 2020, with an estimated U.S. market size of more than $100 million.
3, Cerecor announced its $26.6 million acquisition of Icorion Therapeutics in September 2018.
Cerecor is a pharmaceutical company that aims to develop and commercialize treatment for orphan diseases, while Ichorion focuses on developing treatments for congenital metabolic abnormalities (IEMs).
Ichorion had a good gene-targeted therapy pipeline to complement Cerrecor's neurological product pipeline before it was acquired.
D-semi-lactose and D-glyceride replacement therapy has entered the second-order clinical stage, while L-fructose replacement therapy is in the preclinical stage.
Pfizer completed its $5.2 billion acquisition of Anacor on June 28, 2016, targeting the heavy drug Crisaborole.
non-steroidal external drug used by Crisaborole to treat mild to moderate endexual dermatitis (eczema) in adults and children was approved on 14 December 2016.
the acquisition, Pfizer predicted that Crisaborole would bring in $2 billion in annual revenue.
, Crisaborole's performance did not go as well as expected after the listing.
, large varieties form a market monopoly pattern, small enterprises turn to the liic market to seek a breakout this chapter will focus on the analysis of foreign enterprises in the field of pediatric drugs layout.
In view of the large differences in the focus of overseas and Chinese markets (refer to Industry Research , Paediatric Drug Market and Cross-Border Cooperation Trends (International), this section is intended to provide a competitive landscape reference for domestic companies entering overseas markets.
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