The relationship between China’s healthcare support,
China FDA regulation, and autoinjector market development
Presentation
Xinyi Zhu
2023-02-24
Abstract
Autoinjector Introduction
- An autoinjector (or auto-injector) is a spring-imbedded medical
device that was designed to deliver a dose of a particular drug. The
injectors were initially designed to overcome the limitation of
hospitality and hesitation associated with the self-injecting of the
needle-based drug delivery device. This originated from the design of
the automatic syringes which was known since the 1910s (Patent
GB143084A). And many spring-loaded devices with needle protectors were
patented in the early 20s. By design, autoinjectors are easy to use and
are intended for self-administration by patients, or administration by
trained personnel. The normal injection site is the thigh or the
buttocks, the diabetes insulin injection pen is typically used on the
tummy. the administration sites depend on the drug-loaded and the
administration use. Most of the autoinjectors are single-use, disposable
(or by cartridge number uses), spring-loaded syringes.
Situations
- During several situations of medical emergencies and incidents such
as epinephrine for anaphylactic shock and allergy, diazepam for
seizures, amikacin for antibacterial treatment, sumatriptan for
migraine, military use such as pain relief of buprenorphine or other
acute pain relief drugs, involving mass casualties where drugs and
antidotes will be immediately administered. Self-administration by the
direct affected person or by his/her companion is required as a
life-saving measure during medical emergencies situation and the
limitation of hospital urgent care. Therefore, whoever executes the use
of autoinjector administration needed to be well-trained by doctors,
physicians, and pharmacists during getting access to these devices.
Challenge and Problem
The Missing product in China and Why?
- This research analyzed the autoinjector market development status,
medical needs (in dollar value), and why the product has been in the US
market for over 50 years. Yet, there is no available/NMPA (China FDA)
approved product in China. Due to the Zero-Covid policy, the IV route
medication needs have risen to the highest point, and to evaluate this
medical need (in dollar value) based on the research of Demand for
Global Injection Pen Market Size & Share of Asia Market, exhibit a
CAGR of 7.4%[@turner2020global]. With the
world market development and the growth potential in the China market, I
do see the gap of the missing approved autoinjector product, missing
patients/doctor/physicians/pharmacist training which can be considered
as infrastructure development, missing investment (will dive into the
initial first market research), and missing regulation.
Primary objective
- In this research, efforts have been made for exploring the different
types of FDA approved, GMP complianced and market available
autoinjectors for the management of emergency and chronic diseases.
Research Structure:
This research is structured into the correlation of healthcare
infrastructure (i.e., the healthcare insurance, the R&D level of
manufacturing the qualified product, the China FDA regulation process,
the delivery system status) and the growing acceptance of the new
product by patients, doctors, and pharmacy education
improvement.
Furthermore, this research demonstrates what type of autoinjector
can maximize the ROI Return on Investment. To help investors understand
if they should make the investment decision or if pharmaceutical
companies should make the business development decision.
Question:
Question:
How does the healthcare infrastructure affect autoinjector market
How does the regulation affect the market
Hypothesis
Hypothesis:
H0: There is a no dependence between the healthcare infrastructure
status and the autoinjector market demands.
H1: Increasing levels of regulation will result in decreasing the
combination product application
Dataset
What are the requirements?
Based on the Literature Review in the reference section. There
are a lot of studies that have focused on the US development of
autoinjector. The rising cases of chronic diseases are one of the major
factors driving the market growth of auto-injectors in the global
market. The increasing rate of anaphylaxis cases is pushing the market
growth of auto-injectors as the drug for the treatment of anaphylaxis is
usually self-administered to patients with the help of auto-injectors.
According to the global overview of WAO (World Allergic Organisation),
the percentage of anaphylaxis cases is mostly reported in adults
compared to children. Adults or older people affected by anaphylaxis
mainly seek the support of self-administered auto-injectors for the
dosage intake of drugs like epinephrine. According to PAHO (Pan American
Health Organisation), about 2% of the total American population is
facing the effects of anaphylaxis. The rising trend of home-based
medical care for lifestyle diseases and others is also fuelling the
market growth of auto-injectors compared to conventional syringes. The
benefits offered by auto-injectors in self-administration and
effectiveness in dosage quantity are pushing the market value of
auto-injectors in the global market.
Where can the data be found?
Database: China
NMPA
FDA
Medical
Insurance Information Systems in China
Analytic Scope First Step
First step is to get data from the china FDA and find out if there
are any combination product filling for NDA. And also check if there are
any autoinjector submission for licensing. Than, clean the data of the
healthcare insurance provider which the data might be difficult to get
because the insurance was provided by the government and state owned
organizations. second, the goal is to get the information of if there
are any needs for stay home medical treatment which including but not
limited to drug administration need. third, compare the data to the us
and find out what’s the investment status of the coompanies on this
product. Fourth, analysis and compare the data between china and the
us.
Method
In the normal setting, HITSA and HOMVIT models may not be preferred
practice. However, in the midst of an unimaginable global pandemic,
where major service disruptions are occurring and likely to continue,
rethinking how health care can be delivered provides the opportunity to
preserve ongoing patient care. HITSA and HOMVIT, under the right
assumptions and used in the right patients, can be done safely,
providing a valuable service option for our patients. In the setting of
the current pandemic, this is an avenue that some clinicians may choose
to discuss with selected patients, and this analysis serves as a
catalyst for possible shared decision making in the appropriate context.
Although additional modeling is required to more robustly explore the
sensitivity and generalizability of other patient groups and scenarios,
creative thinking and a willingness to adapt may prove to be a most
valuable resource that the field can mobilize to persevere under less
than ideal circumstances. Clear, concise, and evidence-informed risk
communication is essential, especially in the time of a global pandemic.
This study provides a framework through which physicians can consider
relative risks and benefits contextually of a novel approach to preserve
patient care while maintaining safety in unprecedented times.
Analysis
The analysis is going to proceed with the following questions:
- data of existing submission of the combination product, how many is
in trail of clinical, how many will go on market, what drug and
treatment is these combination product focused on
- investment compare of the us and china between the autoinjector and
the combination product development, including the market and the
R&D
- Regulatory support of the china NMPA, how to quantify this data
- healthcare infulstructure comparision. healthcare insurance, the
hospital education, patient education and the market education
comparasion between china and the us
Reference
S. Lee, E.P. Hess, C. Lohse, D.L. Souza, R.L. Campbell Epinephrine
autoinjector prescribing trends: an outpatient population-based study in
olmsted county, Minnesota. J Allergy Clin Immunol Pract, 4 (2016)
1182–6.e1
P.J. Turner, D.E. Campbell, M.S. Motosue, R.L. Campbell Global trends
in anaphylaxis epidemiology and clinical implications J Allergy Clin
Immunol Pract, 8 (2020), pp. 1169-1176
Evaluation
of adrenaline auto-injector prescription profiles: A population-based,
retrospective cohort study within the National Insurance Claims Database
of Japan
Demand
for Global Injection Pen Market Size & Share to Reach USD 58.6
Billion by 2028, Exhibit a CAGR of 7.4% | Injection Pen Industry Trends,
Growth, Value, Analysis & Forecast Report by Zion Market Research
NEW YORK, June 16, 2022 PRNewswire – As per Zion Market Research
study