Cancer accounts for 18% of all deaths, which is the second leading cause of death after heart disease. Antibody-coupled drugs (ADCs) have shown excellent efficacy in refractory cancer but the quantitative analysis of drug stability a complex process. The ELISA method with strong specificity and high sensitivity can quickly and accurately detect the level of free small molecules to enhance the stability of ADC drugs. ELISA kits can improve efficiency, shorten the time in clinical trials, and indirectly promote the development of new drugs.

Cancer treatment has a large demand market. The ELISA kits for auxiliary cancer detection are also highly anticipated in the market.

1.1 Our Company

Paclisa was founded in August, 2023. Our products are ELISA kits, which can be used to detect the concentration of PTX in plasma. Its main components are antibodies and 96-well plates, and it is mainly aimed at the preclinical research field of cancer treatment drugs.

1.2 Our product

Our products are ELISA kits. Cancer accounts for 18% of all deaths, which is the second leading cause of death after heart disease. Among the mainstream therapies, antibody-coupled drugs (ADCs) have shown excellent efficacy in refractory cancer. ADC can improve the targeting of tumor drugs and reduce toxicity and side effects. There are many kinds of small molecular cytotoxic drugs, among which paclitaxel (PTX) is a classic chemotherapy drug, which can prevent tumor cells from replicating and preventing cancer cells from continuing to divide and die. At the same time, the stability of ADC and its pharmacokinetic behavior can be confirmed by quantifying the level of free small molecules in plasma. The quantitative analysis of drug stability of ADC is a complex process. The ELISA method with strong specificity and high sensitivity can quickly and accurately detect the level of free small molecules to determine the stability of ADC drugs. Our product is such a method and way. Through our market analysis, we can predict that our products will be very promising in the anticancer drug market, because ELISA kits can improve efficiency, shorten the time in clinical trials, and indirectly promote the development of new drugs. At the same time, we hope to help more people in need with this product.

2.1 The Significance of Elisa Kit for Cancer Treatment

According to the 2022 National Cancer Statistics Report published in the National Cancer, there were 4,064,000 new cases of cancer incidence in China, which was almost eight people developing cancer every minute. Of these, the number of deaths due to cancer was 2,414,000 people.

Among the mainstream therapeutic regimens, antibody-coupled drugs (ADCs) have shown excellent efficacy in refractory cancers. ADCs can improve the targeting of oncology drugs and reduce toxic side effects. Among them, paclitaxel (PTX) drugs are classical chemotherapeutic agents. It has been widely studied, among which peptide coupled drug (PDC) coupled to PTX has entered the clinical study. The stability study of ADC is an important topic to evaluate its drug ability, which is mainly affected by antibodies, connectors, loaded small molecules, and the coupling substance itself. The stability of ADCs and their pharmacokinetic behaviour can be confirmed by quantifying the levels of free small molecules in plasma. However, quantitative analysis of ADC drug stability is a complex process, and ELISA with high specificity and sensitivity can quickly and accurately detect the level of free small molecules to determine the stability of ADC drugs.

Based on this practical social problem, we can provide a novel ELISA kit specifically designed for the rapid and accurate detection of free small molecules in ADC drugs, especially for PTX drugs.

2.2 Market Size

The latest market data show that China's anti-tumour drug market size reached 207.5 billion yuan in 2020, a year-on-year increase of 12.9% over the previous year, and further grew to about 241 billion yuan in 2021, a year-on-year increase of 16.1%, with the increasing incidence of cancer in China, the demand for anti-tumour drugs is also relatively strong, and it is expected that China's anti-tumour drugs will be more than 410 billion yuan in 2025, the market prospect is broad. billion yuan, the market prospect is broad.

Currently, 15 ADC drugs have been approved and marketed globally, namely Pfizer's Mylotarg and Besponsa, Roche's Kadcyla and Polivy, AstraZeneca's Lumoxiti and Enhertu, Seagen/Takeda Pharmaceutical's Adcetris and Padcev, Seagen/Genmab's Tivdak, GlaxoSmithKline's Blenrep, Gilead's Trodelvy, Rakuten Medical's Akalux, ADCTherapeutics' Zynlonta, Rongchang Bio's vedicilizumab, and this time, ImmunoGen/Huadong Pharmaceutical's Elahere, treating diseases involving lymphoma, leukemia, breast cancer, multiple myeloma, head and neck cancer, and uroepithelial cancer.

Figure 1 Cancer incidence and mortality in China

Using the latest issue of national cancer statistics released by the National Cancer Centre in February 2022, we can give a predictive analysis of the current cancer profile.

Cancer incidence and mortality in China, 2016 https://www.sciencedirect.com/science/article/pii/S2667005422000047

national cancer statistics released by the National Cancer Centre in February 2022

https://mp.weixin.qq.com/s?__biz=MjM5MzEzMTcwMQ==&mid=2652162158&idx=2&sn=cac18c1ed8959ad2ee46e7a24f81535b&chksm=bd7bd5b48a0c5ca29453cb8907f2b1c797ee502441e08e050f6cc402cb2bf67e7f0a287d6a21&scene=27

Figure 2 Estimated numbers of new cancer cases and incidence rates

The chart shows that the incidence of the previously mentioned cancers is still high, especially breast cancer in women. This shows that there is still a big market for ADC drugs.

Figure 3 China’s anti-tumor drug market size

Influenced by the continuous rise in the prevalence of cancer in China and the continuous innovation of antineoplastic drugs, it gradually be-comes one of the drug types with relatively fast growth rate in China, and the sales of China's antineoplastic drug market also showed a growth trend in recent years, growing from 9.8 billion Dollar in 2016 to 17 billion Dollar in 2020, with an average growth rate of 43.3%; by the end of 2026, China's antineoplastic drug market sales exceeded 306 billion Dollar.

Through the above analysis, it can be known that the market size of anti-cancer drug is still remarkable. And we predict that the market size will become bigger and bigger in the future.

2.3 Market Trend

ELISA kits market is currently showing a steady growth trend. With the increasing incidence of diseases such as cancer, the demand for quantitative analysis of drug stability has also increased. ELISA assay, as a highly specific and sensitive assay, is widely used in ADC drug stability studies.

a) Escalation of anti-cancer efficacy: With the progress of medical research, ADC has achieved outstanding results in the treatment of refractory cancers and gradually become an important means of cancer treatment. Patients' demands for drug effects are getting higher and higher, and ADC, as a kind of targeted therapy, has received widespread attention and application.

b) Alternatives to chemotherapy: Compared with traditional chemotherapeutic drugs, ADC has significant advantages in terms of efficacy and toxic side effects. Its specific targeting and selective effects can reduce the damage to normal cells and improve the therapeutic effect, so ADC is regarded as an important alternative to chemotherapy.

c) Well-established industry chain: The R&D and production of ADC drugs involves a number of links, including antibody R&D, drug linkage technology, and preparation of drug carriers. Relevant drug manufacturers, research institutes and service providers have emerged one after another, promoting the improvement and development of the whole ADC industry chain.

Overall, the ELISA kit market has a broad outlook and the market demand continues to grow. With the continuous progress of technology and the expansion of application areas, it is expected that the ELISA kit market will continue to maintain a good development trend.

2.4 Unique Stakeholders

a) Research organisations and universities: they conduct ADC drug discovery and development and need reliable and specific kits to assess drug stability.

b) Pharmaceutical companies: They need to accurately assess the stability of ADC drugs and use kits in drug manufacturing and preclinical studies.

c) Healthcare organisations: they need to test the stability of ADC drugs to ensure efficacy and safety when treating patients with them.

We can divide our target market into segments such as research institutes, pharmaceutical companies and healthcare organisations. Emphasise the specificity, accuracy and sensitivity of our ELISA kits for ADC drug stability analysis. By collaborating with research institutes to provide kits for drug discovery and development; establishing partnerships with pharmaceutical companies to provide stability testing services; and collaborating with healthcare organisations to promote the significance of the kits in clinical applications.

Our product’s competitions are divided into two different kinds——direct competition and indirect competition.

3.1 Direct competitions

There are two main types of our direct competitors, those that use the same method but measure different targets, and those that use different methods but measure the same target.

The first one is Elisa Kit (same method but different targets). There are many Elisa kits on the market and the technology has matured. These kits have different targets, such as antigens, antibodies, a certain substance and so on. The difference between us and them is that we measure different targets. Here are some data of two competitions from other companies. As a result, such products do not have a relatively significant impact on the market for our products.

a)

Elabscience Human GM-CSF(Granulocyte-Macrophage Colony Stimulating Factor) ELISA Kit
Reaction type:	sandwich assay
Specification:	96T
Reaction time:	3.5h
Reactivity:	Human
Measurement assay:	Colormetric
Detection range:	7.81-500pg/mL
Sensitivity:	4.69pg/mL
Sample volume:	100μL
Sample type:	serum, plasma or other biological fluids

b)

Human IL-6 Quantikine ELISA Kit
Reaction type:	sandwich assay
Specification:	96T
Reaction time:	4.5h
Reactivity:	Human
Measurement assay:	Quantitative Elisa
Detection range:	3.12-300pg/mL
Sensitivity:	0.7pg/mL
Sample volume:	100μL
Sample type:	serum, citrate plasma, EDTA plasma, cell culture supernates

The second kind of competitions are the kits using other assays to test plasma concentration of paclitaxel. After doing some research on the internet, I chose two of the more technologically sophisticated tests currently available as competitions. One of them is gold immunochromatographic assay. This method has fast detection and low cost, so that it is suitable for widespread use among the general public. But its accuracy needs to be improved. For example, we used to use the kits using the method to test the COVID-19 virus in our bodies. However, some people who were not infected tested positive. It means that it has possibility of false positives. The other one is Immunol Fluorescence Staining Kit. It has large sensitivity because of using rare earth ions for labeling. As a result, the cost is high so it’s not suitable for widespread. As you can see, both products are very competitive. Our new product has a moderate cost and not bad sensitivity compared to them, in order to achieve better market competition, we need to show some stronger advantages.

3.2 Indirect competitions

Regarding anti-cancer, the biggest indirect competitor is tumor removal surgery. Other than that, it's a number of anti-cancer foods as well as anti-cancer supplements, all of which can be very helpful in preventing cancer on a daily basis in order to minimize the use of anti-cancer drugs and surgeries.

4.1 SWOT Analysis

Figure 4 SWOT Analysis

Although we are new joiner in relevant industry, we have a strong research and development capability and excellent professional teams to address our weaknesses. At the same time, we will take powerful marketing plans to address the threats of market competition and high prices.

4.2 Our Advantage

The product we make is an Elisa kit that detects the concentration of PTX in plasma. It is made from the culture medium, PBS, centrifuge, disposable pipettes, Gun tips, Purification columns,96-well plates, Aseptic culture flasks, TMB color development and termination solutions, Petri dishes. It is more sensitive and stable than the colloidal gold process.Its main component is antibodies, and its main role is to detect the concentration of PTX in plasma.

Our product is a to-B type product. The target customer groups for our Elisa kits are pharmaceutical companies and ADC drug research organizations. Our products are mainly used to enhance the efficiency of pharmaceutical companies and drug research institutes in preclinical studies. It can rapidly detect the level of PTX drugs in plasma and increase the efficiency of clinical trials.

Enhance experimental efficiency for drug companies and ADC drug research organizations to bring anticancer drugs to market faster.

4.3 Production procedure

The production process of our products is cell culture-transfection-protein expression and purification. It would take about half a month to make this product. Cell culture followed by transfection followed by protein expression and purification. Finally, the antibody is coated. We first cultured the cells to a concentration of 97% to 98% using CD05 medium and then began cell transfection. The cells were then transfected with PEI transfection reagent with a series of mixing of plasmids and cells. After transfection, we put the transfected cells on a shaker and shake them to induce the cells to secrete proteins, which are then extracted through a series of dialysis. Finally, the protein is eluted several times to purify it and make the antibody.These are the details of our main production processes.

4.4 Substitute

Henan University of Science and Technology is one of our competitors, and they invented the colloidal gold assay kit to detect the concentration of PTX in plasma.After dropping plasma onto the test card for a certain period of time, the test card will show color to detect the concentration of plasma antibody. Colloidal gold is a common assay, it is cheaper and easier to operate than our Elisa kit, but it has a fatal problem, that is, its accuracy is not high, and accuracy is one of the most important conditions for our target customers.The resolution of our products is much greater than their colloidal gold method.

Another competitor is the immunofluorescence test kit invented by Southern University of Science and Technology. It employs rare earth ion labeled antibody and uses laser to detect rare earth ions to test PTX concentration. This method has high accuracy, its resolution can even up to 100,000,but its manufacturing cost is extremely high, and our Elisa kit is much more reasonably priced compared to it.Our product is priced at only RMB 3,000 per box, less than one-tenth of their product, while ensuring reasonable accuracy.

4.5 Prototype & packaging

Our products consist of 96-well plates and antibodies. (Fig1.4)

Figure 5 Our products and their processes

4.6 Next-gen product

We will be upgrading our products in the future to refine the details and increase the sensitivity and stability of our products. We expect to capture more markets and increase the scale of commercialization as a way to generate more revenue in the coming years.We plan to refine the details and sensitivity to capture more market in the next year, and according to our estimated results, we will capture about ten percent of the market in the next year. And the refinement of product stability we also plan to complete in the next five years.By that time, our products will account for twenty percent of the market share.

5.1 Promotion Plan

In order to attract the attention of our target group of customers, we decided to participate in trade exhibitions as a way to promote our products. We would like to participate in a medical supplies trade exhibition, such as the Shenzhen international examination medical and IVD exhibition 2023 or the Shanghai International Medical Equipment Exhibition 2024. It covers a wide range of areas, including medical device testing, and we believe that participation in this type of exhibition will be very helpful in promoting our products. We will rent a booth to publicize and recommend our PTX kits to pharmaceutical companies and ADC drug research institutes.In addition, we intend to place fixed advertisements in locations with a high density of distribution of pharmaceutical companies and R&D centers to attract the attention of such companies.Our team also intends to place a modest number of advertisements in medical and academic journals to gain some attention from companies.

5.2 Price

The price of our products is 3000 yuan, and the cost of our raw materials is 1500 yuan. We expect that the market size will continue to expand in the next few years, and the number of products we produce will also increase, so the pricing of our products will decline in the next five years.

6.1 Start-up Fund

Our company Paclisa registration fee is between 50 million and 100 million RMB, and the paid-up capital is about 1 million in the first year and about 800,000 yuan per year thereafter. It is mainly to make PTX antibody ELISA kits, and for pharmaceutical companies, to provide more convenient and efficient cancer treatment possibilities.

Fixed Cost:	Venue fee	utility fee	instrument fee	public relations fee	(It’s about 500,000 yuan per year)
Variable Cost:	Labor cost,	experimental material cost.			(It’s about 400,000 yuan per year)

6.2 Specific implementation, expectations, requirements

a) Financial Support :

The start-up capital will be used for pre-research and development, equipment and materials, and labor cost.

b) Site use:

This part will be included in the start-up capital, which includes the experimental site and the production site, the experimental site is about 200 to 300 square meters, and the production site is about 800 to 1,000 square meters, which will be used for product research and development and office and product specific production.

6.3 Detailed Cost Breakdown

Capital
Building	Amount	Rent(RMB)/year	Year’s Amount	Total Cost
Rent	1	540,250	5	4,322,000
Labor
Section	Amount	Cost	Total
R&D	10	156,237	781,185
Production	20	4,798	23,990
Administration	5	36,789	183,945
Marketing	5	45,898	229,490
		Total	1,218,610
Production
Component	Amount	Total Cost
centrifuges	1	102,500
Ultra-micro Spectrophotometer
electronic balance
enzyme marker
gel imager
-80 degrees Celsius refrigerator
Four degree Celsius refrigerator
inverted microscope
liquid nitrogen tank
shaker
ultra-clean table
cell counter
Raw material
Component	Total Cost
PBS	Total 1,500
Centrifuge tubes
Disposable pipette
Gun Tip
Purification columns
96-well plate
Sterile culture bottles
TMB color development solution and termination solution
Petri dish
culture medium
PBS
Centrifuge tubes
culture medium

Figure 6.1 Detailed list of Cost

6.4 Sales Forecasting

	2023	2024	2025	2026	2027	Five year total
Annual Units Sold	40,000	45,000	46,500	47,650	56,430	235,580
Annual Growth rate%	30%	30%	35%	35%	40%
Price per unit	3,000	3,000	3,000	3,000	2,800	2,360
Revenue	60,000,000	67,500,000	69,750,000	71,475,000	73,359,000	202,598,800
Annual Profit	54,356,890	61,856,890	64,106,890	65,831,890	67,715,890	258,197,250

Figure 6.2 Sales Forecasting

6.5 Preparation

The start-up capital will be used to develop ELISA kits for detecting PTX antibodies, as well as the purchase of related equipment, and it is expected to complete the R&D program within three to four months.

1.2022 National Cancer Statistics Report

https://www.gloryren.com/news/shownews.php?id=520&lang=en

2. Cancer incidence and mortality in China, 2016 https://www.sciencedirect.com/science/article/pii/S2667005422000047

3.national cancer statistics released by the National Cancer Centre in February 2022

https://mp.weixin.qq.com/s?__biz=MjM5MzEzMTcwMQ==&mid=2652162158&idx=2&sn=cac18c1ed8959ad2ee46e7a24f81535b&chksm=bd7bd5b48a0c5ca29453cb8907f2b1c797ee502441e08e050f6cc402cb2bf67e7f0a287d6a21&scene=27

4.China’s anti-tumor drug market size

https://www.cn-healthcare.com/articlewm/20221004/content-1445247.html

5.Human GM-CSF (Granulocyte-Macrophage Colony Stimulating Factor) ELISA Kit

https://www.elabscience.cn/p-

6. human_gm_csf_granulocyte_macrophage_colony_stimulating_factor_elisa_kit-46144.html

7.https://www.rndsystems.com/cn/products/human-il-6-quantikine-elisa-kit_d6050b